Dear Readers,
Just looking at the news of Pfizer, Elan and other Pharma’s laying off a lot of people reminds my to squeeze in a reflection post towards the end of the year. This has truly not been an easy last quarter with financial crises kicking in big time and stock market tumbling, an unpleasant event for all of us with varying degrees of intensity.. ;(
But what does this all mean for pharma and the health economics, pricing & reimbursement fraction like ourselves? The layoffs as we know are due to some well known reasons but its also true that cash strapped governments – with all rescue efforts for banks and automotive companies, the scope is truly amazing to every liberal economist – will start, and have done so already, eyeing at drug prices once more again in order to cut the healthcare bill. The good news of the financial disaster is one finally feels like a customer again when stepping close to bank counter... incredible what is possible if they truly need your money… anyway back to the topic: Many mandatory price reductions are underway or being announced in various countries, especially Eastern Europe. This clearly means for 2009 more challenges for the health economists and pricing folks but where is this all going? Some of my friends are not convinced that health economics has a too bright future in its current application (e.g. developing models for dossiers and haggling until thresholds are met - than its mostly too late) given the shift towards personalized medicines for limited populations where static cost-effectiveness criteria, such as the 30.000 pounds applied by NICE, will never be met anyhow – so why bother developing those expensive economic models in the first place? Indeed it seems that certain commercial arrangements etc. are more successful going foreward than focusing too much on the model details. I guess health economics must be shifting much more towards aiding internal commercial decision making such as licensing/development (with the pipelines drying up of outmost importance when going on the biotech shopping tour) but moreover overall pricing strategy. That is something very much discussed for a long time but in the end still not very well done in many circumstances, at least as I have been told. Decisions about product development and initial pricing have serious consequences at launch these days and therefore early models will become more crucial in “crash testing” commercial viability with payors - of course that brings us back to the threshold problem unless more flexibility is build into the sytem (in that regard I recommend to read a recent post from HTA blog “The QALY must change” http://www.htablog.com/2008/12/qaly-must-change-says-industry.html).
The latest announcements in the UK in order to reform the PPRS (a company will still set the initial launch price for its new product and will be able to increase or decrease this price, as further evidence or new indications change the value that the medicine provides to patients, but only after NICE has conducted an appraisal to determine whether the revised price provides value) certainly point towards that direction. I am curious to hear as to how you see things evolving?
Anyhow it will remain entertaining and surely will we be very busy again in 2009. Until than Merry Christmas, Happy New Year and relaxing holidays to everyone!
Cheers
Ulf
12.16.2008
12.03.2008
British Balance Gain Versus Cost of Latest Drugs
By GARDINER HARRIS
The New York Times
RUISLIP, England — When Bruce Hardy’s kidney cancer spread to his lung, his doctor recommended an expensive new pill from Pfizer. But Mr. Hardy is British, and the British health authorities refused to buy the medicine. His wife has been distraught.
“Everybody should be allowed to have as much life as they can,” Joy Hardy said in the couple’s modest home outside London.
If the Hardys lived in the United States or just about any European country other than Britain, Mr. Hardy would most likely get the drug, although he might have to pay part of the cost. A clinical trial showed that the pill, called Sutent, delays cancer progression for six months at an estimated treatment cost of $54,000.
But at that price, Mr. Hardy’s life is not worth prolonging, according to a British government agency, the National Institute for Health and Clinical Excellence. The institute, known as NICE, has decided that Britain, except in rare cases, can afford only £15,000, or about $22,750, to save six months of a citizen’s life.
British authorities, after a storm of protest, are reconsidering their decision on the cancer drug and others.
For years, Britain was almost alone in using evidence of cost-effectiveness to decide what to pay for. But skyrocketing prices for drugs and medical devices have led a growing number of countries to ask the hardest of questions: How much is life worth? For many, NICE has the answer.
Top health officials in Austria, Brazil, Colombia and Thailand said in interviews that NICE now strongly influences their policies.
“All the middle-income countries — in Eastern Europe, Central and South America, the Middle East and all over Asia — are aware of NICE and are thinking about setting up something similar,” said Dr. Andreas Seiter, a senior health specialist at the World Bank.
Even in the United States, rising costs have led some in Congress to propose an institute that would compare the effectiveness of new medical technologies, although the proposals so far would not allow for price considerations. At the present rate of growth, medical costs will increase to 25 percent of the nation’s gross domestic product in 2025 from 16 percent, with half of the increase coming from new drugs and devices, according to the Congressional Budget Office.
To arrest this trend, the United States needs to adopt at least some of NICE’s methods, said Dr. Mark McClellan and Dr. Sean Tunis, who served earlier in the Bush administration as, respectively, administrator and chief medical officer of the Center for Medicare and Medicaid Services. Dr. Tunis said he spent a lot of time in government “learning about NICE and trying to adopt the processes and mechanisms they used, and we just couldn’t.”
That’s because the idea of using price to determine which drugs or devices Medicare or Medicaid provides has provoked fierce protests. But Dr. McClellan said the American government would soon have no choice.
Drug and device makers, which once routinely denounced the British for questioning product prices, have begun quietly slashing prices in Britain to gain NICE’s coveted approval, especially because other nations are following the institute’s lead. Companies have said that they will consult with NICE to help determine which experimental compounds enter the final stage of clinical trials, so the British agency’s officials will soon influence which drugs enter the market in the United States.
The British government created NICE a decade ago to ensure that every pound spent buys as many years of good-quality life as possible, but the agency is increasingly rejecting expensive treatments. The denials have led to debate over what is to blame: company prices or the health institute’s math.
Dr. Michael Rawlins, chairman of NICE, blames the industry, saying that some companies raise prices “to get profits up so their executives can get better bonuses.” Dr. Karol Sikora, a prominent London oncologist, said that the institute’s math was flawed and that Dr. Rawlins had a “personal vendetta” against cancer treatments.
Drug company executives who were interviewed uniformly promised to cooperate with NICE, but industry advocates were not so kind. Robert Goldberg, vice president of the Center for Medicine in the Public Interest, an advocacy group financed by drug makers, likened Dr. Rawlins and his institute to terrorists and said their decisions were morally indefensible.
Developing a Method
It all started with Viagra.
Pfizer’s introduction of the drug in 1998 panicked British health officials, who feared it would wreck the government’s health budget. So they placed restrictions on its use. Pfizer sued, claiming the government’s decision was arbitrary. To defend itself against similar claims, the government needed a standard method of rationing. The following year, NICE opened.
Asked whether he thought the institute would succeed, Frank Dobson, the Labor health minister at the time, famously said, “Probably not, but it’s worth a bloody good try.”
Britain’s National Health Service provides 95 percent of the nation’s care from an annual budget, so paying for costly treatments means less money for, say, sick children. Before NICE, hospitals and clinics often came to different decisions about which drugs to buy, creating geographic disparities in care that led to outrage. (Such disparities are common in the United States, even for federal Medicare patients.)
Now, any drug or device approved by the institute must be offered to patients. The institute has also written hundreds of treatment guidelines in hopes of improving, and making more consistent, basic medical care.
The institute has analyzed the cost-effectiveness of surgical operations, cancer screening tests and medical devices. For example, it found that drug-coated cardiac stents were worth only $450 more than bare-metal ones. In the United States, stent price differences are often far wider.
Five years ago, the British health institute recommended more emergency room CT scans of patients suffering from head trauma — forcing hospitals to buy more machines.
But the decisions that get the most attention are those involving new drugs. Any drug that provides an extra six months of good-quality life for £10,000 — about $15,150 — or less is automatically approved, while those that give six months for $22,750 or less might get approved. More expensive medicines have been approved only rarely. The spending limits represent the health institute’s best guess for how much the nation can afford.
After consulting a citizens group, the institute decided that the nation should spend the same amount saving or improving the life of a 75-year-old smoker as it would a 5-year-old.
‘Muddling Through’
The institute’s decision-making process involves a series of independent assessments, consultations with manufacturers, committee meetings, comment periods for outsiders and appeals that, taken together, Dr. Rawlins described as “procedural justice,” or “muddling through elegantly.” While the institute provides advice, decisions are made by one of three committees made up of doctors, nurses and economists from outside the government.
Transparency recently became a high priority, but gaps in the idea of openness remain. At the institute’s first public decision-making appraisal meeting in September, staff members handed a reporter a stack of documents, only to snatch them back moments later. The committee’s chairman, Dr. David Barnett, was so intent on keeping the meeting brief that he told a committee member: “This must be the last question. It must be relevant. Otherwise, you will feel my wrath.”
To analyze the value of the drug that Mr. Hardy, the kidney cancer patient, wanted, and the value of three other kidney cancer medicines, the British institute hired a university group that considered how many months the drugs delayed cancer’s progress.
Firestorm of Protest
The academics got drug prices and calculated the costs of administering them and treating their side effects. Not one of the drugs came close to being worth their expense, the group suggested. In a preliminary ruling in August, a committee from NICE agreed.
The decision caused a firestorm. Twenty-six prominent British oncologists wrote a letter to The Sunday Times saying that the institute assessed cancer treatments poorly and that patients were remortgaging their homes to buy drugs freely available in other countries.
Given that fewer than 6,000 people per year in England and Wales are diagnosed with kidney cancer, “Why put ourselves through so much heartache for very little money?” Andrew Dillon, the institute’s chief executive, asked in a September interview. “The answer is that if we don’t apply the same criteria even to small groups of patients, there’s little value to what we do at all.”
Dr. Sikora, who helped organize the August protest, predicted in a September interview that the institute would buckle under political pressure.
Flooded with anguished comments, the institute beat a hasty retreat. A preliminary consultation posted Nov. 5 said that the institute would instruct its appraisal committees to consider approving highly expensive life-saving drugs for terminal illnesses affecting fewer than 7,000 patients per year — a policy that seems tailor-made for Sutent and the three other kidney cancer drugs.
Negotiations with companies on possible discounts are continuing, and a committee is scheduled on Jan. 14 to make public this nascent compromise.
NICE has stood fast in other areas, though, rejecting Kineret for rheumatoid arthritis and Avonex for multiple sclerosis. In 2001, NICE ruled that Aricept and two other drugs used to treat Alzheimer’s disease were worth their costs only if patients’ conditions had increased from mild to moderate severity.
The analysis put a value on patients’ improved thinking skills, and possible savings from delayed entry into nursing homes. Instead of pills, the institute suggested more counseling.
Advocates for patients with Alzheimer’s disease called the decision heartless.
Dr. Rawlins said he was frustrated that his institute had been censured instead of the drug company executives who set sky-high prices. Take the case of Celgene, the maker of Revlimid, a drug for multiple myeloma, a bone-marrow cancer, that in a preliminary ruling on Oct. 28 the institute said was too costly.
Celgene’s first big seller was thalidomide, a decades-old medicine now used as a cancer treatment, which is so cheap to manufacture that a company in Brazil sells it for pennies a pill.
Celgene initially spent very little on research and priced each pill in 1998 at $6. As the drug’s popularity against cancer grew, the company raised the price 30-fold to about $180 per pill, or $66,000 per year. The price increases reflected the medicine’s value, company executives said.
In 2005, the company introduced Revlimid, a derivative of thalidomide that is supposed to be less toxic, but may be no more effective. Celgene priced it at about $260 per pill, or $94,000 per year.
Offering Discounts
Private and public insurers in the United States must pay whatever Celgene and other makers of unique cancer medicines decide to charge, so prices are soaring. Spending on cancer drugs and other such specialty medicines rose 9 percent last year and now represents 24 percent of the nation’s drug bill, according to Health Strategies Group, a New Jersey consulting company. Drug expenses in 2006 grew faster than any other part of the nation’s health bill except home care.
But because of the institute, Britain’s National Health Service has been among the first to balk at paying such prices, which has led many companies to offer the British discounts unavailable almost anywhere else.
Johnson & Johnson, for instance, agreed to charge for Velcade, another drug for multiple myeloma, only if tests showed it was effective in a particular patient. Novartis agreed to give free injections of Lucentis, a drug for age-related macular degeneration, if patients needed more than 14 shots. Dr. Rawlins said these deals were constructed by drug makers to hide from other countries the discounts offered in Britain.
“It’s a good deal for us, but I can’t see that it will work in the long run because I can’t see that others countries will be so dim as to not notice it,” Dr. Rawlins said.
A more prudent bureaucrat would never make such a remark. Dr. Rawlins said that he delighted in controversy, “although I’ll admit that it doesn’t always work out.” He wears thick glasses and fine suits whose pockets are stuffed with nicotine gum packages that rattle as he walks. He laughs easily, plays the piano and viola, and moves effortlessly between politics and medicine.
His criticisms of the pharmaceutical industry have sharpened.
“I want them to produce new drugs for conditions we really need treatments for, but I loathe their marketing practices, which corrupt doctors in a dreadful way,” said Dr. Rawlins, who until recently practiced general medicine and for years was chairman of the British version of the Food and Drug Administration. “And I’m very conscious that the prices the pharmaceutical industry charges are what they think the market will bear.”
In 10 years, the health institute’s budget has grown to $50 million from $13 million, and it is scheduled to rise to $142 million in four years. NICE has 270 employees, who include doctors, economists and pharmacists.
Worldwide Impact
Agencies like NICE are popping up across the globe. Dr. Leonardo Cubillos, Colombia’s national director of insurance, said that Colombia was using British methods to choose drugs for a national health insurance package.
Membership in an international group of drug and device assessment agencies grew to 45 last year from 8 in 1992. The British institute has created a consulting group to advise foreign governments.
Much of the reason for this proliferation of agencies is that, while prescription drugs represent just 10.3 percent of overall medical spending in the United States, that share is 17 percent on average in industrialized countries.
As spending on drugs soared in many nations — often haphazardly — overall health often showed little improvement. So international aid agencies are advising governments to adopt British assessments and deliberations to improve their public’s health while lowering costs, and officials are listening — a trend that is likely to accelerate during the present global economic slowdown.
The health institutes in both Britain and Germany may soon suggest prices for drugs, a strategy intended to deflect political pressure back on the companies and shorten negotiations that now often take months.
“We have been told that the price is the price, but the worm is turning now,” Dr. Barnett said.
Company executives acknowledge that they are increasingly acceding to British demands to slash prices.
But the most pressing question for the industry is what influence the British institute will have in the United States. The United States already spends more than twice as much per capita on health care as the average of other industrialized nations, while getting generally poorer health outcomes.
Michael O. Leavitt, the Bush administration’s secretary of health and human services, said in a September speech that, at its present growth rate, health care spending “could potentially drag our nation into a financial crisis that makes our major subprime mortgage crisis look like a warm summer rain.”
And while there is fierce disagreement about how and whether to control drug and device expenses as part of a broader reform of the health system, many say some cost controls are inevitable. At a September device industry conference in Washington, a seminar on the issue was standing-room only and half of the questioners mentioned NICE.
John R. Dwyer Jr., a Washington lawyer who represents device makers, said that many in the industry have believed that major changes to control costs in the federal Medicare program were inevitable, and “people see NICE as the only workable paradigm.”
Meanwhile, Mr. Hardy waits. In recent weeks his growing tumor has pressed on a nerve that governs his voice. He can barely speak and is increasingly out of breath. The Hardys are hoping that in January NICE will approve the use of Sutent, allowing Mr. Hardy further treatment.
The New York Times
RUISLIP, England — When Bruce Hardy’s kidney cancer spread to his lung, his doctor recommended an expensive new pill from Pfizer. But Mr. Hardy is British, and the British health authorities refused to buy the medicine. His wife has been distraught.
“Everybody should be allowed to have as much life as they can,” Joy Hardy said in the couple’s modest home outside London.
If the Hardys lived in the United States or just about any European country other than Britain, Mr. Hardy would most likely get the drug, although he might have to pay part of the cost. A clinical trial showed that the pill, called Sutent, delays cancer progression for six months at an estimated treatment cost of $54,000.
But at that price, Mr. Hardy’s life is not worth prolonging, according to a British government agency, the National Institute for Health and Clinical Excellence. The institute, known as NICE, has decided that Britain, except in rare cases, can afford only £15,000, or about $22,750, to save six months of a citizen’s life.
British authorities, after a storm of protest, are reconsidering their decision on the cancer drug and others.
For years, Britain was almost alone in using evidence of cost-effectiveness to decide what to pay for. But skyrocketing prices for drugs and medical devices have led a growing number of countries to ask the hardest of questions: How much is life worth? For many, NICE has the answer.
Top health officials in Austria, Brazil, Colombia and Thailand said in interviews that NICE now strongly influences their policies.
“All the middle-income countries — in Eastern Europe, Central and South America, the Middle East and all over Asia — are aware of NICE and are thinking about setting up something similar,” said Dr. Andreas Seiter, a senior health specialist at the World Bank.
Even in the United States, rising costs have led some in Congress to propose an institute that would compare the effectiveness of new medical technologies, although the proposals so far would not allow for price considerations. At the present rate of growth, medical costs will increase to 25 percent of the nation’s gross domestic product in 2025 from 16 percent, with half of the increase coming from new drugs and devices, according to the Congressional Budget Office.
To arrest this trend, the United States needs to adopt at least some of NICE’s methods, said Dr. Mark McClellan and Dr. Sean Tunis, who served earlier in the Bush administration as, respectively, administrator and chief medical officer of the Center for Medicare and Medicaid Services. Dr. Tunis said he spent a lot of time in government “learning about NICE and trying to adopt the processes and mechanisms they used, and we just couldn’t.”
That’s because the idea of using price to determine which drugs or devices Medicare or Medicaid provides has provoked fierce protests. But Dr. McClellan said the American government would soon have no choice.
Drug and device makers, which once routinely denounced the British for questioning product prices, have begun quietly slashing prices in Britain to gain NICE’s coveted approval, especially because other nations are following the institute’s lead. Companies have said that they will consult with NICE to help determine which experimental compounds enter the final stage of clinical trials, so the British agency’s officials will soon influence which drugs enter the market in the United States.
The British government created NICE a decade ago to ensure that every pound spent buys as many years of good-quality life as possible, but the agency is increasingly rejecting expensive treatments. The denials have led to debate over what is to blame: company prices or the health institute’s math.
Dr. Michael Rawlins, chairman of NICE, blames the industry, saying that some companies raise prices “to get profits up so their executives can get better bonuses.” Dr. Karol Sikora, a prominent London oncologist, said that the institute’s math was flawed and that Dr. Rawlins had a “personal vendetta” against cancer treatments.
Drug company executives who were interviewed uniformly promised to cooperate with NICE, but industry advocates were not so kind. Robert Goldberg, vice president of the Center for Medicine in the Public Interest, an advocacy group financed by drug makers, likened Dr. Rawlins and his institute to terrorists and said their decisions were morally indefensible.
Developing a Method
It all started with Viagra.
Pfizer’s introduction of the drug in 1998 panicked British health officials, who feared it would wreck the government’s health budget. So they placed restrictions on its use. Pfizer sued, claiming the government’s decision was arbitrary. To defend itself against similar claims, the government needed a standard method of rationing. The following year, NICE opened.
Asked whether he thought the institute would succeed, Frank Dobson, the Labor health minister at the time, famously said, “Probably not, but it’s worth a bloody good try.”
Britain’s National Health Service provides 95 percent of the nation’s care from an annual budget, so paying for costly treatments means less money for, say, sick children. Before NICE, hospitals and clinics often came to different decisions about which drugs to buy, creating geographic disparities in care that led to outrage. (Such disparities are common in the United States, even for federal Medicare patients.)
Now, any drug or device approved by the institute must be offered to patients. The institute has also written hundreds of treatment guidelines in hopes of improving, and making more consistent, basic medical care.
The institute has analyzed the cost-effectiveness of surgical operations, cancer screening tests and medical devices. For example, it found that drug-coated cardiac stents were worth only $450 more than bare-metal ones. In the United States, stent price differences are often far wider.
Five years ago, the British health institute recommended more emergency room CT scans of patients suffering from head trauma — forcing hospitals to buy more machines.
But the decisions that get the most attention are those involving new drugs. Any drug that provides an extra six months of good-quality life for £10,000 — about $15,150 — or less is automatically approved, while those that give six months for $22,750 or less might get approved. More expensive medicines have been approved only rarely. The spending limits represent the health institute’s best guess for how much the nation can afford.
After consulting a citizens group, the institute decided that the nation should spend the same amount saving or improving the life of a 75-year-old smoker as it would a 5-year-old.
‘Muddling Through’
The institute’s decision-making process involves a series of independent assessments, consultations with manufacturers, committee meetings, comment periods for outsiders and appeals that, taken together, Dr. Rawlins described as “procedural justice,” or “muddling through elegantly.” While the institute provides advice, decisions are made by one of three committees made up of doctors, nurses and economists from outside the government.
Transparency recently became a high priority, but gaps in the idea of openness remain. At the institute’s first public decision-making appraisal meeting in September, staff members handed a reporter a stack of documents, only to snatch them back moments later. The committee’s chairman, Dr. David Barnett, was so intent on keeping the meeting brief that he told a committee member: “This must be the last question. It must be relevant. Otherwise, you will feel my wrath.”
To analyze the value of the drug that Mr. Hardy, the kidney cancer patient, wanted, and the value of three other kidney cancer medicines, the British institute hired a university group that considered how many months the drugs delayed cancer’s progress.
Firestorm of Protest
The academics got drug prices and calculated the costs of administering them and treating their side effects. Not one of the drugs came close to being worth their expense, the group suggested. In a preliminary ruling in August, a committee from NICE agreed.
The decision caused a firestorm. Twenty-six prominent British oncologists wrote a letter to The Sunday Times saying that the institute assessed cancer treatments poorly and that patients were remortgaging their homes to buy drugs freely available in other countries.
Given that fewer than 6,000 people per year in England and Wales are diagnosed with kidney cancer, “Why put ourselves through so much heartache for very little money?” Andrew Dillon, the institute’s chief executive, asked in a September interview. “The answer is that if we don’t apply the same criteria even to small groups of patients, there’s little value to what we do at all.”
Dr. Sikora, who helped organize the August protest, predicted in a September interview that the institute would buckle under political pressure.
Flooded with anguished comments, the institute beat a hasty retreat. A preliminary consultation posted Nov. 5 said that the institute would instruct its appraisal committees to consider approving highly expensive life-saving drugs for terminal illnesses affecting fewer than 7,000 patients per year — a policy that seems tailor-made for Sutent and the three other kidney cancer drugs.
Negotiations with companies on possible discounts are continuing, and a committee is scheduled on Jan. 14 to make public this nascent compromise.
NICE has stood fast in other areas, though, rejecting Kineret for rheumatoid arthritis and Avonex for multiple sclerosis. In 2001, NICE ruled that Aricept and two other drugs used to treat Alzheimer’s disease were worth their costs only if patients’ conditions had increased from mild to moderate severity.
The analysis put a value on patients’ improved thinking skills, and possible savings from delayed entry into nursing homes. Instead of pills, the institute suggested more counseling.
Advocates for patients with Alzheimer’s disease called the decision heartless.
Dr. Rawlins said he was frustrated that his institute had been censured instead of the drug company executives who set sky-high prices. Take the case of Celgene, the maker of Revlimid, a drug for multiple myeloma, a bone-marrow cancer, that in a preliminary ruling on Oct. 28 the institute said was too costly.
Celgene’s first big seller was thalidomide, a decades-old medicine now used as a cancer treatment, which is so cheap to manufacture that a company in Brazil sells it for pennies a pill.
Celgene initially spent very little on research and priced each pill in 1998 at $6. As the drug’s popularity against cancer grew, the company raised the price 30-fold to about $180 per pill, or $66,000 per year. The price increases reflected the medicine’s value, company executives said.
In 2005, the company introduced Revlimid, a derivative of thalidomide that is supposed to be less toxic, but may be no more effective. Celgene priced it at about $260 per pill, or $94,000 per year.
Offering Discounts
Private and public insurers in the United States must pay whatever Celgene and other makers of unique cancer medicines decide to charge, so prices are soaring. Spending on cancer drugs and other such specialty medicines rose 9 percent last year and now represents 24 percent of the nation’s drug bill, according to Health Strategies Group, a New Jersey consulting company. Drug expenses in 2006 grew faster than any other part of the nation’s health bill except home care.
But because of the institute, Britain’s National Health Service has been among the first to balk at paying such prices, which has led many companies to offer the British discounts unavailable almost anywhere else.
Johnson & Johnson, for instance, agreed to charge for Velcade, another drug for multiple myeloma, only if tests showed it was effective in a particular patient. Novartis agreed to give free injections of Lucentis, a drug for age-related macular degeneration, if patients needed more than 14 shots. Dr. Rawlins said these deals were constructed by drug makers to hide from other countries the discounts offered in Britain.
“It’s a good deal for us, but I can’t see that it will work in the long run because I can’t see that others countries will be so dim as to not notice it,” Dr. Rawlins said.
A more prudent bureaucrat would never make such a remark. Dr. Rawlins said that he delighted in controversy, “although I’ll admit that it doesn’t always work out.” He wears thick glasses and fine suits whose pockets are stuffed with nicotine gum packages that rattle as he walks. He laughs easily, plays the piano and viola, and moves effortlessly between politics and medicine.
His criticisms of the pharmaceutical industry have sharpened.
“I want them to produce new drugs for conditions we really need treatments for, but I loathe their marketing practices, which corrupt doctors in a dreadful way,” said Dr. Rawlins, who until recently practiced general medicine and for years was chairman of the British version of the Food and Drug Administration. “And I’m very conscious that the prices the pharmaceutical industry charges are what they think the market will bear.”
In 10 years, the health institute’s budget has grown to $50 million from $13 million, and it is scheduled to rise to $142 million in four years. NICE has 270 employees, who include doctors, economists and pharmacists.
Worldwide Impact
Agencies like NICE are popping up across the globe. Dr. Leonardo Cubillos, Colombia’s national director of insurance, said that Colombia was using British methods to choose drugs for a national health insurance package.
Membership in an international group of drug and device assessment agencies grew to 45 last year from 8 in 1992. The British institute has created a consulting group to advise foreign governments.
Much of the reason for this proliferation of agencies is that, while prescription drugs represent just 10.3 percent of overall medical spending in the United States, that share is 17 percent on average in industrialized countries.
As spending on drugs soared in many nations — often haphazardly — overall health often showed little improvement. So international aid agencies are advising governments to adopt British assessments and deliberations to improve their public’s health while lowering costs, and officials are listening — a trend that is likely to accelerate during the present global economic slowdown.
The health institutes in both Britain and Germany may soon suggest prices for drugs, a strategy intended to deflect political pressure back on the companies and shorten negotiations that now often take months.
“We have been told that the price is the price, but the worm is turning now,” Dr. Barnett said.
Company executives acknowledge that they are increasingly acceding to British demands to slash prices.
But the most pressing question for the industry is what influence the British institute will have in the United States. The United States already spends more than twice as much per capita on health care as the average of other industrialized nations, while getting generally poorer health outcomes.
Michael O. Leavitt, the Bush administration’s secretary of health and human services, said in a September speech that, at its present growth rate, health care spending “could potentially drag our nation into a financial crisis that makes our major subprime mortgage crisis look like a warm summer rain.”
And while there is fierce disagreement about how and whether to control drug and device expenses as part of a broader reform of the health system, many say some cost controls are inevitable. At a September device industry conference in Washington, a seminar on the issue was standing-room only and half of the questioners mentioned NICE.
John R. Dwyer Jr., a Washington lawyer who represents device makers, said that many in the industry have believed that major changes to control costs in the federal Medicare program were inevitable, and “people see NICE as the only workable paradigm.”
Meanwhile, Mr. Hardy waits. In recent weeks his growing tumor has pressed on a nerve that governs his voice. He can barely speak and is increasingly out of breath. The Hardys are hoping that in January NICE will approve the use of Sutent, allowing Mr. Hardy further treatment.
11.28.2008
EU probe finds companies block cheap drugs
By Nikki Tait in Brussels
Published: November 28 2008
Drug companies have blocked or delayed the market entry of cheaper generic medicines to Europe, adding billions to the cost of medicines to patients, a high-profile report from Brussels has found. Anti-competitive practices range from initiating dispute and litigation to hold up competing products, and filing multiple patent applications for the same medicine, to concluding legal settlements with generic companies which constrain their ability to enter the market.
The European Comission report cited one example where “patent clustering” led to 1,300 patents being filed for a single medicine. Patent ligitation cases involving generics, meanwhile, lasted on average nearly three years, with the generic companies ultimately winning more than 60 per cent of these, it calculated.
Originator companies also concluded more than 200 settlement agreements with generic companies in the EU, according to the report. More than 10 per cent were “reverse payment settlements” which limited the entry of generic medicines and involved payments from the originator to the generics. These payments, the report says, totalled more than €200m.
“These preliminary results show that market entry of generic companies and the development of new and more affordable medicines is sometimes blocked or delayed at significant cost to healthcare systems, consumers and taxpayers,” said Neelie Kroes, EU competition commissioner, as she released the preliminary findings of a pharmaceutical sector inquiry.
Although the report does not name individual companies, Ms Kroes said there was likely to be follow-up action against companies which had breached EU laws.
“It is still early days, but the commission will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached,” she said.
But the pharmaceuticals companies accused Brussels of using ”selective quotations to mischaracterise the industry as anticompetitive”, and of overstating the level and reasons for delays in generic market access.
”The commission’s report does not substantiate in any respect their statement made at the opening of the inquiry that the industry is impeding innovation,” said Brian Ager, director-general of the European Federation of Pharmaceutical Industries and Associations.
The report comes days after the commission announced that it had launched dawn raids on a number of companies – including the UK offices of Teva, the world’s largest generic manufacturer - saying it was concerned about breaches of competition rules or abuse of a dominant position.
The report also backs changes to Europe’s patent system – including introduction of a community patent (a single unitary intellectual property right applying across the continent) and changes to its fragmented patent litigation system.
The sector inquiry was established this year, amid signs that there were fewer new medicines in the industry’s pipeline – a development which drug companies themselves say reflects changing a regulatory environment, rather than any abuse. It began in unprecedented fashion with dawn raids on the offices of large pharmaceutical groups, as the commission tried to gather evidence.
Copyright The Financial Times Limited 2008
Published: November 28 2008
Drug companies have blocked or delayed the market entry of cheaper generic medicines to Europe, adding billions to the cost of medicines to patients, a high-profile report from Brussels has found. Anti-competitive practices range from initiating dispute and litigation to hold up competing products, and filing multiple patent applications for the same medicine, to concluding legal settlements with generic companies which constrain their ability to enter the market.
The European Comission report cited one example where “patent clustering” led to 1,300 patents being filed for a single medicine. Patent ligitation cases involving generics, meanwhile, lasted on average nearly three years, with the generic companies ultimately winning more than 60 per cent of these, it calculated.
Originator companies also concluded more than 200 settlement agreements with generic companies in the EU, according to the report. More than 10 per cent were “reverse payment settlements” which limited the entry of generic medicines and involved payments from the originator to the generics. These payments, the report says, totalled more than €200m.
“These preliminary results show that market entry of generic companies and the development of new and more affordable medicines is sometimes blocked or delayed at significant cost to healthcare systems, consumers and taxpayers,” said Neelie Kroes, EU competition commissioner, as she released the preliminary findings of a pharmaceutical sector inquiry.
Although the report does not name individual companies, Ms Kroes said there was likely to be follow-up action against companies which had breached EU laws.
“It is still early days, but the commission will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached,” she said.
But the pharmaceuticals companies accused Brussels of using ”selective quotations to mischaracterise the industry as anticompetitive”, and of overstating the level and reasons for delays in generic market access.
”The commission’s report does not substantiate in any respect their statement made at the opening of the inquiry that the industry is impeding innovation,” said Brian Ager, director-general of the European Federation of Pharmaceutical Industries and Associations.
The report comes days after the commission announced that it had launched dawn raids on a number of companies – including the UK offices of Teva, the world’s largest generic manufacturer - saying it was concerned about breaches of competition rules or abuse of a dominant position.
The report also backs changes to Europe’s patent system – including introduction of a community patent (a single unitary intellectual property right applying across the continent) and changes to its fragmented patent litigation system.
The sector inquiry was established this year, amid signs that there were fewer new medicines in the industry’s pipeline – a development which drug companies themselves say reflects changing a regulatory environment, rather than any abuse. It began in unprecedented fashion with dawn raids on the offices of large pharmaceutical groups, as the commission tried to gather evidence.
Copyright The Financial Times Limited 2008
11.20.2008
Deal reached on NHS drug prices
from BBC news
Drug costs will fall under the plan
The government and the drugs industry have struck a deal which could save the NHS in the UK up to £550m per year. A flexible pricing scheme will mean new drugs can be initially introduced at a lower price, which could be increased if the medicine proves effective.
There are set to be more schemes where the NHS and drug companies share the cost of innovative treatments. An Office of Fair Trading report last year said the NHS spent up to £500m annually on overpriced medicines. The deal is expected to save the NHS around £350m in 2009/10, and around £550m every year after that.In 2006/07, £10.6 billion - 12.7% of the total NHS budget - was spent on drugs.
A more flexible approach to pricing is in everyone's interest.
Health Secretary Alan Johnson
Under the current system, a drug company sets a price for a new medicine when it is launched, and there is little opportunity to change that - so firms set the price at what they think a drug will ultimately be worth, even if there is little evidence for that at the outset. The flexible pricing scheme aims to change that, and means a medicine's cost could go up - or down.
The cost of branded drugs will also be cut.
'In everyone's interest'
Overall, the cost of drugs is predicted to fall from 3.9% from February 2009 with a further cut of 1.9% from January 2010.
The government and ABPI will also look at introducing generic substitution from 2010 - which would mean a pharmacist could give out the cheaper non-branded version of a drug even if the GP had named the branded version on the prescription.
At the moment, that is not allowed.
Health Secretary Alan Johnson said of the new arrangements: "A more flexible approach to pricing is in everyone's interest.
"It gets clinically and cost effective drugs to more patients - providing cheaper options where clinically appropriate - delivers value for money for the NHS and the tax payer, and creates a better market for the pharmaceutical industry while supporting research and innovation."
Dr Richard Barker, director general of the ABPI said it was the first time the pricing agreement between the NHS and the drugs industry had not been purely a financial deal.
"This landmark deal marks a turning point for patients, the NHS and the pharmaceutical industry.
"It is an all-encompassing package that encourages the discovery of new, more effective medicines, while at the same time allowing NHS patients to access these treatments more quickly."
Risk-sharing
Nigel Edwards, director of policy at the NHS Confederation which represents NHS managers, said throughout the debate over top-up payments for cancer drugs, they had said one part of the solution had to be a new pricing model.
"It is good news that this is now starting to happen although we would caution that there needs to be care taken that this does not land doctors and nurses with a heavier workload of form filling and bureaucracy."
But shadow health minister Mark Simmonds said the government had damaged the UK's reputation as a base for the pharmaceutical industry and failed to address the issue of drugs being available to patients in Europe that are not available here.
And Liberal Democrat health spokesman, Norman Lamb said: "This new development is welcome but not enough on its own to deliver real change."
Drug costs will fall under the plan
The government and the drugs industry have struck a deal which could save the NHS in the UK up to £550m per year. A flexible pricing scheme will mean new drugs can be initially introduced at a lower price, which could be increased if the medicine proves effective.
There are set to be more schemes where the NHS and drug companies share the cost of innovative treatments. An Office of Fair Trading report last year said the NHS spent up to £500m annually on overpriced medicines. The deal is expected to save the NHS around £350m in 2009/10, and around £550m every year after that.In 2006/07, £10.6 billion - 12.7% of the total NHS budget - was spent on drugs.
A more flexible approach to pricing is in everyone's interest.
Health Secretary Alan Johnson
Under the current system, a drug company sets a price for a new medicine when it is launched, and there is little opportunity to change that - so firms set the price at what they think a drug will ultimately be worth, even if there is little evidence for that at the outset. The flexible pricing scheme aims to change that, and means a medicine's cost could go up - or down.
The cost of branded drugs will also be cut.
'In everyone's interest'
Overall, the cost of drugs is predicted to fall from 3.9% from February 2009 with a further cut of 1.9% from January 2010.
The government and ABPI will also look at introducing generic substitution from 2010 - which would mean a pharmacist could give out the cheaper non-branded version of a drug even if the GP had named the branded version on the prescription.
At the moment, that is not allowed.
Health Secretary Alan Johnson said of the new arrangements: "A more flexible approach to pricing is in everyone's interest.
"It gets clinically and cost effective drugs to more patients - providing cheaper options where clinically appropriate - delivers value for money for the NHS and the tax payer, and creates a better market for the pharmaceutical industry while supporting research and innovation."
Dr Richard Barker, director general of the ABPI said it was the first time the pricing agreement between the NHS and the drugs industry had not been purely a financial deal.
"This landmark deal marks a turning point for patients, the NHS and the pharmaceutical industry.
"It is an all-encompassing package that encourages the discovery of new, more effective medicines, while at the same time allowing NHS patients to access these treatments more quickly."
Risk-sharing
Nigel Edwards, director of policy at the NHS Confederation which represents NHS managers, said throughout the debate over top-up payments for cancer drugs, they had said one part of the solution had to be a new pricing model.
"It is good news that this is now starting to happen although we would caution that there needs to be care taken that this does not land doctors and nurses with a heavier workload of form filling and bureaucracy."
But shadow health minister Mark Simmonds said the government had damaged the UK's reputation as a base for the pharmaceutical industry and failed to address the issue of drugs being available to patients in Europe that are not available here.
And Liberal Democrat health spokesman, Norman Lamb said: "This new development is welcome but not enough on its own to deliver real change."
11.16.2008
Racing down the pyramid
Nov 13th 2008 | NEW YORK
From The Economist print edition
Big drugmakers’ love affair with America is coming to an end
FOR many years America has been the heart and soul of the pharmaceuticals business. The adoption of price controls and government-run health systems in Europe, where the industry began, led many drugs firms to pitch their tents in the land of the free market. Keen to encourage innovation and suspicious of big government (until recently, anyway), America has allowed drugs companies to price their wares more or less as they please. As a result, over half of the leading firms’ profits come from America alone. So it might seem odd to suggest that the industry’s future now lies in the developing world. Indeed, for years drugs firms resisted the trend, fashionable in other industries, towards pouring billions into emerging markets. They justified their stance by pointing to weak patent protection and low incomes in those markets. But now the industry has changed its mind. When he took over as boss of Britain’s GlaxoSmithKline (GSK) earlier this year, Andrew Witty declared that emerging markets would be at the heart of his growth strategy. GSK has since agreed a path-breaking licensing agreement with Aspen, a South African “branded generics” firm, and has just paid some $200m for Bristol Myers-Squibb’s Egyptian operations. For its part Pfizer, the world’s biggest pharmaceuticals firm, recently announced a restructuring that makes emerging markets a priority. Jean-Michel Halfon, who is in charge of that effort, says serving customers in developing countries is now “a business, not a charity.” Why the U-turn? The tremendous growth of drugs markets in the developing world proved too tempting to ignore. IMS, an industry consultancy, forecasts that sales in the biggest emerging markets will hit $300 billion by 2017, equal to today’s sales in the top five European markets and America combined. Even before the latest downward lurch in prospects for rich economies, growth in those countries was expected to be much slower than in big emerging markets (see chart). If growth is the carrot luring the drugs giants into emerging markets, the stick is the change in regulatory outlook in America from friendly to possibly frosty. The industry is concerned that Barack Obama, once in office, might allow cheap drugs to be imported from Canada or force Medicare, the government health-care system for the old and disabled, to negotiate big discounts with drugs firms. Peter Lawyer of Boston Consulting Group estimates that the latter reform alone could reduce the industry’s American revenues by 3-10%. In fairness, any move by Mr Obama towards universal health-coverage could boost drugs sales by giving more people insurance, but the industry nevertheless worries about a squeeze on margins. Hence the industry’s zealous push into places like China and India. But if it is to succeed in emerging markets, its strategy and tactics will have to change. In the past, observes Loic Plantevin of Monitor, a management consultancy, Western drugs firms did not fare well because they often lazily “recycled” the products and marketing plans that worked in America for use in poorer countries. But now he thinks firms are doing better. Some are offering products of particular relevance to developing countries, such as treatments for hepatitis B, or combination therapies, which are especially popular in India. Western firms have also dropped their traditional resistance to tiered pricing: Pfizer’s Viagra, a drug for erectile dysfunction, and Merck’s Gardasil, a vaccine against cervical cancer, were both introduced in India at a fraction of their American price. The health-care arm of Bayer, a German conglomerate, has seen its sales in emerging markets soar as it has included more locals in drugs trials and brought new pills to market soon after launching them in America. Some firms are going further, venturing beyond the familiar big cities to more difficult, but potentially more lucrative, territories. Mr Halfon says Pfizer has expanded in the past couple of years into over 130 Chinese cities. His firm has also set up a joint venture with Grameen Bank in Bangladesh to cultivate rural markets for basic drugs by developing “microinsurance” products. Mr Halfon is convinced there is plenty of money to be made among the underserved poor. He thinks the drugs market for those earning less than $3,000 a year is already worth $30 billion annually, and he expects this to increase to $60 billion-70 billion by 2012. Novartis, a Swiss rival, recently unveiled a pilot project to expand into rural India; the firm aims to reach 50m new customers by 2010. Further evidence of emerging markets’ potential comes from the experience of Britain’s AstraZeneca in China. Unlike rivals, which focused on Shanghai and Beijing, its trailblazing marketers pushed into the country’s remote western provinces. The going was tough, but with little foreign competition the firm’s efforts paid off. It has just reported that during the third quarter, sales in mature markets grew by 2% compared with the same period a year ago, but increased by 35% in China—and by 18% in emerging markets overall. It seems that there is indeed a fortune at the bottom of the pyramid.
From The Economist print edition
Big drugmakers’ love affair with America is coming to an end
FOR many years America has been the heart and soul of the pharmaceuticals business. The adoption of price controls and government-run health systems in Europe, where the industry began, led many drugs firms to pitch their tents in the land of the free market. Keen to encourage innovation and suspicious of big government (until recently, anyway), America has allowed drugs companies to price their wares more or less as they please. As a result, over half of the leading firms’ profits come from America alone. So it might seem odd to suggest that the industry’s future now lies in the developing world. Indeed, for years drugs firms resisted the trend, fashionable in other industries, towards pouring billions into emerging markets. They justified their stance by pointing to weak patent protection and low incomes in those markets. But now the industry has changed its mind. When he took over as boss of Britain’s GlaxoSmithKline (GSK) earlier this year, Andrew Witty declared that emerging markets would be at the heart of his growth strategy. GSK has since agreed a path-breaking licensing agreement with Aspen, a South African “branded generics” firm, and has just paid some $200m for Bristol Myers-Squibb’s Egyptian operations. For its part Pfizer, the world’s biggest pharmaceuticals firm, recently announced a restructuring that makes emerging markets a priority. Jean-Michel Halfon, who is in charge of that effort, says serving customers in developing countries is now “a business, not a charity.” Why the U-turn? The tremendous growth of drugs markets in the developing world proved too tempting to ignore. IMS, an industry consultancy, forecasts that sales in the biggest emerging markets will hit $300 billion by 2017, equal to today’s sales in the top five European markets and America combined. Even before the latest downward lurch in prospects for rich economies, growth in those countries was expected to be much slower than in big emerging markets (see chart). If growth is the carrot luring the drugs giants into emerging markets, the stick is the change in regulatory outlook in America from friendly to possibly frosty. The industry is concerned that Barack Obama, once in office, might allow cheap drugs to be imported from Canada or force Medicare, the government health-care system for the old and disabled, to negotiate big discounts with drugs firms. Peter Lawyer of Boston Consulting Group estimates that the latter reform alone could reduce the industry’s American revenues by 3-10%. In fairness, any move by Mr Obama towards universal health-coverage could boost drugs sales by giving more people insurance, but the industry nevertheless worries about a squeeze on margins. Hence the industry’s zealous push into places like China and India. But if it is to succeed in emerging markets, its strategy and tactics will have to change. In the past, observes Loic Plantevin of Monitor, a management consultancy, Western drugs firms did not fare well because they often lazily “recycled” the products and marketing plans that worked in America for use in poorer countries. But now he thinks firms are doing better. Some are offering products of particular relevance to developing countries, such as treatments for hepatitis B, or combination therapies, which are especially popular in India. Western firms have also dropped their traditional resistance to tiered pricing: Pfizer’s Viagra, a drug for erectile dysfunction, and Merck’s Gardasil, a vaccine against cervical cancer, were both introduced in India at a fraction of their American price. The health-care arm of Bayer, a German conglomerate, has seen its sales in emerging markets soar as it has included more locals in drugs trials and brought new pills to market soon after launching them in America. Some firms are going further, venturing beyond the familiar big cities to more difficult, but potentially more lucrative, territories. Mr Halfon says Pfizer has expanded in the past couple of years into over 130 Chinese cities. His firm has also set up a joint venture with Grameen Bank in Bangladesh to cultivate rural markets for basic drugs by developing “microinsurance” products. Mr Halfon is convinced there is plenty of money to be made among the underserved poor. He thinks the drugs market for those earning less than $3,000 a year is already worth $30 billion annually, and he expects this to increase to $60 billion-70 billion by 2012. Novartis, a Swiss rival, recently unveiled a pilot project to expand into rural India; the firm aims to reach 50m new customers by 2010. Further evidence of emerging markets’ potential comes from the experience of Britain’s AstraZeneca in China. Unlike rivals, which focused on Shanghai and Beijing, its trailblazing marketers pushed into the country’s remote western provinces. The going was tough, but with little foreign competition the firm’s efforts paid off. It has just reported that during the third quarter, sales in mature markets grew by 2% compared with the same period a year ago, but increased by 35% in China—and by 18% in emerging markets overall. It seems that there is indeed a fortune at the bottom of the pyramid.
11.14.2008
ISPOR Athens 2008 re-cap
Hello everyone,
back from 14 days of travel I thought I put together a short note on this year's European ISPOR conference in Athens. Certainly the venue was so much better than last year, and the weather for early November couldn't have been nicer, especially over the weekend. Needless to say that Athens had a lot to offer from cultural aspects to entertainment. Hope you all checked out the view from the Galaxy bar at the Hilton - the illuminated Acropolis by night, just amazing.
I have been networking and doing lots of internal stuff therefore didn't attend too many sessions. Just a few comments therefore on points I personally found interesting.
The harmonization discussion of the first plenary session was obviously not new and the idea still reminds me of the approaches taken by centralized economies of the former Eastern socialist block where many people seemed to believe that centralization and broad government interference and small long term planning committees will know better about the preferences of individuals and society, instead of letting the mechanisms of 'trial and error' combined with some healthy competition find out what might work best in each setting. From that perspective, the outcome of this session was to be expected - harmonization of methods and frameworks perhaps possible and useful to some extend, decision making and cost-effectiveness is a local matter - well, what else and rightly so. This topic is now probably sufficiently discussed and needs no repetition.
The old QALY discussion has not come too any new insights either, however here I find is still some work to be done as I am a strong believer that the QALY doctrine of some countries needs to be revisited - especially for the patient's benefit.
The second plenary about improving equity of access was an interesting debate from my perspective, I especially liked the presentation of Tienne Stander from South Africa. A while ago we both presented on biologic treatments at a South African health conference and the wide open discrepancy of basic health care needs versus the availability of highly sophisticated treatment options are especially pronounced in his country and is in need of actions. However, as long as the current health minister down there believes that HIV can be cured with herbal remedies, there is still a long way ahead.
On the poster front I noticed an increasing amount of work in the vaccine area, which I found very interesting as epidemiological models have gotten so much better. Also Oncology - needless to say - was broadly represented.
I haven't paid too much attention to the booths etc. but the usual "suspects" ;) and some new consulting companies where widely represented. Here it remains to be seen how the market will shape the scene up. Clearly with current restructuring in industry and the build up of broader market access capabilities, consultancies who get better at broader economics, understanding of payer systems and pricing strategies / deals will be better positioned as I believe we do not need to invest so much more in statistical model overkill, at least in most areas.
By the way, everyone I was talking to was anticipating the second Latin American conference In Rio de Janeiro, Sep. 2009 to be a huge success - I already offered my Brazilian colleagues a lot of support in order to make that event happen myself ;)
I guess I'll see you all over Caipirinha next year!
As always, best wishes
Ulf
back from 14 days of travel I thought I put together a short note on this year's European ISPOR conference in Athens. Certainly the venue was so much better than last year, and the weather for early November couldn't have been nicer, especially over the weekend. Needless to say that Athens had a lot to offer from cultural aspects to entertainment. Hope you all checked out the view from the Galaxy bar at the Hilton - the illuminated Acropolis by night, just amazing.
I have been networking and doing lots of internal stuff therefore didn't attend too many sessions. Just a few comments therefore on points I personally found interesting.
The harmonization discussion of the first plenary session was obviously not new and the idea still reminds me of the approaches taken by centralized economies of the former Eastern socialist block where many people seemed to believe that centralization and broad government interference and small long term planning committees will know better about the preferences of individuals and society, instead of letting the mechanisms of 'trial and error' combined with some healthy competition find out what might work best in each setting. From that perspective, the outcome of this session was to be expected - harmonization of methods and frameworks perhaps possible and useful to some extend, decision making and cost-effectiveness is a local matter - well, what else and rightly so. This topic is now probably sufficiently discussed and needs no repetition.
The old QALY discussion has not come too any new insights either, however here I find is still some work to be done as I am a strong believer that the QALY doctrine of some countries needs to be revisited - especially for the patient's benefit.
The second plenary about improving equity of access was an interesting debate from my perspective, I especially liked the presentation of Tienne Stander from South Africa. A while ago we both presented on biologic treatments at a South African health conference and the wide open discrepancy of basic health care needs versus the availability of highly sophisticated treatment options are especially pronounced in his country and is in need of actions. However, as long as the current health minister down there believes that HIV can be cured with herbal remedies, there is still a long way ahead.
On the poster front I noticed an increasing amount of work in the vaccine area, which I found very interesting as epidemiological models have gotten so much better. Also Oncology - needless to say - was broadly represented.
I haven't paid too much attention to the booths etc. but the usual "suspects" ;) and some new consulting companies where widely represented. Here it remains to be seen how the market will shape the scene up. Clearly with current restructuring in industry and the build up of broader market access capabilities, consultancies who get better at broader economics, understanding of payer systems and pricing strategies / deals will be better positioned as I believe we do not need to invest so much more in statistical model overkill, at least in most areas.
By the way, everyone I was talking to was anticipating the second Latin American conference In Rio de Janeiro, Sep. 2009 to be a huge success - I already offered my Brazilian colleagues a lot of support in order to make that event happen myself ;)
I guess I'll see you all over Caipirinha next year!
As always, best wishes
Ulf
Czech health ministry cuts prices of reimbursed medicines
The Czech Republic's health ministry has cut ex-manufacturer prices of around 3,000
reimbursed medicines, both original and generic. National legislation regulates prices of
reimbursed medicines only, while all other pharmaceuticals are entitled to free pricing.
Price changes followed an amendment of Act 48/1997 on public health insurance after a
long dispute over the poor compliance of Czech legislation with the EC Transparency
Directive and the national Constitutional Court's requirement that pharmaceutical pricing
and reimbursement be more transparent.
The new prices are based either on the average ex-manufacturer prices in eight EU
reference states (Austria, Estonia, France, Hungary Italy, Lithuania, Portugal and Spain),
set in accordance with the average of the product's three lowest prices in the EU, or refer
to the price of a therapeutically comparable medicine.
Last summer the health ministry reduced the number of products with regulated prices
from 8,600 to 4,100, and the state institute for drug control (SUKL) re-evaluates their exmanufacturer
prices. It determines the maximum ex-factory prices of reimbursed
medicines, and wholesale and retail mark-ups are fixed using a digressive scheme. This
approach allows maximum pharmacy prices for all reimbursed medicines to be
calculated.
The institute told Scrip that it aims at re-evaluating drug prices rather than at capping
them. It is expected that prices of around three quarters of all medicines now in the reevaluation
procedure will be reduced and those of the remainder will be increased.
All price changes are now being made in transparent individual administrative
proceedings, and companies can appeal against pricing decisions and file their cases in
an administrative court, the SUKL said. All drug suppliers have equal opportunities on
the market, and their businesses are no longer affected by old prices which were set
under non-transparent and unpredictable rules, it added.
It is estimated that the price changes could save around CK1.1 billion ($81.6 million) for
patients and CZK1.6 billion for insurance companies. However, it is impossible to make
an accurate savings forecast because various evidence presented by manufacturers and
insurers during the individual administrative proceedings can have an unpredictable
effect on final drug prices, SUKL said.
The planned savings will be used to extend the list of reimbursed innovative medicines
and increase the number of fully reimbursed medicines (currently around 2,000) by
around one third. The number of partially reimbursed medicines, whose annual cost is
repaid by insurance companies to patients when they spend more than an established
maximum (currently CK5,000), might also be raised. SCRIP - World Pharmaceutical
News - www.scrippharma.com FILED 13 November 2008 COPYRIGHT Informa UK
Ltd 2008
COPYRIGHT BY T&F Informa UK Ltd
reimbursed medicines, both original and generic. National legislation regulates prices of
reimbursed medicines only, while all other pharmaceuticals are entitled to free pricing.
Price changes followed an amendment of Act 48/1997 on public health insurance after a
long dispute over the poor compliance of Czech legislation with the EC Transparency
Directive and the national Constitutional Court's requirement that pharmaceutical pricing
and reimbursement be more transparent.
The new prices are based either on the average ex-manufacturer prices in eight EU
reference states (Austria, Estonia, France, Hungary Italy, Lithuania, Portugal and Spain),
set in accordance with the average of the product's three lowest prices in the EU, or refer
to the price of a therapeutically comparable medicine.
Last summer the health ministry reduced the number of products with regulated prices
from 8,600 to 4,100, and the state institute for drug control (SUKL) re-evaluates their exmanufacturer
prices. It determines the maximum ex-factory prices of reimbursed
medicines, and wholesale and retail mark-ups are fixed using a digressive scheme. This
approach allows maximum pharmacy prices for all reimbursed medicines to be
calculated.
The institute told Scrip that it aims at re-evaluating drug prices rather than at capping
them. It is expected that prices of around three quarters of all medicines now in the reevaluation
procedure will be reduced and those of the remainder will be increased.
All price changes are now being made in transparent individual administrative
proceedings, and companies can appeal against pricing decisions and file their cases in
an administrative court, the SUKL said. All drug suppliers have equal opportunities on
the market, and their businesses are no longer affected by old prices which were set
under non-transparent and unpredictable rules, it added.
It is estimated that the price changes could save around CK1.1 billion ($81.6 million) for
patients and CZK1.6 billion for insurance companies. However, it is impossible to make
an accurate savings forecast because various evidence presented by manufacturers and
insurers during the individual administrative proceedings can have an unpredictable
effect on final drug prices, SUKL said.
The planned savings will be used to extend the list of reimbursed innovative medicines
and increase the number of fully reimbursed medicines (currently around 2,000) by
around one third. The number of partially reimbursed medicines, whose annual cost is
repaid by insurance companies to patients when they spend more than an established
maximum (currently CK5,000), might also be raised. SCRIP - World Pharmaceutical
News - www.scrippharma.com FILED 13 November 2008 COPYRIGHT Informa UK
Ltd 2008
COPYRIGHT BY T&F Informa UK Ltd
10.29.2008
UK cancer patients threaten to sue NHS for drug cost refunds
Patients 'demand refunds for expensive cancer drugs' on the NHS
Patients denied expensive cancer drugs on the NHS are threatening to sue their local healthcare trusts for refunds.
By Kate Devlin, Medical Correspondent
Last Updated: 3:28AM GMT 28 Oct 2008
from The Telegraph
Hundreds of patients have been told that the life extending medications are not "cost-effective" enough to be available on the National Health Service.
Many have chosen to pay to buy the drugs themselves, costing up to tens of thousands of pounds.
Now some are demanding refunds from their local Primary Care Trusts (PCTs).
One trust, Bromley in London, has already compensated a patient for the cost of privately bought cancer drugs, after an internal panel overturned the PCT's decision to refuse the drug.
At least three PCTs have faced calls for refunds from patients.
Later this year the Government is expected to announce that patients can pay for the drugs themselves without facing a bill for the rest of their NHS care, following widespread public anger over the issue of so-called "top ups".
Ian Reynolds, chairman of Wandsworth PCT, said patients were demanding refunds for the money they have spent. Patients can challenge a PCT's decision by applying to be treated as an "exceptional case" before a specially convened panel.
Mr Reynolds said: "We're being sent bills by people turned down by exceptional treatment panels and who have then gone private. "We're not liable to pay but the reality is that these claims will now end up in court."
Keith Farmer, assistant director of corporate affairs at Bromley PCT, said: "As a result of a case going through our normal appeals process we decided to pay back the money that this patient had spent.
"This was a one-off and to my knowledge we have not done anything similar for any other patient."
A spokesperson for the Department of Health said that the issue was a matter for PCTs. He said: "If an individual challenges a trust decision to refuse a drug on the NHS it is for the trust to judge whether or not to refund."
There was widespread outrage earlier this year when the National Institute for Health and Clinical Excellence (Nice), the Government's drugs rationing body, ruled that a kidney cancer drug, Sutent, was too expensive for the NHS.
Patients groups and charities accused the organisation of condemning sufferers to an "early death sentence" by not providing the £24,000-a-year drug.
10.28.2008
Rising Diabetes cost in the US
From The Wall Street Journal
CHICAGO -- Americans with diabetes nearly doubled their spending on drugs for the disease in just six years, with the bill last year climbing to $12.5 billion.
Newer, more costly drugs are driving the increase, said researchers, despite a lack of strong evidence for the new drugs' greater benefits and safety. And there are more people being treated for diabetes.
The new study follows updated treatment advice for Type 2 diabetes, issued last week. In those recommendations, an expert panel told doctors to use older, cheaper drugs first.
And a second study, also out Monday, adds to evidence that metformin -- an inexpensive generic used reliably for decades -- may prevent deaths from heart disease while the newer, more expensive Avandia didn't show that benefit.
"We need to pay attention to this," said David Nathan, diabetes chief at Boston's Massachusetts General Hospital, who wrote an editorial but wasn't involved in the new studies. "If you can achieve the same glucose control at lower cost and lower side effects, that's what you want to do."
The studies, appearing in Monday's Archives of Internal Medicine, were both funded by federal grants.
In one, researchers from University of Chicago and Stanford University looked at which pills and insulin doctors prescribed and total medication costs. Diabetes drug spending rose from $6.7 billion in 2001 to $12.5 billion in 2007, a period when costs dropped for metformin.
More patients got multiple prescriptions as new classes of drugs came on the market. And more patients with diabetes were seeing doctors, increasing from 14 million patients in 2000 to 19 million in 2007.
"There's been a remarkable change in diabetes treatments and remarkable increases in the cost of treatments over the past several years," said study co-author Caleb Alexander, assistant professor of medicine at the University of Chicago. "We were surprised by the magnitude of the changes and the rapid increase in the cost of diabetes care."
Nearly 24 million Americans, 8% of the population, have Type 2 diabetes, which can lead to kidney failure, blindness and heart disease.
Current guidelines say doctors should prescribe metformin (about $30 a month) to lower blood sugar in newly diagnosed patients and urge them to eat healthy food and get more exercise. Other drugs can be added later, on top of metformin, to help patients who don't meet blood sugar goals. The updated guidelines don't include Avandia, which costs about $225 a month.
Susan Spratt, an endocrinologist at Duke University Medical Center, said she prescribes whatever it takes to lower her patients' future risk of blindness and amputations. That can mean coupling more costly drugs with metformin to hit blood sugar goals.
"I think cost-analysis is important from a public health standpoint," Dr. Spratt said. "But when you're sitting across from a patient, you want to use whatever is going to help them get control of their diabetes."
In the other study, Johns Hopkins University researchers analyzed findings from 40 published trials of diabetes pills that measured heart risks. Compared to other diabetes drugs or placebo, metformin was linked to a lower risk of death from heart problems.
The findings hint that Avandia has a possible increased risk for heart disease death, but that increase wasn't statistically significant, meaning it could have been the result of chance.
Few of the studies lasted longer than six months. The researchers cited a "critical need" for long-term studies of diabetes pills and heart risks.
Last year, the Food and Drug Administration issued a safety alert on Avandia, made by British-based GlaxoSmithKline PLC, after another pooled analysis of studies found a risk of heart attacks. And in July of this year, FDA advisers said the agency should require drug makers to show new diabetes drugs don't increase heart risks.
GlaxoSmithKline spokeswoman Mary Anne Rhyne said FDA-approved labeling for Avandia says available data on the risk of heart attack are inconclusive. The medication, approved in 1999, has been used by well more than 7 million patients, she said.
Copyright © 2008 Associated Press
CHICAGO -- Americans with diabetes nearly doubled their spending on drugs for the disease in just six years, with the bill last year climbing to $12.5 billion.
Newer, more costly drugs are driving the increase, said researchers, despite a lack of strong evidence for the new drugs' greater benefits and safety. And there are more people being treated for diabetes.
The new study follows updated treatment advice for Type 2 diabetes, issued last week. In those recommendations, an expert panel told doctors to use older, cheaper drugs first.
And a second study, also out Monday, adds to evidence that metformin -- an inexpensive generic used reliably for decades -- may prevent deaths from heart disease while the newer, more expensive Avandia didn't show that benefit.
"We need to pay attention to this," said David Nathan, diabetes chief at Boston's Massachusetts General Hospital, who wrote an editorial but wasn't involved in the new studies. "If you can achieve the same glucose control at lower cost and lower side effects, that's what you want to do."
The studies, appearing in Monday's Archives of Internal Medicine, were both funded by federal grants.
In one, researchers from University of Chicago and Stanford University looked at which pills and insulin doctors prescribed and total medication costs. Diabetes drug spending rose from $6.7 billion in 2001 to $12.5 billion in 2007, a period when costs dropped for metformin.
More patients got multiple prescriptions as new classes of drugs came on the market. And more patients with diabetes were seeing doctors, increasing from 14 million patients in 2000 to 19 million in 2007.
"There's been a remarkable change in diabetes treatments and remarkable increases in the cost of treatments over the past several years," said study co-author Caleb Alexander, assistant professor of medicine at the University of Chicago. "We were surprised by the magnitude of the changes and the rapid increase in the cost of diabetes care."
Nearly 24 million Americans, 8% of the population, have Type 2 diabetes, which can lead to kidney failure, blindness and heart disease.
Current guidelines say doctors should prescribe metformin (about $30 a month) to lower blood sugar in newly diagnosed patients and urge them to eat healthy food and get more exercise. Other drugs can be added later, on top of metformin, to help patients who don't meet blood sugar goals. The updated guidelines don't include Avandia, which costs about $225 a month.
Susan Spratt, an endocrinologist at Duke University Medical Center, said she prescribes whatever it takes to lower her patients' future risk of blindness and amputations. That can mean coupling more costly drugs with metformin to hit blood sugar goals.
"I think cost-analysis is important from a public health standpoint," Dr. Spratt said. "But when you're sitting across from a patient, you want to use whatever is going to help them get control of their diabetes."
In the other study, Johns Hopkins University researchers analyzed findings from 40 published trials of diabetes pills that measured heart risks. Compared to other diabetes drugs or placebo, metformin was linked to a lower risk of death from heart problems.
The findings hint that Avandia has a possible increased risk for heart disease death, but that increase wasn't statistically significant, meaning it could have been the result of chance.
Few of the studies lasted longer than six months. The researchers cited a "critical need" for long-term studies of diabetes pills and heart risks.
Last year, the Food and Drug Administration issued a safety alert on Avandia, made by British-based GlaxoSmithKline PLC, after another pooled analysis of studies found a risk of heart attacks. And in July of this year, FDA advisers said the agency should require drug makers to show new diabetes drugs don't increase heart risks.
GlaxoSmithKline spokeswoman Mary Anne Rhyne said FDA-approved labeling for Avandia says available data on the risk of heart attack are inconclusive. The medication, approved in 1999, has been used by well more than 7 million patients, she said.
Copyright © 2008 Associated Press
10.22.2008
New Health Economics & Market Access Opportunities
Dear All,
all new positions just came in. Interested folks please contact Peter Fortune at Eames.Jones.Judge.Hawkings, 29 High Street, Welwyn, Herts AL6 9EE. Telephone: +44 [0]1438 840984 or email your to: Peter.Fortune@EJJH.CO.UK
Cheers
Ulf
ECONOMIC MARKET ACCESS – YOUR CHALLENGE!
Health Economics and Market Access Manager
Field based
outstanding package + car
Our client is the UK and Ireland affiliate of a US based, $multibillion global healthcare company with a reputation for developing advanced technologies and innovation in the service of patients and physicians. With a very strong product portfolio and a rich programme of development, their growth is set to continue and their high-value products to provide fascinating professional challenges.
Joining a highly-skilled team, you’ll be the product champion and responsible for managing the HTA processes for your particular cluster. Drafting submissions and consulting with key healthcare decision makers and critical influencers, you’ll be developing robust budget impact models for the sales teams to use, and mapping and targeting areas where the post code lottery is at its worst. You will also represent the UK affiliate at European and global level.
With an MSc in HEOR or similar and experience of modelling and comprehensively managing three full NICE submissions, your proven track record of working with all levels of the NHS is complemented by a formidable results orientation and interpersonal and team working talents.
FOLLOW INNOVATION WHERE IT LEADS
Health Economics & Market Access Manager c.£55,000 + car/allowance & benefits
West London
Established for over a decade, this biopharmaceutical company has pursued discovering, developing and commercialising original, small-molecule drugs to serve high unmet medical needs by following innovation where it leads. And, it’s led to some great things. By combining the entrepreneurial spirit and flexibility of a biotech with the disciplines of a pharma company, they have demonstrated their ability to discover and swiftly move products to commercialisation. Their rapidly-expanding pipeline - that includes five compounds in the final stages of clinical development - contains a first-in-class candidate. With strong values of innovation, trust and teamwork, they operate in an enthusiastic and stimulating environment that underpins their drive for results. To continue their progress they now need to make this new appointment – a HEALTH ECONOMICS & MARKET ACCESS MANAGER.
You will be responsible for the HTA process and the development of economic proposals at local and national levels, for both in market and pipeline products. As the UK and Eire affiliate’s expert on HEOR issues, you will provide strategic advice to management, and liaise with the European based global Economics, Pricing and Reimbursement team. With the small field based team of Market Access Managers, you will develop market access strategies ensuring alignment with the broader product plans. A key player in the delivery of market access plans, your contribution will help to ensure access to funds for company products.
With an MSc in HEOR or similar and experience in HEOR, Pricing and Reimbursement or Market Access, your detailed knowledge of the UK/Ireland healthcare environment is, ideally, in the specialised services arena and your ability to resolve complex and ill-defined problems is proven. You are results focussed, analytical, highly IT literate, astute and good with people. Naturally your organisation and communication skills (both written and oral) are impressive.
And now for something completely different!
Global Market Access Manager
West London
Very competitive and attractive package
Are you:
• ready to establish a core capability ?
• constrained by only working in health economics, market access or pricing and
reimbursement?
• fed up of operating in a risk averse, slow decision making environment?
• able to manage a thriving portfolio, a strong pipeline and global challenges?
Our client is a specialist pharmaceutical company that offers you solutions to all of the above. This growing company, with sales of over €220m, has reached the point where it needs to establish a market access capability to ensure its products [pipeline, in market and off patent] are properly supported from an HEOR and pricing and reimbursement point of view, and are accessible to prescribers.
In this brand new role, you’ll have the freedom to establish the capability in the way you know it should be. With an appropriate higher degree, you must have a successful track record of at least one of the P&R, market access or HEOR disciplines - and have an interest and an appreciation of the others – ideally along with some international experience. Your influencing and interpersonal skills enable you to build effective relationships with colleagues right across the business, from R&D to the commercial function and at all levels.
all new positions just came in. Interested folks please contact Peter Fortune at Eames.Jones.Judge.Hawkings, 29 High Street, Welwyn, Herts AL6 9EE. Telephone: +44 [0]1438 840984 or email your to: Peter.Fortune@EJJH.CO.UK
Cheers
Ulf
ECONOMIC MARKET ACCESS – YOUR CHALLENGE!
Health Economics and Market Access Manager
Field based
outstanding package + car
Our client is the UK and Ireland affiliate of a US based, $multibillion global healthcare company with a reputation for developing advanced technologies and innovation in the service of patients and physicians. With a very strong product portfolio and a rich programme of development, their growth is set to continue and their high-value products to provide fascinating professional challenges.
Joining a highly-skilled team, you’ll be the product champion and responsible for managing the HTA processes for your particular cluster. Drafting submissions and consulting with key healthcare decision makers and critical influencers, you’ll be developing robust budget impact models for the sales teams to use, and mapping and targeting areas where the post code lottery is at its worst. You will also represent the UK affiliate at European and global level.
With an MSc in HEOR or similar and experience of modelling and comprehensively managing three full NICE submissions, your proven track record of working with all levels of the NHS is complemented by a formidable results orientation and interpersonal and team working talents.
FOLLOW INNOVATION WHERE IT LEADS
Health Economics & Market Access Manager c.£55,000 + car/allowance & benefits
West London
Established for over a decade, this biopharmaceutical company has pursued discovering, developing and commercialising original, small-molecule drugs to serve high unmet medical needs by following innovation where it leads. And, it’s led to some great things. By combining the entrepreneurial spirit and flexibility of a biotech with the disciplines of a pharma company, they have demonstrated their ability to discover and swiftly move products to commercialisation. Their rapidly-expanding pipeline - that includes five compounds in the final stages of clinical development - contains a first-in-class candidate. With strong values of innovation, trust and teamwork, they operate in an enthusiastic and stimulating environment that underpins their drive for results. To continue their progress they now need to make this new appointment – a HEALTH ECONOMICS & MARKET ACCESS MANAGER.
You will be responsible for the HTA process and the development of economic proposals at local and national levels, for both in market and pipeline products. As the UK and Eire affiliate’s expert on HEOR issues, you will provide strategic advice to management, and liaise with the European based global Economics, Pricing and Reimbursement team. With the small field based team of Market Access Managers, you will develop market access strategies ensuring alignment with the broader product plans. A key player in the delivery of market access plans, your contribution will help to ensure access to funds for company products.
With an MSc in HEOR or similar and experience in HEOR, Pricing and Reimbursement or Market Access, your detailed knowledge of the UK/Ireland healthcare environment is, ideally, in the specialised services arena and your ability to resolve complex and ill-defined problems is proven. You are results focussed, analytical, highly IT literate, astute and good with people. Naturally your organisation and communication skills (both written and oral) are impressive.
And now for something completely different!
Global Market Access Manager
West London
Very competitive and attractive package
Are you:
• ready to establish a core capability ?
• constrained by only working in health economics, market access or pricing and
reimbursement?
• fed up of operating in a risk averse, slow decision making environment?
• able to manage a thriving portfolio, a strong pipeline and global challenges?
Our client is a specialist pharmaceutical company that offers you solutions to all of the above. This growing company, with sales of over €220m, has reached the point where it needs to establish a market access capability to ensure its products [pipeline, in market and off patent] are properly supported from an HEOR and pricing and reimbursement point of view, and are accessible to prescribers.
In this brand new role, you’ll have the freedom to establish the capability in the way you know it should be. With an appropriate higher degree, you must have a successful track record of at least one of the P&R, market access or HEOR disciplines - and have an interest and an appreciation of the others – ideally along with some international experience. Your influencing and interpersonal skills enable you to build effective relationships with colleagues right across the business, from R&D to the commercial function and at all levels.
Cost-benefit assessment in Germany: IQWiG publishes revised version of the methods draft
An editorially revised version of the methods draft on the assessment of the cost-benefit relations of drugs was published by the German Institute for Quality and Efficiency in Health Care (IQWiG) on 14 October 2008. Version 1.1 primarily clarifies misunderstandings and reacts to questions raised by the draft presented in January 2008 (Version 1.0). All comments on Version 1.0 submitted to the Institute, the scientific reply, as well as three technical appendices highlighting key aspects of the practical implementation of the efficiency frontier methodology are now completely available online. With the publication, IQWiG intends to constructively support the ongoing lively discussion among experts and in the media about the appropriateness of the costs of medical services.
Basic statements remain unchanged
A total of 46 comments on the methods draft on efficiency frontiers (Version 1.0), published on 24 January 2008, were received on time by the end of March. Parties submitting comments included associations of the pharmaceutical industry as well as companies, medical organizations, scientific societies, hospitals, patients, and other private persons. About 20% of the comments originated from abroad and were written in English. In addition, the German Federal Ministry of Health, as well as the IQWiG Board of Trustees, provided comments outside the framework of the formal commenting procedure.
Compared with Version 1.0, the basic statements of Version 1.1 remain unchanged. However, the new version now presented formulates individual statements more clearly and is therefore more precise. The Institute thereby also reacts to queries and misunderstandings addressed in the comments. In a separate document ("Scientific Reply”), IQWiG and its international expert panel respond to the arguments and objections frequently presented in the comments.
Model calculations are necessary for the cost side
Three technical appendices presented simultaneously aim to contribute to an understanding of the proposed methodology. They specify three important aspects for the implementation of the methodology: modelling, cost estimation, and uncertainty.
When considering costs and benefits, the time period investigated should reflect the course of disease appropriately. However, clinical trials are often considerably shorter, which is why model calculations may be necessary for the cost side. However, as with every prediction, model calculations are extremely uncertain, as specific assumptions have to be made. The technical appendix "Modelling” therefore describes, among other things, principles for the development of models and their implementation in health care. The technical appendix "Cost estimation” addresses the issue of how costs are made up and how they can be determined from different perspectives, for example, that of statutory health insurance (SHI) or society as a whole. In the technical appendix "Uncertainty”, it is primarily discussed how information on the degree of bias can be gained in the estimation of efficiency frontiers.
With the publication of Version 1.1 together with the comments, the scientific reply, and the technical appendices, the Institute aims to ensure the greatest possible transparency in the methods development and involve a large circle of experts, in particular health economists. As all documents are available both in the English and German languages, international experts can also participate in the scientific discussion, or at least follow it.
Final version of the methods should be available in the summer of 2009
In the first stage of the methods development, the Institute commissioned a group of well-known health economists from eight countries. In this way, the Institute aimed to ensure that the methodology complied with internationally accepted standards, which are also required by law. From now on, IQWiG's Scientific Advisory Board will be even more closely involved in the consultations. For this purpose, the Scientific Advisory Board has formed its own working group. In order to ensure continuity and the involvement of international expertise on the one hand, and to add weight to health economics of German character on the other, the Scientific Advisory Board also appointed external researchers. These researchers are members of the Working Group: Methods of Health Economic Evaluation (AG MEG) of the German Society for Social Medicine and Prevention (DGSMP); the Panel for Health Economics in the Society for Social Policy; and IQWiG's international health economic expert panel.
This working group will advise IQWiG's Scientific Advisory Board, and its advice will be incorporated in the methods draft 2.0, which will also be open to comments. In parallel, IQWiG will test the practicability of the method for the German setting in several dry runs. If this process runs in an optimal manner, the future final methods 1.0 could be available in the second quarter of 2009 and be the binding basis for the assessment of the relations of the costs and benefits of drugs. However, only the general procedure will be described. For each assessment, the specific project-related methodology will be discussed initially with all interested parties on the basis of a preliminary report plan, and will then be specified in a binding manner in the final report plan.
Basic statements remain unchanged
A total of 46 comments on the methods draft on efficiency frontiers (Version 1.0), published on 24 January 2008, were received on time by the end of March. Parties submitting comments included associations of the pharmaceutical industry as well as companies, medical organizations, scientific societies, hospitals, patients, and other private persons. About 20% of the comments originated from abroad and were written in English. In addition, the German Federal Ministry of Health, as well as the IQWiG Board of Trustees, provided comments outside the framework of the formal commenting procedure.
Compared with Version 1.0, the basic statements of Version 1.1 remain unchanged. However, the new version now presented formulates individual statements more clearly and is therefore more precise. The Institute thereby also reacts to queries and misunderstandings addressed in the comments. In a separate document ("Scientific Reply”), IQWiG and its international expert panel respond to the arguments and objections frequently presented in the comments.
Model calculations are necessary for the cost side
Three technical appendices presented simultaneously aim to contribute to an understanding of the proposed methodology. They specify three important aspects for the implementation of the methodology: modelling, cost estimation, and uncertainty.
When considering costs and benefits, the time period investigated should reflect the course of disease appropriately. However, clinical trials are often considerably shorter, which is why model calculations may be necessary for the cost side. However, as with every prediction, model calculations are extremely uncertain, as specific assumptions have to be made. The technical appendix "Modelling” therefore describes, among other things, principles for the development of models and their implementation in health care. The technical appendix "Cost estimation” addresses the issue of how costs are made up and how they can be determined from different perspectives, for example, that of statutory health insurance (SHI) or society as a whole. In the technical appendix "Uncertainty”, it is primarily discussed how information on the degree of bias can be gained in the estimation of efficiency frontiers.
With the publication of Version 1.1 together with the comments, the scientific reply, and the technical appendices, the Institute aims to ensure the greatest possible transparency in the methods development and involve a large circle of experts, in particular health economists. As all documents are available both in the English and German languages, international experts can also participate in the scientific discussion, or at least follow it.
Final version of the methods should be available in the summer of 2009
In the first stage of the methods development, the Institute commissioned a group of well-known health economists from eight countries. In this way, the Institute aimed to ensure that the methodology complied with internationally accepted standards, which are also required by law. From now on, IQWiG's Scientific Advisory Board will be even more closely involved in the consultations. For this purpose, the Scientific Advisory Board has formed its own working group. In order to ensure continuity and the involvement of international expertise on the one hand, and to add weight to health economics of German character on the other, the Scientific Advisory Board also appointed external researchers. These researchers are members of the Working Group: Methods of Health Economic Evaluation (AG MEG) of the German Society for Social Medicine and Prevention (DGSMP); the Panel for Health Economics in the Society for Social Policy; and IQWiG's international health economic expert panel.
This working group will advise IQWiG's Scientific Advisory Board, and its advice will be incorporated in the methods draft 2.0, which will also be open to comments. In parallel, IQWiG will test the practicability of the method for the German setting in several dry runs. If this process runs in an optimal manner, the future final methods 1.0 could be available in the second quarter of 2009 and be the binding basis for the assessment of the relations of the costs and benefits of drugs. However, only the general procedure will be described. For each assessment, the specific project-related methodology will be discussed initially with all interested parties on the basis of a preliminary report plan, and will then be specified in a binding manner in the final report plan.
10.15.2008
The Pharmaevolution
It is a challenging time for the pharmaceutical industry, with recent announcements of more job cuts at GSK R&D and the latest news of Pfizer abandoning research on key areas of the past, such as cardiovascular, bone health and obesity. In addition, strategic actions are now being taken in order to overcome the in sustainability of the old business model coupled with an increasing pressure on the cost of drugs through government health technology assessment agencies and payers.
Concentration of high need areas and adding new skills to the organizations – “market access” – are fashionable at the moment. In the end, whatever you want to call it, the matter comes down to evidence development and creation of convincing data to payers, which will have a remarkable impact on how successful business is done in future years and who will gain a competitive advantage. As a result, skills and experiences that are related to understanding this new environment are now in high demand. In particular, those individuals who comprehend not only payer business models but also how the decisions of these organizations are affected by outside influencers will be invaluable in determining the future pricing and positioning of drugs.
The gradual shift by payers to an “outcomes-based” analysis or “risk-sharing” agreements as recently proposed by the UK NHS is further complicating the cost/benefit analysis of R&D investments. This shift will increase pharmaceutical company risk because it will make it much more difficult to exactly forecast the expected revenues generated from the drug portfolio under development. Payers do not yet have sufficient data to conduct such analyses on a wide-scale basis, nor is it easy for the industry to provide such data at the time of launch, at least not comprehensively in most cases. Maybe in the near future, as physicians and hospitals shift to electronic medical records, it will be easier to collect the required data.
Just as the R&D areas of pharmaceutical and biotech companies must undergo significant changes, so too will marketing and commercialization. A shift from the “physician-prescriber” to a “stakeholder-payer” model will make the ability to influence payers of paramount importance to drug manufacturers. Consequently, these companies will need fewer people whose primary added value is being able to access physicians. Instead, they will seek individuals who are very sophisticated in working with payers to position and price their products. The industry is in for a big change and that may also open up great opportunities for those companies that manage to concentrate their development on unmet needs areas coupled with a different approach to product commercialization and pricing. It will therefore be very interesting to see how the industry shapes up over time and some significant adaptation is still to be done, however the very good news is that a similar meltdown like in the banking sector is more than unlikely.
10.12.2008
Health Economics Opportunities in North America
All,
please see below a few new jobs on offer in the US and Canada. Please contact Darren Kruszynski.
Global Project Leader Oncology HE/Outcomes/Reimbursement - 130+ New Jersey
Deputy Director, US Health Economics, Outcomes & Reimbursement (HEOR), Women's Healthcare - 150+ New Jersey
Associate Director, Medical Outcomes Research - 150+ Connecticut
Health Economics Manager - 110+ Toronto Canada
Director Pricing/Reimbursement - 130+ Montreal Canada
Darren Kruszynski
Grapevine Executive Recruiters
269 Richmond Street West
Suite 100
Toronto, Ontario
M5V 1X1
416-581-1445 ext 225
www.grapevinerecruiters.com
Darren@grapevinerecruiters.com
http://www.linkedin.com/in/darrenkruszynski
please see below a few new jobs on offer in the US and Canada. Please contact Darren Kruszynski.
Global Project Leader Oncology HE/Outcomes/Reimbursement - 130+ New Jersey
Deputy Director, US Health Economics, Outcomes & Reimbursement (HEOR), Women's Healthcare - 150+ New Jersey
Associate Director, Medical Outcomes Research - 150+ Connecticut
Health Economics Manager - 110+ Toronto Canada
Director Pricing/Reimbursement - 130+ Montreal Canada
Darren Kruszynski
Grapevine Executive Recruiters
269 Richmond Street West
Suite 100
Toronto, Ontario
M5V 1X1
416-581-1445 ext 225
www.grapevinerecruiters.com
Darren@grapevinerecruiters.com
http://www.linkedin.com/in/darrenkruszynski
10.08.2008
UK is negotiating with drugmakers to lower NHS prices
October 07, 2008
by Anna Bratulic
The UK government is negotiating with pharmaceutical companies to offer lower prices for new drugs on the understanding that the NHS will pay more for the treatments if "later evidence proves greater effectiveness." Government officials see the move as "an answer to whether patients should be allowed to "top up" NHS" treatments that are deemed clinically effective but not cost-effective by the National Institute for Clinical Excellence.
Negotiations between government officials and ABPI are underway to arrive at a "risk-sharing" agreement as part of a new pharmaceutical price regulation system that will be launched in 2009. Under the scheme, companies would reduce the price of a drug sufficiently to allow the product to be approved by NICE, and the drug's price would subsequently raise as proof of clinical effectiveness grows.
by Anna Bratulic
The UK government is negotiating with pharmaceutical companies to offer lower prices for new drugs on the understanding that the NHS will pay more for the treatments if "later evidence proves greater effectiveness." Government officials see the move as "an answer to whether patients should be allowed to "top up" NHS" treatments that are deemed clinically effective but not cost-effective by the National Institute for Clinical Excellence.
Negotiations between government officials and ABPI are underway to arrive at a "risk-sharing" agreement as part of a new pharmaceutical price regulation system that will be launched in 2009. Under the scheme, companies would reduce the price of a drug sufficiently to allow the product to be approved by NICE, and the drug's price would subsequently raise as proof of clinical effectiveness grows.
10.07.2008
New Vacancies Health Economics & Pricing
Hi everyone,
all positions below just came in. Please get in touch with Simon Rose.
Cheers
Ulf
- Health Economy Liaison Manager – Field Based, Multiple locations – UK
- Health Economist, Berks – UK
- Senior Health Economist, Home Counties – UK
- Senior Contracts & Pricing Manager, Switzerland
- Senior Project Manager International Health Economics, Switzerland
- Health Economist, Northern Home Counties, UK
- HTA Manager, Northern Home Counties, UK
- HE&OR Manager (Global), Switzerland
- Senior Health Outcomes Analyst/Manager, Surrey,UK
- Health Economist, Ireland
- Health Outcomes Manager, Netherlands
If none or these are suitable please get in contact with me regard other positions. Any queries please contact Simon Rose on +44 (0) 207 922 7155 (Direct Line) or email simon.rose@hayspharma.com. I am a specialist recruiter in HEOR and an available for careers advice or a general discussion. for online Information: http://www.hayspharma.com. If interested please send your CV to the above address. At Hays Pharma we have Health Economic and Outcomes Research positions at all level throughout Europe and now in Asia/Pac.
all positions below just came in. Please get in touch with Simon Rose.
Cheers
Ulf
- Health Economy Liaison Manager – Field Based, Multiple locations – UK
- Health Economist, Berks – UK
- Senior Health Economist, Home Counties – UK
- Senior Contracts & Pricing Manager, Switzerland
- Senior Project Manager International Health Economics, Switzerland
- Health Economist, Northern Home Counties, UK
- HTA Manager, Northern Home Counties, UK
- HE&OR Manager (Global), Switzerland
- Senior Health Outcomes Analyst/Manager, Surrey,UK
- Health Economist, Ireland
- Health Outcomes Manager, Netherlands
If none or these are suitable please get in contact with me regard other positions. Any queries please contact Simon Rose on +44 (0) 207 922 7155 (Direct Line) or email simon.rose@hayspharma.com. I am a specialist recruiter in HEOR and an available for careers advice or a general discussion. for online Information: http://www.hayspharma.com. If interested please send your CV to the above address. At Hays Pharma we have Health Economic and Outcomes Research positions at all level throughout Europe and now in Asia/Pac.
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