Drug Deals Tie Prices to How Well Patients Do

one more interesting article from the NY times...

ANDREW POLLACK
Published: April 22, 2009
Think of it as product guarantees by the drug industry.

Merck, via Bloomberg News
Januvia, by Merck, is part of a cost-control deal with Cigna.
Pressed by insurance companies, some drug makers are beginning to adjust what they charge for their drugs, based on how well the medicines improve patients’ health.
In a deal expected to be announced Thursday, Merck has agreed to peg what the insurer Cigna pays for the diabetes drugs Januvia and Janumet to how well Type 2 diabetes patients are able to control their blood sugar.
And last week, the two companies that jointly sell the osteoporosis drug Actonel agreed to reimburse the insurer Health Alliance for the costs of treating fractures suffered by patients taking that medicine.
“We’re standing behind our product,” said Dan Hecht, general manager of the North American pharmaceutical business of Procter & Gamble, which sells Actonel with Sanofi-Aventis. “We’re willing to put our money where our mouth is.”
Some experts hail such arrangements as a welcome step toward health care that rewards good outcomes for patients.
“We’re going to see a growth in outcomes guarantees for pharmaceuticals, and it’s very healthy,” said Robert Seidman, a consultant who was formerly the chief pharmacy officer for WellPoint, an insurance company.
Traditionally, discounts and rebates that drug companies offer insurers have been based on how much drug is used, not how well patients do. But the emerging, outcomes-based contracts would — in theory — better align the incentives of insurers, drug companies and the employers that provide health coverage toward improving people’s health.
Such pay-for-performance contracts started to take hold a few years ago in countries with national health systems, in which the government could effectively block a drug from being used if it was too costly.
Johnson & Johnson set what is considered the prototype deal in 2007 with Britain’s national health system, which had tentatively decided not to pay for the cancer drug Velcade. To avert that decision, the company offered essentially a money-back guarantee. If Velcade did not shrink a patient’s tumors after a trial treatment, the company would reimburse the health system for the cost of that patient’s drug.
In the United States, where insurance companies do not have national monopolies — and where Medicare, by law, is precluded from negotiating drug prices — insurers have less leverage with drug makers. Even so, they can give favorable treatment to certain drugs, by reducing the required co-payments, for example.
Under the Actonel deal, if a patient insured by Health Alliance suffers a nonspinal fracture despite faithfully taking Actonel, the drug makers will help pay for the medical care — spending $30,000 for a hip fracture, for instance, and $6,000 for a wrist fracture.
This clearly lowers the cost of the drug to Health Alliance, a small insurer in Illinois and Iowa. But Procter & Gamble and Sanofi-Aventis might benefit as well. The deal could reduce the pressure on the insurance company to move patients off Actonel, which costs about $100 a month, to less-expensive generic versions of Fosamax. And the insurer has kept Actonel in a tier of its drug list that requires a smaller co-payment than for a competing brand-name drug, Boniva.

The deal between Cigna and Merck is more complex.

Rather than getting paid more for good results, Merck will actually give Cigna bigger discounts on Januvia and Janumet. Some discounts will be granted if more people diligently take the drugs as prescribed. This helps both Cigna, because people who take their pills are likely to have fewer complications from the disease, and Merck, because it sells more pills. The assumption is that Cigna will push for patient-compliance programs that urge people to take their medicine at the right times and in the proper doses.
Moreover, in an unusual move, Merck will offer even greater discounts to Cigna on Januvia and Janumet if patients’ blood sugar is better controlled — regardless of whether the improvement comes through Merck’s drugs or other medications.
In effect, though, Merck is betting not only that its drugs prove superior but that Cigna’s incentives to reap the benefits of the deeper Januvia and Janumet discounts will prompt the insurer to try to keep patients on those drugs.
As part of the agreement, too, Merck will get better placement for Januvia and Janumet on Cigna’s formulary, meaning a lower co-payment for patients than for some other branded drugs. The deal was made with the pharmacy benefit management division of Cigna, which manages prescriptions for 7.1 million people.
Merck declined a request for an interview. In a statement the company said it was “committed to finding new approaches to demonstrate the value of our products to patients, physicians and payers.”
Januvia, approved in 2006, costs about $150 a month. Janumet, approved a year later, is a combination of Januvia and metformin, a widely used generic drug.
Eric Elliott, the president of Cigna Pharmacy Management, said his company was negotiating similar contracts with other drug makers.

“We wanted a contract that drives performance,” he said. “Getting this one out will provide more momentum.”

Cost-sharing arithmetic

Hello Everyone,

comming back from the Zurich Oncology market access conference I received a couple of mails from readers regarding the entire risk sharing topic - many thanks for that.

For those of you having a subscription to BioCentury there was a very good review article on that matter (just posting the abstract):

• Cover Story - Cost-Sharing Arithmetic - NICE has added Celgene's Revlimid to its approved set of cost-sharing deals. But it has also shown it can walk away from these schemes if it doesn't like the numbers. In the long run, pricing specialists say it will be better to compile data showing superior clinical outcomes.

Also, I also received an interesting article from the US on new risk sharing deals.

Certainly a hot topic at the moment, I'll keep you posted on developments.

Cheers
Ulf

Payers view on risk sharing and outcomes based agreements...?

Dear All,

in order to prepare for a conference talk that I will be giving next week in Zurich I asked the network via linkedin: "I would be interested in hearing your thoughts/comments on how payers view risk sharing and outcomes based agreements?"

Over the last week I have received a lot and valuable comments and therefore would like to thank all of you who provided an answer! Since this is a hot topic and many of you wrote me that you are actually wondering about the same issue, I post all answers below for the broader audience.

best wishes
Ulf

"I would be interested in hearing your thoughts/comments on how payers view risk sharing and outcomes based agreements?"

Answers received (for privacy reasons all names have been erased)

Payers may react positively if they disagree with your value hypothesis and wish proof in daily practice. They may react negatively if they feel no need e.g. one has always reimbursed non responders. Administrative burden is another important element that has to be traded off versus why not just a lower price?

My experience is that it very much depends on the therapy area/drug in question. Risk sharing agreements are very good for expensive drugs that has been approved by early data that has not yet shown its full potential. New oncology drugs are a good example of this I agree with xxx above that the burden of administration should be taken into consideration.

We have found in our work in this area that these schemes are only meant for a small minority of situations, and that over-emphasis on innovative risk sharing pre-launch may distract from basic focus on clinical value shaping and appropriate planning for traditional payer agreements.

In Spain I have tried to settle an agreement with one of our regions. We managed to reach a consensus about the value proposition, but it was impossible to agree on: 1.- Which Health Authority has to sign the agreement: the manager of the hospital, the Regional Health Authority, the National Health Authority. The payor or the provider? 2.- What to measure: subrogate or final variables, clinical or patient reported outcomes 3.- What subpopulation of patients: as SmPC, other. Should the contract be the same in all populations. 4.- Length of the agreement: first years to market or all. 5.- Who will measure the results of the drug?, a CRO, they or us? 6.- Should the agreement be public?

Ulf I have experience of both outcome guarantee and free access period based programs in the UK market. As xxx states, one of the big challenges with outcome based approaches is the ability of healthcare systems to capture the necessary data and also the costs of administration. Despite the challenges outcome based approaches are I believe inherently more appealing to payors as they mitigate risk to a greater extent than free access periods and sponsors have an inbuilt interest in ensuring patients maximize received benefits. In addition, outcome based approaches enable capture of additional, observational data which may support broader market access. If one is going down the road of simple, free access approaches I fully concur with xxx comments about what payors are looking for,ie.: - best cost savings - minimal administerial workload - transparency - aligned with clinical pathways kind regards xxx"

Ulf A couple of additional thoughts on the practicalities: - involve representatives from payor organizations in the development of any schemes - academic involvement can add significantly to the quality and acceptability of schemes, especially outcome based types kind regards xxx

I am seeing a more proactive request for this type of agreements from Spanish Regional Government payers, mainly when talking about very expensive drugs and with a cost-containment exercise in mind. There are already some examples in some regions, although details are kept confidential. However, as it has been mentioned, in my experience, they do not really know how to go about it: they can and do protocolisation of treatment regimens in certain subpopulation groups but do not know what or how to measure outcomes, clinical and economic. I regard this as a big opportunity for industry and payers. Personalized medicines offers a new, easier ground also.

Generally I think payers would like to see them happen more frequently but it is a treacherous pathway to take because of the measurement difficulties over the agreement (the outcomes part if you like) - the area is certainly evolving.

From previous discussion with payers on risk sharing, payers have often told me that they would like to see the true cost savings and/or benefit of getting involved in such a scheme. If the administrative burden and cost outweigh the savings then it is unlikely to generate any interest

…but I'm seeing an increasing number of job specs looking for "risk sharing / pay for performance" type roles.

We know NICE are all for it - in the revised STA submission form, there is even a place for such proposals. Also, in the new process, a risk-share has to be introduced at the time of submission. To date, people would wait to receive a negative ACD before suggesting a risk-share now they have to do it at the start.

...this is highly variable depending on the market. Some markets, such as France, already have financial based schemes in place (payback agreements), and therefore have little interest in outcomes based agreements. Others, are more open to the concept. However, a very important challenge is whether or not the payer has access to the necessary data to execute a risk sharing agreement - do they have the patient level information to be able to adjudicate the agreement later on? Payers, like everyone, are interested in agreements that: 1) Save them the most amount of money 2) Are very transparent (low risk) 3) Involve the least amount of administrative work

…Risk sharing agreements are very good for expensive drugs that has been approved by early data that has not yet shown its full potential. New oncology drugs are a good example of this….

don't have the answer but having the same question…For the time being, we have had a variety of failure and success building those kind of agreements with EU payers …

…..My views on usage of outcomes based agreement would depend very much on the nature of services contracted and market dynamics.

Latest edition of Spanish Journal for health economics online

Hello everyone,

the latest edition of the Spanish journal for health economics is out. The journal is enjoying increasing readership within the Spanish speaking community although there are also publications in English. I contributed en editorial "The Pharmaevolution" speculating a little on the latest developments - consolidation is increasing again and new business and organizational models are being tested and deployed. Would be interesting to hear your thoughts on the sectors' evolution...?

Cheers
Ulf

UK allows private top-ups, privately

Scrip

The UK department of health has published guidance for the national health service on
how to handle patients who want to pay out-of-pocket for licensed drugs that are not
funded by their local health authorities.
Private top-ups to publicly funded healthcare became the subject of heated political
debate after the health technology assessment agency for England and Wales, NICE,
refused to recommend several expensive anticancers for routine use in the NHS on the
grounds of cost.
Patients in some hospitals were allowed to purchase drugs privately and have them
administered at public expense, but other hospitals refused to combine public and private
treatments, insisting that patients choose one system or the other for all of their care.
Some public figures objected to these uneven policies - a postcode lottery, they said -
while others denounced top-ups as the beginning of a two-tier healthcare system. Still
others called for NICE to be abolished, arguing that no patient should be denied
treatment on the grounds of cost.
Professor Mike Richards, the national cancer director, studied the problem and
recommended last year that private payments should be allowed within the health
service. After a consultation period, the government accepted his proposals; the new
policy took effect on March 23rd.
The main principles of the department's guidance are that NHS care should not be
withdrawn from patients who choose to buy additional private care, and that the NHS
should continue to provide free of charge all care that the patient would have been
entitled to had he or she not chosen to have additional private care. But it says the NHS
should never subsidise private care with public money.
It calls for a strict separation of private and public healthcare. "Private care should be
carried out in a different place to NHS care, as separate from other NHS patients as
possible," it advises. By "a different place", it means private facilities or part of an NHS
organisation that has been "permanently or temporarily designated for private care, such
as a private wing, amenity beds or a private room."
Among several illustrations, the department's guidance describes a cataract patient who
wants to pay for a multifocal replacement lens rather than have the NHS standard single
focus lens inserted during surgery. The patient should be informed "that it is not possible
to pay for the multifocal lens while carrying out the surgery on the NHS as it is not
possible to separate the private element from the NHS element of care". SCRIP - World
Pharmaceutical News - www.scrippharma.com FILED 26 March 2009 COPYRIGHT
PHIND: Pharma & Healthcare Ind News - today only (PHID)
Page 23
Informa UK Ltd 2009
COPYRIGHT BY T&F Informa UK Ltd

Drug-Industry Shakeout Hits Small Firms Hard

Another Wave of Acquisitions Is Likely as Companies Worry About Their Drug Pipelines and Health-Care Change – March 10, 2009

By AVERY JOHNSON and RON WINSLOW
Drug makers have begun a frenzied consolidation drive that is redrawing the industry landscape.
Merck & Co.'s $41.1 billion agreement to acquire Schering-Plough Corp., announced Monday, follows Pfizer Inc.'s $68 billion January takeover deal for Wyeth. Roche Holding AG's seven-month pursuit of Genentech Inc. was also nearing an agreement Monday, according to people familiar with the situation.
The push to consolidate is being driven by the knowledge that the big companies' pipelines aren't producing enough new moneymakers to keep growth going when major products lose patent protection over the next couple of years. As a result, the drug giants are looking to consolidations that will cut costs by combining research and sales efforts and eliminating other overlaps.
What will be left is an industry dominated by behemoths, raising questions about the fates of smaller drug companies, as well as the countless small biotechs hungry for suitors. Even though their labs aren't what they used to be, the major pharmaceutical companies have product lineups that still command fat margins, giving most of them the cash to pursue deals.
"There are too many companies chasing smaller revenue opportunities, so there's got to be a shakeout," says analyst Tim Anderson at Sanford C. Bernstein & Co. "If you've got cash and the value of the companies you want to buy is lower, it's the perfect setup."
Johnson & Johnson seems most likely to be involved in the next wave of consolidation in the drug industry, analysts say.
There could also be pressure tied to moves in Washington, where health-care reform could eat into margins. Bigger drug companies might be in a better position to bundle their products and negotiate with the government, analysts say.
The wreckage on Wall Street is also a factor: The health-care sector is traditionally viewed as a relatively safe bet, making it easier for drug companies to get financing than other industries.
But megadeals haven't cured industry problems in the past. Pfizer paid $116 billion for Warner-Lambert in 2000 and an additional $54 billion for Pharmacia in 2003, yet still needed to acquire Wyeth this year to help replenish an anemic pipeline.
As the dust settles, Eli Lilly & Co., Bristol-Myers Squibb Co., AstraZeneca PLC, Sanofi-Aventis SA and Johnson & Johnson seem most likely to be involved in the next wave of consolidation, analysts say. Factors including existing partnerships, the timing of patent expirations and how well drug makers can absorb multiple acquisitions could affect who will be a buyer and who will be a seller.
"Bristol and Lilly stand out in terms of size versus the rest of the industry," says Les Funtleyder, an industry analyst at Miller Tabak. "They'll have to do something, because it's a consolidating industry."
Lilly, based in Indianapolis with a market capitalization of $32 billion, will lose patent protection on its bestselling antipsychotic Zyprexa in 2011. It just bought ImClone for $6.5 billion. Mr. Anderson suggests it could merge with Bristol-Myers, whose chief executive, James Cornelius, came from Lilly.
Lilly, which has strong ties to Indiana and an undesirable series of patent losses coming up, would be more likely to buy than sell. "There's no way Lilly's a takeout," says Mr. Anderson.
Mark Taylor, a Lilly spokesman, says, "We're not interested in large-scale M&A activity in pharma and believe small and medium scale acquisitions, licensing and internal development" are the best way forward for Lilly.
Bristol-Myers faces a similar dilemma, because Plavix, the bloodthinner it sells with Sanofi-Aventis, faces generic competition in 2011. A merger with Lilly could face antitrust hurdles because both companies have clotting drugs and antipsychotics. A tie-up with Sanofi-Aventis is frequently rumored because of Plavix.
Bristol-Myers sold its ConvaTec wound-care business last May for $4.1 billion and offered a $720 million partial initial public offering for its nutritional business last month -- divestitures that could either add to its war chest for deals or make it a more attractive takeover target. Bristol-Myers declined to comment.
Sanofi-Aventis's new chief executive, Christopher Viehbacher, said in an interview last week that he isn't seeking a megamerger but would consider deals of under $19 billion. Some analysts say that could leave Sanofi-Aventis open to buying the U.S. biotech company Biogen Idec Inc., which has a market value of $13.3 billion. Both companies have declined to comment.
Another possibility for Bristol-Myers could be a deal with Britain's AstraZeneca because the companies are co-developing a drug for diabetes called saxagliptin. One rationale for the combination of Merck and Schering-Plough is to run the companies' joint venture selling the cholesterol medicines Vytorin and Zetia under one roof. AstraZeneca declined to comment, but has said in the past it's not interested in big deals.
Catherine Arnold, a drug-industry analyst at Credit Suisse, says that hasn't stopped companies in the past. "Sanofi, Glaxo and Novartis have said they're not interested in big deals, but Jeff Kindler said that nine months ago," she said, referring to a statement in March 2008 by Pfizer's chief executive that he did not see a megamerger on the horizon.
Meantime, 180, or 45%, of publicly traded biotech companies have less than a year of cash on hand, and about half are trading below $1 a share, according to BIO, the trade group for the biotechnology industry based in Washington.
But biotech acquisitions aren't a panacea. One reason is that small companies offer little opportunity for cost savings. Another is the worry that founders and scientists will leave if their companies are taken over.
In the interview last week, Mr. Viehbacher indicated his preferred strategy would be to enter partnerships with biotech companies rather than acquire them. "You don't want to bring them in to the mother ship because then you ruin it," he said.
The severe funding crunch facing small biotech companies is prompting worries that important new drugs won't make it to market, impeding the progress of medicine. "Innovation has been on the biotech side, but now the money is gone," says Edward Saltzman, president of industry consultant DefinedHealth. "We're in a pickle."
Meanwhile, the next target could actually be Schering-Plough. Johnson & Johnson, an historically acquisitive company, could throw a wrench in Merck's plan by making a more attractive offer for Schering. J&J sells Remicade, an anti-inflammatory drug, with Schering-Plough, and a deal for the company could give it full rights to the drug.
--Jeanne Whalen contributed to this article.
Write to Avery Johnson at avery.johnson@WSJ.com and Ron Winslow at ron.winslow@wsj.com
Printed in The Wall Street Journal, page A12

Drugs to be approved for NHS use within six months, ministers announce

Patients will get approved drugs on the NHS within six months instead of waiting up to two years, as ministers announce plans to speed up the National Institute for Health and Clinical Excellence.

by Rebecca Smith, Medical Editor, The Daily Telegraph
Last Updated: 2:12PM GMT 03 Mar 2009

The drug rationing body, Nice, has been accused of being too slow in its appraisals of drugs meaning patients are forced to wait years for medicines which may prolong their lives.

Ministers have announced a package of measures to speed up the process including adding another committee of experts to consider the drugs and 'horizon scanning' earlier in the drug development programme for medicines that will need to be referred to Nice.

The move comes after Nice ordered its committees to put extra weight on the final months of life when appraising drugs for terminal patients with rare conditions.

This followed public outcry over draft guidance which did not approve four kidney cancer drugs, including Sutent, which can extend the lives of sufferers by months.

Guidance is being issued to primary care trusts which decide whether to fund drugs where Nice has not appraised the drug or has not yet come to a decision.

PCTs have their own panels which consider individual patients for 'exceptional case' funding but this has led to a postcode lottery where all people in one area may be funded but none in a neighbouring area. The guidance is aimed at making the decisions more consistent and training will be provided to help.

Health Minister, Lord Darzi, said: "Last year in High Quality Care for All I set out our commitment to speed up the Nice process. Together, the measures set out today build on this commitment and will help provide faster and fairer access to new drugs and treatments – great news for patients.

"We are delighted to be working in partnership with Nice to ensure that new drugs and treatments are assessed sooner and more quickly in future, leading to improved and higher quality care for patients.

"The guidance for PCTs will help the NHS to ensure that local decisions are robust and transparent, leading to more consistency in those exceptional cases where there is no existing NICE guidance."

Andrew Dillon, Chief Executive of Nice, said: "This is an important consultation on the way that topics are chosen and referred for Nice's world-leading appraisals of new drugs and treatments. We are very keen to ensure that our guidance is produced as quickly as possible to benefit patients and the NHS.

"Speeding up non-cancer appraisals by at least three months to come in to line with the cancer appraisals, and increasing transparency by clarifying topic selection criteria, are just some of the potential improvements we and the Department of Health are suggesting.

"The views of patients, the public, health professionals and other stakeholders on the proposed changes to the topic selection process will be very helpful, and we look forward to receiving their comments."

A consultation on the proposals will run for three months.

Obama aims big with healthcare drive

by Stephen Collinson - Mon Mar 2, WASHINGTON (AFP)

President Barack Obama Monday launched a high-stakes drive to remake US healthcare, in his latest attempt to ensure his sweeping agenda is an antidote to and not a victim of the economic crisis.
The president unveiled Kansas Governor Kathleen Sebelius as his new pick to be secretary for health and human services (HHS) ahead of a bi-partisan White House healthcare summit on Thursday.
He also picked health expert Nancy-Ann DeParle as his counselor to coordinate White House efforts to achieve healthcare reform.

"If we are going to help families, save businesses, and improve the long-term economic health of our nation, we must realize that fixing what's wrong with our health care system is no longer just a moral imperative, but a fiscal imperative," Obama said in a written statement.
"Healthcare reform that reduces costs while expanding coverage is no longer just a dream we hope to achieve -- it's a necessity we have to achieve."
Both appointments replaced that of former senator Tom Daschle, originally nominated to simultaneously serve as HHS secretary and White House health czar but who was forced to pull out over a storm over unpaid taxes.
Obama shone a spotlight on healthcare after he placed the issue, a political gamble which has dogged previous Democratic presidents, at the center of his budget last week.
The president asked Congress for 634 billion dollars over 10 years as a "down payment" on refashioning a largely private system which offers some of the world's best care, but leaves nearly 46 million Americans uninsured, according to the National Coalition on Healthcare, an umbrella reform group.
His insistence on pushing the legislation confounds critics who warn Obama must curtail his political wish list because of the economic turmoil and Republicans who charge his plans are too expensive.
Sebelius, 60, who will require Senate confirmation and was once said to be in the running to be Obama's Democratic vice presidential nominee, is serving in her second term as governor of her heartland state.
News of her nomination was welcomed by Democratic Senator Max Baucus, who with ailing Democratic legend Senator Edward Kennedy, plans to pilot healthcare reform through Congress.
"Passing comprehensive health care reform is an absolute imperative this year, and as a former insurance commissioner Governor Sebelius really gets what needs to be done," Baucus said.
But the arrival of Sebelius in Washington was heralded by newspaper stories delving into the questionable success of her past efforts to reform healthcare in Kansas and Republican criticisms.
The Republican National Committee distributed research accusing the president of plotting billions of dollars of new taxes on Americans to pay for healthcare.
It accused Sebelius of being "in the pocket" of labor unions and of also being a prophet of high taxation.
White House officials have already warned Republicans would try to derail the president's healthcare plan and force a victory which would severely diminish his political clout.
Former president Bill Clinton's failed healthcare reform drive, under the direction of his wife Hillary Clinton, still sends shudders down the spines of leading Democrats.
But Obama's budget chief Peter Orszag warned on Sunday that there was no alternative to reforming healthcare -- a priority he said could end up being one of the primary drivers of economic recovery.
"We're going to get health care reform done this year. I think this proposal will get enacted," he said.
The plans are guaranteed a rough ride in Congress where attempts to cover all Americans are often derided by minority Republicans as European-style "socialized medicine."
Obama plans to finance the reforms by letting tax breaks for the rich expire in 2011, and to streamline other healthcare programs.
One of Obama's first actions after taking office in January was signing into law expanded healthcare coverage for low-income children -- a measure vetoed by former president George W. Bush.
With the US economic recession deepening, there are fears that millions more could be added to the ranks of the uninsured, since many rely on employers or their own wage checks to pay for coverage.

Drug Makers Fight Stimulus Provision

By ALICIA MUNDY

WASHINGTON -- The drug and medical-device industries are mobilizing to gut a provision in the stimulus bill that would spend $1.1 billion on research comparing medical treatments, portraying it as the first step to government rationing.

The fight over the provision is highlighting the tensions behind President Barack Obama's plan to overhaul the health-care system. The administration hopes to expand coverage while limiting use of treatments that don't work well, but any efforts that might reduce coverage are politically sensitive.

The House version of the stimulus package sent shudders through the drug and medical-device industry. In a staff report describing the bill, the House said treatments found to be less effective and in some cases more expensive "will no longer be prescribed."

A Senate version backed by Finance Committee Chairman Max Baucus (D., Mont.) doesn't mention cost as a subject to be studied. And the industry won a battle to add the word "clinical" in describing the research -- adding to the implication that the comparison studies won't look at bang for the buck. The final language is likely to be hammered out later this week in a House-Senate conference committee.

Mr. Obama is under pressure to find long-run health-cost savings as projections show that Medicare spending is on track to severely deplete the federal budget. "Without question, we're headed for more of a public and private push for which medicines work best at the lowest cost in particular patients," said Mark McClellan, former Medicare and Medicaid chief under President George W. Bush.

The $1.1 billion in research funding would be doled out to the National Institutes of Health and other government bodies. "We should focus on producing the best unbiased science possible," said Rep. Henry Waxman (D., Calif.), a strong proponent of the House language.

Mr. Obama supported research into comparative effectiveness during his campaign. Administration officials and leading Democrats in Congress say the idea will help government programs direct their dollars to treatments that are worth the money.

Officially, drug and device makers don't object to that sentiment. But they warn of a slippery slope where the government ends up axing useful treatments just because they cost too much. They have lined up patient groups that get industry funding to lobby Capitol Hill.

A coalition called the Partnership to Improve Patient Care includes the lobbying arms of the drug, device and biotechnology industries as well as patient-advocacy groups and medical-professional societies. Coalition spokesman David Di Martino says the research envisioned in the House bill may be used "in an inappropriate manner that may limit treatment options for patients."

A public-relations firm that is part of one of Washington's most influential lobby shops, Barbour Griffith Rogers, is representing the coalition. A major goal is to give industry a seat at the table when federal officials decide what to research with the $1.1 billion.

Companies "want to control the data, how it is reviewed, evaluated, and whether the public and government find out about it and use it," said Harry Selker, a Tufts University professor who directs its clinical-research program.

That also worries Jerry Avorn of Harvard Medical School, a frequent drug-industry critic. Comparative research "has the potential to tell us which drugs and treatments are safe, and which ones work," he said. "This is not information that the private sector will generate on its own, or that the industry wants to share."

Michael Cannon of the libertarian Cato Institute said comparative effectiveness research "isn't going to do any good because the industry will defund it as soon as it presents a threat."

When the government's Agency for Health Research Quality suggested in 1995 that there were too many unnecessary back surgeries, doctors and industry groups attacked the conclusion. Mr. Cannon noted that Congress at the time slashed the agency's budget and stripped its authority to make medicare-payment recommendations.

"They almost killed AHRQ," said Dr. Avorn. "The memory of their near-death experience hasn't been forgotten."

Dr. McClellan, the former Medicare chief, said effectiveness research can be useful but shouldn't assume pricey medicines are automatically bad. "The goal isn't to avoid expensive drugs, it's to get more value for our health-care spending," he said.

—Jacob Goldstein contributed to this article.
Write to Alicia Mundy at alicia.mundy@wsj.com

Faculty positions at University of Utah College of Pharmacy

Tenure Track Outcomes Research Faculty Position

Research Faculty Position
Assistant/Associate Professor
Pharmacotherapy Outcomes Research Center
Department of Pharmacotherapy
College of Pharmacy, University of Utah

This position provides opportunity for Pharmacotherapy Outcomes Research scholarly activity in a research-intensive, interdisciplinary health sciences center.

Review of applications will begin immediately and will continue until the position is filled.

Scholarly Activity:
The individual’s primary focus will be to conduct scholarly activity in health economics and outcomes research in collaboration with Pharmacotherapy Outcomes Research Center faculty and staff. The successful candidate will also be expected to pursue and direct independent outcomes research as well as seek research support from both the public and private sector. The individual will be expected to interact with individuals from the health care industry on a regular basis.

Teaching:
This individual may participate in team-taught courses for PharmD and MS students and serve as a preceptor on PharmD elective outcomes research clerkships. The individual may assist in the training of post-doctoral residents and fellows in pharmacotherapy outcomes research.

Qualifications:
A PhD degree, PharmD degree, pharmacy practice residency or equivalent experience, and fellowship or equivalent experience in health economics and/or outcomes research are preferred. Clinical practice experience and/or research experience are preferred. Excellent verbal and written communication skills and proven ability to work with other health professionals in an interdisciplinary environment are required.

Rank and Salary:
Appointment as a research track assistant or associate professor within the Department of Pharmacotherapy and a salary commensurate with qualifications and experience plus benefits will be provided. This is a calendar year appointment.

This position provides an excellent opportunity for collaboration with practitioners and faculty in a broad range of clinical and scientific disciplines in an interdisciplinary clinical environment. Interested individuals are invited to send their curriculum vitae and the names of three references to provide letters of recommendation to:

Joseph Biskupiak, PhD
Research Associate Professor, Department of Pharmacotherapy
Director, Pharmacotherapy Outcomes Research Center
Department of Pharmacotherapy
University of Utah College of Pharmacy
421 Wakara Way; Suite 208
Salt Lake City, UT 84108
Joseph.Biskupiak@pharm.utah.edu

The University of Utah is an EEO/AA employer and encourages applications from women and minorities.


Assistant Professor Rank
Department of Pharmacotherapy
University of Utah College of Pharmacy
Salt Lake City, Utah
www.pharmacy.utah.edu/pharmacotherapy/

The Department of Pharmacotherapy is seeking to fill a 12-month, tenure track faculty position at the minimum rank of Assistant Professor within the disciplines of outcomes research including health economics, biostatistics, and clinical outcomes. Applicants must possess a graduate degree in a health services research-related field such as behavioral science, pharmacoeconomics, health economics, pharmacoepidemiology, or public health. An undergraduate or professional degree in Pharmacy is preferred to facilitate teaching within the PharmD curriculum. The ideal candidate will possess demonstrated potential as an outstanding researcher, a strong interest, competence and commitment to excellence in teaching in the professional and graduate programs and a commitment to academic service.
The successful applicant is expected to complement the strong research program in the College of Pharmacy. The College of Pharmacy is situated in the foothills of the Wasatch Mountains in L.S. Skaggs Hall, which is part of the Utah Health Sciences Center, the University of Utah Hospital and Clinics, the School of Medicine, the Colleges of Health and Nursing, the Eccles Health Sciences Library and a state of the art Health Sciences Education Building. The Health Sciences Center is an environment conducive to interdisciplinary and translational research. The University of Utah College of Pharmacy is consistently ranked in the top five pharmacy schools nationally receiving National Institutes of Health funding for research. The Department of Pharmacotherapy consists of a strong foundation of clinical, tenure track faculty and research faculty, the Pharmacotherapy Outcomes Research Center, the Utah Poison Control Center and a Continuing Education Program.

Qualified applicants should send by mail and email a letter of intent, current curriculum vitae, and the names and addresses of three references to:
Diana Brixner, PhD, RPh
Chair, Outcomes Research Faculty Search
c/o Sara Ray, Administrative Officer
Department of Pharmacotherapy, University of Utah College of Pharmacy
30 South 2000 East – Room 258
Salt Lake City, UT 84112-5820
(801) 581-5984
sara.ray@pharm.utah.edu or diana.brixner@pharm.utah.edu

The University of Utah is an EEO/AA employer and encourages applications from women and minorities.

Health Economics Position - Grapevinerecruiters

Folks,
this just came in, please contact Darren (see below)
best
Ulf

Associate Director of Health Economics and Outcomes

REPORTS TO: Strategic Affairs

LOCATION: Markham

OVERALL PURPOSE/MAJOR FUNCTION
• Develop timely, appropriate health economic data to support reimbursement initiatives for all products
• Manage economic and outcomes research projects in support of international and local pricing and reimbursement programs
• Provide interpretative expertise for economic/outcomes research data as needed by internal/external customers
• Mentor junior associates to improve skill sets
• MINIMUM REQUIREMENTS
• In-depth understanding of outcomes research and epidemiological study design.
• Working knowledge of biostatistics and data analysis
• Capabilities in health economic modeling
• Advanced communication capabilities
• Experience in government and patient advocacy lobbying
• Masters Degree in epidemiology, health economics, health policy
• 10 years work experience in health industry

RESPONSIBILITIES
• Implement local health economic and outcomes research strategies that support the overall reimbursement strategies
• Design health economic and outcomes research studies that are scientifically sound and timely
• Collaborate with International medical affairs to incorporate health economic measures into clinical trials
• Analyze and report results from health economics outcomes research studies, including publication and presentation of data
• Provide input into global health economics and outcomes research studies and programs.
• Communicate results of health economic and outcomes research studies to internal and external customers
• Recruit and manage investigators/vendors to conduct health economics and outcomes research studies

RECOMMENDATIONS
• Impactful outcomes in outcomes studies
• Analysis plan for health economic and outcomes studies
• GO/NO GO decisions for health economic studies
• Health economic approach for submission/presentation to customers
• Publication strategies for completed studies

Darren Kruszynski
Grapevine Executive Recruiters
269 Richmond Street West
Suite 100
Toronto, Ontario
416-581-1445 ext 225
www.grapevinerecruiters.com
Darren@grapevinerecruiters.com
http://www.linkedin.com/in/darrenkruszynski

NICE splits renal cancer drugs assessment - "yes" for Pfizer's Sutent, "no" for Roche, Bayer, Wyeth

by Nick Smith

LONDON, Feb 4 (APM) - NICE on Wednesday split its controversial review of renal cancer drugs into two, saying 'yes' to Pfizer's Sutent (sunitinib) but rejecting three others - Wyeth's Torisel (temsirolimus), Bayer's Nexavar (sorafenib) and Roche's Avastin (bevacizumab).

In effect NICE has all but guaranteed that one product will reach patients, while pushing problematic appeals back down the appraisal process.

In a statement issued late on Tuesday for Wednesday release, NICE said in an attempt to get guidance out the NHS as quickly as possible it had published later-stage guidance recommending sunitinib as a first-line treatment option in advanced and/or metastatic renal cell carcinoma.

In a second set of guidance, bevacizumab, sorafenib and temsirolimus were not recommended as first-line treatment options for advanced and/or metastatic renal cell carcinoma.

Also in the second set of guidance, the two drugs also licensed for second-line treatment of advanced or metastatic renal cell carcinoma, sorafenib and sunitinib, are not recommended for this indication.

A spokeswoman for NICE told APM the sunitinib document was a so-called Final Appraisal Determination (FAD), which in the absence of an appeal will become guidance to the NHS. The second is a first draft which is now out for public consultation ahead of a later FAD.

RIGHT TO APPEAL?

Initially all four cancer drugs were assessed and rejected together, leading to a huge public outcry that dying people were being denied life-extending drugs.

Following this, new flexibilities for NICE's appraisal committees were announced by the government.

This gave them a more formal freedom to exceed NICE's generally understood maximum cost per quality-adjusted life year of 30,000 pounds (33,000 euros) under certain conditions, including low incidence and end-of-life cases.

In its statement, NICE says the approval of sunitinib comes under these new flexibilities and stresses its desire to get this treatment to patients as soon as possible.

NICE said: "Having decided that one of these treatments should be recommended for use in the NHS, we felt that it was in the interests of patients to get that advice out as quickly as possible.

Although this final recommendation is subject to appeal we very much hope it will form the basis of our guidance to the NHS."

The approval for sunitinib is specifically in patients with renal cell carcinoma (RCC) who are suitable for immunotherapy with an Eastern Cooperative Oncology Group performance status of 0 or 1.

Despite the mention of an appeal it was not clear what grounds companies with rejected drugs might use. It is unusual for patient organisations to appeal an approval from NICE.

The spokeswoman confirmed that after NICE split the assessment, the sunitinib FAD only deals with the Pfizer drug. Although she insisted all consultees - which would include Wyeth, Bayer and Roche - had the right to appeal regardless of whether their product was included or not, she could not say how they might benefit from an appeal.

In the absence of a rejection of their own drugs, it seems any appealing company could only succeed in slowing down access or stopping patients accessing any drug at all.

Pfizer is one of two companies which offered "patient access schemes" - incentives to the National Health Service that in some way reduce the price paid by the service - in order to gain NICE approval in cases which would otherwise have led to rejection.

Pfizer offered the NHS the first cycle of sunitinib in renal cell carcinoma free. "The independent advisory committee concluded that sunitinib does represent a cost effective use of NHS resources when used as a first-line treatment for advanced and/or metastatic RCC," NICE said in the statement without giving its estimated cost per QALY.

NICE also noted the Department of Health said the Pfizer scheme, "does not constitute an excessive administrative burden on the NHS".

Bayer also agreed a patient access scheme with the Department of Health, in which the first pack of sorafenib is free to the NHS, NICE said.

ns/ak

nick.smith@apmnews.com
[14114] 04/02/2009 09:31 GMT - INDUSTRY

More Velcade-Style Risk-Sharing in the UK?

via the IN VIVO Blog by Melanie Senior on 21/01/09

It appears that Janssen-Cilag feels a lot better now about its pay-for-performance scheme around multiple myeloma drug bortezemib (Velcade) than it did when the program was introduced in 2007.
The Velcade Response Scheme (VRS) came about out of desperation: cost-effectiveness watchdog NICE had turned down the drug as too expensive, so Janssen-Cilag, to its credit, said to the UK’s state payer, the Department of Health, ok, well if we promise to charge only when the drug is effective (and refund you if not), then will you give this to patients? The answer was yes. And now, not only have all of the UK’s Primary Care Trusts have signed up to the VRS, according to a Janssen spokesperson, but this scheme “may now be a good example of how a performance-based scheme could be structured.” That’s not a statement from Janssen; it’s from a position document issued last year by the British Oncology Pharmacy Association on risk-sharing schemes.
Indeed, such schemes have, perhaps inevitably, become a rather more regular feature of the UK drug landscape—making Janssen feel more pioneering than desperate (though Janssen isn’t the first to guarantee performance; Pfizer tried with Lipitor too).

Most of the other recent flavors of risk-sharing programs around expensive cancer drugs emerged, like VRS did, as a result of a negative NICE appraisal. Merck-Serono offered the Cetuximab Cost-Share Program around Erbitux in metastatic colorectal cancer, which involved refunding primary care trusts the cost of any vials of the drug used for patients that fell into a pre-agreed ‘non-responder’ category at up to 6 weeks. Roche instigated the ‘Tarceva Access Program’ for its NSCLC drug erlotinib, offering a rebate, in the form of a credit note against any future Roche purchase, for the amount that the drug cost over and above the cost of the incumbent NSCLC treatment docetaxel (Sanofi-Aventis' Taxotere) for an average patient duration (with an upper limit on the total number of packs).

Now granted, Roche’s program was initially introduced as a means to claw market share off docetaxel, which it was struggling to do ahead of NICE guidance. But when NICE found Tarceva to be un-cost effective—with questions around the lack of comparative data with docetaxel in particular--the scheme was formally proposed to NICE as part of a re-review. In November 2008, NICE issued positive guidance—but only on condition that the overall treatment cost remained in line with that of docetaxel. Roche had to drop the price by about 7.5%.

Critics say such programs are simply a way for industry to coerce NICE into a ‘yes’. Maybe. But there’s no denying that such schemes represent a logical way to improve patient access without breaking the bank. Indeed, the new UK drug pricing contract, the PPRS, formalizes a bunch of patient access schemes, including risk-sharing programs. And NICE, as we heard from CEO Andrew Dillon last week, would prefer such schemes to be proposed up front, before a drug is submitted for review, rather than as a last-resort of the drug fails the cost-test.

Small wonder, then, that in the last three or four months since the PPRS was published, the department of health has been in contact with various companies about schemes around several “high profile” drugs, according to David Thomson, Lead Pharmacist at the Yorkshire Cancer Network and author of the BOPA position statement.

The big problem is administration. As it is, it’s complex to administer rebates and track outcomes. The more different schemes are available, the harder that becomes. “Anecdotal evidence suggests that the VRS [and a similar scheme around Sutent] aren’t necessarily bringing the expected levels of financial benefit to the National Health Service,” Thomson told The IN VIVO Blog.

Add to this the problem of patchy uptake or availability of some of the existing handful of programs across the country, and the possibility of multiple risk-programs across a single drug for different indications, and it’s easy to see why BOPA's pushing for some sort of risk-sharing plan template....and why we may not, after all, see a flood of VRS-followers soon.

image by flickr user fboosman used under a creative commons license

© Copyright 2008 Windhover Information Inc. www.windhover.com/blog

NICE to put QALY under examination

LONDON, Jan 27 (APM) - NICE on Tuesday announced an arms-length investigation into how it values health technology, potentially putting the quality-adjusted life year (QALY) under the microscope.
In a press release, the cost-effectiveness body said NICE chairman, Professor Mike Rawlins, has written to England's top health minister announcing a "short study of how value is taken into account when looking at new health technologies". The study will involve submissions and the use of a series of workshops involving the healthcare industries, patients and the wider public, together with representatives of the NHS to explore this issue, NICE said.
NICE also said the Professor of health law, ethics and policy at University College London, Ian Kennedy has agreed to lead the study. Quoted in the release, Rawlins said: "This study which will look at whether particular forms of value are more important than others; and will explore factors that should be taken into account in establishing the value of new health technologies."

QALY

No particular mention of the QALY was made in the release but the measure is at the centre of NICE's work and has been doggedly defended by the institute despite increasing hostility from industry. However, a shift may have taken place with the new UK pricing contract which outlined a greater role for NICE, bringing it to the centre of UK drug pricing.

The pharma industry is known to have pressed for a much wider examination of the benefits of medicines including keeping people in work, reducing the workload of carers and saving the National Health Service costs in reduced hospital admissions.
Rawlins noted a recent report on the future of the biotechnology industry stressed the importance of NICE and the pharmaceutical industry working towards a shared understanding of how to value innovative new health technologies, adding, "NICE supports that view."

ns/ak

nick.smith@apmnews.com
[14027] 27/01/2009 11:02 GMT - INDUSTRY

Wales sidesteps NICE recommendation on kidney cancer drug access

Scrip

Welsh patients will be able to receive four kidney cancer drugs that have not been
recommended by the National Institute for health and Clinical Excellence (NICE), the
Welsh health minister Edwina Hart has announced.
The decision will allow greater access to four drugs currently being reviewed by NICE
for advanced renal cancer - Pfizer's Sutent (sunitinib), Genentech's Avastin
(bevacizumab), Bayer's Nexavar (sorafenib) and Wyeth's Torisel (temsirolimus). None
of the drugs was found cost-effective a draft NICE appraisal last August; the assessment
of the treatments has since been extended, with final guidance expected this month
(Scrip Online, October 21st, 2008). However, the health minister has instructed Local Health Boards (LHBs) to provide the drugs to end-of-life patients with kidney cancer, with immediate effect, choosing not to wait for NICE's decision. Although describing the move as a "temporary arrangement", the health minister added it was "unacceptable" for patients to be kept waiting for the treatments.
The decision follows a clinical audit of Sutent issued last December. Originally, NICE
and the All Wales Medicines Strategy Group (AWMSG) issued guidance that the drug
should not be funded by the NHS as it was too expensive (Scrip Online, August 8th,
2008), thus leaving funding decisions to LHBs for individual patients. However, a study undertaken by the Medical Director of NHS Wales Professor Mike Harmer found that of 73 requests for Sutent only 23 received the treatment in 2008, raising questions of consistency; the report revealed that all patients who were recommended the treatment in Neath, Port Talbot and Bridgend received it, while only one of 13 patients received the drug in Cardiff and none of the 14 patients recommended received the drug in Swansea.
The health minister has already shown she is prepared for Wales to make its own
decisions regarding drug availability; in July last year she made Novartis's Lucentis
(ranibizumab) for wet age-related macular degeneration (AMD) in both eyes available
on the Welsh NHS, a month before final guidance for England and Wales was confirmed
by NICE (Scrip Online, July 17th 2008 and August 27th, 2008).
NICE has proposed changing its cost-effectiveness parameters for end-of-life drugs,
partly in response to a public outcry over the initial draft of its assessment of the four
kidney anticancers.

SCRIP - World Pharmaceutical News - www.scrippharma.com
FILED 26 January 2009 COPYRIGHT Informa UK Ltd 2009
PHIND: Pharma & Healthcare Ind News - today only (PHID)