Pharmaceutical Pricing & Reimbursement Conference 2008

Arrowhead-Spectra Conferences announces that it is hosting an Expert Opinion Conference on Pharmaceutical Pricing and Reimbursement at the Royal Society of Medicine, in Central London, UK on the 29th May, 2008

For the program please klick here


Comparative-Effectiveness Bill to Hit Senate

FDAnews Drug Daily Bulletin
April 14, 2008 Vol. 5 No. 73

Comparative-Effectiveness Bill to Hit Senate
A bill establishing a comparative-effectiveness research institute is scheduled for introduction in the Senate this week, congressional staffers say.
The Comparative Effectiveness Research Act of 2008, sponsored by Sens. Kent Conrad (D-N.D.) and Max Baucus (D-Mont.), would establish an institute to evaluate the effectiveness of different drugs and medical devices that exist for the same treatment.
The creation of such an organization was the subject of a public meeting held last week by the Medicare Payment Advisory Commission (MedPAC), an independent agency that advises Congress on issues affecting Medicare. The group supports a comparative-effectiveness program and recommends that Congress establish an independent entity to sponsor and disseminate such information. The entity would conduct prospective, head-to-head clinical trials of competing products as well as clinical reviews.
In a report last June, MedPAC said not enough credible, empirically based information is available for providers and payers to make decisions on alternative treatments and diagnostics for the most common conditions. New services become routine medical care without their comparative effectiveness being taken into account, the commission said. Recently, Centers for Medicare & Medicaid Services’ Chief Medical Officer Barry Straube said Medicare would have to address comparative-effectiveness and cost-effectiveness issues to achieve greater value for the program. MedPAC agreed. One committee member said the research needed today is not to support another device or “me-too drug” but to promote value. The commission also advised that the institute have no role in making or recommending coverage or payment decisions.


Co-Payments Go Way Up for Drugs With High Prices

April 14, 2008

The New York Times
National Desk; SECTA

Health insurance companies are rapidly adopting a new pricing system for very expensive drugs, asking patients to pay hundreds and even thousands of dollars for prescriptions for medications that may save their lives or slow the progress of serious diseases.
With the new pricing system, insurers abandoned the traditional arrangement that has patients pay a fixed amount, like $10, $20 or $30 for a prescription, no matter what the drug's actual cost. Instead, they are charging patients a percentage of the cost of certain high-priced drugs, usually 20 to 33 percent, which can amount to thousands of dollars a month.
The system means that the burden of expensive health care can now affect insured people, too.
No one knows how many patients are affected, but hundreds of drugs are priced this new way. They are used to treat diseases that may be fairly common, including multiple sclerosis, rheumatoid arthritis, hemophilia, hepatitis C and some cancers. There are no cheaper equivalents for these drugs, so patients are forced to pay the price or do without.
Insurers say the new system keeps everyone's premiums down at a time when some of the most innovative and promising new treatments for conditions like cancer and rheumatoid arthritis and multiple sclerosis can cost $100,000 and more a year.
But the result is that patients may have to spend more for a drug than they pay for their mortgages, more, in some cases, than their monthly incomes.
The system, often called Tier 4, began in earnest with Medicare drug plans and spread rapidly. It is now incorporated into 86 percent of those plans. Some have even higher co-payments for certain drugs, a Tier 5.
Now Tier 4 is also showing up in insurance that people buy on their own or acquire through employers, said Dan Mendelson of Avalere Health, a research organization in Washington. It is the fastest-growing segment in private insurance, Mr. Mendelson said. Five years ago it was virtually nonexistent in private plans, he said. Now 10 percent of them have Tier 4 drug categories.
Private insurers began offering Tier 4 plans in response to employers who were looking for ways to keep costs down, said Karen Ignagni, president of America's Health Insurance Plans, which represents most of the nation's health insurers. When people who need Tier 4 drugs pay more for them, other subscribers in the plan pay less for their coverage.
But the new system sticks seriously ill people with huge bills, said James Robinson, a health economist at the University of California, Berkeley. ''It is very unfortunate social policy,'' Dr. Robinson said. ''The more the sick person pays, the less the healthy person pays.''
Traditionally, the idea of insurance was to spread the costs of paying for the sick.
''This is an erosion of the traditional concept of insurance,'' Mr. Mendelson said. ''Those beneficiaries who bear the burden of illness are also bearing the burden of cost.''
And often, patients say, they had no idea that they would be faced with such a situation.
It happened to Robin Steinwand, 53, who has multiple sclerosis.
In January, shortly after Ms. Steinwand renewed her insurance policy with Kaiser Permanente, she went to refill her prescription for Copaxone. She had been insured with Kaiser for 17 years through her husband, a federal employee, and had had no complaints about the coverage.
She had been taking Copaxone since multiple sclerosis was diagnosed in 2000, buying 30 days' worth of the pills at a time. And even though the drug costs $1,900 a month, Kaiser required only a $20 co-payment.
Not this time. When Ms. Steinwand went to pick up her prescription at a pharmacy near her home in Silver Spring, Md., the pharmacist handed her a bill for $325.
There must be a mistake, Ms. Steinwand said. So the pharmacist checked with her supervisor. The new price was correct. Kaiser's policy had changed. Now Kaiser was charging 25 percent of the cost of the drug up to a maximum of $325 per prescription. Her annual cost would be $3,900 and unless her insurance changed or the drug dropped in price, it would go on for the rest of her life.
''I charged it, then got into my car and burst into tears,'' Ms. Steinwand said.
She needed the drug, she said, because it can slow the course of her disease. And she knew she would just have to pay for it, but it would not be easy.
''It's a tough economic time for everyone,'' she said. ''My son will start college in a year and a half. We are asking ourselves, can we afford a vacation? Can we continue to save for retirement and college?''
Although Kaiser advised patients of the new plan in its brochure that it sent out in the open enrollment period late last year, Ms. Steinwand did not notice it. And private insurers, Mr. Mendelson said, can legally change their coverage to one in which some drugs are Tier 4 with no advance notice.
Medicare drug plans have to notify patients but, Mr. Mendelson said, ''that doesn't mean the person will hear about it.'' He added, ''You don't read all your mail.''
Some patients said they had no idea whether their plan changed or whether it always had a Tier 4. The new system came as a surprise when they found out that they needed an expensive drug.
That's what happened to Robert W. Banning of Arlington, Va., when his doctor prescribed Sprycel for his chronic myelogenous leukemia. The drug can block the growth of cancer cells, extending lives. It is a tablet to be taken twice a day -- no need for chemotherapy infusions.
Mr. Banning, 81, a retired owner of car dealerships, thought he had good insurance through AARP. But Sprycel, which he will have to take for the rest of his life, costs more than $13,500 for a 90-day supply, and Mr. Banning soon discovered that the AARP plan required him to pay more than $4,000.
Mr. Banning and his son, Robert Banning Jr., have accepted the situation. ''We're not trying to make anybody the heavy,'' the father said.
So far, they have not purchased the drug. But if they do, they know that the expense would go on and on, his son said. ''Somehow or other, myself and my family will do whatever it takes. You don't put your parent on a scale.''
But Ms. Steinwand was not so sanguine. She immediately asked Kaiser why it had changed its plan.
The answer came in a letter from the federal Office of Personnel Management, which negotiates with health insurers in the plan her husband has as a federal employee. Kaiser classifies drugs like Copaxone as specialty drugs. They, the letter said, ''are high-cost drugs used to treat relatively few people suffering from complex conditions like anemia, cancer, hemophilia, multiple sclerosis, rheumatoid arthritis and human growth hormone deficiency.''
And Kaiser, the agency added, had made a convincing argument that charging a percentage of the cost of these drugs ''helped lower the rates for federal employees.''
Ms. Steinwand can change plans at the end of the year, choosing one that allows her to pay $20 for the Copaxone, but she worries about whether that will help. ''I am a little nervous,'' she said. ''Will the next company follow suit next year?''
But it turns out that she won't have to worry, at least for the rest of this year.
A Kaiser spokeswoman, Sandra R. Gregg, said on Friday that Kaiser had decided to suspend the change for the program involving federal employees in the mid-Atlantic region while it reviewed the new policy. The suspension will last for the rest of the year, she said. Ms. Steinwand and others who paid the new price for their drugs will be repaid the difference between the new price and the old co-payment.
Ms. Gregg explained that Kaiser had been discussing the new pricing plan with the Office of Personnel Management over the previous few days because patients had been raising questions about it. That led to the decision to suspend the changed pricing system.
''Letters will go out next week,'' Ms. Gregg said.
But some with the new plans say they have no way out.
Julie Bass, who lives near Orlando, Fla., has metastatic breast cancer, lives on Social Security disability payments, and because she is disabled, is covered by insurance through a Medicare H.M.O. Ms. Bass, 52, said she had no alternatives to her H.M.O. She said she could not afford a regular Medicare plan, which has co-payments of 20 percent for such things as emergency care, outpatient surgery and scans. That left her with a choice of two Medicare H.M.O's that operate in her region. But of the two H.M.O's, her doctors accept only Wellcare.
Now, she said, one drug her doctor may prescribe to control her cancer is Tykerb. But her insurer, Wellcare, classifies it as Tier 4, and she knows she cannot afford it.
Wellcare declined to say what Tykerb might cost, but its list price according to a standard source, Red Book, is $3,480 for 150 tablets, which may last a patient 21 days. Wellcare requires patients to pay a third of the cost of its Tier 4 drugs.
''For everybody in my position with metastatic breast cancer, there are times when you are stable and can go off treatment,'' Ms. Bass said. ''But if we are progressing, we have to be on treatment, or we will die.''
''People's eyes need to be opened,'' she said. ''They need to understand that these drugs are very costly, and there are a lot of people out there who are struggling with these costs.''

PHOTO: Robin Steinwand had been paying $20 a month for her multiple sclerosis drug, which she keeps in the refrigerator. When she went to pick up her prescription in January, it cost $325. (PHOTOGRAPH BY DANIEL ROSENBAUM FOR THE NEW YORK TIMES) (pg.A17)

CHART: COSTLIER PRESCRIPTIONS: Insurance companies have been adopting a pricing system for prescription drugs, often called Tier 4, in which patients pay 20 to 33 percent of the cost of certain highpriced drugs instead of a fixed fee for a prescription.

Copyright 2008 The New York Times Company. All Rights Reserved.


Brazil may reject patent of AIDS drug due to price

RIO DE JANEIRO, April 10 (Reuters) - Brazil has decreed U.S. pharmaceutical firm Gilead's AIDS drug Tenofovir "in the public interest", signaling it may reject its patent request because of a high price and negotiate imports of generic drug.
The Health Ministry said in a decree published on Wednesday patenting the drug in Brazil "was generating expectations of monopoly rights with an impact on the price of the product."
Latin America's largest country has an internationally-lauded AIDS prevention and treatment program, in which patients get free antiretroviral treatment.
The ministry said it had requested a priority examination of the patent filing by the company with the Brazilian INPI patent body, which will have to take into account the ministry's objections.
"If no patent is issued, Brazil will be free to negotiate prices of the drug, be it generic or brand name," a health ministry source told Reuters on Thursday, adding that the case was "not about compulsory licensing" or breaking patents.
A representative of Gilead Sciences Inc. in Brazil declined to comment on the issue but said high-ranking Gilead officials were in contact with the ministry to discuss the case.
The Health Ministry source said the case was different from last year's bypassing of a Merck patent for Efavirenz drug.
Last May, President Luiz Inacio Lula da Silva authorized Brazil to sidestep the patent on an AIDS drug made by Merck & Co. Inc. and import a generic version from India instead. It was the first time Brazil bypassed a patent to acquire cheaper drugs for its AIDS program.
The process then also started with the government declaring the drug "in the public interest" and saying it was too expensive to buy.
If the Tenofovir patent is rejected, Brazil may choose to import generic drug using a clause in World Trade Organization rules to flout drug patents in the name of public health.
Other countries, including Canada, Italy and Thailand, have also used the WTO clause to gain access to cheaper AIDS drugs.

(Reporting by Pedro Fonseca and Maria Pia Palermo, writing by Andrei Khalip; Editing by Derek Caney)


Host of pricing models proposed for UK drugs

April 09, 2008
Financial Times

UK pharmaceuticals companies are introducing new drug pricing models as pressure mounts to offer better value for money.
The National Institute for Health and Clinical Excellence (Nice), the government's medicines advisory body that studies clinical and cost effectiveness, has agreed three different experimental approaches to pricing with drug companies in the past year alone.
Manufacturers have also proposed their own money-back offers and discounts as a way to win reimbursement by the National Health Service or boost sales for costly new treatments. The initiatives are important for drug companies' sales and future pricing strategy around the world.
Belen Garijo, senior vice-president for Europe and Canada for Sanofi-Aventis, said: "Pressure to keep costs under control is forcing us more and more to document the value of new products. These are times of unprecedented change. The UK has almost invented pay for performance."
While the UK accounts for about 3 per cent of global pharmaceutical sales, it has a disproportionately greater influence internationally, reflecting its importance in research and development, relatively high prices and methods of scrutiny.
Since its creation in 1999, Nice has advised against NHS use of costly new drugs including GlaxoSmithKline's antiviral flu drug Relenza, its first decision, to more recent rejections of Pfizer's oral insulin Exubera for diabetics and Eisai's Aricept in patients with early Alzheimer's disease.
Aside from threats and legal appeals, the industry has also responded commercially. Drug pricing in the UK, like elsewhere in Europe, is tightly regulated. The UK's Pharmaceutical Price Regulation Scheme (PPRS), currently being renegotiated, forbids increases - although it permits and even periodically imposes reductions.
Pfizer worked within the system to launch a pioneering "outcomes guarantee programme" with 18 primary care trusts in 1999. It agreed to reimburse the extra costs of using its higher priced cholesterol-lowering Lipitor over other similar drugs if patients did not show improvement.
Other variants have followed. When in 2002 Nice advised against reimbursement of beta interferons, a class of drugs to treat multiple sclerosis, the Department of Health established a "risk-sharing" scheme. The NHS would pay but periodically review effectiveness, adjusting price as a result.
Then last June, Janssen-Cilag, a subsidiary of Johnson & Johnson, avoided a negative Nice recommendation by agreeing to reimburse the NHS for the cost of Velcade, its multiple myeloma treatment, to any patients who failed to respond significantly.
The Office of Fair Trading last year endorsed "value- based pricing", which is designed to link costs more closely to benefits, in a report calling for an overhaul of the PPRS. GSK argued prices should be re-examined after two to three years of patient use, with price increases or reductions in response to efficacy.
However, Panos Kanavos from the London School of Economics warns that such an approach "does not encourage risk taking or reward innovation".
There are also practical difficulties. With Velcade, Nice was able to identify very precise medical measures to assess how far the medicine is helping patients. But for many other drugs, outcomes are more difficult to measure.
Michael Rawlins, chairman of Nice, suggests the potential for risk-sharing schemes is limited. "I doubt whether they have legs in the long run," he said. He suggests companies propose them to avoid cutting prices in the UK - a decision that would spark copycat reductions by payers across Europe, but which is in any case inevitable over time.

(c) 2008 The Financial Times Limited. All rights reserved .


Summer Institute in Pharmacoepidemiology and Outcomes in Rhode Island, USA

The University of Rhode Island College of Pharmacy will hold the second annual Summer Institute in Pharmacoepidemiology on June 9-11, 2008 at the Whispering Pines Conference Center of the Alton Jones Campus of the University of Rhode Island in West Greenwich, Rhode Island.

The Summer Institute in Pharmacoepidemiology was conceived to provide a forum for the continued acquisition of information and methods in pharmacoepidemiology, and the exchange of ideas between government, academia and industry. It is targeted at the many professionals and students planning careers in drug safety, development of practice guidelines, drug policy and clinical trials.

Pharmacoepidemiology is a relatively new (2-3 decades) application of epidemiology, and the only branch of epidemiology that is directed entirely at health issues arising from therapies intended to treat or prevent disease. Medications are prescribed to improve the health of patients, but all medications are accompanied by some level of risk. When medications are used inappropriately, or when the level of risk is not well understood, medication use can lead to a decline, rather than an improvement in health.

The University of Rhode Island College of Pharmacy Summer Institute in Pharmacoepidemiology is the first of its kind to begin to address the higher level training needs of professionals finding themselves responsible for surveillance, pharmacovigilance, formulary development, practice guidelines, risk management and related activities in government and industry.

Five courses, 3.5 hours each, will take place over a three day period. Meal times will permit faculty and students to continue discussions, exchange information, and identify topics for future research. Courses and faculty are described below.

Pharmaceutical Outcomes Research,
Diana Brixner, PhD/ Joanne LaFleur, PharmD, MPH
University of Utah

Individualized Medicine,
Sean P. David, MD, SM, DPhil,
Brown University

Systematic Literature review and Meta-analysis,
Susan D. Ross, MD, FRCPC
Consultant in Evidence Based Medicine

Drug Safety Surveillance at FDA ,
Judy A. Staffa, PhD, RPh,

Therapeutical Risk Management: Pharmaceutical Industry Practice
Songlin Xue, MD, PhD,
Novartis Pharmaceuticals

Tuition for the entire three days is $925 and includes all five courses with our nationally recognized faculty, all course materials, and lunches for each of the three days, June 9, 10 and 11, 2008.

Register online at: www.uri.edu/pharmacy/ce/si08.

Accomodations at the Alton Jones are $360 for single occupancy and $240/person for double occupancy.

For reservations, download form at: www.uri.edu/pharmacy/ce/si08/room_reservation_form.pdf or telephone (401) 397-3361, ext. 6056.

Accomodation fees include dinner on Monday and Tuesday evening, June 9 and 10, 2008, and breakfasts on Tuesday, and Wednesday, June 10 and 11, 2008. Lunches are included in course registration fee. Payment is NON-REFUNDABLE after May 8, 2008 Reservations will be honored in the order in which they are received.

For more information see our website:

Diana Brixner, RPh, PhD
Associate Professor and Chair
Department of Pharmacotherapy
Executive Director Outcomes Research Center
President International Society of Pharmacoeconomics and Outcomes Research (ISPOR)