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Comments on the draft revision of the Model Guidelines

December 28, 2005
US Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD 20852
Attn: Deborah Perfetto
Dear Sirs:
In response for the request for comments on the draft revision of the Model Guidelines, Consumers Union, the independent, non-profit publisher of Consumer Reports submits the following.
Even before getting to the question of affordability, the key concern of American healthcare consumers is that when they need a prescription drug, that it be safe and effective. Because of the incredible complexity of modern medicine, consumers rely on their doctors, pharmacists, and health plans to ensure that they receive such safe and effective medicines. It is essential that the Pharmacy and Therapeutics Committees of the Part D drug plans help ensure this safety and effectiveness.
Consumers Union understands that your immediate project this December is to receive comment on the revision of the proposed categories and classes of drugs—and that is very important. But even more important in the long-run is the need to ensure that Part D P&T Committees and the formularies they create give priority to safety and effectiveness.
Consumers Union has been engaged in project to help consumers obtain the most effective, safe medicines. The Consumer Reports Best Buy Drugs campaign relies on the independent, transparent, evidence-based research of the Oregon Health and Science University’s Drug Effectiveness Review Project (DERP) to identify the safest and most effective drugs in various major categories. We then match those drugs with national average drug prices and make ‘best buy recommendations.’ Enclosed are samples of our recent publications designed to help consumers make safe, effective, and best value decisions. As you can see, our recommendations range from a heavy emphasis on generics to a use of brand name drugs where those drugs provide the best value and appear to be both safe and effective. Our recommendations are not based on just price alone.
We are concerned that many Part D P&T Committees will make their decisions based on the best drug rebate and discount for the plan and not on whether the drug is the safest and most effective. In many other cases, P&T Committees may list a drug because it is heavily advertised and in popular demand, not because it is the safest, most effective or best buy. There is extensive research literature on how pharmaceutical advertising drives consumers to ask for, and doctors to accede to the prescribing of unnecessarily dangerous and dubious drugs. Other stories show how sales representatives, with a ‘little hair toss and a tug on his sleeve’* persuade doctors to order drugs. We assume that Part D P&T Committee members will be subject to similar pressures and inducements, especially since the law does not require that a majority of the P&T Committees be free of industry or Plan control.
Those charged with the challenge of helping Medicare beneficiaries navigate this incredibly complex marketplace need a way to rate the quality of Part D plan P&T Committees and the formularies they offer the public. At this time, Medicare beneficiaries who are Internet-savvy have access to a wealth of information about their projected costs under various plans, but virtually no accessible information about the basis for selection of drugs for plans’ formularies. This is a long-range project, beyond the subject of this year’s comment period. But we urge you to begin to give consideration, now, on how we can achieve this ultimate consumer protection. We urge you to announce that you will seek input on this question, with the long-term goal of developing a ‘gold standard’ in P&T operations and formularies based on the most rigorous, unbiased, transparent reviews of the clinical evidences that are available.
Thank you for your consideration of this request.
William Vaughan
Senior Policy Analyst
Washington Office
* “Gimme an Rx! Cheerleaders Pep Up Drug Sales,” by Stephanie Saul. New York Times, November 28 2005