PCMA: Medicare Should Base Prescription Drug Class Decisions on Clinical Evidence, Not Politics
March 18, 2009
Comparative Effectiveness, Not Protected Classes for ‘Me-Too’ Drugs
(Washington, DC)-The Pharmaceutical Care Management Association (PCMA) released the following statement today on the Medicare Advantage and Prescription Drug Programs (MIPPA) Drug Formulary & Protected Classes Policies:
“PCMA strongly believes that clinical evidence, not political considerations, should guide Medicare formulary decision-making. While the comparative effectiveness provision in the American Recovery and Reinvestment Act of 2009 (ARRA) relies solely upon clinical evidence, the ‘protected classes’ provision of last year’s MIPPA statute is arbitrary, offers no proven ability to increase access and, according to the Centers for Medicare & Medicaid Services, will increase costs by $4.2 billion over 10 years.
“As Consumer Reports noted in its research released yesterday, comparative effectiveness improves both patient and physician decision-making.
“History shows that manufacturers of ‘me too’ drugs have no incentive to offer deep discounts unless they face some chance that their competitors will be included on a given formulary instead of themselves. All other drug benefit coverage including FEHBP, union plans, and private retiree plans address this by making rival manufacturers of ‘me-too’ drugs offer lower prices in order to compete for better formulary placement. This is accomplished while also maintaining an excellent record of ensuring that patients get the medications they need. This is particularly true of those in vulnerable populations who suffer from mental illness, HIV/AIDs and other conditions which ‘protected classes’ are meant to address.
“The ‘protected classes’ concept presents a step backward and, unfortunately, only ‘protects’ the pricing policies of drug manufacturers.”
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PCMA represents the nation’s pharmacy benefit managers (PBMs), which improve affordability and quality of care through the use electronic prescribing (e-prescribing), generic alternatives, mail-service pharmacies, and other innovative tools for 200-plus million Americans.





