Proposed Guidelines for Medicare Prescription Drug Benefit Formulary Released
As expected, the United States Pharmacopeial Convention on Thursday released its proposed guidelines for the creation of a prescription drug formulary for the new Medicare drug benefit, the AP/Las Vegas Sun reports. The guidelines listing 146 classes of medications that should be covered by Medicare, including categories for antidepressants, HIV/AIDS drugs, cholesterol-lowering medications and anti-inflammatories (Sherman, AP/Las Vegas Sun, 8/19). USP, which will receive $1.1 million to create the guidelines, began working on the project in April with the help of four advisory panels that represent beneficiaries, health care providers, drug companies and companies that will sell drug insurance, including pharmacy benefit managers.
The process to create the formulary has resulted in intense lobbying between drug and insurance companies. Insurers and PBMs say that private health plans generally have 50 to 90 separate drug classes, and they contend that a Medicare drug formulary with a small number of classes would create more competition among drug makers and give negotiators more leverage to procure lower drug prices. However, the Pharmaceutical Research and Manufacturers of America says that it found the number of drug classes in four private-sector formularies ranged between 157 and 311 classes. Drug makers want more than 200 drug classes to enhance their companies' odds of having products listed on the formulary and to give consumers broader access to drugs (California Healthline, 8/19).
According to the AP/Sun, neither insurers nor PBMs were "happy" with the proposal. A statement issued by the Pharmaceutical Research and Manufacturers of America said the proposal "would set back treatment for conditions including but not limited to diabetes, asthma, heart disease, depression, migraine, epilepsy and gastrointestinal conditions." The AP/Sun reports that for anti-arthritic drugs, cholesterol-lowering medications and antidepressants, the guidelines "lump together best-selling brand-name drugs" with older medications, meaning insurers could meet government requirements by covering just the older medications. Mark Merritt, president of the Pharmaceutical Care Management Association, which represents PBMs, said, "If embraced, such an approach ... could have the unintended consequence of increasing costs and jeopardizing a workable Medicare prescription drug benefit for seniors."
CMS Administrator Mark McClellan "declined to endorse the proposed guidelines," the AP/Sun reports. He said, however, that they are a first step to ensure beneficiaries have access to medications at the lowest possible cost. USP's proposal is expected to undergo changes over the next few months as the Bush administration reviews the document. Tricia Neuman, a Kaiser Family Foundation vice president and director of its Medicare Policy Project, said, "The outcome of this process is important because it could determine whether or not seniors get access to the drugs they take." USP is seeking public comments on the proposal until Sept. 17, and a public meeting is scheduled for Aug. 27 in Baltimore (AP/Las Vegas Sun, 8/19).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.