There has been talk lately of Medicare finally providing a drug benefit. There will not be one standard national formularly; each plan providing Medicare services will develop a unique formularly based on federal guidelines. Suggested guidelines to help determine which medications should be included in the new Medicare drug programs have been sent to the Centers for Medicare and Medicaid (CMS). Fierce lobbying battles have developed between pharmaceutical companies and insurers over these guidelines.
Flawed Guidelines?
The proposed guidelines were developed by the United States Pharma-copeial Convention Inc. (USP). The USP guidelines identify a list of drug classes that aid in drug selection for different Medicare plans. The new Medicare law recommended that companies that provide these new drug plans should offer at least two drugs in each class. However, the original drug classes identified resulted in only about 150 available drugs.
Some drug categories were missing from the draft guidelines, others were unusually broad. Critics suggest that if companies use the cost of a drug to determine which drugs will be covered under the new program, generic or older drugs will be overrepresented and the possibility of including any new drugs will be unlikely.
Narrow vs. Broad Drug Classes
Drug companies wanted the guidelines to designate a large number of narrow classes-over 200-because that would increase the likelihood that more of their products would be included on the drug formulary.
Pharmacy-benefits managers advocated between 50 to 90 drug classes; fewer and broader categories would give them more freedom to pick cheaper drugs or bargain down the prices of blockbusters.
According to the USP, the organization proposed a list of 146 classes, seeking a middle ground between the two groups. In some areas, USP leaned toward fairly narrow classes, including five categories of HIV drugs. With other drug categories, the guidelines recommend broader classes that lump together newer, expensive drugs with older categories that are often available in generic form. The classification plan does not automatically grant preferred status to certain popular categories of brand-name medicines. For example, statins are classified with older products in the antilipemic category. This means that many brand-name drugs would have to fight their way onto the list by giving discounts to bring prices closer to generics.
Fierce lobbying battles over the USP guidelines have developed between pharmaceutical companies and insurers.
A recent Wall Street Journal article pointed out problems with narrow classes in which new products are lumped together with decades-old medicines. For example, selective serotonin reuptake inhibitors are classed with tricyclic antidepressants. As a result, a formulary could meet government requirements, but offer only inexpensive generic antidepressants such as amitriptyline or fluoxetine. Another proposed classification mixes all arthritis drugs into a broad, nonsteroidal anti-inflammatory category, which places Cox-2 inhibitors in the same category as older generics such as naproxen.
Insurance companies, the pharmaceutical industry, and provider representatives are shocked that they had such little input into the USP guideline development. One public meeting was held to solicit comments. There was no mention of prior authorization or waivers to allow patients to get nonformularly drugs. Based on the heated response at the meeting, some suspect CMS may make their own modifications to the guidelines. The CMS continues to offer open-door sessions so interested clinicians can comment on specifics in the formularly.