USP Offers Few Changes In Part D Draft Model Formulary Guidelines For 2009

The U.S. Pharmacopeia's draft model formulary guidelines version 4.0 do not include additional therapeutic categories or pharmacologic classes compared with the current version.

Once final, the guidelines will serve as a point of reference for Part D formularies in 2009. Part D plans that choose to follow the USP model are required to cover at least two drugs in each unique category or class.

The deadline for submission of public comments on the draft model guidelines is Dec. 6. USP plans to submit the final version to CMS by Feb. 3.

Like the 3.0 version of the guidelines, the draft lists 50 therapeutic categories, 119 pharmacologic classes, and a total of 138 unique categories and classes. No categories or classes were phased out in the draft version, but a few were renamed to accommodate newly-approved drugs or to promote clarity.

While the draft 4.0 version is fairly static in terms of categories and classes, last year's version made a number of additions (¹ (Also see "USP Final Formulary Guidelines Drop Combo HIV Drug Class At CMS’ Request" - Pink Sheet, 5 Mar, 2007.), p. 22).

The draft 4.0 version does include two new "formulary key drug types," a grouping of drugs developed by USP to break down categories and classes to a more granular level.

CMS uses the FKDTs as an outlier test in evaluating Part D formularies for completeness under a revised policy put into place for the 2008 benefit year. Prior to that, CMS expected plans following the USP guidelines to provide coverage for at least one product in each FKDT.

The change was prompted by the conclusion that the requirement was duplicative to other formulary "checks" employed by CMS and to allow further flexibility in negotiations between drug firms and plan sponsors.

In the USP draft, the FKDT "multitargeted kinase inhibitors, HER2 receptor, tyrosine kinase inhibitors" was added to the molecular target inhibitors class within the antineoplastics category.

The addition is meant to accommodate GlaxoSmithKline's new breast cancer drug Tykerb (lapatinib), USP notes.

To cover Novartis' hypertension treatment Tekturna (aliskiren), the draft guidelines add a "direct renin inhibitors" FKDT to the renin-angiotensin-aldosterone system inhibitors class.

CMS has reported that of the 387 unique formularies that Part D plan sponsors submitted for review for 2007, 60 percent were based on USP's model. In contrast, more than 70 percent of formularies reviewed followed USP's format in 2006. The agency has not released similar statistics for the 2008 plans.

USP's Medicare Model Guidelines Expert Committee addressed the future relevance of the model guidelines during a meeting last summer.

According to a summary of the Aug. 6 meeting, the group agreed an analysis of data on plans' use of the model guidelines "would facilitate modification of the [guidelines] to ensure that they continue to be relevant in the marketplace." The group further observed that data on formulary appeals "would be useful."

Applying USP's Expertise

The committee also discussed other potential applications for its expertise in formularies. For example, the group identified an "opportunity to help improve the quality of prescribing for older adults and others covered by Medicare by providing evidence-based recommendations for use of drugs by older adults," the summary states.

USP could "evaluate research data and perform drug-to-drug comparisons. Both prescribers and drug plans might benefit from this activity," the summary continues.

Addressing reimbursement for drugs provided through physicians' offices, the committee discussed making USP "more public" on the value of formularies in prescribing decisions. "Medicare has overpaid through direct negotiation for Part B drugs," the summary maintains.

- Cathy Kelly ([email protected])