Radar on Drug Benefits

Although several PBM reform measures are already circulating in Congress, lawmakers recently added even more legislative proposals to the fray. The Senate Finance Committee released a discussion draft that would introduce a host of financial reporting requirements for PBMs contracted by Medicare Part D plans, and then announced it would mark up a package including that measure and other PBM reforms later this month. And, following a markup, the House Education and Workforce Committee advanced a spate of bills focused on promoting transparency for PBMs, health care providers and insurers.

A Capitol Hill insider tells AIS Health, a division of MMIT, that how exactly these measures will fit into a final package of PBM reform legislation remains to be seen, although a few possible scenarios are beginning to come into view.

Since the first biosimilar for Humira launched in the U.S. this January, it’s been joined by several other biosimilars referencing AbbVie Inc.’s blockbuster immunosuppressive drug — with each manufacturer trying to differentiate their offerings in a suddenly crowded market. Major PBMs Optum Rx and Express Scripts have both responded by adding some of the newly launched biosimilars to their standard commercial formularies, while CVS Caremark appears to be still considering its options.

Experts who spoke with AIS Health, a division of MMIT, shared a variety of viewpoints about how coverage of the newly launched biosimilars is shaping up. But all are closely watching how PBMs, physicians and patients respond to the influx of competition for AbbVie’s cash cow, which has earned the drugmaker $208 billion globally since it was first approved by the FDA in 2002.

The FDA last month approved two new gene therapies for Duchenne Muscular Dystrophy (DMD) and hemophilia A, and major PBMs tell AIS Health, a division of MMIT, that they have not yet decided how to cover the new treatments. If current trends are any indication, health plans will impose strict utilization management requirements and attempt to negotiate outcomes-based reimbursement pacts with the treatments’ manufacturers.

The FDA on June 22 granted accelerated approval to Sarepta Therapeutics, Inc.’s Elevidys (delandistrogene moxeparvovec-rokl), the DMD treatment. It will have a list price of $3.2 million. BioMarin Pharmaceutical Inc.’s Roctavian (valoctocogene roxaparvovec), for hemophilia A, gained full FDA approval on June 29, and will have a list price of $2.9 million. Both therapies are administered as a one-time dose. Roctavian also typically requires an indefinite period of simultaneous treatment with corticosteroids to reduce patients’ immune-system response to the gene therapy.

For the past couple of years, payers have been focusing more attention on health inequities related to race, income and other factors by hiring staff and investing money in programs to improve access to care and lower costs. More recently, they have adopted similar strategies to address inequities in the pharmacy side of their businesses, according to health plan executives who spoke at a conference last month at the University of Pittsburgh.

The push among payers is known as “pharmacoequity,” a term popularized by Utibe Essien, M.D., an internal medicine physician and assistant professor at UCLA. Essien, who moderated the panel with the payer executives, defines pharmacoequity as “equity in access to pharmacotherapies or ensuring that all patients, regardless of race and ethnicity, socioeconomic status, or availability of resources, have access to the highest quality of pharmacotherapy required to manage their health conditions.”