Radar on Drug Benefits

When the FDA in July granted full approval to the Alzheimer’s drug Leqembi (lecanemab), CMS followed with a swift announcement that Medicare will cover it — although just for people with a specific diagnosis who have a physician willing to participate in a qualifying clinical registry. However, payers so far seem reluctant to cover the drug for their commercially insured populations, which represent a smaller but still important portion of the addressable market for Leqembi.

Two Pennsylvania-based insurers — Highmark Inc. and Independence Blue Cross — are taking heat for deciding not to cover the drug for their commercial members. A Philadelphia-area neurology practice recently sent them a critical open letter that claims the insurers are wrong to deem Leqembi “experimental.”

CMS revealed on Aug. 29 the list of the initial 10 drugs that will be subject to drug price negotiations in the Medicare program starting in 2026. However, even before the agency’s announcement, several pharmaceutical companies and other stakeholders filed lawsuits seeking to curtail the negotiation program’s implementation.

During a KFF webinar on Sept. 12, a Medicare policy expert and two attorneys discussed the legal challenges and potential ramifications.

Zachary Baron, associate director of the Health Policy and the Law Initiative at Georgetown University’s O’Neill Institute, said that if courts rule in favor of the drug manufacturers, there could potentially be changes in how Medicare reimburses hospitals and providers, among other consequences.

A bill that “delinks” PBM pay from drug list prices and utilization in Medicare Part D could “shift billions of dollars annually from patients and taxpayers to drug manufacturers and retail pharmacy companies,” according to a new paper funded by the PBM industry’s main trade group. However, some experts argue that the research may not offer a completely accurate assessment, even if it makes some valid points.

“I’m a little bit of two minds on this paper,” says Matthew Feidler, a senior fellow at The Brookings Institution’s Schaeffer Initiative on Health Policy. Feidler, who was not involved in the National Bureau of Economic Research (NBER) paper, recently coauthored an issue brief assessing the current landscape of PBM reform proposals.

New PBM regulations are one step closer to becoming a reality, as leadership of the U.S. House of Representatives released their draft package of health care reforms on Sept. 8. Lobbyists representing plan sponsors tell AIS Health, a division of MMIT, that the House package is not as aggressive as possible legislation in the U.S. Senate, but they point out that much could change when both chambers consider floor versions of their PBM bills.

The House legislation, called the Lower Costs, More Transparency Act, would, according to a summary of the bill prepared by House staffers:

List prices for the 25 branded drugs associated with the highest Medicare Part D spending in 2021 have increased by an average of 226% since they first entered the market, according to a recent report from AARP’s Public Policy Institute. These drugs were responsible for $80.9 billion in total Medicare Part D spending in 2021.

Overall, lifetime price increases among the 25 drugs ranged from 20% to 739%, with all but one of them greatly exceeding the annual rate of inflation over the same period. The list price of Enbrel (etanercept), a treatment for rheumatoid arthritis and psoriatic arthritis, skyrocketed by 701% since entering the market in 1998.