Radar on Drug Benefits

Eli Lilly & Co. announced on March 1 that it would cap the out-of-pocket costs for its insulin products at $35 per month and reduce the list price of its most commonly prescribed insulins by 70%. President Joe Biden released a statement calling the move “a big deal” and has called on Congress to mandate a $35 out-of-pocket insulin cost cap for all commercial health plan members. Yet health policy insiders tell AIS Health the company’s decision may be tied in part to an upcoming change in Medicaid rebates. Plus, it’s unclear whether it will lower the net cost of the widely used therapies.

The American Rescue Plan Act that passed in 2021 includes a provision that eliminates the Medicaid drug rebate cap in 2024. Since 2010, there has been a rebate cap for Medicaid at 100% of a drug’s average manufacturer price (AMP), meaning drug companies that exceed the cap do not have to pay Medicaid additional money for increasing prices, as the Kaiser Family Foundation noted in a brief last year.

At the American College of Cardiology’s annual meeting in New Orleans, Esperion Therapeutics, Inc., presented data from a highly anticipated clinical trial that shows its cholesterol-lowering drug Nexletol (bempedoic acid) can reduce the risk for heart attack, stroke and other serious cardiac events. Company executives say the results position bempedoic acid as the logical next step for patients who can’t or won’t tolerate statins. Yet some pharmacy benefits experts say it may be a while before the therapy makes a major dent in the market.  

“If any impact is seen, it may be slow as the results of the studies were recently released over the weekend,” Mesfin Tegenu, chairman and CEO of RxParadigm, Inc., tells AIS Health, a division of MMIT. “In theory, there would be an increase in uptake for patients with an established atherosclerotic vascular disease and in those at high risk for vascular disease who are unable or unwilling to take statins,” he adds. “However, coverage may continue to be slow until the data is fully analyzed.” 

Two Alzheimer’s disease drugs developed by Biogen Inc. — Aduhelm (aducanumab) and Leqembi (lecanemab-irmb), which are both meant to attack the buildup of amyloid plaque in the brain — have been met with skepticism by providers and payers. A new report by Tufts University researchers found that few commercial carriers cover Aduhelm, while the Institute for Clinical and Economic Review (ICER) concluded that Leqembi’s high price exceeds its expected clinical value — and one expert says that neither finding is surprising, given the controversies surrounding both drugs. 

The FDA on March 6 said that Leqembi, which Biogen developed in a joint venture with Eisai Co., Ltd., will have a full approval decision by July 6. In February, the agency granted Leqembi priority review; the drug gained an accelerated approval designation in January. Aduhelm, meanwhile, garnered accelerated approval in June 2021, despite broad controversy. Aduhelm's accelerated approval was broadly denounced by practitioners, and the HHS Office of Inspector General is investigating improper contacts between FDA staff and Biogen. 

In 2028, the federal government will likely negotiate the prices of 38 drugs covered under Medicare Part D and two under Medicare Part B, according to an analysis published this month in the Journal of Managed Care & Specialty Pharmacy. Inmaculada Hernandez, Pharm.D., Ph.D., one of the study’s authors, tells AIS Health the evaluation “is going to be very helpful for health plans and PBMs to know which drugs are going to be negotiated” as they evaluate the impact of the Inflation Reduction Act (IRA).

The IRA, which passed last year, includes a provision that requires the government to negotiate for the first time with pharmaceutical manufacturers the prices of some high-cost medications that are not subject to generic or biosimilar competition. It will begin with 10 Part D drugs in 2026, an additional 15 Part D drugs for 2027, another 15 Part D and Part B drugs in 2028 and an additional 20 Part D and Part B medications each year starting in 2029. Part D covers retail prescription drugs, while Part B covers provider-administered medications.