Radar on Drug Benefits

  • News Briefs: FDA Sets Date for Donanemab Panel

    The FDA on June 10 will consult a panel of outside experts on donanemab, Eli Lilly & Co.’s Alzheimer’s drug. In the advisory committee hearing, third-party experts in neuroscience and drug development will hear presentations from the FDA and Lilly, then be able to question Lilly and FDA officials on the data behind donanemab’s application for approval. A decision on the drug had been expected earlier this year, but the FDA decided to delay it in order to let the advisory committee hearing take place. However, the advisory committee’s recommendation does not carry any official weight. That was a point of controversy after the FDA in 2021 granted accelerated approval to Biogen Inc. & Eisai’s Co.’s Aduhelm (aducanumab), ignoring near-unanimous disapproval from a similar panel. Several advisers resigned from the advisory panel after the Aduhelm accelerated approval decision.
  • AMCP Panel, GAO Report Sharpen Focus on State PBM Regulation

    Although PBM-targeted legislation has stalled at the federal level, states are forging ahead in their efforts to rein in the highly scrutinized industry. In fact, the volume of state measures aimed at PBMs recently led the Government Accountability Office (GAO) to publish a review that zeroed in on five states that have taken a variety of approaches. Meanwhile, speakers at the Academy of Managed Care Pharmacy (AMCP) annual meeting told attendees about pending measures in states like California that industry stakeholders should be closely watching.

    “We talk about states as the laboratories of democracy a lot,” Adam Colborn, director of government affairs at AMCP, said during an April 17 session at the conference, which was held in New Orleans. “There are a lot of experiments; I don’t know that they’re all successful experiments, but a lot of policies — particularly in the health care space — that are first enacted at the state level are then later implemented at the federal level.”

  • Rumored Regs Could Help Payers, PBMs Streamline Digital Therapeutic Coverage

    Notable changes to the way breakthrough medical devices are covered by Medicare and other payers could be coming soon, with CMS poised to make some therapeutics eligible for Medicare coverage, and some stakeholders pushing for new legislation to expand digital therapeutic coverage. In the meantime, commercial health plans and PBMs are grappling with how best to cover prescription digital therapeutics (PDTs).

    Health plans and PBMs have varying approaches to digital therapeutic reimbursement. Some plans may place one digital therapeutic in the medical benefit, while others may cover PDTs as part of a pharmacy benefit. That’s because PDTs occupy a unique space in the health benefits landscape: They aren’t pharmaceuticals, but they share many characteristics of a maintenance medication in practice.

  • Expiring Policies Threaten Progress on Opioid Use Disorder Med Uptake

    States and the federal government have taken steps in recent years to increase access to medications to treat opioid use disorder (OUD), such as allowing prescribing via telehealth and easing other restrictions for providers. However, some of those policies are set to expire in the coming months and more needs to be done to ensure patients receive the much-needed treatments, health policy experts tell AIS Health, a division of MMIT.

    A KFF analysis found a 24% increase from 2019 to 2022 in the dispensing of buprenorphine, one of three FDA-approved medications for OUD. A separate KFF report published last month showed that 63% of Medicaid enrollees with an OUD diagnosis received medication treatment in 2020.

  • ICER President, Gene Therapy Report Tackle Tough Cost-Control Questions

    One week before the Institute for Clinical and Economic Review released a white paper laying out ways to manage ultra-high-cost gene therapies, ICER President and CEO Sarah Emond shared frank views about the consequences that result when medications are priced far higher than they need to be.

    “We’re making tradeoff decisions all the time,” Emond said during an April 16 presentation at the Academy of Managed Care Pharmacy annual conference in New Orleans. “Anyone who thinks that we are not rationing care in the United States is not paying attention. It has a lot to do with how good your health insurance is and how much money you have.”

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