Radar on Drug Benefits

The state of California announced last week that it would become the first state to manufacture its own insulin, while a payer-owned coalition said it would distribute its initial generic medication later this summer. Taken together, the moves show that some payers, be they the government or health insurers, are serious about reining in the costs of generics and dealing with inefficiencies in the pharmaceutical supply chain, according to health policy and drug pricing experts who spoke with AIS Health, a division of MMIT. 

California Gov. Gavin Newsom (D) revealed the insulin plans on July 7 via a video on Twitter, keeping to a promise he had first made in 2019 when he was elected to office. The announcement followed the news in June that EmsanaRx became the first PBM to join CivicaScript, a company founded two years ago by a consortium of payers that is aiming to manufacture and lower the cost of generic medications in outpatient settings. In addition, Navitus Health Solutions, a startup PBM that touts a 100% pass through model, joined the CivicaScript partnership on July 13.

After more than a year of deliberation and false starts, Congress might finally reform pricing and federal purchasing of prescription drugs in the fall, D.C. insiders tell AIS Health, a division of MMIT. The substance of the drug pricing bill is similar to previous proposals, but the political ground inside the Democrats’ Senate caucus may have shifted enough to allow prescription drug pricing to eke through as part of a diminished catch-all spending bill that would still be the signature achievement of the beleaguered Biden administration.

Progress on the drug pricing bill resumed when Senate Majority Leader Chuck Schumer (D-N.Y.) on July 7 submitted the text of a bill to the Senate parliamentarian. The parliamentarian will deem whether the bill conforms with the Senate rules that govern the budget reconciliation process. Budget reconciliation is an arcane procedure that allows the Senate to pass legislation with a simple majority, so long as the bill in question relates largely, in the parliamentarian’s judgment, to the budget.

Digital evidence from apps, wearables and remote sensors is already being used by medical product developers to test and measure their effectiveness. The FDA issued draft guidance earlier this year on the use of digital health technologies to acquire data remotely from clinical trial participants. And the European Medicines Agency approved its first digital endpoint, accepting one to be used to evaluate medications for Duchenne Muscular Dystrophy. 

Payers are next, warned Jennifer Goldsack, CEO of the Digital Medicine Society (DiMe), speaking at the AHIP 2022 conference in Las Vegas, N.V.