Spotlight on Market Access

Emerging technologies such as artificial intelligence (AI) are being incorporated into numerous processes within the health care system with an eye on improving a wide range of results. But rather than applying them across the board, a balance must be struck between what tasks are best suited for automation and what work best when provided with a human touch.

When it comes to patient onboarding, for instance, automated solutions may help fulfill certain requirements quickly, allowing patients to start needed therapies soon. But adherence to those treatments may be better achieved with a human touch that can help personalize approaches.

While over 90% of health plans receive specialty medication rebates under the pharmacy benefit, the receipt of medical-benefit rebates has risen in the past one to two years, according to the 2024 Trends in Specialty Drug Benefits Report, published by Pharmaceutical Strategies Group, an EPIC company. The report also covered topics like the management strategies of Humira biosimilars and the financial risk associated with cell and gene therapy.

The report is based on responses from 185 benefits leaders from employers, unions/Taft-Hartley plans and health plans representing plan sponsors of approximately 86.6 million covered lives, conducted from Sept. 18, 2023, through Oct. 13, 2023.

The FDA recently approved the second gene therapy for hemophilia B, Pfizer Inc.’s Beqvez (fidanacogene elaparvovec-dzkt). But while the manufacturer priced the agent at parity to the other treatment, that price may still be too high for many payers, according to a Zitter Insights survey.

On April 25, the FDA approved Beqvez for the treatment of adults with moderate to severe hemophilia B who use factor IX prophylaxis therapy; have current or historical life-threatening hemorrhage; or have repeated, serious spontaneous bleeding episodes and do not have neutralizing antibodies to adeno-associated virus (AAV) serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. The manufacturer launched a warranty program for the intravenous infusion based on durability of patient response to treatment.

On April 24, Walgreens Boots Alliance Inc.’s Walgreens revealed that it will launch Walgreens Specialty Pharmacy on Aug. 1. The company is touting the new division, which will include AllianceRx Walgreens Pharmacy and four central specialty pharmacies, as being able to swiftly serve patients without being invested in a PBM. And that could mean enhanced opportunities for contracting with payers and manufacturers, according to one expert.

The new unit will also feature nearly 300 community-based specialty pharmacies across the U.S. and a new 18,000-foot Gene & Cell Services Pharmacy and Innovation Center in Pittsburgh. The division will have more than 1,500 specialty-trained pharmacists, 5,000 patient advocacy support staffers and 10 Specialty360 teams. It also has access to more than 240 limited distribution drugs, including 40 narrow networks and 12 exclusive limited distribution agents.

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.