Spotlight on Market Access

The FDA has approved a handful of drugs to treat atopic dermatitis recently. Among them is LEO Pharma Inc.’s Adbry (tralokinumab-ldrm), an interleukin-13 (IL-13) antagonist. According to a Zitter Insights survey, payers may take a bit of a restrictive approach in managing the drug.

On Dec. 28, the FDA approved Adbry for the treatment of people at least 18 years old with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those treatments are not advisable. The decision made it the first biologic that LEO Pharma has launched in the U.S. Recommended dosing is an initial dose of 600 mg via four 150 mg subcutaneous injections and then 300 mg every other week.

With its roots in the health insurance industry stemming back to 1917, Cambia Health Solutions is a nonprofit health insurance company and member of the Blue Cross Blue Shield Association, offering Blues products in Idaho, Oregon, Utah and Washington. Known as The Regence Group until 2013, Cambia operates four regional managed care organizations under its Regence BlueCross BlueShield branding. Outside of its Blues brands, Cambia also operates BridgeSpan Health Company, which focuses on Affordable Care Act exchange products, and Asuris Northwest Health, a community-based insurer offering commercial and Medicare Advantage plans in Washington state.

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.

On Oct. 15, 2021, the FDA granted interchangeability status to Cyltezo for all of its approved uses. Boehringer Ingelheim’s Phase III VOLTAIRE-X clinical trial found no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity and safety over multiple switches between Humira and Cyltezo. Per the Biologics Price Competition and Innovation Act (BPCIA) of 2009, the drug will have one year of exclusivity upon launch during which the FDA cannot grant interchangeable status to another Humira biosimilar.

The FDA approval of the first biosimilar for ocular use is poised to bring savings to a costly class, particularly in Medicare. However, ophthalmologists’ and retinologists’ lack of experience with biosimilars is a potential roadblock to these drugs’ uptake. Payers should focus on provider education and outreach ahead of these drugs’ launches in order to ease concerns about their use, say industry experts.

As precision medicine continues to evolve, companion diagnostics (CDxs) are increasingly being used to guide sometimes life-or-death treatment decisions. Their aim is to improve clinical outcomes by using predictive biomarkers to target patients, especially those with cancer, who could respond well to particular therapeutics. But industry experts cite a disconnect at times between FDA approval and payer reimbursement, slowing the potential impact of a burgeoning array of CDxs and prompting pharma companies to take proactive steps to market them.