Spotlight on Market Access

Founded in 1944 as the Florida Hospital Service Corp., GuideWell Mutual Holding Corp. is one of the largest Blue Cross and Blue Shield affiliates in the U.S. GuideWell is the parent company of Florida Blue, Capital Health Plan, Inc., Florida Health Care Plan, Inc. and, as of Feb. 1, Triple-S Management Corp. With more than 3.7 million members enrolled its in commercial and Medicare Advantage products, Florida Blue is the largest insurer in Florida.

The oncology space is undergoing a tremendous amount of innovation, as novel new products and practices become available. But those treatments can do only so much good if oncologists aren’t using them. Biopharma companies have an opportunity to differentiate themselves from their competitors by addressing oncologists’ specific needs, industry experts tell AIS Health, a division of MMIT.

When it comes to drug information, oncologists not only want to understand a product’s efficacy, “but also how to efficiently and effectively diagnose the patient and get that patient to the right targeted drug or combination using the patient’s genetics and the genetics of the tumor,” such as BRCA1 mutation-positive in breast cancer, explains Kristen Pothier, principal at KPMG U.S. Healthcare and life sciences deal advisory and strategy leader.

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.