Spotlight on Market Access

The FDA recently approved the first novel long-acting granulocyte colony-stimulating factor (G-CSF) in more than 20 years. Payers say they are likely to manage the new agent similar to existing ones, but oncologists have indicated that they are willing to prescribe it in place of other neutropenia agents, according to Zitter Insights.

On Sept. 9, the FDA approved Spectrum Pharmaceuticals, Inc.’s Rolvedon (eflapegrastim-xnst) to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. The company developed the drug with South Korea’s Hanmi Pharmaceutical Co. The recommended dose is 13.2 mg administered subcutaneously once per chemotherapy cycle. The company says it expects the product to be available in fourth-quarter 2022. It has not revealed the agent’s price yet.

Mark Cuban Cost Plus Pharmacy, the online pharmacy and generic manufacturing startup backed by the eponymous billionaire investor, recently struck its first deals with a health plan, Pennsylvania’s Capital Blue Cross, and a PBM, Rightway Healthcare Inc. The direct contracting deal represents a major step for the startup, which has done most of its business so far as a direct-to-consumer retailer — and one drug pricing expert tells AIS Health, a division of MMIT, that the deals help Cost Plus moves toward its ambitious, disruptive goals.

Genetic testing is becoming a greater part of health care, as providers can take advantage of it to help inform patients’ diagnosis and treatment. Multiple tests are now available, and many health plans are covering their costs if certain criteria are met. But that’s a tall order with more than 77,000 genetic tests available and new tests constantly coming to market.

Many payers have prior authorization for genetic tests: An AHIP industry survey conducted between September and December 2019 found that genetic testing was the third most common treatment for prior authorization behind specialty drugs and high-tech imaging.

The monthly Medicare Part D base beneficiary premium for 2023 will be $32.74, a slight decrease from $33.37 in 2022, according to CMS. The Part D national average monthly bid amount continues to drop, from $38.18 in 2022 to $34.71 in 2023. Regional low-income premium subsidy amounts have increased over the past few years in most states, yet five states — New York, Illinois, New Jersey, Indiana and Kentucky — are projected to see a decline larger than 5% in 2023. South Carolina is projected to see the biggest jump, with its average subsidy amount going up from $31.12 in 2022 to $37.84.

As companies are exploring different strategies to keep their pharmaceutical costs in check, a spate of so-called alternate funding companies has emerged in the industry. And while they might appeal to a potential client at first glance, some — such as ones that carve out certain specialty drugs and seek coverage from patient assistance funds — may not be worth the investment, say some industry sources, who encourage companies to take a closer look at what their savings actually are.

During a July 29 webinar titled Specialty Drugs Update: Trends, Controversies, and Outlook, longtime industry expert Adam J. Fein, Ph.D., CEO of Drug Channels Institute, noted that while the use of copay accumulators and maximizers has risen, “there is another newer trend that’s even scarier, and that’s the business of what some people call specialty carve-outs,” he said, calling this “the shady business of specialty carve-outs.” Vendors such as ImpaxRX, Payd Health, SHARx, PayerMatrix and Script Sourcing get payers to exclude specialty drugs and then get those drugs covered via patient-assistance programs at manufacturers or charitable foundations. If patients are denied patient assistance, coverage reverts to the company’s payer/PBM/specialty pharmacy.