Radar on Specialty Pharmacy

As President Joe Biden’s administration nears its end, two promised rules on copayment accumulators and maximizers have yet to be released. They stand to have a huge impact on whether pharma manufacturer-provided patient assistance — much of which is provided for specialty drugs — must be counted toward patients’ out-of-pocket responsibility.

The first concerns a lawsuit over the 2021 Notice of Benefit and Payment Parameters (NBPP) and its stance toward copay accumulators.

Health plans and PBMs several years ago began implementing accumulators to counter manufacturer copay assistance programs. Traditionally, that assistance would count toward beneficiaries’ annual out-of-pocket expenses. When those out-of-pocket maximums were reached, health plans would cover the remainder of members’ costs for the year. With accumulators, patients can still use that assistance, but it does not help reduce their out-of-pocket costs.

Most industry experts would agree that paying for costly cell and gene therapies (CGTs) is one of the top issues facing payers. And with more than 4,000 gene, cell and RNA therapies in the pipeline, the issue isn’t disappearing any time soon. One relatively new company is taking a slightly different approach to tackling the issue.

Quantile Health is focused on increasing patient access to CGTs, explained Yutong Sun, co-founder and CEO, during AHIP’s 2024 Medicare, Medicaid, Duals & Commercial Markets Forum, held earlier this year in Baltimore. As almost one-third of self-insured plans have dropped their coverage of gene therapies, the company is focused on this sector of the health care marketplace, which faces “quite different challenges” than other entities, she said. While CGTs may be “a drop in the bucket” for major national plans with annual budgets of a few billion dollars, one CGT could represent half of the annual budget for a self-insured plan with 100 to 500 employees.

The Inflation Reduction Act (IRA) was a sweeping piece of legislation that impacted multiple industries, but the prescription drug aspects of the law have arguably gotten the most attention, both positive and negative. CMS recently released the eagerly anticipated negotiated prices for the first 10 drugs, which will go into effect on Jan. 1, 2026. In preparation for the law’s potential impact, research from Zitter Insights found that both Medicare and commercial plans already have begun to modify their drug management approach.

Aug. 7: The FDA approved Citius Pharmaceuticals, Inc.’s Lymphir (denileukin diftitox-cxdl) for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one systemic therapy. The immunotherapy is the only CTCL treatment that targets the interleukin-2 (IL-2) receptor found in T-cell lymphomas and regulatory T cells (Tregs). The rare disease is a chronic non-Hodkin lymphoma that primarily affects the skin. The drug is a reformulation of Ontak (denileukin diftitox), which was on the U.S. market from 2008 to 2014, when it was voluntarily withdrawn “to enable manufacturing improvements.” The FDA gave the therapy orphan drug designation. The recommended dose is 9 mcg/kg per day based on actual body weight via a 60-minute intravenous infusion on days one through five of a 21-day cycle. The company says it expects to launch the agent within the next five months.