RADAR on Specialty Pharmacy

As scrutiny over what Americans pay for prescription drugs continues, the Federal Trade Commission (FTC) is joining the action. In early June, the agency voted unanimously to launch an investigation of the business practices of the six largest PBMs. Then a little over a week later, it issued a statement on its enforcement policy on certain rebates and fees that manufacturers give PBMs that result in the exclusion of lower-cost drugs on their formularies. Industry experts say that PBMs should heed this “aggressive approach,” which appears to be challenging them to show that these rebates are justifiable and being passed on to patients and payers.

The focus comes after President Biden’s July 9, 2021, Executive Order on Promoting Competition in the American Economy in which he called for “a fair, open, and competitive marketplace” across numerous industries. “Americans are paying too much for prescription drugs and healthcare services — far more than the prices paid in other countries. Hospital consolidation has left many areas, particularly rural communities, with inadequate or more expensive healthcare options. And too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.”

Only days before the end of CMS’s Oncology Care Model (OCM), the agency unveiled a successor that will start next year. While oncologists have been overall positive about the new program, they still have had some complaints.

Offered through the Center for Medicare and Medicaid Innovation (CMMI), the Enhancing Oncology Model (EOM) is a five-year, value-based, patient-centered care model that will start on July 1, 2023. Participants may include oncology physician group practices, private payers, Medicare Advantage plans and state Medicaid agencies. The application submission period started when the voluntary model was introduced on June 27 and will close Sept. 30.

As Congress again proposes drug pricing efforts, many of its members, as well as a couple of government agencies, have pharma manufacturers in their crosshairs for a somewhat related reason: their patent processes. The FDA and the U.S. Patent and Trademark Office (PTO) recently said they would be working together to scrutinize certain practices that could potentially lead to delays in competition from biosimilars and generics.

The move follows President Biden’s July 9, 2021, Executive Order on Promoting Competition in the American Economy in which he called for “a fair, open, and competitive marketplace” across numerous industries. “Too often, patent and other laws have been misused to inhibit or delay — for years and even decades — competition from generic drugs and biosimilars, denying Americans access to lower-cost drugs.”

The U.S. market recently welcomed the first ophthalmologic biosimilar onto the market: Samsung Bioepis Co., Ltd. and Biogen Inc.’s Byooviz (ranibizumab-nuna), which references Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab). While the agent is entering what is becoming a fairly crowded space, it will offer a cost-effective option for payers, say industry sources.

On Sept. 20, 2021, the FDA approved Byooviz for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). Under an agreement with Genentech, Samsung Bioepis and Biogen were not able to market the vascular endothelial growth factor (VEGF) inhibitor in the U.S. until June 2022. Biogen Inc. and Samsung Bioepis Co., Ltd. said on June 2 that they had launched Byooviz, and the medication became commercially available on July 1. The list price of the intravitreal injection is $1,130 per single use vial, which is 40% less than Lucentis’ list price.

While plan sponsors continue to use traditional utilization management (UM) tools for specialty drugs, some of these tactics have evolved over the years, as well as been joined by newer ones, such as new-to-market formulary blocks, according to a new report from Pharmaceutical Strategies Group (PSG), an EPIC company. And plans’ tracking of specialty spend under the medical benefit has improved, with 70% of respondents having this capability, up from 50% in 2019, according to the 2021 Trends in Specialty Drug Benefit Design Report.

The report, which is co-sponsored by Roche Group member Genentech USA, Inc., is the ninth annual version. It previously was published under the Pharmacy Benefit Management Institute (PBMI) brand.