Radar on Specialty Pharmacy

As we look back over the past year, the COVID-19 pandemic has been top of mind for many involved in pharma commercialization and coverage. Less than a year after scientists sequenced the COVID genome, the FDA granted emergency use authorization to vaccines from Pfizer Inc./BioNTech SE and Moderna, Inc. in December — an unprecedented time frame for vaccine development, testing and rollout. Shortly thereafter, vaccinations started to be administered. AIS Health spoke with a variety of industry experts on COVID-related trends over the past year.

Could you comment on the COVID-19 pandemic and its impact over the past year?

Dan Danielson, R.Ph., senior director of the access experience team at PRECISIONvalue: “I don’t think you [can] underestimate the economic and societal impact that COVID-19 has. In the U.S., the overall economy has contracted from the pre-pandemic period, with consummate contraction in GDP [i.e., gross domestic product] and job losses on a scale most of us have not seen before.

Centene Corp. celebrated the end of 2020 by closing on its acquisition of specialty pharmacy PANTHERx Rare, LLC on Dec. 30, then started 2021 with an agreement to acquire Magellan Health, Inc. The deals will strengthen Centene’s expertise in the specialty pharmacy space, particularly in the burgeoning orphan drug space by bringing onboard PANTHERx, an experienced company that’s shown remarkable growth over the past 10 years.

Centene and PANTHERx did not disclose terms of the deal, which was unveiled Dec. 15.

✦ HHS has moved ahead with its plan to eliminate rebates to PBMs and plans in Medicare Part D. The administration issued a final rule (85 Fed. Reg. 76666, Nov. 30, 2020) providing safe harbor to rebates given to beneficiaries at the point of sale and to certain PBM service fees. The move follows a proposed rule initially released Jan. 31, 2019 (RSP 2/19, p. 1). The final rule pushed back the implementation date from Jan. 1, 2020, to Jan. 1, 2022. View the rule at https://bit.ly/3gxs6Q3.

✦ Specialty drugs represented 48.5% of net costs in Medicaid in 2019 but accounted for only 1.3% of utilization, according to Magellan Rx Management’s fifth annual Medicaid Pharmacy Trend Report. Specialty trend mainly was driven by net cost per claim, which rose from 2018 by $141.12, while specialty drug utilization declined 0.9%. The report projects that specialty drugs will make up half of overall Medicaid net spend in 2020. Download the report at https://bit.ly/3mZKkvR.

✦ Nov. 9: The FDA expanded the label of Foundation Medicine, Inc.’s FoundationOne Liquid CDx to identify people with BRCA1, BRCA2 and/or ATM alterations in metastatic castration-resistant prostate cancer who may be appropriate for treatment with AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib). The agency initially approved the liquid biopsy test in August (RSP 9/20, p. 8); it’s now approved as a companion diagnostic for seven targeted therapies across four tumor types. The manufacturer says it is the only FDA-approved blood-based test that can analyze more than 300 genes. Visit https://bit.ly/3gINu3h.

✦ Nov. 13: The FDA gave accelerated approval to Merck’s Keytruda (pembrolizumab) in combination with chemotherapy for the treatment of people with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express programmed death-ligand 1 (PD-L1) as determined by an FDA-approved test (see brief below). The agency initially approved the programmed death receptor-1 (PD-1) inhibitor in 2014 (RSP 9/14, p. 4); it now has almost 30 approvals across almost 20 types of cancer. This newest approval is its first in breast cancer. Dosing for this indication is 200 mg every three weeks or 400 mg every six weeks via a 30-minute intravenous infusion. The list price for dosing every three weeks is $9,869.94; for every six weeks, it’s $19,739.88, according to the Keytruda website. Visit www.keytruda.com.

The most-favored-nation (MFN) interim final rule issued in late November is not the first time the current administration has attempted to implement some kind of drug pricing model based on prices in other countries.

The first effort, the International Pricing Index (IPI) model (83 Fed. Reg. 54546, Oct. 30, 2018), was unveiled on Oct. 25, 2018, in an Advanced Notice of Proposed Rulemaking (ANPRM). It proposed that instead of CMS reimbursing Medicare Part B drugs at their average sales price (ASP) plus 6%, it would reimburse these medications per an IPI based on drug pricing data from not only the U.S. but also 16 other developed countries (RSP 11/18, p. 1).