Radar on Specialty Pharmacy

Over the past decade, commercial per-member per-month (PMPM) drug spend under the medical benefit has almost doubled, according to Magellan Rx Management, a division of Magellan Health, Inc.

The company just released the 10th edition of its Medical Pharmacy Trend Report, which also found that 61% of payers were concerned with their medical benefit spend, up from 32% of payers who said this in the inaugural edition of the report.

With numerous hospitals focused on the COVID-19 pandemic and many areas under stay-at-home mandates, home infusion is more important than ever. Changes within the industry already have been seen, and the current situation is likely to result in permanent shifts within the home infusion space.

“If you can do infusion at home, you need to do it there,” maintains Ashraf Shehata, KPMG national sector leader for Healthcare & Life Sciences. “This is about controlling infection risk in the near term, and many home infusion candidates are in a high-risk category. Longer term, there has been a shift toward delivering care in the most economical and clinically appropriate setting, largely driven by payers.”

As people are urged to stay home during the COVID-19 pandemic, CMS has been relaxing a series of health care service policies in support of this need. But one change it hasn’t made is to allow home infusion to be fully covered for all Medicare beneficiaries. Numerous industry stakeholders and members of Congress are pushing for a waiver to allow this to happen.

Traditionally, Medicare reimbursed for home infusion drugs but not the professional services associated with the infusions themselves. This changed in December 2016 with the signing of the 21st Century Cures Act, which established a reimbursement structure for the professional services that are provided with home infusion therapies (RSP 2/18, p. 1). However, this does not take effect until Jan. 1, 2021. But the Cures Act also changed the payment methodology for Medicare Part B drugs furnished through durable medical equipment (DME) starting Jan. 1, 2017, with a handful of drugs seeing a steep decline in reimbursement.

✦ Herzuma (trastuzumab-pkrb) launched on March 16, bringing the total number of Herceptin (trastuzumab) biosimilars to four. Herzuma, from Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Celltrion Healthcare Co., Ltd., is approved for all the indications of its reference product, which is from Genentech USA, Inc., a Roche Group company. Herzuma’s wholesale acquisition cost for a 150 mg vial is $1,402.50, while a 420 mg vial is $3,927, both 10% less than Herceptin’s WAC. Visit www.herzuma.com.

✦ Prime Therapeutics LLC launched its PreserveRx gene therapy reinsurance solution on April 6. The company is working with BCS Insurance Co., a subsidiary of BCS Financial Corp., on the product, which will give Blues plans financial protection for five gene therapies: the already-available $850,000 per person one-time therapy Luxturna (voretigene neparvovec-rzyl) and $2.1 million PP one-time therapy Zolgensma (onasemnogene abeparvovec-xioi), as well as valoctocogene roxaparvovec (valrox), LentiGlobin and GT-AADC, three products expected to gain FDA approval this year. PreserveRx also has a clinical services component that will help forecast the products’ financial impact and potential use and ensure appropriate utilization. Contact Jenine Anderson at Jenine.Anderson@primetherapeutics.com.

✦ March 9: The FDA approved Acacia Pharma Group plc’s Barhemsys (amisulpride) for the prevention of postoperative nausea and vomiting in adults either alone or with an antiemetic of a different class and treatment of PONV in adults who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis. Dosing for prevention of PONV is 5 mg via an intravenous injection over one to two minutes at the time of induction of anesthesia and 10 mg in the event of nausea and/or vomiting after a surgical procedure. The company says it expects the product to be available in the second half of this year. Visit https://barhemsys.com.

✦ March 9: The FDA expanded the label of Ofev (nintedanib) to include the treatment of people with chronic fibrosing interstitial lung diseases with a progressive phenotype. The agency initially approved the Boehringer Ingelheim Pharmaceuticals, Inc. capsule in October 2014 (RSP 11/14, p. 4); this is its third approval, and it had priority review and breakthrough therapy designations. The recommended dose is 150 mg twice daily approximately 12 hours apart. Website Drugs.com lists the price of 60 150 mg capsules as $10,955.35. Visit www.ofev.com.