Radar on Specialty Pharmacy

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.

CVS Pharmacy is expanding its co-branding efforts through a recently unveiled deal with Schnuck Markets Inc. by which it will acquire the company’s retail and specialty pharmacy businesses.

CVS, a subsidiary of CVS Health Corp., will acquire and operate 99 of the Midwest-based grocery chain’s pharmacies and rebrand them as CVS Pharmacy. The company also is purchasing the prescription files from 11 Schnucks pharmacies and transferring them to CVS Pharmacy locations. The stores are located in Illinois, Indiana, Iowa, Missouri and Wisconsin.

On March 2, the FDA approved Sanofi’s Sarclisa (isatuximab-irfc) for the treatment of multiple myeloma, a hematologic malignancy. The move added another therapy to a class full of products, both indicated for the condition and used off label. Almost half of payers responding to a Zitter Insights survey said they anticipate their company will manage the new treatment on parity with other multiple myeloma drugs that have a similar indication.

The FDA approved Sarclisa, a CD39-directed cytolytic antibody, for use in combination with Pomalyst (pomalidomide) and dexamethasone (pom-dex or Pd) — the latter of which is available under multiple brand names — for the treatment of adults with relapsed refractory multiple myeloma who have received at least two therapies including Celgene Corp.’s Revlimid (lenalidomide) and a proteasome inhibitor (RSP 3/20, p. 8).