Radar on Specialty Pharmacy

While arguably the biggest news within the specialty pharmacy arena in 2019 was the U.S. approval and launch of the $2.1 million gene therapy Zolgensma (onasemnogene abeparvovec-xioi) (RSP 6/19, p. 1), plenty of other happenings stood out in the industry. Among them were FDA approvals for promising treatments for cancer, sickle cell disease (SCD) and cystic fibrosis (CF), as well as double-digit approvals for biosimilars. Independent specialty pharmacies continued to be squeezed by a variety of factors (see story, p. 1), as larger combined entities took up more and more market share. AIS Health asked various industry experts to weigh in on the biggest specialty pharmacy events in 2019.

Looking back over the past year, what do you think were the most noteworthy occurrences within the specialty pharmacy industry, and why?

✦ Express Scripts and Prime Therapeutics LLC unveiled a partnership by which the former will offer the latter services related to retail pharmacy network and drug manufacturer contracts. Through the three-year deal, Express Scripts, a Cigna Corp. subsidiary, will provide pharmacy network development and negotiate with drugmakers for pharmacy benefit drugs on behalf of Prime’s 28 million members, as well as its own 75 million customers. Each company will work independently on managing medical benefit therapies and value-based contracting. In a Jan. 7 Drug Channels blog, Adam Fein, Ph.D., CEO of Drug Channels Institute, a subsidiary of Pembroke Consulting, Inc., maintains that the transaction “has potentially major implications,” as “manufacturers and pharmacies will face the biggest PBM ever.” Contact Prime’s Karen Lyons at klyons@primetherapeutics.com and Cigna’s Will McDowell at William.mcdowell2@cigna.com. Read Fein’s blog at https://bit.ly/36xvnJb.

✦ Prime Therapeutics has entered into an oncology value-based arrangement with Pfizer Inc. “Prime will utilize real-world patient pharmacy data to support a value-based agreement related to patients’ adherence to their cancer treatment,” says that company in a press release. Prime declined to respond to AIS Health questions about the partnership. Contact Prime’s Jenine Anderson at jenine.anderson@primetherapeutics.com.

✦ Dec. 3: The FDA expanded the label of Tecentriq (atezolizumab) in combination with Abraxane (paclitaxel protein-bound) and carboplatin for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. The agency initially approved Tecentriq from Genentech USA, Inc., a Roche unit, in May 2016 (RSP 6/16, p. 6); it has multiple oncologic indications. Dosing for the newest use is 1,200 mg delivered via intravenous infusion over 60 minutes every three weeks prior to chemotherapy. If the initial 60-minute infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. After four to six cycles of chemotherapy are completed, Tecentriq 840 mg is administered every two weeks, 1,200 mg every three weeks or 1,680 mg every four weeks. Website Drugs.com lists the price of an 840 mg/14 mL vial of Tecentriq as more than $6,500. For more information, visit www.tecentriq.com.

✦ Dec. 4: The FDA expanded the indication for FoundationOne CDx for use as a companion diagnostic for Novartis AG’s Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated advanced breast cancer following progression on or after an endocrine-based regimen. The agency initially approved Piqray in May 2019 (RSP 6/19, p. 8). The Foundation Medicine, Inc. test is approved for use with 18 therapies. Visit https://bit.ly/2ORBOAs.

Diplomat Pharmacy, Inc.’s sale to OptumRx (see story, p. 1) will mark the end of a specialty pharmacy that is nearly half a century old.

Diplomat began operations in 1975 as a small, regional operation, and, in 2014, it made the decision to go public (RSP 7/14, p. 1). At the time, the company was the fourth largest specialty pharmacy in the U.S., and the move was hailed by industry experts. Diplomat made multiple acquisitions to expand into areas such as bleeding disorders, immune globulin therapy and hepatitis C (RSP 7/15, p. 1).

Late last month, the Trump administration moved ahead with a proposed rule and draft guidance that could open the door to drug importation. The moves, it contended, would lower U.S. prescription drug prices. But skepticism exists as to whether the policies will ever be implemented, as well as if all involved entities would even participate in the efforts.

An HHS notice of proposed rulemaking (84 Fed. Reg. 70796, Dec. 23, 2019) would allow states and certain nonfederal government entities to submit for review to HHS proposals for programs to import drugs from Canada that have been approved by Health Canada’s Health Products and Food Branch. Those programs also may have co-sponsors, which could be a pharmacist, a wholesaler, another state or another nongovernment entity. Drugs not eligible for importation include controlled substances, biologics, infusibles, intravenous injectables, drugs inhaled during surgery, certain parenteral drugs and drugs with Risk Evaluation and Mitigation Strategies (REMS).