✦ 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Late last month, the Trump administration moved ahead with a proposed rule and draft guidance that could open the door to drug importation.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).
An earlier version of this story incorrectly said that Neupogen (filgrastim) and Neulasta (pegfilgrastim) are Pfizer Inc. treatments. They are Amgen Inc. products. This version has been corrected.
So far, biosimilar uptake has been relatively slow in the U.S. since the 2015 launch of Sandoz Inc.’s Zarxio (filgrastim-sndz), the first product to use the 351(k) approval pathway. But recent and pending launches have resulted in therapeutic classes with more than one biosimilar, which may be the push that payers need to begin preferring them over their reference products, according to Zitter Insights data and, in turn, realizing savings in some costly therapeutic classes.
As independent specialty pharmacies and infusion providers continue to be squeezed by various market pressures, 2019 saw an end to two long-time industry presences. In August, BioScrip, Inc. and Option Care Enterprises, Inc. finalized a merger. And in December, Diplomat Pharmacy, Inc. said that it had agreed to be acquired by UnitedHealth Group unit OptumRx, putting an end to its struggles over the past couple of years.
On Dec. 9, Diplomat and OptumRx unveiled a deal by which OptumRx would acquire Diplomat’s outstanding common stock for $4 per share — well under the $5.81 per share at which it was valued when the markets closed before that weekend. Diplomat’s board unanimously approved the deal, through which OptumRx gains locations in all 50 states and Washington, D.C. The transaction is expected to close early this year.
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