RADAR on Specialty Pharmacy

  • New FDA Specialty Approvals

     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 Enters Deal to Purchase, Rebrand Schnucks Pharmacies

    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.

  • Sarclisa Is Likely to Be Managed At Parity With Similar Drugs

    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).

  • Manufacturers Can Assist Other Stakeholders in COVID Battle

    As the new coronavirus continues its spread, pharma companies are finding themselves facing a spate of challenges. And although they’ll need to find ways to counter those setbacks, they also can help address issues facing other health care industry stakeholders.

    “This is an unprecedented time and one that is full of challenges for companies of all sizes and in all sectors,” observes Mike DeLone, principal at Deloitte Consulting and U.S. life sciences sector leader. “We believe there are five fundamental qualities of resilient leadership that should serve as guiding principles now more than ever: Be genuinely, sincerely empathetic while maintaining a hard, rational line to protect financial performance; put the mission first; aim for speed over elegance; own the narrative; and embrace the long view. While it will take time and effort, this crisis can become an opportunity to move forward and create even more value and positive societal impact.”

  • Specialty Pharmacies Have Many Roles to Play During Outbreak

    As the COVID-19 pandemic continues its assault on the globe and the U.S. passes 12,000 deaths from it, all eyes are on the health care industry. While the public looks to pharma manufacturers for potential treatments and vaccines, labs for testing to detect the virus, and providers and others in their realm for being on the front line of the defense against it, specialty pharmacies still have a vital role to play.

    “During this unprecedented time, specialty pharmacies need to be nimble and possess the flexibility necessary to continue serving patients while keeping team members safe,” says John Stephens, vice president, transformation and growth at AllianceRx Walgreens Prime. At that specialty pharmacy, 75% of employees are working from home, with the rest “still working on site to dispense and ship lifesaving medications. Ship-to-home is the basic skill or capability keeping people out of pharmacies and hospitals, especially since specialty patients are more at risk due to the pandemic.”

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