Radar on Specialty Pharmacy

  • CVS-CTCA Pilot Offers In-Home Infusion of Cancer Therapies

    As the U.S. surpasses 500,000 deaths from the COVID-19 pandemic, people with cancer continue to unsurprisingly be hesitant to visit a provider office or hospital for treatment. So, Cancer Treatment Centers of America (CTCA) is working with CVS Health to bring therapies into certain patients’ homes, helping keep immunocompromised people safer and allowing them to continue much-needed cancer treatment.

    Multiple studies have shown how the pandemic has affected all aspects of cancer care, from screening and diagnostic workups to actual oncology treatments, follow-up services and patient support (RSP 6/20, p. 1). “The COVID-19 pandemic created new challenges for immunocompromised patients with cancer looking for ways to safely continue their care while minimizing their exposure to the virus,” explains Sree Chaguturu, M.D., senior vice president at CVS Health and chief medical officer at CVS Caremark. “CTCA is seeing a 50% reduction in infusions, and, while a slight delay in treatments may have been appropriate at the pandemic’s onset, data is now pointing to increased mortality risk with every month of delayed care. There is a critical need for providing in-home therapy where possible to safely treat patients who are immunocompromised.”

  • FDA Approval Makes Breyanzi Third CAR-T Therapy in NHL

    With the FDA’s approval of Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) last month, there are now three chimeric antigen receptor T cell (CAR-T) therapies to treat a certain type of non-Hodgkin’s lymphoma (NHL). A Zitter Insights poll shows that payers do not anticipate its approval as having much of an impact on their management of the space. However, with more of these therapies in the pipeline, payers should take a closer look at these therapies and their management of them, say industry experts.

    On Feb. 5, the FDA approved Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B (see brief, p. 8). The agency gave the CD19-directed CAR-T therapy orphan drug, regenerative medicine advanced therapy and breakthrough therapy designations.

  • News Briefs

     Implementation of the most- favored-nation (MFN) model continues to be stalled. Following court rulings in December that temporarily blocked its Jan. 1 enactment (RSP 1/21, p. 8), the U.S. District Court for the District of Maryland issued a joint motion to stay in the case (No. 8:20-cv-03531-GJH) until a final rule that’s based on the MFN interim final rule, which was published in late November, is published in the Federal Register. It requires that the defendants not appeal the preliminary injunction a California court issued and that “the performance period for any final regulation stemming from the MFN Interim Final Rule shall not commence earlier than 60 days” after its publication. View the motion at https://bit.ly/39EfoNw.

     A court also has pushed back implementation of the rebate rule until January 2023. The rule would require that drug rebates currently given to plan sponsors would instead be offered to seniors as discounts at the point of sale. It would exclude the rebates given to Part D plans or their PBMs from a safe harbor they now are included in and establish two new safe harbors. However, the Pharmaceutical Care Management Association filed a lawsuit (No. 1:21-cv-00095-JDB) in the U.S. District Court for the District of Columbia against implementation of the rule. On Jan. 30, the court ordered postponement of the provisions set to take effect after Dec. 31, 2021. View the order at https://bit.ly/36zP2uh.

  • New FDA Specialty Approvals

     Jan. 14: The FDA granted an additional indication to Pfizer Inc.’s Xalkori (crizotinib) to treat children at least 1 year old and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK)-positive. The agency initially approved the drug on Aug. 26, 2011 (RSP 9/11, p. 6). The tyrosine kinase inhibitor had breakthrough therapy designation for the newest indication. The recommended dosage of the capsule is 280 mg/m2 twice daily based on body surface area. Website Drugs.com lists the price of 60 200 mg capsules as more than $19,400. Visit www.xalkori.com.

     Jan. 15: The FDA gave accelerated approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with Velcade (bortezomib) from Takeda Pharmaceutical Company Limited subsidiary Millennium Pharmaceuticals, Inc., cyclophosphamide and dexamethasone for the treatment of adults with newly diagnosed light chain amyloidosis. The agency initially approved the drug, which is a subcutaneous formulation of Darzalex, on May 1, 2020 (RSP 5/20, p. 8). The recommended dose is 1,800 mg daratumumab and 30,000 units of hyaluronidase. Drugs.com lists the price of an 1,800 mg-30,000 units single-dose vial as more than $7,916. Visit www.darzalex.com.

  • Specialty Pharmacy, Infusion M&A Activity Is Slowing Down

    The level of merger and acquisition (M&A) activity within the specialty pharmacy and home infusion arenas that has been occurring for numerous years has certainly depleted the number of companies available for deals. But that’s not to say they aren’t happening. Last month, Shields Health Solutions unveiled a deal to acquire ExceleraRx Corp. (see story, p. 7). And approximately one month ago, Centene Corp. acquired PANTHERx Rare, LLC, and revealed a deal to acquire Magellan Health, Inc. (RSP 1/21, p. 1). AIS Health spoke with Bill Bolding, a senior analyst for Provident Healthcare Partners, and Michael Patton, managing director at the firm, to get their perspective on M&A trends within those industries.

    AIS Health: Did you notice any COVID-spurred M&A activity last year?

    Bolding and Patton: Two areas within health care that observed some COVID-spurred M&A activity were diagnostics and telehealth. Interest in testing, lab and diagnostics capacity spurred interest from both capital investors and strategic consolidators. Telehealth, which was undergoing investment and consolidation activity at very attractive valuations even prior to COVID, clearly benefited from potentially permanent adoption at both the provider and patient levels. It’s also important to state that generally speaking, areas of health care that are relatively insulated from the direct effects of COVID benefited in the market due to simple supply-and-demand factors. Private-equity dry powder remains very high, and investors need to deploy the funds they’ve raised, which explains why an industry such as pharmacy could benefit from a valuation perspective.

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