Radar on Specialty Pharmacy

  • BioMatrix Continues to Expand Its Capabilities Via Deals

    While specialty pharmacy merger and acquisition activity has certainly slowed, one independent specialty pharmacy continues to snap up other complementary organizations — and, as a result, may find the M&A focus on itself.

    BioMatrix Specialty Pharmacy revealed in early July that it had acquired InfuCare LTD, an infusion-focused specialty pharmacy. Located in Tyler, Texas, InfuCare provides BioMatrix with a physical location in what the latter calls a “key geographic area,” providing “access to additional covered lives in one of the nation’s largest states,” according to a company press release. It also brings expertise in chronic, complex conditions that require home infusion with therapies such as intravenous immune globulin (IVIG) and parenteral nutrition.

  • MedPAC Suggests Biosimilars Are Helping Bring Down ASPs

    While total Medicare spending on all Part B drugs continued to rise from 2018 to 2019, a Medicare Payment Advisory Commission (MedPAC) report found that average sales prices (ASPs) for some traditionally costly drugs actually decreased, a trend that may be due to biosimilar competition, posits the recent report.

    The report, titled Health Care Spending and the Medicare Program, was published in July 2021. In 2018, total Part B drug spending was just shy of $35 billion, an amount that rose to more than $39 billion the following year. Among the top 10 drugs, 2018 total spend was almost $15 billion, increasing to more than $16 billion in 2019 — or about 41% of all Part B spending for the year.

  • What Might Be Impact of First Interchangeable Biosimilar?

    More than 10 years after the passage of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as part of the Affordable Care Act, the FDA finally has approved the first interchangeable biosimilar. But while many in the industry are hailing the move, at least one expert wonders whether interchangeables will hamstring use of biosimilars that do not have that designation.

    On July 28, the FDA approved Viatris Inc. and Biocon Ltd. subsidiary Biocon Biologics Ltd.’s Semglee (insulin glargine-yfgn) to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. It is a biosimilar to and interchangeable with its reference product, Sanofi Aventis’ Lantus (insulin glargine), a long-acting insulin analog. The product will be available in 10 mL vials and 3 mL prefilled pens and is administered subcutaneously once daily. It also has 12 months of exclusivity under section 351(k)(6) of the Public Health Service (PHS) Act during which the FDA cannot approve another biosimilar that is interchangeable with Lantus.

  • FDA Approval Gives Third Option to Treat Rare, Deadly Disease

    The FDA recently approved a third agent to treat paroxysmal nocturnal hemoglobinuria (PNH). With some conditions, that number of treatments may prompt payer preferencing, but that is unlikely to happen with this ultra-rare, potentially fatal disease, observe industry experts.

    On May 14, the FDA approved Apellis Pharmaceuticals, Inc.’s Empaveli (pegcetacoplan) as the first and only targeted C3 therapy for the treatment of adults with PNH. It is approved for both treatment-naïve people, as well as ones switching from any C5 inhibitor. The FDA has approved two of those drugs: Soliris (eculizumab) and Ultomiris (ravulizumab-cwvz), both from Alexion Pharmaceuticals, Inc., which was just acquired by AstraZeneca in July.

  • News Briefs

     Merck & Co., Inc. will voluntarily withdraw the accelerated approval indication for Keytruda (pembrolizumab) for the treatment of people with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed death-ligand 1 (PD-L1), as determined by an FDA-approved test, with disease progression on or after at least two lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, human epidermal growth factor receptor 2 (HER2)/neu-targeted therapy. The move follows the April 29 Oncologic Drugs Advisory Committee meeting in which members voted against keeping the indication after late-stage confirmatory trials did not show clinical benefit. Merck says it will begin the withdrawal in six months.

     The expected average cost of new FDA-approved specialty drugs in 2020 was just under $350,000 per year. That was one of the findings of analytics company AMS’s 2020 Specialty Drug Trends Report, based on drugs added to the firm’s PredictRx module, which incorporates pertinent clinical information and AMS Cost Projection (ACP) pricing. It also found that the average yearly cost for newly approved orphan drugs was $449,507, compared with $144,130 for traditional drugs.

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