Radar on Specialty Pharmacy

  • How Will Beqvez Fare in Challenging Market for Cell and Gene Therapies?

    The FDA recently approved the second gene therapy for hemophilia B, Pfizer Inc.’s Beqvez (fidanacogene elaparvovec-dzkt). While the agent offers an additional treatment option with the potential for freedom from regular infusions of factor therapy, its price — which is equal to that of its competitor — may be too high for many payers, according to a Zitter Insights survey. Industry experts say that it may suffer from some of the challenges other cell and gene therapies have faced in gaining a foothold in the U.S. market.

    On April 25, the FDA approved Beqvez for the treatment of adults with moderate to severe hemophilia B who use factor IX prophylaxis therapy; have current or historical life-threatening hemorrhage; or have repeated, serious spontaneous bleeding episodes and do not have neutralizing antibodies to adeno-associated virus (AAV) serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. The manufacturer launched a warranty program for the intravenous infusion based on durability of patient response to treatment.

  • Report: Led by Anti-Inflammatories, Specialty Drugs Continue Upward Trend

    Specialty drugs are still taken by only a small percentage of people but represent more than half of total drug costs. Anti-inflammatory specialty therapies continue to be a huge driver of those costs, according to the recently released 2023 Drug Trend Report from PBM analytics firm Xevant. The specialty pipeline remains strong, and payers should expect these agents to continue to affect their costs, says one industry expert.

    Based on Xevant’s book of business for 2022 and 2023, the company observed an 11% increase in the number of prescriptions filled for specialty drugs. The plan-paid amounts for those agents rose 19%, slightly less than nonspecialty medications’ 22% plan-paid costs. In addition, the average plan cost per specialty prescription rose from $6,100 in 2022 to $6,700 in 2023.

  • Home Infusion Providers Can Navigate Contracting Process With Various Strategies

    While home infusion has been an option for patients for decades, the space continues to evolve. Within this landscape, providers must successfully execute the contracting process with PBMs and government and commercial insurers, navigating various pitfalls along the way.

    Attorney Jesse Dresser, a partner in law firm Frier Levitt’s life sciences department who heads the firm’s pharmacy practice group and frequently helps pharmacies and pharmacy providers on issues with payers and PBMs, moderated a panel discussion titled “Strategies for Successful Payer and PBM Contracts in Home Infusion” at the National Home Infusion Association’s (NHIA) annual conference, held March 23 through 27 in Austin, Texas.

  • Studies Reveal Impact of SonarMD Program on Managing IBD

    Data from two clinical studies found that people with inflammatory bowel disease — ulcerative colitis and Crohn’s disease — who were enrolled in one company’s IBD-focused digital care coordination program experienced decreases in both emergency department (ED) visits and hospitalizations compared with control groups. The data, says the company’s CEO, show the benefits of partnerships among stakeholders to manage chronic gastrointestinal (GI) care.

    Established in 2018, SonarMD, Inc. enters into risk-bearing value-based care arrangements with health plans and gastroenterology practices. It currently has five such arrangements with large plans and partners with hundreds of U.S. gastroenterologists.

  • Cell and Gene Therapies Pose Multiple Challenges but No Easy Solutions

    While health care payers are facing a variety of issues, paying for multimillion-dollar cell and gene therapies (CGTs) is one of the most pressing, as evidenced by sessions at two recent AHIP conferences. Multiple speakers discussed various approaches to the agents, as well as challenges payers need to tackle, but all acknowledged that a truly successful model has yet to be implemented.

    Many CGTs are in the pipeline, impacting potentially millions of patients and prompting many questions around affordability and accessibility, stated Sean Dickson, senior vice president of pharmaceutical policy at AHIP, during a session in Baltimore titled “Cell and Gene Therapies: Regulatory Updates and Coverage Policies.” “Oncology is where it will get really interesting,” and these agents will have the greatest impact on Medicare payers.

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