Radar on Specialty Pharmacy
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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.
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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.
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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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New FDA Approvals: FDA Expanded Mircera’s Patient Population
April 30: The FDA expanded the patient population of CSL Vifor’s Mircera (methoxy polyethylene glycol-epoetin beta) to include the treatment of anemia associated with chronic kidney disease in pediatric patients 3 months old to 17 years old on dialysis and not on dialysis who are converting from another erythropoiesis-stimulating agent after their hemoglobin level was stabilized with an ESA. The agency also approved a subcutaneous route of administration for pediatric patients. The FDA first approved the long-acting ESA on Nov. 14, 2007. Dosing for the newest use is once every four weeks based on total weekly epoetin alfa or darbepoetin alfa dose at the time of conversion. The agent is available in both intravenous and subcutaneous formulations, and patients younger than 6 years old should maintain the same route of administration as the previous ESA. Drugs.com lists the price of one 75 mcg/0.3 mL injectable solution as more than $237.
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News Briefs: Multiple Developments Around Biosimilar Humiras Occurred
Multiple developments around biosimilar versions of AbbVie Inc.’s Humira (adalimumab) have occurred. Teva Pharmaceuticals, a unit of Teva Pharmaceuticals Industries Ltd., and Alvotech launched Simlandi (adalimumab-ryvk) in the U.S., the companies disclosed on May 20. The FDA approved the interchangeable, high-concentration, citrate-free drug on Feb. 23 for nine of its reference drug’s indications.…Boehringer Ingelheim said on May 13 that it had signed an agreement with Quallent Pharmaceuticals, a private-label pharmaceutical distributor that is a wholly owned subsidiary of The Cigna Group, to offer both high- and low-concentration, citrate-free versions of adalimumab-adbm through a copay assistance program. The tumor necrosis factor (TNF) inhibitor’s interchangeable designation applies to the low-concentration version. Boehringer will continue to commercialize that agent and its branded version, Cyltezo, which has approval for nine of Humira’s indications.…Celltrion USA has made its high-concentration, citrate-free adalimumab-aaty available at a low wholesale acquisition cost that is an 85% discount to Humira’s WAC, the company revealed on May 9. Its branded version, Yuflyma, remains available at a 5% discount to Humira’s WAC. The agent is approved for eight of Humira’s indications.
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