News Briefs: Otezla for Pediatric Use Is Now Available

Otezla (apremilast) is available in the U.S. for the treatment of pediatric patients 6 to 17 years of age and weighing at least 20kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, Amgen Inc. said Aug. 20. The FDA approved the agent for that use on April 25 while also registering an additional packaging facility to support new packaging configurations for the pediatric population. The Cigna Group’s Express Scripts will exclude AbbVie Inc.’s Humira (adalimumab) from its largest commercial formularies in 2025, the company said on Aug. 23. Instead, the company will offer certain biosimilars: Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm) and its unbranded version, the first low-concentration interchangeable Humira biosimilar, which also is available in noninterchangeable high-concentration formulations; Teva Pharmaceuticals, Inc.’s high-concentration, interchangeable 40 mg strength Simlandi (adalimumab-ryvk); Sandoz’s high-concentration adalimumab-adaz in interchangeable 10 mg, 20 mg and 80 mg strengths and noninterchangeable 40 mg strength; and Quallent Pharmaceuticals' co-branded high- and low-concentration interchangeable products. Celltrion USA, Inc. said that Costco has placed its unbranded, high-concentration, citrate-free Humira biosimilar adalimumab-aaty in its member prescription program. The product also is available as branded Yuflyma. The company first offered the agent to self-funded employer plans on Oct. 1, 2023, while the newest move expands it to all members and their eligible dependents. Pharmaceuticals Strategies Group (PSG), an EPIC company, is offering GeneCQ, a new solution on its proprietary Artemetrx integrated data platform, the company revealed on Sept. 10. It analyzes various datapoints of patient populations, as well as pharmacy and medical benefit claims data, to predict payers’ exposure to high-cost gene therapies. Among its features are Exposure by Therapy, LOB, ASO Group, Member; Stop-Loss Modeler; and Longitudinal Member Profiles. A U.S. district court judge has allowed a case (No. 3:20-md-02966-RS) accusing Jazz Pharmaceuticals Plc and Hikma Pharmaceuticals Plc of conspiring to delay the launch of a generic version of Jazz’s narcolepsy agent Xyrem (sodium oxybate) to proceed to trial. A status hearing is scheduled for October. Following an April 5, 2017, settlement with Jazz, Hikma brought the first authorized generic of Xyrem to the market at the beginning of 2023. Plaintiffs including the Blue Cross Blue Shield Association, the city of Providence, Rhode Island, and the New York State Teamsters Council Health and Hospital Fund allege the arrangement led to higher costs for health plans. They also claim that Jazz increased Xyrem’s price by more than 800% between 2007 and 2014. Jazz has denied the allegations and said other narcolepsy treatments are available. Other manufacturers have been involved in lawsuits with Jazz over bringing their Xyrem competitors to market. Ahead of the expected move of preexposure prophylaxis for HIV from Medicare Part D to Part B, CMS launched a PrEP for HIV & Related Preventive Services informational website for health care providers. The agency is encouraging all stakeholders to prepare for the move, which is expected later this month. In a technical frequently asked questions for pharmacies posted June 25, CMS said that a National Coverage Determination is “expected to be made public and effective in late September 2024” and that it is “expected to be similar” to the proposed NCD published July 12, 2023. The agency also issued an initial fact sheet on April 12 in response to several comments on the proposed NCD suggesting that the transition could be complex and might result in beneficiaries missing needed PrEP doses.