Radar on Specialty Pharmacy

June 6: The FDA expanded the label of Roche Group member Genentech USA, Inc.’s CellCept (mycophenolate mofetil) to include, in combination with other immunosuppressants, prophylaxis of organ rejection in people at least 3 months old who have received an allogenic heart transplant or an allogenic liver transplant. The agency first approved the drug on May 3, 1995. Dosing for the newest uses is based on body surface area and indication. The drug is available as a capsule, tablet, oral suspension and intravenous injectable. Website GoodRx.com lists the price of 60 500 mg tablets as more than $1,070.

June 7: The FDA granted another indication to Sanofi and Regeneron Pharmaceuticals, Inc.’s Dupixent (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in people between the ages of 6 months and 5 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The agency initially approved the subcutaneous injectable on March 28, 2017. The FDA gave the new indication priority review. Dosing for people weighing 5 kg to less than 15 kg is 200 mg every four weeks; for those weighing 15 kg to less than 30 kg, dosing is 300 mg every four weeks. The drug’s list price, regardless of dose, is $3,384.83 per carton, which includes either two prefilled pens or two prefilled syringes.

The Oncology Care Model (OCM) that CMS’s Center for Medicare & Medicaid Innovation (CMMI) launched almost six years ago is nearing its June 30 end. And while CMMI introduced its Oncology Care First model in November 2019 with an eye on the OCM successor launching before its predecessor’s end, it is unclear what the program’s status is at this point. OCM participants tell AIS Health, a division of MMIT, that their overall experience has been good as they await next steps from CMMI.

The OCM voluntary pilot started in July 2016 with 17 payers and 196 practices; five payers and 126 practices currently are participating. While it began as a five-year program, CMMI extended it for one additional year in 2020 due to the COVID-19 pandemic. The program reimburses providers for episodes of care in the form of a per-beneficiary per-month payment, as well as a possible performance-based payment, if Medicare expenditures are below a target price for an episode. The amount of the payment is tied to a provider’s achievement on various quality measures. All participants began with one-sided risk but could shift to two-sided risk in 2017. Following the 2018 introduction of an alternative two-sided risk arrangement, starting in January 2020, practices that did not earn at least one performance-based payment had to enter one of the two-sided risk options or leave the OCM. Practices that earned at least one performance-based payment could remain in one-sided risk.

The FDA recently gave an additional indication to AbbVie Inc.’s Rinvoq (upadacitinib) in ulcerative colitis, broadening that therapeutic class even more. And while a study revealed some concerns around another agent with a similar mechanism of action, payers and gastroenterologists last year expressed interest in Rinvoq over other late-stage pipeline agents.

On March 16, the FDA expanded the label of Rinvoq to include the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) blocker. The agency initially approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. The recommended starting dose for the tablet is 45 mg once daily for eight weeks, followed by a maintenance dose of 15 mg once daily. The wholesale acquisition cost for a 30-day supply is $5,671.26.