Radar on Specialty Pharmacy

From identifying eligible patients and training providers to seeking reimbursement and collecting data, cell and gene therapies (CGTs) present unique challenges to the health care system. One company has launched a new offering with an eye on simplifying one aspect of the process.

Cardinal Health recently unveiled its Advanced Therapy Connect, a unified ordering portal for CGTs. Providers have had to log in to different product platforms with distinct reporting structures and procedures for invoicing and reimbursement. But the new solution allows providers to order all in-network CGTs within a single platform, helping decrease errors from manual inputs and optimizing access to the agents.

Patient nonadherence to therapy can be an issue for people with cancer, despite the potential for poor prognosis and remission, several studies have found. A recent study from Walgreen Co. is reinforcing the idea that supporting cancer patients and giving them tools to help remain adherent can benefit both patients and payers.

Walgreens’ Connected Care Oncology (CC-Onc) is a patient-centered clinical management program that offers 21 oral hematological cancer therapies. The program utilizes a high-touch, personalized approach to boost adherence and improve outcomes. Researchers sought to find “significant associations” between discontinuation rates for those oral oncolytics and total medical costs, hospitalizations and inpatient length of stay, according to a recent poster presentation.

Jan. 15: The FDA approved Eli Lilly and Co.’s Omvoh (mirikizumab-mrkz) for the treatment of adults with moderately to severely active Crohn’s disease. The agency first approved the interleukin-23p19 (IL-23p19) inhibitor on Oct. 26, 2023. Dosing for the newest indication starts with 900 mg via a 90-minute-plus intravenous infusion at weeks zero, four and eight; maintenance dosing is 300 mg via subcutaneous injection at week 12 and then every four weeks. The agent’s list price is $9,593.22 for one 300mg/15ml infusion and $10,878.70 for two 100mg injections.

Jan. 15: The FDA approved two new vial sizes of Incyte Corp. and Syndax Pharmaceuticals’ Niktimvo (axatilimab-csfr) for the treatment of chronic graft-versus-host disease (GVHD) after the failure of at least two lines of systemic therapy in adults and pediatric patients weighing at least 40 kg. The agency first approved the colony stimulating factor-1 receptor (CSF-1R)-blocking antibody on Aug. 14, 2024, as a 50 mg single-dose vial, and it now also has 9 mg and 22 mg vials. The recommended dose is 0.3 mg/kg via a 30-minute intravenous infusion every two weeks. At the time of the initial approval, the company said that it was waiting to launch until those smaller vial sizes were approved. All three sizes are now available. The price of a 9 mg vial is $4,725, and the price of the 22 mg vial is $11,550.

The FDA warned that glatiramer acetate can cause anaphylaxis at any time while undergoing treatment with the multiple sclerosis drug, the agency said in a Drug Safety Communication on Jan. 22. While the reaction is rare, it has resulted in hospitalization and death, said the agency, which identified 82 cases worldwide that occurred from December 1996 through May 2024. Of those, 19 occurred more than a year after starting treatment, and six died. Most experienced anaphylaxis within one hour of taking the drug, which is available as Teva Neuroscience, Inc.’s Copaxone and Sandoz Inc.’s Glatopa, as well as multiple generics. The FDA is adding the risk to a new boxed warning on the drugs’ labels, as well as updating the Warning and Precautions section. Patients should seek immediate medical attention by going to an emergency room or calling 911, the agency recommended, and providers should educate patients on the signs of anaphylaxis. The medication should not be restarted unless a clear alternative reason for the response is identified. It recommends that patients and health care providers report any side effects of the drug to the FDA’s MedWatch.

Amgen Inc. has tapped Optum Health Solution’s new biosimilars-focused private-label subsidiary Nuvaila to be the sole distributor of its Wezlana (ustekinumab-auub), the first available biosimilar of Stelara (ustekinumab) from Johnson & Johnson Innovative Medicine (formerly Janssen Biotech, Inc.). While such deals may be beneficial to manufacturers that can strike them, they are essentially locking out competitors that can’t from the biosimilar market, asserts an industry expert.

Stelara is approved for the treatment of adults and pediatric patients at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adults and pediatric patients at least 6 years old with active psoriatic arthritis, adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis.