Top 3 PBMs Provide Coverage for Zymfentra

Celltrion has announced that the company has agreements with the top three pharmacy benefit managers (PBMs) for Zymfentra (infliximab-dyyb). The three PBMs — CVS Caremark, Express Scripts and Optum Rx — handle about 80% of the U.S. market. No information is available about whether prior authorization or utilization management is required. Express Scripts was the first to include Zymfentra on its National Preferred Formulary in April 2024.

The FDA had approved Zymfentra in October 2023 as the first subcutaneous formulation of infliximab to be used a maintenance therapy for adults with moderate-to-severe active ulcerative colitis and Crohn’s disease. Celltrion USA launched Zymfentra in March 2024 with a price of $6,181.08 for two shots over four weeks.

Celltrion provides commercially insured patients with copay assistance of $5 per month for eligible patients. This is subject to a maximum annual limit, but so far, this limit is not shown on the Zymfentra product site. The terms indicate that the benefit could be adjusted if plans have accumulator or maximizer programs to “ensure that the program is for the sole benefit of the patient.”

Celltrion was the first company to develop a biosimilar of Janssen’s Remicade (infliximab). The FDA approved Inflectra (infliximab-dyyb) in April 2016 to treat patients with several conditions, including Crohn’s, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Both Remicade and Inflectra are administered by intravenous infusion.

Zymfentra was approved through the stand-alone biologics license application process. It is considered a new drug due to the subcutaneous administration. It has patent protection through 2037 for its dosage form and through 2040 for its route of administration.

Data from the extended LIBERTY studies (LIBERTY-CD and LIBERTY-UC) support the long-term efficacy and safety of Zymfentra in patients with ulcerative colitis and Crohn’s disease. The studies evaluated the impact of anti-drug antibodies on drug levels and efficacy in patients treated with Zymfentra.

In both LIBERTY-CD and UC studies, efficacy results, including clinical remission, clinical response and corticosteroid-free remission, were generally well maintained at week 102 compared with those of Week 54. The data were presented at the Digestive Disease Week annual meeting in May 2024.

“These studies reaffirm efficacy and tolerance of Zymfentra as maintenance therapy and underscore Celltrion USA’s commitment to delivering different treatment options for patients in the gastroenterology space,” Thomas Nusbickel, chief commercial officer at Celltrion USA, said in a news release.