Zitter Pulse Check: Crohn’s Disease (November 2023)

Coverage

Crohn’s disease is a high-cost category with an increasing number of therapies that treat the condition. To help stakeholders absorb datapoints and perceptions from all directions and synthesize those insights into a tangible strategy for Crohn’s, Zitter Insights surveys a leading panel of pharmacy and therapeutics (P&T) decision makers at payers and integrated delivery networks (IDNs). The Managed Care Biologics and Injectables Index: Crohn’s Disease combines deep payer insights with the industry standard in market access information to produce quarterly reports and insights summaries on leading specialty brands.

Payer Management

More than half of payers said that managing branded Crohn’s treatments is a high priority. Payers with more than two-thirds of commercial lives and almost half of Medicare lives said they were aggressive in their management of the condition. Payers and gastroenterologists varied in how much unmet need they perceive there to be in the treatment of Crohn’s.

Payers with around three-fourths of both commercial and Medicare lives, as well as almost two-thirds of gastroenterologists, said they had average satisfaction with the current therapies for Crohn’s. Around half of payers and gastroenterologists said there is a high disease burden for people with the condition. Respondents with more than three-quarters of commercial beneficiaries said that the disease has a high budget impact.

Key Findings

Zeposia

Bristol Myers Squibb’s Zeposia (ozanimod) is in Phase III clinical trials for Crohn’s disease. The sphingosine 1-phosphate (S1P) receptor modulator already has FDA approval for ulcerative colitis and multiple sclerosis. Payers representing almost half of commercial lives and more than one-third of Medicare beneficiaries are moderately aware of the drug for use in Crohn’s, while almost one-third of gastroenterologists expressed the same level of awareness. Almost one-fifth of gastroenterologists, however, said they had no awareness of the agent for the treatment of Crohn’s.

Rinvoq

On May 18, 2023, the FDA expanded the label of AbbVie Inc.’s Rinvoq (upadacitinib) to include the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to at least one tumor necrosis factor (TNF) inhibitor, making it the first oral treatment and the first Janus kinase (JAK) inhibitor for the condition. Two-thirds of payers said they were extremely aware of the drug for treating Crohn’s. Almost half of gastroenterologists said they expected Rinvoq’s availability would have a moderate impact on their treatment approach, meaning they expect it to change for a considerable portion of patients. Payers that had completed a P&T review of the agent varied in how they expected the drug to change their approach to other Crohn’s therapies.

Humira Biosimilars

In 2023, nine biosimilars of AbbVie’s Humira (adalimumab) launched in the U.S. Physicians who had prescribed one of the biosimilars in the six to 12 months prior to the survey said those drugs have had a minimal impact on their treatment approach to people with one of the diseases for which they are indicated. Two of the biosimilars so far — Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm) and Pfizer Inc.’s Abrilada (adalimumab-afzb) — have interchangeable status. Payers with almost all lives said that interchangeability is of high or very high importance when considering whether to add an adalimumab biosimilar to their formulary, while the label’s breadth and citrate-free, high-concentration formulations also were highly ranked characteristics. Physicians found interchangeability, a similar formulation to Humira and the device’s ease of use were the most important factors.

Trends

Contracting

Message: “Pfizer [is] participating in semi-annual assessment of immunology category. This includes portfolio contracting, preferred product selection and value-based contracting updates. Pfizer portfolios are very attractive in general, but we are challenged to accept many due to preference for ‘biosimilars first’ strategy.”

Payer Thoughts: “[Pfizer’s] Inflectra has often been a preferred biosimilar for us. We have established preferred contract arrangements for all new starts at several IDN clients. We hope to gain some clout with Pfizer for taking this strategy, but it is unclear if Pfizer is just too big to care at this point.”

FDA Approves First Subcutaneous Infliximab

On Oct. 23, 2023, the FDA approved Celltrion USA’s subcutaneous Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn’s disease following treatment with an intravenously administered infliximab product. The agent, which is commercialized by Pfizer Inc. in the U.S., is the first FDA-approved subcutaneous formulation of infliximab; it also is available as an intravenous infusion under the name Inflectra. The latter drug was initially approved April 5, 2016, as the first biosimilar of the Janssen Pharmaceutical Companies of Johnson & Johnson’s Remicade (infliximab), but the FDA approved Zymfentra as a novel drug. Following an intravenous induction regimen with an infliximab product, starting at week 10 and thereafter, 120 mg of Zymfentra is given via subcutaneous injection every two weeks. The new drug will be available in first-quarter 2024.

Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online

With Rinvoq’s Recent Approval for Crohn’s Disease, Agent Enters Highly Competitive Class

The FDA recently expanded the indication of AbbVie Inc.’s Rinvoq (upadacitinib), making it the first oral treatment and the first Janus kinase (JAK) inhibitor for Crohn’s disease. Still, the agent is entering a highly competitive class in which manufacturer rebates play a big role. And while respondents to a Zitter Insights survey said the drug will somewhat lessen the unmet need in the treatment of the condition, they said that a moderate level of need still exists with the agent’s approval.

Subscribers to AIS’s RADAR on Specialty Pharmacy may read the in-depth article online

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