Zitter Pulse Check: Crohn’s Disease (November 2022)

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. 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

Payers covering almost 70% of both commercial and Medicare lives said there is a high to very high level of priority for managing branded Crohn’s treatments. Payers with almost half of Medicare lives said they were somewhat aggressive in their management of the condition, while a little less said they were very aggressive. More than half of gastroenterologists said they had average satisfaction with the current therapies for Crohn’s.

Payers representing almost half of commercial and Medicare lives said there is a high level of unmet need in the treatment of Crohn’s. More than half of gastroenterologists said there is a high or very high burden for people with the condition. Respondents with almost three-quarters of lives said that the disease has an average budget impact.

Key Findings

Social Determinants of Health

Among payers covering Medicare lives, the top social determinants of health initiatives for disadvantaged members with Crohn’s are greater access to telehealth — which is offered by payers with almost all lives — transportation to and from medical appointments and educational content about healthy living. Commercial payers’ top initiative also was greater access to telehealth, followed by services to assist in health/medicine language barriers and educational content about healthy living. Gastroenterologists cited socioeconomic status, education and health literacy, and occupation and job security as the top non-medical factors impacting the ability of people with Crohn’s to access health care services and therapy.

Skyrizi

On June 16, 2022, the FDA expanded the label for AbbVie Inc.’s Skyrizi (risankizumab-rzaa) to include the treatment of adults with moderately to severely active Crohn’s disease. At the time of the survey, payers covering about three-fourths of commercial and Medicare lives had conducted a P&T review of the interleukin-23 (IL-23) antagonist. With the drug’s availability, payers with almost all lives that had not conducted a P&T review said they expected the level of priority for managing Crohn’s to decline. Almost half of gastroenterologists stated that Skyrizi’s availability would have some impact on their treatment of new patients, while more than a third expected it to have a moderate impact on their treatment approach for current patients.

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 more than half of Medicare lives are somewhat aware of the drug for use in Crohn’s, while more than one-third of gastroenterologists said they are moderately aware of the agent. Both payers and gastroenterologists said they anticipate that the level of disease burden for people with Crohn’s would slightly decrease once Zeposia is available. Payers covering commercial and Medicare lives said that an average annualized net price of around $51,000 would be an appropriate price. Zeposia’s annual wholesale acquisition cost for its two approved indications is more than $90,000.

Trends

AGA Guidelines

Message: “Crohn’s disease is a chronic, intermittent, progressive inflammatory disease. AGA’s [i.e., American Gastroenterological Association] treatment guidelines now recommend early use of biologic therapy in moderate to severe Crohn’s. Best to get patients on therapy as soon as possible.”

Payer Thoughts: “New guidelines will drive increased spend in this space. We were unaware of the guideline change, and specialists have not been pushing on this. Until there is significant provider pushback, would not expect health plans to change their prior authorization policies unless this is tied to rebates.”

Researchers Examine CF, UC/Crohn’s Adherence, Say Specialty Pharmacies ‘Could Help Reduce Medical Burden’

Two recent studies of specialty-drug treated conditions examined the impact of adherence on hospitalizations and medical costs. Findings of the studies — one on cystic fibrosis (CF) and the other on ulcerative colitis (UC)/Crohn’s disease — from AllianceRx Walgreens Prime (which changed its name to AllianceRx Walgreens Pharmacy in late June) demonstrate the importance of specialty pharmacy interventions in helping keep patients adherent to therapy.

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

FDA Grants Additional Indication to Skyrizi

On June 16, 2022, the FDA expanded the label for AbbVie Inc.’s Skyrizi (risankizumab-rzaa) to include the treatment of adults with moderately to severely active Crohn’s disease. The agency initially approved the interleukin-23 (IL-23) antagonist on April 23, 2019. The recommended induction dose for the new indication is 600 mg via intravenous infusion over at least one hour at weeks zero, four and eight; the maintenance dose is 360 mg via subcutaneous injection at week 12 and then every eight weeks. The list price for one dose is $18,272.79.

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

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