MMIT Reality Check on Atopic Dermatitis

Payer Coverage:

A review of market access for atopic dermatitis treatments shows that under the pharmacy benefit, about 31% of the lives under commercial formularies are covered with utilization management restrictions. Around 54% of the lives under Medicare formularies are not covered for at least one of the drugs.

Sanofi and Regeneron Pharmaceuticals, Inc.’s Dupixent (dupilumab) and LEO Pharma Inc.’s Adbry (tralokinumab-ldrm) are covered under the medical benefit. About 47% of the lives under commercial policies are covered with utilization management restrictions. Only 6% of the lives under health exchange policies have access to the drugs without utilization management restrictions.

For about 52% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 39% require multiple steps. Around 55% of payer-controlled pharmacy benefit covered lives require prior authorization, with 32% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Grants Additional Indication to Rinvoq

In January 2022, the FDA expanded the label of AbbVie Inc.’s Rinvoq (upadacitinib) to include the treatment of moderate-to-severe atopic dermatitis in people at least 12 years old whose disease did not respond to previous treatment and is not well controlled with other pills or injections or when those treatments are not recommended. The agency initially approved the Janus kinase (JAK) inhibitor on Aug. 16, 2019. Dosing of the tablet for people weighing at least 40 kg who are at least 12 years old and less than 65 is 15 mg once daily and can be increased to 30 mg once daily. For people at least 65, the recommended dose is 15 mg once daily. Website Drugs.com lists the price of 30 15 mg tablets as more than $5,500.

FDA Approves Cibinqo

In January 2022, the FDA approved Pfizer Inc.’s Cibinqo (abrocitinib) for the treatment of adults with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products or when use of those therapies is inadvisable. Recommended dosing of the JAK inhibitor tablet is 100 mg once daily or 200 mg once daily for people not responding to the lower dose.

Adbry, Others Add to Growing Class Of Atopic Dermatitis Biologics

The FDA has approved a handful of drugs to treat atopic dermatitis recently. Among them is LEO Pharma Inc.’s Adbry (tralokinumab-ldrm), an interleukin-13 (IL-13) antagonist. According to a Zitter Insights survey, payers may take a bit of a restrictive approach in managing the drug. And with multiple new biologics approved for the condition and more potential agents coming onto the market, payers may impose more utilization management strategies on the therapeutic class as a whole, say industry experts.

Key Findings:

Market Events Drive Changes

In January 2022, the FDA expanded the label of AbbVie Inc.’s Rinvoq (upadacitinib) to include the treatment of moderate-to-severe atopic dermatitis in people at least 12 years old whose disease did not respond to previous treatment and is not well controlled with other pills or injections or when those treatments are not recommended. In the same month, the agency also approved Pfizer Inc.’s Cibinqo (abrocitinib) for the treatment of adults with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products or when use of those therapies is inadvisable.

Competitive Market Landscape

The real competitive market lies in Sanofi and Regeneron Pharmaceuticals, Inc.’s Dupixent (dupilumab) and Pfizer’s Eucrisa (crisaborole), which compete for third-line (or fourth-line) use following trial/failure of topical corticosteroids (TCSs), topical calcineurin inhibitors (TCIs) and/or phototherapy. Numerous companies are poised to enter the same market space, with over 10 agents in Phase III trials, most of which are new biological agents.

Pharmacy, Medical Benefit Implications

Pharmacy benefit coverage is commonplace, with the exception of medical benefit coverage for Dupixent and LEO Pharma Inc.’s Adbry (tralokinumab-ldrm). Coverage of TCIs with generic Protopic (tacrolimus) is quite favorable. Most therapeutic agents past generic topicals will require a prior authorization and usually step through of preferred agents. Phototherapy is often the preference for second-line therapy, with biologicals being the final step. Access to biological agents is currently fairly restrictive, requiring one or more steps through products before approval.

Key Players in Market:

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• Reality Check