MMIT Reality Check on Atopic Dermatitis (2Q2023)

Payer Coverage:

A review of market access for atopic dermatitis treatments shows that under the pharmacy benefit, about 43% of the lives under commercial formularies are covered with utilization management restrictions. Around 25% of the lives under health exchange 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 both the pharmacy and the medical benefit. For the latter benefit, about 36% of the lives under commercial policies are covered with utilization management restrictions. Only 5% of the lives under health exchange policies have access to the drugs without utilization management restrictions.

For about 40% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 45% require multiple steps. Around 64% of payer-controlled pharmacy benefit covered lives require prior authorization, with 27% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.

Trends:

FDA Expands Patient Population of Cibinqo

In February 2023, the FDA expanded the patient population of Pfizer Inc.’s Cibinqo (abrocitinib) to include the treatment of people at least 12 years old and less than 18 with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is not advised. The agency initially approved the Janus kinase (JAK) inhibitor on Jan. 14, 2022. Dosing of the tablet is 100 mg once daily. The drug’s price for 30 tablets of all three strengths — 50 mg, 100 mg and 200 mg — is $4,914.

FDA Grants Additional Indication to Dupixent

In June 2022, the FDA granted another indication to Sanofi and Regeneron Pharmaceuticals, Inc.’s Dupixent (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in people between the ages of 6 months and 5 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The agency initially approved the subcutaneous injectable on March 28, 2017. The FDA gave the new indication priority review. Dosing for people weighing 5 kg to less than 15 kg is 200 mg every four weeks; for those weighing 15 kg to less than 30 kg, dosing is 300 mg every four weeks. The drug’s list price, regardless of dose, is $3,384.83 per carton, which includes either two prefilled pens or two prefilled syringes.

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 February 2023, the FDA expanded the patient population of Pfizer Inc.’s Cibinqo (abrocitinib) to include the treatment of people at least 12 years old and less than 18 with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is not advised. In June 2022, the agency granted another indication to Sanofi and Regeneron Pharmaceuticals, Inc.’s Dupixent (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in people between the ages of 6 months and 5 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 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.

Competitive Market Landscape

The real competitive market lies in the newer biological agents, including Dupixent, Pfizer’s Eucrisa (crisaborole), and LEO Pharma Inc.’s Adbry (tralokinumab-ldrm), 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 multiple 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 Adbry. 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:

reality-check-atopic dermatitis-2Q2023-player

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© 2024 MMIT
AIS Health Staff

AIS Health Staff

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