ADBRY (tralokinumab-ldrm)

ADBRY (tralokinumab-ldrm)

Self-Administration - injectable

Diagnosis considered for coverage: 

• Indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adbry can be used with or without topical corticosteroids.

Coverage Criteria:

For diagnosis of Atopic Dermatitis:

• Dose does not exceed initial dose of 600 mg (four 150 mg injections) subcutaneously, followed by 300 mg (two 150 mg injections) subcutaneously administered every other week, AND
• Patient is 18 years of age or older, AND
• Prescribed by or in consultation with a dermatologist, AND
• Chart note documentation required documenting a diagnosis of moderate-to-severe atopic dermatitis, drugs tried and failed and reason for failure, AND
• Member has an Investigator's Global Assessment (IGA) score of 3 or 4, AND
• Exacerbating factors that could contribute to the member's atopic dermatitis have been evaluated and addressed (e.g., non-compliance with therapy, environmental triggers, allergy patch testing, etc.), AND
• Trial and failure of all of the following (note: failure is defined as the member being refractory to daily treatment for at least 1 month for topical corticosteroids and 6 weeks for topical calcineurin inhibitor or maximum duration recommended by the product's prescribing information):
  • At least one medium to very high potency topical corticosteroid, AND
  • At least one topical calcineurin inhibitor (Elidel, Protopic), AND
  • At least one oral DMARD (e.g., cyclosporin)

Reauthorization Criteria:

For diagnosis of Atopic Dermatitis:

• Dose does not exceed maintenance dose of 300 mg (two 150 mg injections) administered every other week, AND
• Member has had a clinical reduction in body surface area (BSA) affected, AND
• Member has had a clinical reduction in pruritus and flares, AND
• Member has had an improvement of at least 2 points on the IGA from initiation of treatment

Coverage Duration: 

• Initial: 4 months
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Dosing: 
  • An initial dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every other week.
  • After 16 weeks of treatment, for patients with body weight below 100 kg who achieve clear or almost clear skin, a dosage of 300 mg every 4 weeks may be considered.
• Parasitic (Helminth) Infections: Treat patients with pre-existing helminth infections before initiating treatment with Adbry. If patients become infected while receiving Adbry and do not respond to anti-helminth treatment, discontinue treatment with Adbry until the infection resolves.

Policy Updates:

• 5/17/2022 – New policy approved by P&T.

References:

• Adbry [package insert]. Summit (NJ): Celgene Corporation; January 2022.
• Davis, DM, Drucker AM, Alikhan A, et al. AAD Guidelines: awareness of comorbidities associated with atopic dermatitis in adults.  J Am Acad Dermatol. 2022. doi: https://doi.org/10.1016/j.jaad.2022.01.009.
• Dupixent [package insert], Tarrytown, NY: Regeneron Pharmaceuticals; December 2021.
• Howe W. Treatment of atopic dermatitis (eczema). UpToDate. Updated March 11, 2022. www.uptodate.com. Accessed April 12, 2022.