Adbry denials in California external review

What the reviewers wrote

Where the denial was overturned

ature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Adbry injectable 150 mg/mL every other week. Findings: The physician reviewer found that (FDA) approves the use of Adbry (generic name tralokinumab) for the treatment of moderate-to-severe atopic dermatitis (AD) in adults whose disease is not adequately controlled with topical prescription therapies. Boguniewicz and colleagues define moderate-to-severe AD as disease that affects more than 10% BSA and/or involves highly visible areas, or those areas important for function such as the hands, neck, face, and genitals, and that significantly impairs quality-of-life. Silverberg and colleagues note that tralokinumab 300 mg in combination with topical corticosteroids as needed is effective and well tolerated in patients with moderate-to-severe AD.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Adbry. The U.S. Food and Drug Administration approves Adbry (tralokinumab) for treating moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies. Researchers define moderate-to-severe atopic dermatitis as the involvement of over ten percent of body surface area and/or the involvement of highly visible areas or those important for function, such as the hands, neck, face, or genitals, with significant impairment of quality of life.

Where the denial was upheld

Findings: The physician reviewer found that The patient has requested authorization and coverage for Adbry solution prefilled syringe 150 mg/mL. The U.S. Food and Drug Administration (FDA) has approved Adbry for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies. A recent consensus article on atopic dermatitis experts defined moderate-to-severe atopic dermatitis as greater than 10% body surface area (BSA) involvement and/or involvement of highly visible areas or those important for function and significantly impaired quality of life. The records document that this patient has moderate-to-severe atopic dermatitis given involvement of the face and involvement of the trunk. Several recent randomized clinical trials have shown the efficacy of Adbry in treating atopic dermatitis.

Nature of Statutory Criteria/Case Summary: The patient’s parent has requested authorization and coverage for Adbry 150 mg/mL injection syringe (inject 4 mL (600 mg) under the skin once for a loading dose, inject 2 mL (300 mg) under the skin every 14 days for maintenance dose). In this case, the patient has several potential medications that would help this patient to control her severe atopic dermatitis and avoid the side effects she has experienced with previous therapy. The patient’s provider has recommended treatment with Adbry. Recently, the provider noted that the patient requires hospitalization due to flare of her atopic dermatitis. However, there are alternative medications for this patient’s disease. In addition, Adbry has not been demonstrated to be more effective in preventing hospitalization than other available therapies.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Adbry, then check the rights and deadlines that apply to your plan.