Actemra denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Actemra (tocilizumab). Post-acute or long COVID can include a wide range of ongoing health problems, which can last weeks, months, or years. Long COVID occurs more often in patients who have had severe COVID-19 illness, but anyone who has been infected can experience it. Unfortunately, the mechanism for long COVID is poorly understood, and there is not any currently approved or standard treatment available. Inflammatory cytokines and chemokines, including IL-6, IL-1b, and TNF-a, are significantly elevated in patients with severe SARS-CoV-2 infection. IL-6 has major effects on cellular immunity with both proinflammatory and anti-inflammatory functions. IL-6 levels are undetectable, or below 10 pg/mL, in healthy controls.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Actemra. The American College of Rheumatology (ACR) guidelines for the treatment of rheumatoid arthritis specifically recommend that when patients have not responded adequately to one class of biologic therapy, such as tumor necrosis factor (TNF) inhibitors, switching to a different mechanism of action is conditionally recommended over continuing within the same class. In this case, the patient presents with seronegative rheumatoid arthritis and has failed multiple prior therapies, including two TNF inhibitors as well as conventional disease-modifying anti-rheumatic drugs. The ACR guidelines support the use of Actemra (tocilizumab) in this patient, which works through interleukin 6 receptor inhibition.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Actemra 162 mg autoinjector. Findings: The physician reviewer found that records provided for review document that this patient has a history of rheumatoid arthritis and interstitial lung disease. The patient’s provider has recommended treatment with Actemra. The provider has been reluctant to treat the patient with methotrexate or Arava given the patient’s comorbid interstitial lung disease. In addition, the provider states that sulfasalazine and Plaquenil are contraindicated because they are inadequate for the patient’s diagnosis given the severity of his symptoms. According to the American College of Rheumatology (ACR) guideline for the treatment of patients with rheumatoid arthritis, methotrexate and Arava are recommended as first-line disease modifying anti-rheumatic drugs (DMARDs).

Nature of Statutory Criteria/Case Summary: An enrollee has requested Actemra for the treatment of his medical condition. Findings: The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. Bortezomib would be the next agent to attempt to eliminate donor specific antibodies. Per the current medical evidence, there is a lack of support for Actemra in treating antibody mediated rejection. The medical records do not support the requested medication in this clinical setting. All told, Actemra is not medically indicated for the treatment of this patient. Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patient’s medical condition. Therefore, the Health Plan’s denial should be upheld.

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 Actemra, then check the rights and deadlines that apply to your plan.