Benlysta denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Benlysta 200 mg/mL. In this case, the provider notes that the patient has positive anti-ribosomal protein antibodies and therefore has a positive antinuclear antibody (ANA) screening as well. While ANA positivity has been viewed as a defining feature of systemic lupus erythematosus (SLE), Pisetsky and Lipsky report that many patients with SLE are ANA negative at screening. Limitations in the ANA assays or a transition in some patients to a serologically negative state may explain ANA negativity in persons with true SLE.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for weekly Benlysta 200 mg injections. Findings: The physician reviewer found that submitted documentation supports the medical necessity of the requested medication. A SELENA-SLEDAI (systemic lupus erythematosus disease activity index) score of 13 is noted in the medical records. She has failed to respond to other standard drugs for SLE treatment, such as hydroxychloroquine. Furie and colleagues performed a phase III, multicenter, randomized, placebo-controlled trial of antinuclear antibody-positive or anti-double-stranded DNA-positive SLE patients with SELENA-SLEDAI scores greater than or equal to 6. This trial included a large number of patients with musculoskeletal symptoms due to SLE, as experienced by this patient.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for Benlysta systemic lupus erythematosus (SLE). Findings: The physician reviewer found that a review of the medical record and the current medical literature, the requested Benlysta is not medically necessary for the treatment of this patient’s SLE. According to the 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases, Benlysta use is not currently recommended for the treatment of SLE during pregnancy and should be discontinued once conception has occurred. In this case, the records reveal that the patient did not respond favorably to treatment with steroids and Plaquenil.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Benlysta 200 mg/mL auto injection. In this case, the patient has been diagnosed with SLE. However, a review of the record establishes that the patient’s laboratory results show normal complements level, no proteinuria, and a positive QuantiFERON tuberculosis test. Further, the patient’s blood work does not include results showing positive lupus-specific antibodies such as antinuclear antibody (ANA), double-stranded DNA (dsDNA), or anti-Smith (ant-Sm) antibodies. In addition, the patient’s physical examination and symptoms do not include an indication of malar rash, photosensitivity, synovitis aside from erosive osteoarthritis (EOA)-related distal interphalangeal joint pain/swelling, or mucosal ulcerations.

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