Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Systemic Lupus Erythematous

Treatment: Benlysta 200 milligrams (mg)/milliliter (ml)

The insurer denied coverage for Benlysta 200 milligrams (mg)/milliliter (ml)

The denial is overturned

This case involves a patient with a subject for review for the denial of coverage for Benlysta 200 milligrams (mg)/milliliter (ml) Autoinjector.

The patient's Immunology-Serology report showed a negative result for Hepatitis B and QuantiFERON tuberculosis (TB).

The patient was seen for a history of lupus (+ antinuclear antibody [ANA] 1:160/Raynaud's/dry eyes and dry mouth/inflammatory arthritis). During the visit, the patient reported minimal pain, still temporizing with prednisone and stated that it helped moderately for their joint pain. The patient's Raynaud's is managed with Amlodipine 5 mg. It was noted that the patient has a score of 18 with the systemic lupus erythematous disease activity index 2000 (SLEDAI-2K).

A letter was submitted by the provider for the request of Benlysta injections for the treatment of uncontrolled Lupus. Per the letter, the first denial was due to lack of information regarding the SELENA SLEDAI (systemic lupus erythematous disease activity index) and the information was resubmitted with a score of 18. The second request was denied for "Active central nervous system (CNS)", which the member does not have, and it was an error with entrustable professional activities (EPA). The second appeal was denied for the lack of information regarding Hepatitis B and TB which are both resubmitted, and the result was negative for both. 

An External Review Application was submitted.

In this case, this is a patient with a diagnosis of lupus. During the visit, the patient reported minimal pain and stated that the prednisone 5mg helps them moderately for their joint pain. The patient was ordered to continue prednisone 5 mg, celecoxib 200 mg, and amlodipine 5 mg for Raynaud's. The patient scored 18 with SLEDAI-2K, and was negative for Hepatitis B and QuantiFERON TB on the Immunology-Serology report.

The request was previously denied due to the drug with other illness being not advised. A denial was sent stating the provider would have to submit test results for Hepatitis B virus infection or Hepatitis C virus infection and for latent tuberculosis and made a statement that the member does not have Human Immunodeficiency Virus (HIV) infection. The second appeal was denied for the lack of information regarding Hepatitis B and TB which are both resubmitted, and the result was negative for both.

According to the referenced literature, in a population of patients with active SLE (SELENA-SLEDAI score of 8 or more) belimumab reduced disease activity after 52 weeks compared to placebo, as measured by SLE responder index (SRI) response. Although belimumab reduced the risk of a severe flare over this time period, it did not elicit a reduction in prednisone dosage.

Based on the medical records received for this review, the previous denial reasons for both denials have been addressed; there was an error regarding the "Active CNS", and the lack of information regarding Hepatitis B and TB, and SLEDAI-2K has been resolved. The patient's Immunology-Serology report showed a negative result for Hepatitis B and QuantiFERON TB, the member does not have "Active CNS", and it was an error with EPA, and it was noted on the visit notes that the patient scored 18 with the SLEDAI-2K. As such the denial for Benlysta 200 milligrams (mg)/milliliter (ml) Autoinjector is overturned and is considered medically necessary.

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Benlysta 200 milligrams (mg)/milliliter (ml) Autoinjector services is substantiated.