Appeal type: Formulary Exception
Decision: Upheld

Diagnosis:  Psoriatic Arthritis.
Treatment:  Pharmacy/Prescription Drugs (Stelara).

The health plan denied the requested prescription drug (Stelara).  The health plan's determination is upheld.

The patient is a female with Psoriatic Arthritis (PsA) for whom coverage of Stelara (Ustekinumab) 45 mg on weeks 0, 4 and every 12 weeks thereafter was requested.  A prior authorization form stated that the patient had tried and failed Cosentyx and Humira and that Methotrexate resulted in elevated liver enzymes.  The initial request was denied by the health plan because coverage criteria were not met.  Specifically, the denial cited lack of documentation of an inadequate response or intolerable adverse event with at least three preferred formulary agents available for PsA, including Cosentyx, Enbrel, Humira, and Otezla.  The denial was subsequently appealed.  In handwritten comments, the prescribing rheumatologist noted that the patient had tried and failed Cosentyx and that Enbrel and Humira were contraindicated due to serological findings of "lupus".  No comment was made regarding Otezla.  A chart entry was submitted and stated that the patient had tried and failed both NSAIDs (non-steroidal anti-inflammatory drugs) and Cosentyx in combination.  Methotrexate and Leflunomide were contraindicated due to fatty liver and evidence of transaminitis.  TNF (tumor necrosis factor) inhibitors were contraindicated due to various "lupus" serologies (high titer anti-nuclear antibody (ANA) of 1:1280 and positive anti-SSA (antiSjogren's-syndrome-related antigen A) and anti-B2 (glycoprotein I) and rashes.  The patient had severe pain in the DIPs (distal interphalangeal joints) and lower back pain.  Hence, the provider stated that Stelara was the only remaining choice. 

The health plan's determination is upheld.

The formulary drug Otezla is as effective for PsA with no anticipated greater adverse effects as compared with the non-formulary drug, Stelara.  In this case, the patient had several other comorbidities, which impacted treatment decisions regarding her PsA.  First, she had multiple and repeatedly positive systemic lupus erythematosus (SLE) serologies.  TNF antagonists have been associated with induction of lupus phenomenon including drug induced lupus.  Regardless, the patient had already tried and failed Humira.  Second, she had elevated liver enzymes, which precluded use of potentially hepatotoxic DMARDs (disease modifying anti-rheumatic drugs) of which she had already tried and failed Methotrexate.  She had also failed Cosentyx, an IL-17 (Interleukin 17) antagonist.  A switch to a different mechanism of action at this time is appropriate.  However, the patient had not tried and failed a third preferred formulary agent which would include either Enbrel (another TNF antagonist which was to be avoided) or Otezla.  The provider has not commented on the rationale for choosing Stelara over Otezla.  There is no evidence in current medical literature, which conclusively demonstrates superior efficacy in Stelara over Otezla in the treatment of PsA.  Furthermore, neither agent is contraindicated in the context of SLE antibodies or liver disease.  As such, the preferred agent, Otezla is as effective and would not be anticipated to have more adverse effects than Stelara.