Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Alopecia Areata
Treatment: Olumiant 2 milligrams (mg) tablet
The insurer denied the Olumiant 2 mg tablet.
The denial is overturned.

The patient is an adult male with alopecia areata affecting > (greater than) 50% (percent) of the beard area, for whom Olumiant is requested. He started taking Olumiant one month prior and noticed early signs of hair growth. This is a request to continue treatment.

The requested Olumiant is medically necessary.

The patient has severe alopecia areata affecting > 50% of the beard area. He started taking Olumiant (baricitnib) one month ago and is seeing early hair growth. Alopecia areata is an autoimmune condition characterized by rapid hair loss in the scalp, eyebrows, and eyelashes, for which treatments are limited. Baricitinib, an oral, selective, reversible inhibitor of Janus kinases 1 and 2, may interrupt cytokine signaling implicated in the pathogenesis of alopecia areata. The 2 mg (milligrams) dose of baricitnib has been partially effective for the patient after he failed multiple other therapies. The 4 mg dose is standard dosing for severe alopecia areata if inadequate response or in patients with nearly complete or complete scalp hair loss. There is no comparable drug on the formulary available to the patient. In a recent meta-analysis, the results of the safety analysis revealed no significant differences between the baricitinib and placebo groups for any of the outcomes with the exception of acne, which was significantly higher in the placebo group when compared to the baricitinib group. Two recent randomized, placebo-controlled, phase 3 trials (BRAVE-AA1 and BRAVE-AA2) involving adults with severe alopecia areata with a Severity of Alopecia Tool (SALT) score of 50 or higher (range, 0 [no scalp hair loss] to 100 [complete scalp hair loss]) were conducted. Patients were randomly assigned in a 3:2:2 ratio to receive once daily baricitinib at a dose of 4 mg, baricitinib at a dose of 2 mg, or placebo. The primary outcome was a SALT score of 20 or less at week 36.

There were 654 patients enrolled in the BRAVE-AA1 trial and 546 in the BRAVE-AA2 trial. The estimated percentage of patients with a SALT score of 20 or less at week 36 was 38.8% with 4 mg baricitinib, 22.8% with 2 mg baricitinib, and 6.2% with placebo in BRAVE-AA1 and 35.9%, 19.4%, and 3.3%, respectively, in BRAVE-AA2. In BRAVE-AA1, the difference between 4 mg baricitinib and placebo was 32.6 percentage points (95% confidence interval [CI], 25.6 to 39.5), and the difference between 2 mg baricitinib and placebo was 16.6 percentage points (95% CI, 9.5 to 23.8) (P < [less than] 0.001 for each dose vs. placebo). In BRAVE-AA2, the corresponding values were 32.6 percentage points (95% CI, 25.6 to 39.6) and 16.1 percentage points (95% CI, 9.1 to 23.2) (P < 0.001 for each dose versus placebo). Secondary outcomes for baricitinib at a dose of 4 mg but not at a dose of 2 mg generally favored baricitinib over placebo. Acne, elevated levels of creatine kinase, and increased levels of low- and high-density lipoprotein cholesterol were more common with baricitinib than with placebo. In conclusion, in two phase 3 trials involving patients with severe alopecia areata, oral baricitinib was superior to placebo with respect to hair regrowth at 36 weeks. Olumiant (baricitinib) is FDA (United States Food and Drug Administration)-approved for use in the circumstances of this patient. Therefore, given the above, the requested Olumiant is medically necessary.