Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriasis
Treatment: Humira (adalimumab)
The insurer denied coverage for Humira (adalimumab).
The denial is overturned.

This is a female patient with psoriasis. The patient requested treatment with Humira. However, there is no documentation that the patient has failed treatment with the preferred formulary cyclosporine. The patient used samples of Otezla in the past with gastrointestinal (GI) upset. The insurer advised that the patient use medication on the preferred list and recommended cyclosporine. 

As per Choi et al. (2017), "Although intermittent short courses of cyclosporine therapy can induce rapid improvement of psoriasis, sustained remission and disease control after discontinuation of cyclosporine are limited. In one study, the average interval between the withdrawal of cyclosporine and the initiation of another systemic therapy was reported to be 182 days. Because psoriasis is a chronic and relapsing disease, long-term treatment using a single systemic agent can be harmful for the patients." 

According to Papp et al. (2016), "Current treatment guidelines suggest that psoriasis may be treated with topical, ultraviolet (UV)-based, traditional systemic, or biologic therapies, depending on specific patient and disease characteristics. The majority of patients with psoriasis who are prescribed biologic therapy have previously received treatment with other systemic therapies, including methotrexate (MTX), cyclosporine, and psoralen plus UVA (PUVA) therapy. It is of clinical relevance to understand whether patients who have received prior systemic therapy, especially patients who did not respond to previous treatment, will respond to biologics to the same degree as patients who are naive to systemic treatments. Systemic therapies for the treatment of moderate to severe psoriasis include MTX, which acts as an immunosuppressant and is often a first-line systemic therapy, and cyclosporine, which is a short-term treatment alternative owing to its potential for nephrotoxicity. This analysis confirmed that adalimumab is efficacious for the treatment of moderate to severe psoriasis in patients who have received prior systemic therapy, including patients who did not respond to previous treatment. [Psoriasis Area Severity Index (PASI) 75] response rates for patients treated with adalimumab who had previous exposure to, or lacked a response to, other systemic therapies or phototherapy were similar to the overall population. The effect was evident at the earliest assessment (week 4) and was maintained through the end of the analysis period (week 16). Similar patterns were observed for PASI90 and PASI100 response rates. This finding demonstrates that adalimumab is an efficacious treatment option for patients who received prior systemic therapy regardless of their prior treatment responses." 

As per Burness and McKeage (2015), "adalimumab remains an important treatment strategy in adults with moderate-to-severe chronic plaque psoriasis and provides a promising new systemic treatment option for children and adolescents from 4 years of age with severe psoriasis."

Based on the review of the literature, the use of cyclosporine for long-term treatment of psoriasis is not medically appropriate, and is only intended for short-term use due to its potential for nephrotoxicity. Thus, as cyclosporine cannot be used long-term, and psoriasis is a long-term disease that requires continual treatment, it would be in the best interest of the patient to allow for the request for Humira (adalimumab) for treatment. It is considered that Humira is medically necessary for this patient.

The health plan did not act reasonably with sound medical judgment, and in the best interest of the patient. 

The carrier's denial of coverage for Humira (adalimumab) should be overturned. The medical necessity is substantiated.