Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Skin Disorders.
Treatment:  Pharmacy/Prescription Drugs (Otezla).

The insurer denied the Otezla.  The denial is upheld in whole.

The patient is a male with psoriasis involving the hands.  The patient has a body surface area (BSA) of approximately 6%.  The patient has failed topical steroids.  The provider is requesting Otezla.  The subject under review is the medical necessity for Otezla.

The health plan's determination is upheld in whole. 

No, Otezla is not medically necessary.  According to the American College of Rheumatology and National Psoriasis Foundation guidelines phototherapy and oral agents for psoriasis (i.e., acitretin, cyclosporine, and methotrexate [MTX]) may be used first-line in various clinical situations.  For example, acitretin is a first-line systemic drug for palmoplantar or pustular psoriasis and is especially useful in those with severely sun damaged skin, in which it may suppress actinic keratoses and even invasive malignant neoplasms.  Cyclosporine may be effective long-term but is normally reserved for intermittent use (up to 12 weeks) to control a flare, so the patient can transition to another drug for long-term maintenance.  When used intermittently, a course of cyclosporine can induce an average decrease of greater than (>) 75% in psoriasis severity.  MTX is considered a first-line systemic agent for plaque psoriasis that may be used continuously for many years or decades with durable benefits.  Per Wong et al. (2013), "Phototherapy is one of the most efficacious treatment options for psoriasis. New, emerging studies are beginning to define the biologic mechanisms by which phototherapy improves psoriasis ....  Phototherapy acts through a combination of pathways to confer therapeutic benefits in psoriasis, and these different modalities may help explain its particular usefulness in treating this cutaneous disease."

Per Racz et al. "Phototherapy is a first-line option for the treatment of moderate to severe psoriasis.  Systematic reviews indicate near comparable efficacy of the different forms of phototherapy.  Localized phototherapy can be an adjunctive treatment of recalcitrant plaques during systemic treatment of psoriasis.  More than 200 psoralen-UVA therapy treatment sessions is associated with an increased risk of keratinocytic cancers, whereas no increased risk has been demonstrated for narrow-band UVB therapy.  The mechanism of action of phototherapy in psoriasis is via inhibition of keratinocyte proliferation; induction of apoptosis in keratinocytes, dendritic, and T cells; and inhibition of Th1 and Th17 pathways, but activation of Th2."

As stated by authors Chiricozzi et al., "Acitretin is one of the systemic agents used for the treatment of psoriasis.  Because different acitretin dosages resulted therapeutically successful, there is no general agreement on the optimal dose regimen.  To report acitretin efficacy and safety in a real-life setting, wherein patient-tailored dose regimen is usually prescribed, a retrospective analysis evaluating charts of all plaque-type psoriasis patients treated with acitretin from the clinic database was performed.  Psoriasis area and severity index (PASI) score improvement, as well as PASI 50, 75, 90, and 100 responses were assessed throughout the observational period.  Overall, 52% PASI score reduction and a satisfactory safety profile were detected.  PASI 50, 75, 90, and 100 response was achieved by 53%, 48%, 28%, and 14%, respectively.  Treatment consisted of a mean daily acitretin dose of 25.01 milligrams (mg). The initial dose was increased (51.2% of cases) or decreased (48.8%) prescribing a mean daily dose of 29.8 mg and 20.02 mg, respectively.  This study proposed a dose regimen customized on clinical response and patient's needs, to optimized acitretin benefit."

Per Colombo et al. (2013), "Cyclosporine A (CsA) is one of the most effective systemic drugs available for the treatment of psoriasis, as evidenced by the results of several randomized studies and by a prolonged experience in dermatological setting.  In clinical practice, CsA is usually used for the induction of psoriasis remission at a daily dose included in the range of 2.5-5 milligrams per kilogram (mg/kg) and with intermittent short-term regimens, lasting on average 3-6 months."

Per authors Greb et al. (2016), "Methotrexate is an anti-inflammatory agent used to treat psoriasis, psoriatic arthritis, and other immune mediated disorders ....  The folic acid analogue methotrexate is used as an anti-neoplastic agent and treatment for inflammatory disorders including psoriasis, dermatomyositis, lupus erythematous, sarcoidosis, and systemic sclerosis. Despite the introduction of newer biologic agents, methotrexate remains a first-line systemic therapy for many patients with disorders of chronic inflammation."

Methotrexate has proven efficacy, per West et al. (2016)," in terms of efficacy, the present meta-analysis finds that approximately 40% of patients achieve a PASI 75 by 12 weeks of treatment.  Nonetheless, it means that many psoriasis patients requiring systemic therapy are likely to benefit to methotrexate, even more so, as flexible dose adjustment and adaptation of route of dosing are applied under real-world conditions which would be expected to increase efficacy and reduce limiting adverse events."  The patient does not have a history of skin cancer or elevated LFTs or liver disease or uncontrolled hypertension.  The patient has no documented contraindication, intolerance, or failure (CIF) to conventional therapy with phototherapy or the plan preferred agents.  Otezla is not medically necessary.