Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Psoriasis.  
Treatment: Otezla (apremilast).  

The insurer denied the Otezla (apremilast).  
The denial is overturned.  

The patient is a female with psoriasis of the head, trunk, and extremities (moderate, three to ten percent body surface area [BSA]) for whom Otezla is requested. When she uses lidex, Protopic, and triamcinolone, the rash and itching improve but flare when she stops. She is not breastfeeding, and there is no history of depression, anxiety, diarrhea/constipation. The letter of medical necessity was submitted and noted the patient is not a candidate for phototherapy due to affected area on her scalp. The physician also noted oral immunosuppressants are not appropriate due to Covid risk for her and her newborn. The letter states the patient has an elevated body mass index (BMI) and increased risk of non-alcoholic steatohepatitis (NASH) with administration of methotrexate (MTX), and has a family history of hypertension (HTN) so cyclosporine (CYA) is not appropriate.  

Yes, the requested health service, Otezla, is medically necessary.  

The patient is not a candidate for conventional systemic medications due to being a female of child-bearing potential and for phototherapy due to the location of affected areas on the scalp which cannot be reached by light.  

Otezla, an inhibitor of phosphodiesterase four (PDE4), is indicated for the treatment of adult patients with active psoriatic arthritis and patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.  (Celgene)  Otezla is an oral small molecule inhibitor of phosphodiesterase four (PDE4) specific for cyclic adenosine monophosphate (cAMP) and is indicated for the treatment of adult patients with active psoriatic arthritis (PsA) as well as the treatment of patients with moderate to severe plaque psoriasis. (Celgene)  The patient has severe psoriasis for which therapy with Otezla is appropriate and medically necessary.  

The current treatment guidelines that are in accordance with nationally accepted standards of medical practice for moderate to severe plaque psoriasis recommend typical first line treatments such as topical corticosteroids and calcipotriene followed by typical second line treatments such as ultraviolet phototherapy, oral systemic treatments (methotrexate, cyclosporine) and newer therapies, such as small molecule drugs and biologics.  

This patient has moderate to severe psoriasis for which systemic therapy is indicated. She is not a candidate for phototherapy due to the location of psoriasis in the scalp.  With psoriasis of the head, phototherapy is not an appropriate option for treatment. Cyclosporine is not a reasonable long-term option for the patient because of the side effect profile which precludes long-term use when other options are available.  Methotrexate has life-threatening side effects and a much more severe side effect profile than Otezla.  In the era of small molecules (Otezla) and biologic therapies for psoriasis, the use of methotrexate, cyclosporine, or acitretin (acitretin is contraindicated in women of childbearing potential) is not the most appropriate first-line treatment because their long term safety and efficacy are inferior to newer therapies.