Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with Crohns disease. In an undated letter, the provider noted that the patient has ileocolonic and perianal Crohn's disease, status post subtotal colectomy and end-ileostomy. Per the provider, an ileostomy revision was performed due to abscess and fistula. The patient has tried and failed multiple medications, including Humira, Remicade, 6-mercaptopurine, and methotrexate. The patient was noted to have had a response to Tysabri, but this medication was stopped after the patient moved abroad. The patient also tried and failed treatment with Entyvio. The patient began treatment with Stelara. The provider noted that an ileoscopy in November showed active Crohns disease in the distal ileum. A flexible sigmoidoscopy revealed a diffuse area of moderately erythematous and friable mucosa with contact bleeding in the rectal stump.  The patient reported rectal pain. The provider noted the treatment plan included increasing the patients Stelara dose to 90 mg every four weeks. The provider noted that the patient was at risk for more surgeries for recurrent stricturing if the Crohns disease was not controlled. The patient has requested authorization and coverage for Stelara 90 mg subcutaneous injections every four weeks. The Heath Plan denied the request and reported the requested medication regimen is not medically necessary for the treatment of this patient. Per the Health Plan, the U.S. Food and Drug Administration (FDA) maximum recommended treatment with Stelara is every eight weeks. At issue in this case is whether Stelara 90 mg subcutaneous injections every four weeks is medically necessary for the treatment of the patients medical condition. Researchers reported, Patients with moderate-to-severe Crohns disease that was resistant to tumor necrosis factor (TNF) antagonists had an increased rate of response to induction with ustekinumab, as compared with placebo. Patients with an initial response to ustekinumab had significantly increased rates of response and remission with ustekinumab as maintenance therapy. Studies reported, Subcutaneous ustekinumab treatment resulted in an initial clinical response in 73.7% of anti-TNF resistant Crohns disease patients. The clinical response was maintained in a majority of the initial responders for six to 12 months. Dose escalation was frequently required to achieve or maintain response. In this case, the patient has failed multiple biologic medications and conventional alternatives. The patient has disease symptoms and objective disease findings while being treated with Stelara every eight weeks. Continuation of Stelara dosing at every eight weeks or a change to another medication may result in complications such as fistula, stricture, bowel obstruction, flare, hospitalization, need for surgery, or other complications. The medical evidence supports the requested medication regimen in this clinical setting. Therefore, Stelara 90 mg subcutaneous injections every four weeks is medically necessary for the treatment of this patient.  Final Result: The reviewer determined that the requested medication regimen is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.