Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Crohn's Disease 

Treatment: Stelara intravenous (IV) injection (ustekinumab)

The insurer denied coverage for Stelara intravenous (IV) injection (ustekinumab)

The denial is upheld

This is a patient for whom the provider requested the provision of Stelara as treatment for Crohn's disease (CD). The patient has severe disease. The patient has failed Remicade. The patient has not tried and failed Humira. The plan declined coverage as the patient has not tried and failed Humira. The provider notes that the patient does not want to try another anti-TNF (Anti- tumor necrosis). The provider cites a phase 2b and phase 3 level studies in their assertion that the patient would not benefit from another anti-TNF and should therefore start Stelara.

Per office note, the patient has been on maintenance with Remicade. The patient had increase dose of Remicade without change to increased gastrointestinal symptoms. Treatment plan is to consider change of Remicade therapy due to presence of aphthae in colonoscopy.

While Stelara is an appropriate medication for this patient, there is no mandate to use this medication over Humira. There is insufficient literature to mandate the use of Stelara over Humira. As such, the insurer's preferred available medications are as appropriate for their condition. In conclusion, Stelara intravenous (IV) injection (ustekinumab) is not considered medically necessary for this patient.

"Recommendation 2C. In adult outpatients with moderate to severe CD who previously responded to infliximab (secondary nonresponse), the American Gastroenterological Association (AGA) recommends the use of adalimumab or ustekinumab (Strong recommendation, moderate certainty evidence) and suggests the use of vedolizumab over no treatment for the induction of remission. (Conditional recommendation, low certainty evidence)" (3).

"The optimal management approach for Crohn's disease incorporates patient risk stratification, patient preference, and clinical factors in therapeutic decision-making. First-line therapy generally consists of steroids for rapid palliation of symptoms during initiation of anti-tumor necrosis factor  therapy. Other treatments may include monoclonal antibodies to (interleukin) IL-12/23 or integrin 47, immunomodulators, combination therapies, or surgery. Effective control of inflammation reduces the risk of penetrating complications (such as intra-abdominal abscesses and fistulae), although more than half of patients will develop complications that require surgery. Adverse reactions to therapy include antibody formation and infusion reactions, infections, and cancers associated with immune modulators and biologics and toxicity to the bone marrow and the liver. Both Crohn's disease and corticosteroid use are associated with osteoporosis. Vaccinations to prevent infections, such as influenza, pneumonia, and herpes zoster, are important components of health maintenance for patients with Crohn's disease, although live vaccines are contraindicated for patients receiving immune suppression therapy" (1).

"In September 2016, the United States Food and Drug Administration approved the use of ustekinumab for use in CD. It is an (interleukin) IL-12 and IL-23 antagonist. It is used in patients with moderate to severe CD who have failed treatment with corticosteroids or immunosuppressants . The adverse effects of using ustekinumab are anaphylactic reactions, diarrhea, upper respiratory tract infections, and injection site reactions" (2).                                                         

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Stelara intravenous (IV) injection (ustekinumab) is not substantiated.