Letter of Medical Necessity

Pacific Northwest Gastroenterology Associates, 450 Sutter St, Suite 1200, San Francisco, CA 94108

Attn: Dr. Robert Vance, Medical Director Blue Shield of California 601 12th Street Oakland, CA 94607

RE: Marcus Vance 14/08/1982 POL-8849201-CA CLM-2023-994812

Request: Authorization for treatment with ustekinumab (Stelara®) Diagnosis: Crohn's disease of both small and large intestine with rectal bleeding (ICD-10: K50.811) Dosage: ustekinumab (Stelara®) 390 mg IV once, followed by 90 mg SC q8w

24/10/2023 Dear Dr. Vance,

I am writing on behalf of my patient, Marcus Vance, to establish the medical necessity of ustekinumab (Stelara®), which is indicated for treating moderately to severely active Crohn's disease.

This request is based on the information below

Summary of Patient History

• Ileocolonic Crohn's disease established via colonoscopy and biopsy on 12/03/2019.
• Fecal calprotectin 850 µg/g, CRP 42 mg/L, Hb 10.8 g/dL, and serum adalimumab trough level < 0.5 µg/mL with positive anti-drug antibodies (obtained 15/10/2023).
• Active flare with 6-8 bloody BM/day, RLQ abdominal pain, and 5 kg unintentional weight loss over 2 months.
• Prior therapies: prednisone 40 mg PO daily (tapered), azathioprine (Imuran®) 150 mg PO daily, and adalimumab (Humira®) 40 mg SC q2w. Ongoing: budesonide (Entocort® EC) 9 mg PO daily as bridge therapy.
• Initial clinical remission on adalimumab for 2 years, followed by secondary loss of response over the past 3 months.
• Azathioprine discontinued on 18/06/2020 due to drug-induced hepatotoxicity (elevated AST/ALT); adalimumab discontinued on 16/10/2023 due to secondary loss of response and immunogenicity.

Rationale for Treatment

In view of the patient’s medical history, present condition, and the established uses of ustekinumab (Stelara®), I consider treatment with ustekinumab (Stelara®) at this stage justified, suitable, and medically necessary.

The following materials are enclosed

• ustekinumab (Stelara®) full Prescribing Information
• Feagan BG, et al. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease (UNITI-1 and UNITI-2 trials), N Engl J Med 2016; for Crohn's disease of both small and large intestine with rectal bleeding; ICD-10: K50.811
• Colonoscopy report with pathology (10/10/2023), recent GI clinic progress notes, and laboratory results (15/10/2023)

Please contact my office at (415) 555-0192 if further information or records are needed. I would appreciate your prompt reply.

Sincerely,

Elena Rostova, MD Dr. Elena Rostova, MD | NPI: 1942385719

Enclosures