natalizumab (TYSABRI) Medical Benefit Prior Authorization STEP 1: CLEARLY PRINT AND COMPLETE TO EXPEDITE PROCESSING Date: Prescriber First & Last Name: Member First & Last Name: Prescriber NPI: Member Address: Prescriber Address: Member ID: Prescriber Phone: Member Birth Date: Prescriber Fax: STEP 2: INDICATE MEDICATION REQUESTED natalizumab (TYSABRI) (J2323) Initial Therapy MS: Maximum of 6 infusions (300 mg for each infusion) in a 6 month period Initial Therapy CD: Maximum of 3 infusions (300 mg for each infusion) in a 3 month period Continuing Therapy: Maximum of 12 infusions (300 mg for each infusion) in a 1 year period STEP 3: REQUESTED DRUG INFORMATION Strength/Dosage and Dosing Frequency: If the prescriber would like a different strength, dosage and/or dosing frequency than listed above, please provide medical rational for exception: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________ Location of Administration Home (POS: 12) Clinic/Office (POS: 11) Outpatient Treatment Center (POS: 22) Other: __________________ Name of Facility: ___________________________________________________________________ Address: _____________________________________________ Phone Number: _______________ STEP 4: COMPLETE REQUIRED CRITERIA Indicate Diagnosis: _______________________________ ICD 10 Code (Required): __________ Rev. 05/07/2020 Page 1 of 3 Version 1.3 natalizumab (TYSABRI) Medical Benefit Prior Authorization DIAGNOSIS A: Multiple Sclerosis (MS) REQUIRED FOR ALL REQUESTS: AND Prescribed by a Neurology Specialist INITIAL THERAPY (approved for 6 months): AND Member has a clinical diagnosis of relapsing multiple sclerosis (MS) (including active secondary progressive disease, relapsing-remitting disease, or clinically isolated syndrome (CIS)) AND Indicate ONE (1) of the following: AND Member has a contraindication, allergy, intolerance, or failure of an adequate trial of an interferon-based product (e.g. AVONEX, EXTAVIA, PLEGRIDY, REBIF) or a glatiramer product (e.g. COPAXONE) IOR Member has high risk/aggressive MS AND Indicate ONE (1) of the following: OR Member has a contraindication, allergy, intolerance, or failure of an adequate trial of AUBAGIO, GILENYA, or TECFIDERA OR Member has high risk/aggressive MS AND If member has high risk/aggressive MS, prescriber attests that chart documentation indicates ONE (1) of the following: OR Multiple spinal cord lesions (greater than or equal to (≥) 2) OR Brainstem/infratentorial lesions (greater than or equal to (≥) 1) OR Significant disease burden on magnetic resonance imaging (MRI) (greater than or equal to (≥) 10 lesions) OR Short interval between relapses (2 or more relapses in 2 years or less) OR Treatment failure (clinically or radiographically) with a previous disease-modifying treatment OR Incomplete recovery from previous relapse (e.g. residual symptoms remaining) OR Motor-based relapse (e.g. gait disturbances) AND Member has had anti-John Cunningham Virus (JCV) antibody testing with an enzyme-linked immunosorbent assay (ELISA) prior to initiating treatment and will test annually thereafter CONTINUING THERAPY (approved for 1 year): AND Prescriber attests that documentation indicates the member is NOT receiving natalizumab (TYSABRI) in combination with any other disease modifying treatments (e.g. interferons, AUBAGIO, COPAXONE, GILENYA, GLATOPA, or TECFIDERA), B cell targeted therapy (e.g. belimumab, ofatumumab, rituximab), or lymphocyte trafficking blockers (e.g. alemtuzumab, mitoxantrone) AND Member continues to be regularly seen by a provider specializing in the care of MS Rev. 05/07/2020 Page 2 of 3 Version 1.3 natalizumab (TYSABRI) Medical Benefit Prior Authorization DIAGNOSIS B: Crohn’s Disease (CD) REQUIRED FOR ALL REQUESTS: AND Prescribed by a Gastroenterology Specialist INITIAL THERAPY (approved for 3 months): AND Member has a clinical diagnosis of moderate-to-severe Crohn’s Disease (CD) AND Member has had an inadequate response to, or is unable to tolerate at least ONE (1) medication in EACH of the following categories: AND Anti-inflammatory drugs (e.g. sulfasalazine) AND Corticosteroids AND Formulary self-injectable tumor necrosis factor (TNF)-α inhibitors (e.g. HUMIRA) AND Formulary medical benefit infusables (e.g. ENTYVIO, an infliximab product) AND Member has had anti-John Cunningham Virus (JCV) antibody testing with an enzyme-linked immunosorbent assay (ELISA) prior to initiating treatment and will test annually thereafter CONTINUING THERAPY (approved for 1 year): AND Prescriber attests that documentation (including chart notes) indicates disease stability or improvement. Examples of stability or improvement include: • Laboratory Assessment: C-reactive protein (CRP), hemoglobin, erythrocyte sedimentation rate (ESR), white blood cell (WBC), albumin • Symptom Assessment: bleeding, stooling pattern, abdominal pain, extraintestinal complaints, fatigue • Endoscopy Results STEP 5: SIGN AND FAX TO: PRIOR AUTHORIZATION: 855-668-8551 Prescriber Signature: ___________________________________________ Date: ______________ If member meets criteria, allow 2 business days for processing. If criteria not met, submit chart documentation with form citing complex medical circumstance. If approved, coverage allowed as indicated above (subject to formulary changes). For Questions, please call Dean Customer Service 1-800-279-1301 or www.deancare.com Rev. 05/07/2020 Page 3 of 3 Version 1.3 .