Prior Authorization Conditions for Approval of Humira (adalimumab) Website Form Submit request via: Fax

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1 Prior Authorization Conditions for Approval of Humira (adalimumab) Website Form Submit request via: Fax All requests for Humira (adalimumab) require a prior authorization and will be screened for medical necessity and appropriateness using the criteria listed below. Humira (adalimumab) Prior Authorization Criteria: For all indications, the member must be evaluated and screened for the presence of latent TB infection and for the presence of Hepatitis B (antibody and/or surface antigen). For all indications, the member should not be receiving another biologic DMARD product in combination with Humira The prescribing physician must be a Rheumatologist, Gastroenterologist, Ophthalmologist, or Dermatologist Coverage is provided for moderate to severe, active Rheumatoid Arthritis in the following situations: o Member has tried methotrexate for 3 months with an inadequate response and Humira will be used in combination with methotrexate Maintenance dosing will not exceed 40 mg every other week when using with methotrexate o Or the member has a contraindication to methotrexate and has tried/failed a 3 month trial of a DMARD other than methotrexate (e.g. leflunomide, sulfasalazine, hydroxychloroquine) Maintenance dosing will not exceed 40 mg every week when not receiving methotrexate Coverage is provided for moderate to severe Psoriatic Arthritis in the following situations: o Member has peripheral disease and has experienced a therapeutic failure with at least 2 of the following: Methotrexate for at least 3 months NSAIDS (unless contraindicated) Another DMARD for at least 3 months (e.g. leflunomide, cyclosporine, azathioprine, hydroxychloroquine) o Or the member has axial disease and has experienced treatment failure with NSAIDs o Maintenance dosing will not exceed 40 mg every other week Coverage is provided for moderate to severe Crohn s Disease in adult and pediatric members (> 6 years of age) in the following situations: o Member must have tried/failed or has a contraindication to conventional treatments including at least 2 of the following: Aminosalicylates, 5-ASAs (e.g., sulfasalazine, Pentasa, Asacol, Colazal) Antibiotics (e.g., metronidazole, ciprofloxacin) Steroids (e.g., prednisone, Entocort) Immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate) o Or the member has fistulizing disease (defined as diffuse inflammatory disease with fistula present, any involvement of the distal small bowel and/or large bowel, or significant anemia/gastrointestinal bleed/poor nutrition with weight loss/abdominal pain) o Maintenance dosing in adult and pediatric members > 40 kg for controlled disease will not exceed 40 mg every other week o Maintenance dosing in pediatric members 17 kg to < 40 kg for controlled disease will not exceed 20 mg every other week Coverage is provided for moderate to severe Ulcerative Colitis in adult members in all of the following situations: o Member must have tried/failed or has a contraindication to conventional treatments including at least 2 of the following: Topical mesalamine products (e.g., Rowasa) Oral aminosalicylates, 5-ASAs (e.g., sulfasalazine, Pentasa, Asacol, Colazal) Steroids, topical or oral (e.g., prednisone, hydrocortisone, Entocort) Immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate, cyclosporine) o Member has moderately to severely active disease or steroid refractory/dependent disease o Maintenance dosing will not exceed 40 mg every other week Coverage is provided for moderate to severe, chronic plaque psoriasis in all of the following situations: o Disease defined as > 5% body surface area (BSA) affected or BSA involvement of < 5% in critical areas (palms, soles, or face) that interferes with daily activities o Member must be considered a candidate for systemic therapy o Member must have a therapeutic failure of a > 3 month trial of psoralens with UVA light (PUVA) or UVB light

2 o Member must have tried/failed a 3 month trial of or had a contraindication to at least 1 the following systemic oral treatments: Immunomodulators (e.g., methotrexate, cyclosporine) Retinoids (e.g., Soriatane) o Maintenance dosing will not exceed 40 mg every other week Coverage is provided for moderate to severe, active Polyarticular Juvenile Idiopathic Arthritis in pediatric members > 2 years of age in the following situations: o Member must have a therapeutic failure of a > 3 month trial of methotrexate o Or alternative DMARD (e.g., cyclosporine, leflunomide, sulfasalazine, methotrexate, azathioprine) Coverage is provided for Ankylosing Spondylitis in all of the following situations: o Member has tried and failed at least 2 NSAIDs each for at least 4 weeks in duration Coverage is provided for moderate to severe Hidradenitis Suppurativa in all of the following situations: o The member has had a trial of or intolerance to systemic antibiotics AND o Documentation of Hurley classification or description of symptoms including: Recurrent abscesses with sinus tracts and scarring (Stage II); OR Presence of skin lesions (Stage II); OR Diffuse skin involvement (Stage III); OR Multiple interconnected tracts and abscesses across the entire affected site (Stage III) Coverage is provided for Uveitis in all of the following situations: o The disease is Non-infectious Intermediate Uveitis, Posterior Uveitis, Panuveitis o Member is 18 years of age and older o Member has experienced continued intraocular inflammation after systemic corticosteroid treatment or immunosuppressive treatment (methotrexate, azathioprine, cyclosporine) Initial authorization is approved for 6 months Reauthorization benefit (12 months) will be approved if there is documented, significant improvement with prior courses of treatment Coverage may be provided for any non-fda labeled indication if it is determined that the use is a medically accepted indication supported by nationally recognized pharmacy compendia or peer-reviewed medical literature for treatment of the diagnosis(es) for which it is prescribed. These requests will be reviewed on a case by case basis to determine medical necessity. Dosing Table Requests for dosages outside the recommended parameters below will be forwarded to the medical director for review. INDICATION Rheumatoid Arthritis Juvenile Idiopathic Arthritis Crohn s Disease (Adult) Crohn s Disease (Children) Ulcerative Colitis Plaque Psoriasis DOSING and DURATION (combo with MTX): 40mg every other week (monotherapy): 40mg every week 10kg - <15kg: 10mg every other week 15kg - <30kg: 20mg every other week 30kg: 40mg every other week Initial: 160mg over one or two days, 80mg on day 15 Maintenance: 40mg every other week 17kg - <40kg: (Initial): 80mg on day 1, 40 mg on day 15 (Maintenance): 20mg every other week 40kg: (Initial): 160mg over one or two days, 80 mg on day 15 (Maintenance): 40mg every other week Initial: 160mg over one or two days, 80mg on day 15 Maintenance: 40mg every other week Initial: 80mg one time

3 Hidradenitis Suppurativa Non-infectious Intermediate Uveitis, Posterior Uveitis, Panuveitis Maintenance: 40mg every other week starting week one after initial dose Initial: 160mg over one or two days, 80mg on day 15 Maintenance: 40mg every week Initial: 80mg one time Maintenance: 40mg every other week References: 1. Humira [package insert]. North Chicogo, IL: Abbott Laboratories; Menter A, Korman NJ, Elmets CA et al. Guidelines of Care for the Management of Psoriasis and Psoriatic Arthritis. J Am Acad Dermatol. 2011; 65(1): Singh JA, Saag KG, Bridges SL et al American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care and Research. 2015; : Ward MM, Deodhar A, Akl EA et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis and Rheumatology. 2015: : Farrell RJ, Peppercorn MA. Overview of the Medical Management of Severe or Refractory Crohn s Disease in Adults. UpToDate. Updated January Accessed November Kornbluth A, Sachar DB; Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol 2010; 105: Ringold S, Weiss PF, Beukelman T, et al update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Rheum. 2013;65(10): Gulliver W, Zouboulis CC, Prens E, Jemec GBE, Tzellos T. Evidence-based approach to the treatment of hidradenitis suppurativa/acne inversa, based on the European guidelines for hidradenitis suppurativa. Reviews in Endocrine & Metabolic Disorders. 2016;17(3): doi: /s Lichtenstein GR, Hanauer SB, Sandbord WJ, et al. Management of Crohn s Disease in Adults. Am J Gastroenterol. 2009;104: Babu K, Mahendradas P. Medical Management of Uveitis Current Trends. Indian Journal of Ophthalmology. 2013;61(6): doi: /

4 Humira (Adalimumab) PRIOR AUTHORIZATION FORM Please complete and fax all requested information below including any progress notes, laboratory test results, or chart documentation as applicable to Gateway Health SM Pharmacy Services. FAX: (888) If needed, you may call to speak to a Pharmacy Services Representative. PHONE:(800) Monday through Friday 8:30am to 4:30pm Requesting Physician: Physician Specialty: Office Address: Patient Name: Gateway ID: PROVIDER INFORMATION NPI: Office Contact: Office Phone: Office Fax: MEMBER INFORMATION DOB: DRUG INFORMATION Medication: Strength: Frequency: Duration: New medication Ongoing treatment (if this is selected answer the remaining questions) Date initiated: Did the patient show improvement while on therapy: Yes No Has the member been exposed to Tuberculosis risk factors since last PPD test? Yes No (risk factors include: close contacts of persons known or suspected to have active TB, foreign-born persons from areas that have a high incidence of active TB, persons who visit areas with a high prevalence of active TB, residents and employees of congregate settings whose clients are at increased risk for active TB, health care workers who serve clients who are at increased risk for active TB) If Yes, please provide most updated PPD test date with results: PLEASE COMPLETE THE FOLLOWING QUESTIONS FOR ALL DIAGNOSES Disease Severity: Mild Moderate Severe Date of last PPD (tuberculin) test: Result: Positive Negative Has the member been tested for Hepatitis B immunity? (antibody or surface antigen) Result: Yes No Is the member currently using another TNF inhibitor or Yes No biologic agent in combination with Humira? If yes, please indicate drug: Please indicate the diagnosis and complete the corresponding questions Rheumatoid Arthritis Has the member tried and failed a three month of methotrexate? Yes No Has the member tried and failed a three month trial of Leflunomide, sulfasalazine, or hydroxychloroquine? Yes No If yes to any of the above: Why was it discontinued: Please provide dates of therapy and dosage: Psoriatic Arthritis 1. Does the member have dominant peripheral disease? Yes No 2. Does the member have dominant axial disease? Yes No 3. Has the member tried and failed a three month of methotrexate? Yes No 4. Has the member tried and failed a three month trial of Leflunomide, sulfasalazine, or azathioprine? Yes No

5 5. If yes to any of the above: Why was it discontinued: Please provide dates of therapy and dosage: 6. Has the patient tried and failed NSAIDs? C Why was it discontinued: Please provide dates of therapy and dosage: Crohn s Disease Has the member tried and failed or have a contraindication to any of the following agents? (check all that apply) Aminosalicylates or 5-ASA (Sulfasalazine, Pentasa, Asacol, Colazal) Antibiotics (Ciprofloxacin, Metronidazole) Steroids (Prednisone, Entocort) Immunomodulators (Azathioprine, 6-Mercaptopurine, Methotrexate) Does the patient have a diagnosis of fistulizing disease? Yes No Ulcerative Colitis Has the member tried and failed or have a contraindication to any of the following agents? (check all that apply) Topical mesalamine products (Rowasa) Oral aminosalicylates (Sulfasalazine, Asacol, Pentasa, Colazal) Topical or oral steroids Immunomodulators (Azathioprine, 6-Mercaptopurine, cyclosporine, methotrexate) Polyarticular Juvenile Iodpathic Arthritis Has the member tried and failed a three month of methotrexate? Yes No Has the member tried and failed a three month trial of Leflunomide, sulfasalazine, or hydroxychloroquine? Yes No If yes to any of the above: Why was it discontinued: Please provide dates of therapy and dosage: Ankylosing Spondylitis Has the member tried and failed two scheduled therapy NSAIDs for at least 4 weeks each? Yes No Which NSAIDs? Why was it discontinued: Please provide dates of therapy and dosage:

6 Plaque Psoriasis Please indicate the percentage of body surface area (BSA) involvement: % Does the member have psoriasis on the palms, soles, head, neck or genitalia? Yes No Has the member tried and failed topical treatments? Yes No Why was it discontinued: Please provide dates of therapy and dosage: Has the patient tried and failed any of the following? (check all that apply) A three month trial of psoralen with UVA light (PUVA) or UVB light A three month trial of immunomodulators A three month trial of Retinoids Hidradenitis Suppurativa What Hurley Stage is the member s disease? Does the member have any of the following symptoms? (check all that apply) Recurrent abscess with sinus tracts and scarring Presence of lesions Diffuse skin involvement Multiple interconnected tracts and abscesses across the entire affected site Has the member had a trial or intolerance to systemic antibiotics? Yes No Uveitis Is the disease Non-infectious intermediate uveits, posterior uveitis, or panuveitis? Yes No Has the patient tried and failed either of the following? Systemic Corticosteroids Immunosuppressive therapy SUPPORTING INFORMATION or CLINICAL RATIONALE

7 Prescribing Physician Signature Date

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