Prior Authorization Conditions for Approval of Enbrel (etanercept) Website Form Submit request via: Fax

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1 Prior Authorization Conditions for Approval of Enbrel (etanercept) Website Form Submit request via: Fax All requests for Enbrel (etanercept) require a prior authorization and will be screened for medical necessity and appropriateness using the criteria listed below. Enbrel (etanercept) 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). The prescribing physician must be a Rheumatologist, Gastroenterologist or Dermatologist. For all indications, Enbrel (etanercept) will not be used in combination with another biologic DMARD product For all indications, the dosing is within recommended dosing guidelines Coverage is provided for the treatment of moderate to severe rheumatoid arthritis in the following situations o Member has experienced a therapeutic failure with a minimum of three months treatment with methotrexate or has had an inadequate response to methotrexate o OR if member has a contraindication to methotrexate, the member pas tried and failed a three month trial of a DMARD other than methotrexate (eg. Leflunomide, sulfasalazine, hydroxycholorquine) o Maintenance dosing should not exceed 50mg once weekly Coverage is provided for the treatment of moderate to severe psoriatic arthritis in the following situations: o Member has experienced a therapeutic failure with a minimum of three months treatment with two or more of the following: o Methotrexate, AND o NSIADs (unless contraindicated) o Another DMARD (leflunomide, cyclosporine, azathioprine, hydroxychloroquine, psoralen with UV light) o If the disease is classified as axial, conventional DMARDs are not recommended and this members are only required to fail NSAIDs o Maintenance dosing should not exceed 50mg once weekly Coverage is provided for the treatment of moderate to severe Polyarticular juvenile idiopathic arthritis in the following situations: o Member has experienced a therapeutic failure of a three month trial with methotrexate OR an alternative DMARD (i.e cyclosporine, leflunomide, sulfasalazine, methotrexate, azathioprine). o Member is 2 years of age or older o Maintenance dosing is as follows: o <63kg: 0.8mg/kg once weekly (max of 50mg/dose) o >63kg: 50mg once weekly Coverage is provided for the treatment of active ankylosing spondylitis in the following situations: o Member has tried and failed at least two NSAIDs for 28 days each o Dosing should not exceed 50mg once weekly Coverage is provided for a diagnosis of moderate to severe plaque psoriasis defined as 5% or more 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 candidate for systemic therapy o Patients must have therapeutic failure of a three or more month trial of psoralens with UVA light (PUVA) or UVB light. o Must have tried/failed a three or more month trial or have a contraindication to systemic oral treatments including: o Immunomodulators (i.e. Methotrexate, Cyclosporine, Amevive, Raptiva, Enbrel, Remicade) OR o Retinoids (i.e. Soriatane) o Initial dosing should not exceed 50mg twice weekly for a 3 month duration. o Maintenance dosing is as follows: o Adults: 50mg twice per week o Children: 0.8mg/kg once weekly (max: 50mg/dose)

2 Benefit is approved for a 6 month duration. Reauthorization is considered in 12 months when there is chart documentation of verification of clinical benefit from Enbrel therapy such as remission of the disease or improvement in the severity of symptoms. Coverage may be provided for any non-fda labeled indication if it is determined that the use is 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. References: 1. Enbrel [package insert]. Thousand Oaks, CA: Immunex Corporation; Singh JA, Saag KG, Bridges SL, et al American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2016;68(1): 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) 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): 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: : 1-17

3 Enbrel (entanercept) 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: Has the member been exposed to Tuberculosis risk factors since last PPD test? (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: Is the member currently using another TNF inhibitor or Yes No biologic agent in combination with Enbrel? 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? Has the member tried and failed a three month trial of Leflunomide, sulfasalazine, or hydroxychloroquine? If yes to any of the above: Psoriatic Arthritis 1. Does the member have dominant peripheral disease? 2. Does the member have dominant axial disease? 3. Has the member tried and failed a three month of methotrexate? 4. Has the member tried and failed a three month trial of Leflunomide, sulfasalazine, or azathioprine?

4 5. If yes to any of the above: 6. Has the patient tried and failed NSAIDs? C Polyarticular Juvenile Iodpathic Arthritis Has the member tried and failed a three month of methotrexate? Has the member tried and failed a three month trial of Leflunomide, sulfasalazine, or hydroxychloroquine? If yes to any of the above: Ankylosing Spondylitis Has the member tried and failed two scheduled therapy NSAIDs for at least 4 weeks each? Which NSAIDs? Why was it discontinued: 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? Has the member tried and failed topical treatments? 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 Please provide dates of therapy, dosage, and why it was discontinued : SUPPORTING INFORMATION or CLINICAL RATIONALE Prescribing Physician Signature Date

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