Policy Number: 1055 Policy History Approve Date: 06/01/2018 Effective Date: 06/01/2018 Preauthorization All Plans Benefit plans vary in coverage and some plans may not provide coverage for certain service(s) listed in this policy. Decisions for authorization are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations as well as applicable state and/or federal laws. Please review the benefit plan descriptions for details. We utilize a combination of MCG and internally developed evidence-based clinical guidelines to support our prior authorization work. All internally developed prior authorization guidelines follow a rigorous process including, but not limited to, review by clinical pharmacist, clinical nurse manager, Chief Medical Officer, independent 3 rd party physician review agency and Health Tradition s Medical Advisory Committee. Prior authorization guidelines are reviewed at least annually, or when there are significant labeling changes made by FDA or peer-reviewed clinical outcomes (via Cochrane or Hayes). INSTRUCTIONS: Please review section I and complete sections II, III, and IV (type or print clearly). Prescribers are asked to submit this form along with supporting clinical documentation to Health Tradition for review. Submission of form does not guarantee approval. Submit preauthorization (PA) by fax to Health Tradition at (608) 781-9654 or by mail to Health Tradition, Correspondence, P.O. Box 21171, Eagan MN 55121. Section I Approval Criteria I. sub-q is medically necessary when the following criteria are met for either indication: A. Psoriatic arthritis (PsA) when ALL of the following are met: i. Individual is 18 years of age or older with active PsA AND ii. Individual has failed to respond to, is intolerant of, or has a medical contraindication to conventional therapy (such as non-biologic DMARDs) after having verified 80% adherence to therapy over the previous 180 days (PDC of at least 0.80) CALCULATED BY HEALTH TRADITION PHARMACY B. Plaque psoriasis (Ps) when ALL of the following are met: i. Individual is 12 years of age or older with chronic moderate to severe plaque Ps with either of the following: a. Plaque Ps involving greater than 5% body surface area (BSA) AND b. Plaque Ps involving less than or equal to 5% BSA involving sensitive areas or areas that significantly impact daily function (such as palms, soles of the feet, head/neck, or HT MHS 7006 1018
Page 2 ii. genitalia) AND Individual has failed to respond to, is intolerant of, or has a medical contraindication to phototherapy or other systemic therapy (such as acitretin, cyclosporine, or methotrexate) II. IV infusion for single-dose induction is medically necessary in: A. Crohn s disease when the following are met: i. In adults with moderate to severely active disease AND ii. Failed immunotherapy or corticosteroids over six months at 80% or greater adherence AND iii. Intolerant to above therapies III. is not medically necessary for an individual with ANY of the following: A. Use of ustekinumab in combination with other immunosuppressive therapy or phototherapy OR B. History of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) OR C. Tuberculosis, invasive fungal infection, other active serious infections, or a history of recurrent infections OR D. Individual has not had a tuberculin skin test (TST) or a Centers for Disease Control (CDC) - recommended equivalent test to evaluate for latent tuberculosis prior to initiating Stelara (ustekinumab) IV. is considered investigational and is not medically necessary for the treatment of all other indications, including, but not limited to treatment of Ankylosing spondylitis (AS), and relapsing-remitting multiple sclerosis (RRMS), and Rheumatoid arthritis (RA) A. Requests for a greater quantity will be reviewed on a case by case basis Renewal Criteria I. Psoriatic arthritis: Documentation that the patient has experienced or maintained a 20% or greater improvement in tender or swollen joint count while on therapy. II. Psoriasis: Documentation that the patient has achieved or maintained clear or minimal disease or a decrease in PASI (Psoriasis Area and Severity Index) of at least 50% or more. References 1. FDA approved product labeling and Lexicomp. 2. Ritchlin CT1, Kavanaugh A, Gladman DD, Mease PJ, Helliwell P, Boehncke WH, de Vlam K, Fiorentino D, Fitzgerald O, Gottlieb AB, McHugh NJ, Nash P, Qureshi AA, Soriano ER, Taylor WJ; Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). Treatment recommendations for psoriatic arthritis. Ann Rheum Dis. 2009 Sep;68(9):1387-94. doi: 10.1136/ard.2008.094946. Epub 2008 Oct 24. 3. Coates LC, Kavanaugh A, Ritchlin CT; GRAPPA Treatment Guideline Committee. Systematic review of treatments for psoriatic arthritis: 2014 update for the GRAPPA. J Rheumatol. 2014 Nov;41 (11):2273-6. doi: 10.3899/jrheum.140875. 4. Gossec L1, Smolen JS, Gaujoux-Viala C, Ash Z, Marzo-Ortega H, van der Heijde D, FitzGerald O, Aletaha D, Balint P, Boumpas D, Braun J, Breedveld FC, Burmester G, Cañete JD, de Wit M, Dagfinrud H, de Vlam K, Dougados M, Helliwell P, Kavanaugh A, Kvien TK, Landewé R, Luger T, Maccarone M, McGonagle D, McHugh N, McInnes IB, Ritchlin C, Sieper J, Tak PP, Valesini G, Vencovsky J, Winthrop KL, Zink A, Emery P; European League Against Rheumatism. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum Dis. 2012 Jan;71(1):4-12. doi: 10.1136/annrheumdis-2011-200350. Epub 2011 Sep 27. 5. McInnes IB, Kavanaugh A, Gottlieb AB, Puig L, Rahman P, Ritchlin C, Brodmerkel C, Li S, Wang Y,
Page 3 Mendelsohn AM, Doyle MK, PSUMMIT 1 Study Group. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebocontrolled PSUMMIT 1 trial. Lancet. 2013;382(9894):780. 6. Ritchlin C, Rahman P, Kavanaugh A, McInnes IB, Puig L, Li S, Wang Y, Shen YK, Doyle MK, Mendelsohn AM, Gottlieb AB, PSUMMIT 2 Study Group. Efficacy and safety of the anti-il-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional nonbiological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial. Ann Rheum Dis. 2014;73(6):990 7. Gottlieb A, Menter A, Mendelsohn A, Shen YK, Li S, Guzzo C, Fretzin S, Kunynetz R, Kavanaugh A. Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet. 2009;373(9664):633. 8. Menter A1, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, Gottlieb AB, Koo JY, Lebwohl M, Lim HW, Van Voorhees AS, Beutner KR, Bhushan R. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 4. Guidelines of care for the management and treatment of psoriasis with traditional systemic agents J Am Acad Dermatol. 2009 Sep;61(3):451-85. doi:10.1016/j.jaad.2009.03.027.epub 2009 Jun 3.
Page 4 Section II Member Information Name (Last, First, Middle Initial) Date of Birth Health Tradition Subscriber Number Diagnosis 1. MEDICATION 2. STRENGTH 3. DIRECTIONS 4. QUANTITY PER 30 DAYS Specify: 5. DIAGNOSIS: 6. APPROVAL CRITERIA: CHECK ALL BOXES THAT APPLY NOTE: Any areas not filled out are considered not applicable to your patient and MAY AFFECT THE OUTCOME of this request. A RESPONSE IS REQUIRED FOR EACH OF THE FOLLOWING: Yes No Individual will be using ustekinumab in combination with other immunosuppressive therapy or phototherapy Yes No Individual has a history of Reversible Posterior Leukoencephalopathy Syndrome (RPLS) Yes No Individual has tuberculosis, invasive fungal infection, other active serious infections, or a history of recurrent infections Yes No Individual has had a tuberculin skin test (TST) or a Centers for Disease Control (CDC) recommended equivalent test to evaluate for latent tuberculosis prior to initiating Psoriatic Arthritis (PsA): Yes No Individual has a diagnosis of active Psoriatic arthritis (PsA) Yes No Individual is 18 years of age or older Yes No Individual has failed to respond to, is intolerant of, or has a medical contraindication to conventional therapy (such as non biologic DMARDs) after having verified adherence to therapy over prior three months as defined by 80% adherent (PDC of at least 0.80) CALCULATED BY HEALTH TRADITION PHARMACY Plaque Psoriasis (Ps): Yes No Individual is 12 years of age or older Yes No Individual has chronic moderate to severe plaque psoriasis (Ps) with either of the following: Plaque psoriasis involving greater than 5% body surface area with plaque Ps Plaque psoriasis involving less than or equal to 5% body surface area involving sensitive areas or areas that significantly impact daily function (e.g. palms, soles of feet, head/neck, or genitalia) Yes No Individual has failed to respond to, is intolerant of, or has a medical contraindication to phototherapy or other systemic therapy (e.g. acitretin, cyclosporine, methotrexate) after having verified adherence to therapy over prior three months as defined by 80% adherent (PDC of at least 0.80)
Page 5 Section III Physician Information Physician Name National Provider Identification (NPI) Number Clinic Name Address (Street, City, State, Zip Code) Physician Telephone Number Physician Fax Number Physician Signature Date Section IV For Health Tradition Use Only Plan: Copay Tiers: Date of Receipt: Remarks: Approve Deny More information is needed Incomplete form Submission and review of this form does not guarantee approval of this request. Unless approved, payment of the brand-name medication will be limited to the amount Health Tradition would have paid for the generic equivalent. Insureds and providers will be informed of the decision in writing within approximately 30 days. Fax to: Pharmacy Services (608) 781-9654 Mail to: Health Tradition Correspondence PO Box 21171 Eagan MN 55121