AETNA BETTER HEALTH Non-Formulary Prior Authorization guideline for Biologic Response Modifiers Drugs covered by this policy: Xeljanz, Orencia, Tysabri, Stelara, Cosentyx, Entyvio Authorization guidelines: Orencia, Xeljanz May be authorized for Rheumatoid Arthritis (RA) when the following are met: Patient is at least 18 years old Prescribed by a rheumatologist Patient is NOT on another biological DMARD Patient is up to date with all recommended vaccinations Patient has been screened for latent TB and hepatitis B If patient has COPD, the prescriber confirms that the benefit of using Orencia outweighs the risk in the patient Patient has moderate or high disease activity despite an adequate 3-month trial of BOTH of the following: o 2 different oral DMARD regimens (1 of which must include methotrexate (MTX) unless contraindicated) Monotherapy: MTX, sulfasalazine (SSZ), or leflunomide (LEF) Combination: MTX+SSZ+hydroxychloroquine (HCQ), MTX+HCQ, MTX+LEF, MTX+SSZ, SSZ+HCQ o ONE formulary anti-tnf (Note: anti-tnf s require PA) May be authorized for Juvenile Idiopathic Arthritis (JIA) when the following are met: Patient is at least 6 years old Prescribed by a rheumatologist Request is for the IV formulation (Orencia) Patient is NOT on another biological DMARD Patient is up to date with all recommended vaccinations Patient has been screened for latent TB and hepatitis B For SEVERE Polyarticular JIA:
o Patient has failed an adequate 3-month trial with ONE formulary anti-tnf For MODERATE Polyarticular JIA: o Patient has failed an adequate 3-month trial of MTX AND one formulary anti-tnf For Systemic JIA: o Patient does NOT have currently ACTIVE systemic features (i.e., fever, evanescent rash, lymphadenopathy, hepatomegaly, splenomegaly, or serositis) o Patient has continued synovitis in >1 joint despite treatment for 3 months with MTX or leflunomide AND one formulary anti-tnf Stelera, Cosentyx May be authorized for Plaque Psoriasis when the following criteria are met: Patient is at least 18 years old Prescribed by a dermatologist Symptoms are not controlled with topical therapy Disease has a significant impact on physical, psychological or social wellbeing Patient has failed a 3-month compliant trial with MTX or cyclosporine or has a true contraindication to both Psoriasis is severe and extensive (for example, more than 10% of body surface area affected or a PASI score of more than 10) Phototherapy has been ineffective, cannot be used or has resulted in rapid relapse (rapid relapse is defined as greater than 50% of baseline disease severity within 3 months) Patient has failed a compliant, 3-month trial of at least ONE formulary anti-tnf May be authorized for Psoriatic Arthritis when the following criteria are met: Patient is at least 18 years old Prescribed by a dermatologist or rheumatologist Patient is currently on an NSAID which will be continued when Stelara is initiated OR has a contraindication to NSAID use Patient meets ONE of the following: o Has active PsA despite a 3-month trial of adequate dose MTX (or leflunomide or sulfasalazine if MTX is contraindicated) o Patient has predominantly axial disease AND active PsA despite a 3-month trial of TWO different NSIADs at an adequate dose OR has a contraindication to NSAID use Patient has failed a compliant, 3-month trial of at least ONE formulary anti-tnf May be authorized for Ankylosing spondylitis with documentation of trial and failure of two formulary anti-tnf agents (Cosentyx only) Tysabri, Entyvio
General Criteria: Prescribed by a gastroenterologist 18 years of age or older Will be used as monotherapy and NOT in combination with antineoplastic, immunosuppressive, or immunomodulating agents (e.g., azathioprine, 6-mercaptopurine cyclosporine, methotrexate, TNF-inhibitors) Additional Criteria for Inducing Remission in Crohn s Disease: (Tysabri or Entyvio) STEROID-DEPENDENT CROHN S : Patient meets ONE of the following: o Relapse occurs within three months of stopping glucocorticoids o Glucocorticoids cannot be tapered to <10 mg/day within three months without symptom recurrence Patient has failed a compliant, 3-month trial of ONE of the following: o 6-mercaptopurine(6-MP) or azathioprine (AZA) o Methotrexate (for patients with a contraindication to 6-MP and AZA) Patient has failed a compliant, 3-month trial of ONE formulary anti-tnf STEROID-REFRACTORY CROHN S: Inadequate response to IV glucocorticoids within 7-10 days (NOTE: it is recommended to switch to IV glucocorticoids for patients who are not responding to oral glucocorticoids) Patient has failed a compliant, 3-month trial of ONE formulary anti-tnf Additional Criteria for Steroid-Dependent Ulcerative Colitis: (Entyvio only) Relapse occurs within three months of stopping glucocorticoids OR tapering prednisone to <10 mg/day Patient has failed a compliant, 3-month trial of ONE of the following: o 6-mercaptopurine(6-MP) or azathioprine (AZA) o Sulfasalazine 4-6g per day, mesalamine 4.8g per day, or balsalazide 6.75g per day (if patient has a contraindication to 6-MP and AZA) Patient has failed a 3-month trial of ONE formulary anti-tnf Additional Criteria for Steroid-Refractory Ulcerative Colitis: (Entyvio only) Inadequate response to IV glucocorticoids within 7-10 days (NOTE: it is recommended to switch to IV glucocorticoids FIRST for patients who are not responding to oral glucocorticoids) Patient meets ONE of the following: o Patient had a previous failure on 6-MP and AZA or a contraindication to both medications and is therefore not a candidate for treatment with these agents for current episode o Patient has symptoms after surgical intervention o Patient is not a surgical candidate or refuses surgery AND had an inadequate response to cyclosporine (NOTE: Switching to anti-tnf s after cyclosporine failure is NOT recommended by clinical practice guidelines)
o Patient has a contraindication to cyclosporine (NOTE: cyclosporine is used as a bridge therapy for patients who will be started on the slower acting 6-MP or AZA) Patient has failed a 3-month trial of ONE formulary anti-tnf Additional Information: These agents are NOT covered for members with the following criteria: Use not approved by the FDA; AND The use is unapproved and not supported by the literature or evidence as an accepted off-label use. Approval Duration: Orencia, Xeljanz Initial Approval: 4 months Renewals: Indefinite Renewals require at least 20% symptom improvement Stelara, Cosentyx Initial Approval: 6 months Renewal: 2 years, with clinical notes documenting an improvement (e.g., reduction in PASI, decreased swollen/painful joints) Tysabri, Entyvio Initial Approval: 3 months First Renewal: 3 months (Requires at least 20% symptom improvement) Additional Renewals: 6 months (if patient is responding, for Tysabri, documentation steroids have been tapered off in the initial 6mo) Medically Necessary A service or benefit is Medically Necessary if it is compensable under the MA Program and if it meets any one of the following standards: The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition or disability. The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition, injury or disability. The service or benefit will assist the Member to achieve or maintain maximum functional capacity in performing daily activities, taking into account both the functional capacity of the Member and those functional capacities that are appropriate for Members of the same age.
Determination of Medical Necessity for covered care and services, whether made on a Prior Authorization, Concurrent Review, Retrospective Review, or exception basis, must be documented in writing. The determination is based on medical information provided by the Member, the Member s family/caretaker and the Primary Care Practitioner, as well as any other Providers, programs, agencies that have evaluated the Member. All such determinations must be made by qualified and trained Health Care Providers. A Health Care Provider who makes such determinations of Medical Necessity is not considered to be providing a health care service under this Agreement. References: 1. Orencia (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; Revised June 2015. 2. Singh JA, Furst DE, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res. 2012;64(5):625-639. 3. Ringold S, Weiss PF, Beukelman T, et al. 2013 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 Care Res. 2013;65(10):1551-1563. 4. Weiss PF. Polyarticular juvenile idiopathic arthritis: Clinical manifestations and diagnosis. Waltham, MA: UptoDate; Last modified September 29, 2015. http://www.uptodate.com/contents/polyarticular-juvenile-idiopathic-arthritistreatment?source=search_result&search=juvenile+arthritis&selectedtitle=8%7e150 Accessed October 5, 2015. 5. Ustekinumab. (2015) In Clinical Pharmacology online. Retrieved from http://www.clinicalpharmacologyip.com/forms/drugoptions.aspx?cpnum=3586&n=stelara&t=0. 6. Stelara (ustekinumab) [package insert]. Horsham, PA: Janssen Biotech, Inc. 2014 March.; 7. Feldman SR. Treatment of psoriasis. Waltham, MA: UptoDate; Last modified July 13, 2015. http://www.uptodate.com/contents/treatment-ofpsoriasis?source=search_result&search=psoriasis&selectedtitle=1%7e150#h42. Accessed September 25, 2015. 8. National Institute for Health and Clinical Excellence (NICE). Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence (NICE); 2012 Oct. 61 p. (NICE clinical guideline; no. 153). 9. Cosentyx (secukinumab) [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; January 2015. 10. Feldman SR. Treatment of psoriasis. Waltham, MA: UptoDate; Last modified July 13, 2015. http://www.uptodate.com/contents/treatment-ofpsoriasis?source=search_result&search=psoriasis&selectedtitle=1%7e150#h42. Accessed September 25, 2015. 11. Terdiman JP, Gruss CB, Heidelbaugh JJ, Sultan S, Falck-Ytter YT. American gastroenterological association institute guideline on the use of thiopurines, methotrexate, and anti TNF-a biologic drugs for the induction and maintenance of remission in inflammatory crohn s disease. Gastroenterol. 2013;145:1459 1463. 12. The Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults. Am J Gastroenterol. 2010;105:501-523. 13. Farrell RJ, Peppercorn MA. Overview of the medical management of severe or refractory Crohn disease in adults. Waltham, MA: UpToDate; Last modified June 10, 2015. http://www.uptodate.com/contents/overview-of-themedical-management-of-severe-or-refractory-crohn-disease-inadults?source=search_result&search=crohns&selectedtitle=2%7e150. Accessed October 1, 2015 14. Cohen RD., Stein AC. Approach to adults with steroid-refractory and steroid-dependent ulcerative colitis. Waltham, MA: UpToDate; Last modified July 2015. http://www.uptodate.com/contents/approach-to-adults-with-steroidrefractory-and-steroid-dependent-ulcerative-colitis?source=see_link. Accessed August 11, 2015.
15. Peppercorn MA., Farrell RJ. Management of severe ulcerative colitis. Waltham, MA: UpToDate; Last modified July 2015. http://www.uptodate.com/contents/management-of-severe-ulcerativecolitis?source=search_result&search=ulcerative+colitis&selectedtitle=2%7e150. Accessed August 11, 2015 16.