Step Therapy: Part B Medications Origination: December 19, 2018 Review Date: December 19, 2018 Next Review: December 2020 Medicare Part C Medical Coverage Policy DESCRIPTION OF PROCEDURE SERVICE Step Therapy is a program that requires members to first try a safe, effective, lowercost drug to treat their condition before Blue Cross NC will cover another drug for that condition. POLICY STATEMENT Coverage will be provided for Step Therapy Part B medications when it is determined to be medically necessary, as outlined in the below guidelines and medical criteria. BENEFIT APPLICATION Please refer to the member s individual Evidence of Coverage (E.O.C.) for benefit determination. Coverage will be approved according to the E.O.C. limitations if the criteria are met. Coverage decisions will be made in accordance with: The Centers for Medicare & Medicaid Services (CMS) national coverage decisions; General coverage guidelines included in original Medicare manuals unless superseded by operational policy letters or regulations; and Written coverage decisions of local Medicare carriers and intermediaries with jurisdiction for claims in the geographic area in which services are covered. Benefit payments are subject to contractual obligations of the Plan. If there is a conflict between the general policy guidelines contained in the Medical Coverage Policy Manual and the terms of the member s particular Evidence of Coverage (E.O.C.), the E.O.C. always governs the determination of benefits. INDICATIONS F COVERAGE Preauthorization by the Plan and Clinical Review Pharmacist is required; Eylea (aflibercept; J0178) and Lucentis (ranibizumab; J2778) will be approved when ONE of the following is met: A. ONE of the following
I. There is evidence of a claim that the member is currently being treated with the requested agent within the past 108 days II. The prescriber states the member is currently being treated with the requested agent B. ALL of the following: I. ONE of the following: a. The member has a diagnosis of neovascular (wet) agerelated macular degeneration ONE of the following: the preferred agent Avastin (bevacizumab) the member had a documented intolerance, ineffective treatment response, FDA labeled contraindication or hypersensitivity to Avastin II. III. (bevacizumab) agent, Avastin (bevacizumab) b. The member has another FDA labeled indication or an indication that is supported in CMS approved compendia The member meets the criteria in the National or Local Coverage Determinations for the requested agent The member does NOT have any FDA labeled contraindication(s) to the requested agent Cinqair (reslizumab; J2786), Nucala (mepolizumab; J2182), and Xolair (omalizumab; J2357) will be approved when ONE of the following is met: A. ONE of the following: I. There is evidence of a claim that the member is currently being treated with the requested agent within the past 108 days II. The prescriber states the member is currently being treated with the requested agent B. BOTH of the following: I. ONE of the following: a. The member has a diagnosis of asthma ONE of the following: i. The member s medication history includes use of BOTH a Medicare Part D formulary inhaled corticosteroid either a Medicare Part D formulary long-acting beta-
II. 2 agonist, leukotriene modifier, or theophylline within the past 90 days, the member had a documented intolerance, ineffective treatment response, FDA labeled contraindication or hypersensitivity to these Medicare Part D formulary agents The prescriber has submitted documentation to support the use of the requested agent for the member s diagnosis instead of the Medicare Part D formulary inhaled corticosteroids either a Medicare Part D formulary long-acting beta-2 agonist, leukotriene modifier, or theophylline b. The member has another FDA labeled indication or an indication that is supported in CMS approved compendia The member meets the criteria in the National or Local Coverage Determinations for the requested agent Inflectra (infliximab-dyyb; Q5103), Remicade (infliximab; J1745), and Renflexis (infliximab-abda; Q5104) will be approved when ONE of the following is met: A. ONE of the following: I. There is evidence of a claim that the member is currently being treated with the requested agent within the past 108 days II. The prescriber states the member is currently being treated with the requested agent B. ALL of the following: I. ONE of the following: a. The member has a diagnosis of ankylosing spondylitis ONE of the following: TWO preferred : Cosentyx (secukinumab), Enbrel (etanercept), or Humira (adalimumab), the member had a hypersensitivity to TWO preferred biologic immunomodulator agents
b. The member has a diagnosis of adult Crohn s disease ONE of the following: the TWO preferred biologic immunomodulator agents: Humira (adalimumab) and Stelara (ustekinumab), the member had a hypersensitivity to the TWO preferred biologic immunomodulator agents c. The member has a diagnosis of pediatric Crohn s disease ONE of the following: the preferred biologic immunomodulator agent, Humira (adalimumab), the member had a hypersensitivity to the preferred biologic immunomodulator agent, Humira (adalimumab) biologic immunomodulator agent, Humira (adalimumab) d. The member has a diagnosis of plaque psoriasis ONE of the following: TWO preferred : Cosentyx (secukinumab), Enbrel (etanercept), Humira (adalimumab), or Stelara (ustekinumab), the member had a documented intolerance, ineffective treatment response, FDA labeled contraindication or hypersensitivity to TWO preferred
e. The member has a diagnosis of psoriatic arthritis ONE of the following: TWO preferred : Cosentyx (secukinumab), Enbrel (etanercept), Humira (adalimumab), or Stelara (ustekinumab), the member had a documented intolerance, ineffective treatment response, FDA labeled contraindication or hypersensitivity to TWO preferred f. The member has a diagnosis of rheumatoid arthritis ONE of the following: the TWO preferred biologic immunomodulator agents: Enbrel (etanercept) and Humira (adalimumab), the member had a hypersensitivity to the TWO preferred biologic immunomodulator agents g. The member has a diagnosis of ulcerative colitis ONE of the following: the preferred biologic immunomodulator agent, Humira (adalimumab), the member had a hypersensitivity to the preferred biologic immunomodulator agent, Humira (adalimumab) biologic immunomodulator agent h. The member has another FDA labeled indication or an indication that is supported in CMS approved compendia
II. The member meets the criteria in the National or Local Coverage Determinations for the requested agent III. If the request is for Remicade (infliximab), ONE of the following: a. The member s medication history includes use of a preferred biosimilar agent, Inflectra (infliximab-dyyb) or Renflexis (infliximab-abda), the member had a response, FDA labeled contraindication or hypersensitivity to a preferred biosimilar agent b. support the use of the requested agent for the member s diagnosis instead of the preferred biosimilar agent Inflectra (infliximab-dyyb) or Renflexis (infliximab-abda) IV. The member does NOT have any FDA labeled contraindication(s) to the requested agent V. ONE of the following: a. The member is NOT currently being treated with another biologic immunomodulator agent b. The member is currently being treated with another biologic immunomodulator agent will discontinue the other biologic immunomodulator agent prior to starting the requested agent LENGTH OF APPROVAL When the above criteria are met, the approval will be effective indefinitely. WHEN COVERAGE WILL NOT BE APPROVED When the above criteria are not met. COVERED CODES/Physician Documentation Information This policy may apply to the following codes. Inclusion of a code in the section does not guarantee reimbursement. Applicable codes: J0178, J1745, J2182, J2778, J2357, J2786, Q5104, Q5103 The Plan may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included. Special Notes Prerequisite drugs may require prior review under Medicare Part D or Medicare Part B.
References: 1. Centers for Medicare & Medicaid Services HPMS memo: Prior Authorization and Step Therapy for Part B Drugs in Medicare Advantage; August 7, 2018. Accessed via HPMS on 11/15/18. 2. Centers for Medicare & Medicaid Services Fact Sheet for Prior Authorization and Step Therapy. Available at: https://www.cms.gov/newsroom/fact-sheets/medicare-advantage-priorauthorization-and-step-therapy-part-b-drugs. Accessed on 11/6/18. 3. Eylea. American Hospital Formulary Service Drug Information. Available at: 4. Eylea. Micromedex, IBM Corporation 2018. Available at: 5. Eylea prescribing information. Regeneron Pharmaceuticals, Inc. August 2018. 6. Lucentis. American Hospital Formulary Service Drug Information. Available at: 7. Lucentis. Micromedex, IBM Corporation 2018. Available at: 8. Lucentis prescribing information, Genentech, Inc., March 2018. 9. Avastin. American Hospital Formulary Service Drug Information. Available at: 10. Avastin. Micromedex, IBM Corporation 2018. Available at: 11. The CATT Research Group. Ranibizumab and Bevacizumab for Neovascular Age-Related Macular Degeneration. N Engl J Med 2011; 364:1897-1908. May 19, 2011. DOI: 10.1056/NEJMoa1102673 12. The CATT Research Group. Ranibizumab and Bevacizumab for Neovascular Age-Related Macular Degeneration. Opthalmology. Volume 119, Issue 7, pages 1388-1398. July 2012. 13. Cinqair. American Hospital Formulary Service Drug Information. Available at: 14. Cinqair. Micromedex, IBM Corporation 2018. Available at: 15. Cinqair prescribing information. Teva Respiratory, LLC. May 2016. 16. Nucala. American Hospital Formulary Service Drug Information. Available at: 17. Nucala. Micromedex, IBM Corporation 2018. Available at: 18. Nucala prescribing information. GlaxoSmithKline, LLC. December 2017. 19. Xolair. American Hospital Formulary Service Drug Information. Available at: 20. Xolair. Micromedex, IBM Corporation 2018. Available at: 21. Xolair prescribing information. Genetech USA, Inc. September 2018. 22. Inflectra. American Hospital Formulary Service Drug Information. Available at: 23. Inflectra. Micromedex, IBM Corporation 2018. Available at: 24. Inflectra prescribing information. Pfizer Inc. November 2017. 25. Remicade. American Hospital Formulary Service Drug Information. Available at: 26. Remicade. Micromedex, IBM Corporation 2018. Available at: 27. Remicade prescribing information. Janssen Biotech, Inc. October 2017. 28. Renflexis. American Hospital Formulary Service Drug Information. Available at: 29. Renflexis. Micromedex, IBM Corporation 2018. Available at:
30. Renflexis prescribing information. Merck Sharp & Dohme Corp. November 2017. 31. Humira. American Hospital Formulary Service Drug Information. Available at: 32. Humira. Micromedex, IBM Corporation 2018. Available at: 33. Humira prescribing information. AbbVie Inc. October 2018. 34. Enbrel. American Hospital Formulary Service Drug Information. Available at: 35. Enbrel. Micromedex, IBM Corporation 2018. Available at: 36. Enbrel prescribing information. Amgen Inc. November 2017. 37. Cosentyx. American Hospital Formulary Service Drug Information. Available at: 38. Cosentyx. Micromedex, IBM Corporation 2018. Available at: 39. Cosentyx prescribing information. Novartis Pharmaceuticals Corporation. June 2018. 40. Stelara. American Hospital Formulary Service Drug Information. Available at: 41. Stelara. Micromedex, IBM Corporation 2018. Available at: 42. Stelara prescribing information. Janssen Biotech, Inc. June 2018. Policy Implementation/Update Information: Revision Dates: Approval Dates: Medical Coverage Policy Committee: December 19, 2018 Policy Owner: Carolyn Wisecarver, RN, BSN Medical Policy Coordinator