Approval of a drug under this criteria document does not ensure full coverage of the drug.

Transcription

1 Criteria Document: Reference #: PC/B006 Page 1 of 5 and Therapeutics Quality PRODUCT APPLICATION: PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne Administrative Services, Inc. (PAS) Non-ERISA PreferredOne Community Health Plan (PCHP) PreferredOne Insurance Company (PIC) Individual PreferredOne Insurance Company (PIC) Large Group PreferredOne Insurance Company (PIC) Small Group Coverage is subject to the terms of a member s benefit plan. To the extent there is any inconsistency between this criteria document or policy and the terms of a member s benefit plan, the member s benefit plan govern. Approval of a drug under this criteria document does not ensure full coverage of the drug. PURPOSE: The intent of the Biologics for Crohn s Disease criteria document is to: Ensure the intended use is medically necessary; and Require a failed trial of oral/self-administered drug(s) before a provider administered drug; and Consider overall cost effectiveness where appropriate. GUIDELINES: Medical Necessity Criteria Must satisfy any of the following: I-III Table 1: First-Line Provider Administered Biologics Biologics Entyvio Inflectra Remicade Renflexis Stelara Route of Administration Recommended Age Generic Name(s) FYI ONLY Biosimilar(s) adult vedolizumab N Drug Class integrin receptor antagonist not age specific infliximab-dyyb Y TNFα blocker not age specific infliximab Y TNFα blocker not age specific infliximab-abda Y TNFα blocker adult ustekinumab N I. Initial request for Entyvio, infliximab, or Stelara - must meet: A and one of B-D A. Ordered (or followed) by a gastroenterologist; and B. The request is for infliximab and the member has had an ileocolonic resection; or IL-12 and IL-23 antagonist C. If the member is 18 years of age or older, the member has not responded to, is intolerant to, responds to but cannot taper off without recurrent symptoms, or is a poor candidate for one self-administered biologic (see Table 3); or D. The request is for infliximab and the member is 17 years of age or younger, either of the following: 1 or 2 1. Ordered (or followed) by a pediatric gastroenterologist; or

2 Criteria Document: Reference #: PC/B006 Page 2 of 5 and Therapeutics Quality 2. There must be documentation of both of the following: a and b a. Symptomatic disease - such as, but not limited to, fever, abdominal distention, pain, diarrhea, bleeding, weight loss, intestinal fistula, intestinal obstruction; and b. The member has not responded to, is intolerant to, responds to but cannot taper off without recurrent symptoms, or is a poor candidate for both of the following: i and ii i. One corticosteroid; and ii. One of the following: a) e) a) Aminosalicylates; or b) Azathioprine (Imuran); or c) Cyclosporine (Sandimmune); or d) Methotrexate (Trexall, Rheumatrex); or e) 6-mercaptopurine (6MP). Table 2: Second-Line Provider Administered Biologic Biologic Tysabri Route of Administration Recommended Age II. Initial request for Tysabri - must meet: A and B A. Ordered (or followed) by a gastroenterologist; and Generics Available FYI ONLY Generic Name Biosimilar Drug Class adult N natalizumab N α4-integrin blocker B. The member has not responded to, is intolerant to, or responds to but cannot taper off without recurrent symptoms, or is a poor candidate for one first-line provider administered biologic: Entyvio, infliximab or Stelara (see Table 1). III. Continuation request Allow an additional 24 months Table 3: Self-Administered Biologics* Biologics Cimzia Humira Route of Administration subcutaneous injection subcutaneous injection Recommended Age Generics available FYI ONLY Generic Name Biosimilar Drug Class adult N certolizumab N TNFα blocker adult or child 6 years of age or older N adalimumab N TNFα blocker subcutaneous Stelara adult N ustekinumab N injection * Listing of drugs in table above does not ensure coverage. Please check member s prescription benefit. IL-12 and IL-23 antagonist

3 Criteria Document: Reference #: PC/B006 Page 3 of 5 and Therapeutics Quality DEFINITIONS: Biologic/biological: Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Infliximab: Reference product or biosimilar BACKGROUND: This criteria document is based on U.S. Food and Drug Administration (FDA) approved indications and dosing, expert consensus opinion and/or available reliable evidence.

4 Criteria Document: Reference #: PC/B006 Page 4 of 5 and Therapeutics Quality FOR INTERNAL USE ONLY COVERAGE: Prior Authorization: Yes Entyvio or infliximab - initial, authorize for 12 months; continued use, authorize for 24 months Stelara - initial, authorize one dose, only - not FDA approved for continued administration Tysabri initial, approve for 3 months; continued use, authorize for 3 months if patient receiving corticosteroids or 6 months if not receiving corticosteroids Coverage is subject to the member s contract benefits. CODING: HCPCS J1745 Injection, infliximab, excludes biosimilar, 10mg NDC Remicade J2323 Injection, natalizumab, 1 mg (Tysabri) J3357 Injection, ustekinumab, 1mg (Stelara) J3380 Injection, vedolizumab, 1mg (Entyvio) Q5102 Injection, infliximab, biosimilar, 10mg (Inflectra, Renflexis) RELATED CRITERIA/POLICIES: Integrated Healthcare Services Process Manual: UR015 Use of Medical Policy and Criteria REFERENCES: 1. Yoshida EM. The Crohn s Disease Activity Index, its derivatives and the Inflammatory Bowel Disease Questionnaire: a review of instruments to assess Crohn s disease. 2. Entyvio [package insert]. Deerfield, IL:Takeda Pharmaceuticals America, Inc.; Cheifetz, AS. Management of active Crohn disease. JAMA. 2013;309(20). 4. Remicade [package insert]. Horsham, PA: Janssen Biotech Inc Tysabri [package insert]. Cambridge, MA. Biogen Idec Inc ClearScript. Prior Authorization. Infliximab (Remicade). Revision Date 8/31/ ClearScript. Prior Authorization. Tysabri (natalizumab). 09/15/ American Gastroenterological Association (AGA). American Gastroenterological Association Institute Technical Review on the Use of Thiopurines, Methotrexate, and Anti-TNF-α Biologic Drugs for the Induction and Maintenance of Remission of Inflammatory Crohn s Disease. Gastroenterology 2013;145: Retrieved from 9. Singh S, Garg SK, Pardi DS, et al. Comparative efficacy of biologic therapy in biologic-naïve patients with Crohn disease: a systematic review and network meta-analysis. Mayo Clin Proc Dec;89(12): doi: /j.mayocp Retrieved from Stelara [package insert]. Horsham, PA: Janssen Biotech Inc Inflectra (infliximab-dyyb) [package insert]. Lake Forest, IL. CELLTRION, Inc Renflexis (infliximab-abda) [package insert] Kenilworth, NJ. Merck & Co., Inc DOCUMENT HISTORY: Created Date: 05/17/06 Reviewed Date: 12/27/12, 12/27/13, 12/22/14, 12/22/15, 09/23/16, 09/19/17 Revised Date: 04/18/07, 04/23/08, 3/26/09, 06/02/09, 03/25/10, 01/13/11, 06/08/11, 09/07/11, 01/02/12, 08/01/12, 12/27/12, 05/02/13, 07/01/13, 12/22/14, 03/21/16, 04/11/16, 09/23/16, 04/14/17, 07/10/17, 10/25/17

5 Attachment A Tumor Necrosis Factor (TNF) Blockers FDA Contraindications and Warnings Drug FDA Contraindications FDA Warnings Cimzia None Serious active infection and/or invasive fungal infections Central Nervous System demyelinating disease (exacerbation or onset) Formation of autoantibodies (Lupus-like syndrome) Live or live-attenuated vaccines Enbrel Sepsis Serious active infection and/or invasive fungal infections Known hypersensitivity to Enbrel components Wegener's Granulomatosis Moderate to severe alcoholism Humira None Serious active infection and/or invasive fungal infections Formation of autoantibodies (Lupus-like syndrome) Live vaccines Remicade > 5mg/kg doses in moderate to severe heart failure Known hypersensitivity to Remicade components Serious active infection and/or invasive fungal infections Formation of autoantibodies (lupus-like syndrome) Hepatoxicity Live vaccines Simponi None Serious active infection and/or invasive fungal infections Live vaccines For more details, check each drug's FDA-approved label on the FDA's website:

6 PreferredOne Community Health Plan Nondiscrimination Notice PreferredOne Community Health Plan ( PCHP ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PCHP does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. PCHP: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact a Grievance Specialist. If you believe that PCHP has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Grievance Specialist PreferredOne Community Health Plan PO Box Minneapolis, MN Phone: (TTY: ) Fax: customerservice@preferredone.com You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, a Grievance Specialist is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C , (TDD) Complaint forms are available at Language Assistance Services NDR PCHP LV (10/16)

7 PreferredOne Insurance Company Nondiscrimination Notice PreferredOne Insurance Company ( PIC ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PIC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. PIC: Provides free aids and services to people with disabilities to communicate effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible electronic formats, other formats) Provides free language services to people whose primary language is not English, such as: Qualified interpreters Information written in other languages If you need these services, contact a Grievance Specialist. If you believe that PIC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Grievance Specialist PreferredOne Insurance Company PO Box Minneapolis, MN Phone: (TTY: ) Fax: customerservice@preferredone.com You can file a grievance in person or by mail, fax, or . If you need help filing a grievance, a Grievance Specialist is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C , (TDD) Complaint forms are available at Language Assistance Services NDR PIC LV (10/16)