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

Transcription

1 Department of Origin: Pharmacy Department(s) Affected: Integrated Healthcare Services and Pharmacy 09/13/18 Pharmacy Criteria Document: Biologics for Psoriatic Arthritis: infliximab, Orencia, and Simponi Aria Reference #: PC/B011 Page 1 of 4 Approved by: Pharmacy and Therapeutics Quality Management Subcommittee Effective Date: Replaces Effective Policy Dated: 03/21/18 Date approved: 12/29/17 PRODUCT APPLICATION: PreferredOne Community Health Plan (PCHP) PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne Administrative Services, Inc. (PAS) Non-ERISA PreferredOne Insurance Company (PIC) Large Group PreferredOne Insurance Company (PIC) Small Group PreferredOne Insurance Company (PIC) Individual 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 Psoriatic Arthritis criteria document is to: Ensure the intended use is medically necessary; and Require a failed trial of self-administered drug(s) before a provider administered drug; and Consider overall cost effectiveness where appropriate. GUIDELINES: Medical Necessity Criteria Must satisfy either of the following: I or II Table 1: Provider Administered Biologics Biologic Inflectra Ixifi Orencia Remicade Renflexis Simponi Aria Route of Administration Recommended Age not age specific not age specific Drug Class TNFα blocker TNFα blocker adult abatacept N T lymphocyte inhibitor not age specific infliximab Y TNFα blocker not age specific FYI ONLY Generic Name Biosimilar infliximabdyyb Y infliximabqbtx Y infliximababda Y TNFα blocker adult golimumab N TNFα blocker I. Initial request for infliximab, Orencia, or Simponi Aria - must satisfy: A and B A. Ordered (or followed) by a rheumatologist; and

2 Department of Origin: Pharmacy Department(s) Affected: Integrated Healthcare Services and Pharmacy 09/13/18 Pharmacy Criteria Document: Biologics for Psoriatic Arthritis: infliximab, Orencia, and Simponi Aria Reference #: PC/B011 Page 2 of 4 Approved by: Pharmacy and Therapeutics Quality Management Subcommittee Effective Date: Replaces Effective Policy Dated: 03/21/18 Date approved: 12/29/17 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 two self-administered medications with different mechanisms of action, ie, from different drug classes (see Table 2). II. Continuation request Allow an additional 24 months Table 2: Self-Administered Medications* Biologics Cimzia Cosentyx Enbrel Humira Orencia Otezla Simponi Stelara Taltz Route of Administration Recommended Age Generics available FYI ONLY Generic Name Biosimilar Drug Class adult N certolizumab N TNFα blocker adult N secukinumab N IL-17A antagonist not age specific N etanercept N TNFα and β blocker adult N adalimumab N TNFα blocker adult N abatacept N not age specific T lymphocyte inhibitor N apremilast N PDE4 inhibitor adult N golimumab N TNFα blocker adult N ustekinumab N IL-12 and IL-23 antagonist adult N ixekizumab N IL-17A antagonist Xeljanz oral adult N tofacitinib N JAK inhibitor Xeljanz XR oral adult N tofacitinib N JAK inhibitor * Listing of drugs in table above does not ensure coverage. Please check member s prescription benefit. DEFINITIONS: Biologic (BLA): Biologic agents are derived from natural sources (human, animal, microorganisms); these are large complex proteins applicable to the prevention, treatment, or cure of a disease or condition of human beings. Given the complexity of the drug and the difficulty to characterize a biologic, the manufacturing process is proprietary. Licensed by the Public Health Services Act (PHS) (section 351), the 351(a) pathway is utilized for the approval of biologics. Examples of biologics include: vaccine, blood products, antitoxin, allergy shots and cellular therapies. DMARDs: Disease Modifying Antirheumatic Drugs are a category of drugs used in many autoimmune disorders to slow down disease progression. They were first used in rheumatoid arthritis (RA) but use has come to include many other diseases, such as Crohn's disease, systemic lupus erythematosus (SLE), idiopathic thrombocytopenic purpura (ITP),

3 Department of Origin: Pharmacy Department(s) Affected: Integrated Healthcare Services and Pharmacy 09/13/18 Pharmacy Criteria Document: Biologics for Psoriatic Arthritis: infliximab, Orencia, and Simponi Aria Reference #: PC/B011 Page 3 of 4 Approved by: Pharmacy and Therapeutics Quality Management Subcommittee Effective Date: Replaces Effective Policy Dated: 03/21/18 Date approved: 12/29/17 myasthenia gravis and various others. Some of these drugs are also used in the treatment of ulcerative colitis which may not, strictly speaking, be an autoimmune disorder. Some DMARDs are mild chemotherapeutics but use a sideeffect of chemotherapy - immunosuppression - as its main therapeutic benefit. 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. FOR INTERNAL USE ONLY COVERAGE: Prior Authorization: Yes - initial authorize for 12 months; continued use, authorize for 24 months CODING: J0129 Injection, abatacept, 10mg (Orencia) J1602 Injection, golimumab, 1mg, for use (Simponi Aria) J1745 Injection, infliximab, excludes biosimilar, 10mg NDC Remicade Q5103 Injection, infliximab-dyyb, biosimilar, 10mg (inflectra) Q5104 Injection, infliximab-abda, biosimilar, 10mg (renflexis) RELATED CRITERIA/POLICIES: Integrated Healthcare Services Process Manual UR015 Use of Medical Policy and Criteria Pharmacy Policy: PP/F002 Formulary Development, Structure and Management REFERENCES: 1. ClearScript. Prior Authorization. Orencia (abatacept) IV. Revision Date 4/15/ ClearScript. Prior Authorization. Infliximab (Remicade). Revision Date 8/31/ Inflectra (infliximab-dyyb) [package insert]. Lake Forest, IL. CELLTRION, Inc Ixifi (infliximab-qbtx) [package insert]. Co. Cork, Ireland. Pfizer, Inc Remicade [package insert]. Horsham, PA: Janssen Biotech Inc Renflexis (infliximab-abda) [package insert] Kenilworth, NJ. Merck & Co., Inc Simponi Aria [package insert]. Horsham, PA. Janssen Biotech DOCUMENT HISTORY: Created Date: 06/15/11 (separated out from PC/B004) Reviewed Date: 01/02/12, 12/28/12, 12/27/13, 12/23/14, 12/23/15, 09/23/16, 09/19/17 Revised Date: 02/16/12, 08/01/12, 12/28/12, 09/26/13, 10/04/13, 02/09/15, 03/21/16, 04/11/16, 06/03/16, 09/23/16, 04/14/17, 10/16/17, 10/25/17, 01/19/18, 08/10/18

4 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:

5 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)

6 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)