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

Transcription

1 Criteria Document: Reference #: PC/B016 Page: 1 of 4 and Therapeutics Quality PRODUCT APPLICATIO: PreferredOne Community Health Plan (PCHP) PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne Administrative Services, Inc. (PAS) on-erisa 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 governs. Approval of a drug under this criteria document does not ensure full coverage of the drug. PURPOSE: The intent of the criteria document is to: Ensure the intended use is medically necessary; and Require a failed trial of self-administered drug(s) before an infused drug, where appropriate; and Consider overall cost effectiveness where appropriate GUIDELIES: Medical ecessity Criteria - Must satisfy one of the following: I III Table 1: Provider-Administered Biologics Biologics Lemtrada Ocrevus Tysabri Route of Administration intravenous infusion intravenous infusion intravenous infusion MS Type Generics Available FI OL Generic ame Biosimilar alemtuzumab or primary progressive ocrelizumab natalizumab Drug Class anti-cd20 monoclonal antibody anti-cd20 monoclonal antibody anti-cd20 monoclonal antibody Progressive Multifocal Leukoencephalopathy (PML) Revised 06/21/17 I. Initial request for biologics for forms of multiple sclerosis must satisfy: A or B A. Request for Ocrevus or Tysabri must satisfy: 1 and either 2 or 3 1. Ordered (or followed) by a neurologist; and 2. The member is currently receiving the requested medication; or PML Warning 3. The member has not responded to (at least a 4-week trial), is intolerant to, or is a poor candidate for two self-administered drugs (see Table 2).

2 Criteria Document: Reference #: PC/B016 Page: 2 of 4 and Therapeutics Quality B. Request for Lemtrada must satisfy: 1 and one of Ordered (or followed) by a neurologist; and 2. The member is currently receiving the requested medication; or 3. The member has been previously treated with Lemtrada must satisfy both of the following: a and b a. At least 12 months has elapsed since the first treatment with Lemtrada or 12 months will have elapsed prior to the next treatment with Lemtrada; and b. The member has not received the FDA-recommended lifetime limit of 2 treatment courses with Lemtrada. 4. The member has not been previously treated with Lemtrada must satisfy both of the following: a and b a. The member has not responded to (at least a 4-week trial), is intolerant to, or is a poor candidate for two self-administered medications (see Table 2). b. The member has not responded to (at least a 4-week trial), is intolerant to, or is a poor candidate for Ocrevus or Tysabri. II. III. Initial request for Ocrevus for primary progressive multiple sclerosis must be ordered (or followed) by a neurologist. Continuation request Ocrevus and Tysabri - Allow an additional 24 months Table 2: Self-Administered Medications * Drugs Route of Administration MS Type Generics available FI OL Generic ame Biosimilar Aubagio oral teriflunomide Avonex Betaseron Copaxone Extavia intramuscular or beta-1a beta-1b glatiramer acetate beta-1b Gilenya oral fingolimod Drug Class selective immunosuppressants PML Warning other immunostimulant selective immunosuppressant

3 Criteria Document: Reference #: PC/B016 Page: 3 of 4 and Therapeutics Quality Table 2: Self-Administered Medications * (continued) Drugs Glatopa 20mg Plegridy Rebif Route of Administration intramuscular or MS Type Generics available /A Tecfidera oral FI OL Generic ame glatiramer acetate peg beta-1a beta-1a dimethyl fumarate Biosimilar * Listing of drugs in table above does not ensure coverage. Please check member s prescription benefit. Progressive Multifocal Leukoencephalopathy (PML) Drug Class other immunostimulant PML Warning selective immunosuppressant DEFIITIOS: 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. Immunomodulatory: Directly alters the behavior of the immune system. Multiple Sclerosis (MS) Disease Courses Relapsing-remitting MS Most common form; episodes of acute worsening of neurologic function occur with some amount of recovery and no progression in between. Secondary progressive MS Involves an initial -remitting course; disease transitions to a steadily progressive form with function loss. Primary progressive MS Involves continued worsening of MS course from onset without specific relapses. Progressive MS Occurs as a progressive disease at onset; occasional acute relapses occur but with continuing disease progression. Progressive Multifocal Leukoencephalopathy: A neurological disorder characterized by destruction of cells that produce the myelin, an oily substance that helps protect nerve cells in the brain and spinal cord, also known as central nervous system (CS) white matter. It can be caused by the John Cunningham virus (JCV) in immunocompromised individuals. BACKGROUD: 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/B016 Page: 4 of 4 and Therapeutics Quality FOR ITERAL USE OL COVERAGE: Prior Authorization: es Lemtrada approve for up to 18 months to allow for completion of first and second course FI OL Administer LEMTRADA by intravenous infusion over 4 hours for 2 treatment courses: 7 First course: 12 mg/day on 5 consecutive days. Second course: 12 mg/day on 3 consecutive days 12 months after first treatment course. Ocrevus initial, approve for 12 months; continued use, authorize for 24 months Tysabri initial, approve for 12 months; continued use, authorize for 24 months CODIG: HCPCS J0202 Injection, alemtuzumab, 10mg (when used for Lemtrada) J2323 Injection, natalizumab, 1mg (Tysabri) J2350 Injection, ocrelizumab, 1mg (Ocrevus) RELATED CRITERIA/POLICIES: Integrated Healthcare Services Process Manual: UR015 Use of Medical Policy and Criteria Policy: PP/F002 Formulary Development, Structure and Management REFERECES: 1. Hughes BL. Update on new and emerging therapies for the treatment and symptom management of multiple sclerosis American Health & Drug Benefits Supplement, 4(4):S97-S DST Solutions. ClearScript. Prior Authorization. Tysabri (natalizumab). 03/01/ DST Solutions. Multiple Sclerosis (MS) Agents: Prior Authorization Policy. Lemtrada. 04/15/ DST Solutions. Multiple Sclerosis (MS) Agents: Prior Authorization Policy. Ocrevus. 03/01/ Tysabri [package insert] Cambridge, MA; Biogen Idec, Inc; Ocrevus [package insert]. South San Francisco, CA; Genentech, Inc; Lemtrada [package insert]. Cambridge, MA; Genzyme Corporation; DOCUMET HISTOR: Created Date: 09/30/16 (previously part of PC/M001) Reviewed Date: 07/18/17, 07/06/18 Revised Date: 11/09/16, 06/21/17, 03/08/18

5 PreferredOne Community Health Plan ondiscrimination otice 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, M Phone: (TT: ) Fax: customerservice@preferredone.com ou 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. ou 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 DR PCHP LV (10/16)

6 PreferredOne Insurance Company ondiscrimination otice 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, M Phone: (TT: ) Fax: customerservice@preferredone.com ou 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. ou 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 DR PIC LV (10/16)