Approved by: Pharmacy and Therapeutics Quality Management Subcommittee Effective Date: Department of Origin: Pharmacy. Date approved: 06/21/17

Transcription

1 Integrated Healthcare Services and Criteria Document: Reference #: PC/B016 Page: 1 of 4 PRODUCT APPLICATION: PreferredOne Community Health Plan (PCHP) PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne Administrative Services, Inc. (PAS) Non-ERISA PreferredOne Insurance Company (PIC) Individual PreferredOne Insurance Company (PIC) Large Group PreferredOne Insurance Company (PIC) Small Group PURPOSE: The intent of the criteria document is to: Ensure the intended use is medically necessary; and Require a failed trial of oral/self-administered drug(s) before an infused drug, where appropriate; and When a less costly biosimilar product becomes available, it takes the place of its respective reference product in the criteria and treatment regimen; and Consider overall cost effectiveness where appropriate GUIDELINES: Medical Necessity Criteria - must satisfy one of the following: I III Table 1: Infused Biologics Biologic Route of Administration Generic Name FYI ONLY Biosimilar Lemtrada intravenous infusion alemtuzumab N Ocrevus intravenous infusion ocrelizumab N Tysabri intravenous infusion natalizumab N Revised I. Initial request for biologics for relapsing 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 (board eligible or board certified); and 2. The member is currently taking the medication; or 3. The member has not responded to (at least a 4-week trial), is intolerant to, or is a poor candidate for two oral/self-administered drugs (see Table 2). B. Request for Lemtrada must satisfy: 1 and one of Ordered (or followed) by a neurologist (board eligible or board certified); and 2. The member is currently taking the 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

2 Integrated Healthcare Services and Criteria Document: Reference #: PC/B016 Page: 2 of 4 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 oral/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 (board eligible or board certified) Continuation request must satisfy both of the following: A and B A. The member has been previously approved by PreferredOne for the medication being requested; and B. There has been a positive clinical response to therapy. Table 2: Oral/Self-Administered Drugs * FYI ONLY Drugs Route of Administration Generics available Generic Name Aubagio oral N teriflunomide Avonex intramuscular or subcutaneous injection N interferon beta-1a Betaseron subcutaneous injection N interferon beta-1b Copaxone 20mg subcutaneous injection Y glatiramer acetate Copaxone 40mg subcutaneous injection N glatiramer acetate Extavia subcutaneous injection N interferon beta-1b Gilenya oral N fingolimod Glatopa 20mg subcutaneous injection N/A glatiramer acetate Plegridy subcutaneous injection N peginterferon beta-1a Rebif intramuscular or subcutaneous injection N interferon beta-1a Tecfidera oral N dimethyl fumarate * Listing of drugs in table above does not ensure coverage. Please check member s prescription benefit.

3 Integrated Healthcare Services and Criteria Document: Reference #: PC/B016 Page: 3 of 4 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. 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 relapsing-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 relapsing MS Occurs as a progressive disease at onset; occasional acute relapses occur but with continuing disease progression. 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 Integrated Healthcare Services and Criteria Document: Reference #: PC/B016 Page: 4 of 4 FOR INTERNAL USE ONLY COVERAGE: Prior Authorization: Yes Lemtrada initial, approve for one treatment course; continued use, if 12 months since completion of first treatment course, approve 1 additional treatment course Ocrevus initial, approve for 12 months; continued use, authorize for 12 months Tysabri initial, approve for 12 months; continued use, authorize for 12 months CODING: HCPCS J2323 Injection, natalizumab, 1mg (Tysabri) J9010 Injection, alemtuzumab, 10mg (when used for Lemtrada) 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. RELATED CRITERIA/POLICIES: Integrated Healthcare Services Process Manual: UR015 Use of Medical Policy and Criteria Policy: PP/B002 Biosimilar Products REFERENCES: 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 Tysabri [package insert] Cambridge, MA; Biogen Idec, Inc; OptumRx Class Review Update. Multiple Sclerosis Agents. February ClearScript. Prior Authorization. Tysabri (natalizumab) injection OptumRx. National and Therapeutics Committee (NP&TC) Quarterly Meeting Drug Review Summary. Multiple Sclerosis Agents. February Ocrevus [package insert]. South San Francisco, CA; Genetech, Inc; DOCUMENT HISTORY: Created Date: 09/30/16 (previously part of PC/M001) Reviewed Date: Revised Date: 11/09/16,

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)