DRUG POLICY
Multiple Sclerosis BENEFIT APPLICATION Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This policy may not apply to FEP. Benefits are determined by the Federal Employee Program. DESCRIPTION The intent of the Multiple Sclerosis drug policy is to ensure appropriate selection of patients for therapy based on product labeling, clinical guidelines and clinical studies while steering utilization to the most costeffective medication within the therapeutic class. For this program, Betaseron, Rebif, Copaxone, Glatopa, Gilenya, Tecfidera and Aubagio are the preferred products. The criteria will require the use of the health plan’s preferred products for multiple sclerosis (Betaseron, Rebif, Copaxone, Glatopa, Gilenya, Tecfidera, Aubagio) before the use of targeted products (Avonex, Extavia and Plegridy), unless there are clinical circumstances that exclude the use of the preferred products. TWO Preferred Formulary Products are required in members who are naïve to treatment with the requested targeted product. ONE Preferred Formulary Product is required in members who are treatment-experienced with the requested targeted product. Lemtrada and Tysabri are excluded from the preferred multiple sclerosis product requirement. Targeted Multiple Sclerosis Products Medication
Generic Name
FDA-Approved Indications
Betaseron
interferon beta-1b
Relapsing forms of MS, First clinical episode of MS
Rebif
interferon beta-1a
Relapsing forms of MS
Copaxone/Glatopa
glatiramer
Relapsing forms of MS
Gilenya
fingolimod
Relapsing forms of MS
Tecfidera
dimethyl fumarate
Relapsing forms of MS
Aubagio
teriflunomide
Relapsing forms of MS
Preferred Products:
Targeted Products: Relapsing forms of MS, First clinical episode of MS Relapsing forms of MS, First clinical episode of MS
Avonex
interferon beta-1a
Extavia
interferon beta-1b
Plegridy
peginterferon beta-1a
Relapsing forms of MS
Zinbryta
daclizumab
Relapsing forms of MS
MS = multiple sclerosis
Wellmark Blue Cross and Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. © 2017 Wellmark,Inc.
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POLICY Criteria for Initial Approval I.
Aubagio (teriflunomide) may be considered medically necessary for members who have been diagnosed with ANY of the following relapsing forms of multiple sclerosis: a. Progressive-relapsing multiple sclerosis (PRMS) b. Relapsing-remitting multiple sclerosis (RRMS) c. Secondary progressive multiple sclerosis (SPMS) with documented relapses AND a. Pregnancy has been excluded
Approval will be for 24 months. II. Avonex (interferon beta-1α) may be considered medically necessary when the following criteria are met: a. Must have ONE of the following diagnoses: • Progressive-relapsing multiple sclerosis (PRMS) • Relapsing-remitting multiple sclerosis (RRMS) • Secondary progressive multiple sclerosis (SPMS) with documented relapses • First clinical episode of multiple sclerosis and have magnetic resonance imaging (MRI) features consistent with multiple sclerosis AND a. Must have had an inadequate response or tried and was intolerant to or had confirmed adverse event to TWO Preferred Formulary Products if naïve to treatment with Avonex (interferon beta1α); OR b. Must have had an inadequate response to or tried and was intolerant to or had confirmed adverse event to ONE Preferred Formulary Product if treatment-experienced with Avonex (interferon beta-1α) Approval will be for 24 months. III. Betaseron (interferon beta-1β), Copaxone (glatiramer acetate), Glatopa (glatiramer acetate), and Rebif (interferon beta-1α) may be considered medically necessary when the following criteria are met: a. Members who have been diagnosed with ANY of the following relapsing forms of multiple sclerosis: • Progressive-relapsing multiple sclerosis (PRMS) • Relapsing-remitting multiple sclerosis (RRMS) • Secondary progressive multiple sclerosis (SPMS) with documented relapses OR a. Members who have experienced a first clinical episode of multiple sclerosis and have magnetic resonance imaging (MRI) features consistent with multiple sclerosis Approval will be for 24 months. IV. Extavia (interferon beta-1β) may be considered medically necessary when the following criteria are met: a. Must have ONE of the following diagnoses: • Progressive-relapsing multiple sclerosis (PRMS) Wellmark Blue Cross and Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. © 2017 Wellmark,Inc.
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Relapsing-remitting multiple sclerosis (RRMS) Secondary progressive multiple sclerosis (SPMS) with documented relapses First clinical episode of multiple sclerosis and have magnetic resonance imaging (MRI) features consistent with multiple sclerosis
AND a. Must have had an inadequate response or tried and was intolerant to or had confirmed adverse event to TWO Preferred Formulary Products if naïve to treatment with Extavia (interferon beta1β); OR b. Must have had an inadequate response to or tried and was intolerant to or had confirmed adverse event to ONE Preferred Formulary Product if treatment-experienced with Extavia (interferon beta-1β) Approval will be for 24 months. V. Gilenya (fingolimod) may be considered medically necessary for members who have been diagnosed with ANY of the following relapsing forms of multiple sclerosis: a. Progressive-relapsing multiple sclerosis (PRMS) b. Relapsing-remitting multiple sclerosis (RRMS) c. Secondary progressive multiple sclerosis (SPMS) with documented relapses AND a. Baseline QTc interval is NOT ≥ 500 msec. Approval will be for 24 months. VI. Plegridy (peginterferon beta-1α) may be considered medically necessary for members who have been diagnosed with ANY of the following relapsing forms of multiple sclerosis: a. Progressive-relapsing multiple sclerosis (PRMS) b. Relapsing-remitting multiple sclerosis (RRMS) c. Secondary progressive multiple sclerosis (SPMS) with documented relapses AND a. Must have had an inadequate response or tried and was intolerant to or had confirmed adverse event to TWO Preferred Formulary Products if naïve to treatment with Plegridy (peginterferon beta-1α); OR b. Must have had an inadequate response to or tried and was intolerant to or had confirmed adverse event to ONE Preferred Formulary Product if treatment-experienced with Plegridy (peginterferon beta-1α) Approval will be for 24 months. VII. Tecfidera (dimethyl fumarate) may be considered medically necessary for members who have been diagnosed with ANY of the following relapsing forms of multiple sclerosis: a. Progressive-relapsing multiple sclerosis (PRMS) b. Relapsing-remitting multiple sclerosis (RRMS) c. Secondary progressive multiple sclerosis (SPMS) with documented relapses Approval will be for 24 months. VIII. Zinbryta (daclizumab) may be considered medically necessary for members who have been diagnosed with ANY of the following relapsing forms of multiple sclerosis: a. Progressive-relapsing multiple sclerosis (PRMS) b. Relapsing-remitting multiple sclerosis (RRMS) c. Secondary progressive multiple sclerosis (SPMS) with documented relapses Wellmark Blue Cross and Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. © 2017 Wellmark,Inc.
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AND a. Must have had an inadequate response or tried and was intolerant to or had confirmed adverse event to TWO or more Preferred Formulary Products despite adequate duration of treatment Approval will be for 24 months. IX. Lemtrada (alemtuzumab) and Tysabri (natalizumab)* may be considered medically necessary as monotherapy for the treatment of relapsing forms of MS when the patient has tried and failed two multiple sclerosis therapies, or when the patient has evidence of highly active disease despite glatiramer or interferon-β as demonstrated by 1 relapse in the previous year and either a) ≥1 gadolinium-enhancing MRI lesion or (b) at least 9 T2-hyperintensive lesions on cranial MRI. Approval will be for lifetime *Tysabri is also considered medically necessary for the treatment of Crohn’s Disease (CD) refractory to other agents Continuation of Therapy All members (including new members) requesting authorization for continuation of therapy must meet ALL initial authorization criteria. The aforementioned drugs are considered not medically necessary for patients who do not meet the criteria set forth above. Quantity limits apply: Trade Name
Generic Name
Quantity Limit
Aubagio®
teriflunomide
30 tablets per 30 days
Avonex®
interferon beta-1α
4 vials per 28 days
Betaseron®
interferon beta-1β
15 vials per 30 days
Copaxone® 20 mg/ Glatopa™ 20mg
glatiramer acetate
30 syringes (1 kit) per 30 days
Copaxone® 40 mg
glatiramer acetate
12 syringes per 28 days
Extavia®
interferon beta-1β
15 vials per 30 days
Gilenya™
fingolimod
30 capsules per 30 days
Plegridy™
peginterferon beta-1α
Initiation of therapy: 1 starter pack per first 28 days Maintenance: 2 pens per 28 days
Rebif®
interferon beta-1α
12 vials per 28 days
Tecfidera™
dimethyl fumarate
Initiation of therapy: 1 starter pack per first 28 days Maintenance: 60 capsules per 30 days
Tysabri®
natalizumab
1 vial per 28 days
Wellmark Blue Cross and Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. © 2017 Wellmark,Inc.
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Trade Name
Generic Name
Quantity Limit
Zinbryta™
daclizumab
1 syringe per 28 days
PROCEDURES AND BILLING CODES To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-CM diagnostic codes. • Q9979 - Injection, alemtuzumab, 1 mg • J2323, natalizumab, 1 mg REFERENCES • • • • • • • • • • • • •
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Aubagio [package insert].Cambridge, MA: Genzyme Corporation; October 2014. Avonex [package insert]. Cambridge, MA: Biogen Idec Inc.; August 2014. Betaseron [package insert]. Montville, NJ: Bayer HealthCare Pharmaceuticals Inc.; September 2015. Copaxone [package insert]. Kansas City, MO: Teva Neuroscience, Inc.; January 2014. Extavia [package insert]. East Hanover, NJ: Novartis Pharmaceutical Corporation; December 2014. Gilenya [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; August 2015. Lemtrada [package insert ]. Cambridge, MA: Genzyme Corporation; November 2014. Plegridy [package insert]. Cambridge, MA: Biogen Idec Inc.; August 2014. Rebif [package insert]. Rockland, MA; EMD Serono Inc.; March 2015. Tecfidera [package insert]. Cambridge, MA : Biogen Idec Inc.: April 2015. Tysabri [package insert ]. Cambridge, MA: Biogen Idec Inc.; June 2013. Zinbryta [package insert]. Cambridge, MA: Biogen, Inc.; May 2016. National Multiple Sclerosis Society. Disease Management Consensus Statement. New York, NY: National Multiple Sclerosis Society; 2008. Available at: http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/ExpOp_Cons ensus.pdf. Accessed April 26, 2016. Goodin DS, Frohman EM, Garmany GP, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. 2002;58:169-178. Cohen JA, Rovaris MD, Goodman MD, et al. Randomized, double-blind, dose-comparison study of glatiramer acetate in relapsing-remitting MS. Neurology 2007;68:939-944. Fox RJ, Miller DH, Phillips T, et al. Placebo controlled phase 3 study for oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012; 367:1087-1097. Gold R, Kappos L, Arnold DL et al. Placebo controlled phase 3 study for oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012; 367:1098-1107. Jacobs LD. Cookfair DL, Rudick RA. el al. Intramuscular interferon beta-1a for disease progression in relapsing multiple sclerosis, The Multiple Sclerosis Collaborative Research Group (~ISCRG). Ann Neural.1996;39(3):285-294. No authors listed. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS study group. Lancet. 1998;352(9139):1498-504. No authors listed. Interferon beta-1b in the treatment of multiple sclerosis: final outcome of the randomized controlled trial. The IFNB Multiple Sclerosis Study), Group and The University of British Columbia MS/MRI Analysis Group. Neurology. 1995;45(7):1277-85. No authors listed. Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. Clinical results of a multicenter, randomized, double blind, placebo-controlled trial. The IFNB Multiple Sclerosis Study Group. Neurology. 1993:43(4):655-61.
Wellmark Blue Cross and Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. © 2017 Wellmark,Inc.
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Johnson KP, Brooks BR, Cohen JA, et al. Copolymer I reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double blind placebocontrolled trial. The Copolymer 1 Multiple Sclerosis Study Group. Neurology. 1995;45(7):1268-76. Kappos L, Radue EW, O'Connor P. et al. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010;362(5):387·401. Polman CH. O'Connor PW, Hayrdoyu E, et A randomized, placebo controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006:354(9):899-910. O'Connor P. Wolinsky JS. Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med. 2011;365(14):1293-1303. Qizilbash N, Mendez I, Sanchez-de la Rosa R. Benefit-risk analysis of glatiramer acetate for relapsing-remitting and clinically isolated syndrome multiple sclerosis. Clin Ther. 2012;34(1):159-176. Comi G, Martinelli V, Rodegher M, et al.; and the PreCISe Study Group. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome: a radomised, double-blind, placebo-controlled trial. Lancet 2009;374(9700):1503-1511. Scolding N, Barnes D, Cader S, et al. Association of British Neurologists: revised (2015) guidelines for prescribing disease-modifying treatments in multiple sclerosis. Pract Neurol Published Online First [20, April 2016] doi:10.1136/practneurol-2015-001139. Kappos L, Wiendl H, Selmaj K, et al. Daclizumab HYP versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2015;373(15):1418-1428. Gold R, Giovannoni G, Selmaj K, et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomized, double-blind, placebo-controlled trial. Lancet. 2013;381(9884):2167-2175.
*Some content reprinted from CVSHealth POLICY HISTORY Policy #: 05.01.75 Policy Creation: August 2008 Reviewed: September 2016 Revised: December 2016 Current Effective Date: January 1, 2017
Wellmark Blue Cross and Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. © 2017 Wellmark,Inc.
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