Medication Policy Manual. Topic: Plegridy, peginterferon beta-1a Date of Origin: December 12, 2014

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1 Medication Policy Manual Policy No: dru376 Topic: Plegridy, peginterferon beta-1a Date of Origin: December 12, 2014 Committee Approval Date: December 11, 2015 Next Review Date: December 2016 Effective Date: January 1, 2016 IMPORTANT REMINDER This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status. Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care. Description Peginterferon beta-1a (Plegridy) is a subcutaneously administered immunotherapy used in the treatment of relapsing forms of multiple sclerosis (MS). It helps to reduce the number of clinical exacerbations and slow the disease progression associated with this condition. dru376.1 Page 1 of 6

2 Policy/Criteria I. Most contracts require prior authorization approval of peginterferon beta-1a (Plegridy) prior to coverage. Peginterferon beta-1a (Plegridy) may be considered medically necessary in patients with relapsing-remitting or secondary-progressing multiple sclerosis when treatment with one of the following is ineffective or not tolerated: A. Avonex (interferon beta-1a). OR B. Rebif (interferon beta-1a). II. Administration, Quantity Limitations, and Authorization Period A. OmedaRx considers peginterferon beta-1a (Plegridy) to be a self-administered medication. B. When prior authorization is approved, peginterferon beta-1a (Plegridy) may be authorized in quantities of two pre-filled syringes per 28 days. C. Authorization may be reviewed at least annually to confirm that current medical necessity criteria are met and that the medication is effective. Position Statement - All interferon beta formulations (interferon beta-1a and interferon beta-1b) and glatiramer acetate decrease the number of attacks in patients with relapsing remitting multiple sclerosis. [1-3] - There is no reliable evidence of increased efficacy or safety of one interferon beta product over another in reducing relapse rate or slowing the progression of disease. [2] - Peginterferon beta-1a (Plegridy) is a pegylated form of interferon beta-1a (Avonex). Pegylation allows for peginterferon beta-1a (Plegridy) to be dosed once every two weeks compared to weekly dosing with interferon beta-1a (Avonex). Clinical Efficacy - One randomized, controlled study compared peginterferon beta-1a (Plegridy) to placebo. Peginterferon significantly reduced annualized relapse rate and slowed the progression of disability compared to placebo. However, the duration of study was only 48 weeks. [4] - Plegridy (peginterferon beta-1a) has not been proven in reliable clinical studies to be more effective than other beta interferon products or glatiramer acetate. - There are no clinical studies comparing peginterferon beta-1a (Plegridy) to other disease modifying therapies for MS. Safety - The safety profile of peginterferon beta-1a (Plegridy) is similar to other interferon beta dru376.1 Page 2 of 6

3 products. - Common adverse events include injection site erythema, influenza-like symptoms, chills, headaches, myalgia, chills, injection site pain, asthenia, injection site pruritus, arthralgia, and nausea. Background on Multiple Sclerosis (MS) - There are four clinical courses of multiple sclerosis (characterized in Table 1 below). - Relapsing-remitting forms of multiple sclerosis account for up to 85% of cases. Table 1: Multiple Sclerosis Forms/Clinical Course Definitions [5,6] Relapsing-remitting (RRMS) Secondary progressive (SPMS) Primary progressive (PPMS) Progressive relapsing (PRMS) Characterized by acute relapses that are followed by some degree of recovery; patients do not develop worsening of disability between relapses. The American Academy of Neurology (AAN) defines RRMS as the first clinical course of MS and is characterized by self-limited attacks of neurologic dysfunction. These attacks develop acutely, evolving over days to weeks. Over the next several weeks to months, most patients experience a recovery of function that is often (but not always) complete. Between attacks the patient is neurologically and symptomatically stable. Defined as sustained progression of physical disability occurring separately from relapses, in patients who previously had RRMS. The AAN defines SPMS as the second clinical course which begins as RRMS, but at some point the attack rate is reduced and the course becomes characterized by a steady deterioration in function unrelated to acute attacks. Defined as progression of disability from onset without superimposed relapses. The AAN defines PPMS as the third clinical type characterized by a steady decline in function from the beginning without acute attacks. Defined as primary progressive patients who develop acute relapses well after disease onset. The AAN defines PRMS as the fourth clinical type which also begins with a progressive course although these patients also experience occasional attacks. dru376.1 Page 3 of 6

4 Guidelines and Dosing Considerations - The American Academy of Neurology Clinical Practice Guidelines on the treatment of Multiple Sclerosis and a Cochrane analysis do not clearly indicate that one interferon beta product is superior to another on the basis of clinical trial evidence. [6] - The relationship between neutralizing antibody (NAb) formation and subsequent effects on clinical efficacy and safety of the interferon products is not entirely understood and remains controversial. However, studies suggest that the presence of NAbs against interferon beta reduce the clinical efficacy of the drug and should therefore play a role in treatment decisions. [7] - According to FDA approved package labeling of the five commercially available interferon beta products, the immunogenicity of each product (formation of NAbs) in controlled clinical trials are as follows: * Interferon beta-1b (Betaseron, Extavia ): 45% [8,9] * Interferon beta-1a (Rebif ): 24% [10] * Interferon beta-1a (Avonex ): 5% [11] * Peginterferon beta-1a (Plegridy TM ): 1% [12] Appendix A: Disease-Modifying Agents Used in the Treatment of Multiple Sclerosis (MS) alemtuzumab (Lemtrada ) dimethyl fumarate (Tecfidera ) fingolimod (Gilenya ) glatiramer acetate (Copaxone ) interferon beta-1a (Avonex, Rebif ) interferon beta-1b (Betaseron, Extavia ) mitoxantrone (Novantrone ) natalizumab (Tysabri ) peginterferon beta-1a (Plegridy ) teriflunomide (Aubagio ) dru376.1 Page 4 of 6

5 Cross References Self-Administered Injectables, Medication Policy Manual, Policy No. 110 Aubagio, teriflunomide, Medication Policy Manual, Policy No. 283 Gilenya, fingolimod, Medication Policy Manual, Policy No. 229 interferon beta-1b (Betaseron, Extavia ), Medication Policy Manual, Policy No. 108 Lemtrada, alemtuzumab, Medical Policy Manual, Policy No. Tecfidera, dimethyl fumarate, Medication Policy Manual, Policy No. 299 Tysabri, natalizumab, Medication Policy Manual, Policy No. 111 Codes Number Description ICD-10 G35 Multiple Sclerosis References 1. La Mantia, L, Munari, LM, Lovati, R. Glatiramer acetate for multiple sclerosis. The Cochrane database of systematic reviews. 2010(5):CD PMID: Filippini, G, Del Giovane, C, Vacchi, L, et al. Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis. The Cochrane database of systematic reviews. 2013;6:CD PMID: La Mantia, L, Di Pietrantonj, C, Rovaris, M, et al. Interferons-beta versus glatiramer acetate for relapsing-remitting multiple sclerosis. The Cochrane database of systematic reviews. 2014;7:CD PMID: Calabresi, PA, Kieseier, BC, Arnold, DL, et al. Pegylated interferon beta-1a for relapsingremitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. The Lancet Neurology Jul;13(7): PMID: The Use of Disease-Modifying Therapies in Multiple Sclerosis: Principles and Current Evidence: A Consensus Paper by the Multiple Sclerosis Coalition, July [cited 9/12/2014]; Available from: b005-ab537d495c3c/dmt_consensus_ms_coalition_color 6. Goodin, DS, Frohman, EM, Garmany, GP, Jr., 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 Jan 22;58(2): PMID: Goodin, DS, Frohman, EM, Hurwitz, B, et al. Neutralizing antibodies to interferon beta: assessment of their clinical and radiographic impact: an evidence report: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2007;68: PMID: Extavia [package insert]. East Hanover, NJ: Novartis; March Betaseron [package insert]. Whippany, NJ: Bayer; January Rebif [package insert]. Rockland, MA: EMD Serano/Pfizer; April Avonex [package insert]. Cambridge, MA: Biogen Idec; March Plegridy TM [package insert]. Cambridge, MA: Biogen Idec; August 2014 dru376.1 Page 5 of 6

6 Revision Date Revision Summary 12/11/2015 No Criteria Changes dru376.1 Page 6 of 6