Multiple Sclerosis Agents Drug Class Prior Authorization Protocol

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1 Multiple Sclerosis Agents Drug Class Prior Authorization Protocol Line of Business: Medi-Cal Effective Date: August 16, 2017 Revision Date: August 16, 2017 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Injectable Drugs: Avonex (interferon beta-1a intramuscular), Betaseron, Extavia (interferon beta-1b), Copaxone, Glatopa (glatiramer acetate), Lemtrada (alemtuzumab), Ocrevus (ocrelizumab), Plegridy (peginterferon beta-1a), Rebif (interferon beta-1a subcutaneous), Tysabri (natalizumab), Zinbryta (daclizumab) Oral Drugs: Aubagio (teriflunomide), Gilenya (fingolimod), Tecfidera (dimethyl fumarate) Supportive Drug: Ampyra (dalfampridine) FDA Approved Indications: Injectable drugs Avonex (interferon beta-1a intramuscular), Rebif (interferon beta-1a subcutaneous), Plegridy (peginterferon beta-1a) Betaseron, Extavia (interferon beta-1b), Copaxone, Glatopa (glatiramer acetate), Lemtrada (alemtuzumab), Zinbryta (daclizumab) MS (relapsing) Ocrevus (ocrelizumab) Relapsing or progressive Tysabri (natalizumab) Oral drugs Aubagio (teriflunomide), Gilenya (fingolimod) Tecfidera (dimethyl fumarate) Supportive drug Ampyra (dalfampridine) MS= Multiple Sclerosis; CD= Crohn s Disease CD

2 Policy/ A. Drug: Ampyra (dalfampridine) a. Multiple sclerosis b. Documentation that member has the ability to ambulate at least 25 feet within 8 to 45 seconds; c. Documented significant limitation of daily activities (e.g. meal preparation, household chores, etc.) Authorization Duration: 12 months Re-authorization B. Drug: Aubagio (teriflunomide) b. Documentation of liver transaminase and bilirubin levels; c. If female, confirmation of negative pregnancy test at initiation of therapy and use of contraceptive throughout treatment duration;

3 d. Failure or clinically significant adverse effects to one glatiramer (e.g. Copaxone, Glatopa), one interferon alternative (e.g. Avonex Betaseron, Extavia, Rebif), as evidenced by at least one of the following: 1. Member continues to have clinical relapses (at least one relapse within the past 12 months); 2. Member continues to have CNS lesion progression as shown in MRI; 3. Member continues to have worsening disability (e.g. decreased mobility, decreased ability to perform daily activities, increase in EDSS score, etc.) Authorization Duration: 12 months Re-Authorization C. Drugs: Avonex (interferon beta-1a), Betaseron (interferon beta-1b), Copaxone (glatiramer acetate 40mg), Extavia (interferon beta-1b), Glatopa (glatiramer acetate), Rebif (interferon beta-1a), Plegridy (peginterferon beta-la) a. Confirmed diagnosis by a neurologist Authorization Duration: 12 months Re-Authorization a. Documentation of meeting therapeutic goal (e.g. disease stability, improvement in daily activities, stable or improved CNS lesion in MRI and/or remission from

4 Formulary Status: Non-formulary preferred, PA applies D. Drug: Copaxone (glatiramer acetate 20mg) b. Failure or clinically significant adverse effects to Glatopa Authorization Duration: a. 12 months Re-Authorization daily activities, stable or improved CNS lesion in MRI and/or remission from E. Drug: Gilenya (fingolimod) b. Failure or clinically significant adverse effects to one glatiramer (e.g. Copaxone, Glatopa), one interferon alternative (e.g. Avonex Betaseron, Extavia, Rebif), as evidenced by at least one of the following: 1. Member continues to have clinical relapses (at least one relapse within the past 12 months); 2. Member continues to have CNS lesion progression as shown in MRI;

5 3. Member continues to have worsening disability (e.g. decreased mobility, decreased ability to perform daily activities, increase in EDSS score, etc.) c. No history or recent (within the last 6 months) of any of the following cardiac conditions. Must have plan for cardiac monitoring at initiation by provider per label 1. Heart attack ( myocardial infarction ), chest pain while resting ( unstable angina ), stroke, mini-stroke ( transient ischemic attack (TIA) ), decompensated heart failure requiring hospitalization or Class III/IV heart failure within the last 6 months; 2. History or presence of second-degree or third-degree heart block ( Mobitz Type II atrioventricular (AV) block ) or sick sinus syndrome, unless patient has a functioning pacemaker; 3. Baseline QTc interval 500 ms; 4. Concurrent use of Class Ia or Class III anti-arrhythmic drug Authorization Duration: a. 12 months Re-Authorization F. Drug: Lemtrada (alemtuzumab) b. Failure or clinically significant adverse effects to all of the following: 1. Glatiramer (e.g. Copaxone, Glatopa), one interferon alternative (e.g. Avonex Betaseron, Extavia, Rebif );

6 2. One oral disease modifying therapy for multiple sclerosis (e.g. Aubagio Gilenya, Tecfidera); c. Ineffectiveness of above therapy is evidenced by one of the following: 1. Member continues to have clinical relapses (at least one relapse within the past 12 months); 2. Member continues to have CNS lesion progression as shown in MRI; 3. Member continues to have worsening disability (e.g. decreased mobility, decreased ability to perform daily activities, increase in EDSS score, etc.) e. Contraindicated in member with HIV infection; f. Recommend premedication with corticosteroids and herpes prophylaxis Authorization Duration: a. 12 months b. Treatment course beyond two years is considered investigational Re-Authorization G. Drug: Ocrevus (ocrelizumab) [Medical Benefit] a. Primary progressive multiple sclerosis; b. Relapsing form of multiple sclerosis b. Primary progressive multiple sclerosis: 1. Confirmed diagnosis by a neurologist c. Relapsing form of multiple sclerosis:

7 1. Failure or clinically significant adverse effects to all of the following: i. Glatiramer (e.g. Copaxone, Glatopa), one interferon alternative (e.g. Avonex Betaseron, Extavia, Rebif ); ii. One oral disease modifying therapy for multiple sclerosis (e.g. Aubagio Gilenya, Tecfidera); 2. Ineffectiveness of above therapy is evidenced by one of the following: i. Member continues to have clinical relapses (at least one relapse within the past 12 months); ii. iii. Authorization Duration: a. 6 months Member continues to have CNS lesion progression as shown in MRI; Member continues to have worsening disability (e.g. decreased mobility, decreased ability to perform daily activities, increase in EDSS score, etc.); Re-Authorization H. Drug: Tecfidera (dimethyl fumarate) b. Failure or clinically significant adverse effects to Glatiramer (e.g. Copaxone, Glatopa), one interferon alternative (e.g. Avonex Betaseron, Extavia, Rebif ), as evidenced by at least one of the following: 1. Member continues to have clinical relapses (at least one relapse within the past 12 months);

8 2. Member continues to have CNS lesion progression as shown in MRI; 3. Member continues to have worsening disability (e.g. decreased mobility, decreased ability to perform daily activities, increase in EDSS score, etc.) Authorization Duration: 12 months Re-Authorization disease flares) I. Drug: Tysabri (natalizumab) [Medical Benefit] a. ONE of the following: 1. Failure or clinically significant adverse effects to all of the following: i. Glatiramer (e.g. Copaxone, Glatopa), one interferon alternative (e.g. Avonex Betaseron, Extavia, Rebif ) ii. One oral disease modifying therapy for multiple sclerosis (e.g. Aubagio Gilenya, Tecfidera) iii. Ineffectiveness of above therapy is evidenced by one of the following: a. Member continues to have clinical relapses (at least one relapse within the past 12 months); b. Member continues to have CNS lesion progression as shown in MRI; c. Member continues to have worsening disability (e.g. decreased mobility, decreased ability to perform daily activities, increase in EDSS score, etc.)

9 2. Documented aggressive initial disease course as evidenced by one of the following (please consult IEHP pharmacist): i. Multiple (at least two) relapses with incomplete resolution in the past year ii. At least two MRI showing new or enlarging T2 lesions despite treatment over 6 months iii. The presence of spinal or brainstem lesions on MRI Authorization Duration: 12 months Re-Authorization disease flares) J. Drug: Zinbryta (daclizumab) b. Failure or clinically significant adverse effects to all of the following: 1. Glatiramer (e.g. Copaxone, Glatopa), one interferon alternative (e.g. Avonex Betaseron, Extavia, Rebif ) 2. One oral disease modifying therapy for multiple sclerosis (e.g. Aubagio Gilenya, Tecfidera) c. Ineffectiveness of above therapy is evidenced by one of the following: 1. Member continues to have clinical relapses (at least one relapse within the past 12 months); 2. Member continues to have CNS lesion progression as shown in MRI;

10 3. Member continues to have worsening disability (e.g. decreased mobility, decreased ability to perform daily activities, increase in EDSS score, etc.) d. Contraindicated in pre-existing hepatic disease or hepatic impairment, including ALT or AST at least 2 times the ULN or history of autoimmune hepatitis or other autoimmune condition involving the liver Authorization Duration: 12 months Re-Authorization. Clinical Justification: Interferon Beta Jacobs et al conducted a multicenter, randomized and placebo-controlled study in relapse remitting multiple sclerosis (RRMS) patients in which participants were treated with either Avonex (interferon beta-1a) 30 µg per week or placebo IM for two years. Compared with placebo, there were fewer Avonex treated patients who progressed on the Expanded Disability Status Scale (EDSS) by one point (-37%; p = 0.02). The clinical exacerbation (-18%; p = 0.04) and MRI (-33%; p = 0.05) attack rate were also reduced in the interferon beta-1a treated patients compared to placebo. In a similar randomized, multicenter, double-blind, placebo-controlled trial, the PRISMS Study Group found a significant benefit of treating patients with either Rebif (interferon beta-1a) 22 µg or 44 µg compared to placebo subcutaneously three times weekly for two years. In the primary endpoint, the Rebif 44 µg treated group reduced the clinical attack rate (-32%; p < 0.005). Furthermore, the MRI attack rate (-78%; p < ), measured by the median number of T2 active lesions, and the reduction of Expanded Disability Status Scale (EDSS) progression rate by one point (-30%; p < 0.05) was seen in the interferon beta-1a treated group in comparison with placebo.

11 The PRISMS Study Group continued the Rebif trial for an additional two years to evaluate a dose-response relationship. The placebo treated group was randomized to receive either interferon beta-1a 22 µg or 44 µg subcutaneously three times weekly. The high dose interferon beta-1a group was more effective (p < 0.05) in reducing the relapse rate during the third and fourth year, prolonging the time to a second relapse, and increasing the percentage of relapse free patients. High dose interferon beta-1a also reduced the MRI disease and T2 lesion activity (p < 0.001) compared to low dose interferon beta-1a. The IFNB Multiple Sclerosis Study Group conducted a randomized, double-blind, placebocontrolled trial comparing Betaseron (interferon beta-1b) with placebo treated patients. Patients received low dose interferon beta-1b (50 µg), high dose interferon beta-1b (250 µg), or placebo subcutaneously every other day. High dose interferon beta-1b reduced the relapse rate after two years (-34%; p < ). In addition, the MRI attack rate (-83%; p < 0.009), measured by the median number of T2 active lesion, and the median volume of MRI T2 disease burden (-17.3%; p = 0.001) were reduced in the interferon beta-1b group compared to placebo treated patients. After a five year follow-up, the incidence of disease progression was lower in the high dose interferon beta-1b compared to placebo, 35% and 46%, respectively. Other Injectable Agents Johnson et al conducted a large multicenter, randomized, double-blind, placebo controlled trial in which patients received either Copaxone (glatiramer acetate) 20 mg or placebo subcutaneously daily. The trial found that glatiramer acetate significantly reduced the clinical attack rate after two years (-29%, p = 0.007). In two trials comparing interferon beta with glatiramer acetate (BEYOND and REGARD study), interferon beta and glatiramer acetate have shown to have similar clinical efficacy. In a Cochrane review, the efficacy, tolerability and safety of Tysabri (natalizumab) were assessed in patients with RRMS. There was statistically significant evidence of natalizumab reducing the risk of exacerbation rate as well as experiencing progression after two years. However, safety data was not conclusive among studies. Cases of progressive multifocal leukoencephalopathy (PML) were identified. According to clinical guidelines, natalizumab is not a first line agent because of the potential development of PML. Natalizumab should be reserved for patients with active RRMS who are resistant or contraindicated to beta interferons or glatiramer acetate. CAMMS223 and CARE-CM studies showed alemtuzumab is an efficacious disease-modifying therapy, with benefits on relapse, disability outcomes, and MRI (magnetic resonance imaging) activities. Infection incidence was elevated with alemtuzumab in clinical studies. Autoimmune adverse events occurred in approximately 1/3 of patients, manifesting mainly as thyroid disorders, and less frequently as immune thrombocytopenia or neuropathy. Infusion associated reactions are common. In the SELECT trial, 600 adult patients with RRMS were randomly assigned to either receive daclizumab 300 mg, daclizumab 150 mg or placebo every four weeks in a 1:1:1 ratio. At one year, the annualized relapse rate was significantly lower in groups assigned to daclizumab of

12 either strength compared to placebo (0.21 for daclizumab 150mg and 0.23 for daclizumab 300mg, vs for placebo), which translates to a reduction of 54% and 50%, respectively. Additionally, daclizumab groups had significant reduction in the risk of three-month sustained disability progression (hazard ratio 0.43 for daclizumab 150mg and 0.57 for daclizumab 300mg). However, daclizumab groups had a 2% rate of serious infection (1 death) compared to no infection in placebo. Furthermore, patients in daclizumab treated group experienced more cutaneous events and hepatic enzymes elevations >5 times the upper limit of normal. In the DECIDE trial, 1800 adults with RRMS were randomly assigned to receive either subcutaneous daclizumab 150mg every 4 weeks or intramuscular interferon beta-1a 30 mcg once a week for up to 144 weeks. Daclizumab treated patients had a significantly lower annualized relapse rate than those assigned to interferon beta-1a (0.22 vs. 0.39), which is a 45% reduction. At 96 weeks, daclizumab group also experienced a significantly lower number of new or newly enlarged brain lesions on T2-weighted MRI compared to interferon beta-1a group (4.3 vs. 9.4). However, there was no significant difference in the estimated rate of sustained disability progression (16% vs. 20%). Serious adverse events were more common in the daclizumab group than in interferon treated group (15% vs. 10%), including a higher rate of infection (4% vs. 2%). Daclizumab group also experienced more cutaneous adverse event and higher aminotransferase levels. Oral Agents Goodman et al conducted a double-blind, placebo-controlled trial in which patients were randomly assigned to receive either Ampyra (dalfampridine; 4-aminopyridine) 10 mg or placebo twice daily. The proportion of patients who responded to consistent improvement on a timed 25- foot walk was greater in the dalfampridine group compared to placebo. Timed walk responders also showed greater improvement in a 12-item multiple sclerosis walking scale score than timed walk non-responders. There is concern that Ampyra has a narrow therapeutic index. Increased seizures were observed and appeared to be dose-related. Doses should not exceed 10 mg twice daily and is not recommended for use in patients with a history of seizure or in those with moderate to severe renal impairment. In a randomized, placebo-controlled trial conducted by O Connor et al, patients received Aubagio (teriflunomide), 7 or 14 mg, or placebo daily. Following two years of treatment, there was a significant reduction in relapse rate amongst the teriflunomide treated group compared to placebo. The high dose teriflunomide group significantly reduced disability progression compared with placebo. Additionally, there were improved MRI measures of MS disease activity in the high dose teriflunomide group. The FREEDOMS trial, conducted by Kappos et al, compared oral Gilenya (fingolimod 0.5 mg and 1.25 mg daily) with placebo. After two years, the annualized relapse rate decreased among both fingolimod groups more significantly than placebo. Furthermore, there were statistically significant reductions in the risk of disability progression and new lesions on brain MRI with fingolimod treatment. The incidence of serious infections and herpes virus infections were similar in all groups. Macular edema developed in seven patients in the high dose fingolimod group. The TRANSFMS trial randomly assigned patients to either oral fingolimod (0.5 mg or 1.25 mg daily) or interferon beta-1a 30 mcg weekly. Following twelve months, the relapse rate was significantly lower in both high and low dose fingolimod compared to interferon beta-

13 1a. However, there were more adverse events in the both fingolimod groups. Significant adverse reactions seen with fingolimod include bradyarrhythmia, atrioventricular block, macular edema, reduced respiratory function, hepatic effects, tumors, and herpes virus infections. There have been post marketing reports of deaths associated with fingolimod. It is recommended that patients be assessed prior to initiating fingolimod and monitored for six hours following the first dose for bradycardia or atrioventricular block in addition to the treatment duration for signs of adverse reactions. The DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in RRMS) and CONFIRM (Comparator and an Oral Fumarate in RRMS) trials showed early benefits of dimethyl fumarate (as early as 12 weeks) and sustained benefits over the course of the studies. Oral Fumarate demonstrated significant and clinically meaningful reductions in MS relapses and brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS) compared to placebo or copaxone, as well as showed benefit in slowing the progression of the disease. MOA Usual Dosing FDA Indication Pediatric Indication Administration Ocrevus (Ocrelizumab) Presumed binding to CD20 surface antigens resulting in antibody-dependent cellular cytolysis and complement-mediated lysis Initial doses: 300 mg in 250 ml THEN 300 mg in 250 ml administered 2 weeks later Subsequent doses: 600 mg in 500 ml every 6 months Relapsing or primary progressive MS Not established IV infusion HBV Screening Complete prior to treatment initiation Active infection Determine if active infection and delay infusion until resolved Vaccinations Complete at least 6 weeks prior to treatment PK/PD Contraindications Warnings Drug-drug Interactions Premedication (1) 100 mg methylprednisolone (or equivalent) IV 30 minutes prior to each infusion (2) Antihistamine minutes prior to each infusion (3) Consider antipyretic Distribution: 2.78 L t 1/2 = 26 days Reduces CD19+ B-cell counts in blood by 14 days after infusion Active HBV History of life-threatening infusion reaction to OCREVUS Infusion reactions Infections respiratory tract infections, herpes, progressive multifocal leukoencephalopathy (PML), HBV reactivation, increased immunosuppression with other immunosuppressant, vaccinations Malignancies breast cancer Immunosuppressive or Immune-Modulating Therapies

14 Common Side Effects Monitoring Pregnancy Lactation Storage and Stability How Supplied Relapsing MS URTI and infusion reactions Primary Progressive MS URTI, infusion reactions, skin infections, and lower respiratory tract infections None No adequate data No data Protect from light and store refrigerated at 2-8 C. Do not freeze or shake. Injection 300 mg/10 ml (30 mg/ml) single-dose vial References: 1. Cohen JA, Barkhof F, Comi G, et al. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010; 362: 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 2002;58: Goodin DS, Cohen BA, O'Connor P, et al. Assessment: the use of natalizumab (Tysabri) for the treatment of multiple sclerosis (an evidence-based review): report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2008;71: Goodman AD, Brown TR, Krupp LB, et al. Sustained-Release Oral Fampridine in Multiple Sclerosis: A Randomised, Double-Blind, Controlled Trial. Lancet 2009, 373(9665): 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: Korenke AR, Rivey MP, and Allington DR. Sustained-Release Fampridine for Symptomatic Treatment of Multiple Sclerosis. Ann Pharmacother 2008;42(10): Mikol DD, Barkhof F, Chang P, et al. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial. Lancet Neurol 2008; 7: O'Connor P, Filippi M, Arnason B, et al. 250 microg or 500 microg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol 2009;8: O'Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med 2011;365: Pucci E, Giuliani G, Solari A, Simi S, Minozzi S, Di Pietrantonj C, Galea I. Natalizumab for relapsing remitting multiple sclerosis. Cochrane Database of Systematic Reviews 2011, Issue 10. Art. No.: CD Fox RJ, Miller DH, Hutchinson M, Havrodova E, et al. Placebo-controlled pharse 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367: Gold R, Kappos L, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012;367:

15 13. Cohen JA, Coles AJ, Arnold DL, et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomized controlled phase 3 trial. Lancet 2012; 380(9856): Coles AJ, Twyman CL, Arnold DL, et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomized controlled phase 3 trial. Lancet 2012; 380(9856): Gold R, Giovannoni G, Selmaj K, et al. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet 2013;381(9884): 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): Change Control Date Change 08/16/2017 Added Copaxone as NF Preferred to the Medi-Cal Formulary Revised prior authorization criteria for all drugs listed Revised criteria for Ampyra: Revised criteria for Tysabri for patients with RRMS who failed other therapies those who have aggressive initial disease course: Added criteria for Ocrevus:

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