Multiple Sclerosis Agents Step Therapy with Quantity Limit Program Summary

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1 Multiple Sclerosis Agents Step Therapy with Quantity Limit Program Summary OBJECTIVE The intent of the Multiple Sclerosis (MS) Agents Step Therapy (ST) program is to encourage the use of preferred multiple sclerosis agents before the nonpreferred agents for patients initiating therapy and to accommodate for use of nonpreferred multiple sclerosis agents when ONE preferred agent cannot be used due to previous trial and failure. Patients will need to have a documented intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration), FDA labeled contraindication, or hypersensitivity to all preferred agents before being allowed to try a non-preferred agent if they have not previously tried and failed a preferred therapy. The program allows continuation of therapy with a nonpreferred MS agent when there is documentation that the patient is receiving the requested agent. Studies supporting concomitant therapy of any two disease modifying agents have been limited, and because the risk for developing serious adverse effects may be higher with combination therapy, the criteria will allow coverage of only one disease modifying agent at a time. Requests for the nonpreferred agents will be reviewed when patient-specific documentation has been provided. TARGET DRUGS Preferred agents Betaseron (interferon -1b) Copaxone (glatiramer) Glatopa (glatiramer)* Plegridy (peginterferon -1a) Rebif (interferon -1a) Tecfidera (dimethyl fumarate) Nonpreferred agents Aubagio (teriflunomide) Avonex (interferon -1a) Extavia (interferon -1b) Gilenya TM (fingolimod) * generic for Copaxone 20 mg/ml PRIOR AUTHORIZATION CRITERIA FOR APPROVAL The requested agent will be approved when the following are met: 1. The patient will not be taking an additional disease modifying agent (DMA) at the same time as the requested agent AND 2. ONE of the following: a. There is documentation that the patient is currently being treated with the requested agent OR b. The prescriber states the patient is using the target agent AND is at risk if therapy is changed OR c. The requested agent is a preferred agent AL_PS_MS_STQL_ProgSum_AR0115_r0615 Page 1 of 7

2 OR d. The agent is a nonpreferred agent AND ONE of the following: i. The patient s medication history indicates use of ONE preferred agent (i.e.betaseron, Copaxone, Glatopa, Plegridy, Rebif, or Tecfidera) OR ii. The patient has a documented intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration), FDA labeled contraindication, or hypersensitivity to ALL the preferred agents Length of Approval: 12 months NOTE: If Quantity Limit program also applies, please refer to Quantity Limit documents. AL_PS_MS_STQL_ProgSum_AR0115_r0615 Page 2 of 7

3 1-7, 23,25,26,27,28 FDA APPROVED INDICATIONS AND DOSAGE Available Products Aubagio (teriflunomide) tablet Avonex (interferon -1a) intramuscular Betaseron, Extavia (interferon -1b) Copaxone (glatiramer acetate) Gilenya (fingolimod) tablet Glatopa (glatiramer acetate ) Lemtrada (alemtuzumab) Plegridy (peginterferon -1a) Rebif (interferon -1a) Tecfidera (dimethyl fumerate) Tysabri (natalizumab) Indication b b, 7 mg or 14 mg orally once daily Dosage and Administration 30 mcg intramuscularly once weekly Patients should be started at mg ly every other day, and increased over a six-week period to 0.25 mg every other day. See recommended titration table: Recommended Dose Volume Titration Weeks % mg 0.25 ml Weeks % mg 0.50 ml Weeks % mg 0.75 ml Week % 0.25 mg 1.0 ml 20 mg ly daily or 40 mg ly three times per week at least 48 hours apart (doses are not interchangeable) 0.5 mg orally once daily 20 mg injected ly once daily (Glatopa 20mg/mL dose is not interchangeable with glatiramer acetate 40mg/mL dose) Administer by intravenous infusion over 4 hours for 2 treatment courses: -First course: 12 mg/day on 5 consecutive days -Second course: 12 mg/day on 3 consecutive days 12 months after first treatment course Maintenance dose is 125 mcg ly every 14 days. Titration schedule is 63 mcg on day 1, 94 mcg on day 15 and 125 mcg on day 29 followed by maintenance dose every 14 days thereafter. 22 mcg or 44 mcg injected ly three times per week. Patients should be started at 20% of the prescribed dose three times a week and increased over a 4-week period to the targeted dose, either 22 mcg or 44 mcg three times a week. See recommended titration table: Recommended Titration Dose Titration Dose Titration for 22 mcg for 44 mcg Weeks % 4.4 mcg 8.8 mcg Weeks % 11 mcg 22 mcg Weeks % 22 mcg 44 mcg Starting dose: 120 mg orally twice daily for 7 days Maintenance dose: 240 mg twice daily 300 mg infused intravenously over approximately 1 hr, given at 4-week (28-day) intervals a,c AL_PS_MS_STQL_ProgSum_AR0115_r0615 Page 3 of 7

4 Available Products Indication Dosage and Administration intravenous infusion Moderate to severe CD RRMS- -remitting multiple sclerosis CD- Crohn s disease a- In Crohn s disease, discontinue in patients that have not experienced therapeutic benefit by 12 weeks of induction therapy, and in patients that cannot discontinue chronic concomitant steroids within six months of starting therapy. b- approved for patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis c- in adult patients with moderately to severely active disease who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of tumor necrosis factor-alpha (TNF-a) CLINICAL RATIONALE Injectable Disease Modifying Agents (DMAs) for Multiple Sclerosis (MS) DMAs for the treatment of MS reduce the number and severity of relapses, reduce the number of new lesions appearing on magnetic resonance imaging, and may reduce long-term progression of MS. 8,9 Guidelines from the United States and Europe recommend treatment for RRMS be initiated with either glatiramer or interferon beta (INF ). The INF agents are considered appropriate for patients at high risk of developing clinically definite MS, or those who already have RRMS or secondary progressive MS and are experiencing relapses. Currently there are three Interferon beta-1a agents (Rebif, Avonex, and Plegridy). The three products differ in dose and frequency of dosing (three times a week, once weekly, and once every other week respectively). There is a probable dose or frequency of dosing response curve associated with use of INF agents. Interferon beta-1a has been associated with less neutralizing antibody formation than interferon beta-1b (Betaseron, Extavia). The clinical effects of these neutralizing antibodies are uncertain. Their presence has been associated with a possible decrease in interferon efficacy. The route of administration of the INF agents does not have apparent effects on efficacy but side effect profiles differ between routes of administration. Because glatiramer works by a different mechanism than interferons, the side effect profile is different from interferons and may make this agent an option for some patients unable to tolerate interferons. 9 Glatiramer is considered an appropriate option for patients with RRMS or those experiencing a first clinical episode with MRI imaging consistent with MS. Natalizumab is recommended for patients with relapsing who have had an inadequate response to, or are unable to tolerate other MS therapies. 8,9 Concurrent use of more than one injectable DMA has been studied in clinical trials. The combinations of INF with natalizumab and glatiramer with natalizumab have been studied. Although a beneficial effect was seen (such as improved magnetic resonance imaging (MRI) parameters), there may be more adverse reactions associated with combination therapies. The study with a combination of INF and natalizumab was halted due to reported cases of progressive multifocal leukoencephalopathy (PML). 21 The adverse effects seen with combination therapies are similar to those reported with the individual agents, but it is unclear if the risk for developing these adverse effects is higher in combination therapy. Some of the clinical effects of glatiramer may occur by entry of regulatory glatiramer-reactive cells into the central nervous system (CNS) across a disrupted blood-brain-barrier (BBB) and effects on CNS resident cells. It is possible that combining glatiramer with therapies that close the BBB like INF and natalizumab may limit the effectiveness of glatiramer. 21 The benefits of combination therapies and the safety concerns associated with concurrent therapy still need further investigation. Oral DMAs for MS 10,23 Fingolimod, a sphingosine 1 phosphate (S1P) receptor modulator, is the first oral disease modifying therapy for RRMS. Fingolimod works by trapping lymphocytes (T-cells and B-cells) in AL_PS_MS_STQL_ProgSum_AR0115_r0615 Page 4 of 7

5 the lymph nodes so that they cannot attack the central nervous system. Clinical studies have shown fingolimod to be effective in preventing MS relapses, and fingolimod was superior to Avonex in one comparative study. However, its place in therapy is undetermined. Fingolimod has not been studied in combination with (concurrently with) other DMAs. Higher doses (1.25 mg compared to 0.5 mg) of fingolimod were studied in clinical trials, but there was not a statistical difference in efficacy. More serious adverse events, including increased bradycardia, were reported with 1.25 mg. 1 Dose-related first dose bradycardia and atrioventricular heart block has been reported. Patients should receive their first dose of fingolimod under medical supervision and be monitored for six hours post dose. 5 Ophthalmic exams are recommended to detect macular edema as a greater incidence of macular edema was seen in the fingolimodtreated group compared to the placebo group in clinical trials. Dose-dependent decrease of pulmonary function (forced expiratory volume within one second [FEV1]) was observed in clinical trials with fingolimod. It is unclear whether pulmonary function changes will continue to worsen over time with uninterrupted fingolimod dosing. Long term safety data is not available for fingolimod as the longest phase 3 trial to date was 2 years in duration. Contraindications to therapy include patients in the last 6 months who have experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure. Patients with Mobitz Type II second or third degree atrioventricular block (AV) or sick sinus syndrome, unless the patient has a functioning pacemaker, those with a baseline QTc interval 500 ms and those receiving treatment with Class Ia (e.g. disopyramide, procainamide, quinidine) or Class III (e.g. amiodarone, sotalol, dofetilide) antiarrhythmic drugs. 5 A National MS Society consensus statement recommends changing from one disease modifying therapy to another only for medically appropriate reasons (e.g., lack of efficacy, adverse effects, or if better treatments options become available). 8 This consensus statement was written prior to the approval of the oral MS therapies. The European Medicines Agency review of fingolimod recommends it as second line therapy based on evaluation of quality, safety, and efficacy for patients with high disease activity despite treatment with a beta-interferon or for patients with rapidly evolving severe relapsing remitting MS. 22 Teriflunomide is a pyrimidine synthesis inhibitor. The exact mechanism for its therapeutic effect in MS is unknown but thought to reduce the number of activated lymphocytes in the CNS. Clinical trial results showed a significant reduction in annualized relapse rates at both doses of teriflunomide compared to placebo. There was not an active comparator in the study but reductions in annual relapse rates were similar (30% to 50%) to the injectable disease modifying agents. Teriflunomide is contraindicated in severe hepatic impairment and pregnancy. There is a boxed warning for hepatoxicity and teratogenicity. The most common adverse events include increased ALT, alopecia, diarrhea, influenza, nausea and paresthesia. 23 The therapeutic effects of dimethyl fumarate in MS is unknown but its metabolite has been shown to active the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway which is involved in the cellular response to oxidative stress. Clinical trial results for Study 1 which was a placebo controlled study, showed a significant reduction in the proportion of relapsing remitting patients with relapses at 2 years. The proportion of patients relapsing were 27% (n=410) versus 46% (n=408) [p=<0.0001] for the dimethyl fumarate and placebo groups respectively, with a relative risk reduction of 49%. The annualized relapse rate was for the treated group and for placebo [p<0.0001] with a relative risk reduction of 53%. Study 2 was also a placebo controlled study that included an open label active comparator with a primary endpoint of annualized relapse rate at 2 years. The results of this trial showed a statistically significant reduction in annualized relapse rates compared to placebo. The annualized relapse rate for dimethyl fumarate was (n=359) and (n=363) for AL_PS_MS_STQL_ProgSum_AR0115_r0615 Page 5 of 7

6 placebo [p=<0.0001], with a relative risk reduction of 44%. The proportion of patients relapsing was similar to those in Study The most common adverse events ( 10% and 2% placebo) include flushing, abdominal pain, diarrhea, and nausea. Crohn s Disease The American College of Gastroenterology (ACG) practice guidelines for CD in adults (2009) 13 recommend treatment for mild to moderate CD with oral aminosalicylates (mesalamine and sulfasalazine), antibiotics (metronidazole or ciprofloxacin), and corticosteroid treatment (controlled-release budesonide or other conventional corticosteroids). 13,14 For moderate to severe disease, azathioprine or 6-mercaptopurine (6-MP) are effective. 13 Infliximab is recommended by ACG, the American Gastroenterological Association (AGA),and the British Society of Gastroenterology as a second-line treatment option in patients with moderately to severely active, refractory CD (including fistulizing disease). 12,13,15,16 The 2009 ACG guidelines for CD 13 state that infliximab, adalimumab, and certolizumab are all effective in the treatment of moderate to severely active CD in patients who have not responded despite complete and adequate therapy with a corticosteroid or an immunosuppressive agent. Natalizumab is effective in patients who have had an inadequate response or are unable to tolerate conventional CD therapy and anti-tnf-α monoclonal antibody therapy. 13 For additional clinical information see Prime Therapeutics Formulary Chapter 9.6C Multiple Sclerosis Agents. REFERENCES 1. Avonex prescribing information. Biogen Idec, Inc. August Betaseron prescribing information. Bayer HealthCare Pharmaceuticals Inc. January Copaxone prescribing information. Teva Neurosciences, Inc. January Extavia prescribing information. Novartis. March Gilenya prescribing information. Novartis. April Rebif prescribing information. Serono, Inc./Pfizer Inc. April Tysabri prescribing information. Biogen Idec, Inc./Elan Pharmaceuticals, Inc. December National Multiple Sclerosis Society Disease Management Consensus Statement- Recommendations from the MS Information Sourcebook; 2007 Update. National Multiple Sclerosis Society. Available at: Accessed January 2, 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. Reaffimed 9/24/2010. Neurology 2002;58; Available at Accessed September 24, Peripheral and Central Nervous System Drugs Advisory Committee Meeting. Fingolimod (NDA ) Background Package. June 10, Available at s/peripheralandcentralnervoussystemdrugsadvisorycommittee/ucm pdf. Accessed September 14, Marshall JK, Blackhouse G, Goeree R, Brazier N, Irvine EF, Faulkner L, Dipchand C, O Brian BJ. Infliximab for the Treatment of Crohn s Disease: A Systematic Review and Cost-Utility Analysis. Ottawa: Canadian Coordinating Office for Health Technology AL_PS_MS_STQL_ProgSum_AR0115_r0615 Page 6 of 7

7 Assessment; Technology report no 24 Available at: Accessed February 1, Carter MJ, Lobo AJ, Travis SPL, on behalf of the IBD Section of the British Society of Gastroenterology. Gut. 2004;53(suppl V):v1-v Lichtenstein GR, Hanauer SB, Sandborn WJ and the Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn s Disease in Adults. Online publication January 6, 2009; doi: /ajg Sandborn WJ, Feagan BG, Lichtenstein GR. Medical management of mild to moderate Crohn s disease: evidence-based treatment algorithms for induction and maintenance of remission. Aliment Pharmacol Ther. 2007;26: Lichtenstein GR, Abreu MT, Cohen R, Tremaine W. American Gastroenterological Association Institute Medical Position Statement on Corticosteroids, Immunomodulators, and Infliximab in Inflammatory Bowel Disease. Gastroenterology. 2006;130: American Gastroenterological Association Institute Medical Position Statement: Perianal Crohn s Disease. Gastroenterology. 2003;125: American Gastroenterological Association Institute. American Gastroenterological Association Consensus Development Conference on the Use of Biologics in the Treatment of Inflammatory Bowel Disease, June 21-23, Gastroenterology. 2007;133: Baumgart DC, Sandborn WJ. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet. 2007;369: Center for Drug Evaluation and Research. FDA Alert. August Available at: Accessed 12/19/ FDA MedWatch. Natalizumab MedWatch Alert. 2/5/2010. Available at: Products/ucm htm. Accessed 12/19/ Graber J, McGraw C, Kimbrough D, Dhib-Jalbut S. Overlapping and distinct mechanisms of action of multiple sclerosis therapies. Clinical Neurology and Neurosurgery. 2010;112: European Medicines Agency (EMA). Assessment report: Gilenya. Doc Ref: EMA/108602/2011. February 17, Available at: _Public_assessment_report/human/002202/WC pdf. Accessed on November 2, Aubagio prescribing information. Genzyme Corporation, Cambridge, MA. October Deleted. 25. Tecfidera prescribing information. Biogen Idec, Inc. March Plegridy prescribing information. Biogen Idec, Inc. August Lemtrada prescribing information. Genzyme. November Accessed on 11/17/ Glatopa prescribing information. Sandoz. March Accessed on 06/23/2015. AL_PS_MS_STQL_ProgSum_AR0115_r0615 Page 7 of 7

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