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Prior Authorization Protocol
AVONEXR, REBIFR (interferon beta-1a), EXTAVIATM, BETASERONR (interferon beta-1b), COPAXONER, GLATOPA (glatiramer acetate), mitoxantrone, GILENYATM (fingolimod), AUBAGIOR (teriflunomide), TECFIDERATM (dimethyl fumarate), PLEGRIDYTM (peginterferon beta-1a), LEMTRADATM (alemtuzumab)

HNCA

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:

    Avonex:

    • Treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis
    Rebif:
    • Treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability
    Extavia, Betaseron:
    • Treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis
    Copaxone, Glatopa:
    • For the treatment of patients with relapsing-forms of multiple sclerosis.
    Mitoxantrone:
    • Reducing neurologic disability and/or the frequency of clinical relapses in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., patients whose neurologic status is significantly abnormal between relapses)
    • In combination with corticosteroids as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer
    • In combination with corticosteroids as initial therapy of acute nonlymphocytic leukemia in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias
    Aubagio:
    • Treatment of patients with relapsing forms of multiple sclerosis
    Tecfidera:
    • Treatment of patients with relapsing forms of multiple sclerosis
    Gilenya:
    • Treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

    Plegridy:

    • Treatment of patients with relapsing forms of multiple sclerosis
    Lemtrada:
    • Treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.
  2. Health Net Approved Indications and Usage Guidelines:
    Relapsing remitting multiple sclerosis (RRMS) confirmed by a neurologist
    • Avonex, Aubagio, Betaseron, Rebif, Copaxone 20 mg or 40 mg, Glatopa, Plegridy, Tecfidera, or Gilenya can be approved
    • Extavia or Lemtrada can be approved after failure or clinically significant adverse effects to two of the following: Aubagio, Tecfidera, Gilenya, Avonex, Betaseron, Plegridy, Copaxone, Glatopa or Rebif
    • Extavia can be approved if a patient is receiving ongoing therapy with Extavia
    • Lemtrada can be approved if a patient is receiving ongoing therapy with Lemtrada
    • Mitoxantrone can be approved in patients with frequent relapses or severe disease despite therapy with one of the other agents
    Secondary Progressive Multiple Sclerosis (SPMS) confirmed by a neurologist
    • Mitoxantrone can be approved
    • Betaseron can be approved in patients who also have active relapsing disease
    • Rebif can be approved in patients who also have active relapsing disease or if a patient is receiving ongoing therapy with Rebif
    Progressive relapsing multiple sclerosis (PRMS) confirmed by a neurologist
    • Mitoxantrone can be approved
    Hormone-refractory prostate cancer
    • Mitoxantrone can be approved
    Acute nonlymphocytic leukemia (ANLL) in adults
    • Mitoxantrone can be approved, This category includes myelogenous, (i.e. acute myelogenous leukemia), promyelocytic, monocytic, and erythroid acute leukemias
    Hodgkins lymphoma or non-Hodgkins lymphoma which has relapsed following treatment with other chemotherapy
    • Mitoxantrone can be approved
  3. Coverage is Not Authorized For:
    • Primary progressive multiple sclerosis
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • Serono has discontinued the marketing of Novantrone the branded product of mitoxantrone. Generic equivalents are available.
    • Criteria for evaluation of continuous therapy have not been firmly established. The following are efficacy endpoints used in clinical trials:
      • Number of courses of adrenocortioctropic (ACTH) or corticosteroids per 24 months
      • Number of hospitalizations per 24 months
      • Number of exacerbations per 24 months
      • Repeat evaluation of Expanded Disability Status Scale (EDSS)
      • Repeat Magnetic Resonance Imaging (MRI) or other imaging
    • The following criteria should be considered for cessationof current treatment:
      • Steady progression of disability over two years
      • Treatment with at least three (3) courses of ACTH or corticosteroids during a 2 year period required despite therapy
      • Consistent non-compliance in taking the medication as prescribed by the physician
      • Severe drug toxicity
    • Mitoxantrone should be reserved for patients who have failed or who have had a clinically significant adverse reaction to other disease-modifying agents or for those patients who have developed SPMS or PRMS.
    • Four clinical subtypes of MS include: 1) Relapsing remitting (RR) MS - acute relapses with full recovery, 2) Secondary progressive (SP) MS - progression of disease with relapsing course, 3) Primary progressive (PP) MS - progression of disability from onset, and 4) Progressive relapsing (PR) MS - progression of disease from onset, with clear acute relapses.
    • Patients with some preexisting conditions (e.g., ischemic heart disease, history of myocardial infarction, congestive heart failure, history of cardiac arrest, cerebrovascular disease, uncontrolled hypertension, history of symptomatic bradycardia, history of recurrent syncope, severe untreated sleep apnea, AV block, sinoatrial heart block) may poorly tolerate the Gilenya -induced bradycardia, or experience serious rhythm disturbances after the first dose of Gilenya . Prior to treatment with Gilenya, these patients should have a cardiac evaluation by a physician appropriately trained to conduct such evaluation, and, if treated with Gilenya, should be monitored overnight with continuous electrocardiogram (ECG) in a medical facility after the first dose. Gilenya is contraindicated in patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization or Class III/IV heart failure).
    • Gilenya has been designated an orphan drug by the US Food and Drug Administration (FDA) for use in the treatment of chronic inflammatory demyelinating polyneuropathy; however, this use is not in the FDA-approved labeling for the drug.
    • Co-administration of Aubagio with leflunomide is contraindicated
    • Mitoxantrone has IIa recommendations from Drugdex for use in anthracycline resistant breast cancer, liver cancer and ovarian cancer, however these indications are not listed by the National Comprehensive Cancer Network (NCCN) guidelines.
    • Prescribing information for Lemtrada includes a boxed warning about the potential for serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. It also warns about serious and life-threatening infusion reactions, increased risk of malignancies (including thyroid cancer, melanoma, and blood cancers). Lemtrada will only be available from certified prescribers, and patients will be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program to ensure that ongoing periodic monitoring will be maintained to detect potential problems.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

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    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Avonex

    30 mcg IM Q Wk

    Avonex may be titrated to reduce the incidence of flu-like symptoms,
    starting with 7.5 mcg for the first week and increasing the dose by 7.5 mcg each week
    for the next 3 weeks until the recommended dose of 30 mcg weekly is obtained.

    HNCA: 6 month or to member's renewal period, whichever is longer

    Betaseron

    250 mcg SC QOD

    Generally, start at 0.0625 mg (0.25 mL) SC QOD,
    and increase over a six week period to 0.25 mg (1 mL) QOD.

    HNCA: 6 month or to member's renewal period, whichever is longer

    Copaxone

    20 mg SC QD or 40 mg SC TIW
    Doses are not interchangeable

    HNCA: 6 month or to member's renewal period, whichever is longer

    Rebif

    22 mcg or 44 mcg SC TIW titrated over a 4 week period.

    HNCA: 6 month or to member's renewal period, whichever is longer

    Mitoxantrone

    Multiple Sclerosis
    12 mg/m2 IV infusion every three months with a cumulative lifetime maximum dose of 140 mg/m2.
    Hormone-Refractory Prostate Cancer
    12 to 14 mg/m2 IV infusion every 21 days
    Acute Nonlymphocytic Leukemia
    12 mg/m2 IV infusion on days 1-3 with 100 mg/m2 of cytarabine days 1-7

    HNCA: 6 month or to member's renewal period, whichever is longer

    Aubagio

    7 mg or 14 mg PO QD

    Length of Benefit

    Gilenya

    0.5 mg PO QD

    HNCA: Length of Benefit

    Tecfidera

    120 mg PO BID for 7 days followed by 240 mg PO BID
    Administration with food may reduce the incidence of flushing
    HNCA: Length of Benefit

    ExtaviaTM (interferon beta-1b)*

    250 mcg SC QOD

    HNCA: 6 month or to member's renewal period, whichever is longer

    PlegridyTM

    125 mcg SC every 14 days
    Dose should be titrated, starting with 63 mcg on day 1, 94 mcg on day 15, and 125 mcg (full dose) on day 29

    HNCA: 6 month or to member's renewal period, whichever is longer

    Lemtrada

    Multiple Sclerosis
    First year:
    12 mg/day IV infusion for 5 consecutive days (60 mg total dose)
    Second year:
    12 mg/day for 3 consecutive days (36 mg total dose)
    HNCA:
    Once per year
    First year: 5 vials
    Second year: 3 vials

    Extavia

    250 mcg SC QOD

    HNCA:
    6 months or to members renewal period, whichever is longer

    Glatopa

    20 mg SC QD, dose is not interchangeable with glatiramer acetate 40 mg/ml

    HNCA: 6 month or to member's renewal period, whichever is longer

  7. Product Availability:
    • Avonex: 30 mcg (6.6 MIU) powder for injection single-use vial; 30 mcg/0.5ml (6.6 MIU) single-use pre-filled syringe; 30 mcg/0.5ml (6.6 MIU) single use pre-filled autoinjector
    • Rebif Pre-filled Syringes (single-use): Titration Pack  contains six 8.8 mcg/0.2ml and six 22 mcg/0.5ml; 22mcg/0.5ml; 44mcg/0.5ml
    • Rebif Rebidose. Autoinjectors (single-use): Titration Pack  contains six 8.8 mcg/0.2ml and six 22 mcg/0.5ml; 22mcg/0.5ml; 44mcg/0.5ml
    • Betaseron: 0.3 mg lyophilized powder for injection in a single-use vial kit
    • Extavia: 0.3 mg lyophilized powder for injection in a single use glass vial kit
    • Copaxone: 20 mg/ml single use pre-filled syringe kit (30-count cartons), 40 mg/ml single use pre-filled syringe kit (12-count cartons)
    • Glatopa: 20 mg/ml single-dose prefilled syringe
    • Lemtrada: 12 mg/1.2 ml single use vial
    • mitoxantrone: multi-dose vials of 20mg/10ml, 25mg/12.5ml, 30mg/15ml solution for injection
    • Aubagio: 7 mg, 14 mg tablets
    • Gilenya: 0.5 mg capsules
    • Tecfidera: 30-day Starter Pack: 7-day bottle 120 mg capsules, quantity 14 and 23-day bottle 240 mg capsules, quantity 46, 120 mg, 240 mg capsules
    • Plegridy: 125 mcg per 0.5 mL of solution in a single-dose prefilled pen, Starter Pack containing 63 mcg per 0.5 mL of solution in a single-dose prefilled pen and 94 mcg per 0.5 mL solution in a single-dose prefilled pen, 125 mcg per 0.5 mL of solution in a single-dose prefilled syringe, Starter Pack containing 63 mcg per 0.5 mL of solution in a single-dose prefilled syringe and 94 mcg per 0.5 mL of solution in a single-dose prefilled syringe
  8. References:
    1. Avonex [Prescribing information] Cambridge, MA: Biogen, Inc August 2014.
    2. Rebif [Prescribing information] Rockland, MA: Serono, Inc. March 2015.
    3. Betaseron [Prescribing information] Montville, NJ: Berlex Laboratories. January 2014.
    4. Extavia [Prescribing Information] Montville, NJ: Novartis. December 2014.
    5. Copaxone [Prescribing information] North Wales, PA: Teva-Neuroscience, Inc. January 2014.
    6. Plegridy [Prescribing information]Cambridge, MA: Biogen Idec Inc. August 2014.
    7. Mitoxantrone [Prescribing information] North Wales, PA: Teva, March 2012.
    8. Aubagio [Prescribing Information] Cambridge, MA: Sanofi Company. October 2014.
    9. Gilenya [Prescribing Information] East Hanover, NJ: Novartis Pharmaceuticals; April 2014.
    10. Lemtrada [Prescribing information] ] Cambridge, MA: Genzyme, Inc. November 2014.
    11. Goodin DS, 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;58:169-78.
    12. Changing therapy in relapsing multiple sclerosis: considerations and recommendations of a task force of the national multiple sclerosis society. Expert Opinion Paper 2008. (Accessed July 1, 2013 at http://www.nationalmssociety.org.)
    13. McEvoy GK, ed. AHFS:Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1143-45, 3678-85, 3687-90.
    14. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 5, 2015.
    15. AHFS Drug Information Updates Web site. Available at: http://www.ahfsdruginformation.com. Accessed June 5, 2015.
    16. Fernandez O. Combination therapy in multiple sclerosis. J Neurologic Sci. 2007;259:95-103.
    17. Costello F, Stuve O, Weber MS, Zamvil SS, Froham E. Combination therapies for multiple sclerosis: scientific rationale, clinical trials, and clinical practice. Curr Opin Neurol. 2007;20:281-85.
    18. 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;68:977-84.
    19. Montalban X. MS treatment: postmarketing studies. J Neurologic Sci. 2007;259:42-45.
    20. Federal Register. Determination That Novantrone (Mitoxantrone Hydrochloride) Injection, Equivalent to 25 Milligrams Base/12.5 Milliliter and Equivalent to 30 Milligrams Base/15 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness / Vol. 76, No. 71 / Wednesday, April 13, 2011Accessed at http://www.gpo.gov/fdsys/pkg/FR-2011-04-13/pdf/2011-8819.pdf on July 1, 2013.
    21. Tecfidera [Prescribing Information] Cambridge, MA: Biogen Idec Inc. April 2015.
    22. Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012;367(12):1098-1107.
    23. Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012;367(12):1087-97 Kappos L, Radue EW, OConnor P, et al. FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med 2010;362(5):387-401.
    24. Cohen JA, Barkhof F, Comi G, et al. TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med 2010;362(5):402-415
    25. OConnor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Eng J Med. 2011;365:1293-1303.
    26. OConnor P, Li D, Freedman MS, et al. A Phase II study of the safety and efficacy of teriflunomide in the multiple sclerosis with relapses. Neurology. 2006;66;894-900.
    27. Freedman MS, Wolinsky JS, Wamil B, et al. Teriflunomide added to interferon-beta in relapsing multiple sclerosis: A randomized phase II trial. Neurology. 2012; 78:1877-1885.
    28. National Comprehensive Cancer Network. Non-Hodgkins Lymphoma Version 2.2014. Available at: http://www.nccn.org/professionals/physician_gls/.pdf.
    29. DRUGDEXR System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: http://www.micromedexsolutions.com/. Accessed 6.5.15.
    30. Glatopa [Prescribing information] Princeton, NJ: Sandoz Inc., June 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.