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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Specialty Quantity Limit Multiple Sclerosis Medications 1798-H P2022b

Policy:

      I.  PROGRAM DESCRIPTION

           The standard limit is designed to allow a quantity sufficient for
           the most common uses of the medication. If the member’s plan
           allows a quantity limit exception review for the requested
           medication, coverage of an additional quantity may be provided
           up to the exception limit with prior authorization.


     II.  COVERED QUANTITIES

    Medication

    Standard
      Limit*#

   Exception
      Limit*

  FDA-recommended dosing

  Ampyra
  (dalfampridine)
  tablets 10mg

  60 tablets per
  30 days

  Not applicable

  •    10 mg orally twice daily

  Aubagio
  (teriflunomide)
  tablets 7mg

  30 tablets
  per 30 days

  Not applicable

  •    7 mg or 14 mg orally
       once daily

  Aubagio
  (teriflunomide)
  tablets 14mg

  30 tablets 
  per 30 days

  Not applicable

  Avonex
  (interferon beta-1a) prefilled syringe
  30mcg/0.5mL

  1 box
  (4 syringes)
  per 28 days

  Not applicable

  •    The recommended dose
        is 30 mcg
        intramuscularly once
        weekly

  •    To reduce the incidence
       and severity of flu-like
       symptoms Avonex may
       be started at a dose of
       7.5 mcg and the dose
       increased by 7.5 mcg
       each week for the next 3
       weeks until the
       recommended dose of
       30 mcg is achieved.

  Avonex
  (interferon beta-
  1a) pen
  30mcg/0.5mL

  1 box
  (4 pens)
  per 28 days

  Not applicable

  Bafiertam
  (monomethyl
  fumarate) 95mg
  oral capsules

  120 capsules
  per 30 days

  Not applicable

  •    The starting dose is
        95mg twice a day orally
        for 7 days.  After 7 days
        the dosage should be
        increased to the
        maintenance dosage of
        190mg twice a day
        orally. 

  Betaseron
  (interferon beta-
  1b) vial 0.3mg

  14 vials
  per 28 days

  Not applicable

  •    The recommended
        starting dose is 0.0625
        mg (0.25 mL)
        subcutaneously every
        other day, with dose
        increases over a six-
        week period to the
        recommended dose of
        0.25 mg (1 mL) every
        other day

  Briumvi
  (ublituximab-xiiy)
  vial 150mg/6mL

  3 vials
  per 168 days

  4 vials
  per 15 days

  •    First infusion: 150 mg

  •    Second infusion: 450
        mg administered two
        weeks after the first
        infusion

  •    Subsequent infusions:
        450 mg every 24 weeks
        (first subsequent
        infusion is administered
        24 weeks after the first
        infusion)

  Copaxone
  (glatiramer
  acetate)
  prefilled syringe
  20mg/mL

  30 prefilled
  syringes
  per 30 days

  Not applicable

  •    20 mg subcutaneously
        once daily

  Copaxone
  (glatiramer
  acetate)
  prefilled syringe
  40mg/mL

  12 prefilled
  syringes
  per 28 days

  Not applicable

  •    40 mg subcutaneously
        three times weekly and
        at least 48 hours apart

  Extavia (interferon
  beta-1b) vial 0.3mg

  15 vials
  per 30 days

  Not applicable

  •    The recommended
        starting dose is 0.0625
        mg (0.25 mL)
        subcutaneously every
        other day, with dose
        increases over a six-
        week period to the
        recommended dose of
        0.25 mg (1 mL) every
        other day.

  Glatopa
  (glatiramer
  acetate) prefilled
  syringe 20mg/mL

  30 prefilled
  syringes
  per 30 days

  Not applicable

  •    20 mg subcutaneously
        once daily

  Glatopa (glatiramer
  acetate) prefilled
  syringe 40mg/mL

  12 prefilled
  syringes
  per 28 days

  Not applicable

  •    40 mg subcutaneously
        three times weekly and
        at least 48 hours apart

  Gilenya (fingolimod
  hydrochloride)
  capsules 0.25mg

  30 capsules
  per 30 days

  Not applicable

  •    0.5 mg orally once daily
        in adults and pediatric
        patients 10 years of age
        and older weighing
        more than 40 kg

  •    0.25 mg orally once
        daily for pediatric
        patients 10 years of age
        and older weighing less
        than or equal to 40 kg

  Gilenya (fingolimod
  hydrochloride)
  capsules 0.5mg

  30 capsules
  per 30 days

  Not applicable

  Kesimpta 
  (ofatumumab)
  20 mg/0.4 mL
  prefilled syringe

  1 syringe
  per 28 days

  3 syringes
  per 15 days

  •    20mg subcutaneously
        weekly for 3 weeks then
        once monthly dosing
        starting week 4.

  Kesimpta 
  (ofatumumab)
  20 mg/0.4 mL
  prefilled
  sensoready pen

  1 pen
  per 28 days

  3 pens
  per 15 days

  Lemtrada
  (alemtuzumab)

  See Stand Alone Policy

 

  Mavenclad
  (cladribine)
  tablets 10mg

  20 tablets
  per 301 days

 

  Not applicable

  •    3.5mg/kg divided into
        two treatment courses
        (1.75mg/kg per
        treatment course).
        Each treatment course
        is divided into 2
        treatment cycles.

  •    Maximum recommended
        dose per cycle (110 kg
        and above): 100 mg

  Mayzent
  (siponimod)
  0.25mg tablets
  starter pack
  (for 2-mg dose)

  12 tablets
  per 5 days

 

  Not applicable

  •  Titration to reach 2 mg
      maintenance dosage:

      °  Day 1: 0.25mg
      °  Day 2: 0.25mg
      °  Day 3: 0.50mg
      °  Day 4: 0.75mg
      °  Day 5: 1.25mg

  •  Do not use the starter
      pack for patients who will
      be titrated to the 1-mg
      maintenance dosage

  Mayzent
  (siponimod)
  0.25mg tablets
  starter pack
  (for 1-mg dose)

  7 tablets
  per 4 days

  Not applicable

  •  Titration to reach 1 mg
      maintenance dosage:

      °  Day 1: 0.25mg
      °  Day 2: 0.25mg
      °  Day 3: 0.50mg
      °  Day 4: 0.75mg

  •  Do not use the starter
      pack for patients who will
      be titrated to the 2-mg
      maintenance dosage

  Mayzent
  (siponimod)
  0.25mg tablets

  12 tablets
  per 5 days

  Not applicable

  •  Titration to reach 1 mg
      maintenance dosage:

      °  Day 1: 0.25mg
      °  Day 2: 0.25mg
      °  Day 3: 0.50mg
      °  Day 4: 0.75mg


  •  Titration to reach 2 mg
      maintenance dosage:

      °  Day 1: 0.25mg
      °  Day 2: 0.25mg
      °  Day 3: 0.50mg
      °  Day 4: 0.75mg
      °  Day 5: 1.25mg

  Mayzent
  (siponimod)
  1mg tablets

  30 tablets
  per 30 days

  Not applicable

  •  1 mg daily after starter
      pack

  Mayzent
  (siponimod)
  2mg tablets

  30 tablets
  per 30 days

  Not applicable

  •  2 mg daily after starter
      pack

  Ocrevus
  (ocrelizumab)
  vial 300mg/10mL

  2 vials
  per 168 days

  2 vials
  per 15 days

  Initial dose (two infusions):

  •  Infusion 1: 300 mg

  •  Infusion 2 (2 weeks later): 300 mg

  Subsequent doses:
  600 mg (one infusion) every
  6 months (1st subsequent
  dose is administered 6
  months after Infusion 1 of
  the initial dose)

  Plegridy
  (peginterferon
  beta-1a) pen or
  prefilled syringe
  125mcg/0.5mL

  1 carton
  (2 pens or
  prefilled
  syringes)
  per 28 days

  Not applicable

  •  The recommended dose is
     125 mcg intramuscularly
      or subcutaneously every
      14 days.

  •  Treatment initiation:

      °  Day 1: 63 mcg
      °  Day 15: 94 mcg
      °  Day 29 and every 14
         days thereafter: 125
         mcg (full dose) 

Plegridy (peginterferon beta-1a) Starter Pack pen or prefilled syringe

  1 Starter
  Pack/1
  Titration kit

  (2 pens or
  prefilled
  syringes)
  per 28 days

  Not applicable

  Plegridy
  (peginterferon
  beta-1a)
  Titration kit
  prefilled syringe for
  intramuscular use

  1 Titration kit
  (2 prefilled
  syringes)
  per 28 days

  Not applicable

  Ponvory
  (ponesimod)
  Starter pack

  1 Starter Pack
  (14 tablets)
  per 14 days

  Not applicable

  •  The recommended dose is
      20 mg taken orally once
      daily starting on day 15.

  •    Treatment Initiation

        °  Days 1 and 2: 2 mg
        °  Days 3 and 4: 3 mg
        °  Days 5 and 6: 4 mg
        °  Day 7: 5 mg
        °  Day 8: 6 mg
        °  Day 9: 7 mg
        °  Day 10: 8 mg
        °  Day 11: 9 mg
        °  Days 12, 13, and 14:
           10 mg

  •  Maintenance dose: 20 mg
      daily starting on day 15

  Ponvory
  (ponesimod)
  20 mg tablet

  30 tablets
  per 30 days

  Not applicable

  Rebif
  (interferon beta-
  1a) prefilled syringe
  or autoinjector
  22mcg/0.5mL

  12 prefilled
  syringes or
  autoinjectors
  (6 mL) per
  28 days

  Not applicable

  •  The recommended dose is
      either 22 mcg or 44mcg
      subcutaneously three
      times weekly (at least 48
      hours apart)

  •  Generally, patients should
     be started at 20% of the
     prescribed dose three
     times weekly and
     increased over a 4-week
     period to the targeted
     dose, either 22 mcg three
     times weekly or 44 mcg
     three times weekly.

  •  Titration schedule for a
     22 mcg prescribed dose:

     °  Weeks 1 and 2
         titration: 4.4mcg three
         times weekly
     °  Weeks 3 and 4
         titration: 11mcg three
         times weekly
     °  Week 5 and after: 22
         mcg three times
         weekly

  •  Titration schedule for a
      44 mcg prescribed dose:

      °  Weeks 1 and 2
          titration: 8.8mcg three
          times weekly
      °  Weeks 3 and 4
          titration: 22mcg three
          times weekly
      °  Week 5 and after: 44
          mcg three times
          weekly

  Rebif (interferon
  beta-1a) prefilled
  syringe or
  autoinjector
  44mcg/0.5mL

  12 prefilled
  syringes or
  autoinjectors
  (6 mL) per
  28 days

  Not applicable

  Rebif (interferon
  beta-1a) titration
  pack w/ prefilled
  syringes or titration
  pack w/
  autoinjectors)

  12 prefilled
  syringes or
  autoinjectors
  (4.2 mL)
  per 28 days

  Not applicable

  Tascenso ODT
  (fingolimod lauryl
  sulfate) tablets
  0.25mg

  30 tablets
  per 30 days

  Not applicable

  •  0.5 mg orally once daily
     for pediatric patients 10
     years of age and older
     weighing more than 40 kg

  •  0.25 mg orally once daily
     for pediatric patients 10
     years of age and older
     weighing less than or
     equal to 40 kg

  Tascenso ODT
  (fingolimod lauryl
  sulfate) tablets
  0.5mg

  30 tablets
  per 30 days

  Not applicable

Tecfidera (dimethyl fumarate) capsules 120mg

14 capsules per 28 days

56 per 84 days

 

Temporary dose reductions are permitted once every 84 days

  •  The starting dose is 120
      mg orally twice a day.
      After 7 days, the dose
      should be increased to
      the maintenance dose of
      240 mg orally twice daily.

  •  Temporary dose
      reductions to 120 mg
      twice daily may be
      considered for individuals
      who do not tolerate the
      maintenance dose.
      Within 4 weeks, the
      recommended dose of
      240 mg twice daily
      should be resumed.

  Tecfidera
  (dimethyl
  fumarate)
  capsules 240mg

  60 capsules
  per 30 days

  Not applicable

  Tecfidera (dimethyl
  fumarate) 30-day
  Starter Pack

  60 capsules
  per 30 days

  Not applicable

  Tysabri
  (natalizumab)

  See Stand Alone Policy

  Vumerity (diroximel
  fumarate) 30-day
  Starter dose bottle
  (bottle of 106
  capsules) 231mg

  106 capsules
  per 30 days

  Not applicable

  •  The starting dosage for
      Vumerity is 231 mg twice
      a day orally. After 7 days,
      the dosage should be
      increased to the
      maintenance dosage of
      462 mg (administered as
      two 231 mg capsules)
      twice a day orally.

  •  Temporary dosage
      reductions to 231 mg
      twice a day may be
      considered for individuals
      who do not tolerate the
      maintenance dosage.
      Within 4 weeks, the
      recommended dosage of
      462 mg twice a day
      should be resumed.

  Vumerity (diroximel
  fumarate) 30-day
  Maintenance dose
  bottle (bottle of
  120 capsules)
  231mg

  120 capsules
  per 30 days

  Not applicable

  Zeposia (ozanimod)

  See Stand Alone Policy

*# The limit may apply to the generic equivalent medications
* Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.

                                                         


Place of Service:

Outpatient

The above policy is based on the following references:
  1. Ampyra [package insert]. Ardsley, NY: Acorda Therapeutics, Inc.; November 2021.
  2. Aubagio [package insert]. Cambridge, MA: Genzyme Corporation; April 2022.
  3. Avonex [package insert]. Cambridge, MA: Biogen Inc.; December 2020.
  4. Betaseron [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; November 2021.
  5. Copaxone [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; April 2022.
  6. Extavia [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; November 2021.
  7. Glatopa [package insert]. Princeton, NJ: Sandoz Inc.; July 2020.
  8. Gilenya [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2022.
  9. Kesimpta [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2022.
  10. Mavenclad [package insert]. Rockland, MA: EMD Serono; February 2022.
  11. Mayzent [package insert]. East Hanover, NJ: Novartis; June 2022.
  12. Ocrevus [package insert]. South San Francisco, CA: Genentech, Inc.; November 2021.
  13. Plegridy [package insert]. Cambridge, MA: Biogen Inc.; March 2022.
  14. Rebif [package insert]. Rockland, MA: EMD Serono Inc.; November 2021.
  15. Tecfidera [package insert]. Cambridge, MA: Biogen Inc.; February 2022.
  16. Vumerity [package insert]. Cambridge, MA: Biogen; February 2022.
  17. Zeposia [package insert]. Summit, NJ: Celgene Corporation; April 2022.
  18. Caremark Clinical Programs Review. Focus on Multiple Sclerosis Clinical Programs. November 14, 2018.
  19. Bafiertam [package insert]. High Point, NC: Banner Life Sciences LLC; April 2020.
  20. Ponvory [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; February 2022.
  21. Tysabri [package insert]. Cambridge, MA: Biogen Inc; June 2022.
  22. Lemtrada [package insert]. Cambridge, MA: Genzyme Corporation; June 2022.
  23. Tascenso ODT [package insert]. San Jose, CA: Handa Neuroscience, LLC; December 2021.\
  24. Briumvi [package insert]. Morrisville, NC: TG Therapeutics, Inc; December 2022.

 

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

March 29, 2023
Aetna
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