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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsWashington HCA Dalfampridine Coverage | OpenPayer
    Ask Trek AI about this page
    CurrentWashington State Health Care AuthorityPolicy 62.40.60.30

    Multiple Sclerosis Agents – Dalfampridine (Ampyra)

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    This policy governs prior authorization and coverage of dalfampridine (Ampyra) to improve walking in adults with multiple sclerosis, including approval criteria, reauthorization, dosing, quantity limits, and clinical eligibility requirements.

    Policy Summary
    PayerWashington State Health Care Authority
    PolicyMultiple Sclerosis Agents – Dalfampridine (Ampyra)
    Policy CodePolicy 62.40.60.30
    Change TypeNo material change
    Effective DateJuly 1, 2018
    Next Review DateN/A
    Key ActionDocument disease stability or lack of disease progression, such as improved baseline T25W or EDSS, for reauthorization.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 monthsInitial approval duration
    12 monthsReauthorization duration
    20 mg/dayMaximum daily dose

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    60 tabletsQuantity limit per 30 days
    18 yearsMinimum age for initial approval
    G35Diagnosis code

    Medical Necessity and Coverage Criteria

    Medical Necessity

    Dalfampridine (AMPYRA®) may be considered medically necessary when ALL of the following are met:

    ALL of the following

    • Patient has multiple sclerosis (MS).
    • Patient is an adult (18 years of age or older).
    • Dalfampridine is used to improve walking.

    Initial Therapy

    Ampyra® may be covered when ALL of the following initial approval requirements are met:

    ALL of the following

    • Diagnosis of multiple sclerosis (MS).
    • Concurrent use of, documented intolerance to, or contraindication to a disease-modifying agent for MS.
    • Patient is 18 years of age or older.≥ 18 years
    • No applicable coverage exclusion; see Coverage Exclusions below.
    • Prescribed by or in consultation with a neurology specialist.
    • Baseline walking speed is documented using the timed 25-foot walk (T25W) or the expanded disability status scale (EDSS).
    • Dose does not exceed 20 mg per day (10 mg every 12 hours).≤ 20 mg/day

    Continuation Therapy

    Continuation of Ampyra® requires ALL of the following:

    ALL of the following

    • Documentation of disease stability or lack of disease progression, such as an improved baseline walking speed measured by T25W or an improved EDSS score.

    Coverage is excluded for patients with any of the following: a history of seizures; moderate to severe renal insufficiency (creatinine clearance [CrCl] ≤ 50 mL/min); or a non-ambulatory status.

    Diagnosis, Dosing, and Utilization Parameters

    Diagnosis CodeICD-10Covered
    G35Multiple sclerosis
    Minimum age
    Minimum age≥ 18 years
    Applies toAdults with multiple sclerosis
    Initial approval duration6 months
    Renal function exclusion
    Creatinine clearance thresholdCrCl ≤ 50 mL/min
    Clinical classificationModerate to severe renal insufficiency
    Coverage conditionMust be absent for initial approval

    Prior Authorization and Documentation Requirements

    Prior Authorization

    Initial Prior Authorization

    Submit an initial prior authorization request for dalfampridine (AMPYRA®) when all initial clinical criteria are met. Initial approval may be granted for 6 months.

    • Diagnosis of multiple sclerosis (MS).
    • Concurrent use of, documented intolerance to, or contraindication to an MS disease-modifying agent.
    • Patient is at least 18 years of age.
    • No seizure history, moderate to severe renal insufficiency, or non-ambulatory status.
    • Prescribed by or in consultation with a neurology specialist.
    • Baseline T25W or EDSS documentation is provided.
    • Dose does not exceed 20 mg per day (10 mg every 12 hours).
    Prior Authorization

    Renewal Prior Authorization

    Submit a renewal prior authorization request with documentation supporting continued clinical benefit and disease stability. Reauthorization may be granted for 12 months.

    Multiple Sclerosis and Dalfampridine

    Multiple sclerosis is an immune-mediated disease that can damage myelin and nerve fibers in the central nervous system, disrupting nerve impulse transmission and causing neurologic symptoms. Because these effects may impair mobility, dalfampridine is covered under this policy when used to improve walking in adults with multiple sclerosis.

    Clinical Measures and Terms

    T25W
    T25WTimed 25-foot walk
    PurposeDocuments baseline walking speed
    Authorization useBaseline T25W documentation is required for initial approval, unless EDSS is documented
    EDSS
    EDSSExpanded disability status scale
    PurposeMeasures disability and functional status in multiple sclerosis
    Authorization useMay be documented as the baseline functional assessment for initial approval

    Initial Approval Criteria

    Initial Approval

    Covered when ALL of the following are met:

    Initial approval criteria

    • The patient has a diagnosis of multiple sclerosis (MS).

    • ONE of

      • The patient is concurrently using a disease-modifying agent for MS.
      • The patient has documented intolerance to a disease-modifying agent for MS.
      • The patient has a contraindication to a disease-modifying agent for MS.

    Reauthorization Criteria

    Reauthorization

    Reauthorization requires ALL of the following:

    Continuation criteria

    • Documentation supports disease stability or lack of disease progression.

    • For example, ONE of

      • Improved baseline walking speed measured by the timed 25-foot walk (T25W).
      • An improved expanded disability status scale (EDSS) score.

    Preferred Agent Requirements

    Applies toRequirementException
    Non-preferred agent in the multiple sclerosis agents class or categoryDocument an inadequate response or intolerance due to a severe adverse reaction or contraindication to at least two preferred agents.If only one preferred agent exists, document an inadequate response to that one preferred agent.

    Dalfampridine Quantity Limits

    Dalfampridine (AMPYRA)
    MedicationDalfampridine (AMPYRA)
    Daily quantity limit2 tablets per day
    30-day quantity limit60 tablets per 30 days
    Policy Summary
    PayerWashington State Health Care Authority
    PolicyMultiple Sclerosis Agents – Dalfampridine (Ampyra)
    Policy CodePolicy 62.40.60.30
    Change TypeNo material change
    Effective DateJuly 1, 2018
    Next Review DateN/A
    Key ActionDocument disease stability or lack of disease progression, such as improved baseline T25W or EDSS, for reauthorization.
    SourceLink
    On This Page
    Medical Necessity and Coverage CriteriaDiagnosis, Dosing, and Utilization ParametersPrior Authorization and Documentation RequirementsMultiple Sclerosis and DalfampridineClinical Measures and TermsInitial Approval CriteriaReauthorization CriteriaPreferred Agent RequirementsDalfampridine Quantity Limits
    Maximum daily dose
    Maximum daily dose20 mg per day
    Administration10 mg every 12 hours
    Coverage conditionDose must not exceed the daily maximum
    Dosing schedule
    Dose10 mg
    FrequencyEvery 12 hours
    Total daily dose20 mg per day maximum
    Quantity limit
    Daily limit2 tablets per day
    30-day limit60 tablets per 30 days
    MedicationDalfampridine (AMPYRA)
    • Document disease stability or lack of disease progression.
    • Examples include improved baseline timed 25-foot walk (T25W) or EDSS score.
    Step Therapy

    Non-Preferred Class Requirement

    Dalfampridine is subject to the non-preferred class requirement. Before approval, document an inadequate response or documented intolerance due to a severe adverse reaction or contraindication to the required preferred agents.

    • Trial of at least TWO preferred agents is required when two or more preferred agents are available.
    • If only one preferred agent is available in the class/category, document an inadequate response to that ONE preferred agent.
    • A new-to-market drug entering an existing class/category is considered non-preferred and is subject to the class/category prior authorization criteria.
    Documentation Required

    Initial Clinical Documentation

    For initial approval, document the clinical information needed to establish eligibility for dalfampridine.

    • Multiple sclerosis diagnosis.
    • Age of at least 18 years.
    • Concurrent use of, documented intolerance to, or contraindication to an MS disease-modifying agent.
    • Prescription by, or consultation with, a neurology specialist.
    Documentation Required

    Baseline Functional Assessment

    Provide a baseline functional assessment before treatment. The prescriber must document either timed 25-foot walk (T25W) performance or the expanded disability status scale (EDSS).

    • The baseline T25W or EDSS assessment should support subsequent evaluation of disease stability or progression.
    • Dalfampridine must be prescribed by or in consultation with a neurology specialist.
    Documentation Required

    Reauthorization Documentation

    For reauthorization, submit documentation demonstrating that the disease remains stable or has not progressed during treatment.

    • Documentation may include an improved baseline T25W result or improved EDSS score.
    • Renewal approval may be granted for 12 months.
    Denial Risk

    Seizure, Renal, and Ambulation Exclusions

    Dalfampridine should not be approved when any specified seizure, renal, or ambulation exclusion is present.

    • History of seizures.
    • Moderate to severe renal insufficiency, defined as creatinine clearance (CrCl) ≤ 50 mL/min.
    • Non-ambulatory status.
    Denial Risk

    Clinical Eligibility Requirements

    Deny or do not approve the request when core clinical eligibility or prescribing requirements are not met.

    • Patient is younger than 18 years of age.
    • Multiple sclerosis diagnosis is not documented.
    • The patient is not concurrently using, intolerant of, or contraindicated to an MS disease-modifying agent.
    • The prescription is not issued by or in consultation with a neurology specialist.
    Denial Risk

    Dose and Quantity Limits

    Do not approve requests that exceed dalfampridine's daily dose or quantity limits.

    • Maximum dose: 20 mg per day, administered as 10 mg every 12 hours.
    • Quantity limit: 2 tablets per day, or 60 tablets per 30 days.
    CrCl ≤ 50 mL/min
    CrCl thresholdCreatinine clearance of 50 mL/min or less
    Clinical meaningModerate to severe renal insufficiency
    Policy statusAn exclusion from coverage
    The patient is at least 18 years of age.≥ 18 years

  1. NONE of the following

    • No history of seizures.
    • No moderate to severe renal insufficiency with CrCl ≤ 50 mL/min.CrCl > 50 mL/min
    • The patient is not non-ambulatory.
  2. The drug is prescribed by or in consultation with a neurology specialist.

  3. ONE of

    • Baseline walking speed is documented using the timed 25-foot walk (T25W).
    • Baseline disability or functional status is documented using the expanded disability status scale (EDSS).
  4. The dose does not exceed 20 mg per day and is administered as 10 mg every 12 hours.≤ 20 mg/day; 10 mg every 12 hours