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Prior Authorization Protocol
AMPYRATM (dalfampridine)

NATL
Coverage of drugs is first determined by the memberís pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • To improve walking in patients with multiple sclerosis (MS), demonstrated by an increase in walking speed.
  2. Health Net Approved Indications and Usage Guidelines:
    • Clinically definite MS confirmed by a neurologist

    AND

    • Estimated Creatinine Clearance (CrCl) > 50 ml/min
  3. Coverage is Not Authorized For:
    • 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.
    • Patients with a prior history of seizure

  4. General Information:
    • Use of doses above 10 mg twice daily may increase the risk of seizures. Ampyra is contraindicated in patients with a history of seizure. Should a seizure occur during Ampyra treatment, the drug should be discontinued and the event reported to Acorda drug safety at 1-800-367-5109 or to the Food and Drug Administration at 1-800-FDA-1088.
    • Epilepsy is more common in patients with multiple sclerosis (MS) than in the general population, occurring in 2 to 3 percent of patients. Approximately two-thirds of seizures in patients with MS are primary or secondary generalized seizures, while the remainder are partial. Simple partial seizures are about twice as common as complex partial seizures in patients with MS. This differs from the general population, where complex partial seizures are more frequent than simple partial.
    • Ampyra is contraindicated in moderate or severe renal impairment defined as a creatinine clearance (CrCl) of ≤50 ml /min. Patients with mild renal impairment (CrCl 51-80 ml/min) may exhibit Ampyra levels that approach those attained at higher doses and that have been associated with a higher risk of seizures. Ampyra should be used with caution in this patient population and CrCl should be estimated or known prior to initiating Ampyra therapy.
    • Creatinine Clearance can be estimated using the Cockcroft-Gault formula: CrCl = (140-age) X (Wt in kg) X (0.85 if female) / (72 X Cr)
  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

    Ampyra

    10 mg PO every 12 hours

    Length of Benefit

  7. Product Availability:
    Tablet: 10 mg
  8. References:
    1. Ampyra [Prescribing information], Acorda Therapeutics. June 2013.
    2. DRUGDEXR System [Internet database]. Greenwood Villlage, Colo:Thomson Healthcare. Updated periodically. Accessed June 19, 2014.
    3. Ampyra. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 19, 2014.
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.