AMPYRA (dalfampridine)

AMPYRA (dalfampridine)

SELF ADMINISTRATION - ORAL

Indication for Prior Authorization:

• Indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS)

Coverage Criteria:

• Patient has a documented diagnosis of multiple sclerosis, AND
• Prescribed by a neurologist or MS specialist, AND
• Physician confirmation that patient has difficulty walking (e.g., timed 25-foot walk test)

Reauthorization:

• Physician confirmation that the patient’s walking improved with therapy

Dosing:

• Maximum adult dose: 10 mg tablet twice daily
• There is no evidence of additional benefit at doses greater than 10 mg twice daily
• Moderate or severe renal impairment (CrCl≤50 mL/min): Ampyra is contraindicated
• Avoid concomitant use with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is Not Covered for the Following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.

Additional Information:

• Ampyra is contraindicated in the following conditions:
  • History of seizure
  • Moderate or severe renal impairment (CrCl≤50 mL/min) 
  • History of hypersensitivity to Ampyra or 4-aminopyridine; reactions have included anaphylaxis
• Additional warnings for: seizures, renal impairment, concurrent treatment with other forms of 4-aminopyridine, anaphylaxis
• Pregnancy: There are no adequate data on the developmental risk associated with use of Ampyra in pregnant women. Administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses
• Lactation: There are no data on the presence of dalfampridine in human milk, the effects of dalfampridine on the breastfed infant, or the effects on milk production
• Safety and effectiveness in patients younger than 18 years of age have not been established

Review History:

• 4/20/21- Criteria and format updated
• 11/17/20- Class review
• 3/7/17- Annual review

References:

• Ampyra Prescribing Information. Acorda Therapeutics, Inc. Ardsley, NY. September 2017.
• Goodman AD, Brown TR, Krupp LB, et al. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet 2009;373:732-738.
• Goodman AD, Brown TR, Cohen JA, et al. Dose comparison trial of sustained-release fampridine in multiple sclerosis. Neurology. 2008;1134-1141.
• OptumRX Therapeutic Class Overview – Multiple Sclerosis Agents.  Publication Date:  June 22, 2020.