Pharmacy Prior Authorization Criteria

Ampyra (dalfampridine) - PA, NF

Indications for Prior Authorization

Ampyra (dalfampridine)

• For diagnosis of Improvement in walking in patients with multiple sclerosis
  Indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed.

Criteria

Brand Ampyra, Generic dalfampridine extended-release

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of multiple sclerosis [A]
AND
• Physician confirmation that patient has difficulty walking (e.g., timed 25-foot walk test) [B]
AND
• One of the following:
• Patient has an expanded disability status scale (EDSS) score less than or equal to 7
• Patient is not restricted to using a wheelchair (if EDSS is not measured)
AND
• For brand Ampyra, trial and failure or intolerance to generic dalfampridine extended-release
AND
• Prescribed by or in consultation with a neurologist

Brand Ampyra, Generic dalfampridine extended-release

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Physician confirmation that the patient’s walking improved with therapy
AND
• One of the following:
• Patient has an expanded disability status scale (EDSS) score less than or equal to 7
• Patient is not restricted to using a wheelchair (if EDSS is not measured)
AND
• For brand Ampyra, trial and failure or intolerance to generic dalfampridine extended-release

Brand Ampyra

Non Formulary

Length of Approval: 12 Month(s)

• Diagnosis of multiple sclerosis [A]
AND
• Submission of medical records (e.g., chart notes) documenting physician confirmation that patient has difficulty walking (e.g., timed 25-foot walk test) [B]
AND
• Submission of medical records (e.g., chart notes) documenting one of the following:
• Patient has an expanded disability status scale (EDSS) score less than or equal to 7
• Patient is not restricted to using a wheelchair (if EDSS is not measured)
AND
• Submission of medical records (e.g., chart notes) documenting trial and failure or intolerance to generic dalfampridine extended-release
AND
• Prescribed by or in consultation with a neurologist

P & T Revisions

2024-05-24, 2023-10-25, 2023-05-15, 2022-07-05, 2022-05-04, 2021-09-27, 2021-05-10, 2020-03-30

References

1. Ampyra Prescribing Information. Acorda Therapeutics, Inc. Ardsley, NY. November 2021.
2. 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.
3. Goodman AD, Brown TR, Cohen JA, et al. Dose comparison trial of sustained-release fampridine in multiple sclerosis. Neurology. 2008;1134-1141.

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End Notes

1. Patients with clinically definite MS of any type were included in the pivotal trials for Ampyra. [2, 3]
2. Inclusion criteria in the Ampyra pivotal trials included patients who were able to walk (with or without an assistive device) 25 feet in 8-45 seconds and 8-60 seconds in the two studies, respectively. [2, 3]

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Revision History

• 2024-05-24: 2024 UM Annual Review. No criteria changes
• 2023-10-25: Added t/f requirement to generic dalfampridine
• 2023-05-15: 2023 UM Annual Review. No changes
• 2022-07-05: Addition of NF criteria for Brand Ampyra only
• 2022-05-04: Annual Review, no changes.
• 2021-09-27: 2021 UM Annual Review.
• 2021-05-10: 2021 UM Annual Review.
• 2020-03-30: 2020 UM Annual Review. Operational clean up to remove drug name from reauthorization criteria.

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