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    Ampyra

    Drug - Ampyra™ (dalfampridine)

    June 2010

    Therapeutic area - Multiple sclerosis (MS)

    Exclusion criteria

    • Patient has a history of seizure disorder
    • Patient has moderate to severe renal dysfunction (CrCl ≤ 50 mL/min)

    Initial approval criteria

    • Patient has MS and has documented difficulty walking
    • Patient has no history of seizure disorder
    • Patient has renal function > CrCL 50mL/min
    • Two fills of 30 days supply allowed initially

    Subsequent approval criteria

    Further fills approved only after clinic documentation of improvement in walking speed or physical functioning.

    Dosing will not exceed 10 mg twice daily. No additional benefit was demonstrated at doses greater than 10 mg twice daily and adverse events, including seizures, were more frequent at higher doses.

    Ampyra is dispensed only by specialty pharmacies: Accredo, Aetna, Bioscript, Caremark, Curascript, Diplomat Specialty Pharmacy, Walgreens-Specialty, US Bioservices, Prescription Solutions, PharmaCare. Must be dispensed by a pharmacy that has signed the Minnesota Provider agreement.

    Creatinine Clearance Calculation
    CLcr (male) = (140-age) * (Wt in kg) / (72 * Cr)
    CLcr (female) = (140-age) * (Wt in kg) * (0.85) / (72 * Cr)

    These equations are valid for adult patients with serum creatinine level (Scr) >0.5 and < 5 mg/dL

    FDA approved indication

    Ampyra (dalfampridine) is indicated as a treatment to improve walking in patients with multiple sclerosis (MS). This is a new indication, never granted by the FDA. This drug is not indicated to decrease relapse rate or prevent the accumulation of disability.

    Rationale

    • Ampyra is contraindicated in patients with moderate to severe renal impairment (CrCl≤50 mL/min) and in patients with a history of seizures. 
    • The primary outcome variable for the Ampyra clinical trials was % responders on dalfampridine compared to placebo, where a responder completed a 25 foot walk test faster than baseline on 3 of 4 visits. At study endpoint, there was no difference in walking speed between placebo and active treatment groups. Only 35% of the treated population was considered responders. Considering the entire treated population, the walking speed change favored the dalfampridine group by 0.88 seconds for the time to walk 25 feet. In Ampyra pivotal trials (F203 and F204), responders in both the placebo-treated and dalfampridine-treated groups had the same magnitude of response. 

    Questions?

    MHCP Provider Call Center 651-431-2700 or 800-366-5411

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