AMPYRA, Dalfampridine Form

Dalfampridine (Ampyra®) is a potassium channel blocker. FDA Approved Indication(s) Ampyra is indicated to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Ampyra is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Multiple Sclerosis (must meet all):

1. Diagnosis of MS;
   2. Prescribed by or in consultation with a neurologist;
   3. Age ≥ 18 years;
   4. Member has sustained walking impairment but is able to walk with or without assistance;
2. If request is for brand Ampyra, member must use generic dalfampridine, unless contraindicated or clinically significant changes are experienced;
3. Dose does not exceed 20 mg (2 tablets) per day. Approval duration:
   Medicaid/HIM – 6 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or Page 1 of 5

   CLINICAL POLICY Dalfampridine b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Multiple Sclerosis (must meet all):
6. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for brand Ampyra, member must use generic dalfampridine, unless contraindicated or clinically significant changes are experienced;
7. If request is for a dose increase, new dose does not exceed 20 mg (2 tablets) per day. Approval duration:
   Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):
8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

9. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   Page 2 of 5

   CLINICAL POLICY Dalfampridine III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CrCl: creatinine clearance FDA: Food and Drug Administration MS: multiple sclerosis Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): history of seizure; moderate or severe renal impairment (CrCl ≤ 50 mL/min); history of hypersensitivity to Ampyra or 4-aminopyridine • Boxed warning(s): none reported Appendix D: General Information • Use of doses above 10 mg twice daily may increase the risk of seizures. There is no evidence of additional benefit with doses greater than 10 mg twice daily. • 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. • CrCl can be estimated using the Cockcroft-Gault formula: CrCl = [(140-age) x (weight in kg) x (0.85 if female)] / (72 x Cr). V. Dosage and Administration
   Indication MS Dosing Regimen 10 mg PO BID (approximately 12 hours apart) Maximum Dose 20 mg/day VI. Product Availability
   Tablet: 10 mg VII.