ModifiedCentenePolicy CP.PHAR.248

Dalfampridine (Ampyra) coverage

Policy governing medical necessity and prior authorization criteria for dalfampridine (Ampyra) to improve walking in patients with multiple sclerosis for Centene lines of business including Commercial, Medicaid, and HIM/ICHRA.

Policy Summary

PayerCentene

PolicyDalfampridine (Ampyra) coverage

Policy CodePolicy CP.PHAR.248

Change TypeMaterial revisions to approval duration and generic-first requirement

Effective DateAug 1, 2016

Next Review Date

Key ActionSubmit prior authorization documentation showing member meets all approval criteria, including neurologist involvement, age ≥18, sustained walking impairment, generic use unless contraindicated, and dose ≤20 mg/day.

SourceLink

POLICY UPDATE CHANGES

For Medicaid and HIM, initial approval duration for this maintenance medication was extended from 6 to 12 months.

ICHRA line of business was added.

Policy/criteria revised to include generic dalfampridine and redirect requests for brand Ampyra to generic unless contraindicated or clinically significant changes are experienced.

10 mgtablet strength available

20 mg/daymaximum recommended daily dose

≥18minimum age for coverage

12 months

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approval duration (Medicaid/HIM/ICHRA & Commercial)

History of seizuresafety exclusion

Coverage Criteria for Dalfampridine (Ampyra)

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial MS criteria: 1. Diagnosis of multiple sclerosis (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; 5. If the request is for brand Ampyra, the member must use generic dalfampridine unless contraindicated or clinically significant changes are experienced; 6. Dose does not exceed 20 mg (2 tablets) per day.

inv-02: Continuation Therapy

Covered for continuation when ALL of the following are met:

Continued MS criteria: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If the request is for brand Ampyra, the member must use generic dalfampridine unless contraindicated or clinically significant changes are experienced; 4. If the request is for a dose increase, the new dose does not exceed 20 mg (2 tablets) per day.

inv-03: Other Indications

For other diagnoses/indications:

Other uses pathway: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, refer to the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (see referenced policies); 2. If the requested use (e.g., diagnosis, age, dosing regimen) is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 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/ICHRA, and CP.PMN.53 for Medicaid).

See referenced policies (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53) for adjudication.

Non‑FDA approved indications that are not specifically addressed by this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, and CP.PMN.53 for Medicaid) or evidence of coverage provisions.

Coverage under this clinical policy is subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance). Decisions about payment and benefit administration follow those documents and applicable law and Health Plan policies.

Use of dalfampridine is not medically necessary for members with a history of seizure or other contraindications listed in the policy (for example, moderate or severe renal impairment or hypersensitivity to Ampyra/4‑aminopyridine). Requests for members with these contraindications will be denied.

This clinical policy is intended as a guide to medical necessity and does not guarantee payment. Services that do not meet medical necessity as defined by the Health Plan and the member’s coverage documents may be denied in accordance with those documents and applicable plan policies.

Coding and Dosage Information

Drug codes (not specified)NDC

NDC	Not specified in this part of document

inv-09: Maximum daily dose

Maximum daily dose20 mg/day (10 mg twice daily; maximum 20 mg/day).

Tablet strength available10 mg

Dosing schedule10 mg PO twice daily (approximately 12 hours apart).

inv-10: Dose associated with increased seizure risk

Dose associated with increased seizure riskUse of doses above 10 mg twice daily may increase the risk of seizures.

No additional benefitNo evidence of additional benefit with doses greater than 10 mg twice daily.

Clinical caution

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must include documentation demonstrating that all initial approval criteria are met, including diagnosis of multiple sclerosis, neurologist involvement, age ≥ 18 years, sustained walking impairment (able to walk with or without assistance), and that dose will not exceed 20 mg (2 tablets) per day. For brand Ampyra requests, documentation must show the member uses generic dalfampridine unless contraindicated or there have been clinically significant changes.

Initial approval requires documentation of all criteria listed under "I. Initial Approval Criteria".
Brand Ampyra requests require prior demonstration of contraindication to generic dalfampridine or clinical justification for brand use.

Note

Prior Authorization Guidance

This clinical policy is a guide to medical necessity used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee of payment. Coverage decisions are subject to the member's coverage documents and applicable state and federal requirements.

Background

Dalfampridine is a potassium channel blocker indicated to improve walking speed in patients with multiple sclerosis. Use is intended for adults with sustained walking impairment who remain ambulatory, with or without assistive devices. The usual dosing regimen is 10 mg twice daily (approximately 12 hours apart), and the maximum recommended daily dose is 20 mg/day; doses above 10 mg twice daily have been associated with an increased risk of seizures.

Definitions

inv-21: CrCl

DefinitionCrCl = creatinine clearance, estimated using the Cockcroft-Gault formula provided in the policy.

Cockcroft-Gault formulaCrCl = [(140 - age) x (weight in kg) x (0.85 if female)] / (72 x serum creatinine).

Clinical noteEstimate CrCl prior to initiating therapy; patients with mild renal impairment (CrCl 51-80 mL/min) may have increased Ampyra levels and higher seizure risk.

inv-22: Health Plan

Health Plan definitionHealth Plan — a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or affiliates.

ScopeApplies to members covered under the adopting Health Plan and is used as a guide to medical necessity for coverage decisions.

Policy Summary

PayerCentene

PolicyDalfampridine (Ampyra) coverage

Policy CodePolicy CP.PHAR.248

Change TypeMaterial revisions to approval duration and generic-first requirement

Effective DateAug 1, 2016

Next Review Date

SourceLink

On This Page

Avoid exceeding 10 mg twice daily due to seizure risk; monitor patients closely if higher exposure is suspected (e.g., renal impairment).

Policy is based on current standards of medical practice and available evidence.
Date of posting may differ from policy effective date; check Health Plan notices for legal/regulatory notifications.

Denial Risk

Off‑Label / Non‑FDA Uses

Requests for non–FDA approved (off-label) indications not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided in accordance with applicable off-label use policies and evidence of coverage documents.

Commercial: follow CP.CPA.09 for off-label documentation.
Health Insurance Marketplace/ICHRA: follow HIM.PA.154.
Medicaid: follow CP.PMN.53.

Note

Coverage Document Limitations

Coverage decisions are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance). Authorization does not guarantee payment; benefits, limitations, and member cost-share are determined by the applicable plan documents and state/federal requirements.

Verify member eligibility and benefit coverage prior to submitting a request.
Authorization must align with plan-level administrative policies and procedures.

Documentation Required

Required Documentation

Provider must submit supporting documentation (e.g., office chart notes, neurologist consultation notes, lab results, walking assessment documentation) showing the member meets all applicable approval criteria. Failure to provide adequate documentation may result in denial.

Examples of acceptable documentation: neurologist notes confirming diagnosis and treatment plan; objective or provider-documented evidence of walking impairment; medication history demonstrating prior use or intolerance of generic dalfampridine when brand requested.
Include documentation of positive response to therapy for continuation requests and justification for any dose increases (dose must not exceed 20 mg/day).

Not a contractThis clinical policy does not constitute a contract or guarantee of payment; coverage remains subject to the member's coverage documents and plan terms.