Print

Date Printed: December 18, 2017: 11:40 AM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J2000-20

Original Effective Date: 09/15/14

Reviewed: 08/09/17

Revised: 09/15/17

Subject: Dalfampridine (Ampyra™) Oral

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Dosage/ Administration Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Multiple sclerosis (MS) is a chronic disease affecting the central nervous system (CNS). It is characterized by triad of inflammation, demyelination, and scarring of the central nervous system and manifests as pathological (immune-mediated CNS demyelination and axonal injury) and clinical (exacerbations, disability progression) dissemination in time and space. Although the clinical course of the disease is capricious, MS has been categorized into four types: relapsing-remitting (RRMS), secondary progressive (SPMS), primary progressive (PPMS), and progressive-relapsing (PRMS). The most common type is RRMS, which is characterized by acute attacks followed by periods of remission.

Treatment of MS can be divided into three categories: disease modifying therapies (DMTs) (e.g., glatiramer acetate [Copaxone], interferon beta-1a/1b, dimethyl fumarate [Tecfidera]), symptomatic therapies (e.g., urinary antispasmodics), or treatment of acute exacerbations (e.g., corticosteroids, plasmapheresis). Dalfampridine (Ampyra™), which was approved by the US Food and Drug Administration (FDA) in January 2010, was the first symptomatic therapy approved. Dalfampridine is indicated to improve walking in persons with MS. In clinical studies, this was demonstrated by an increase in walking speed. Dalfampridine is a broad spectrum potassium channel blocker; however, the mechanism by which it exerts its therapeutic effect in MS is not completely understood.

Dalfampridine has demonstrated therapeutic potential in many disorders, but its toxicity has severely limited its use. In addition, clinical studies evaluating this agent for any indication are limited and small in sample size.

POSITION STATEMENT:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

I. Initiation of dalfampridine (Ampyra™) meets the definition of medical necessity when ALL of the following criteria are met:

A. The member has a documented diagnosis of multiple sclerosis.

B. The prescriber is a neurologist or the prescriber consulted with a neurologist who has recommended this medication for the member.

C. The member is ambulatory.

D. The member does not have a history of seizures.

E. The member’s creatinine clearance (CrCl) is greater than 50 ml/min.

F. The dosage does not exceed 10 mg twice daily.

Approval duration: 90 days

I. Continuation of dalfampridine meets the definition of medical necessity when ALL of the following criteria are met:

A. The member has been previously approved by Florida Blue or another healthplan in the past 2 years, OR the member has previously met all indication-specific criteria

B. The member has a documented diagnosis of multiple sclerosis.

C. The member has demonstrated a beneficial response to therapy (e.g., improvement in walking speed)

D. The dose does not exceed 10 mg twice daily

Approval Duration: 180 days

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved: dalfampridine is indicated to improve walking in persons with MS. In clinical studies, this was demonstrated by an increase in walking speed. The maximum recommended dose is 10 mg twice daily (approximately 12 hours apart) with or without food. Members should not take double or extra doses if a dose is missed. Tablets should be taken whole; do not divide, crush, chew, or dissolve.

NOTE: no additional benefit was demonstrated at doses greater than 10 mg twice daily and adverse reactions and discontinuations because of adverse reactions were more frequent at higher doses.

Dose Adjustments: the manufacturer does not provide recommendation for dosage adjustment in persons with impaired renal or hepatic function. Dalfampridine is primarily renally excreted; as such person with a CrCl of 50 ml/min or less should not take dalfampridine. Estimated CrCl should be calculated prior to dalfampridine therapy initiation.

Drug Availability: dalfampridine is supplied as a film-coated, extended-release 10 mg tablet.

PRECAUTIONS:

CONTRAINDICATIONS: The use of dalfampridine is contraindicated in the following conditions:

• History of seizure.

• Moderate or severe renal impairment (CrCl 50 ml/min or less).

• History of hypersensitivity to dalfampridine or 4-aminopyridine

WARNINGS AND PRECAUTIONS

• Seizures: treatment with dalfampridine has been associated with seizures; the risk of seizures increases with increasing dalfampridine doses. Dalfampridine should be discontinued indefinitely if a member has a seizure while on dalfampridine therapy.

• Anaphylaxis: dalfampridine therapy has been associated with anaphylaxis; if anaphylaxis occurs while on treatment, dalfampridine should be discontinued indefinitely.

• Drug interactions: dalfampridine should not be co-administered with other form of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same.

• Pregnancy category C: there are no well-controlled studies of dalfampridine in pregnant women; based on animal data, administration to pregnant women may cause fetal harm.

In rats, the dosages tested (approximately 2, 6, and 18 mg/kg/day) were approximately 1, 3, and 9 times the MRHD on based on a body surface area (mg/m2). There was a significant increase in uterine polyps at the highest dose tested.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J8499

Prescription drug, oral, non-chemotherapeutic, Not Otherwise Specified

ICD-10 Diagnoses Codes That Support Medical Necessity:

G35

Multiple sclerosis

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

Medicare Part D: Florida Blue has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Botulinum Toxins, 09-J0000-29

Diagnosis and Treatment of Chronic Cerebrospinal Venous Insufficiency in Multiple Sclerosis, 02-35000-01

Dimethyl Fumarate (Tecfidera), 09-J1000-96

Fingolimod (Gilenya™), 09-J1000-30

Functional Neuromuscular Stimulation, 09-E0000-54

Immune Globulin Therapy, 09-J0000-06

Magnetic Resonance Imaging (MRI) Brain and Head, 04-70540-11

Multiple Sclerosis Self Injectable Therapy, 09-J1000-39

Natalizumab (Tysabri®) IV, 09-J0000-73

Teriflunomide (Aubagio), 09-J1000-82

OTHER:

None applicable.

REFERENCES:

  1. Ampyra (dalfampridine) [package insert]. Acorda Therapeutics, Inc. Ardsley (NY): March 2017.
  2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2016. URL: www.clinicalpharmacology-ip.com. Accessed 7/24/2017.
  3. Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 7/24/2017.
  4. National Clinical Advisory Board of the National Multiple Sclerosis Society. Disease management consensus statement. Available at http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/treatments/index.aspx Accessed 08/13/2012.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 08/09/17.

GUIDELINE UPDATE INFORMATION:

09/15/14

New MCG.

05/15/15

Revision; updated billing/coding.

09/15/15

Review and revision;consisting of updating dosage/administration, references.

11/01/15

Revision: ICD-9 Codes deleted.

09/15/16

Review and revision to guideline; consisting of updating position statement and references.

09/15/17

Review and revision to guideline; consisting of updating position statement and references.

Date Printed: December 18, 2017: 11:40 AM