Product Details

Firdapse

Amifampridine Phosphate
10 mg
Tablet


DIN/PIN/NPN

02502984

Manufacturer

KYE Pharmaceuticals Inc.

Formulary Listing Date

2023-08-02  

Unit Price

18.0000

Amount MOH Pays

18.0000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

N07XX05

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Central Nervous System Drugs

Amifampridine phosphate

  • Brand(s): Firdapse
  • Dosage Form/Strength: 10 mg tab
  • Effective Date: August 2, 2023

Initiation Criteria:

For the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in patients who meet all the following criteria:

  1. 18 years of age and older; AND

  1. Confirmatory symptoms, bloodwork (as applicable), and test results that support the diagnosis of LEMS is provided. Please include the baseline Triple Timed Up and Go (3TUG) test results prior to initiation of amifampridine treatment; AND

  1. Patient is under the care of a neurologist with expertise in the diagnosis and management of LEMS.

Note:

  1. Provide details of other treatments (e.g., pyridostigmine, immunomodulators, steroids, or immunosuppressants) that have been or will be used with amifampridine. 

  1. Patients should be assessed for a response to treatment within 3 months of initiating amifampridine. A response to treatment is defined as an improvement of at least 30% on the Triple Timed Up and Go (3TUG) test. 

  1. Case-by-case consideration will be provided for patients who are non-ambulatory and therefore unable to complete the 3TUG test.

Renewal Criteria:

First renewal:
Renewals will be considered in patients who demonstrate an improvement of at least 30% on the Triple Timed Up and Go (3TUG) test from pre-treatment levels after 3 months of treatment.

Second and subsequent renewals:
Renewals will be provided for patients who continue to experience and maintain symptomatic benefit from treatment and who have not developed unacceptable toxicities. 

Exclusion Criteria: 

Amifampridine will not be funded in combination with another amifampridine or 3,4-diaminopyridine potassium channel blocker.

Approved doses:

Doses to be individualized to optimal effect.

Up to a maximum recommended total daily dose of 80 mg. The maximum single dose is 20mg. 

Approval Duration:
- Initials: 6 months
- Initial Renewal: 6 months
- Subsequent Renewals: 1 year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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