Product Details

Apo-Fingolimod

Fingolimod
0.5 mg
Capsule


DIN/PIN/NPN

02469936

Manufacturer

Apotex Inc.

Formulary Listing Date

2019-12-20  

Unit Price

73.9096

Amount MOH Pays

73.9096

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L04AA27

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02469561 Teva-Fingolimod 73.9096 73.9096
02469618 Taro-Fingolimod 73.9096 73.9096
02482606 Sandoz Fingolimod 73.9096 73.9096
02469782 PMS-Fingolimod 73.9096 73.9096
02469715 Mylan-Fingolimod 73.9096 73.9096
02474743 Mar-Fingolimod 73.9096 73.9096
02487772 Jamp Fingolimod 73.9096 73.9096
02365480 Gilenya 86.9525 73.9100
02469936 Apo-Fingolimod 73.9096 73.9096
02475669 ACH-Fingolimod 73.9100 73.9100
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Multiple Sclerosis Drugs

Fingolimod

  • Brand(s): Gilenya and generics
  • Dosage Form/Strength: 0.5 mg capsule

As monotherapy for the treatment of patients with Relapsing Remitting Multiple Sclerosis (RRMS) who meet all of the following criteria:

  1. The patient’s physician provides documentation setting out the details of the patient’s most recent neurological examination within ninety (90) days of the submitted request. This must include a description of any recent attack(s), the date(s) of the attack(s), and the neurological findings; AND 

  2. Failure to respond to full and adequate courses1 of at least one of interferon OR glatiramer acetate OR dimethyl fumarate; OR teriflunomide OR ocrelizumab OR documented intolerance or contraindication to 2 of the above listed therapies; AND 

  3. Experienced one or more clinically disabling relapses in the previous year; AND

  4. Has had a significant increase in T2 lesion load compared with that from a previous MRI scan (i.e., 3 or more new lesions) OR at least one gadolinium-enhancing lesion.

  5. Is being followed by a neurologist experienced in the management of RRMS.

  6. Has a current EDSS of less than or equal to 5.5 (i.e., patients must be able to ambulate at least 100 meters without assistance). 

Exclusion Criteria (Patients meeting any of the following exclusion criteria will not be funded): 

  • Patient’s receiving combination therapy of Gilenya with other disease modifying therapies (e.g., Aubagio, Avonex, Betaseron, Copaxone/Glatect, Extavia, Rebif, Extavia, Ocrevus, Tysabri, and Tecfidera). 

  • Patients with EDSS greater than 5.5 

  • Patients who have had a heart attack or stroke in the last 6 months of the funding request, history of sick sinus syndrome, atrioventricular block, significant QT prolongation, bradycardia, ischemic heart disease, or congestive heart failure. 

  • Patients younger than 18 years of age. 

  • Patients requesting Gilenya due to needle phobia or preference for oral therapy over injection who do not have a clinical contraindication to interferon or glatiramer therapy. 

  • Skin reactions at the site of injection do NOT qualify as a contraindication to interferon or glatiramer therapy.

Dosage: 0.5 mg once daily 

1Failure to respond to full and adequate courses: defined as having received a trial of at least 6 months of interferon or glatiramer or dimethyl fumarate therapy or teriflunomide AND experienced at least one disabling relapse (attack) while on interferon or glatiramer or dimethyl fumarate or teriflunomide. 

MRI reports do NOT need to be submitted with the initial request. 

Duration of Approval: 1 year 

Renewals are considered. Renewals can be submitted through the Telephone Request Service and will be considered for patients who have benefited from therapy. 

Physicians must provide the following information: 

  • Documentation providing the date and details of the Patient’s most recent neurological examination and EDSS scores (exam must have occurred within the last ninety (90) days); AND 

  • Evidence that the patient is stable and has experienced no more than one (1) disabling attack/relapse in the past year. (Note: If the Patient has had more than one attack/relapse, the request will be sent for external review. Please include details of the attack(s) including the dates on which they occurred); AND 

  • A recent Expanded Disability Status Scale (EDSS) that is less than or equal to 5.5 (Note: Requests with an EDSS greater than 5.5 will not be funded). 

Dosage: 0.5 mg once daily. 

Duration of Approval:
- First Renewal: 2 years
- Second and subsequent renewals: 5 years

EAP Drug Request Form:

Standard Form for EAP Drug Requests
Renewals of Multiple Sclerosis Drugs – Telephone Request Service (TRS) Drugs

Fingolimod

  • Brand(s): Gilenya and generics
  • Dosage Form/Strength: 0.5 mg Capsule

EAP will renew coverage of Fingolimod for patients with RRMS who are stable and experienced no more than one disabling attack/relapse in the past year and have an EDSS score less than or equal to 5.5.

Prescriber must provide the following information:

  • Description of the patient’s clinical course in the last year, including details of all attacks; 

  • Date and details of the most recent neurological examination (within the last 90 days); AND 

  • EDSS score 

Standard Approval Duration: 2 years for first renewal; 5 years for 2nd and subsequent renewals.

Renewal requests where patients have experienced more than 1 attack in the past year will be externally reviewed.

Product Monograph

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