Product Details

Kalydeco

Ivacaftor
150 mg
Tablet


DIN/PIN/NPN

02397412

Manufacturer

Vertex Pharmaceuticals (Canada) Incorporated

Formulary Listing Date

2014-06-20  

Unit Price

420.0000

Amount MOH Pays

420.0000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

R07AX02

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Respirology Therapies

Ivacaftor

  • Brand(s): Kalydeco
  • Dosage Form/Strength: 150 mg tablets
  • Effective date: June 20, 2014; Updated December 20, 2019

For the treatment of cystic fibrosis in patients meeting the following criteria:

  1. the Patient is at least 6 years old and has one of the following mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R;

    OR

  2. the Patient is at least 18 years old with an R117H mutation in the CFTR gene. 

Initial approval period: 1 year

Initial renewal criteria: 

Documented response to treatment (after at least 6 months of therapy), as evidenced by the following: 

  1. In cases where the patient’s sweat chloride levels prior to commencing therapy were above 60mmol/litre:
    •     the Patient’s sweat chloride level fell below 60mmol/litre;
    OR
    •     the Patient’s sweat chloride level is 30% lower than the level reported in a previous test; 

  1. In cases where the patient’s sweat chloride levels prior to commencing therapy were below 60mmol/litre:
    •     the Patient’s sweat chloride level is 30% lower than the level reported in a previous test;
    OR
    •     the patient demonstrates a sustained absolute improvement in FEV1 of at least 5% when compared to the FEV1 test conducted prior to the commencement of therapy. 

Duration of approval: 1 year 

Subsequent renewal criteria: The patient is continuing to benefit from therapy with Kalydeco. 

1It should be noted that, while baseline sweat chloride levels and FEV1 are not required to meet initial approval criteria for Kalydeco, these parameters are used to evaluate the effect of Kalydeco at the time of renewal. To avoid delays, the prescriber should submit a copy of the mutation report, recent baseline sweat chloride levels before starting Kalydeco, and recent baseline FEV1 with the initial request for funding of Kalydeco. 

These baseline values will be used to evaluate the patient’s response to therapy at the time of renewal and would be logistically difficult to obtain once treatment is initiated. 

Duration of Approval: 1 Year

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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