Product Details

Trikafta

Elexacaftor/Tezacaftor/Ivacaftor + Ivacaftor
100 mg/50 mg/75 mg + 150 mg
Tablet


DIN/PIN/NPN

02517140

Manufacturer

Vertex Pharmaceuticals (Canada) Incorporated

Formulary Listing Date

2021-09-22  

Unit Price

280.0000

Amount MOH Pays

280.0000

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

R07AX32

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Respirology Therapies

Elexacaftor/Tezacaftor/Ivacaftor and Ivacaftor

  • Brand(s): Trikafta
  • Dosage Form/Strength: 100 mg / 50 mg/ 75 mg and 150mg
  • Original Effective date: September 22, 2021; Updated: July 8, 2022

For the treatment of cystic fibrosis (CF) in patients who meet all of the following criteria: 

  1. 6 years of age and older; AND 

  1. Confirmed diagnoses of CF with documentation of at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR gene) through a validated test. (Note: please submit report); AND 

  1. Patient has been optimized on best supportive care for their CF prior to starting Trikafta; AND 

  1. Prescribed by a clinical specialist affiliated with a Canadian cystic fibrosis centre.

The following measurements must be completed prior to initiating treatment with Trikafta: 

  1. Baseline spirometry measurements of forced expiratory volume in 1 second (FEV1) in litres and percent predicted (ppFEV1) (within the last 3 months); AND 

  1. Number of days treated with oral and/or intravenous (IV) antibiotics for pulmonary exacerbations in the previous 6 months OR number of pulmonary exacerbations requiring oral and/or IV antibiotics in the previous 6 months; AND 

  1. Number of CF-related hospitalizations in the previous 6 months; AND 

  1. Weight, height, and body mass index (BMI); AND 

  1. An age-appropriate Cystic Fibrosis Questionnaire (i.e., Cystic Fibrosis Questionnaire Child (CFQ-C) and Cystic Fibrosis Questionnaire-Parent (CFQ-P) for those 6 to 13 years old OR Cystic Fibrosis Questionnaire Revised (CFQ-R teen/adult) Respiratory Domain score for those 14 years and older)

Exclusion criteria for Initial and Renewal criteria:
(Patients meeting any of the following will not be funded)

  • Patient has undergone lung transplantation; 

  • Patient is using Trikafta as combination therapy with another cystic fibrosis transmembrane conductance regulator (CFTR) modulator.

Initial approval duration: 7 months

Initial Renewal Criteria:

Renewal of funding will be considered in patients demonstrating at least ONE of the following improvements after 6 months of treatment with Trikafta:

  1. Improvement of percent predicted FEV1 by 5% or more above the baseline measurement; OR 

  1. A decrease in the total number of days for which the patient received treatment with oral and/or IV antibiotics for pulmonary exacerbations compared with the 6-month period prior to initiating treatment OR a decrease in the total number of pulmonary exacerbations requiring oral and/or IV antibiotics compared with the 6-month period prior to initiating treatment; OR 

  1. Decreased number of CF-related hospitalizations in the 6 months after initiation of Trikafta treatment compared with the 6-month period prior to initiating Trikafta; OR 

  1. No decline in BMI at 6 months compared with the baseline BMI assessment; OR 

  1. If the patient is 6 to 13 years of age evaluated using the CFQ-C and CFQ-P at baseline, scores following use of Trikafta demonstrating improved or sustained quality of life; OR 

  1. If the patient is 14 years of age or older, improvement by 4 points or more in the CFQ-R Respiratory Domain scale compared to baseline scores.

Subsequent renewal criteria: 

For patients who have met the initiation criteria and initial renewal criteria.

Ongoing renewal of funding will be provided for those who are continuing to benefit from therapy with Trikafta and who do not meet any of the exclusion criteria. 

At the time of renewal application, include the patient’s most recent ppFEV1 and a clinical update to confirm the treatment benefits or response experienced by the patient.

Approval Duration of renewals: 1 year

Approved doses: 

  • 6 to 11 years of age (weighing ≥ 30 kg) OR 12 years of age and older: 2 tablets (each containing elexacaftor 100mg/ tezacaftor 50mg/ ivacaftor 75mg) taken in the morning & one tablet (ivacaftor 150mg) taken in the evening approximately 12 hours apart.

  • 6 to 11 years of age (weighing less than 30 kg): 2 tablets (each containing elexacaftor 50mg/tezacaftor 25mg/ivacaftor 37.5mg) taken in the morning & one tablet (ivacaftor 75mg) taken in the evening approximately 12 hours apart.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph