Product Details

Opsumit

Macitentan
10 mg
Tablet


DIN/PIN/NPN

02415690

Manufacturer

Janssen Inc.

Formulary Listing Date

2021-04-20  

Unit Price

132.0550

Amount MOH Pays

132.0550

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

C02KX04

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Pulmonary Arterial Hypertension

Ambrisentan

  • Brand(s): Volibris
  • Dosage Form/Strength: 5 mg, 10 mg tablet

Bosentan

  • Brand(s): Tracleer, Generics (Co-, Mylan-. PMS-, Sandoz-)
  • Dosage Form/Strength: 62.5 mg, 125 mg tablet

Macitentan

  • Brand(s): Opsumit
  • Dosage Form/Strength: 10 mg tablet

Updated April 20, 2021

Drugs for Pulmonary Arterial Hypertension (PAH) under EAP

  1. Phosphodiesterase (PDE)-5 inhibitor: sildenafil (Revatio), tadalafil (Adcirca) 

  1. Endothelin receptor antagonists (ERAs): ambrisentan (Volibris), bosentan (Tracleer), macitentan (Opsumit) 

  1. Prostanoids: epoprostenol (Flolan, Caripul), treprostinil (Remodulin), selexipag (Uptravi) 

All requests (initial, renewal, monotherapy, combination therapy) for a PAH drug must come from one of the following recognized PAH referral centres:

  • Pulmonary Hypertension Centre
    Hamilton Health Sciences – General Hospital 

  • The Firestone Institute Pulmonary Hypertension Program
    St. Joseph's Healthcare Hamilton and McMaster University 

  • Pulmonary Hypertension Clinic
    Hotel Dieu Hospital/Kingston General Hospital 

  • Pulmonary Hypertension Program
    London Health Science Centre – Victoria Hospital 

  • Ottawa Pulmonary Hypertension Clinic
    University of Ottawa Heart Institute and the Ottawa Hospital 

  • University Health Network Pulmonary Hypertension Program
    Toronto General Hospital

Requests from other physicians/centres must include a recent (less than or equal to 3 months old) consult note/recommendation from a recognized PAH referral centre that supports the request; 

Out-of-province referral centre consults (e.g., from Winnipeg for patients in Northern Ontario) will also be considered on a case-by-case basis

Initial Criteria:

For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1 Pulmonary hypertension] who meet all the following criteria:

  1. PAH defined as a resting mean pulmonary artery pressure (mPAP) of ≥ 25 mmHg at rest AND normal pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg on right heart catheterization1; AND 

  2. The drug request meets one of the following circumstances of use:
    a) Drug is being used as monotherapy in a patient with WHO-functional class III or IV;
    OR
    b)     Drug is being used as monotherapy in a patient with WHO-functional class II who has contraindication or has intolerance to a PDE-5 inhibitor;
    OR
    c)     Drug is being used as sequential dual therapy in combination with a funded PDE-5 (i.e., sildenafil, tadalafil) or a funded prostanoid (i.e., epoprostenol, treprostinil) in a patient who has had an inadequate response with monotherapy (i.e., failure to achieve WHO-FC I or II; or 6MWD >440 metres; or no/mild RV failure);
    OR
    d)     Drug is being used as up-front dual therapy in combination with a funded PDE-5 (i.e. sildenafil, tadalafil) or a funded prostanoid (i.e., epoprostenol, Treprostinil) in a patient with advanced disease (i.e., WHO-functional class III or IV; OR 6MWD less than 380 metres; OR evidence of RV failure.) 

1Note: Left ventricular end-diastolic pressure ≤15 mmHg is also acceptable.

For all funded PAH Drugs, case-by-case consideration may be provided for the following:

  • Requests for triple therapy (Including patients awaiting lung transplant.) 

  • Patients who may have mixed co-morbidities that include ILD, COPD or LV failure (i.e., patients with mixed WHO Group 1 and Group 3 pulmonary hypertension OR mixed WHO Group 1 and Group 2 pulmonary hypertension) 

Exclusion Criteria: 

Combinations of drugs targeting similar pathways will not be funded (i.e., combination regimen may only include one agent from each drug class -- phosphodiesterase type 5 [PDE-5] inhibitors, endothelin receptor antagonists (ERA), and/or prostanoids) 

Renewal criteria for funded PAH Drugs:

Renewals will be provided for patients who remain under the care of a physician from a recognized PAH Centre (see list above) and who continue to benefit from therapy. 

Approval Durations:
- Duration of Approval for Initial Requests: 1 year
- Duration on triple therapy regimens awaiting lung transplantation: 1 year
- Duration of first renewal: 1 Year
- Duration of subsequent renewals: 5 Years

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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