Product Details

Sandoz Bosentan

Bosentan Monohydrate
62.5 mg
Tablet


DIN/PIN/NPN

02386275

Manufacturer

Sandoz Canada Inc.

Formulary Listing Date

2012-07-27  

Unit Price

32.0893

Amount MOH Pays

32.0893

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

C02KX01

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02244981 Tracleer 85.5100 32.0893
02483130 Taro-Bosentan 32.0893 32.0893
02386275 Sandoz Bosentan 32.0893 32.0893
02383012 PMS-Bosentan 32.0893 32.0893
02467984 Nat-Bosentan 32.0893 32.0893
02386194 Co Bosentan 32.0893 32.0893
02399202 Apo-Bosentan 32.0893 32.0893
 

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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