Product Details

Uptravi

Selexipag
400 mcg
Tablet


DIN/PIN/NPN

02451166

Manufacturer

Janssen Inc.

Formulary Listing Date

2023-04-28  

Unit Price

70.5245

Amount MOH Pays

70.5245

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

B01AC27

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Pulmonary Arterial Hypertension

Selexipag

  • Brand(s): Uptravi
  • Dosage Form/Strength: 200mcg, 400mcg, 600mcg, 800mcg, 1000mcg, 1200mcg, 1400mcg, 1600mcg Tablets

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. Patient with World Health Organization (WHO) functional class II to IV; AND 

  3. Selexipag is being used in a patient experiencing inadequate control2 with a Phosphodiesterase (PDE)-5 inhibitor (i.e., tadalafil or sildenafil) AND an endothelin receptor antagonist (ERA) (i.e., bosentan, ambrisentan, or macitentan) 

Notes: 

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

  1. Unable to meet treatment targets (i.e., failure to achieve WHO-FC I or II; or 6MWD >440 metres; or no/mild RV failure) 

Case-by-case consideration may be provided for the following:

  • Requests for Selexipag in patients who demonstrate intolerance or have a contraindication to either PDE-5 inhibitors (i.e., both sildenafil and tadalafil) or ERAs (i.e., each of bosentan, ambrisentan, macitentan)

  • 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: 

Combination therapy with prostacyclin or prostacyclin analog therapies and Selexipag will not be covered. 

Renewal criteria: 

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

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