Product Details

Sandoz Riociguat

Riociguat
1.5 mg
Tablet


DIN/PIN/NPN

02533588

Manufacturer

Sandoz Canada Inc.

Formulary Listing Date

2024-06-28  

Unit Price

24.0460

Amount MOH Pays

24.0460

Coverage Status

Off-Formulary Interchangeable Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

C02KX05

Interchangeable Products

DIN/ PIN/ NPN Brand name Unit Price Amount MOH pays
02412799 Adempas 43.7200 24.0460
02533588 Sandoz Riociguat 24.0460 24.0460
 

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Pulmonary Arterial Hypertension

Riociguat

  • Brand(s): Adempas
  • Dosage Form/Strength: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet

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

For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria:

  1. the physician making the request is a clinician with experience in the diagnosis and treatment of CTEPH1; AND 

  2. the patient is diagnosed with inoperable CTEPH (World Health Organization [WHO] Group 4); OR persistent or recurrent CTEPH after surgical treatment in adult patients (18 years of age or older) with WHO Functional Class (FC) II or III pulmonary hypertension. 

1Request should come from a clinician from a Pulmonary Hypertension referral centre (See Pulmonary Arterial Hypertension referral clinics above). 

Duration of Approval: 1 Year 

Renewal of funding will be considered for patients who continue to respond to therapy with riociguat. When submitting a request for renewal of funding, the physician should submit clinical information to support that the patient is deriving benefit from the treatment compared to before they started the treatment. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat. 

Duration of Approval: 1 Year 

Requests for subsequent funding renewals (i.e., beyond the first two years of treatment) will be considered when a physician provides written confirmation that the patient continues to respond to therapy with riociguat. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat compared to baseline or that supports that the patient’s condition is stable while on riociguat.

Duration of Approval:
- Subsequent Renewals: 5 Years

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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