Background

Since June 2015, our organizations have been working with the pulmonary arterial hypertension (PAH) and scleroderma communities to advocate for publicly funded access to all Health Canada-approved treatments for PAH, including Opsumit, Adempas, and Uptravi. We continue to be concerned about disparities that exist in the quality of care PAH patients, including those with systemic scleroderma-associated PAH (SSc-PAH), may receive depending on what province they live in or whether they have private insurance.

Here is an overview of what has happened for each treatment so far:

Opsumit (macitentan)

Approval:

In November 2013, Health Canada approved Opsumit for sale in Canada for the treatment of PAH. Opsumit, an endothelin receptor antagonist (ERA), is approved for the treatment of patients with idiopathic PAH (PAH with no known cause), heritable PAH, PAH associated with connective tissue disorders, and PAH associated with congenital heart disease. Opsumit is currently the only oral treatment proven in a randomized controlled trial to reduce long-term morbidity in patients, including reductions in PAH worsening and hospitalizations.

Public Reimbursement:

In October 2014, Quebec began providing public reimbursement for Opsumit. In January 2015, the national Common Drug Review (CDR) recommended that Opsumit be publicly funded (with criteria and a condition) for the long-term treatment of PAH to reduce morbidity in patients with Functional Class II or III. However, at the end of 2015, pricing negotiations for Opsumit through the pan-Canadian Pharmaceutical Alliance (pCPA) were closed. As a result, PAH patients outside of Quebec who could benefit from Opsumit, including those affected by SSc-PAH, continue to be unable to access it through public funding.

Advocacy Status:

The PAH and scleroderma communities continue to urge governments to provide public reimbursement for Opsumit and hope that pricing negotiations with pCPA will resume in the near future.

Adempas (riociguat)

Approval:

In March 2014, Health Canada approved Adempas for sale in Canada for the treatment of PAH. Adempas, a soluble guanylate cyclase stimulator, is also the only drug therapy approved for chronic thromboembolic pulmonary hypertension (CTEPH).

Public Reimbursement:

In December 2015, the Common Drug Review (CDR) recommended that Adempas be publicly funded (with criteria and a condition) for the treatment of PAH, as monotherapy or in combination with endothelin receptor antagonists (ERAs), in adult patients with Functional Class II or III. Quebec declined to list Adempas for PAH for public funding in February 2015, while Saskatchewan denied public funding in September 2016. In January 2017, it was announced that pricing negotiations for Adempas for PAH through the pan-Canadian Pharmaceutical Alliance (pCPA) had been closed because an agreement could not be reached, leaving patients throughout the country unable to access it through public funding.

Advocacy Status:

The PAH and scleroderma communities continue to urge governments to provide public reimbursement for Adempas for PAH.

Uptravi (selexipag)

Approval:

In January 2016, Health Canada approved Uptravi for sale in Canada for the treatment of PAH. Uptravi, the first oral selective IP prostacyclin receptor agonist, is approved for the long-term treatment of idiopathic PAH (PAH with no known cause), heritable PAH, PAH associated with connective tissue disorders, and PAH associated with congenital heart disease, to delay disease progression in adult patients with Functional Class II or III.

Public Reimbursement:

In October 2016 the Common Drug Review (CDR) recommended that Uptravi be publicly funded in the rest of Canada for the long-term treatment of PAH, in patients whose disease is not being adequately controlled with a first- and second-line therapy, but with a significant price reduction. In December 2017, the pan-Canadian Pharmaceutical Alliance (pCPA) successfully completed pricing negotiations for Uptravi.

To date, Uptravi is accessible through public funding in the following provinces: QuebecNewfoundland and LabradorSaskatchewanManitoba, Alberta Ontario, and New Brunswick.

Advocacy Status:

The PAH and scleroderma communities are urging all remaining provinces to immediately fund Uptravi through their public drug programs and ensure all PAH patients (including those with SSc-PAH) have timely and equitable access to optimal treatment options to improve and extend their lives.

PAH Advocacy and Reimbursement Timeline

Please click here for a detailed advocacy and reimbursement timeline.

Canada’s Drug Approval and Funding Process

Please click here for more information on Canada’s drug approval and funding process.