Wednesday, 3 February 2016

Accessibility of PAH Therapies in Canada: Part II

Part II: Treatments for PAH That Are Not Available In Canada

As someone with Pulmonary Hypertension, I was very disappointed to learn that a couple of potentially life altering medications that have been available for many years in the United States of America are not available here in Canada. I had assumed that because Canada offers free “universal” health care, that it also had the best interest of its patients in mind. Needless to say, I was completely shocked to learn that some prostanoid-family medications like Tyvaso (inhaled treprostinil) and Ventavis (inhaled iloprost) and Orenitram (oral tablet form of treprostinil) are not available here in Canada. These medications are a less invasive form of intravenous prostanoids such as epoprostenol (Flolan, Caripul) and subcutaneous treprostinil (Remodulin). I asked PH specialist Dr. Sanjay Mehta to answer some questions I have regarding the accessibility of of PH therapies in Canada.

Serena: Could you explain the benefits of inhaled and oral versions of treprostinil over the intravenous and subcutaneous prostanoid treatments? Do you believe that medications like Tyvaso and Orenitram should be available to Canadians with PH? Could you briefly explain why these medications are not currently available here in Canada?  Is there anything that we can do as a community to have these medications available here?

Dr. Mehta:  Treprostinil is a very effective treatment for PH. It is currently approved and available in Canada both for intravenous and subcutaneous administration as Remodulin.  Both of these approaches require an external pump and a cassette or syringe to be filled regularly, usually every 1 or 2 days. 

Treprostinil has been modified for patients to be able to take it by either breathing it in (inhaled Tyvaso in the US) or by taking a pill (oral Orenitram in the US). Both of these approaches have been shown to be effective in treating PH. Moreover, the inhaled and oral routes of drug administration clearly simplify the treatment compared with much more complex intravenous/subcutaneous treprostinil administration.  However, inhaled and/or oral treprostinil are not the best treatments for all PH patients. Inhaled treprostinil may not be as effective as intravenous/subcutaneous treprostinil, and is typically only used as an addition to other oral PH therapies in the US. Oral treprostinil is effective, but side-effects of nausea, abdominal pain, and diarrhea can be difficult for some patients. 

Ultimately, both inhaled and oral treprostinil are not available to Canadian PH patients because the pharmaceutical manufacturer never submitted an application for Health Canada approval. This is largely because of business reasons, as the PH market in Canada is much smaller than in the US, and it is expensive to launch a new medication in Canada.  Moreover, many PH medications cost less in Canada than in the US, because of government regulations. As such, the cheaper price for a new PH medication in Canada can lead to pressure on a company to reduce the price in the US, which would mean they make less money in the much bigger American market. 

Serena:  Are you able to speak to a trial for and the benefits of having Remodulin administered through an implantable pump as opposed to subcutaneous or intravenous methods? Do you foresee this implatable pump being available in Canada?

Dr. Mehta:  There was an exciting trial in the US that studied whether Remodulin could be administrated via an implantable pump, rather than an external pump.  Such an implanted pump has a reservoir of medication that could last for a prolonged period, such as a month. This reservoir could be refilled regularly, such as every month, in the PH clinic.  As a result, patients would not have to look after preparing medication every day or every second day at home, or changing tubing / cassettes / needles, which would clearly improve their quality of life.  This implantable pump for Remodulin may become available in the US in 2016, and then hopefully one day in Canada.

Serena: This concludes our two-part interview. Are you able to share any insight on any exciting and promising treatments on the horizon in Canada?

Dr. Mehta: Despite all the advances we have seen in the last years in regard to PH therapies, PAH is still a progressive, often fatal illness for which we have no cure.  Tremendous research both in Canada and around the world continues to better understand the disease and what exactly is happening to the blood vessels of the lungs to cause PAH.  There are many ideas for new treatment approaches, including both pharmaceuticals and potentially gene-therapies.  This is a very hopeful time that PAH patients will continue to benefit from this research and new therapies, until such a time when we can say to a patient, “You have PAH, but we can treat you so that it will not affect you in everyday life and will not shorten your life.”

The PHight or Flight Project would like to thank Dr. Sanjay Mehta and The Pulmonary Hypertension Association of Canada for their assistance on the Accessibility of PAH Therapies in Canada Series.

*This is the second part of a three part series. The first part of the series, Access to Opsumit in Canada can be found here. The third and final part of the series will share testimonials from PH patients in the US who are on the various medications for PH that are not available in Canada. 

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