Any Canadians on here?

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cfsucks

Guest
<div class="MessageText_Container">
Are there any Canadians on here?
Anyone read this on the Canadian CF site?
<a href="http://www.cysticfibrosis.ca/assets/files/pdf/VertexCommunique_1%20May2012_E.pdf">http://www.cysticfibrosis.ca/assets/files/pdf/VertexCommunique_1%20May2012_E.pdf</a>
Mentions up to a 2 year wait for Kalydeco to be approved in Canada- we have to petition this- this is ridiculous- by the time 809 is approved in the States we will just be getting Kalydeco!
We need to band together to get this drug here faster. Please post here or PM me if you are interested!
 
C

cfsucks

Guest
<div class="MessageText_Container">
Are there any Canadians on here?
Anyone read this on the Canadian CF site?
<a href="http://www.cysticfibrosis.ca/assets/files/pdf/VertexCommunique_1%20May2012_E.pdf">http://www.cysticfibrosis.ca/assets/files/pdf/VertexCommunique_1%20May2012_E.pdf</a>
Mentions up to a 2 year wait for Kalydeco to be approved in Canada- we have to petition this- this is ridiculous- by the time 809 is approved in the States we will just be getting Kalydeco!
We need to band together to get this drug here faster. Please post here or PM me if you are interested!
 
S

samb

New member
I am in Edmonton, Kalydeco doesnt help my daughter but I would be more than willing to sign a petition to get it here faster!
 
S

samb

New member
I am in Edmonton, Kalydeco doesnt help my daughter but I would be more than willing to sign a petition to get it here faster!
 
C

cfsucks

Guest
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>samb</b></i> I am in Edmonton, Kalydeco doesnt help my daughter but I would be more than willing to sign a petition to get it here faster!</end quote>
I've been reading about the positive effects Kalydeco has been having on other mutations- it's very possible that your daughter could benefit- I want any patient with CF in Canada to be able to try it to see if it has any effect! I will private message you my email address so we can discuss this further.
 
C

cfsucks

Guest
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>samb</b></i> I am in Edmonton, Kalydeco doesnt help my daughter but I would be more than willing to sign a petition to get it here faster!</end quote>
I've been reading about the positive effects Kalydeco has been having on other mutations- it's very possible that your daughter could benefit- I want any patient with CF in Canada to be able to try it to see if it has any effect! I will private message you my email address so we can discuss this further.
 
C

CyrilCrodius

New member
What the hell?!? There goes my hope to get it off-label! This is ridiculous! I'm going to write to my deputy about this. We need a bill like US's S.2236 Advancing Breakthrough Therapies for Patients Act of 2012I'm in Quebec. I will be watching this thread closely.
 
C

cfsucks

Guest
I spoke to vertex and there are programs in place to get vertex to patients in Canada if you can AFFORD it. Otherwise you're stuck waiting like the rest of us <img src="i/expressions/face-icon-small-sad.gif" border="0">
 
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CyrilCrodius

New member
That's great. I am not sure... but depending on the price, I think I could afford it with some help. I am brewing a petition text. It won't be only for Kalydeco, since a legislation like the two bills proposed in the United States to fast track the acceptation of breakthrough drugs would benefit more than just CFer if something similar was adopted here. So it is better if we make that petition about all life threatening diseases, we would get way more signatures this way.
It would be great if we could ask for collaboration from forums about other diseases.
 
C

cfsucks

Guest
I'm extremely interested in helping you with this. Send me your email/facebook so we can discuss this in more detail.

I'm guessing the price will be roughly 250k a year <img src="i/expressions/face-icon-small-sad.gif" border="0">
 
C

CyrilCrodius

New member
250k a year... ouch. That's 20k a month.I am going to call to Vertex in Laval today. Also, I did some more research on the approval process of new drugs in Canada and I found this : http://www.mswatch.ca/en/ms-today/your-guide-to-ms-treatment-approval.aspx
It turns out that "breakthrough" drugs already benefit a priority review status much like the new legislation in the US intends to do :
------------------
Why do some treatments get fast-tracked? Priority review status may be granted to New Drug Submissions and some medical device applications intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating illnesses or conditions where: - no product is currently marketed in Canada; or - the new product offers a significant increase in efficacy and/or significant decrease in risk, so that the overall risk-benefit profile is better than that of existing therapies.
------------------

However, it doesn't say anything about drugs being approved as soon as Phase II trials demonstrate their safety. So I think there could be something to do there. It would be great for getting VX-809 (or any other upcoming molecule) here faster. We could also pressure our provincial governments to fast track the inclusion of breakthrough drugs on the list of drugs eligible for reimbursement if there isn't already something to that effect. Looking at the TOBI Podhaler full approval process... (It wasn't approved in the US as of April 2nd! :( ) It has received its NOC on April 6 2011. It was added to the list in Quebec on October 2011 and in Alberta on Febuary 1st 2012. That's 6 and 10 months respectively. I could not find anything for Ontario. Is it even approved? Anyway... 6 months it's not *that* long, but it's long enough that many people could die in the mean time. 10 months is too long. I dare to hope that Vertex's drugs would get a faster approval. Given enough pressure, maybe provinces could make the process faster.

Edit :
I found that there is indeed a similar process in Quebec at least, to speed up the addition of new drugs to the list. However, the criterias *might* not apply to Vertex's drugs.
It states :
"The drug product's file can be evaluated and a notice can be sent to the Minister of Health and Social Services on a priority basis if INESSS deems that:
- Delaying the evaluation may lead to patients who need the drug product suffering from an irreversible and rapid progression of their illness, and lead to great harm
and
- No other therapeutic solution in the form of a drug is available on the List of Medications covered by the basic prescription drug insurance plan or on the List of Medications Institutions."
This could reduce the approval time on the provincial level in Quebec to 2 to 4 months instead of 6 months.

Edit 2 :
The approval process in Ontario is 6 to 8 months for non-cancer drugs. I did not find anything about a sped up process for breakthrough drugs. You might want to push this way to have something done about this.

Edit 3 :
Alberta seems to be 4 or 5 months. Nothing about a fast-track for breathrough drugs either.
 
C

CyrilCrodius

New member
I just called! And I think I come back with good news! So, the Vertex representative told me that we can have access to Kalydeco through our Named Patient Program, which here is called "Special Access Programme".

Quoting Health Canada :
"The Special Access Programme (SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada. Drugs considered for release by the SAP include pharmaceutical, biologic, and radio-pharmaceutical products not approved for sale in Canada."
Source : http://www.hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/index-eng.php

So your doctor has to initiate the process and you should be good to have it. Hopefully, they won't check for mutations...
Reading the fact sheet, they do say :
"Can SAP be considered a fast-track approval process for drugs?
No. SAP is not intended to be a mechanism to promote or encourage the early use of drugs or to circumvent the clinical trials review and approval process or the new drug approval process, but rather to provide compassionate access to drugs on a patient by patient basis.

What types of drugs and for what conditions could be authorized under the SAP?
These range from pharmaceutical, biologic, and radiopharmaceutical products that are not approved for sale in Canada. Most of these drugs treat patients with life threatening diseases or serious conditions such as intractable depression, epilepsy, transplant rejection, hemophilia and other blood disorders, terminal cancer, and AIDS. The SAP can also respond to specific health crises, such as an outbreak of a communicable disease, by providing access to nonmarketed drugs."

So maybe you would have to be very sick in order to have early access to it. I hope not... but it's a strong possibility.
Now as of the price, I don't know yet. The fact sheet says :
"Who pays for the drugs being released though SAP?
While there is no requirement for manufacturers to provide drugs released through the SAP free of charge, many do. When manufacturers do charge, the cost is covered by either the patient, the patient's family, the hospital, a public and/or private insurance plan."
I am personally not sure my pneumologist would agree to initiate a process for me considering that I don't have the right mutation. Someone with the right mutations should definitely try though and give us some news about it (and maybe ask their doctor to tell them whether they were asked about the mutations).

I made a new thread about it to attract more attention to the possibility of getting it in Canada : http://forums.cysticfibrosis.com/messageview.cfm?catid=4136&threadid=619431&enterthread=y
 
C

CyrilCrodius

New member
I sent an email to my representative to ask him whether he will agree to present a petition to create a new class of drugs for breakthrough drugs, speed up the approval process of drugs in that new class and facilitate the access to these drugs under the Special Access Programme.
Should he agree, I will send him the draft of the petition so he can make sure that it's keeping with the rules and practices of the House. I will then post the petition here for people to print and sign and I will include my home address so people can post the petition pages back to me. Once I have gathered enough signatures, I will bring it to my representative for him to present it to the House.
Thankfully, my representative is a conservative, so it increases the chances that the government will actually do something about it.
 
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