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Tedstehr

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PALS
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I am creating this thread as a discussion on how to get Edavrone in Canada, and what I have discovered.

Here is what I have learned so far.

Mistubushi Tanabe Pharma is the creator of the drug. It is ultimately up to them if they want to sell the drug in Canada. If they do, it sounds like Health Canada would not put up any roadblocks. Unfortunately, we are simply not a big market, so it may not make sense for them to rush it. I have a message in to their US office to ask if Canada is in the works.

So if we cannot get it through the regular channels, we could get it through sites like socialmednetwork.com. But in order to get that way, we need it to be on the approved import list or have a Special Access Permit from Health Canada.

The branch that oversees importation is called the Border Importation Unit (BIU.) I phoned them at 1-800-267-9675. They could not find Edavarone on their list (they do not use brand names like Radicut, only Edavarone.) The agent was very helpful and is going to contact Ottawa to see if this could be added. He will email me. But for now, ordering online is not an option through that method because it would be stopped at the border.

The Special Access Program (SAP) is the next method. The form would be filled out by your doctor/neurologist and Health Canada would review and provide a letter/permit for importation. It sounds like this would not be a problem or take long because of the drug's prior approval in other countries. Once you have this letter, you can import the drug.

I will be making that request to my neurologist later today.

So to review, as of today, an ALS patient needs:
Health Canada Special Access Program authourization
A prescription for the drug from a physician
A big stack of money

The next hurdle is purchasing Radicut or Radicava or Aravon etc. It seems like it would be easy to use a website. My messaging with SocialMedNetwork uncovered that they have to contact Health Canada to see if they can ship the drug here. I know the answer is no based on the BIU information.
If one can get the SAP, one can get their drugs through customs. Cursory research shows a few sources. I did not look at the US because the cost is about $145K USD per year.
The SocialMedNetwork is about $4000 CAD a month, and a Japanese source is about the same. India has a few generics including one called Aravon. Those ones are a fraction of the price. I am waiting for a quote from a reseller there.

I will keep the Canadian members informed on:

News from BIU on Edavarone clearance
Mitsubishi Tanabe Pharma feedback on their interest in Canada
My luck in receiving a Special Access Permit
The price and availabilty of Aravon

May your progression be slow!
 

lgelb

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This article seems to imply some kind of country-wide policy on in-hospital administration, though obviously you still have to obtain/import it.
 

ShiftKicker

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Posted elsewhere- als canuck dot org is an excellent resource. They are currently quite active on FB to help educate people on procedures for Canadians who need to navigate this situation. You may want to check in with them, as they seem to have done a lot of the legwork tracking down info already.
 

Vincent

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There are people in Canada getting radacava directly from Japan. But even having the drug is just the first step, now you have to find a hospital willing to infuse you with a drug not authorized for use in Canada. Using the backdoor to get these drugs just slows the approval process down. If PALS are getting the drug through other channels there is less pressure on Health Canada to approve radacava. This drug is not the cure, just a better riluzole.
Vincent
 

Tedstehr

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PALS
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08/2017
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New Westminster
This article seems to imply some kind of country-wide policy on in-hospital administration, though obviously you still have to obtain/import it.

Thanks for that link. It was a news article about this woman that brought Edavarone to my attention in the first place. It sounds like physically importing the drug yourself may have different rules than shipping.
 

Tedstehr

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Messages
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PALS
Diagnosis
08/2017
Country
CA
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BC
City
New Westminster
Posted elsewhere- als canuck dot org is an excellent resource. They are currently quite active on FB to help educate people on procedures for Canadians who need to navigate this situation. You may want to check in with them, as they seem to have done a lot of the legwork tracking down info already.

Wow Fiona, this is a completely different story than the story I got! This looks very promising. I followed the link to "righttotrycanada.com/edavarone" and they describe how to get the drug from Japan and how to import it. They also had Terri and Bruce Bishop's email, the people who travelled to Japan for the treatment and now import. I contacted Bruce and he sent me the most up to date steps.

Thanks again for that link.
 

Tedstehr

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Messages
199
Reason
PALS
Diagnosis
08/2017
Country
CA
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BC
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New Westminster
Using the backdoor to get these drugs just slows the approval process down. If PALS are getting the drug through other channels there is less pressure on Health Canada to approve radacava. This drug is not the cure, just a better riluzole.
Vincent

Vincent, this was not what the Border Importation Agent and my neighbour who is a drug research nurse told me. They told me the drug company takes the first step by deciding to market their drug in a specific country. Health Canada only evaluates drugs that companies have decided to sell. Because there are only about 4,000 people in Canada with ALS, companies like Mitsubishi Tanabe Pharma probably don't see much profit potential in Canada. However, the positive side is that if they decided to market in Canada, there would be pressure on Health Canada to authorize the drug quickly. Mainly because ALS is high profile and life threatening. The other positive is that because of the low numbers of PALS the insurance companies and provincial health authorities would not try to delay approving or claim "experimental" exemption because they wouldn't end up having to pay huge amounts.

So if there is some way the drug companies track sales in countries they don't sell to, the more demand the better!
 

Tedstehr

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PALS
Diagnosis
08/2017
Country
CA
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BC
City
New Westminster
ALSCanuck had a link to that Greg. From there I got Terri and Bruce Bishop's email. Bruce sent me the most up to date and accurate steps for importing.

Thanks so much for pointing it out. It is important that anyone else thinking of importing Edavarone or generic version in Canada needs this reference.
 

Tedstehr

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Joined
Aug 25, 2017
Messages
199
Reason
PALS
Diagnosis
08/2017
Country
CA
State
BC
City
New Westminster
Sorry everyone, my steps are completely wrong. Best to go to righttotrycanada.com and click the link for Edavarone. There are steps there, but it is best to click on Terri And Bruce Bishop's email and request the latest steps.
 
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