Front Line Treatment in Canada?

[alpek]

My father was just at his CLL appointment with a specialist here in Vancouver, BC and we were advised that targeted therapies like Ibrutnib are not approved in Canada unless you are 17p deleted. What are members in Canada using a front line treatment? Is it all just FCR even if you unmutated? Is Ibrutnib approved for all cases as front-line treatment in the USA? Trying to understand options, as he will be needing treatment based on current progression soon.

thank you

[Cllcanada Top Poster CURE Hero]

Every province is different. Yes Imbruvica (ibrutinib) is approved front line, it is in Canada under Health Canada, but each province has different funding criteria. It is approved in all provinces Yukon and the territories for secondline.

You are correct for BC... Imbruvica (ibrutinib) is only funded in special cases for firstline in BC... other options might be Gazyva Chlorambucil GC, FR fludara and rituxan, FCR, and bendamustine/rituxan [BR] perhaps. There are compassionate access to drugs on occasion through the federal Special Access Program, SAP, as well.. but the drugs and use is limited, and soley at the descretion of the drug company... sometimes its fully, sometimes its partially funded etc.

Private health insurance often adds option, but not always.

Here is a list of BCCA protocols for lymphomas.. stick to CLL.

bccancer.bc.ca/health-profe...

Ibrutinib Protocol Firstline

bccancer.bc.ca/chemotherapy...

SAP

canada.ca/en/health-canada/...

~chris

[alpek in reply to Cllcanada]

thanks Chris, do you know of cases for being able to qualify for the federal access program or through private insurance (he has standard benefits package from work)? He is not 17p deleted, we are waiting to hear back if he's mutated or unmutated. Options seem very limited in Canada compared to what we were expecting, isn't Ibrutnib covered for all cases in the USA for front line?

[Cllcanada Top Poster CURE Hero in reply to alpek]

Yes Imbruvica (ibrutinib) is approved firstline 8n the U.S. and in Europe, but that doesn't mean its funded.

We lag the U.S. by 18 months to 2 years are so... sometimes the markets in Cadavare just too small. its economics, which nobody want to hear.

SAP most frequently is for drugs going through funding recommendation process, called pCODR. Venetoclax, Rituxan was the last one to be recommended , but second line...

Here are the funding conditions, BC is quite narrow

cadth.ca/sites/default/file...

You should inquire aboutba clinical trial , my CLL specialist just opened one in Ottawa for Calquence (acalabrutinib)... there might be similar at BCCA.

~chris

[alpek in reply to Cllcanada]

thanks again Chris, just frustrating to hear of all the new treatments/progress but not actually have them funded here. Do you know of any trials coming up in Canada or of members that have been able to get on trials that are funded? May be going to the US is an option, shame that Canada is so limited.

[Cllcanada Top Poster CURE Hero in reply to alpek]

We are limited in clinical trials, its a question of numbers... CLL is very very rare in Canada and last time I flew from YOW to YVR its a rather large... 🙂...country.

Patients blame managed healthcare.. but it's actually more to do with drug companies assessing if its worth it... the approval process is fairly easy, but the cost negotiations delay drugs by about a year to 18 months

Example Abbvie started venetoclax approval process too early, and after a year were declined due to incomplete data... they did a resubmit, but now costs must be reduced, so they delayed things substantially. 😣

cadth.ca/sites/default/file...

~chris

[janerawluk in reply to Cllcanada]

Chris, does Manitoba offer Ibrutinib or Venetoclax in summer of 2019 as a frontline option.

[alpek in reply to janerawluk]

Would recommend watching the below linked webinar, the presenter is a CLL specialist from Manitoba, I believe she did mention that Ibrutinib is available in the front line setting in Ontario/Manitoba already, changes are being made to available funding in other provinces as well. I don't believe that Venetoclax is available any where in Canada yet in the front line setting although it may soon become available as a 2nd line treatment option soon.

lymphoma.ca/post/webinar-ad...

[Cllcanada Top Poster CURE Hero in reply to janerawluk]

ManitobaCC does fund Imbruvica (ibrutinib) first line for patients unsuitable for fludarabine based treatments. These would be high risk, patients and is open to some interpretation obviously.

Venetoclax is not currently funded in Canada, second line, (but some patients who have failed Imbruvica (ibrutinib) have received it, third line). We should hear second line if Venetoclax and Rituxan will be recommended for funding early April, but it usually takes a year or more before price negotiations with the drug company are completed.

cadth.ca/venclexta-combo-ri...

Private health insurance may have broader access to these newer treatments, so it would be the first avenue to investigate.

Patients often blame our healthcare systems, and in general there is a two year lag from Health Canada approval, but it is far more about market size and the process is totally initiated by the drug companies. Some drugs with small use simply don't come to small markets, and even bendamustine was delayed a few years, since the licence company felt Canada was not a viable market. Lundbeck secured the rights to Canada and moved it forward.

Recently, AbbVie, went for funding approval of venetoclax and pCDOR rejected it for funding, based on slim data... this was a year delay...and the drug was resubmitted and funding is still in negotiation in all provinces.

So, nothing is a 'slam dunk' in this system.., don't assume, verify everything with your doctor, and understand drugs are a provincial matter and funding varies widely.

Quebec is a whole other story...

~chris 🇨🇦