Monday, June 02, 2014

not as simple as it would seem

As someone living with metastatic breast cancer, I pay keen attention to the development of new cancer drugs. And of course I pay particular attention to the drugs that are likely to one day benefit me.

I have been on Herceptin for 7.5 years. My response was rapid and complete and there is no sign that the drug has stopped working. That doesn't mean, however, that I don't worry about the future and how I will proceed once I come to the end of the line with this miracle drug.

Enter trastuzumab emtansine, or TDM-1, as it was more commonly known. Over the last couple of years, I watched with great interest as clinical trials occurred all over North America. I have been personally in touch with several women who had as thorough a response to TDM-1 as I did to Herceptin. It was very exciting.

Then the trials ended and we had to wait for Health Canada to grant their approval. When that hurdle was cleared, I breathed a sigh of relief. Unfortunately, the sigh was a little premature.

The time between Health Canada approval and provincial funding can be long and complicated. Once Health Canada grants its approval, a body called the Pan Oncology Drug Review (pCODR) assesses the drug, a process that can take up to 149 days. After pCODR makes a recommendation, each province decides if it will fund it. And while this is happening, Ontario, unlike some other provinces "...does not have a mechanism in place that would grant cancer patients access on compassionate grounds to a drug that has been approved by Health Canada."

I heard last week from the Canadian Breast Cancer Network that TDM-1, now known as Kadycla, has been approved for funding "for the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with trastuzumab (Herceptin)and taxane". Phew.

[Update: I learned from Delaney (see the comments and the Toronto Star interview) that OHIP funding will only be granted for "second line treatment." Should I need Kadycla, it will be for third line treatment, as I will already have done my first 6 rounds of TAC (first line) and then the vinorelbine and Herceptin combo (second line). I'm only on Herceptin now but the treatment that follows will be third line. That means I'll only get Kadycla if my private insurance will cover it. This despite the fact that I have known women who've had Kadycla as a third line treatment, with great success.]


CBCN is urging voters to contact "local candidates and ask them their stance on improving access to breast cancer treatments." Improving access to cancer drugs is also a goal of FairCancerCare.ca. If you haven't already signed our petition, please do so today. You can also ask your local candidates to sign our pledge to advocate for fair cancer care in Ontario. This is super easy to do and takes almost no time at all via the website.

Meanwhile, I've also heard from CBCN that a drug that crosses the brain-blood barrier is in a phase 2 clinical trial. Will this drug be as effective as it promises to be? Will it be available by the time I need it? 

I'm holding my breath a little.


snarky brilliance credit: Andrea Ross

3 comments:

Delaney said...

Laurie,
I too am frustrated by how long it takes for a new drug to become available here in Ontario!! And TDM1 was only funded for 2nd line treatment. That is not acceptable! So anyone who is HER2+ and has already received 2 or more forms of chemo, and would now like to try TDM1, has to do so out of their own pocket...Grrrr...My oncologist at Sunnybrook is also very upset about this and is pushing for better funding. I'll keep in touch with him to see if there is anything else I can do. Meanwhile I signed your petition.

laurie said...

Delaney! I meant to @ you in my FB post, since I linked to the Star article that featured you. You were the first person to tell me about TDM-1. Your response to it was the same as mine to Herceptin. This is a valuable drug.

laurie said...

And I've just realized (two days later) that second line funding would not include me. I had my initial treamtment, then vino + herceptin, so whatever happens next will be third line. And there's no evidence it wouldn't work in my case - after all, Delaney, wasn't your treatment on the trial third line?