“Are we there yet?”
Well, we have the roadmap and several key meetings under our belts, but unfortunately in most of Canada we still do not have the open and flexible choices for treatments that we are pushing towards.
Our goal is really quite simple. Imagine two baskets:
1. First-line treatment: a basket of funded choices that would include Sutent, Votrient, and Torisel.
2. Second-line treatment: a basket of funded choices that would include Afinitor and Inlyta (and more options if a cytokine was used in the first-line, though hardly used any more.)
How hard can that be? Two funded lines of therapy, no restrictions — and clinical trials beyond that.
Where’s the Evidence?
Well, in an “evidence-based” system, you need evidence to support each sequence. So, for example, where is the clinical trial data to support Inlyta after Votrient? You guessed it — that evidence doesn’t exist (because those trials have never been conducted).
What we need is some flexibility so that the VEGF-TKIs (Sutent or Votrient) are considered equivalents in terms of sequencing — and that either drug can lead to either second-line drug (either Afinitor or Inlyta). We’re not there yet, and we are lost in bureaucracy now with Inlyta (axititinib) thanks to Canada’s new “pan Canadian Purchasing Alliance (pCPA).
Lost in Government Bureaucracy: The Story of Inlyta in Canada
Here’s the quick run-down on what we THINK is happening with Inlyta across Canada:
1. If you’re in Quebec, you’re home free… approved. If you’re somewhere else, sadly you must read on:
2. Health Canada gave its approval (Notice of Compliance) meaning the drug is SAFE and EFFECTIVE on July 12, 2012 (over 2 years ago).
3. pCODR (pan-Canadian Oncology Drug Review) finished its work on Inlyta issuing a “Notice to Implement” to the provinces on March 22, 2013. (Kidney Cancer Canada was heavily involved in this work with pCODR, but then more delays…)
4. Nothing happened. We were informed that all drugs with a positive pCODR recommendation (as we had) would now need to go before the pCPA. We asked questions, but no one could clarify how this process was working or the expected timelines.
5. Over SIX additional months have gone by since the pCODR finalization, and we have no access whatsoever in any province except Quebec (and excepting those patients who have private insurance that will cover the drug). Worse, there is no transparency, and no way to find out how much longer.
What’s a Patient to Do?
In the meantime, we’ve been encouraging patients to look at some excellent clinical trials in the 2nd line, but these opportunities are always for a limited time only. The Nivolumab trial will close soon, and the cabozantinb trial hasn’t started yet.
Thankfully we have ONE drug in the 2nd line basket in every province except PEI — and that drug is Afinitor. However, in the fight for access and choice, a choice of one isn’t choice — and if a patient was not suitable for Afinitor, they would be in serious need of something else.
We’ll keep you posted, but please know that we are working behind the scenes to bring these issues to the attention of key decision makers. If you are in need of a therapy and you can’t access it, let us know and we’ll do what we can to help. Sometimes it takes the right patient story to make a difference for all other patients.
As always, if this work matters to you, please do what you can to support Kidney Cancer Canada. We run on a pretty lean budget — strangely enough governments don’t fund us to speak up for patients, so we count on you.
Comments/Questions appreciated as always. Onward!