Survey to help Canadian CLL (chronic lymphocytic leukemia) Patients

If you have CLL could you please read the below and consider taking a 10 minute survey to help patients in Canada.
The Canadian regulatory system for the approval of new medicines is very similar to Australia, but different than in the USA. Lymphoma Canada It is currently preparing submissions to their decision makers for the following treatments:
· Ibrutinib (Imbruvica) for patients with previously untreated CLL for whom fludarabine based treatment is considered inappropriate
· Ventetoclax (ABT – 199) for patients with relapsed/refractory CLL
Lymphoma Canada like Lymphoma Australia can survey patients and caregivers to provide data to regulators on the side effects and quality of life experienced by those on current therapies and how a new therapy may improve the quality of life for patients. This information can then help the regulators better understand the value of new therapies for patients and their families.
HOW CAN ANY CLL PATIENTS HELP?
Please complete the survey below for Lymphoma Canada. You do not need to live in Canada to complete this survey.
The survey will be open until midnight (Pacific Time- Canada) on Wednesday, April 20th and should only take 10 minutes of your time.
You may access the survey by clicking the link below.
https://www.surveymonkey.com/r/SRWKYMX

Experience with Idelalisib (Zydelig) in CLL (chronic lymphocytic leukemia)? A chance to can help fellow patients in Canada.

I received this email today with a link to a survey for those of us who have had experience with idelalisib. It is a chance to help our fellow patients with CLL in Canada. 

The email speaks for itself. Please help if you can.

Hello Dr. Koffman,

My name is Elizabeth Lye and I am the Scientific Advisor with Lymphoma Canada. I am reaching out to you to see if you can help put us in touch with patients who may have experience with idelalisib (Zydelig) for CLL. This treatment is not currently available in Canada and Lymphoma Canada is working to help Canadians gain access to this treatment. 

If you are not familiar already, the pan-Canadian Oncology Drug Review (pCODR) makes recommendations to the provinces and territories to help them decide whether they will provide funding for new cancer drugs in Canada. Understanding the experiences of patients is a key element in the pCODR review process and pCODR allows patient groups to do this through "patient submissions".

In order for Lymphoma Canada to have a strong submission, we really need to have patients who have direct experience with idelalisib (Zydelig) to complete an online survey or to participate in an interview with one of our staff. To ensure patient privacy and confidentiality, individual responses will not be identifiable.

I am writing to see if you would be able to help us find patients to participate in our survey.  Given that not a lot of people in Canada have had experience with idelalisib, we are seeking input from patients internationally to complete our survey to support our government submission. 

Would it be possible to post the link to the survey on any of the patient forums you post to? Or perhaps you have some other ideas that may help us locate patients who have experience with idelalisib (Zydelig) for CLL.

As always, the timelines are very tight. The closing date for the surveys is April 7th. The link to the survey is: http://www.lymphoma.ca/news/idelalisib-cll-survey

Thank you in advance for your consideration of our request.

Kind regards,

Elizabeth

///////////////////////////////////////////////////////////////////////////////////////////////////////

Elizabeth Lye

Scientific Advisor

Lymphoma Canada

7111 Syntex Dr., Suite 351, Mississauga

ON, L5N 8C3

Phone 905.822.5135 x 3

Toll-Free 1-866-659-5556

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CLL (chronic lymphocytic leukemia) Treatment Internationally: We Can't Always Get What We Want

Below is an article from the Brampton Guardian.

This unfortunate CLL patient can't even get bendamustine and rituximab in Ontario, Canada, let alone ibrutinib or idelalisib or ABT-199 or obinutizumab. OHIP, the provincial insurance won't pay for any of it.

Here in the USA, she would automatically qualify for ibrutinib as as second line therapy or she could get her BR or enter a trial or a host of other choices. Not so in Canada.

I am so lucky to be able to have received ibrutinib in a clinical trial long before it was approved.

Others, mostly those wanting a non-chemo first line therapy, have been less fortunate. Still on clinical trials.gov, a quick look found eight open trials for untreated CLL patients with either ABT-199 or ibrutinib or idelalisib or obinutuzumab. And there are many more options using other very promising TKIs and mAbs in development. It's true that you can't be assured that you can get ibrutinib by prescription for frontline treatment, but at least most American untreated patients have many fine options with or without chemo.

When I advocate for more research on the the multi-drug non -chemo treatments for those of us such as myself not in CR after two years of ibrutinib, it is not meant at the expense of those needing other therapies or better access.

I want to see improved access for all of us. One way that might be possible is by following a path such a Professor Hallek outlined at ASH 2013 to limit the duration of therapy and thus control cost. I would just leave out or at least severely restrict the chemo piece of his protocol. His full article is available and well worth reading. It is a thoughtful discussion and one vision of the possible future of CLL treatment.

This is all new territory and we need the trials on untreated patients and we need the trials on relapsed patients and we need the trials on patients not in CR.

Truth is we are barely at the break of dawn of this new era of treatment and we need so many studies to help guide us. We are making this up as we go along.

What we also need to remember is that we are are all in this together and none of us, myself included, should wish for an option that limits another's choices. At least in the USA, we are not at that point.

Canada may be a different story. There is a petition at the end of the attached article. Her denial of care seems cruel, unjust, unscientific, and just plain dumb to me.

I understand that nearly all cancer treatment is expensive. I understand society must make tough choices about how to allocate limited resources. But making choices based solely on arbitrary protocols and short term dollars signs is not good policy, especially when it clearly stands against both the best evidence based medicine and the specific clinical circumstances of the patient.

Truth is that ibrutinib might be a smarter choice than BR for this patient after relapsing only four years post FR. Truth is we learn nothing in this article about the state of her marrow. Can it handle more chemo? We don't even know her FISH. If she is 17p deleted, BR could be a dangerous waste of time and resources, and might leave her worse off than before the therapy.

In the end with CLL, one has to chose which battles to fight. Anne and her oncologist have made their choice and are pushing for BR, so I am assuming they are on their game and have done their due diligence.

Yesterday, I heard from patients in Turkey and China looking in vain for novel therapies. I quote from the latter email discussing ibrutinib: Indeed the medicine cost is too high, and even if it's approved to be imported to China, the market price in China would be still higher (with extremely high custom rate), and yet any imported medicine is out of the range of medical insurance in China.

It's tough for my friends in Europe too. NICE that regulates new drugs in the EU can be very price sensitive and there seems to be be fewer non-chemo trials.

I know how spoiled I am living in the USA. I know how lucky I am to have nabbed a spot in my trial.

I wish everyone everywhere had access to what they needed to be well.

After all, we are all in this together. 

But there is only one of me and I am spread pretty thin already, so I narrow my focus, and try to make sure that at least those of us in North America get the best possible and smartest treatments out there.

The LLS is doing important work on improving access through its patient advocacy and other efforts. They deserves our support. See the photo below.

Brampton woman denied OHIP coverage for life-saving cancer drugs

Brampton Guardian

BRAMPTON — 

Anne Mitchell is fighting an uphill battle.
After four years in remission, the 67-year-old mother of two is gearing up for her second battle with Chronic Lymphocytic Leukemia.
But dealing with cancer isn’t the only obstacle the Brampton woman must overcome. The real challenge now — apart from fighting the illness — is coming up with the money to pay for life-saving drugs.
“My mother can’t receive chemotherapy drugs, purely for bureaucratic reasons,” said Mitchell’s daughter Eleanor Elliott, who has launched on an online petition in a bid to pressure the provincial government to dole out the $52,000 her mother needs for the chemotherapy drugs Bendamustine and Rituximab.

The drugs are covered by OHIP.

Mitchell is being denied coverage based on what family members say is a technicality. Bendamustine is covered for first-time chemotherapy treatments.
But, since Mitchell has undergone chemo before, the drug isn’t covered by OHIP. The other drug, Rituximab, is approved for second line use, but only in tandem with Fludarabine — a drug that Mitchell can’t take because she suffered an extreme, adverse reaction to it during her first bout with chemotherapy.
“The drugs that my mother’s oncologist prescribed are funded by the government. However, in my mother’s case, they have denied her funding,” Elliott said. “If a drug is approved for funding, how can you deny a Canadian citizen access to that drug? How is this possible in our great country that prides itself on universal healthcare?”
In October 2010, doctors treated Mitchell’s cancer with Fludarabine and Rituximab, two very powerful chemotherapy drugs.
Mitchell, who has lived in Bramalea for nearly 40 years, received got through two treatments before the regime was abruptly stopped because of her negative reaction to Fludarabine.
Mitchell was hospitalized for weeks with a severe lung infection that nearly killed her.
Despite that setback, her cancer went into remission and Mitchell and husband John, 68, were looking forward to better days.
But the cancer has returned and doctors believe Mitchell’s fighting chances are good if treated with a combination of Bendamustine and Rituximab.
However, the hefty price tag on those drugs now stands in Mitchell’s way.
Mitchell’s latest chemo treatment was to start April 7. Shortly after arriving in the oncology department at Brampton Civic Hospital, she received news that the $8,700 for the Bendamustine and Rituximab would have to come out of her own pocket.
“I felt complete and utter shock,” said an emotional Mitchell, describing her reaction when told OHIP denied her payment.
Mitchell used a credit card to cover the $4,500 cost for the first round of Bendamustine. She needs six treatments in total and can’t afford the cost.
Elliott said the hospital administered the Rituximab at no charge and has put through an appeal to Ontario’s health ministry for the $4,200.
“I sat in shock as my mother had to pull out a credit card to pay for her treatment,” said Elliott, who is concerned that her parents will be forced to spend their retirement savings on cancer treatments.
With her mother facing an uphill fight, Elliott has taken to social media for support. Her online petition has so far garnered more than 600 signatures, She plans to present the petition to provincial health officials.
Bramalea MPP Jagmeet Singh has offered his support in the form of a letter sent to Ontario Health Minister Deborah Matthews appealing for help

Meanwhile, Elliott has also reached out to the manufacturer of Bendamustine.
According to Elliott, Lundbeck Canada has agreed to cover 20 per cent of the cost of the Bendamustine, but the family will have to pay the cost up front and then apply for a rebate.
But, as Elliott noted, that works out to be just about 10 per cent of the total cost of her mother’s required treatment.
Elliott argues that her mother wasn’t able to complete her first round of chemotherapy and therefore should still be considered a first-time patient.
Falling under the category of first-time chemotherapy patient would make her eligible for the Bendamustine. Elliott also wants Ontario to waive the requirement that OHIP will only cover Rituximab if taken with Fludarabine.
She argues that approved chemotherapy drugs be approved “without discrimination and without bureaucratic intervention that could cost Canadians, like her mother, their lives.”
To view the online petition click here .

Paul Henderson Battles Back Against Cancer

Paul Henderson and me in Niagara Falls

Thank you, Toronto Sun for this good news story in your hockey section.

OK, I am still a Canadian.

OK, I am still a huge hockey fan.

OK, I still remember the goal he scored against the Soviets.

When we met in Niagara Falls in 2012 at CLLPAG conference, I suggested he look into the NIH trial for ibrutinib. At that time, I had not yet started ibrutinib, but was still in the ofatumumab stage of the clinical trial at OSU with Dr. John Byrd where I would eventually get ibrutinib and do so well.

I am glad to see he is having the extraordinary success that I and so many others are enjoying with ibrutinib and the other new medications for CLL.

I am moved but his spiritual response to his cancer challenge. Paul is a man of faith and this is the season of miracles.

I hope and pray that the cost of these medicines will not delay their access in Canada- in every province, for every patient that would benefit.

I salute Paul Henderson for getting on a plane and flying to Bethesda. Not everyone has the resources or the knowledge or guts to do that. Not everyone fits the admission criteria for a trial.

I want to build a CLL community where every patient across all borders has the opportunity for the best possible care.

I am traveling, having met with other blood cancer patient advocates in Greece, so I appreciate the Toronto Sun doing my work for me on this post. Little time to write here.

One comment:

The hockey great tells the truth when he says what we know is that ibrutinib will work for about two years, but that is only because that is the best data we have. Only a handful of patients have taken it for around 4 years now and nearly all of those are still cruising along with their disease controlled, but the truth is that most of the data is out about two years or less. The curves are very flat for the treatment naive (those whose first treatment is ibrutinib), meaning that nearly all do not develop resistance and are doing great. In the relapsed and refractory population, the great majority also continue to respond, but there is a slightly bigger drop off. There are clearly some late CLL relapses seen after a year or more on drug, mostly seen in those with genomic instability such as those of us with a deletion 17p. More on this with the exact statistics from the papers at ASH when I get back stateside.

When I get home, I promise that I will write more about the news about CLL from iwCLL and ASH.

But first this feel good article.

BY JOE WARMINGTON ,TORONTO SUN
FIRST POSTED: MONDAY, DECEMBER 16, 2013 09:50 PM EST | UPDATED: MONDAY, DECEMBER 16, 2013 10:48 PM EST
TORONTO - 

All Paul Henderson wanted for Christmas was a clean bill of health from his deadly cancer.
It was actually more his wife of 50 years, Eleanor, their three daughters — Heather, Jennifer and Jill — and seven grandkids who were doing the asking.

It was no secret it was wishing for a lot. A miracle may be more what they were praying for.

It was not looking promising.

Just a year ago, the thought that the legendary Canadian hockey hero, suffering from chronic lymphocytic leukemia, would even be around for another Christmas was a dream.
In a column on Henderson in 2012, he was open about his ongoing battle with a rare, often terminal, form of cancer.

“There are signs of it getting worse,” he told me. “I have to admit the tumours are not getting any smaller. The cancer is now in my stomach, chest and lymph nodes.”

He had dropped from 184 pounds to 160 pounds.

The man who scored the winning goal in the final three games of the 1972 Summit Series against the then mighty Soviet Union was running out of both time and options.

The only goal he was focused on was trying to stay alive.

But Henderson has been known to thrive in tough circumstances, including scoring the goal of the century with just 34 seconds remaining in the final game in Moscow.

More than 41-years removed, he has proved his flare of beating the odds once again.
“It’s either chemotherapy or a clinical trial,” he said in 2012.

He chose the clinical trial and with fingers crossed went down to Bethesda, Md.

“The tumour in my stomach was the size of a grapefruit,” said Henderson, who was at the Toronto Sun’s downtown offices for an appearance on Michael Coren’s Sun News Network show, The Arena. “My spleen was double the size and the tumours were all over my body including in my armpits and my lymph nodes were swollen.”

Enter an experimental drug, called Ibrutinib, which is now being referred to as “breakthrough” therapy. “I take two little pills in the morning.”

The tumours began to shrink and now while Henderson can’t say his cancer is in remission, it is as close to that as someone with his form of the disease can ever hope for. “In my bones, they said they were 87% affected and now it’s down to 5%,” he added. “And the tumour in my stomach that was the size of the grapefruit is all but gone.” He has put all his weight back on and is back to 184 pounds.

“I just feel great,” he said. “I feel terrific but I think it’s even better for my family.” Yes, Eleanor, the kids and grandkids’ prayers have been answered.

It’s a Christmas Miracle!

“The Lord be good,” was Don Cherry’s reaction.

Henderson said the good news is also that most of the people in his clinical trial have had similar results and that one day Canadians may be able to gain access to this yet-to-be approved treatment.

He is hopeful it could mean that chemotherapy could become a thing of the past.

“When people say it’s a miracle I just say I will wait until I get to heaven and ask,” teased a smiling and upbeat Henderson.

He feels fantastic and looks even better.

“My wife joked she wants to take some of those pills because they must have Botox in them,” he said.

The Hendersons are realistic that with cancer, every day is special.

“I am told that this drug will work, they think for two years, so we don’t know what is going to happen after that.”

But what he does know is Henderson is feeling positive about enjoying Christmas with his family and even his 71st birthday on Jan. 28.

“I feel blessed because my dad died at 49,” he said. “I have never been worried because when you have hope and peace, you can handle anything.”

Henderson said he wouldn’t change a thing.

“I think having the cancer allowed me to be able to freely talk about my faith,” he said.

And, this Christmas, he is also able to reflect on another remarkable do-or-die moment he pulled out from suspected defeat and turned into victory just in the nick of time. 

My Cousins, Arlene and Bob: Bob was the Best Prime Minister that Canada NEVER Had

Another quick break from CLL, this time to commemorate the passing of an era for Canada in general and my extended family in particular, as my cousin Bob Rae steps down as leader on the Liberal Party in Canada.

Most of you know that I was born in Canada and retain my Canadian citizenship and also my Ontario medical license, making me a legal citizen and doctor in two great countries.

What few of you may know is how much one of my family member has been involved in the highest echelons of Ontario and Canadian politics.

Being an only child, my cousin Arlene was a wise and charming part-time older sister to me when I was growing up in the 50's and 60's in Toronto. Years later, Arlene married a young lawyer and politician, and I married an American musician and our lives went different ways. We stayed in touch across the miles and the years as we raised our families and pursued our dreams.

The hardest thing about leaving Canada was leaving behind my friends and family.

Although now I have lived in the USA for the last 32 years, and I haven't always agreed with my cousins on all things political or about health care delivery, I love and respect their public service, their highest ethical standards, their wisdom, and their pride of country.

Bob Rae is a great man.

He is certainly the best prime minister Canada NEVER had.

WIRED AND TIRED, GEESE AND BEAVERS

Beaver Mischief

(the mischief maker swam off just before I got his photo)

After a mostly sleepless night and a wasted day (sounds like back in college, but not nearly as much fun), I am quickly crashing from my "roids" driven high. Patty and I did manage a lovely short walk at the wetlands a mile from here where we saw beavers and Canada geese and a million other birds before the floor dropped out from under me and I stumbled home. The scene made me long for my birth land, O, Canada, the true north strong and free. Thanks for the tip, Wayne. Much appreciated.

The winter seems to have vanished in Columbus, which is just fine with me. What a difference a week makes. Last week it was snow flurries and howling winds. This weeks it's golf and biking weather.

But I am getting dreamy and have work to do tomorrow, so I forced myself to not nap today so I can sleep tonight.

Just because I teach others about sleep disorders, doesn't mean I have to demonstrate them.

Goodnight all.

Off to my Home and Native Land

Catching an early morning plane to Seattle, then it's a drive up highway 5 to visit a most wise and enlightened and silly friend in northern Washington before crossing the border to spend time with my dad in Vancouver, actually White Rock.

I will also be visiting a solid and unafraid friend from high school and his family.

Both friends are one of a kind. I am lucky to know them both.

While on the northwest coast, I feel it's my duty as a Canadian to make certain that the family gets to explore the Museum of Anthropology and Stanley Park.

But mostly it is to spend time with my old man. His two grandsons are coming along. It is not easy for either my dad or me to travel much these days. My busy schedule belies the planning and effort that goes into making my trips safe, even possible for someone whose platelets are under attack. It is not easy to pull the three generations together for family trips. So it will be good to just spend time with him.

Got a surprise on my GI biopsy report: Intestinal metaplasia. It means a recheck upper scope in 2-3 years instead of 10, as it carries a slightly higher risk of malignant transformation. More watching and waiting. Actually it rarely progresses and is a pretty trivial issue in the big picture. I got bigger zucchinis to chop.

No worries mate.

Maybe I will go off my diet in Canada and have some Granville Island Smoked Salmon. Or a Tim Horton donut.

Not a chance. Not a chance.