Wednesday, July 31, 2013

CML Patients: What Should I Ask My Doctor?

Hearing the words, “You have leukemia” is the beginning of a new, often frightening, and unexpected journey. Once these words have sunk deeply into your brain, you will want to do everything in your power to ensure that you map out the most favorable path in which to lead you, on your way.

Often when people are diagnosed with cancer, they have little knowledge of what their future holds. They are often scared, confused and do not know what to do. One of the first orders of business, is to secure a competent oncologist; one that specializes in their specific type of cancer. Chronic Myelogenous Leukemia is a rare form of leukemia and therefore should be treated by a medical professional whom specializes in CML.

CML is a chronic cancer, meaning that it is currently controlled by medication, as opposed to being traditionally cured. It is a beast, all its’ own; it sets up shop in your bone marrow and acts like an “on” switch for the production of white blood cells; white blood cells that eventually take over your bloodstream; unless the switch is turned off. This is where your oncologist comes into play and why it is so important to choose a hematological oncologist that is familiar with CML. This person will likely be a part of your life, for the rest of your life, so choose wisely!

Many people are under the impression that they have little choice when choosing a doctor; they do not realize that it is their prerogative to choose a doctor that is a good fit; for them. They do not know how to “Doctor Shop” and do not know what to ask a prospective physician.  They revere doctors’ word as law and often continue to employ a doctor even though they are uncomfortable.

For me, rapport is the key; I do not wish to feel intimidated or rushed and I want to feel as though my input is considered and respected. I want to be able to trust my physician and to question him, as well. I also want to be able to reach my physician in case of an emergency or panic attack! With Chronic Myelogenous Leukemia there is also a list of questions that we all should ask.

Questions to be brought to your first appointment:
1.           In which stage was my Chronic Myelogenous Leukemia diagnosed?
2.           What are my treatment choices?
3.           What are the expected benefits for each treatment?
4.           What are the risks involved in each treatment?
5.           What are the side effects of each treatment?
6.           How will these treatments affect my daily life?
7.           How will these treatments affect my overall well-being?
8.           Should I consider clinical trials?
9.           Which clinical trials are available to me?
10.         What are the chances of my cancer progressing to a more serious stage?
11.         What are my chances of being cured?
12.         What are the chances of me developing another type of cancer; due to treatment?
13.         What changes should I make in my current lifestyle?
14.         Should I follow a specific diet?
15.         Am I allowed to ingest over the counter medication along with my treatment?
16.         What symptoms and/or side effects should I report to you?
17.         What is your experience with CML?
18.         What is the protocol in communicating with you?
19.         Do you believe that you and I have the rapport that will best serve my medical needs?

I know that this may seem like a lot of questions, but I believe that they are important ones. I also believe that you, as a survivor, must listen and asses the questions that the physician asks you; are they relevant to your CML, your treatment and your quality of life? If so, and you like the answers to your questions, consider yourself extremely fortunate, as this person will likely be a part of your life, for the rest of your life.

It is your choice; choose wisely.

CML and Raising Grand Kids is A Lot of Work!

Sometimes I am astounded at how quickly time can pass; a day, a week, a month or a year. In some ways, it seems as though it were only yesterday that I heard those life altering words, “Michele, I am so sorry to have to tell you this, but you have Leukemia.” That was twenty nine months ago and I am still alive and kicking!

The past six months have flown by in a blip and the neglect to my updates is sorely apparent! In January, Joe and I decided to take on the privilege of having our grandson Jack, ten years old, come to live with us, in the mountains, for six months. During this time, we home schooled Jack and tried to explain why it is, that all of the lights that get left on, cost money! He learned to cook, plant a garden, split wood and just how cold snow was, when it went down your pants! He learned that no city lights meant that you could see the Milky Way and that there were more stars in the sky, than you could ever imagine.

He loved bonfires and ‘smores, making snow angels and sledding, and loved being a kid that had the good fortune to “run a-muck”, like we used to do when we were kids. He had friends up here in the mountains and loved exploring acres and acres of un-fenced territory; without the accompaniment of an adult. We visited the Birds of Prey, the War Hawk Museum and the Boise Aquarium. He learned to appreciate the “peace and quiet” and in his words, “The most amazing place on the planet”. He reminded me of the amount of patience and stamina that it requires to raise a child and how bright the world is; through a child’s eyes. I marvel at how all of the mother's, with CML, do all of this every day. My hat's off to you!

It was a time that we are so appreciative and grateful to have had and hope that the memories created, will be with him for a lifetime. I am still finding small traces of his presence and often long to hear his footsteps on the stairs, but we are also glad to be able to have the privilege to once again just be “Nana and Papa”. Being the “parent” requires an entirely different set of skills and responsibilities; it is a parent’s duty to raise a kind, responsible asset to society; it is a grandparents privilege to just plain old Love Them!!

So, now that I am smarter than the average fourth grader and have five extra hours a day to call my own, I shall get back down to business and fill you in on all that I have learned; one step at a time! 

Saturday, July 27, 2013

Sprycel May Have Slight Edge Over Tasigna

Bristol-Myers Squibb: Sprycel May Have Slight Edge Over Tasigna; 55% of Newly Diagnosed CML Patients Will 
Likely Choose Either Sprycel (30% Share) or Tasigna (25%) 

While there are several factors working in favor of each drug (Sprycel and Tasigna), we believe Sprycel stands to have an
edge over Tasigna for the following reasons.

Factors favoring Sprycel: 
• No black-box warning: Tasigna’s label includes a black-box warning for QT prolongation. It excluded patients
with uncontrolled cardiovascular (CV) disease in its Phase III as did Sprycel. Given the exclusion criteria in Phase
III for both products, we would not be surprised if their Phase III CV risk profiles look similar; however, given
Tasigna’s black-box warning, we would expect Sprycel to be viewed more favorably.
• More convenient dosing: Sprycel has a clear dose advantage over Tasigna (QD vs. BID). Additionally, Sprycel
does not have food restrictions like Tasigna. Patients taking Tasigna are required to avoid food 2 hours before and
1 hour after taking medication.
• Lower price point: While both Tasigna ($265/day) and Sprycel ($230/day) are expected to be priced at a
premium to Gleevec ($210/day), Sprycel is likely to have some pricing advantage vs. Tasigna.
Factors favoring Tasigna:
• Potential 6 month head-start: The PDUFA date for Tasigna’s application is in late June, while we assume
Bristol will file around mid-2010 and request a priority review status. If it were to get priority review status, we
would expect an FDA decision around the end of the year. This scenario would give Tasigna a 6 month head-start
over Sprycel.
• Novartis currently owns the market: Since Novartis currently owns the 1st line market with Gleevec, we would
not be surprised if Novartis has a strategy in place to aggressively convert patients to Tasigna especially since
Gleevec is going generic in 2015.

If Data Plays Out, We Believe Sprycel Sales Could Top $2.5B by 2015:
Switch from newly diagnosed patients: From 2011 onwards newly diagnosed, 1st-line CML patients representing about
11% of the total 1st-line population will have a choice among three front line therapies – Gleevec, Tasigna and Sprycel.
We believe that 55% of these newly diagnosed patients will choose either Tasigna or Sprycel due to their more
benign side effect profiles. Sprycel could take 30% share and Tasigna to take 25% share.
Switch from Gleevec maintenance therapy patients: Both Bristol-Myers and Novartis have ongoing studies evaluating the
switch of patients that are suboptimally treated with Gleevec. The Novartis studies (LASOR and ENESTcmr) will begin
to report data in 2011. Bristol-Myers also has a switch study on which we are waiting for an update from the company.
We estimate that about 20% of the patients on Gleevec maintenance therapy will switch to either Tasigna or
Sprycel starting in 2011, with the rate rising to 45% by 2015. For now we assume that these switch patients will be
shared equally by Sprycel and Tasigna until we get more data.
In 2nd-line, we estimate that the ~2:1 market share ratio between Sprycel and Tasigna will decline as Sprycel gains greater
share in front-line treatment. In 3rd-line, we estimate Sprycel’s market share will somewhat decline (as will Tasigna’s
share) over time as it gains share in earlier lines of therapy; however, we assume that it will still continue to dominate the
Based on these assumptions, we estimate Sprycel’s global sales to grow from about $420M in 2009 to about $2.6B in
Source: UBS/Goodman, May 18, 2010
Oncology Indication: Hematologic
Keyword: Market Overview

Bricks for the Brave!!