Sunday, February 09, 2014

Getting Ibrutinib

Update: Ibrutinib has just been approved by the FDA for CLL, which should make it widely available to CLL and Richter's patients.

I have been on Ibrutinib for just six days now -- 420 mg daily -- and the effect has been nothing short of extraordinary. An abdominal lymph node mass that I keep track of has shrunk considerably and I have lost 14 pounds, most of it edema caused by the swollen nodes blocking things up. My belly has gone from looking about seven months pregnant to about three.

This good response is particularly welcome since Ibrutinib was my last, best hope in terms of therapy to reduce and control my post-Richter's aggressive lymphoma, DLBCL. The smaller the tumor burden when it comes time for transplant conditioning, the better. And if I can enter the transplant with nodes under 5 cm, my chances of success are greatly improved. 

As you may know, Ibrutinib has shown excellent results in clinical trials in both CLL and DLBCL. It's not approved by the FDA for either disease yet, but when it is approved it will no doubt be a game-changer.

But what if you need it now?

As a public service, let me tell you a little bit about my experience of not getting Ibrutinib, and then getting it. It comes down to standard of care -- your local oncologist may lack the wherewithal to get the job done, while a doctor at an institution that provides better care may have a better idea of how the system works and how to get the drug.

Ibrutinib (now also known as Imbruvica) was approved in November by the FDA for Mantle Cell Lymphoma, making it more widely available, including for "off-label" use. I had assumed that one needed to get into a clinical trial to get Ibrutinib. Dr. Droll, my local oncologist, thought maybe I could qualify for compassionate use of the drug. He assigned the task of inquiring to a research nurse in his office, and nothing happened. (He is part of a mid-level, multi-doctor practice, so it's not podunk, but not adequate to the task, either.) He was reticent to pursue off-label use, and my guess is this may have had something to do with the liability policies of his practice.

Meanwhile, January 1 rolled around and, thanks to the Affordable Care Act, I was able to get much-improved insurance through Blue Cross. On January 7, I went in for a transplant consultation with Dr. Jose Leis at the Mayo Clinic in Phoenix. Dr, Leis also thought Ibrutinib might be my best option. How do I get my hands on it?, I inquired.

Dr. Leis simply wrote a prescription. Ibrutinib is available at a small number of specialty pharmacies. Back when I took Revlimid, I dealt with one of those -- Biologics, a specialty pharmacy in North Carolina. They would send me a new supply of Revlimid via FedEx once a month.

Well, Ibrutinib is handled in a similar way. In this case, the prescription went to another specialty pharmacy, Avella, which then contacted Blue Cross for approval. The helpful lady at the pharmacy explained that other patients in my situation had all been approved by my insurance, and after about four business days, I was, too. Et voila, a bottle of Ibrutinib was sent to me via FedEx.

No fuss, no muss, and it took about three weeks from the time Dr. Leis wrote the prescription. If you could truly benefit from Ibrutinib and your doctor is telling you it is impossible or nearly impossible to get, that's just not the case. 

One of the great benefits of my new insurance is being able to have access to a higher standard of care. For a patient in a tricky situation, such as myself, this makes an important difference. Dealing with a doctor and a staff who are on top of things, who haven't missed a beat, is a great relief.


Anonymous said...

The moral of this, and other similar stories, is that when your life and health is at stake, don't take no for an answer.


Anonymous said...

David, great news. I think you may have dodged a small caliber round there by not having to rush into a transplant. Who knows, maybe Ibrutinib will keep you away from a transplant and all the chemo associated with one. I hope so. Your marrow needs a rest.

Thank you for your blog. I have been following along for over seven years now. Found your diary just after I was diagnosed and it has helped me deal with my own CLL journey.


Anonymous said...

David……Dancing again!! This is such sweet news. The prospects look good given the trial experiences thus far!!! So pleased. You have fought the fight and I hope this is the drug that gives you some rest.

As a side note …any idea what they are charging your insurance for the drug? Rumors of off the chart pricing for all these new drugs (including my ABT-199) are likely real.

Continued good news and love to you and M!!


David Arenson said...

Thanks everyone for the encouraging words! It's a relief that things appear to be working out for me after they headed dangerously south . . . Wendy, I'm not sure what insurance is charged. I have a $25 copay for one month's supply. Hope ABT-199 is still doing the trick for you.

Season Reza said...

It must have been a relief for you to get quality doctors, pharmacists and even shipping! Not everyone is as fortunate as you, whose insurance plans are not accepted for one reason or another, or don't know on what to do. Hopefully you're feeling better now. Have a good day!
Season Reza @

Rita said...

I have just completed my first round of treatment for CLL. I had a "good partial response" which means that, unless I am hit by a truck any time soon, I will be needing a second round of treatment. I am also a patient of Dr. Leis at Mayo Phoenix. Dr. Leis has explained that the newly approved ibrutinib, will be treatment of choice for second round patients. I will be medicare eligible as of July 2014, and in researching drug plans, I have found that no plans cover this drug. My estimated annual cost of the drugs I take, including the ibrutinib, was $151,000. I cannot believe that anyone would have the nerve to even suggest such a number! I am so upset that I can barely think. The "patient advocate" at J&J suggests that I may be eligible for assistance with the cost of the drug - Why on earth should I have to apply for assistance? Do other cancer patients have to and beg to get the drugs that their doctors prescribe? I would appreciate any suggestions or advice anyone might have.

Rita Healey -