Fair Access to Cancer Treatment (FACT) Act (HB2078) becomes law in Arizona

The signing of the Fair Access to Cancer Treatment Act

 Pat Elliott, Governor Jan Brewer, Dr. La Verne

Jim Brewer (LLS), Pat Elliott, Dr. La Verne, Sen. Anna Tovar

July 1, 2014 the Arizona House Bill 2078, known as the Fair Access to Cancer Treatment (FACT) Act, was signed into law at a ceremonial signing at Virginia G. Piper Cancer Center at Scottsdale Healthcare Shea Medical Center. The bill passed by unanimous vote within one year. My only disappointment is that I wanted it to be effective January 1, 2015. The law becomes effective January 1, 2016.

There were no oral cancer treatments 14 years ago, so the law needed to be updated to fit today’s innovative medical treatments. Drugs administered orally for cancer treatment should be covered by insurance the same as drugs administered intravenously. HB2078 offers fair and equal coverage for patients with orally-administered cancer treatments for patients in Arizona who are covered by health care insurance entities, such as disability insurers, health care services organizations, and hospital, medical, optometric service corporations (HMDO). For some patients the oral cancer treatment is their only option and not having access because of the high out-of-pocket costs means they will not survive.

Gratitude goes to the Fair Access to Cancer Treatment Coalition of 21 organizations consisting of nonprofits, cancer centers, professional organizations, etc.) spearheaded by the Arizona Chapter of the Leukemia & Lymphoma Society (LLS). Thank you Jim Brewer, Executive Director of LLS, and Shayna Diamond, patient access and education manager. Gratitude also goes to Rep. Heather Carter (District 15) who sponsored the bill after it was passed to her by Senator Adam Driggs (District 28). Gratitude goes to Senator Anna Tovar (District 19) for her role on the LLS Board and the State Legislature. And lots of love and gratitude to the patient advocates who joined me in giving testimony to the Legislature, as well as those who used social media to expose the inequity (i.e. Pat Elliott).

Thank you Governor Jan Brewer for signing this bill into law.  Regardless of what your political beliefs may be, this is one of the most life-changing Arizona bills that was signed by Governor Brewer for cancer patients.

Professor Matthew H. Hils, my blood brother

Professor Matthew H. Hils teaching botany at Hiram College.

Professor Matthew H. Hils, George St. Clair, and I are the three musketeers. We started the ibrutinib clinical trial at NIH at the same time. We decided we were eternally bonded as blood siblings. Dr. Matt was a botany professor. George was a retired counselor. I was a computer graphics technology professor. We kept tabs on each other.

Matt and I were diagnosed with 17p deletion, but our bodies responded to the experimental drug differently. Within months of taking ibrutinib (a.k.a. PCI-32765 and Imbruvica) Matt was in full remission. I just remember his favorite saying: "I'm about as happy as a pig in slop." We couldn't stop laughing. George and I called him our poster child.

I -- on the other hand -- have not reached remission in almost two years. When I voiced concern a year ago he said to me, “I am the hare and you are the tortoise. But don’t forget who won the race.”

CLL/SLL is not a stupid cancer like CML. I wish it were. CLL is a sneaky little devil and has a tendency to find another pathway, especially in high-risk patients. That is why researchers use the experimental oral cancer treatments to block the leukemia in different parts of the pathway.

Ibrutinib stopped working for Matt in the fall of 2013 and he was sent to The Ohio State University for another clinical trial with IPI-145, another oral kinase inhibitor. In April 2014 IPI-145 stopped working for him. Matt continuously reported his symptoms and his vitals to George and I so that we would have a record.

He was scheduled to fill the one slot in May for ABT-199, another inhibitor, which has been very successful in clinical trials so far. The drug manufacturer for ABT-199 did not give The Ohio State University a slot for May, so that option was closed for Matt.

He had to move forward to another plan – either a stem cell transplant (umbilical cord) or another clinical trial. Both required completion of a chemotherapy regiment, which would take him to July or August. A weeklong course of chemotherapy called R-EPOCH was administered beginning, Monday May 12, 2014.

Matt was to be released from the hospital at the end of the week and return for the next round on Monday, June 9^th through 13^th. Then he would either have the transplant or enter another clinical trial. He reported that this plan did not work out. He said he was having trouble with his strength and stamina and could not walk around the nurse’s station without panting. Fluid in his lungs prevented him from breathing deeply. Abdominal pain and some bleeding he said was probably because of a low platelet episode.

The next news I got was that Matt was being released to Hospice on June 3, 2014. He was supposed to email us to let us know how he was doing.

Tuesday afternoon, June 10^th I could not figure out why I could not stop the tears from flowing. That evening I received the following email from his daughter:

Friends and family: 

This evening, just before 7:00 PM, my dad passed away peacefully in his home, his "tree house," surrounded by his children, family, his "Gorgeous" Gloria, and friends. We were talking happily around him, discussing his storming the Castle of all castles, and storming the gates of Heaven. (I trust we all know Dad's love and fondness of Billy Crystal's line in The Princess Bride: "Bye bye! Have fun stormin' the castle!") Just seconds after this, we realized his pain and discomfort had come to an end and that he was at peace.

Shawn and I cannot thank you enough for all of the love and positivity you provided our dad with during these last three years, and all the additional years of laughs and love you gave him as his friends and family. I don't think I'm alone in saying that my dad handled his cancer and treatments with a kind of quiet grace and bravery that was truly something to behold. Just yesterday, he was smiling at us, sneaking kisses on cheeks, and laughing at our very bad jokes. Not to be competitive, but I think he has set a high, golden standard for what an incredible person and father can become. 

He was a father to Shawn and I, and also to our friends and his students. He was a brother to Kathy, Linda, Sandy, Mary, Beth, and Dave, and also to all of his friends and colleagues. Dad was happily, blissfully in love with his partner Gloria. While we so wish that he had had many more years with all of us, Shawn and I know that my dad was happier in these last three years than we have ever seen him before. That is due in large part to all of the beautiful people and relationships in his life. He always saw teaching as his passion; being a father as his greatest pride and joy; and being a selfless, loving friend and brother as his honor.

We are all better for knowing my dad, Prof. Matthew H. Hils (November 27,1955-June 10,2014).

My heart is heavy, but I know Matt is all right. His spirit is alive and well. :-) I am dancing the Florin dance with tears in my eyes celebrating my blood brother Matt's life.

Florin dance https://www.youtube.com/watch?v=PNgI026JDGU

A Cure for CLL/SLL?

Meeting Patient #3

When I was in Washington, D.C. at the Leukemia & Lymphoma Conference, I sat at a table for a small group discussion. I was honored to be in the presence of Dr. Carl June’s “Patient #3” – Doug Olson. He was cured of the same 17p deleted leukemia that I have.

Doug Olson, a scientist involved with blood testing, had been a patient of Dr. David Porter at the Abramson Cancer Center at the University of Pennsylvania since he was diagnosed at the age of 49 in 1996.

Doug Olson’s Prior Cancer Treatments:

Doug Olson was initially diagnosed in stage I CLL/SLL. In 2002 he received his first treatment of two cycles of rituximab plus fludarabine to combat his progressive leukocytosis (elevated white blood cell count greater than 11,000 per mm³) and adenopathy (enlarged lymph nodes). His blood count normalized and he had a partial resolution of enlarged lymph nodes.

In 2006 Olson was treated with four cycles of rituximab and fludarabine, since the cancer was progressing. Again his response was normalization of blood counts and a partial regression of enlarged lymph nodes. Olson’s cancer did not progress for 20 months, and he was not treated for another two years.

A bone marrow biopsy indicated his bone marrow was infiltrated with leukemia cells February 2009. Three out of 15 cells contained 17p deletion and a FISH (fluorescence in situ hybridization) test showed that 170 of 200 cells had a deletion of TP53 on chromosome 17p. He was treated with rituximab with bendamustine for one cycle and bendamustine without rituximab for three additional cycles. He had a severe allergic reaction to rituximab. This cancer treatment resulted in only a slight improvement in lymphocytosis (an abnormal increase in the number of lymphocytes, which can be B-cells, T-cells or NK-natural killer cells). Olson had a CT (computed tomography) scan and he was found to have progressive enlarged lymph nodes.

Re-engineered Serial Killers

Olson was running out of options. His physician Dr. David Porter was working on an experimental cancer treatment process with Dr. Carl June training a person’s own immune system to kill cancer cells. Olson decided that he wanted to be a participant in that clinical trial (ClinicalTrials.gov number NCT01029366) to assess the safety and feasibility of infusing autologous CART19 T-cells in patients with relapsed or refractory B-cell neoplasms.

In December 2009 the researchers at U of Penn collected Olson’s T-cells by leukapheresis (passing his blood through a machine that removed the cells and returned the other blood components back into the patient’s veins). The T-cells were then frozen while Olson was treated with chemotherapy to get rid of any remaining T-cells in his body. Olson received alemtuzumab (an anti-CD52, mature-lymphocyte, cell-surface antigen) for 11 weeks. Olson had stable disease for six months and was officially enrolled in the Phase I clinical trial July 2010.

Olson’s T-cells were re-engineered by a bold approach – by being injected with a disabled H.I.V.-1 that turned into “serial killers.” The reprogrammed T-cells produce chimeric antigen receptors (CARs) that target a protein called CD19 and attack the B-cell carrying that protein. Dr. June’s team was the first to use the H.I.V.-1 as the vector in gene therapy for cancer patients. Three patients were enrolled. All three participants in the study had advanced p53-deficient CLL.

The new T-cells were then introduced back into his body. Olson said after two weeks he thought he had the worst case of the flu he had ever had. The researchers were concerned that he was dying. Apparently the serial killers were doing their job. All his B-cells were destroyed (both healthy and leukemic). It took Olson two weeks to recover. When the researchers found that there was no evidence of leukemia in his body, they were as surprised and elated as Olson.

The re-engineered T-cells remain in his body to keep the cancer in check. The problem of no B-cells results in vulnerability to infection. Every three to four weeks Olson has to go in for an infusion of intravenous gammaglobulin (IVIG) -- a blood product containing antibodies from plasma donors.

The Leukemia & Lymphoma Society is funding Dr. Carl June’s team CARs research. The next milestone is to target only leukemic B-cells. This blood cancer procedure will soon be developed to apply to other cancers (i.e. pancreatic, colon, mesothelioma and ovarian).

I hope to hang in there long enough (with the help of ibrutinib) to also reap the benefits of this cancer treatment. And to think … I was looking in the face of a man that could be the forerunner of my cure. It was a good day. J

The scientific articles can be read in full in:

New England Journal of Medicine

http://www.nejm.org/doi/full/10.1056/NEJMoa1103849

Science Translational Medicine: Integrating Medicine and Science

http://stm.sciencemag.org/content/3/95/95ra73.short

Also refer to my post 3-30-13 This is a new day! With smart T-Cell vaccines.

Storming Capitol Hill: LLS Leads the Charge for Cures and Access

DECLARE IT! Cancer ends with me.

Blood cancers are the #3 leading causes of cancer death in the United States – right behind #1 cancers of the respiratory system (including lung cancer), and #2 cancers of the digestive system (including colorectal cancer), according to the American Cancer Society. Breast cancer is #4.

Since the Leukemia & Lymphoma Society (LLS) was formed, it has invested more than $1 billion in blood cancer research and is motivated to ensure patient access to these innovative therapies. What many people are not aware of is that blood cancer research is a gateway to cures for other cancers. Multi-drug chemotherapy and stem cell transplantation began as blood cancer therapies. Almost half of all cancer drugs newly approved by the US Food & Drug Administration (FDA) in the past dozen years were first approved for blood cancers.

LLS is a leader in a unique approach to research and fundraising. The non-profit forms partnerships with biotechnology and pharmaceutical companies, the National Institutes of Health, universities, and medical centers to discover innovative medical therapies and to move them to market.

I am proud to be an LLS patient advocate. Last week over 500 LLS patient advocates from all around the country stormed Capitol Hill lobbying for two health care bills (HR 460 the Patients’ Access to Treatments Act and S 1365/HR 2827 the Medicare Part D Beneficiary Appeals Fairness Act) to improve access to innovative therapies for patients. These bills address Medicare and private commercial insurance plans. The bill that was passed in Arizona addressed individual insurance plans and small group insurance. Both U.S. Congress bills when passed will make “specialty tier” drugs affordable.

We went through training workshops and formed teams to deliver a message to our legislators in the U.S. Congress. My team consisted of LLS staff, Board members, leukemia physician, patient (me). NOTE: I will be posting more about these wonderful team members in my next blog.

We met with the offices of two senators and five representatives:

(1) Rep. Kyrsten Sinema (Arizona District 9) (D)

(2) Sen. Jeff Flake (R)

(3) Rep. Ann Kirkpatrick (D)

(4) Office of Sen. John McCain (R)

(5) Office of Rep. Paul Gosar (R)

(6) Office of Raul Grijalva (D)

(7) Office of Rep. Trent Franks (R)

Another Arizona team met with several other representatives.

We did not even get pushback from the insurance companies when they realized that passing the bills would increase premium costs about $3 more per year. Not having access to these drugs would mean additional hospitalization costs, etc.

To say that these two bills are personal is an understatement. They directly affect my particular situation. If I do not have access after the clinical trial, I will not be able to afford the cost. The cancer will progress.

I will keep a very close watch on the voting of these bills.