Congressional Bills to help Medicare Cancer Patients with Drug Costs

Washington, D.C. Capitol

 From L to R: Jim Brewer, Rocky Harris (my son), Andy Gordon

La Verne Abe Harris, Senator Flake, Carolyn Earley, and Wes Gullet

Forty-three states and Washington, D.C. have advanced laws to ensure that patients taking oral drugs at home receive equitable coverage to patients treated at a clinic. These laws apply to those patients who have a state insurance. For those patients on Medicare or on a federal insurance, these state laws do not apply. That is why six of us were in Washington, D. C. the first week of May to talk to members of the U.S. Congress about the affordability of cancer drugs for those on federal insurance.

Wednesday, May 3, 2017 Senator Jeff Flake took a break from FBI Director James Comey's testimony before a Senate Judiciary Committee hearing to talk to the six of us representing the Leukemia & Lymphoma Society (LLS). Sen. Flake mumbled ”mildly nauseous” and shook his head as he approached us.

The LLS group talked to Senator Flake, Senator McCain’s office, and several House of Representative offices ( Representative David Schweikert's office, Representative Kyrsten Sinema's office) about several bills going through Congress that directly affect cancer patients. Thank you Jackie Davis of Nebraska, T. Irwin, Trudy Erickson, and Jerry A. Dale for providing letters that I hand delivered to the Congressmen and Congresswomen.

Here were our LLS Mission Day talking points for the Senate:

The Ask for the Senate was to cosponsor the C-THRU Act, 5.637 (Medicare Part D bill) to lower drug costs for seniors.

Problem:

Medicare Part D prescription drug plans are becoming more costly to Medicare patients. Cancer drugs placed on a specialty tier force patients to pay a percentage of the retail drug price, not a flat co-pay.

Solution:

Medicare patients would be able to negotiate the cost of the drug and use the plan-negotiated price —not the retail price— as the foundation for cost-sharing. This would lower the out-of-pocket costs substantially.

The Ask for the Senate was to vote NO on the AHCA, H.R. 1628

Problem:

Insurance would not be affordable for cancer patients and the USA would revert to a health system where much higher prices are charged to a person who has a pre-existing condition, such as a cancer diagnosis. In the past this accounted for survivors paying more than 10 times the premium charged to a healthier person. Medicaid coverage for millions will be eliminated leading to an additional 24 million more Americans without insurance, according to the Congressional Budget Office.

Solution:

Reject the AHCA and Congress needs to identify solutions to the problems between patients and their treatments by working with groups like the Leukemia & Lymphoma Society.

The Ask for the House of Representatives was to sponsor the Oral Parity bill, H.R. 1409.

Problem: Over one-third of the new drugs to fight cancer come in the form of oral pills. Because health insurance rules were written before the invention of oral drugs, chemo drugs delivered intravenously are covered, but oral drugs fall under prescriptions. This results in patients paying hundreds of thousands of dollars more to the health plan for oral drugs, even if the chemo drugs delivered intravenously cost more.

Solution: Cancer drugs are cancer drugs whether they are delivered intravenously or orally. There should be parity for Medicare patient out-of-pocket costs and for patients on federal health insurance. Forty-three individual states have adopted oral parity laws with no negative impact on insurance premiums. This protection needs to be extended to those 65 and older.

The following Ask was not honored by the House: The Ask was to vote NO on the AHCA, H.R. 1628

Problem:

Insurance would not be affordable for cancer patients and the USA would revert to a health system where much higher prices are charged to a person who has a pre-existing condition, such as a cancer diagnosis. In the past this accounted for survivors paying more than 10 times the premium charged to a healthier person.

Medicaid coverage for millions will be eliminated leading to an additional 24 million more Americans without insurance, according to the Congressional Budget Office.

Solution:

Reject the AHCA and Congress needs to identify solutions to the problems between patients and their treatments by working with groups like the Leukemia & Lymphoma Society.

Andrew Schorr, Co-Founder and President of Patient Power posted very good news from the Business Wire for Washington, D.C. cancer patients: http://www.businesswire.com/news/home/20170511005460/en/Patient-Power-Law-District-Columbia-Protect-Local.

The Specialty Drug Copayment Limitation Act signed by D.C. Mayor Murial Bowser was reported on May 11, 2017 to protect local patients from high copays for prescription medications. The new law, titled the "Specialty Drug Copayment Limitation Act,” will “impose a limit on the amount that a person must pay in copayment or coinsurance through a health benefit plan for a prescription for a specialty drug.” This refers to prescriptions for progressive, debilitating diseases such as cancer – the bill specifically mentions the blood cancer multiple myeloma. 

 

“The law doesn’t go into effect until January, but we want to acknowledge this important step now amidst all of the turmoil over federal healthcare legislation,” said Andrew Schorr, Co-Founder and President of Patient Power and a 21 year cancer survivor. “High out of pocket payments can prevent many patients from taking the full dose of medications they need. Putting a limit on those personal payments can help patients like me. I’ve depended on specialty medications to keep me alive and well and working 21 years since my initial diagnosis.” 

Esther Schorr, Patient Power Co-Founder and Chief Operating Officer, added, “The law will limit out of pocket payments to $150 for a 30-day supply of specialty medicines and $300 for a 90 day supply. This is critically important not just for patients but for their families. We should never have to make the terrible choice between the health of our loved one and the prospect of bankruptcy or losing our home.” 

Affordable copayments do make a difference. Greg Simon, Executive Director of the Cancer Initiative for the Biden Foundation and a CLL survivor, recently told Patient Power in an interview that manageable copays made a big difference for him. He said that although some innovative cancer therapies can be very expensive, his own copay was very affordable. 

This may sound costly to the healthcare system, but it actually saves money. A 2013 report study published in the Journal of Clinical Oncology said patients not taking their medications as prescribed “resulted in $105 billion in avoidable health care costs in 2012.” 

Similar bills have also passed in California, Delaware, Louisiana, Maine, Maryland, Montana, New York, and Vermont. The D.C. law takes effect January 1, 2018.

Now if we could just get this passed across the USA for Medicare patients!

Co-Pay Assistance on Medicare

Early Monday morning, May 1^st, I am flying to Washington, D.C. with my son to attend a Leukemia & Lymphoma Society (LLS) conference. The main purpose for me is to talk to several Congressmen and Congresswomen about drug parity bills that are on the table. Once cancer patients go on Medicare (age 65), the out-of-pocket cost of oral cancer drugs becomes unaffordable for most people.

Cancer drugs are cancer drugs whether they are delivered intravenously or orally. The insurance laws were written before oral cancer drugs were invented. This needs to be changed.

In the meantime, Len K (lenkeck) gave me permission to repost his Health Unlocked response to help those Medicare patients struggling with co-pay payments and access to their cancer drugs. Please note that these non-profit organizations are usually funded by Pharma companies.

See the full list:

rxassist.org/patients/res-c...

Programs that Assist with Medication

Co-pays

Some organizations offer to help insured patients that are having difficulty paying the co-pays for their medications or their insurance. These programs are for very specific diseases or medications. Some of these programs include:

Caring Voice Coalition was established early in 2003 to serve comprehensive needs of all individuals affected by serious and chronic disorders, through collaborative efforts and partnerships with organizations established to serve those patient populations. Current programs include: Insurance Reimbursement and Advocacy, Vital Relief (need based financial assistance limited to certain disorders or medical conditions), Compassionate Care (counseling and counseling referrals) and Public Advocacy. Visit:caringvoice.org/

The Chronic Disease Fund, a non-profit organization founded in 2003. Its focus is to provide assistance to those under-insured patients who are diagnosed with chronic or life altering diseases that require the use of expensive, specialty therapeutics. Visit: https://www.guidestar.org/profile/61-1462062/ 

The HealthWell Foundation, a 501(c)(3) non-profit organization established in 2003 to address the needs of individuals who cannot afford their insurance copayments, premiums, coinsurance, or other out-of-pocket health care costs. Visit: healthwellfoundation.org

The National Marrow Patient Assistance Program and Financial Assistance Fund. The Marrow Foundation is the fund-raising partner of the National Marrow Donor Program (NMDP). Funds from this program help patients pay for searching the National Marrow Donor Program (NMDP) Registry and/or some post-transplant costs. Applications for Patient Assistance Program funds must be submitted by an NMDP transplant center. Eligible patients may ask their transplant center coordinator to apply for one or both programs. Call 1 (888)999-6743 or email patientinfo@nmdp.org.

Visit: bethematch.org

The Patient Access Network Foundation is a non-profit 501(c)(3) organization dedicated to supporting the needs of patients that cannot access the treatments they need due to out-of-pocket health care costs. Visit: patientaccessnetwork.org

The Patient Advocate Foundation, a national non-profit organization that seeks to safeguard patients through effective mediation assuring access to care, maintenance of employment and preservation of their financial stability. The Patient Advocate Foundation's Co-Pay Relief (CPR) Program provides direct co-payment assistance for pharmaceutical products to insured Americans who financially and medically qualify. The Program offers personal service to all patients through the use of CPR call counselors. Visit: copays.org

Patient Services Incorporated, developed in 1989, is a non-profit charitable organization primarily dedicated to subsidizing the high cost of health insurance premiums and pharmacy co-payments for persons with specific chronic illnesses and rare disorders. PSI is committed to assisting persons with chronic medical illnesses in accessing health insurance and pharmacy co-payment assistance. Families requiring assistance in maintaining the high cost of their health insurance premiums or co-payments are offered assistance based upon the severity of medical and financial need. PSI offers a "safety net" for persons who have expensive chronic illnesses and for those persons who "fall through the financial assistance cracks. 

Visit: https//www.patientservicesinc.org 

Love & Gratitude,

Dr. La Verne

PLAN B AND PLAN C

Sometimes it is good to be doing activities that help me forget that I am a cancer patient – like tai chi, playing with my grandchildren, painting, and stand-up comedy. But being a patient advocate is very rewarding, and often introspective for me.

I recently returned from the Seattle Cancer Care Alliance (SCCA) to establish a Plan B and Plan C in case I (or anyone in my situation) relapses on ibrutinib, has problems with side effects, or fails to have access to the drug due to financial reasons. My Plan A has been ibrutinib (aka brand name: Imbruvica) so far.

I started on the drug to combat Chronic Lymphocytic Leukemia (CLL) in a clinical trial July 12, 2012. I obtained complete clinical remission January 2015. What most people don’t realize is that does not necessarily mean you are cured of cancer. If you are MRD-positive (minimal residual disease) like me, there are still 0.5% leukemic cells floating around in my bone marrow. That is why I take an oral cancer drug every day.

A F2F MEETING WITH A VIRTUAL FRIEND

When I entered the Seattle Cancer Care Alliance building, I stopped by one of the infusion rooms on the fifth floor to see a CLL virtual friend in the flesh … Lisa M. Weiss. Lisa had been intolerant on ibrutinib, and relapsed and was refractory to chemo. She is now on acalabruitinib. Lisa and I spent a couple hours chatting. We had talked before on the phone and she recommended the SCCA. She is a CLL patient, a patient advocate, and manages a Facebook group for women with blood cancers (CLL/SLL/NHL Cancer support for women). She is very knowledgeable and I loved talking shop with her.

We discussed how CLL is a disease of the immune system. Lisa gave me the link to a couple articles:

(1) Scientists have discovered 41 DNA changes that influence the risk of CLL (https://medicalxpress.com/news/2017-02-immune-genes-linked-common-leukaemia.html)

(2) The Center for Prevention of Progression of Blood Cancers (CPOP) research initiative at Dana Farber Cancer Institute in Boston is researching chromosome mutations in CLL patients (http://www.dana-farber.org/Research/Departments-and-Centers/Blood-Cancer-Prevention-of-Progression-Clinic.aspx).

PLANS B AND C

After my visit with Lisa, my husband and I sat down with Dr. Mazyar Shadman from Fred Hutch/SCCA to discuss the 400 pages of my medical records and to discuss my Plans B and C.  Mazyar Shadman, M.D., M.P.H is an Assistant Professor, Medical Oncology, University of Washington, and an Assistant Member, Clinical Research Division, Fred Hutchinson Cancer Research Center. He spent an hour and a half with us. He told us about the genetic research that is being done at SCCA, the CAR-T cell therapy, allogeneic bone marrow transplants (which many CLL experts see as a last resort), and the research being done by Dr. Richard James, which is funded by an NIH grant.

If a cancer patient relapses on ibrutinib, it will usually be within the first few years. Most are 17p-deleted folks like me. It has been four years and eight months for me. Dr. Shadman said that for patients like me, it has been found that the quality of response and the side effects get better with time. My worst side effect was the severe cramping in muscles in my body and my limbs. Hydration and exercise with stretching seems to have been the key for me. I have to be mindful of what I eat because of inflammation. If I give you a fist bump instead of a handshake, it is because I am immune-compromised and hands are the number one carrier of germs. I am not trying to be cool. LOL.

Here is a tidbit of information for you science nerds:

Dr. Shadman said that there are two CLL mutations in resistance that are key to patients who are taking IMBRUVICA (A.K.A. ibrutinib): (1) BTK-C481S mutation, and (2) PCG2 mutation, an enzyme mutation that makes the BTK pathway independent. The PCG2 mutation is the one he said would apply to me, if I relapse.

So what are my Plans B and C in case I either relapse on ibrutinib or do not have access to the drug? Dr. Shadman said there are many novel agents available in clinical trials. One drug that is off trial and FDA approved is venetoclax. That would be his first choice for me.

If I have disease on board, I would be pre-treated with FC (Fludarabine + Cyclophosphamide) chemotherapy before a CAR-T Cell procedure. I wrote about this trial at the University of Penn in one of my previous postings. Now remember I am chemo-resistant (17p deleted and p53 mutation), so I asked him why I would be treated with chemo. He said it is to suppress the immune system.

SCCA has done 150 CAR-T therapies in their clinical trial. It targets CD19. Because CD19 is also found on healthy B-cells, the patient will have to have IVIG infusions every month or two, but the cancer is essentially gone from your body. It is a small price to pay.

It is in those moments when I meet with the medical team or researchers that I remember how serious immune deregulation disease is.

CAR-T CLINICAL TRIAL AT SCCA

Cyndi Stansbury entered my NIH trial with ibrutinib five months before me and relapsed in 2015. Here is a success story of the CAR-T Cell procedure:

E-mail from Bill Stansbury:

“My wife, Cynthia Stansbury, was one of the original patients in the NIH Ibrutinib trial for CLL. My wife has the 17p deletion. She was admitted into the trial in February 2012. She did well on the drug with little side effects, other that bruising easily and one bout of A Fib. In October of 2015 she began to relapse with escalating WBC. Cynthia was referred to Stanford where she was admitted into a trial for ABT-199 (Venetoclax). She was hospitalized briefly at the beginning of the trial due to tumor lysis. She relapsed off the Venetoclax after eight months showing enlarged lymph nodes on a CT scan.

It was suggested to us by the staff at Stanford that here best option was CAR-T immunotherapy.  To make a long story short, we just got back from three months in Seattle where Cynthia underwent CAR-T therapy. It was not easy by any means. She underwent three days of chemotherapy prior to the day when she was to have her cells re-infused. At that time she contracted RSV (a viral infection). She had to get over the infection before she could get her cells re-infused. That took two weeks. They then had to repeat the initial chemo then re-infuse her cells several days later. One week after re-infusion she was hospitalized for 11 days due to cytokine release syndrome. She was extremely ill during this period. About 20 days after the re-infusion, Cynthia underwent a spinal puncture, bone marrow biopsy, blood tests and PET/CT scans. There was no evidence of CLL in her blood, bone marrow or spinal fluid. Her lymph nodes showed a 40-70% reduction in size. Her FISH test showed no 17p. The care she received in Seattle was excellent. Cynthia goes back in April for a check-up.”

Cynthia was on the Emerald Team at the SCCA clinic, and Dr. Maloney oversaw the CAR-T clinical trial in which she was enrolled. Dr. Ramos was her doctor during the procedure, and follow-up will be with Dr. Shadman and Dr. Turtle. Bill and Cynthia Stansbury have graciously offered their email (billstans@msn.com) if anyone has any other questions.

IN CONCLUSION

Life goes on. I am preparing for a stand-up comedy show at the Improv this month to benefit cancer research for the Leukemia & Lymphoma Society. I am still alive and kickin’ because of cancer research. I am eternally grateful and I thank God for every beautiful day I have on this earth. I am even thankful for the crappy days. LOL.

Laughter Therapy

“The most wasted of all days is one without laughter.” – E. E. Cummings

A&K Sisters (Diane Miner and MaMa La Verne)

Laughter therapy uses the gift of humor to counter stress. It is learning how to laugh at things in your life that don’t seem funny at the time. Being diagnosed with cancer and the passage that follows is a stressful situation. I decided early on in my cancer journey that I could either use my limited energy to cry about it (which is acceptable and necessary every once in a while)… or I could heal myself and promote my wellbeing through comedy.

Even in my “horizontal days” – the days I did not have the energy to do anything – I watched comedy movie marathons lying on the sofa without guilt. I was listening to my body and it needed rest. I was listening to my mind and heart and they needed joy.

When I reached clinical complete remission January 2015, I decided I would do something out of my comfort zone. I signed up for a class on how to write jokes at out local arts center. There I was… the only female in a roomful of 20- and 30-somethings. It made me feel like I was back working with my university graduate students – something I missed terribly, since I had to leave my professorship shortly after I was diagnosed, because of the fatigue and side effects. Most of my jokes centered on my husband Carl, who I refer to as “Coach” in my act. I have been married to the man for over 40 years, so I had plenty of material.

Next session was the stand-up delivery class. I showed up and I was the only person from the joke-writing class to move on. The rest of the “students” were stand-up comedians who had performed in public before. Some were even headliners at the comedy clubs. Oh, brother! I wondered if I had made a BIG mistake. Now granted, I had lectured in front of hundreds of university students, but the students had to be there or they would flunk. LOL. This was different.

Then the leader “Creepy Guy” asked me to go up to the mic, introduce myself, and say something funny. The first thing that went through my head was that I was going to flunk this class!

But I am not a quitter, so I slowly walked up to the mic. “Hello, I’m MaMa La Verne and I’m a virgin [long pause and confused looks on their faces] … of comedy. Everyone laughed. I was rather surprised. So I guess it was going to be okay.

I wrote my jokes for my first show and rehearsed in front of Coach. He said to me, ”Are you planning on making people laugh?”

“Well, of course,” I said.

“Well, you are going to have to turn it up a notch!” he advised.

“But most of the jokes are about YOU!” I said.

My husband responded, “I don’t care. Just make them laugh.” Coach is my inspiration and one of the finest men I know.

I had gotten to know several of the female stand-up comedians at the center. One was Diane. In our after-class conversations I shared with her my cancer diagnosis. She shared with me the death of her husband of 48 years and the cancer journey of her 20-year-old son. We bonded.

So I performed in a series of three class clowns acts at the arts center, when it struck me: Who needs laughter therapy the most? Cancer patients! So I formed a group: The A&K Sisters (Alive & Kickin’). The only problem was that I was the group.

A few months later Diane came up to me after class and was a little shaken. “The doctor says I have multiple myeloma!” I blurted out, “Oh, good! Then you can be my partner and we can do stand-up comedy for cancer survivors!” At first she looked confused. And then she gave me a big smile. She said that was the strangest response she had ever gotten.

So Diane and I have performed at the Improv for a room of about 200 cancer survivors, caregivers, and donors. We performed at the Virginia Piper Cancer Center in Scottsdale several times, and we will be performing for about 100 women in February at St. Joseph’s Hospital in Phoenix for a non-profit called Face-in-the-Mirror (http://www.faceinthemirror.org/). These pro bono stand-up comedy performances are gifts of love and gratitude for those who did not choose to go on the Big-C journey. This is our volunteer work in our soup kitchen.

MaMa La Verne: Hope is the word: Spread the laughter, heal the soul.

Diane: In the end what matters most is how well you live,

MaMa La Verne: how well you love,

Diane: how well you learn to let go,

MaMa La Verne: how much you laugh

MaMa La Verne & Diane: and how hard you kick cancer’s ass!

Pass it on…

Love & Gratitude

 Carl and I with our 14 grandbabies (half are adopted and special gifts to our family).

45 years and still counting.

This has been a very busy time of year for me, and believe me I am not complaining. I am very grateful for every day I have on this earth. I am grateful for my family and my friends. And I am VERY thankful for the medical researchers who conduct clinical trials.

Sharing my Story with Pharmacyclics

I recently returned from a visit with the Pharmacyclics folks in Sunnyvale, California.
Here I am with Wulff-Erik ("Erik") von Borcke, the President, and posing with the painting that I was commissioned to paint for their lobby "A Piece of my Heart (Part 2)."

I met with Erik for about 40 minutes and then he interviewed me in front of a crowd of about 300-400 employees for about an hour. Ibrutinib is one of their cancer drugs, so we discussed my cancer journey. What a remarkable experience for me. The employees wanted to put a human face with the drug they are manufacturing. In the audience was a recent grad of the Computer Graphics Technology Department at Purdue University, where I taught, researched and wrote grants. Small world; isn't it?

4 years and 3 months on ibrutinib

I just returned from the National Institutes of Health in Bethesda, Maryland with a medical update. After four years and three months on ibrutinib, my blood work remains good, specifically my white blood count, which is still in the normal range (8.3K).

I had the opportunity to meet two patients on the ACP-196 clinical trial, and met Nancy, a retired school teacher from Houston, who is in the same leg of the ibrutinib trial as I am, and still doing well. My blood brother George is still alive and kickin’ on ibrutinib. He started the trial the same day as me.

However, as of Thursday, Oct. 13, 2016, 17 participants in my clinical study with ibrutinib have relapsed after four to four and a half years on the drug. Most were 17pDEL, some were complex karyotypes, and all received prior treatment before ibrutinib. If ibrutinib is a frontline treatment for you (as it was for me), it may work in your favor, according to Dr. Ahn Inhye.

The good news is that there are lots of options now if you relapse that were not available when I was originally diagnosed August 2009. Clinical trials with venetoclax (an Abbvie drug) have shown amazing results. Trials combining ibrutinib and venetoclax have resulted in some MR negative results, which are associated with long-term survival. Minimal residual disease (MRD) is when a person is in remission, but there are still a small trace of leukemic cells from the bone marrow that remain, even though the patient shows no sign of disease. That’s me. It’s those little boogers that can cause a relapse.

I have another unrelated issue I am taking care of that has to do with my immune system. My GP said that recent bloodwork indicated I tested positive in three blood tests: (1) anti-nuclear antibody (ANA) test, (2) rheumatoid arthritis (RA) test, and Sjogren Syndrome. The important thing to remember is that any of these tests can be a false positive, so I will not worry about it until I find out otherwise.

The ANA test reveals the abnormality of autoantibodies attacking the body’s own cells, which may indicate the diagnosis of lupus. Further testing is needed. The RA test checks for autoimmune disease of the joints. I have an appointment with a specialist in December. Sjogren Syndrome is an inflammatory disease affecting the immune system and tear and salivary glands – hence dry eyes and dry mouth issues.

So now I am trying to get my short-term memory cells to communicate with each other, because I am performing in two stand-up comedy routines next weekend. As the Alive & Kickin’ (A&K Sisters), my stand-up partner Diane Miner and I will be opening for the Decoding Annie Parker movie and book signing in Scottsdale on Saturday. It is about the discovery of the breast cancer gene.

On Sunday in Tempe I will be doing a stand-up comedy act as MaMa La Verne at the IMPROV, along with other comics, to benefit the Leukemia & Lymphoma Society.

So there it is. Life is unexpected and concerning, yet joyful. Hope is the word: Spread the laughter, heal the soul.

In the end what matters most is how well you lived,

how well you loved,

how well you learned to let go,

how much you laughed

and how hard you kicked cancer’s ass!