The challenge of providing financial assistance for expensive cancer drugs

Drug companies must be especially cautious when interacting with patients and nonprofits. Such interactions must navigate a policy minefield designed to protect patients as well as ensure fair market conpetition.

One example of such policy is regulation that prohibit drug companies from enticing patients to take one drug instead of another. This is important from a medical ethics perspective. However, such policies complicate the process of assisting patients with affording expensive newer drugs like cancer targeted therapies and immunotherapy.

Most patients could not afford to take the expensive ($17K+ per month) FDA-approved drug — like crizotinib, the one that keeps me going as a ROS1 cancer patient — without insurance and copay assistance. This is especially problematic for Medicare patients, who must pay out of pocket to get through the prescription drug coverage “donut hole” every year. I’ll be there soon.

To be fair, and to comply with regulations, patient assistance programs should help all patients access any approved targeted therapy. But who should pay for that? If one drug maker supports such a program, must all makers of competing drugs do so? If only one or two drugmakers participate in the program, does that make it unethical? Does such a program support higher drug prices, or fuel innovation by allowing patients rapid access to new, more effective drugs?

I don’t have the brainpower to answer those questions. I just know that cancer targeted therapy has made a huge difference in my life for nearly seven years, and I want every patient to have the same opportunity to access an appropriate new therapy that matches their biomarker.

The article below explores some of the pitfalls awaiting those who try to help patients pay for expensive new drugs. Sorry it’s behind a paywalll.

Two patient charities settle allegations of helping drug makers pay Medicare kickbacks (STAT News)

Want to be a #lungcancer patient research advocate? Inaugural @IASLC STARS program application period is open!

    • Have you or a family member been diagnosed with lung cancer?
      Are you already active in providing lung cancer support and/or education to others?
      Do you want to ramp up your advocacy work and learn more about the science of lung cancer research?

    THEN …

    Apply for the brand-new STARS (Supportive Training for Advocate in Research and Science) program!  STARS was developed by the IASLC (International Association for the Study of Lung Cancer) in collaboration with international lung cancer patient research advocates and advocacy nonprofits.

    Those accepted in the program will be assigned a mentor from their own country, meet and learn lung cancer science from researchers, develop science communication skills, and attend the World Conference on Lung Cancer (WCLC) in Barcelona, Spain in September 2019.

    To learn more and to find the online application, click here:
    https://www.iaslc.org/supportive-training-advocates-research-and-science-stars

    The application period is open from March 8 to May 1, 2019. Hope you’ll apply!

    Thinking about a “drug vacation” from crizotinib? Read this first!

    Original post is on The ROS1ders website

    I’m Janet Freeman-Daily, a cofounder of The ROS1ders.  I’m writing this post in response to some of the comments we’ve seen recently in our private Facebook group “ROS1 Positive (ROS1+) Cancer.”

    Many of our members who have ROS1+ cancers take the targeted therapy crizotinib (Xalkori), a tyrosine kinase inhibitor (TKI).  It was approved by the US FDA for ALK+ non-small cell lung cancer (NSCLC) in 2011, and for ROS1+ NSCLC in 2016.

    Many ALK+ and ROS1+ NSCLC patients have had long-term stability or no evidence of disease (NED) on crizotinib, and are tolerating it well. Some of these patients suggested they might “take a vacation” from crizotinib for a while, as some people do with chemo. They think this could help them avoid developing resistance to crizotinib (which could allow them to stay on the drug longer), and that they can start taking the drug again later if the cancer returns. Their oncologist might even agree with this idea.  But …

    PLEASE — If crizotinib (Xalkori) is working for you and you can tolerate it, consult a ROS1 expert before stopping treatment!  

    If your doctor tells you should stop taking crizotinib for a medical reason (like a severe side effect or toxicity), or temporarily during surgery or radiation, you should follow their advice. But don’t stop taking crizotinib just because you want a drug vacation.

    ROS1+ cancer is a rare disease. Oncologists who have seen no or few ROS1 patients usually haven’t followed the fast-moving research into this disease.

    Dr. Ross Camidge and Dr Robert Doebeleare among a handful of doctors who have treated dozens of ROS1+ and ALK+ patients with crizotinib. Globally, they are considered experts in ROS1+ NSCLC.  Both have told me they think it’s a bad idea for patients to stop taking Xalkori just because they’re NED or stable on the drug. Below are the reasons they gave me.

    • Targeted therapies are not the same as chemo. TKIs inhibit the cancer, but do not kill it. For metastatic cancer patients, cancer cells likely remain in the blood, lymphatic system, or body (we just don’t have the means to detect them–that’s why we say “no evidence of disease” instead of “cancer free”).  If you stop treatment, you stop inhibiting those cancer cells, and any cancer that remains can resume growing—sometimes very fast. Those cells can continue to mutate. There is no guarantee that crizotinib will be effective against your cancer when you restart it after a “drug vacation.”
    • TKI flare is well documented for EGFR and ALK patients on TKIs like Xalkori.  What is TKI flare? Some patients (not all) on TKIs who stop taking the drug can see their cancer grow quickly after just a week or two. When they restart the drug, it doesn’t always work again.
    • We don’t have much evidence of what may happen if NED patients stop taking their TKI, except for one study.  In the study,  EGFR+ NSCLC patients who had no evidence of disease on Tarceva (a TKI like Xalkori) stopped taking their cancer drug. All saw their cancer return within a year.
    • While chronic myeloid leukemia (CML) patients on a TKI (Gleevec) have been able to stop taking their TKI, their blood cancer is not as aggressive and deadly as lung cancer.

    Each patient has the right to make up their own mind about their treatment,  In my case, I have had no evidence of disease on crizotinib for 6 years. When I asked about stopping crizotinib, Dr. Camidge has told me that he does not want me to stop taking my cancer drug. I’m going with his expert opinion.

    Join me for @TheALCF Lung Cancer Living Room 1/15 5:30 PM Pacific

    Please join lung cancer patients/survivors Teri Kennedy, Jeff Julian, Don Stranathan, Andy Trahan, and me, along with Dr. Amy Moore (Director of Science and Research, Bonnie J. Addario Lung Cancer Foundation, also know as ALCF) Tuesday January 15, 2019 5:30-7:30 pm Pacific Time for a discussion on “Navigating the Latest Advances in Lung Cancer Treatment.” I’ll have an opportunity to talk about The ROS1ders and the research project we created  in partnership with ALCF.

    Join us in person in San Carlos, California, watch live on Facebook, or watch later on YouTube or in the Living Room Library.

     

    My #WCLC2018 Presentations

    I’ll be attending the annual World Conference on Lung Cancer (#WCLC2018) in Toronto Canada later this month.  For those who are interested, I will be making two presentations.  Hope I’ll see you in the audience!

    OA10 – Right Patient, Right Target & Right Drug – Novel Treatments and Research Partnerships
    Tuesday 9/25 10:00 AM to 12:00 PM
    Oral Abstract Session in the Targeted Therapy Track
    Moderated by Howard (Jack) West, Jyoti Patel

    ES05 – Collaboration Between Stakeholders to Improve Lung Cancer Research 
    Tuesday 9/25 15:15 PM to 16:45 PM
    Education Session in Advocacy Track
    Moderated by Bonnie Addario, Toshiyuki Sawa

    Call to Action — Lung Cancer Patients & Doctors in Oregon

     

    pills in dollar sign

    Are you from Oregon? You may be losing a very important tool to help you survive cancer. Please stand up to keep providing Medicaid coverage of FDA approved comprehensive genomic sequencing. Many lives depend on it!

    OREGON CALL TO ACTION!
    The state of Oregon Health Authority Health Evidence Review Commission (HERC) recently released proposed guidance to not provide coverage for the use of FDA-Approved Next Generation Sequencing (NGS) tests for cancer patients in the state with Medicaid.

    LUNGevity Foundation and Caring Ambassadors are seeking volunteers–both lung cancer survivors and health care professionals–who live in the state of Oregon, to provide testimony at a public meeting on this issue scheduled for 1:00pm-4:00pm on  September 27, 2018 in Wilsonville, Oregon. Ideal testimony would be provided by survivors who have received NGS, or other comprehensive biomarker testing, to guide their treatment and by health care professionals who order, consult, or care for patients who have received NGS, or other comprehensive biomarker testing.For more information or to volunteer, please contact:

    • Anna Pugh, LUNGevity Foundation Director of Public Policy Initiatives, at agpugh@lungevity.org or 240-454-3105 or
    • Cindy Langhorne, Caring Ambassadors Lung Cancer Program Director at cindy@caringambassadors.org or 503-632-9032 ext. 1.

    A copy of the comments submitted by LUNGevity Foundation to the HERC can be found here.

    Thanks to Matt Ellefson at SURVIVEiT! for helping to make this need known.

    Medicare approves genomic testing for cancers

    Today the Centers for Medicare and Medicaid announced they will cover Next Generation Sequencing (NGS) for cancer! This is a major victory for all cancer patients.

    Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N)