CANCER ABCs, Inc.
315 HICKS STREET
SUITE 2F
BROOKLYN, NEW YORK 11201
Administrator Seema Verma
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
December 7, 2020
Re: CMS-5528-IFC
Dear Administrator Verma:
Cancer ABCs is an advocacy and educational organization that assists people affected by cancer
to become CANCER THRIVERS. We have become very concerned by the recent news that
CMS will be utilizing a drug reimbursement plan called the Most Favored Nation (CMS-5528-
IFC.).
We want to let you know that we are in strong opposition to CMS utilizing this model because it
will significantly have a negative impact people with cancer, especially when they are most
vulnerable. CMS should be focused on assuring that Americans have access to life-extending
drugs. The Most Favored Nation scheme will limit access to certain drugs and treatments to
people with cancer.
Cancer ABCs is in opposition to the entire Most Favored Nation scheme, but we are most
concerned about its potential negative impact on men with prostate cancer. Cancer ABCs works
with thousands of men who have prostate cancer. The Most Favored Nation plan will
immediately block access to a significant life-extending immunotherapy treatment called
Provenge (sipuleucel-T).
Provenge has demonstrated, in multiple clinical trials, its ability to extend men’s lives, but it does this without the many terrible side effects that often plague men with other treatments.
Provenge’s life extending ability is important, despite the false folklore that prostate cancer is not a lethal disease. Prostate cancer is deadly; it kills over 33,600 men in the US every year (cancer.net), and is the second leading cause of cancer deaths in men (ACS).
Prostate cancer is also the most commonly diagnosed cancer, other than skin cancers, in men, causing an enormous impact on our economy, on the families of men with prostate cancer, and the men themselves.
We ask that you familiarize yourself with Provenge and the process involved in giving it to
patients so that you will understand how this scheme will block access to this treatment. Under the proposed scheme, clinicians would find that their add on payments for administering Provenge would be reduced by 92.5%, making it economically impossible for them to offer Provenge to any man with prostate cancer.
Provenge’s administration involves three treatments on a precisely timed cell collection regime and infusion over six weeks. Providing Provenge is an administratively and logistically complex and resource-intensive treatment regimen for clinicians.
Without adequate add on payments to clinicians, access to this life-extending treatment will be
denied to American men. The proposed reimbursement schedule for Provenge will not come
close to covering a clinician’s direct costs for providing Provenge. As a result of this
proposal, we have become aware that some men in some areas of the country have already had access to Provenge denied because their clinicians, concerned about reimbursement, have cancelled their treatment!
Provenge is an immunotherapy that involves a highly complex and time-sensitive administration process. Providing Provenge is intricate and time-consuming. Unlike the other 49 drugs on the list, Provenge is not just a simple injection or prescribed pill. It involves three treatment cycles; each cycle includes apheresis followed by a precisely scheduled infusion.
The proposed reimbursement scheme will not even cover the clinician’s direct overhead.
Clinicians will not be able to offer this life-extending treatment to men with prostate cancer.
Since Provenge is the only immunotherapy in prostate cancer, and is administered only in the
US, there are no international comparisons, and it is subjected to the most drastic add on payment price reduction on the entire drug list in CMS-5528-IFC. This is unacceptable for cancer patients, and not even in alignment with the stated purpose of CMS-5528-IFC which mentions taking “into account the discounts that other countries enjoy” and “preserving or enhancing quality of care furnished to Medicare beneficiaries”. This proposal does the opposite for prostate cancer patients.
In a time that we have become more aware of racial disparities in cancer care and treatment, we also want to point out to you that African American men are at a much higher risk of dying from prostate cancer than Caucasian men. Research (February 2020 - Sartor, O., Armstrong, A.J., Ahaghotu, C. et al. Survival of African-American and Caucasian men after sipuleucel-T
immunotherapy: outcomes from the PROCEED registry. Prostate Cancer Prostatic Dis 23,
517–526 (2020). https://doi.org/10.1038/s41391-020-0213-7) has shown that Provenge provides a superior survival advantage to African American men.
Including Provenge in the Most Favored Nation scheme will have a magnified negative impact on African American men, who are at a higher risk of dying from prostate cancer. Including Provenge in this scheme will deny access to this treatment preventing those who are most in need of accessing this life extending treatment.
Cancer ABCs asks that CMS immediately exclude Provenge from this experiment
because it is a cell or gene therapy; with similar supply chain criteria used to exclude vaccines.
The proposed reimbursement schedule will not cover the basic significant healthcare practitioner costs. Clinicians who provide their patients with Provenge incur high costs that need to be reimbursed; otherwise, they will stop providing this treatment.
Just like every other American, we are sympathetic to CMS’s focus on lowering beneficiary out-
of-pocket costs. However, this cannot come at the expense of men’s access to life-extending
therapies.
.
Sincerely,
Joel T Nowak, MA, MSW
CEO, Cancer ABCs
