I am writing to you as both a concerned urologist and the President of LUGPA to update you on the lack of co-payment assistance funding for Medicare and other federal beneficiaries battling metastatic castrate resistant prostate cancer (mCRPC). Those of you who treat advanced prostate cancer are undoubtedly aware of the recent lack of foundation-based financial assistance for the costly advanced therapeutics we routinely prescribe. The lack of assistance will impact an estimated 43,000 men and families in the next year.1
While uninsured or commercially insured patients in financial need may receive assistance directly from pharma companies, under the law, charitable copayment assistance foundations are the only source of financial relief for Medicare patients who have difficulty affording medication. Unfortunately, since about June of this year, charitable co-pay assistance foundations have run out of funds to distribute to Medicare patients in need.
As we approach 2017, the lack of funding presents a crisis point for men battling metastatic prostate cancer. More than 10,000 men on active treatment who received financial support in 2016 and need to renew their grants in order to continue their fight against the disease will find no funding available next year. Moreover, without funding in 2017, more than 33,000 new patients in need will go without financial relief.
The lack of foundation patient assistance funding stems from the following:
- In May 2014, the federal government issued new and stricter guidelines for charitable co-pay assistance. The new guidance required foundations to broaden their definition of disease states (for example, covering all metastatic prostate cancer patients, versus the narrower group of patients with metastatic castrate resistant prostate cancer). The need for foundations to cover all medications in broader disease states, including generics, has resulted in an influx of patients eligible for assistance, and a dilution of funds available specifically for mCRPC patients, who often require the most costly therapeutics.
- Since 2014, media and government scrutiny of assistance foundations and their relationship to pharma donors has increased. Just this year, the U.S. Department of Justice issued subpoenas to some charitable foundations and dozens of pharmaceutical companies related to co-pay assistance programs. As a result, donations from pharma in many disease states (including prostate cancer) have dried up.
- The combined effect of broader disease state coverage and reluctance on the part of pharma to donate to foundations in the current regulatory climate has led to the funding shortage that we are experiencing today.
While financial assistance is at a crisis point for Medicare patients, remember that pharma companies operate their own Patient Assistance Programs which are available to uninsured or commercially insured patients in financial need. We strongly encourage you to utilize these forms of assistance for eligible non-Medicare patients. Information regarding Patient Assistance Programs offered by the various companies offering therapeutics for patients with mCRPC is provided here. LUGPA has been in conversation with these companies, and this financial assistance information is provided with the support of each of the companies involved.
Unfortunately, we do not anticipate any quick fix to the tragic lack of foundation co-pay assistance for Medicare patients. LUGPA is working with various stakeholders, including pharma companies and patient advocacy groups, to encourage as much financial assistance as possible for prostate cancer patients. Clearly the legal and regulatory environment is an obstacle. If you have Medicare patients who have been denied access to treatment because of the lack of patient assistance, please pass this along to your pharma rep so that the pharma companies can understand the scope of the problem. Keeping track of this information may also be of use in helping us engage policymakers regarding these issues in the future.
LUGPA will continue to advocate, and keep you updated, regarding this serious crisis in access to care for Medicare patients with advanced prostate cancer.
Gary M. Kirsh, MD
1Data communicated to LUGPA from non-profit patient advocacy organizations.