EACH/PIC Coalition

EACH/PIC Coalition Responds to CO PDAB RFI via Data Submission Guide for Enbrel Rulemaking

The EACH/PIC Coalition submitted information to the CO PDAB in response to the Data Submission Guide on Enbrel for the Upper Payment Limit (UPL) rulemaking process. The letter outlines the special medical needs of those with chronic conditions, specifically those considered disabled or elderly, and urges the board to protect patient access to all needed therapies.

The letter states:

“Impact to Persons with Disabilities: The effects of chronic autoimmune conditions like those treated by Enbrel can differ dramatically from one patient to another. Some individuals may experience relatively mild symptoms and respond well to readily available treatment options. For others, the impact can be profoundly debilitating—preventing them from working, participating in family life, or fulfilling caregiving responsibilities due to ongoing pain or medication side effects. These challenges are often compounded when a patient is managing more than one chronic condition, which is a common occurrence.”

“Impact to Older Adults: Similarly, health complexities typically increase with age and older adults are more likely to have comorbidities that require individualized care plans comprised of multiple treatments. Further, research has shown that early interventions with the right biologic for each person’s disease can result in earlier remission. Therefore, unmitigated access to a broad spectrum of medications early in life is critical to health in later years.”

“For these patients, therapeutic alternatives may not be alternatives at all. Very often drug interactions or other health conditions would prevent individual patients from being able to switch to an alternative medication that, on paper, seems like it would be an appropriate treatment. Further, patients with chronic conditions can build up a tolerance to medications over time, so they must retain access to all treatments in a class of drugs to prolong their treatment.”

“While UPLs are intended to lower costs for patients, the reality is that they will create a new incentive structure for payers that could compromise patient access to the selected medications Patients could see reduction in access to medications in the future due to unforeseen consequences of UPLs, like increased utilization management within drug classes or limits on treatment options due to reduced reimbursement rates for doctors.”

“Broadly, the decision of the board to implement a UPL does not happen in a vacuum, but instead in an increasingly complicated marketplace that already does not appropriately take patient needs and concerns into consideration. Therefore, we strongly urge the board and staff to acknowledge this potential impact and the resulting negative effect it would have on patient access to medications. Furthermore, we urge the board to utilize its authority to fully explore with all healthcare stakeholders how upper payment limits will be implemented and identify in advance any adverse impact to patients.”

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