Mar 10 2023

WASHINGTON, D.C. – This week, U.S. Senator Thom Tillis (R-NC), a member of the Senate Finance Committee, and Senate Republicans pushed back against government health officials on the implementation of a drug-pricing model selected by the Department of Health and Human Services (HHS) to complement the Administration’s prescription drug pricing scheme.  

In a letter to HHS Secretary Xavier Becerra and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure, the senators note the Accelerating Clinical Evidence Model has attracted concerns from a range of stakeholders, including patient advocates and providers, given its potential to slash reimbursement rates for drugs approved through the FDA’s Accelerated Approval Program (AAP).

The senators highlight key concerns with the model, as described in the Secretary’s report, noting, among other issues, its potential to:

  • Slash reimbursement rates for drugs approved through the FDA’s Accelerated Approval Program (AAP);
  • Further deter innovation and timely drug development by undermining the accelerated approval pathway;
  • Delay patient access to life-saving therapies by discouraging drugmakers from pursuing accelerated approval;
  • Hindering cancer care and therapeutic innovations for other conditions with insufficient treatment options;
  • Stray from the CMS’s statutory mission and purpose by supplanting FDA decision-making; and
  • Slash reimbursement rates for frontline health care providers.

“By bringing groundbreaking therapies to patients years before these products could otherwise reach the market, the FDA’s Accelerated Approval Program (AAP) has saved countless lives while upholding strong safeguards and standards,” wrote the senators. “The Accelerating Clinical Evidence Model recently announced by the Biden Administration, unfortunately, risks undermining or even reversing this trend, triggering access gaps for seniors, as well as imposing cuts on frontline providers.” 

“If proposed and finalized as described, this profound policy shift would inevitably chill incentives for leveraging the FDA’s game-changing expedited regulatory avenue, which has served patients with life-threatening diseases for decades. Later approvals and access delays would follow,” the senators continued. 

“We all share the goal of improving prescription drug access and affordability, but this model represents a step in the opposite direction for seniors.  We strongly encourage you not to pursue it any further,” the senators concluded.

Read the full letter here.