President Arrington, Health Task Force Chairman Burgess’s lead letter to CBC on IRA drug development analysis | US House Budget Committee – House Budget Committee

November 20, 2023

WASHINGTON, USA – House Budget Committee Chairman Jody Arrington (R-TX) and Budget Committee Health Care Task Force Chairman Michael C. Burgess, MD (R-TX) sent a letter to Philip Swagel, director of the nonpartisan Congressional Budget Office (CBO), requesting answers to CBO’s questions. An Analysis of Policies Affecting Drug Development in the United States.

Members of the Budget Committee’s Health Care Task Force (HCTF): Rep. Lloyd Smucker (R-PA), Rep. Buddy Carter (R-GA), Rep. Blake Moore (R-SW), Rep. Rudy Yakim (R-IN). ), Rep. Drew Ferguson (R-GA) and Rep. Chip Roy (R-TX), the letter seeks more information on how CBO analyzed the impact of the Inflation Reduction Act (IRA) drug price controls on patient access. new drugs in the US.

The letter reads in part: “CBO’s analysis found that the IRA would result in one fewer drug entering the U.S. market between 2023 and 2032, about five in the next decade, and about seven in the decade after that, for a total of 13 who fewer drugs will come to market in the next decade. 30 years. Independent evaluations and related studies have shown that significantly more new drugs have not been brought to the US market as a result of the law…”.

“With the growing impact of health care costs on the federal budget, we appreciate CBO’s recognition of the power of innovation to reduce health care costs. We fear that the loss of innovation and new treatments reaching patients due to IRA price controls will result in one less tool that can reduce federal health care costs in the future.”

“Accordingly, it is increasingly important that CBO’s analysis of policies affecting drug development in the United States include the most recent and accurate information to ensure that policymakers are fully aware of the impact legislation will have on patient access to new drugs.” :

The letter asks CBO to answer several questions with the goal of better understanding the CBO’s current approach to analyzing policies that affect patient access to new drugs in the United States, including:

1. CBO shared that the drug development model has been continuously updated based on additional information and feedback from stakeholders and independent experts. Since the adoption of the IRA, numerous biopharmaceutical companies, investment funds and financial institutions have made public statements regarding the impact of the IRA on clinical development decisions and investment strategies. Is CBO tracking trends in early-stage drug development investments by venture capital firms since IRA adoption? Are there additional updates or changes that the CPA is currently considering to the drug development model?
2. Is CBO working or willing to work on expanding the drug development model to predict the impact of relevant policies on the total number of post-approval indications received by drugs that come to market, or the differential impact on specific therapeutic areas? Does CBO intend to include not only the impact of overall drug discovery, but also the potential for companies to move away from small molecule indications, as well as indications that will target populations outside of the middle-aged Medicare population?
3. Has CBO changed or considered reassessing its estimate of the impact of the IRA as a result of actions that the Centers for Medicare and Medicaid Services (CMS) has taken since the law’s enactment? In particular, does the selection of drugs with upcoming biosimilar and generic competition as part of the first ten drugs in the drug price negotiation program change the CBC’s expectations regarding reductions in budgetary costs attributable to the IRA?
4. CBO recently published a blog post soliciting feedback on new research on obesity drug use to help inform the agency’s analysis of relevant policies. Will CBO commit to publishing a similar blog post asking for independent feedback on new research and data to help inform possible adjustments and improvements to the drug development model?

Background:

The letter follows last month’s inaugural HCTF roundtable discussion with CBO Director Swagel, which brought together independent experts and stakeholders to examine CBO’s underlying model and analysis of the IRA’s impact on new drug development in the United States.

Pictured, left to right, at the table: Chairman Jody Arrington (R-TX), Rep. Rudy Yakim (R-IN), CBO Director Philip Swagel, HCTF Chairman Michael C. Burgess (R-TX), President of the American Action Forum and former CBO Director Doug Holtz-Icky

HCTF looks forward to continuing to collaborate and work constructively with CPA to ensure that lawmakers have access to the best available analysis when making policy decisions.

Click HERE for the full letter.