CER Daily Newsfeed

Chair Cassidy Delivers Remarks During Hearing on Making Health Care Affordable for American Patients

(7/31, U.S. Senate Committee on Health, Education, Labor & Pensions) comments “...[U.S. Senator Bill Cassidy, M.D. (R-LA):] Another area of bipartisan interest is the 340B program. The common understanding among legislators is that the discounts received by the hospitals are supposed to make health care services more affordable and accessible for low-income and uninsured patients. But the law is unclear on hospitals’ responsibilities to do so and some, perhaps many, do not pass the discounts on to patients. In fact, a recent study by the National Pharmaceutical Council found that 340B may make ESI more expensive, costing workers’ an estimated $4.5 billion from 2017 to 2023. So, not only are discounts not being passed onto patients, but there is a hydraulic effect driving up the cost of insurance for workers. Put simply, families pay more.” Full

Trump Demands Pharma CEOs Implement 'Most Favored Nation' Pricing Within 60 Days

(7/31, Drew Armstrong, Endpoints News) reports “...In the letters, Trump demands that the companies give Medicaid, the US health program for low-income people, access to similar and lower prices to what the companies charge in other developed economies. He tells the companies to match prices for new drugs to foreign introductory prices, and to repatriate any new, higher revenue gained abroad back to the US. And he told them to make the drugs available for direct sale to consumers.” Subscription Required

Keeping Watch on Medicare: Formulary Assessment Shows Large Declines in Access for Certain Rare Disease Treatments

(7/30, Kirsten Axelsen, Karina Lynch, Margaret Martin, Haley Jeppson, DLA Piper) comments “...There may be valid clinical reasons for restricting coverage. However, this decline in formulary coverage, which may be the result of cost constraints on the plans, likely merits further evaluation – particularly because the coverage is more restricted in PDPs relative to MA-PDs, which are less available in rural areas.[10] This data suggests that beneficiaries could face challenges in obtaining their necessary medications, including beneficiaries with rare diseases, as the IRA continues to be implemented. Policymakers and administrators at CMS may want to consider closely monitoring the evolution of formularies under the IRA and taking action to preserve beneficiary access for both selected and nonselected medications.” Full

340B Drug Rebates Coming as HRSA Launches Pilot Program

(7/31, Bridget Early, Modern Healthcare) reports “...Although this is merely a pilot and doesn’t apply to all prescription drugs providers buy through 340B, even partially converting the program from discounts to rebates is a major shift from more than 30 years of standard practice. Under 340B, qualifying safety-net providers get 25%-50% discounts on prescription medications...HRSA must take care not to hamstring 340B providers as it tests this new approach, Aimee Kuhlman, vice president of advocacy and grassroots at the American Hospital Association, wrote in an email.” Subscription Required

COTA and LCP Partner to Expand Use of US Real-World Data in UK and EU Health Technology Assessments

(7/31, Katie McCool, The Evidence Base) reports “...The initiative aims to overcome longstanding challenges around the use of international RWD for HTA in Europe. While UK regulatory bodies have historically relied on US clinical trial data, they have typically sought country-specific RWD for decision-making, due to concerns around comparability and relevance. This collaboration seeks to bridge that gap by developing methods to identify and evaluate US patient groups that reflect UK treatment populations, enabling broader integration of international datasets into European HTA processes.” Full

EU HTAR Conference Insights: How HTA Research Projects Can Support EU Competitiveness and Innovation

(7/31, Katie McCool, The Evidence Base) reports “...In the breakout session, ‘How can we leverage HTA to boost EU competitiveness? Examples from Horizon Europe-funded projects,’ speakers representing Horizon Europe and Innovative Health Initiative (IHI) projects presented their work on early feasibility studies, real-world data (RWD) infrastructure, digital HTA frameworks, and implementation support. The session focused on how HTA research can strengthen innovation and competitiveness in Europe while supporting implementation of the EU HTAR.” Full