President Trump signed the “One Big Beautiful Bill Act” (OBBBA) into law on July 4, 2025. The OBBBA is projected to reduce federal health spending by an estimated $900 billion[1] over the next decade. Central to the legislation is…
The first 100 days of President Trump’s return to the White House have been anything but ordinary. With a true “Flood the Zone” strategy, there has been a flurry of executive orders, leadership reshuffles, and a re-assertion of executive power,…
On January 20, 2025, the Centers for Medicare & Medicaid Services (CMS) announced the set of fifteen drugs targeted for the second round of Maximum Fair Price (MFP) “negotiations” under the Inflation Reduction Act (IRA). With the outcomes…
Cell and gene therapies (CGTs) have ushered in a new era of medicine, offering patients transformative, even potentially curative solutions, with a single treatment. Despite the clinical promise, barriers to patient access remain given administration complexity, gaps in patient…
Yesterday, CMS released the results of the first round of “negotiated” prices for the Inflation Reduction Act (IRA).1 The IRA is a historical landmark legislation for the pharmaceutical industry, and the results from these “negotiations” involving 10 of the top…
Introduction The Trinity team recently attended the Milken Institute’s 2023 Future of Health Summit in Washington, DC. Its theme was “Closing the Gap” in healthcare – as chronic disease becomes more prevalent worldwide and the average life expectancy…
Trinity’s Take Recent guidance for the Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program released by CMS retains all major provisions of the program as written in the IRA The guidance details negotiation methodology, including that CMS will…
Long-awaited Medicare price negotiations look more like statuary discounts than the value-based negotiations seen in global healthcare systems; combined with expanded price increase rebates and out of pocket limits, new regulation may drive prices for new drugs up more than down. Trinity explores the impact and implications for manufacturers of innovative medicines.
Executive Summary In March 2020, the FDA amended its classification of add-on insulin products, changing the approval pathway from that of a chemical drug follow-on to a biosimilar and more closely aligning with the EMA’s longstanding biosimilar insulin approval…
Executive Summary The COVID-19 pandemic has called into question many elements of the US healthcare system across key stakeholders, resulting in changes across patients, providers, payers, researchers, and manufacturers The pandemic has required many healthcare providers and patients to…