CMS price caps are a $1.5 billion wrecking ball [CMS, 2024]. The Inflation Reduction Act lets CMS negotiate “maximum fair prices” for high-cost Medicare drugs—10 in 2026, 15 more in 2027—while capping out-of-pocket costs at $2,000 and demanding rebates if prices rise faster than inflation. CMS slashed Farxiga from $609 to $231/month (62% off) and Entresto from $653 to $197/month (70% off), per 2023 list prices [CMS, 2024; ACHI, 2024]. In 2025, payers are rejecting high-cost therapies at a 30% clip [industry reports]. With 60% of payers citing data gaps [McKinsey, 2024], is this the end for cell and gene therapies at $475K–$2M? Not yet—cell therapies like CAR-T haven’t been negotiated due to inpatient use, but the pressure is on.

Payers are tightening the screws—64 Part B drugs saw lower coinsurance in Q1 2025 alone [CMS, 2024]. But winners are fighting back. A CAR-T therapy used AI-driven real-world evidence (RWE) to prove a 20% reduction in hospitalizations, securing coverage. A gene therapy leveraged outcomes-based agreements (OBAs), tying rebates to patient outcomes, hitting 85% formulary access [industry reports]. These drugs didn’t just survive—they thrived.