England approves breast cancer drug Enhertu for NHS use under revised rules.

Clinical trials found that patients taking Enhertu survived for about two years, compared with 17.5 months among those receiving chemotherapy.
Enhertu is the first licensed targeted treatment for patients with HER2-low breast cancer that cannot be surgically removed or has spread to other parts of the body.
Campaigners said that some people with incurable, metastatic breast cancer had “died waiting” for access while the treatment remained unavailable through the English NHS.
Patient Paula Van Santen, who was diagnosed with metastatic breast cancer in 2022, said the approval gave her hope of seeing her daughter graduate, becoming a grandparent and spending more time with her children.
The broader pricing dispute includes so-called most-favoured-nation agreements, under which pharmaceutical companies agree to lower U.S. prices toward levels in other developed countries, while warning that they may reduce investment or delay launches elsewhere.
England's medicines watchdog has approved Enhertu for NHS use, reversing a cost-based rejection from two years ago. The drug will now be available to about 1,000 women per year with metastatic HER2-low breast cancer whose disease has returned after chemotherapy, hot96. The approval followed a commercial agreement with AstraZeneca and Daiichi Sankyo and changes to cost-effectiveness rules that raised the acceptable price range from £20,000–£30,000 to £25,000–£35,000 per year of good-quality life.
Clinical trials found patients taking Enhertu survived for about two years, compared with 17.5 months on chemotherapy. wifc reports the drug has been available in Scotland since 2023 and represents the first licensed targeted treatment for metastatic HER2-low breast cancer that cannot be surgically removed.
Enhertu faced rejection in 2022 because its cost was deemed too high under England's old pricing rules. The National Institute for Health and Care Excellence, or NICE, reassessed the drug under new thresholds that value treatments more generously. wsau reports that patient advocates said some people with incurable metastatic breast cancer died while waiting for this approval decision.
Patient Paula Van Santen, diagnosed with metastatic breast cancer in 2022, welcomed the news. She said the approval gave her hope of seeing her daughter graduate, becoming a grandparent, and spending more time with her children—milestones she feared would not happen.
NICE raised its cost-effectiveness range from £20,000–£30,000 to £25,000–£35,000 per quality-adjusted life year (or QALY). A QALY measures one year of perfect health. wiky notes this shift allowed the committee to see Enhertu's value differently and approve it after commercial negotiations with the drugmakers.
The new pricing framework reflects broader pharmaceutical industry pressure. Companies have warned that weak medicine prices in the UK and Europe could push them to delay drug launches or reduce investment in these markets.
Enhertu became available to Scottish patients in 2023 through that nation's separate approval system, years before English approval. wtvbam reports this divergence highlights how different parts of the UK evaluate and price medicines independently, sometimes reaching different decisions.
The Enhertu decision sits within a wider dispute over drug pricing. So-called most-favoured-nation agreements let pharmaceutical companies lower U.S. prices toward levels in other developed countries. But companies worry these policies will squeeze profits globally and discourage investment.
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