Biotech & Longevity · Monday, 21 September 2026
A health service in England will now pay for a breast cancer drug it refused for years. The drug's price did not change.
The NHS in England has started paying for Enhertu, which it had turned down on cost, after raising the most it will pay for one extra year of good health from 30,000 pounds to 35,000. EU advisers backed the same drug for an earlier stage of the disease.
35,000 pounds
the most the NHS in England will now pay for one extra year of good health
it was 30,000 pounds, and Enhertu's own price did not change
1,000
women a year in England who can now be prescribed Enhertu
campaigners spent years on it, and Breast Cancer Now says thousands missed out
92.4% vs 83.7%
free of returning HER2-positive early breast cancer at three years
Enhertu against trastuzumab emtansine in the DESTINY-Breast05 trial
9.6%
of patients on Enhertu in that trial had their lungs become inflamed
two of those cases were fatal
The lead story — what happened
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From Thursday, doctors in England can prescribe Enhertu for HER2-low advanced breast cancer, which affects about 1,000 women a year there.
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Doctors in Northern Ireland can prescribe it now too, and Wales is expected to follow.
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The drug treats HER2-low breast cancer, where the cancer cells carry only a little of a marker called HER2.
[1] Enhertu is an antibody that locks onto that marker and carries a chemotherapy drug to the cell. -
The makers, Daiichi Sankyo and AstraZeneca, have not substantially lowered their price since the drug was first refused, the BBC understands.
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What changed is the ceiling. NICE, which decides which medicines the NHS in England pays for, raised its upper limit from 30,000 pounds to 35,000 for one extra year of good health.
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That ceiling rose largely because of a trade deal with the United States, under which the UK government agreed to spend 25% more on medicines.
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At the end of August NICE also changed how it measures a patient's quality of life.
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Breast Cancer Now, the charity that campaigned for the drug, says thousands of people missed out and many died waiting.
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In the EU, advisers recommended the same drug on 17 September for a different, earlier group: patients with HER2-positive early breast cancer who still have disease after pre-surgery treatment.
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In that trial, DESTINY-Breast05, 92.4% of patients on Enhertu were free of returning cancer at three years, against 83.7% on trastuzumab emtansine, an older drug of the same kind.
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The lungs of 9.6% of patients on Enhertu became inflamed, and two of those cases were fatal.
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Who is involved
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NICE
the body that decides which medicines the NHS in England will pay for; it reversed its refusal of Enhertu
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Daiichi Sankyo and AstraZeneca
the Japanese and British drugmakers that sell Enhertu; the BBC understands they have not substantially cut what they charge the NHS
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Breast Cancer Now
a UK charity that campaigned for years to get the drug funded; it says thousands missed out
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The CHMP
the committee that advises the European Medicines Agency on whether a medicine may be sold in the EU; it backed Enhertu for early breast cancer
How it unfolded
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For years NICE refuses to fund Enhertu for HER2-low breast cancer
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End of Aug NICE changes how it measures a patient's quality of life
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This month its top price per extra good year rises from 30,000 to 35,000 pounds
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17 Sep EU advisers back the same drug for early HER2-positive breast cancer
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Thursday doctors in England and Northern Ireland can prescribe it
Where this points
Wales is expected to follow England, and the European Commission still has to turn its advisers' opinion into an approval; watch whether other medicines NICE refused at the old ceiling are looked at again.
What is pushing on the whole day
The bar and the word are our reading of how hard each one is pushing today. The arrow is where it is heading. The evidence is in the stories below.
The NHS in England raised its top price for one extra year of good health from 30,000 to 35,000 pounds.
The US National Institutes of Health is preparing a research centre for people who believe a vaccine made them ill.
Novo Nordisk bought three early obesity drugs that do not work the way its own semaglutide does.
Around 80% of clinical trials miss the date by which they meant to have enrolled their patients.
The rest of the day
15 more stories on this beat.
Each with its own sources. None of these is a link to the story above.
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02
A first treatment for a childhood nerve disease
The US drug regulator approved Aqneursa for the loss of balance and coordination caused by ataxia-telangiectasia, an inherited disease that damages the nervous system from early childhood and also raises the risk of cancer.
[3] It is the first treatment approved for that symptom.[3] The same drug was approved in 2024 for a different rare disease, Niemann-Pick type C.[3] In a 73-patient trial each person took the drug for 12 weeks and a dummy for 12 weeks, and scored better on a balance and speech scale while on the drug.[3] Why it matters — Children with this disease have had nothing approved for the part of it that takes away their walking and their speech. The regulator gave the drug orphan status, the label used for medicines aimed at very small numbers of patients, and approval went to IntraBio.
[3] -
03
Novo buys three early obesity drugs
Novo Nordisk, the Danish maker of the weight-loss drug semaglutide, has bought three early-stage obesity programmes from Kallyope, a New York biotech.
[4] None of them works the way semaglutide does. Semaglutide copies a gut hormone that tells the brain you are full; these three act on other targets.[4] The lead one, a weekly injection called K-554, is ready to enter its first human trial.[4] Novo would not give financial terms.[4] Why it matters — Novo has been losing ground to Eli Lilly in obesity drugs, and buying in outside programmes is faster than growing its own. The day before, it signed a separate deal worth up to $1.4 billion with Orbis Medicines.
[4] -
04
Electra's share sale raises $350m
Electra Therapeutics, a biotech near San Francisco, sold 23.3 million shares on Thursday evening and raised $350 million, above the $296.6 million it had told investors to expect days earlier.
[5] It had planned to sell 21.7 million shares at about $15 each.[6] Most of the money goes to one drug, ipsoprubart: $220 million is set aside to carry it through a global trial in a rare condition where the immune system overreacts and attacks the body.[5] Predicted days earlier$296.60mActually raised$350mWhat Electra told investors to expect, and what the share sale brought in. Why it matters — In an earlier 12-patient study of that syndrome when it follows cancer, all 12 patients were alive after eight weeks. The trial is not due to finish recruiting until 2027, so the money is committed years before any answer.
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05
A US centre for people who say vaccines harmed them
The US National Institutes of Health is preparing a clinical research centre on its campus in Bethesda, Maryland, to study people who believe a vaccine made them ill, including Covid vaccines.
[8] Officials discussed the plan at an internal meeting and it could open in mid-October.[8] The amount of money has not been set.[8] The centre was first proposed in a 2025 report by a White House commission chaired by Robert F. Kennedy Jr., who runs the US health department and has long questioned vaccine safety.[8] Why it matters — A patient advocate who developed lasting side effects after a Covid vaccine told Science it should have happened long ago. A paediatrician at Vanderbilt University called the effort laudable and said that if it is not done scientifically it will become anti-vaccine propaganda.
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06
Covid shots delayed for half of America's children
The US health department has not decided whether Covid vaccines will be supplied through Vaccines for Children, the federal programme that gives free shots to children who are uninsured, on Medicaid, or Native American.
[12] The programme reaches about half of the country's children.[12] States cannot order doses until the department signs off.[12] The hold-up is tied to the committee that normally votes on which vaccines the programme covers, which has been in legal limbo since a judge ruled in March that its members were not qualified.[12] Why it matters — Children whose parents have insurance, or who can pay, can still be vaccinated. So the delay falls on the poorer half of America's children and on nobody else.
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07
The US drug regulator cannot hire fast enough
The US Food and Drug Administration is trying to add more than 2,000 staff, a year after the cost-cutting team run by Elon Musk cut 3,500 jobs there in April 2025 and set off a wider exodus.
[13] The head of the agency's biologics centre told drug manufacturers at a conference on Monday that it is hiring very actively.[13] STAT reports the push is stuck in bureaucratic delays caused by the same cuts it is meant to repair.[13] Why it matters — A year ago the agency lost 3,500 people and more left after them.
[13] Now it is advertising more than 2,000 posts and cannot fill them quickly, because of those same cuts.[13] -
08
Trials cannot fill their places
Around 80% of clinical trials miss the date by which they meant to have enrolled their patients, and fewer than 5% of adult cancer patients who are eligible for a trial take part.
[15] Each delayed day of a late-stage cancer trial costs between $600,000 and $8 million in lost sales, and slow enrolment is estimated to cost the industry $50 billion a year.[15] A research-policy director at Merck told a Boston conference this week that US trial sites are already full.[15] The US regulator has opened a pilot to speed up first-in-human trials.[16] 5 of 100
Eligible adult cancer patients who take part in a trial
Fewer than five in every hundred adults with cancer who could join a trial actually do. Why it matters — A patient who cannot get into a trial loses the chance of a treatment that is not yet on sale anywhere. Drug companies at the conference said the answer is to run trials in ordinary community clinics rather than big teaching hospitals.
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09
An inherited lung cancer gene traced to Appalachia
Researchers analysed genetic and health data from more than 3.3 million people who had used a consumer DNA test, and found an inherited change in a gene called EGFR, known as T790M, in about one person in 15,850.
[9] People carrying it had 25 times the odds of lung cancer, and no raised risk of 17 other cancers that were checked.[9] The variant spread in the United States from a single family line in the Southern Appalachian region about 200 years ago.[9] Why it matters — Most lung cancer is caused by smoking, and this one is not. Lung cancer in people who never smoked is a growing share of cases, and the researchers say carriers of this variant may be the people that genetic testing and scanning would help.
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10
A smouldering fault in the gut
Researchers at WEHI in Melbourne, working with the Royal Melbourne Hospital, studied about 900 human gut samples and mini-guts grown from patients.
[10] They found that in people with inflammatory bowel disease the cells lining the gut stay primed to die, even when the patient feels well and the disease looks controlled.[10] Inflammatory bowel disease covers Crohn's disease and ulcerative colitis, and affects around 180,000 Australians.[10] The work was published in Science.[10] Why it matters — Doctors currently judge whether the disease is under control by how the patient feels. This says a test could look for something still going on underneath, though finding the fault is not the same as showing it starts a flare-up.
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11
Weight-loss drugs change bodies more than lives
Two economists followed the same adults with diabetes through more than ten years of a national US survey, from 2012 to 2023, and looked at what happened after they started a GLP-1 drug such as Ozempic.
[11] They found little measurable change in depression symptoms, distress, self-rated health, employment or marriage.[11] Users did look different from non-users at first, but those gaps mostly disappeared once the same people were tracked over time.[11] It is a working paper, not yet reviewed by other researchers.[11] Why it matters — Insurers and government programmes are deciding whether to widen who can get these drugs, and part of the case has been that the gains spread beyond blood sugar and weight. This study looked for those gains and did not find them.
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12
Weight-loss drugs are changing the shopping
People taking GLP-1 weight-loss drugs are buying less food, eating smaller portions and buying smaller clothes, and food companies are trying to adjust.
[17] Dan Sherry, a 58-year-old nurse in Holland, Michigan, was prescribed Ozempic in spring 2024 at 210 pounds and now weighs 160.[17] He eats out less, drinks less alcohol, usually leaves half a restaurant meal, and buys more meat and protein shakes.[17] He says his grocery bill is 10 to 15% lower.[17] Why it matters — Food companies have built their sales on how much people eat. A medicine prescribed for something else is now changing that from outside their industry.
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13
An untested peptide's use is up 33-fold
BPC-157, a peptide sold online for pain, healing and muscle growth, has not been approved in the United States and has almost no evidence from human trials.
[14] A data firm searched more than 15 million medical records and found 1,039 patients whose doctors had typed it into their notes by hand, because the compound has no drug code to track it by.[14] New confirmed users rose 33-fold between 2020 and 2026.[14] In July a panel of advisers to the US regulator, encouraged by health secretary Robert F. Kennedy Jr., voted to let pharmacies make it.[14] Why it matters — The regulator had previously restricted making BPC-157 because of what it called significant safety risks and insufficient human data. Analysts estimate peptides like it could become a $2 billion to $3 billion market if they are legitimised.
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14
A radioactive therapy paired with a pill
Doctors treated five patients whose pancreatic neuroendocrine tumours had kept growing after several other treatments.
[18] They combined a therapy that carries a radioactive atom to the tumour with sunitinib, a pill that blocks the blood vessels feeding it.[18] Three patients had near-complete responses on scans and two had partial ones.[18] The rest of the paper is laboratory work in tumour cells, showing each treatment makes the other lethal at a lower dose.[18] Why it matters — Five patients is a pilot, not a trial, and there was no comparison group. These tumours do respond to the radioactive treatment but rarely for long, and this is a first look at whether an existing pill extends that.
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15
A robot factory for a virus-free CAR-T
Cellares, which builds automated factories for cell therapies, agreed to move GenomeFrontier's manufacturing onto its Cell Shuttle machine.
[19] GenomeFrontier, based in Taiwan, is developing GF-CART01 for blood cancers including diffuse large B-cell lymphoma, and makes it without using a virus to carry genes into the cells.[19] The company says it has clinical results in Taiwan and is now recruiting for a first trial in the United States.[19] It is Cellares' first development partnership in Asia.[19] Why it matters — CAR-T treatments are built one patient at a time, largely by hand, which is slow, variable and expensive. That cost is a large part of why so few patients ever receive one.
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16
An LSD pill wins a third late-stage trial
Definium Therapeutics said on Monday that a single 100-microgram dose of DT120, a fast-dissolving LSD tablet, cut anxiety scores by 9.8 points after 12 weeks, against 4.7 points for a dummy pill.
[7] The trial, called Panorama, enrolled 245 patients and also compared that dose against a 50-microgram dose meant to be felt but not to help.[20] It is the third late-stage win in a row, after an anxiety trial in August and a depression trial in June.[7] Definium plans to file for US approval in the first half of 2027.[7] Why it matters — A patient who takes a psychedelic knows they have taken it, which is why the low-dose arm matters: it tests whether the benefit comes from the drug or from knowing.
[20] Definium shares rose 5%.[7]
England put a price on one more year of life, and then raised it
The NHS in England has a limit on what it will pay for one extra year of good health, and this month the limit went up.
The twist
Enhertu did not get cheaper and it did not start working better. What changed is that the NHS in England raised the price it will pay for one extra year of good health.
The picture
- 1The old NHS ceiling30 thousand pounds per extra good year
- 2The new NHS ceiling35 thousand pounds per extra good year
How it works
- A health service has a fixed budget
- So it writes down a top price for one extra year of good health
- A medicine costing more than that is refused, however well it works
- The medicine's own price does not have to change
- Raise the written number, and refused medicines become paid-for ones
The same force, elsewhere today
Where this chain is also running, in today's other stories.
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Trials that cannot fill their places
The industry has put a number on a delayed day, $600,000 to $8 million for a late-stage cancer trial, and sites that cannot enrol fast enough do not get the work.
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Electra's share sale
Electra wrote down what each programme was worth before the money arrived, $220 million to one trial and $25 million to another, so each budget was set before any result came in.
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Covid shots delayed for half of America's children
The free programme only supplies a vaccine once a committee has voted on it, so the doses sit ready while the vote has not happened.
Where you've seen this
University admissions
a grade cut-off decides before anyone reads the essay, and moving it one grade changes who gets in
Insurance excess
a claim under the excess is simply not paid, however real the damage
Speed cameras
a set speed decides the fine, not how the driving actually looked
The catch
Without a written limit, every case is argued on its own, and the patients who can campaign hardest win. Enhertu took years, and the women who moved it were the ones still well enough to campaign.
And the whole of it
Kate Wills spent those years on the wrong side of that number, and her friend Jeannie Ambrose died in January still campaigning to move it. Health services elsewhere set their own version of the figure, and the people who set it never meet the patient it turns away.
What is really going on
The NHS in England did not decide that Enhertu was worth more, and Daiichi Sankyo and AstraZeneca did not substantially cut what they charge.
Why it works on us — A refusal that is really about a budget gets announced in the language of value, so 'not cost-effective' sounds like a verdict on the medicine rather than a statement about how much money there is.
Who gains
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Daiichi Sankyo and AstraZeneca
— They now sell Enhertu to the NHS in England at a price they did not substantially cut.
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About 1,000 women a year in England with HER2-low breast cancer
— Their doctors could start prescribing the drug from Thursday.
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Electra Therapeutics
— Its share sale was enlarged and raised $350 million, above the $296.6 million it had predicted days earlier.
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Pharmacies that make BPC-157
— Advisers to the US regulator voted in July to let them compound it, and analysts put the market for peptides like it at $2 billion to $3 billion.
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Novo Nordisk
— It added three obesity drugs that work differently from its own semaglutide, without doing the early work itself.
[4]
Who pays
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Women with HER2-low breast cancer who died waiting
— Breast Cancer Now says thousands missed out during the years of refusal. Jeannie Ambrose, who campaigned for the drug, died in January.
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Other NHS patients in England
— NICE's medicines director says its job is to protect health spending for other services, and a higher ceiling spends more of the same budget on each medicine.
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The poorer half of America's children
— Their Covid shots come through a federal programme that is waiting on a decision, while children with insurance can be vaccinated now.
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People taking BPC-157
— New users rose 33-fold between 2020 and 2026, with almost no evidence of safety or benefit from human studies.
[14] -
Cancer patients who cannot get into a trial
— Fewer than 5% of eligible adults take part, and around 80% of trials miss their enrolment date.
[15] -
People carrying the inherited EGFR T790M change
— About one person in 15,850 carries it and it multiplies the odds of lung cancer 25 times, and the researchers say these are the people genetic testing would help.
[9]
What nobody knows yet
Open questions from across today’s stories — ours included.
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01
Which other medicines NICE refused at the old ceiling would pass at the new one.
No list has been published, and each medicine is assessed separately.
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02
Whether Enhertu helps patients live longer when it is given in early breast cancer.
The DESTINY-Breast05 figures released cover how many patients stayed free of returning cancer at three years. How long patients lived was not among them.
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03
How often the lung inflammation seen with Enhertu will happen outside a trial.
It occurred in 9.6% of patients in DESTINY-Breast05, with two deaths, and a trial watches patients more closely than routine care does.
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04
When children on the US Vaccines for Children programme will get Covid shots.
The US health department has not made a decision, and the committee that normally votes on it has been in legal limbo since a judge's ruling in March.
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05
How much money the US National Institutes of Health will spend on its vaccine-harms centre.
The amount has not been determined, and the plan was discussed at an internal meeting rather than announced.
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06
How many people in the United States are actually taking BPC-157.
The compound has no drug code, so it cannot be counted in health records. Researchers found 1,039 patients only because doctors had typed it into notes by hand.
[14] -
07
Whether the US drug regulator will fill the 2,000 posts it is advertising.
STAT reports the hiring is stuck in delays caused by the same 2025 cuts it is meant to repair.
[13] -
08
Whether the fault found in gut cells actually starts a flare-up of inflammatory bowel disease.
The Melbourne team found it in about 900 biopsies, including from patients in remission, but showing something is present is not showing it causes what comes next.
[10] -
09
Whether the anxiety benefit from Definium's LSD tablet comes from the drug or from knowing you took it.
The trial added a lower dose meant to be felt but not to help, which is an attempt at that question rather than a settled answer.
[20]
Kate Wills is 51, has breast cancer in her bones and lungs, and had been unable to get the drug that could give her more time. From Thursday, doctors in England can prescribe it to her.
Also true today
- Children with ataxia-telangiectasia now have the first approved treatment for the loss of balance and speech the disease causes. The drug was already approved in 2024 for a different rare disease.
- An LSD tablet cut anxiety scores by 9.8 points after 12 weeks against 4.7 for a dummy pill, in 245 patients. It is the third late-stage trial in a row it has passed.
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