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NICE approves Enhertu for HER2-low breast cancer after pricing rule change

NICE approves Enhertu for HER2-low breast cancer after pricing rule change

Rule Changes

Final NICE guidance confirms NHS access for about 1,000 people a year, but patients with more than two prior chemotherapy courses are refused

October 12th, 2026: Parliamentary question on compassionate access

Overview

Updated Oct 24

The National Institute for Health and Care Excellence published final guidance on October 7, confirming that about 1,000 people a year in England can get Enhertu for HER2-low advanced breast cancer. The decision ended a 26-month dispute over price, after the UK raised what it will pay per quality-adjusted life year from £30,000 to £35,000.

NHS England funds the drug only for patients who have had one or two prior chemotherapy courses. Laura Stanford, who has had three, was refused on September 29; charities including Breast Cancer Now want the criteria widened. A written parliamentary question on October 12 asked the health secretary whether she had discussed compassionate access with AstraZeneca and Daiichi Sankyo.

Why it matters

The UK raised drug cost-effectiveness limits under a US trade deal, unlocking a life-extending breast cancer drug for about 1,000 women a year in England.

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Key Indicators

1,000
People eligible per year in England
Patients with HER2-low advanced breast cancer who can now access Enhertu on the NHS.
6.6 months
Median overall survival benefit
Median overall survival was 23.4 months with Enhertu versus 16.8 months with chemotherapy in the DESTINY-Breast04 trial.
£25K–£35K
New cost-effectiveness threshold per QALY
NICE's acceptable ceiling rose from £20,000–£30,000 to £25,000–£35,000 in April 2026 under the UK-US pricing agreement.
26 months
Time from rejection to final guidance
NICE rejected Enhertu in July 2024; final guidance was published on October 7, 2026.
1–2
Prior chemo lines NHS England will fund
Eligibility follows trial evidence and covers only one or two prior courses; patients with more, like Laura Stanford, are refused.

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People Involved

Pascal Soriot
Pascal Soriot
Chief executive of AstraZeneca
Led AstraZeneca through the Enhertu development and UK pricing agreement
 Laura Stanford
Laura Stanford
Breast cancer patient denied Enhertu under NHS England criteria
Raising funds for private Enhertu treatment while charities campaign for a rule change

Organizations Involved

National Institute for Health and Care Excellence (NICE)
National Institute for Health and Care Excellence (NICE)
Government health technology assessment body
Published final guidance on October 7, 2026 confirming NHS funding of Enhertu

The UK body that decides which treatments the NHS in England funds, based on clinical effectiveness and value for money.
AstraZeneca
AstraZeneca
Pharmaceutical company
Co-developer and marketer of Enhertu outside Japan

British-Swedish drugmaker that partnered with Daiichi Sankyo in 2019 to develop and sell Enhertu.
Daiichi Sankyo
Daiichi Sankyo
Pharmaceutical company
Discoverer and co-developer of Enhertu

Japanese pharmaceutical company that discovered Enhertu and co-developed it with AstraZeneca.
NHS England
NHS England
Government healthcare provider
Funds Enhertu for patients with one or two prior chemotherapy courses; charities are pressing it to widen the criteria

The publicly funded healthcare system that will supply Enhertu to eligible patients.
Breast Cancer Now
Breast Cancer Now
Charity
Welcomed the NICE approval and joined the campaign to widen NHS England's eligibility

UK breast cancer charity that led a two-year campaign for NICE to approve Enhertu.
Make 2nds Count
Make 2nds Count
Charity
Campaigning for wider Enhertu access after NICE approval

UK breast cancer charity that joined the October 2026 campaign to widen Enhertu access.
METUPUK
METUPUK
Charity
Campaigning for wider Enhertu access

UK breast cancer charity that joined the October 2026 campaign to widen Enhertu access.

Timeline

August 2022 October 2026

12 events Latest: October 12th, 2026 · 4 weeks ago Showing 8 of 12
Tap a bar to jump to that date

  1. Parliamentary question on compassionate access

    Latest Politics

    A written question asked the health secretary whether she had discussed compassionate access to Enhertu with AstraZeneca and Daiichi Sankyo for patients unable to get the drug because they had received additional lines of chemotherapy.

  2. NICE publishes final guidance on Enhertu

    Regulatory decision

    Final technology appraisal guidance (TA1197) confirms the September recommendation for HER2-low metastatic breast cancer after chemotherapy and replaces the 2024 guidance, TA992.

  3. Charities urge NHS England to widen Enhertu eligibility

    Campaign

    Make 2nds Count, METUPUK and Breast Cancer Now called on NHS England to allow patients with more than two prior chemotherapy lines, or create an exceptional access route. NHS England said new evidence would be needed.

  4. Patient denied Enhertu under NHS England criteria

    Health policy

    Laura Stanford, who had three prior lines of chemotherapy, was told by Medway Maritime Hospital she did not meet NHS England's criteria for Enhertu, which covers one or two prior courses.

  5. NICE recommends Enhertu for HER2-low advanced breast cancer

    Regulatory decision

    NICE approved Enhertu after a commercial solution was agreed; about 1,000 women a year in England become eligible.

  6. Breast Cancer Now welcomes Enhertu approval

    Statement

    The charity said the decision came after more than two years of campaigning for NHS access to Enhertu.

  7. NICE publishes revised quality-of-life assessment method

    Policy change

    The new method for valuing patient health gains factored into Enhertu's assessment.

  8. New NICE cost-effectiveness thresholds take effect

    Policy change

    NICE's acceptable ceiling rose from £30,000 to £35,000 per quality-adjusted life year.

  9. UK-US Pharmaceutical Pricing Agreement signed

    Trade agreement

    The UK and US announced a pricing agreement raising NICE's cost-effectiveness thresholds in exchange for increased medicines investment.

  10. NICE rejects Enhertu on cost grounds

    Regulatory decision

    NICE refused to recommend Enhertu, making it the only breast cancer drug rejected since 2018.

  11. Scotland grants routine NHS access to Enhertu

    Health policy

    Scotland's health authority approved Enhertu for HER2-low breast cancer, nearly three years before England.

  12. US FDA approves Enhertu for HER2-low breast cancer

    Regulatory approval

    The US Food and Drug Administration approved Enhertu based on the DESTINY-Breast04 trial results.

Scenarios

1

Wales and Northern Ireland approve Enhertu within months

Likely Resolves by End of 2026

Discussed by: Reuters and the Pharmaceutical Journal, citing AstraZeneca and Daiichi Sankyo statements

AstraZeneca and Daiichi Sankyo said they will seek approval from health bodies in Wales and Northern Ireland. Wales must fund treatments within 60 days of final NICE guidance unless the Welsh Government directs otherwise. Northern Ireland reviews NICE decisions separately through its Department of Health.

2

NICE expands Enhertu approval to more breast cancer patients

Possible Resolves by Sep 17, 2027

Discussed by: Clinical community tracking DESTINY-Breast06 and follow-up trials

The current approval covers HER2-low metastatic patients after prior chemotherapy. Ongoing trials and updated data could support broader indications, including earlier treatment lines or HER2-ultralow populations. The companies would need to submit new evidence to NICE for each expanded indication.

3

Raised thresholds unlock approvals of other previously rejected drugs

Likely Resolves by Sep 17, 2027

Discussed by: NICE statements at the December 2025 pricing agreement announcement

NICE said raising thresholds would allow it to recommend 3-5 additional new medicines per year. Drugs previously rejected on cost-effectiveness grounds become candidates for reconsideration through NICE's review process. The Enhertu decision appears to be the first notable application of the new rules.

4

NHS England widens Enhertu eligibility or creates an exceptional access route

Possible Resolves by Q1 2027

Discussed by: Make 2nds Count, METUPUK and Breast Cancer Now, in their October 2026 call to NHS England

The charities want NHS England to cover patients who have had more than two prior chemotherapy lines, or to set up an exceptional access route for patients who moved to later treatment lines during the 26-month wait. NHS England said new evidence would be needed before extending the drug to patients with more rounds of chemotherapy.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

2016–2019

Vertex's Orkambi cystic fibrosis dispute (2016–2019)

NICE rejected Vertex's cystic fibrosis drug Orkambi in 2016 as poor value for money. The decision sparked years of patient protests, parliamentary pressure, and stalled talks between Vertex and NHS England over price.

Then

NICE reversed course in October 2019 after Vertex agreed to a confidential price reduction and a managed access arrangement.

Now

The case became the reference point for NICE's hard line on high-cost drugs and the political pressure that can build around denials.

Why this matters now

Like Enhertu, Orkambi won approval only after a commercial deal. The difference is the path: Orkambi's reversal came through company-side price cuts, while Enhertu's came through changes to NICE's own methodology.

2011–2016

NICE Cancer Drugs Fund (2011, reformed 2016)

The UK created the Cancer Drugs Fund in 2011 so patients could access cancer drugs NICE had rejected as poor value. It was reformed in 2016 to require evidence collection and tighter entry criteria.

Then

The fund provided temporary access to dozens of drugs while their real-world effectiveness was measured.

Now

It became a standard route for interim funding and still operates alongside NICE's routine approval process.

Why this matters now

Enhertu did not go through the fund: NICE recommended it for routine NHS use after changing the cost-effectiveness rules it uses to judge value for money.

Sources

(19)
+13
NICE BBC News The Guardian Reuters The Pharmaceutical Journal The Independent ecancer Cancer Network Syenza News The Telegraph Breast Cancer Now RTTNews Kent Online Nursing Times Medical Update Online The BMJ UK Parliament NICE NICE