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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

About 1,000 women a year in England gain NHS access to the treatment after a 26-month dispute

4 days ago: NICE recommends Enhertu for HER2-low advanced breast cancer

Overview

Updated Yesterday

England's drug assessment body NICE approved Enhertu for HER2-low advanced breast cancer on September 17, reversing a rejection that had stood since July 2024. About 1,000 women a year become eligible, and the treatment extended median overall survival by 6.6 months in the pivotal trial.

The reversal followed changes to how NICE judges value for money. The UK raised its cost-effectiveness ceiling from £30,000 to £35,000 per quality-adjusted life year under the UK-US Pharmaceutical Pricing Agreement, and a revised quality-of-life method published August 27 shifted the math on Enhertu's benefits.

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
Women 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 under the December 2025 pricing agreement.
26 months
Time from rejection to approval
NICE rejected Enhertu in July 2024; final draft guidance recommending it came September 2026.

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People Involved

Organizations Involved

Timeline

August 2022 September 2026

7 events Latest: 4 days ago
Tap a bar to jump to that date
  1. NICE recommends Enhertu for HER2-low advanced breast cancer

    Latest Regulatory decision

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

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

    Policy change

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

  3. 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.

  4. 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.

  5. NICE rejects Enhertu on cost grounds

    Regulatory decision

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

  6. 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.

  7. 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.

Historical Context

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

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's interim funding flows through the Cancer Drugs Fund, showing how the mechanism continues to bridge the gap between NICE decisions and patient access.

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.

Sources

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