Enhertu's UK Approval status & What It Means for You as a Patient

Enhertu (fam-trastuzumab deruxtecan-nxki) has been in the spotlight since its first FDA approval. Initially a therapy for HER2-positive breast cancer, Enhertu is now also approved for treating gastric and non-small cell lung cancer, as well as HER2-low breast cancer, and all other HER2-expressing cancers.

Or at least it's approved for these indications in the USA and/or the EU. 

The situation with Enhertu approval in the UK is a bit different. If you're a HER2-positive cancer patient in the UK, you may need a bit more patience before you can start a treatment with Enhertu.

In this article, we'll look at everything you need to know about Enhertu approval and availability in the UK. 

Enhertu UK approval: What's the status?

Currently, the MHRA has conditionally approved the use of Enhertu only in adult patients with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based treatments ¹. 

Enhertu is not yet approved in the UK for use in HER2-positive gastric cancer, non-small cell lung cancer (NSCLC), or HER2-low breast cancer. It's also not apprved as a cancer agnostic treatment. 

Is Enhertu available in the UK (and on the NHS)?

That depends. Local approval is a prerequisite for a medicine's presence on the market, but it doesn't guarantee it. Similarly, presence on the market doesn't mean coverage by the NHS.

In Enhertu's case, market and NHS availability are even trickier, because the medicine is not yet approved for all indications. 

Before this gets too complicated, let's break it down.

• Enhertu availability in the UK for HER2-positive breast cancer patients

Are you looking to access Enhertu in the UK for the treatment of HER2-positive breast cancer? You cannot simply buy it at a pharmacy, even though the medicine is approved for this indication.

Currently, you can only access Enhertu via a managed access program ^{2, 3}. Thanks to an agreement between NICE and Enhertu's manufacturer, Daiichi Sankyo, Enhertu is part of the Cancer Drugs Fund. This means that eligible HER2-positive breast cancer patients can access the medicine free of charge for the duration of the program.

The data collected in this process will be used by NICE to make a final recommendation for wider NHS use of Enhertu. 

• Enhertu availability in the UK for HER2-low breast cancer patients

Enhertu is not yet approved by the MHRA for this indication. Unfortunately, also NICE did not recommend wide NHS use for Enhertu in treating HER2-low breast cancer ⁴. 

This being said, there's still hope for setting up a managed access program within the Cancer Drugs Fund. However, with the negative NICE evaluation Enhertu received in July 2024, the treatment will likely not be available for HER2-low breast cancer patients in the UK any time soon.

• Enhertu availability in the UK for HER2-mutated non-small cell lung cancer (NSCLC) 

The MHRA has not yet approved Enhertu for treating HER2-mutated NSCLC. Similarly, NICE has also not made any recommendations regarding the use of Enhertu for this indication ⁵. NICE's appraisal of Enhertu for lung cancer has been terminated until Daiichi Sankyo provides an evidence submission ⁷. Until then, unfortunately, Enhertu is not available in the UK for NSCLC patients.

• Enhertu availability in the UK for HER2-positive gastric cancer

Also for this type of cancer, neither MHRA nor NICE have provided any recommendation, or timelines for one. As a result, Enhertu is not available in the UK for gastric cancer patients ⁶.

What can you do until Enhertu comes to the UK market?

Are you a patient in the UK with HER2-positive gastric or breast cancer, HER2-mutated NSCLC, or HER2-low breast cancer? If your doctor recommends treatment with Enhertu, and you don't qualify for early access to the treatment, you still have options.

When a medicine is unapproved in a patient's country, or it's approved but not yet available, you can access it via the Named Patient Import regulation.

Everyone.org specializes in helping people access the latest medicines via this regulation. If you have a prescription for Enhertu, you're eager to begin your treatment plan, and need help in accessing the medicine right away, get in touch with us.

Get in touch about Enhertu

References:

1. Freedom of Information request on Trastuzumab deruxtecan and oesophageal/gastric cancer (FOI 21/928). GOV.UK, 20 January 2022.
2. NICE recommends Enhertu for more people with advanced breast cancer. NICE, 20 December 2022.
3. TA704 Managed access agreement. NICE, Accessed 10 October 2023.
4. Liu, Angus. NICE poised to reject Enhertu in HER2-low breast cancer. Fierce Pharma, 27 September 2023.
5. Project information | Trastuzumab deruxtecan for treating HER2-mutated unresectable or metastatic non-squamous non-small-cell lung cancer after 1 or more therapies [ID3934] | Guidance. NICE, Accessed 10 October 2023.
6. Overview | Trastuzumab deruxtecan for treating HER2-positive unresectable or metastatic gastric or gastro-oesophageal junction cancer after anti-HER2 treatment (terminated appraisal) | Guidance. NICE, 6 April 2023.
7. Trastuzumab deruxtecan for treating HER2-mutated unresectable or metastatic non-squamous non-small-cell lung cancer after 1 or more therapies [ID3934], NICE, Accessed 01 November 2023.