Enhertu for secondary breast cancer patients in the Island?

Summary

The request sought data on secondary breast cancer patients eligible for Enhertu and details on non-NICE guideline funding applications. Manx Care disclosed the total number of stage 4 breast cancer patients and historical counts of HER2-low cases, but referred cost-benefit analysis and specific funding application details to the Independent Funding Review (IFR).

Key Facts

• There are 177 patients currently living with secondary/advanced/metastatic breast cancer on the Isle of Man.
• The number of ER+, PR+, HER2- breast cancer cases was 65 in 2021, 88 in 2022, 54 in 2023, and 29 in 2024 (up to July).
• Manx Care stated that cost-benefit analysis for Enhertu should be answered by the Independent Funding Review (IFR).
• The response included the official indications and usage for Enhertu but did not provide specific data on the number of non-NICE guideline applications granted in the last 5 years.
• The request was received on 2024-11-04 and the outcome was 'All information sent' on 2024-12-05.

Data Disclosed

• 177
• 2021
• 65
• 2022
• 88
• 2023
• 54
• 2024
• 29
• 2024-11-04
• 2024-12-05
• 31st October 2024

Original Request

I seek the following information: How many Isle of Man residents are currently being treated for secondary/advanced/metastatic (or any other descriptor for stage 4) breast cancer in the Isle of Man? How many of these patients are clinically eligible for the drug Enhertu, which is available free of charge to patients living in Scotland and 19 other countries but not in England and Wales (ie, how many are diagnosed as ER+, PR+ and HER2 low)? Please provide all and any analysis which has been carried out as to the cost of and benefit to these patients of being prescribed Enhertu free of charge by the Isle of Man health service. On the Mannin Line programme on Manx Radio on 31st October 2024, the Treasury Minister Dr Allinson informed listeners that it is possible for the Island's health service to step outside of the NICE guidelines (he said 'our healthcare system...doesn't necessarily have to follow NICE guidance') in order to prescribe a particular medication for a particular patient; I seek information held as to: The criteria which apply in such incidences, and How many applications have been granted in the last 5 years, and The cost of each one.

Data Tables (1)

Full Response Text

Manx Care Noble’s Hospital, Strang Braddan, Isle of Man IM4 4R (01624) 650 000

Our ref: 4238350 3 December 2024

Dear

We write further to your request, received 4 November 2024, which states:

"I seek the following information:
How many Isle of Man residents are currently being treated for secondary/advanced/metastatic (or any other descriptor for stage 4) breast cancer in the Isle of Man?
How many of these patients are clinically eligible for the drug Enhertu, which is available free of charge to patients living in Scotland and 19 other countries but not in England and Wales (ie, how many are diagnosed as ER+, PR+ and HER2 low)?
Please provide all and any analysis which has been carried out as to the cost of and benefit to these patients of being prescribed Enhertu free of charge by the Isle of Man health service.
On the Mannin Line programme on Manx Radio on 31st October 2024, the Treasury Minister Dr Allinson informed listeners that it is possible for the Island's health service to step outside of the NICE guidelines (he said 'our healthcare system...doesn't necessarily have to follow NICE guidance') in order to prescribe a particular medication for a particular patient; I seek information held as to:
The criteria which apply in such incidences, and
How many applications have been granted in the last 5 years, and
The cost of each one."

Our response to your request is as follows: I have detailed below the information that is being released to you.

"How many Isle of Man residents are currently being treated for secondary/ advanced/ metastatic (or any other descriptor for stage 4) breast cancer in the Isle of Man?

Using the Information held on the Somerset Cancer Registry system, we report a figure of 177 patients currently living with secondary/advanced/metastatic/stage 4 breast cancer on the Isle of Man.

“How many of these patients are clinically eligible for the drug Enhertu, which is available free of charge to patients living in Scotland and 19 other countries but not in England and Wales (i.e., how many are diagnosed as ER+, PR+ and HER2 low)?

Breast Cases ER & PR positive with HER2 negative

Breast Cases ER+ve PR+ve HER2 -ve 2021 65 2022 88 2023 54 2024 (up to July ) 29

Please provide all and any analysis which has been carried out as to the cost of and benefit to these patients of being prescribed Enhertu free of charge by the Isle of Man health service.

This question should be answered by the IFR as they receive all requests for funding by the relevant Consultant.

On the Mannin Line programme on Manx Radio on 31st October 2024, the Treasury Minister Dr Allinson informed listeners that it is possible for the Island's health service to step outside of the NICE guidelines (he said 'our healthcare system...doesn't necessarily have to follow NICE guidance') in order to prescribe a particular medication for a particular patient; I seek information held as to: The criteria which apply in such incidences, and How many applications have been granted in the last 5 years, and The cost of each one. "

INDICATIONS AND USAGE

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of:
• adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH positive) breast cancer who have received a prior anti-HER2-based regimen either:
• in the metastatic setting, or
• in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. (1.1)
• adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. (1.2)

• adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by an FDA approved test, and who have received a prior systemic therapy. (1.3)
• adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ ISH positive) gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. (1.4) • adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options. (1.5)

https://daiichisankyo.us/prescribing-information- portlet/getPIContent?productName=Enhertu&inline=true

Enhertu has been available to eligible breast cancer patients since April 2021 to July 2024 after which time if the patient’s consultant wants to access this drug treatment

for a specific patient he/she would need to apply via the Individual funding Request (IFR) route.

The IFR group is chaired by the Medical Director and Executive Director for Health who should be able to provide the ToR along with the requests + costings of approved treatments

Please quote the reference number 4238350 in any future communications.

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An electronic version of our complaint form can be found by going to our website at https://services.gov.im/freedom-of-information/Review . If you would like a paper version of our complaint form to be sent to you by post, please contact me and I will be happy to arrange for this. Your review request should explain why you are dissatisfied with this response, and should be made as soon as practicable. We will respond as soon as the review has been concluded.

If you are not satisfied with the result of the review, you then have the right to appeal to the Information Commissioner for a decision on; 1. Whether we have responded to your request for information in accordance with Part 2 of the Freedom of Information Act 2015; or 2. Whether we are justified in refusing to give you the information requested.
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I will now close your request as of this date.

Yours sincerely