Genomic Health_ Letterhead for United Kingdom

National Assembly for Wales Health and Social Care Committee inquiry

Progress made on implementing the Welsh Government’s Cancer Delivery Plan

Executive summary

· Access to innovative medical technologies in Wales may be restricted by uncertainty around commissioning arrangements, pressures on NHS budgets, a culture of conservatism to emerging technologies and ageism in clinical decision-making.

· In order to ensure the timely adoption of effective new medical technologies, there should be a clear commissioning policy for those that have received NICE approval.

Introduction

1. Genomic-based diagnostic tests provide personalised information on a patient’s tumour, helping to inform individual treatment decisions. In the context of rising numbers of people living with cancer in the UK, we believe such personalised medicine will play a key role in enabling the NHS to manage its resources more efficiently.

2. Genomic Health’s test for early-stage invasive breast cancer, the Oncotype DX® assay, received a positive NICE recommendation for use in England and Wales in September 2013.[1] We are in discussions with Local Health Boards in Wales to ensure commissioning arrangements are in place so that NHS patients can access the test.

3. Genomic Health welcomes the opportunity to respond to the Committee’s inquiry on progress made to date on implementing the Welsh Government’s Cancer Delivery Plan. Genomic-based diagnostic tests can help achieve the Plan’s objectives to “improve information” and “deliver fast, effective treatment and care”.

Improving Information

4. The Welsh Government’s Cancer Delivery Plan aims to improve information for patients and heath professionals so they can “make decisions about their care and treatment”.

5. Patients with early-stage invasive breast cancer are often prescribed chemotherapy after surgery as a cautionary measure when it is unclear if the cancer is aggressive. However data shows only a very modest proportion of patients benefit from this treatment (only 4 in 100 patients in the NSABPB20 study^{^[2]}). The Oncotype DX test estimates the likelihood of benefit of chemotherapy and the risk of recurrence for patients with early-stage breast cancer, helping clinicians and patients decide on the best treatment option after diagnosis.

6. A study in Wales^{^[3]}showed that just under a third of decisions on the treatment of breast cancer patients would be different with the extra insight provided by the Oncotype DX test. With the introduction of the test into the decision-making process, around half of the patients originally recommended chemotherapy were spared this toxic treatment and the possibility of needlessly experiencing associated side-effects.

7. In the case of breast cancer, avoiding chemotherapy where it is unlikely to be beneficial could improve patient outcomes and save the NHS £8,609 per patient.^{^[4]} This could also free up resources within hospitals and shorten chemotherapy waiting times. Assessment

of the net resource impact of the Oncotype DX test shows it is expected to be cost saving as the cost of the test is absorbed by savings from reduced chemotherapy use.^{^[5]}

Delivering fast, effective treatment and care

8. The Welsh Government’s Cancer Delivery Plan aims to ensure the delivery of “fast, effective treatment and care”. It states that Local Health Boards and Trusts should “identify mechanisms to plan and deliver equitable access to new diagnostic and treatment procedures in line with evidence”.

9. There is considerable uncertainty around commissioning arrangements for new medical technologies. Genomic Health receives enquiries from clinicians every day asking how to access the Oncotype DX test on behalf of their NHS patients.

10. The Oncotype DX test received a positive NICE recommendation for use in the NHS in England and Wales in September 2013, the diagnostics assessment process having commenced in March 2011. We are currently in discussions with Local Health Boards in Wales to confirm commissioning arrangements to ensure that NHS patients have fair and equitable access. The evaluation and commissioning process has so far taken more than three years, during which time many patients could have benefitted from the test.

11. A number of other factors relating to pressures on NHS budgets, a culture of conservatism to emerging technologies and ageism in clinical decision-making may restrict the adoption of new medical technologies in Wales. This would effectively inhibit access to personalised medicine that could improve patient outcomes and reduce costs for the NHS.

Conclusion

12. The introduction of genomic-based diagnostic testing will help breast cancer patients and clinicians make more informed decisions about treatment.

13. A clear commissioning policy to enable cancer patients to access genomic-based diagnostic tests would give them their best chance for treatment success. It is important that patients across the NHS have fair and equitable access to such innovative medical technologies that have received NICE approval.

14. We would be delighted to come and talk to the Committee about the matters raised in our evidence.