Med Tech-related health technology assessments and clinical guidelines from NICE in May 2024

The National Institute for Health and Care Excellence (NICE) develops Interventional Procedures Guidance (IPG) for most novel interventional procedures entering the English market. The program focuses solely on clinical evidence. Recommendations may vary from "for research only" to "for use with standard arrangements for clinical governance, consent, and audit." Recommendations are not binding, although they are followed by providers and commissioners.

In May 2024, NICE published three new IPGs and made the following recommendations:

• Selective internal radiation therapy (SIRT) for neuroendocrine tumours that have metastasised to the liver is recommended with standard arrangements for clinical governance, consent, and audit. The evidence shows that SIRT controls the growth of tumors that have metastasized to the liver and reduces symptoms. There can be serious complications with SIRT, but these are well-recognized and infrequent. For some people with these tumors, SIRT may be better tolerated than other available treatment options. More evidence would help to define which people would benefit the most;
• Endoscopic duodenal mucosal resurfacing for insulin resistance in type 2 diabetes can be used only in the context of research. The evidence on the efficacy and safety of this procedure is limited and comes mainly from one randomized controlled trial with a follow-up of only 24 weeks. This trial found that, compared with a sham procedure, duodenal mucosal resurfacing statistically significantly reduced HbA1c in the European subgroup but not in the whole trial group or the Brazilian subgroup. Overall, there are uncertainties about the safety and long-term outcomes of the procedure;
• Image-guided percutaneous laser ablation for primary and secondary liver tumours can be used in the NHS with special arrangements for clinical governance, informed consent, and audit while more evidence is generated. NICE concluded that the evidence on the procedure raises no major safety concerns. There is some evidence that the procedure can destroy tumors, but more evidence is needed on longer-term outcomes. The procedure may benefit particular groups of patients, but more evidence is needed to confirm this.

The Diagnostic Guidance (DG) program focuses on evaluating innovative medical diagnostic technologies to ensure that the NHS can adopt clinically and cost-effective technologies rapidly and consistently.

In May 2024, NICE published one new DG on tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. NICE made different recommendations depending on the clinical indications, which are provided below.

In the case of lymph node (LN)-positive early breast cancer:

• EndoPredict, Oncotype DX, or Prosigna can be used as options alongside consideration of clinical risk factors to guide adjuvant chemotherapy decisions for treating estrogen receptor (ER)- or progesterone receptor (PR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with 1 to 3 positive lymph nodes for women who have been through the menopause, men, trans, non-binary or intersex people, depending on their hormonal profile;
• For women who have not been through menopause, EndoPredict, Oncotype DX, and Prosigna should not be used to guide adjuvant chemotherapy decisions for ER- or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes;
• MammaPrint should not be used to guide adjuvant chemotherapy decisions for people with ER- or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes.

In the case of LN-negative and micrometastatic early breast cancer:

• EndoPredict, Oncotype DX, or Prosigna can be used in the NHS while more evidence is generated to guide adjuvant chemotherapy decisions for people with ER- or PR-positive, HER2-negative, and LN-negative (including micrometastatic disease) early breast cancer, only if they have an intermediate risk of distant recurrence using a validated tool such as Predict or the Nottingham Prognostic Index and clinicians and companies make timely, complete and linkable record-level test data available to the National Cancer Registration and Analysis Service;
• MammaPrint and IHC4+C should not be used to guide adjuvant chemotherapy decisions for people with ER- or PR-positive, HER2‑negative, and LN-negative early breast cancer.

See the full details here.

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