Presentation (CTI)

OBJECTIVES: This study compares NICE classification of disease severity under the old End-of-Life guidance (gid-tag387) to the new Severity Modifier method (PMG36), published in January 2022. The comparison is conducted across five distinct oncology disease areas. The objective is (i) to understand how the severity modifier is applied at the tumour level, and (ii) how NICE’s valuation of QALYs in cancer patients has changed versus the previous End-of-Life guidance.
METHODS: The analysis focuses on 73 indications across 5 tumour areas: Breast, CRC, Gastric & GOJ, NSCLC, and SCLC. The indications differentiate between biomarker-defined subpopulations and range from early-stage cancers to late-line metastatic diseases. Applicability of the End of life (EoL) criteria is assessed using median OS for the UK standard of care based on published literature and NICE technology appraisal. Applicability of Severity Modifier (SM) was estimated using a 3 health-state model with survival outcomes and health-state utilities based on published literature and technology appraisals, respectively.
RESULTS: 20 cancer indications that would have qualified for EoL do not qualify for the high-severity modifier of x1.7. In contrast, only 2 indications that would not have met EoL qualify for x1.2 SM. All affected indications are in early-line metastatic disease with high unmet need.
CONCLUSIONS: The findings indicate that NICE new methods downgrade severity of cancer relative to the old guidance. This implies that NICE have decreased the value of cancer patient’s QALY, and ultimately their willingness to pay for health benefits in cancer patients which may restrict access to new treatments. Breast and lung cancer patients are most likely to be affected by the downgrade as 12 (60%) of the 20 cancer indications downgraded are in breast or lung cancer.