Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
The clinical evidence from the ASCENT trial shows that sacituzumab govitecan significantly improves overall survival (11.8 months vs. 6.9 months) and progression-free survival (4.8 months vs. 1.7 months) compared to treatment of physician’s choice. The objective response rate was also considerably higher (31.1% vs. 4.2%). This evidence indicates a clear clinical advantage over standard care.
Cost effectiveness
The ICER for sacituzumab govitecan is reported at £47,170 per QALY gained, which is within the acceptable range for NICE, especially considering the high unmet need and substantial improvements in clinical outcomes. This suggests that the treatment is marginally cost-effective but defensible.
Quality of life
While there are uncertainties regarding the quality of life data due to missing scores and dropout rates, the evidence suggests that patients on sacituzumab govitecan experience better quality of life during treatment compared to standard chemotherapy. The clinical experts noted that the treatment leads to reduced symptoms associated with tumor burden, which supports a moderate improvement in HRQoL.
Supporting Domains
Safety and Adverse Effects
The safety profile of sacituzumab govitecan is considered very good, with manageable adverse events reported. Initial gastrointestinal side effects were well managed, and the overall tolerability appears to be favorable compared to standard chemotherapy options.
Comparator Selection
The ASCENT trial compared sacituzumab govitecan against a relevant standard of care (treatment of physician’s choice), which included established therapies for triple-negative breast cancer. This selection is appropriate and reflects current clinical practice.
Patient Population and Subgroups
The trial population in ASCENT is representative of the intended patient population with triple-negative breast cancer, having received multiple prior therapies. The inclusion of diverse patient demographics supports the generalizability of the results.
Care Pathway Integration
Sacituzumab govitecan can be integrated into existing treatment pathways for triple-negative breast cancer with minor adjustments. The treatment aligns with current clinical practices and does not require significant changes to infrastructure.
Resource Use and Cost Implications
The budget impact of sacituzumab govitecan is manageable, especially considering the potential for cost savings through improved patient outcomes and reduced need for subsequent therapies. The commercial arrangement further supports its economic viability.
Evidence Quality and Robustness
The evidence base is strong, supported by a well-conducted Phase III trial (ASCENT) with low bias risk. The results are consistent and robust, although some uncertainties exist regarding quality of life data.
Uncertainty, Sensitivity, and Broader Impacts
While there are some uncertainties regarding long-term survival estimates and quality of life data, the overall context of high unmet need and the treatment’s potential benefits mitigate these concerns. The societal context supports its use.
