Decision problem addressed by the Assessment Group
The decision problem for this appraisal, as described in the final scope issued by NICE,53 is summarised in Table 2.
| Parameter | In the NICE scope53 | Addressed by the AG |
|---|---|---|
| Interventions | Lenvatinib Sorafenib | As per scope |
| Population | Adults with progressive, locally advanced or metastatic, differentiated thyroid carcinoma refractory to radioactive iodine | As per scope |
| Comparators | The interventions listed above will be compared with each other BSC | Explore the feasibility of comparing lenvatinib with sorafenib Comparisons of interventions with BSC |
| Outcomes | The outcome measures to be considered include:OSprogression-free survivalresponse rateadverse effects of treatmentHRQoL | As per scope |
| Economic analysis | The reference case stipulates that the cost-effectiveness of treatments should be expressed in terms of incremental cost per quality-adjusted life-year The reference case stipulates that the time horizon for estimating clinical effectiveness and cost-effectiveness should be sufficiently long to reflect any differences in costs or outcomes between the technologies being compared Costs will be considered from a NHS and Personal Social Services perspective | As per scope |
| Other considerations | If the evidence allows, consideration will be given to subgroups based on previous treatment with TKIs Guidance will only be issued in accordance with the marketing authorisation. When the wording of the therapeutic indication does not include specific treatment combinations, guidance will be issued only in the context of the evidence that has underpinned the marketing authorisation granted by the regulator | As per scope |
The overall aims and objectives of the assessment
The aim of this research was to assess the clinical effectiveness and cost-effectiveness of lenvatinib versus sorafenib, within their respective EU marketing authorisations,45,46 for the treatment of patients with RR-DTC. The research objectives are given below:
- To carry out systematic reviews to compare the clinical effectiveness and cost-effectiveness of –
- treatment with lenvatinib with treatment with sorafenib for RR-DTC
- treatment with lenvatinib with BSC for RR-DTC
- treatment with sorafenib with BSC for RR-DTC.
- To develop an economic model to compare the cost-effectiveness of –
- treatment with lenvatinib with treatment with sorafenib for RR-DTC
- treatment with lenvatinib with BSC for RR-DTC
- treatment with sorafenib with BSC for RR-DTC.