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New HTA Decisions in Scotland
June 2020
Drug name
KISQALI® (ribociclib)
Company
Novartis Pharmaceuticals UK Ltd
Decision date
11/11/2019
Therapeutic area
Cancer
Therapeutic sub area
Breast cancer
Decision
Recommended with restrictions (PACE)
Indication
For the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
Decision Detail
Women who have relapsed on or within 12 months of completing (neo) adjuvant endocrine therapy, or those who have progressed on first-line endocrine-based therapy for advanced breast cancer.
Summary
The key evidence for the use of ribociclib in combination with fulvestrant for the treatment of HR-positive/HER2-negative advanced breast cancer (which comprises metastatic and locally advanced disease not amenable to curative surgery) comes from MONALEESA-3: a phase III, double-blind, placebo-controlled, parallel-group, international study. Ribociclib in combination with fulvestrant significantly increased progression-free survival compared with endocrine monotherapy in women with HR-positive, HER2-negative locally advanced or metastatic breast cancer. The submitting company presented a cost-utility analysis comparing ribociclib plus fulvestrant to either fulvestrant alone or exemestane plus everolimus in women who have relapsed on or within 12 months of completed (neo) adjuvant endocrine therapy, or progressed on first-line endocrine-based therapy for advanced breast cancer. The time horizon for the analysis was 40 years. There were a number of weaknesses with the analysis: - There are weaknesses with the indirect comparison versus everolimus plus exemestane. Differences in PFS were included in the modelled benefits however the submitting company provided additional analysis on request to remove the PFS difference. - For both comparisons, the analysis does predict life year gains for ribociclib plus fulvestrant, but there is uncertainty associated with this given the immaturity of the data provided within the SMC submission. Following the New Drugs Committee, the submitting company provided additional information relating to updated survival analysis, as noted above. The economic analysis was not updated to reflect these updated data but the company commented that the findings were supportive of the outputs modelled in the economic analysis. - There is uncertainty associated with the modelling of time to treatment discontinuation and the ICERs were particularly sensitive to the choice of distributions. - There is uncertainty associated with the assumption of no difference in post-progression survival, particularly with respect to the comparison with everolimus plus exemestane. The impact on this on the ICER is unknown. The Committee also considered the benefits of ribociclib in the context of the SMC decision modifiers that can be applied when encountering high cost-effectiveness ratios and agreed that the criterion for a substantial improvement in life expectancy in the patient population targeted in the submission was satisfied. In addition, as ribociclib is an orphan equivalent medicine, SMC can accept greater uncertainty in the economic case. After considering all the available evidence, the output from the PACE process, and after application of the appropriate SMC modifiers, the Committee accepted ribociclib for restricted use in NHS Scotland.