Recommendation of the President – Treatment of advanced colorectal cancer (ICD-10: C18–C20)
On 04 July 2022 the President of the Agency for Health Technology Assessment and Tariff System issued the following recommendation:
Recommendation No. 64/2022 of 04 July 2022 of the President of the Agency for Health Technology Assessment and Tariff System on the evaluation of Keytruda (pembrolizumab) under the drug program: “Treatment of advanced colorectal cancer (ICD-10: C18–C20).”
Publication in Public Information Bulletin (BIP)
The President of the Agency recommends the reimbursement of Keytruda (pembrolizumab) under the drug program: “Treatment of advanced colorectal cancer (ICD-10: C18–C20),” provided that [information protected as a trade secret] to reduce treatment costs and to reduce the total impact on the payer’s budget.
Grounds for the recommendation
Taking into account the clinical analysis results, it may be stated that the use of pembrolizumab (PEM) provides a statistically significantly (SS) extension of progression-free survival (PFS) in patients with colorectal cancer as compared to the Standard of Care (SoC). For a median follow-up time of 32.4 months, a significant superiority of PEM over SoC was demonstrated in terms of PFS (median: 16.5 months vs. 8.2 months, respectively; HR = 0.60; p = 0.0002). Moreover, clinically significant differences were observed in terms of impact on quality of life (in the EORTC QLQ-C30 GHS/QOL domain and as per the EQ-5D-3L VAS questionnaire, respectively: LSM difference: 8.96 [95% CI: 4.24; 13.69]; LSM difference: 7.38 [95% CI: 2.82; 11.93]). It should be noted that the KEYNOTE-177 study results do not include comparisons with all chemotherapy regimens from among the regimens that may be used in the proposed indication. The technology does not exert a SS impact on overall survival as compared to SoC. The most recent US guidelines (NCCN 2022, NCI 2022) recommend the use of pembrolizumab as first line treatment in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced colorectal cancer.
According to the economic analysis estimations, the use of pembrolizumab instead of SoC [information protected as a trade secret] Attention should be paid to the limitations of the analysis, including the need to extrapolate survival data beyond the KEYNOTE 177 study timespan.
It was also taken into account that, according to the budget impact analysis estimations, the reimbursement of Keytruda under the proposed drug program will result in [information protected as a trade secret] The uncertainty of the above results is associated with the population size determination method, where the population size was calculated based on expert opinions, among others.
Considering the above arguments, including the uncertainty of the budget impact analysis estimations, it is justified to [information protected as a trade secret] and to secure the public payer’s total expenditure associated with the financing of the evaluated technology.