Abstract

The Danish Medicines Council and Norwegian Medicines Agency appraise pharmaceuticals on clinical and economic grounds. Following recommendations from these institutions, manufacturers enter tendering processes which result in rankings of drugs within an indication. The influence of clinical outcomes on these ranks in oncology in practice has not been assessed. This review aims to determine whether efficacy/effectiveness assessments from HTAs are a key driver of the rankings in Denmark and Norway. Tendering ranks for oncology indications in both countries as of May 2019 were extracted. Indications where at least two different drugs/regimens were ranked were included. HTA reports for the included regimens were identified from agency websites, and preference orders presented by the appraisers based on clinical outcomes and other reported decision criteria (e.g. cost-effectiveness) were extracted, if reported. Were these not available, overall survival and progression-free survival outcomes were extracted and rank orders generated using surface under the cumulative ranking (SUCRA) method in network meta-analyses. Rank orders based on clinical data and HTA reports were compared to tendering rank orders and reasons for differences explored. Across both countries, 26 multiple-regimen ranks were being used in oncology where at least one corresponding HTA had been conducted. In most cases, the most efficacious medicines were included in tendering ranks, but in 38% of indications, efficacy ranks were not aligned with tendering ranks. Possible justification for differences relates to added uncertainty in indirect comparisons and interpretation of clinical evidence. The HTA processes in Denmark and Norway allow market access for the most effective drugs, however it appears to have less of a role in treatment prioritisation in oncology. Tendering presents one method for cost containment for pharmaceuticals, but the impact this has on patient access to efficacious treatments in oncology and other indications needs to be evaluated further.

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