Denmark has reported substantial acceleration from a new proportionate assessment pathway that replaces repeated individual HTAs where previous experience makes the likely reimbursement decision highly predictable. The current model applies only to a defined group of cancer immunotherapies, but addresses a wider challenge facing HTA systems as the number of medicines and indication extensions increases.
The Danish Medicines Council (Medicinrådet) had repeatedly assessed PD-(L)1 inhibitors for advanced cancer and found that eligible indications were now almost invariably recommended. Competition had also reduced prices substantially. Continuing to run each indication through the normal 14-week process therefore consumed assessment capacity despite increasingly predictable outcomes.
Since 1 June, eligible new medicines and indication extensions have instead entered a general class-wide recommendation. They can be added within 10 working days once European authorisation is confirmed and an acceptable price is available. Eligibility is restricted to locally advanced inoperable or metastatic disease, monotherapy or combinations with off-patent medicines, comparable class pricing and treatment durations consistent with previous assessments. More complex or higher-cost combinations return to standard HTA.
By 28 August, 22 medicines or indications had been recommended during transition to the model. The Council attributes much of its higher 2026 assessment throughput to the change.
The approach reflects a wider move towards proportionate HTA. NICE has used lighter appraisal processes across several therapeutic areas, reducing some timelines by up to 20 weeks while concentrating resources on more uncertain decisions. Norway similarly introduced case-dependent assessment depth for outpatient reimbursement in July.
Denmark provides a particularly clear test of the principle: when accumulated evidence, pricing and previous decisions substantially reduce uncertainty, HTA intensity can fall without abandoning predefined clinical and economic safeguards.
Source: Danish Medicines Council
Link: Ny proces for immunterapier viser resultater (New process for immunotherapies shows results)
Date: 28 August 2026
Source: Danish Medicines Council
Link: Medicinrådets proces for immunterapi til metastatisk kræft (Danish Medicines Council process for immunotherapy in metastatic cancer)
Date: 1 June 2026
Source: National Institute for Health and Care Excellence
Link: Taking a proportionate approach to technology appraisals
Date: 24 April 2023
