NICE Withdrew Four Appraisals Because the Medicine Went Off Patent
- NICE announced on 15 September 2026 the first test of its whole lifecycle approach, updating 4 technology appraisals covering tirzepatide, ertugliflozin, empagliflozin and canagliflozin to align them with its updated guideline on type 2 diabetes in adults.
- A panel comprising the chair and vice chair of technology appraisal committee B and the chair and vice chair of the guideline committee decided whether alignment was appropriate. That allowed the appraisals to be updated using evidence already reviewed for the guideline, rather than requiring a new evidence submission for each one.
- Separately, 4 appraisals covering specific uses of dapagliflozin and other SGLT-2 inhibitors are being withdrawn: TA288, TA390, TA418 and TA583. NICE states it does not consider it appropriate to routinely update appraisals for medicines no longer under patent, and that dapagliflozin is now covered by a class-level recommendation for SGLT-2 inhibitors.
- That guideline recommends the least expensive suitable SGLT-2 inhibitor, accounting for administration costs, dosages, price per dose and commercial arrangements. NICE confirms recommendations for medicines under patent continue to be supported by a funding mandate. Jeanette Kusel calls the pilot a first step toward applying the approach more widely over the coming year.
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Two sentences in this release change how a product’s NICE position is held over its lifetime, and neither is the headline. Patent status now determines whether a medicine keeps its own appraisal, and losing one carries no appeal.
- Going off patent now costs a medicine its named appraisal. NICE states plainly it does not consider routine appraisal updates appropriate for off-patent medicines. Dapagliflozin loses 4 appraisals and enters a class-level recommendation. The release also confirms the funding mandate continues for medicines under patent, which is where the commercial consequence sits.
- The withdrawal is not appealable and the updates are. NICE describes the removal of TA288, TA390, TA418 and TA583 as a routing decision not subject to appeal, while the 4 updated appraisals go to consultation with standard appeal rights. Loss of an appraisal runs through a lighter process than amendment of one.
- Least expensive suitable option is becoming the standing instruction across European HTA. NICE used the same construction on weekly insulin in August, and Denmark’s Medicinrådet folded PD-(L)1 inhibitors into a class recommendation in June. Assume any mature class will be assessed collectively, with price as the tiebreaker, and price the portfolio accordingly.