Denmark now prices uncertainty into the contract. The council credits the Tecartus reversal to the agreement, and chair Birgitte Klindt Poulsen said it wants more of them. Burosumab is the slower version of the same bargain: a 2019 yes on uncertain evidence, a request for follow-up data, and a lower price when the file reopened.

• Cell and gene therapy companies holding a Danish no: the route back is a contract. Tecartus moved from rejection to recommendation once the risk of non-response shifted to the company, with the terms kept confidential. Single-digit patient numbers cap the payer’s exposure, which makes a pay-on-response offer easy to accept. Expect Amgros to ask for the same structure on the next one-time therapy it doubts.
• Rare disease launch teams: a conditional yes is a future price review. Burosumab’s follow-up data supported earlier starts and a surgical window, but the council still calls the cost very high relative to effect, and the severity principle carried the decision. With new patients put at zero to two a year in the recommendation, Kyowa Kirin traded a lower price for a narrow expansion and a renewed listing.
• Signposts: the next agreement and the first Danish data. Watch whether Amgros signs an effect-based deal outside CAR-T, and whether the council publishes the real-world response data the chair says this agreement will collect. Nordic payers reviewing one-time therapies now have a Danish precedent to cite.