A prior negative recommendation does not automatically subject the company to the new Committee, nor does it render the Ordinance irrelevant.
If the company intends to make a new submission—supported by new evidence, a new indication, a price revision, or a different economic proposal—the Committee may be engaged during the new evaluation process.
The newly established mechanisms allow for the structuring of proposals involving conditional discounts, staggered purchases, managed access agreements, or risk-sharing arrangements. This does not guarantee a reversal of the decision or remedy insufficient clinical evidence. However, when the negative recommendation relates to cost-effectiveness, budget impact, or outcome uncertainty, a new economic and contractual framework could alter the strategy’s viability.