The Danish Medicines Council (DMC) and Amgros have updated the process for alternative agreements, allowing pharmaceutical companies more time to submit proposals during the assessment of medicines with high costs and limited evidence.
Key points:
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Companies can now submit proposals up to and including the 6th week of the assessment process. Before, companies needed to submit these proposals from the beginning of the process.
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The change does not delay planned meetings with expert committees or the expected recommendation timeline.
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Alternative agreements can be used when there is uncertainty about a medicine’s effect or costs.
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The updated approach is part of the revised guidance on alternative agreements and follows cooperation with LIF.
Alternative agreements, including effect-based and economically based models, are already used in Denmark, and the DMC and Amgros encourages companies to utilise this opportunity when it is relevant.
