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AELMHU publishes first report on IPT of orphan drugs

AELMHU publishes first report on IPT of orphan drugs

The Spanish Association of Orphan and Ultra-Orphan Drug Laboratories has launched the first report in Spain on the evolution of Therapeutic Positioning Reports (TPR) for orphan drugs. To do so, and always using public sources, it has examined the reports from 2013 to the first months of 2022. As can be seen in the document, one of the main conclusions that can be drawn is that in Spain it takes an average of one year to evaluate orphan drugs approved by Europe.

Currently, our country takes 70% longer to evaluate orphan products than when the IPTs were created, going from an average of 214 days between the start of the dossier and its submission to the Common Portfolio in 2013, to the current 363 days for the MMHs evaluated by the REvalMed pilot programme.

For AELMHU, orphan drugs should have economic evaluation criteria that take into account the particularities of these diseases with low prevalence and highlight the fact that the unmet needs that these drugs address require an early approach to access.

It also considers it necessary to provide the bodies responsible for evaluation with sufficient financial and human resources to cope with an ever-increasing volume of dossiers.

Executive summary

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Press release