Cost-effectiveness and budget impact to be included in new IPTs

In Spain, The Ministry of Health announced that in 2021 the Therapeutic Positioning Reports (IPT) will be conducted under a new “National Consolidation Plan”. The main changes brought by this new IPT process are the inclusion of cost-effectiveness and budget impact analyses.
The newly added economic evaluation section in the IPTs will include the following information:

  • Treatment cost
  • Cost of comparator treatments
  • Cost per acquisition
  • Cost per treatment cycle/day
  • Direct costs
  • Incremental differential costs with respect to the comparator


The new IPT protocol will allow the manufacturer to perform a cost-minimization analysis once the evidence for the therapeutic equivalence has been defined. However, cost-effectiveness or cost-utility analysis can also be performed. The sensitivity analyses will be carried out on the evaluated variables and their results will be presented in the IPT. In addition, the budget impact estimates at the national level can be conducted based on the available epidemiological data.

After setting the price and financial arrangements of the therapy, the position in the therapeutic pathway will be determined compared to alternative treatment options, either covering the entire indication or in some patient subgroups. Manufacturers looking to enter the Spanish market are now expected to provide higher quality data and more detail to support their submission for pricing and access. The updated Spanish IPT process aims to follow the processes of other HTA agencies in Europe, providing more transparency to the assessment process.

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