Spain will Require Pricing & Cost of Treatment Data for HTA submissions from Next Year: 2021, the Year of Data?

Recently Spain’s medicines regulatory bodies announced the requirement of additional “economic evaluation” data for therapeutics positioning reports (IPTs) which is the equivalent of a Health Technology Assessment process in the country. This change is part of a revolution of the overall HTA process in 2021 which will include 12 steps, proposed to reduce the time required for the overall exercise and should take a maximum of 90-95 days in total.

As part of part of the new economic evaluation portion of the IPT process, manufacturers will be required to provide data and information for both their own drug along with comparators on the following:

  • Acquisition price
  • Dosing
  • Cost per day or per cycle
  • Cost of full treatment or treatment/year
  • Associated direct costs
  • Total cost or total cost per treatment year
  • Incremental cost differential

This data will allow for:

  • Cost minimisation analysis
  • Cost-effectiveness analysis
  • Health costs and outcomes to be measured over a sufficient period
  • Budget impact analysis

Spain’s updated IPT process is following very closely to other HTA markets in Europe that are requiring real world pricing & access data for HTA assessments. This further reinforces the need for every manufacturer looking to enter the European market to have access to a source of high quality and granular data to support pricing and access requirements.

If you would like to learn how GPI pulse can meet those needs and transform your value-based market access strategy in Europe and beyond then please book in some time with our experts below.