In December 2020, the Spanish MoH presented a plan to consolidate Therapeutic Positioning Reports (IPTs) with an aim to formally incorporate health-economic evaluations into these reports (e.g. cost-effectiveness). The key objectives of the plan are to:
- Consolidate IPTs as a reference tool in the positioning and cost-effectiveness evaluation of drugs within the healthcare system
- Improve the current Healthcare drug evaluation system through a governance process based on an expert evaluation network (REvalMED) and the use of tools that optimize the prioritization and tracking system for IPT development.
IPTs: a reference tool in the positioning and cost-effectiveness evaluation of drugs
Currently IPTs are an established resource leveraged by national and sub-national stakeholders and clinical experts to get informed about the clinical profile of a drug and its suggested positioning within the disease’s treatment pathway. With the incorporation of the economic section, a wider overview of the drug’s impact for the healthcare system will be available to decision-makers, which can be incorporated into their pricing and access decisions.
The novel economic section of the IPT is expected to include cost-utility, cost-effectiveness, and/or cost minimization studies, depending on the available evidence. The aim of these analyses is to compare the studied drug against the available alternatives, considering not only the clinical outcomes but also costs, in order to make a more informed decision when deciding the best treatment approach for patients.
In any case, cost-effectiveness analyses would not be as sophisticated as the ones developed in the UK for NICE appraisal. In Spain, these will likely follow a similar approach to reports already being developed by regions and hospitals as part of the SEFH’s GENESIS working group. These reports focus on pharmacological costs mainly (i.e. drug costs) and selectively include direct healthcare resource expenses, such as hospital administration costs. Indirect costs such as productivity or work absence derived costs are not expected to be part of the evaluations.
It is not yet clear to what extent the economic outcomes and cost-effectiveness results will limit P&R outcomes (e.g., no funding of a drug above the agreed CE threshold) or the impact these will have on the drug’s price, access, and positioning, as these calculations are currently already informally considered.
Improvement to the current drug evaluation system
As part of the consolidation plan, the MoH has worked to create a more defined process for IPT development by building a robust expert network (named REvalMED). This network will be in charge of drafting and reviewing the IPTs and more standardized process steps. Deadlines for each step of the process have been assigned, aiming to reduce current development timings (i.e. bringing existing >12 month timings for some IPTs down to a maximum of six months).
Moreover, objective criteria have been laid out in a prioritization matrix to assign scores and determine which IPTs should be prioritized. The prioritization criteria include:
- Therapeutic gap covered
- Incremental clinical benefit over alternatives
- Improvement in safety profile vs. alternatives contributing to better outcomes (assuming similar clinical benefit)
- New indication of a drug already reimbursed and marketed
- General interest for the healthcare system with regard to alternatives
Another key update has been the decision to publish the IPT prior to the start of P&R negotiations to make the information available to all decision-making stakeholders. This first publication will not include the recommended positioning of the drug. Once P&R negotiations are finalized, an updated version of the IPT will be made available, including the recommended positioning for the drug. This would suggest that the P&R decision will have a more evident impact on the recommended positioning of the drug than it has had until now.
For now, the new procedure and report structure is in a pilot phase, with a goal of having at least one drug per therapeutic area to act as a test case. No IPTs have been published so far with the new structure but there are currently ten under development, with a few expected to be published prior to the summer break.