Representatives of Spain's regional payors claim that for full and effective incorporation of the therapeutic positioning reports, they should include cost-effectiveness and budget-impact analysis, but the health ministry disagrees.
IHS Life Sciences perspective | |
Significance | Some of Spain's autonomous communities have proposed that the government includes cost-analysis in therapeutic positioning reports (TPRs). |
Implications | Although the health ministry has clarified that it is open to discuss this topic, it has ratified its position of not including financial assessment. |
Outlook | Despite the health ministry being clear in its position, in the latest TPRs published by the AEMPS, the agency did in fact include economic assessment in order to decide the final validity of the report, which may be the first step towards persuading the health ministry of the relevance of incorporating cost-effectiveness analysis into the reports. |
In a meeting held on 3 July between the Spanish Ministry of Health (MoH) and representatives of the Spanish communities, some autonomous communities have proposed the government includes cost analysis in therapeutic positioning reports (TPRs), according to medical newspaper Redacción Medica. According to the source, the experience at the regional level suggests that for full incorporation of the TPRs, the communities see the inclusion of cost and budgetary assessment as necessary.
Toni Gilabert, representative of the Catalonian Health Service (CatSalut), has stated that TPRs should include benchmarking in terms of efficiency, cost-effectiveness, and budget impact. This is a position support by Iñaki Betolaza, of the Basque government, who explains that for the regional payor, the financial assessment is essential to plan and allocate the sources necessary to fund a drug without waiting until the inter-ministerial commission meeting that addresses the financial impact that reimbursement of a medicine would have.
This regional position has been supported by pharmacoeconomics expert Carme Piñol, who says more should have been done to implement cost analysis in the creation of the TPRs, pointing out that it is very difficult to position a medicine only based on clinical assessment and leaving the price and cost evaluation until later.
Finally, some autonomous communities have also agreed that the inclusion of cost evaluation in the TPRs could improve transparency in the regional payors' publishing prices.
Opposition in the MoH
Although the MoH has clarified that it is open to discuss this topic, it has ratified its position of not including financial assessment. According to the MoH's Carmen del Castillo, the TPRs, that are carried out by the Spanish Agency for Medicines and Health Products (AEMPS), should focus on clinical evaluation that is then used by the MoH to carry out economic assessments, as it is impossible to conduct an economic assessment without knowing the therapeutic positioning of a medicine.
Outlook and implications
The TPRs were introduced in May 2013 by the MoH. They are intended to develop an analysis of the added therapeutic value that new medicines represent for the health system after achieving marketing authorisation. A group of experts provide a therapeutic report related to the new drug compared to other medicines already on the Spanish market. These reports aim to avoid redundancy, maintaining consistency in evaluating and sharing resources with a single report of therapeutic positioning recognisable by the entire health system.
Despite the fact that the AEMPS has made progress with the periodical publication of the TPRs, some covering the most innovative medicines, several regional payors have disagreed that the reports' focus only on the clinical side, which is viewed as inadequate as economic considerations must be taken into account. The lack of cost assessment is making the application of those reports difficult at the regional level.
This is not the first time that parts of the healthcare sector have highlighted the need to better regulate the TPRs by adding cost evaluation and making them mandatory for all autonomous communities in order to achieve harmonisation. Additionally, some experts have stated that the TPRs should be carried out within a short period of time after marketing authorisation to facilitate patient access to new medicines as soon as possible.
Despite the fact that during this meeting the MoH clarified its position of not included cost analysis, in the latest TPRs published by the AEMPS, an economic assessment was included in order to decide the final validity of the report, which may be the first step towards the incorporation of cost-effectiveness analysis into the TPRs (see Spain: 25 June 2015: Spain's AEMPS releases negative therapeutic positioning reports on Boehringer Ingelheim/Eli Lilly's Jardiance and AstraZeneca's Xigduo and Spain: 2 July 2015: Spain's MoH approves Roche's Kadcyla reimbursement, AEMPS publishes therapeutic positioning report on Takeda's Incresyn).