The Association has participated in the Public Consultation of the Draft Order of the Ministry of Health that creates the Pharmacoeconomics Observatory of the Community of Madrid.
Among the objectives that the Regional Ministry has set for this Observatory are: "to analyze the financial and healthcare impact of advanced therapy drugs, rare diseases and orphan drugs" and "to monitor, analyze and assess the evolution of pharmaceutical expenditure, both hospital and prescription, as well as to make proposals aimed at optimizing this expenditure or recommendations aimed at correcting deviations in the event of a significant increase in the cost of pharmaceutical services".
After analyzing the previous public consultation, AELMHU considers that the Pharmacoeconomics Observatory of the Community of Madrid will play a relevant role in access to innovation and some recommendations are provided below:
- Participation of the different agents involved, including the industry: it is essential that, through cooperation and support mechanisms, there be a conjunction and participation of all the agents involved - pharmaceutical industry, medical societies and patients' associations - in the consultative bodies and working groups for decision-making. The aim of this approach is to enable an open and effective institutional collaboration, including the perspective of the aforementioned agents in order to provide a more comprehensive and favorable vision for the patient, placing him or her at the center of decision-making in the short, medium and long term.
AELMHU has been working for more than thirteen years to contribute to improve the situation of people and families affected by rare diseases, promoting the knowledge of their pathologies and the recognition of the therapeutic and social value of orphan drugs.
Therefore, taking into account that one of the purposes of the Observatory is "to analyze the financial and healthcare impact of advanced therapy drugs in rare diseases and orphan drugs", we take advantage of this public consultation to request that AELMHU can collaborate with the observatory and, to this end, participate in the bodies that are created within the observatory to carry out this task. - Specific economic-financial analysis for orphan drugs: research and development of new drugs can be driven by regional policies that support basic research and enable clinical development and regulatory approval.
In this regard, the particularities of HHMs should be taken into account and multi-criteria parameters should be incorporated into the evaluation that address the characteristics of this type of treatment and not only the cost-effectiveness approach. These include the improvement in the quality of life of patients and the real clinical need, as well as the development of models based on Real World Evidence to consider the social perspective, including direct and indirect non-health costs that also have an impact on caregivers and family members.
To this end, progress and digital transformation should be promoted in the Community of Madrid to speed up and facilitate the collection of pharmacoeconomic data, above all, between healthcare centers - including private healthcare - and the different biotechnology companies, establishing homogeneous criteria. Therefore, it is essential to advocate for the digital transformation of the Madrid Health System to allow greater interoperability, better real-time access to clinical trials and an agile exchange of standardized data between the rest of the autonomous regions.
Likewise, it is proposed to define and establish a real, limited and specific deadline for the presentation of the results of the study and the cost/benefit/effectiveness follow-ups of the drugs, not only to increase transparency and access to information, but also to undertake the necessary improvements and measures resulting from the conclusions of this analysis, taking into account the recommendations made by other bodies such as the Standing Committee on Pharmacy or the Advisory Committee for the Financing of the Pharmaceutical Provision of the NHS (CAPF).
