The Ministry of Health is clear that the approval of the Royal Decree on the Assessment of Health Technologies (ETS) is a priority because this aspect must be ordered after the judgment of the National Court canceling the Consolidation Plan for Therapeutic Positioning Reports (IPT). This was explained by the Secretary of State for Health, Javier Padilla, in a media meeting he held after the inauguration ceremony of Padilla himself, as well as Ana María Sánchez as Undersecretary of Health and José Manuel López as Director of cabinet of the minister, which happened this Monday.
Padilla explained that in the field of pharmacy, they intend to “give priority to the approval of the Royal Decree on the Evaluation of Health Technologies” because it is necessary provide an answer to the current situation of lack of regulations. In addition, the Secretary of State briefly explained some of the lines that the new regulation on the evaluation of drugs and other technologies is expected to have.
As explained, it is about separating the evaluation from the decision and in doing so, it is suggested a process divided into three phases. First of all, an “evaluation without denominators”, as you mean it. It is a purely clinical evaluation of the value given by medicine to health, “without additional conditions.” This phase It can be developed by the Spanish Medicines Agency (Aemps), as it has done since the cancellation of the Medicines Evaluation Network (REvalMed). The second phase is where the denominators are “introduced”, such as economic evaluations, disability impact studies, patient comfort, etc. At this point, The autonomous communities and the General Portfolio Directorate itself will participate. Common Services of the SNS and Pharmacy, as well as other agents “such as patients and scientific societies.”
she third level which Padilla considered to be “Must be distinctly different” In the first two, it will make the decision on price and financing. However, it does not explain how to restore the clear separation of evaluation from decision when the same agents participate in phases two and three.
Following this priority royal order, the Ministry of Health keeps the review of the Guarantees Law and the new Royal Price Decree on the calendar and Finance of Medicines and Health Products, although there is no date for its processing. The need to carry out these developments
Shortening deadlines, “a priority”
What Javier Padilla wants very clearly is to take the demand seriously. essibility to shorten deadlines marketing of drugs. “The shortening of deadlines is the priority of this mandate“, explained. Because of this, the Ministry of Health proposed perform the analysis to reach a diagnosis of the situation and establishing corrective measures, beyond the legislative aspect.
In this regard, he indicated that the Permanent Pharmacy Commission of the Interterritorial Council of the SNS is already working on “streamlining and standardizing evaluation processes which depends on the most executive part of shortening the gap between the evaluation dates of EMA and marketing.” Also, he explained that they have already requested the General Portfolio Directorate for a “Detailed drug-by-drug analysis of delays” to find out if this is due to an inherent nature of the Spanish financing model or if there is a failure in the processes or if, on the contrary, it is due to the fact that the companies, in some cases, “don’t request financing.”
On the other hand, Padilla stated that CART and other advanced cellular therapies They are a sample of “how the public goes from the laboratory to the patient’s bedside” and stated that it would be interesting to examine it closely because “there are positive consequences for the development of industrial textiles.” This route can be a way from the historical proposal of its formation in the provision of the system a public pharmaceutical laboratory.