Access to new drugs is one of the points that generates the most tension in the health system. In the last four years, Spain has only financed 16 of the 39 cancer drugs authorized by the European Medicines Agency, 41% . In addition, it has only given its approval to 33% of the treatments dedicated to other diseases, according to the report “Financing of medicines: a challenge for the entire health system in Spain” by the consulting firm Iqvia.
The therapies available in Spain are those that have a lower cost compared to the others approved by Europe. During this period, 79.6% of the drugs approved by the agency applied for marketing in Spain and around 57 treatments received a positive price resolution .
The area of oncology is the one that concentrates a greater number of pharmacological innovations, followed by infectious diseases and those related to the metabolic system.
However, Spain invests more in treatments in the Respiratory, Digestive and Musculoskeletal area . It has authorized half of those approved by the EMA. Therapies dedicated to ocular and endocrine or metabolic pathologies are those in which the least money is disbursed in terms of medicines.
If an X-ray is carried out by type of drug, Spain only financed 38% of the 50 orphan drugs approved in Europe, and they took an average of 23 months to market. It also covered 33% of the non-orphans who were delayed an average of 16.2 months. In reference to conditional approvals, of the 25 drugs approved by the EMA, only six (24%) received approval in Spain and it took 20.2 months for them to be marketed . Furthermore, of the non-conditional ones, 36% obtained financing from the CIMP and took 14.3 months.
Regarding hospital drugs and those sold in pharmacies on the street (also known as retail ), 47% of hospital drugs received the approval of the country of Spain and took 18.3 months . As for retail , only 26% were distributed in Spain and it took an average of 20.3 months.
“These data indicate that in retail products it is, or has been, more difficult to find an agreement between the laboratory and the administration,” the report indicates. “It should be noted that most of the products approved by the European Medicines Agency in this period in Spain are classified as hospital products,” he stresses.
On the other hand, there are differences between the Autonomous Communities in the time frame that a medicine takes from when it receives the green light by the AEMPS until it is available in the hospitals of said region .
Between 2017 and 2019, Catalonia was presented as the place where the least time is required for a health center to report consumption of the drug since its approval (17 months, that is, almost a year and a half). In other territories such as the Community of Madrid, Murcia or the Balearic Islands, sales were already reported at 18 and 19 months. In addition, the Basque Country, Navarra and La Rioja were the communities in which the most months passed, specifically, between 23 and 21 (almost two years) until sales were reported.
The reality that Spain presents is that there are delays in the times in which drugs are available to patients , especially when compared to other socioeconomic powers of the Old Continent. This coexists with a reduction in the number of products and indications that become part of the portfolio of medicines of the National Health System.
The reasons that have led to this situation , according to the Iqvia report, is the lack of transparency in the journey from commercialization until the product is available to patients. In addition, marketing authorization and funding have taken a back seat and “not everything that gets the go-ahead doesn’t have to be funded, especially in recent years.”
Also, there has been a mismatch between the evaluation models that have a more systematic approach, compared to the new products that come with a more targeted focus. On the other hand, some mechanism should be established that allows an accelerated process to facilitate an early arrival of all products that are considered to provide a differential value for patients.