Spain improves the percentage of access to drugs, but adds days of delay

A European study points out that in two years our country has gone from 53% to 62%, compared to 88% in Germany and 77% in Italy. The waiting time adds up to more than a month and goes from 629 to 661 days, almost two years of delay. Despite Spain consolidating itself as one of the leading countries in clinical trials in the world, only surpassed by the US, patients who do not have the opportunity to benefit from therapies in this area must wait more than 600 days from approval by the European Agency. of Medicines (EMA) and the European Commission until it reaches your medicine cabinet.

These data come from the annual report Indicators of access to innovative therapies in Europe 2023 (WAIT Indicator) and serve to measure European countries’ access to innovative therapies in different critical therapeutic areas, such as Oncology and minority diseases. Recently in Economic News, Sanofi CEO Paul Hudson lamented that “it is somewhat disheartening when your doctor tells you that he is going to treat you with the best option he has, instead of the best possible option for that disease.”

The WAIT report is prepared by the consulting firm Iqvia for the European Federation of the Pharmaceutical Industry (Efpia) and analyzes the state of public financing as of January 5, 2024 for medicines authorized between 2019 and 2022. In the analysis of the situation of 36, Spain has improved its figures by going from 58% to 62% in the availability of new treatments approved in the EU. Thus, it means adding almost 10 points in two years.

On the other hand, as seen in the report, half of the new medications available in our country (51%) have limited availability. What does this mean? That 50 of the 98 medicines financed in Spain in the period analyzed are subject to some type of restriction of use, due to therapeutic indication, type of patient, etc. The percentage of medicines with restrictions in Spain is well above other EU countries such as Germany (1%), Italy (12%) and France (17%), and has also increased by 10 percentage points in our country since the previous report.

Of that 62%, some 107 therapies, 52% have limited access, the same percentage as last year. Only 29% of medicines are available without obstacles in the SNS, 32% have restricted access and 1% are obtained through private financing. This is not the case in other countries such as Germany, where eight out of ten drugs are available, or Italy or France where the figures only drop to six and four out of ten respectively.

In the oncology section, only 69% are accessed and it is done after 725 days. That is, of the 48 new approvals from the EMA, 29 arrive in Spain. Far behind Germany, Italy and France, with 46, 40 and 32 respectively. If we address orphan drugs, we exceed half of the available medicine cabinet, but 44% of the 32 available have limited access, and patients wait an average of 700 days.

At this point it is worth underlining Hudson’s statements. “But despite being on the right path, there is still one more step to fully achieve leadership in access to innovation, because the involvement of healthcare professionals in clinical development should then translate into access to medicines in whose discovery and development they have participated”.

What does this delay mean? This shows that Spanish patients can access 103 of the 167 medications approved in the aforementioned period through the National Health System (SNS). However, our country is still far from the rates of reference states such as Germany, with 88% availability; Italy, with 77% and France, with 63%, although it has surpassed England, with 56%. These last three have lowered their figures compared to the previous year.

What are the health plans to reverse the situation?

Just yesterday, in the plenary session of the upper house, the PP senator, José Manuel Aranda Lassa, questioned the head of Health, Mónica García, about what plans her ministry had to deal with these delays. Although neither of them knew the data, they did put key issues on the table. Aranda recalled that the delay has almost doubled since 2018, when the socialists came to government and after five different ministers, “when the delay time stood at 385 days.” Today it reaches 661. Then, he recalled that availability stood at 62%. Although today we are at the same percentage, five years ago it dropped to 53% two years ago. So in terms of drug availability it has improved during this time.

In his response, García listed the axes that support the path to improving the figures, since he recognizes that “there is significant room for improvement in these processes, and therefore, we have established their optimization as a strategic priority.”

The minister addressed the three measures. The first, the Royal Decree on the Assessment of Health Technologies, “which will guarantee a robust and efficient system for the incorporation of innovative and valuable health technologies, ensuring their availability for the population.” Secondly, the Consolidated Text of the Law on Guarantees of Medicines and Health Products, “which aims to modify the current pricing system, generating adequate incentives for the introduction of new medicines in the Spanish market,” he clarified. modification seeks not only to promote competitiveness and accessibility, but also to ensure the sustainability of the health system.”

And the third, “and no less important”, he stressed, the Pharmaceutical Industry Plan, “which aims to promote the development and production of medicines in our country, creating a favorable ecosystem that positions Spain as a leader in preclinical research, complementing our already prominent position in clinical trials.”

However, Aranda delved in his second intervention into the position that Spain occupies in terms of oncological drugs and insisted on how a drug against breast cancer had been rejected three times by the ministry since December. “The availability of these drugs may be the last resort and the last hope that the patient clings to,” he stressed.

García defended himself by explaining again the difference between access to drugs and financing that exists in Spain and used the wild card of clinical trials to show off the privileged access that patients have in our country, “they have access even when they are not authorized and when they are not yet funded. The minister concluded with the invitation to the PP to advance in the aforementioned axes, “to once and for all take the side of the Government to be able to advance in these aspects.”

Industry initiatives to access drugs

As president of EFPIA, Lars Fruergaard Jørgensen, also CEO of Novo Nordisk, has also stressed on more than one occasion that to address these inequalities, a new approach is required. “We need to create a framework for tiered pricing based on equity to ensure that the price of innovative medicines can vary between countries, depending on their economic level and ability to pay.”

Of the 167 medicines approved in the EU, 147 are available in Germany and 103 in Spain, but only 47 in Ireland and 29 in Romania. Figures that show inequality within the old continent. “Innovation is part of the DNA of the pharmaceutical industry, but for it to have a real impact, it has to reach patients,” said Jørgensen.

The impact of new therapies on patients is key to raising quality of life. Different pharmacoeconomic studies suggest that 73% of the increase in life expectancy in developed countries is due to the impact on health of innovative medicines.

There are also other works, such as the study carried out by Professor Frank R. Lichtenberg, from Columbia University (USA)which has just been published in the magazine Value in Healthhas put on the table how pharmaceutical innovation has had an impact on reducing cancer mortality in Spanish patients.

The conclusion of Lichtenberg’s pharmacoeconomic study is that new cancer treatments managed to reduce cancer deaths in Spain by almost 30% in the last decade. Furthermore, she demonstrated that the appearance between 1998 and 2015 of new oncological drugs caused the average age of death of Spanish patients to increase by almost three years (2.77).

For this reason, Jørgensen has also stated that “faster and more equitable access throughout Europe is an achievable goal.” While achieving this “requires a shared understanding of the barriers and delays, as well as concrete commitments from the industry, the EU and member states to work together to achieve real change. That includes exploring models to make medicine prices better reflect both the value they offer to patients and societies and the economic conditions of each country.