Up to 500 days of delay can take for a cancer drug to be approved in Spain from its approval in Europe. It is a situation that has been taking place since 2002, denounces Rafael López, president of the ECO Foundation, which has caused ESpain went from being in third place among the European countries for access to cancer drugs to occupying the current position, on 18.
This reality is verified by the reportReflection on the current situation in Spain and possible areas for improvement in patient access to oncology innovation’, an initiative of the ECO Foundation, whose main objective is to identify areas for improvement where the parties involved in the process need to continue advancing and investing. Because, as Rafael López assures, “time is a determining factor for cancer patients, who cannot accept long waits for drug approval”.
For López, “it is not understood that a country like Spain, which is among the European countries currently leading the clinical development of oncology innovation, is also a country where these innovations take time to arrive, or do not reach patients at all” .
The president of ECO denounces the case that is occurring in our country with NTRAK inhibitors, drugs directed at the so-called agnostic cancers, those tumors that can occur in different parts of the body but, nevertheless, have the same genetic alteration, where Spain is one of the few countries in Europe where its use has not yet been approved. “They affect a very limited percentage of the population, but we have been fighting for years to get it approved in our country.”
López also regrets the cases of drugs approved by the European Regulatory Agency (EMA) for certain lines of treatment that later, in Spain, are modified or conditions are placed to restrict the use of different forms.
The causes? The responsible?
It is the sum of many. Central and regional administration and the industry itself, he acknowledges.
There is no doubt, he explains, that, as detailed in the report, the results show how Spain has one of the lowest percentages of GDP allocated to public health spending among the countries analysed, which could suggest that public health is not receiving sufficient economic resources to be able to provide all the required health care in comparison with other European countries.
But for the president of ECO it would also be necessary “to change the excessively compassionate attitude of the whole society, as well as authorities, etc., towards cancer.” For Lopez, “Spaniards, for reasons unknown to me, do not face cancer like the rest of Europeans».
- Given this context, the report emanates five priorities for the next three years, which allow us to counteract the situation of access to oncology innovation in our country, through not only the state of funding, but also the time for it. Experts suggest:
- reach a greater involvement of cliniciansscientific societies and patients throughout the evaluation process.
- achieve a transparent pricing and financing processpredictable and with shorter introduction times.
- Ensure that there are sufficient resources during the innovation evaluation process and that they are properly managed to avoid the current IPT delays.
- Create mechanisms of financing specific to innovation.
- Separate or improve the reconciliation between the functions of evaluation, financing and purchase of new medicines.
- Based on these priority objectives, the specialists have also defined the six essential recommendations that would allow them to be implemented in the short term:
- Creation of a independent body for evaluation, with the participation of clinicians.
- Improving transparency and establishing criteria that allow for a binding national decision
- Seeking access models to innovation that allow accelerating access.
- Encourage the stake of patients and their adequate training
- Create collaboration groups that guarantee equitable access to the drug in the Autonomous Community
- Increase investment in health and value the creation of funds for high-impact drugs.
Likewise, the study also reveals that Spain takes 469 days in financing the oncology innovation approved by the EMA, compared to 100 in Germany. In addition, of all the cancer drugs approved by this institution, in 2022, only 61% were financed in Spain —compared to 90% in Italy, or 100% in Germany. And of that percentage, 40% had some restriction in the population eligible for financing —a figure that contrasts with 14% in Italy, or 0% restrictions in Germany.
On the other hand, despite the importance of early access for patients to oncology innovation, in recent years in Spain the number of financed medicines has been reduced, as well as access times to these and restrictions on financing, which continue to favor inequities between territories. According to experts, these facts are due, fundamentally, to an economic cause.