The pharmaceutical soap opera of the year is called Kymriah and will define the future of the new gene medicines that are coming
In late 2018, a year and a half after its approval in the United States, the Government of Spain announced that Kymriah was not only going to be approved in the country, but was going to become part of the treatments covered by Social Security. .
Kymriah has been the first of a generation of new custom-engineered gene treatments and breakthrough results. In the case of the Novartis drug, and always according to FDA-audited clinical trials, Kyriah is able to eradicate acute lymphoblastic leukemia from 83% of patients in just three months.
With those figures on the table, it is normal that the announcement of the Ministry of Health was very celebrated. However, what very few expected was that a request for information on the price and the criteria that justified its application would become the 2019 pharmaceutical soap opera. But here we are.
A petition that has become a very important legal conflict
'It is not healthy' is a joint campaign of numerous organizations (from Médicos del Mundo or the Collegiate Medical Organization to the OCU or the CECU) that tries to guarantee universal access to medicines by promoting an "efficient, sustainable medical research system that guarantee the universal right to health. "
It was they who requested, through the Transparency Portal, the information on prices and technical criteria for which the Ministry had approved the Kyriah. Given this, the Government published the cost of the drug (320,000 euros) and some generic information about the approval process.
"It is not healthy" then resorted to the General Council of Transparency to demand that the Government comply with the Law and make the data public. Novartis, for his part, took the case to court to try to prevent that data from coming to light. In this way, what seemed like just a request for information can become a key precedent for the health system.
The limits of access to public information
As they explained to Cadena Ser the members of the campaign "it is important to know the conditions under which this therapy has been approved and its financing." Above all, if the Ministry had access to the cost-effectiveness studies of Kymriah, if it evaluated the possible therapeutic alternatives or if it has information on the costs of development and research of the treatment (because, remember, it is a drug that is developed individualized).
For its part, Novartis explained in a statement that the decision to appeal is based on the fact that the company "was not informed at any time of the procedure and, therefore, had no opportunity to be heard in order to defend its legitimate interests."
In addition, as the company acknowledges, "in this judicial procedure the limits to the right of access to public information will be addressed." Because "although the legislation broadly configures the right of access to public information, this right must be weighted and, where appropriate, limited when it conflicts with other protected interests."
What does this all mean?
Under the guise of boring corporate conflict, this judicial process will lay the foundation for the next steps in next-generation medicine. As we were saying about the Zolgensma, the "most expensive medicine in the world", that gene medicine becomes mainstream is great news, but in the next few years all the world's health systems are going to be tested.
Finding a scheme that guarantees the survival of European healthcare systems, that promotes public debate on healthcare and that allows business models for pharmaceutical companies and research centers is the key task. This case is one of those that will define this scheme in Spain. And, if we listen to the available research, it seems clear that transparency must have a central role in these new balances or we will have problems.