The therapeutic equivalence of drugs is a topic that is more relevant than ever. The use of medicines indicated for a clinical condition, at lower prices than the original for which the patent has expired, constitutes one of the tools to facilitate the rationalization and optimization of healthcare expenditure within a complex context characterized by limited resources of the Health Fund, increase in life expectancy – with the consequent aging of the population and increase in chronic diseases – and the need to guarantee wider access to innovative therapies and treatments. The topic was discussed today on the occasion of the presentation to the press of the Expert opinion ‘Therapeutic Equivalence: Regulatory / Legal Review, Structural Approaches & New Alternative Procedural Models’, organized by Mapcom Consulting, with the unconditional contribution of Gilead Sciences and Sanofi Italia .
The Expert opinion aims to identify legislative revision proposals and innovative procedural models aimed at achieving the necessary balance between economic sustainability and scientific value. The document was edited and signed by experts and representatives of the legal, scientific and civic world: Francesco Saverio Mennini, Paola Minghetti, Francesca Moccia, Vincenzo Salvatore, Francesco Scaglione Paola Lanati, Dario Lidonnici.
The document, thanks to the contribution of the professionals involved in the analysis of the current situation, was able to outline proposals for regulatory revision and some innovative procedure models that provide for the following recommendations: to make an assessment based on strictly scientific criteria, to reduce the risk of arbitrariness in the evaluation process carried out by the Italian Medicines Agency (Aifa); involve marketing authorization holders; grant greater protection to technological innovation; guarantee the effective exercise of the evaluation by the doctor, safeguarding the right to health to adapt the therapy to the conditions of the specific patient.
The Expert opinion also proposes to extend the framework negotiation agreements also to non-biological / biosimilar drugs, and the introduction of the HTA (Health technology assessment). Finally, the experts deem it necessary to urge Aifa to provide therapeutic equivalence assessments without the need for a request from other bodies, which can slow down the tender procedures and give rise to disputes and to encourage multi-awarded tenders, to contain the risks of concentration and less reliable supplies.
In a nutshell, the Expert opinion suggests: entrusting the scientific assessments to the regulatory body in charge but the economic ones to another competent body; carry out the evaluation of the therapeutic equivalence between drugs with different active ingredients, given that it is not certified in the dossiers, but carry it out in a more transparent and clear way; in addition to extending the framework agreements also to these drugs and not just to some categories such as biosimilars, to ensure that the virtuous experiences of some regions are also implemented in others so as to avoid patchy litigation.