Promote the use of equivalents, evaluate the reproducibility and safety of the Stamina method, reduce the authorization process of innovative drugs in a consistent and transparent way. These are some of the imminent commitments for Aifa, as the general manager underlines in an interview Luke Pani (photo). Pani also reiterates, in response to the controversy raised by the president of the SOI Matthew Piovella, that Avastin and Lucentis are not identical and cannot be used alternately.
A recent ruling reiterated that only Aifa can establish therapeutic equivalence. How do you comment and what is your assessment of the consumption of generics in Italy?
The market for equivalents has undoubtedly recorded an improvement compared to the past but I believe that their use should still be promoted to bring it to levels equal to those of countries where these drugs boast a very long tradition. Oddly enough in Italy after an initial penetration, the market settles down and it is not possible to generate the volumes that would allow the price to be reduced even among the various manufacturers of equivalent drugs, generating real and healthy competition.
Approval of the Balduzzi decree on stem cells. AIFA will have to monitor the experimentation of the Stamina method. How do you judge the story?
Parliament is sovereign and the Agency does not judge its decisions but takes immediate action to implement them. To this end, we have already started the planned activity under the coordination of the Istituto Superiore di Sanità to evaluate the reproducibility of the method we will have to receive, the safety effects and its possible effectiveness measured according to objective and internationally recognized parameters.
La Soi has called Aifa heavily involved in the Avastin vs Lucentis affair. How does he answer?
AIFA works to protect the health of citizens and this also means guaranteeing the safety and quality of medicines. The control of pharmaceutical expenditure, however fundamental, cannot be preordained with respect to these principles. For this reason it should be remembered that Avastin is not identical to Lucentis and, for pathologies and applications in ophthalmology, it lacks dedicated registration studies and there are European proceedings on Avastin which demonstrate how adverse reactions have been underreported, a fact that we have – unfortunately – also confirmed in our country. With regard to the hypotheses of possible "cartels" between the manufacturers of the two drugs, it should be remembered that they are subject to scrutiny by the Antitrust from which we await the conclusion of the investigations.
Excessive time for the approval of innovative drugs. It is true? How can the trend be reversed?
There are certainly two factors that can affect approval times. The first consists of the algorithm for innovation developed by AIFA which will allow, by making the evaluation process objective, to reduce the authorization process in a consistent and transparent way; the second concerns the opening of a constructive dialogue with the Regions to reduce the disparities in access to the medicines that AIFA, it should be emphasized, authorizes throughout the national territory, still present in some regions. Another factor that could affect the availability of medicines, as
