AIFA as Pontius Pilate on Biosimilars

(Italian version: https://www.quotidianosanita.it/scienza-e-farmaci/articolo.php?articolo_id=61927)

The new AIFA "position paper" on biosimilars says they are "interchangeable" but not "replaceable" automatically. "The biosimilar compared to its originator has same efficacy, safety and quality ... the same risk-benefit ... either for naive or treated patients ... exhaustively attested by EMA and national authorities ... offering an indispensable saving to the NHS". Would you expect an automatic replacement ruled in this NHS dramatic economic difficulties? No: "the doctor decides"

"Interchangeability" and "substitutability" as concepts from the parallel semantics, modern "homooiusion" and "homoousion" of the First Council of Nicea (325 a.C.), the consubstantiality of the Son-Biosimilar with respect to the Father-Originator. Thorny theme, to be handled with prudence, wandering between interests and various and discordant powers, careful not to dissatisfy them. Today it's up to AIFA like yesterday to the clever Constantine, first Christian Emperor.

Replacement by default is my preference, even if I’d require three essential conditions:

1) all the related savings go in addition to the two 500 millions euro funds for the innovative drugs (biosimilars to pay the innovation): today saving are already around 600 million estimable, growing vertically for future patent expiring.

2) the lowest price of biosimilar does not drive the prescription of the expired patent molecule, a critical bias.

3) Exceptions allowed but to be clearly justified by the prescriber

Instead, the AIFA document, based on EU, EMA, WHO and other Institutions regulations and documents, despite its technical (pharmacological, clinical and economic) emphasis on biosimilars, surprisingly in the end does not give the expected policy indications on their use in place of the respective originator.

A "position" paper with no position. Despite its own technical assertions, it does not finalize, concretizes them, even contradicts them in the end. On the last page fades in fading on the credits, at the crucial time of the policy address, withdraw the hand that should indicate the direction, kicking in the corner.

As Pontius Pilate, AIFA leaves the doctor of the provincial hospital who has chosen the therapy, the decision whether to do it with the biosimilar or the branded. Thus assigning him the final judgment, such as a "Supreme Court", superior to that of EU, EMA and AIFA itself established through thousand analysis of pharmacology, clinic, production technologies, quality controls, pharmaco economics, etc., of hundreds of super-experienced super-specialists.

A set of multidisciplinary conclusions that doctor is therefore required to analyze and refute at the patient's bed, presumably having Nobel candidacy skills. A jump back to the non-regrettable times of benevolent paternalism when decisional discretion was based on subjective individual anecdotal and not on the statistical objectivity of the shared methodology established by the institutions in charge, the regulation syllabus.

The document technical assertions are so precise and exhaustive to be expected guiding straightly to the replacement with biosimilar, as already happens in other countries. But it simply doesn’t.

Why this unusual AIFA“institutional shyness" of AIFA, one of the top EU medicine agency for its very high level of quality, innovation, professionalism and above all the capability to guarantee one of the best and equal pharma coverage at one of the lowest public spending in EU and OCSE? 

In order not to antagonize the doctors (and some of their scientific societies) often opposing the substitution? Or to shift that responsibility on the Regions to drift their doctors by incentives, disincentives, guidelines, moral suasion, tenders, etc.? Taking in account that the rate of substitution has today high variability between Regions, some with peaks to 90%, others less than 10%, with a quite high national average but "deceptive" if not observed with Google Maps.

A shyness, that of the AIFA position paper in its final ("sad y solitario"), after the promising technical part, hidden behind the verbal arabesque, the ethereal semantic subtleties, the articulated suspiciously excessive circumlocutions typical of when too much dialectic is sign of weakness and / or ulterior motives, orchestrating the verbose lexical minuet between interchangeability and substitutability.

However, minuet bows and reverences in venetian white loafers edged with lace are usually difficult to perform. Especially if you're that doctor asked for deciding in front of your patient.