We read with interest the article on the latest type of performance-based managed entry agreement (MEA) very recently introduced in Italy, the “Success Fee” [
1]. Although we regret that the authors did not cite our previous contributions on the subject [
2,
3], we share their conclusion that MEAs in Italy have led to trifling payback and were basically a failure from a financial point of view. Not only was payback minimal, but these schemes are time-consuming and require costly investments to manage all the forms [
3].
In principle, we share the authors’ opinion that the scheme seems to be a “step ahead” of the previous performance-based contracts (i.e., risk-sharing and payment-by-result). As we noted some years ago [
2],
the Italian choice of requesting refunding for non-responders instead of paying for responders … makes a major difference from the Italian National Health Service viewpoint since each hospital pharmacy buys the drug at full price in daily practice, then non-responders have to be documented; otherwise any undocumented non-responder will be paid as a success.
While awaiting financial evidence on the first example (pirfenidone) described in the article, however, we have difficulty sharing the authors’ optimistic view that this newborn scheme will necessarily be a success and goes in the right direction. Besides the major concern the authors raised on the still pending issue of good management (“a failure … in delivering the certificate to the company is interpreted as a successful treatment and money has to be paid to the manufacturer”), which can hardly be ruled out judging from the bad management of the system so far [
3], it should be added that performance-based schemes have not added any value to clinical evidence in almost a decade since their introduction. Going through the forms referring to the patient’s clinical status (all available on the Agenzia Italiana del Farmaco Web site) [
4], it seems clear that they do not provide any additional information useful for an extended clinical assessment. So the information collected is only a self-certified validation of appropriate prescription by the physician [
[3]].
We wonder, instead, whether the MEA trend should not be directed toward cost-sharing agreements, as the English experience of patient access schemes suggests [
5]. Although equivocal results from clinical trials have encouraged policymakers to put new drugs under performance-based contracts, particularly anticancer drugs, these schemes contribute little to robust clinical assessment in practice, given the absence of randomization and the uncertain relationship between short-term surrogate and hard end points. We certainly feel that simple financial-based contracts are arguably more efficient as a means for health services to reduce outlay on costly drugs and ensure access for patients.
https://www.valueinhealthjournal.com/action/showCitFormats?pii=S1098-3015(14)04770-6&doi=10.1016/j.jval.2014.12.003