The case. Scenesse drug. AIFA meets patients affected by erythropoietic protoporphyria

Fedaisf editorial staff

July 7, 2016

The manufacturing company refuses to supply the drug at the price previously applied, asking for a price three to four times higher and consequently depriving patients of the treatment necessary to lead a normal life. The unilateral decision of the Company is, among other things, generating an unacceptable lack of homogeneity of access to treatment on the national territory.

AIFA – 06/07/2016

President Melazzini: “AIFA is committed to doing everything possible to guarantee patients affected by this rare pathology the rapid availability of the drug. We are witnessing an incomprehensible obstructive behavior on the part of the Company, which no longer intends to respect the price established for the disbursement pursuant to Law no. 648, charging three to four times the price. This is producing a lack of homogeneity of access at regional level which cannot be accepted, because all patients have the same rights”.

The Italian Medicines Agency met yesterday with representatives of patients affected by erythropoietic protoporphyria. Clinuvel, the company that produces the drug Scenesse, currently present in the lists of Law no. 648 [editor's note: compassionate use] for the treatment of this pathology. The Company, although invited, declined.
Erano invece presenti il Commissario Straordinario dell’IFO di Roma, Marta Branca, e Luca Barbieri del Centro Porfirie dell’Istituto San Gallicano.

L’AIFA ha ribadito –ai fini della rimborsabilità del farmaco da parte del SSN – l’inclusione di Scenesse nelle liste della legge n. 648/1996 fino a dicembre 2016 (see resolution of 14 April last published in the Official Gazette), and acknowledged that the Company refuses to supply the drug in 648 at the price applied up to now, asking for a price three to four times higher and consequently depriving patients of the treatment necessary to lead a life normal.
LAmong other things, the unilateral decision of the Company is generating an unacceptable lack of homogeneity of access to treatment on the national territory.
AIFA specified that the process for classifying and negotiating the drug is still ongoing, with extremely rapid timing on the part of AIFA, but could be delayed due to the company not presenting the educational material. necessary for the purposes of publication of the provision relating to the marketing authorization and in reimbursement scheme paid by the NHS.

“AIFA's commitment – said President Melazzini – is to ensure that patients from all Regions can have the drug in good time. If necessary, we are ready to warn the Company. Italy is one of the very few European countries to have guaranteed, since the conclusion of clinical trials, i.e. since 2010, constant access to the drug for all patients, with reimbursement paid entirely by the NHS, and we cannot allow our patients are now penalized by the Company's behaviour”.