The marketing of the medicine in Italy was published in the Official Journal in June, but the availability in the C-NN range had sparked controversy over the accessibility of life-saving drugs. However, Sanofi clarifies that it has already started the procedures for the possible inclusion of the drug in class H, at the expense of the NHS.
08 JUL – After Roche, Sanofi also clarifies its position and prospects for the drug aflibercept, one of the anticancer drugs at the center of controversies raised by the first Aifa decisions according to the Balduzzi decree. “The availability of class C-NN aflibercept (for a fee) is only an important first step for patients,” they explain. "But Sanofi has already started the procedures for completing the process to determine the conditions for reimbursement of the drug for inclusion in the so-called class H, paid by the National Health Service".
The story
The AIFA Determination for placing the drug on the market in Italy was published in the Official Gazette last June, and the drug, as reported by the indications of Law Decree 158/2012 - known as the "Balduzzi Decree" - is made available in "provisional" class C-NN (class C - Non-negotiated), for hospital dispensing only. "This means that patients affected by this particularly aggressive form of cancer can potentially have access to therapy before the conclusion of the procedure for the normal price negotiation between the company and AIFA", explain Sanofi.
But the immediate placing on the market in range C of this innovative anticancer drug, pending the negotiation for reimbursement, has raised great controversy regarding probable discrimination in access to new drugs (among which, in addition to the two anticancer drugs by Sanofi and Roche, there was also an anti-AIDS): their price would risk excluding from treatment patients who do not have the financial resources to immediately buy the therapy, at least until - and in this sense there are no maximum time limits, unfortunately - the authorities and companies do not reach an agreement on the refundable price.
So in fact it would limit access to potentially sal drugs