Off-Label Prescription Reimbursement Complaints in Italy

Published By : 11 Feb 2015 | Published By : QYRESEARCH

Representing the pharma industry are three trade groups who have filed a complaint against the country of Italy for expanding the off-label usage of medicines.

The complaint was filed eight months after the IMA decided to give patients their reimbursements for dispensing Avastin. The drug is cancer-related and was being used for treating age-related macular degeneration. Macular degeneration is one of the most common causes of blindness in the elderly.

Avastin was not originally approved for this use; Lucentis was the only approved drug for this purpose. The former, however, is far cheaper than the latter.

The decision has been the result of a growing list of payers who were complaining about the increasing medicine expenses. The complaints were being registered with private investors as well as the government.

The move was received with great alarm by the pharmaceutical industry. They quickly voiced their concerns over similar steps being taken by other governments in the European Union.

The decision to reimburse was made shortly after the anti-trust authorities of Italy had made accusations against Roche and Novartis. Both companies are the sellers of Lucentis in Europe. The accusation was of colluding in order to favor the distribution of the more costly treatment.

Roche manufactures both the drugs and markets them in the U.S. Novartis markets them only in Europe.

The trade groups that lodged the complain said that Italy is undermining the regulatory system of the European Union, along with drug development incentives and patent protections. The complaint was filed by the EFPIA, the ECPE, and the European Association for Bio-Industries.
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