New Italian law allowing reimbursement for off-label prescribing causes concern
- The European Federation of Pharmaceutical Industries and Associations (EFPIA) has spoken out against a new Italian law which allows reimbursement of off-label drugs for economic reasons.
- Italy’s medicines agency, AIFA, has decided that in certain cases it will not only permit off-label use, but reimburse for it, even if other approved treatment alternatives exist.
- EFPIA cites safety concerns as one of the major reasons it is against the new Italian law.
AIFA has endorsed the use of Avastin (bevacizumab) — indicated for the treatment of lung cancer -- for the treatment of age-related macular degeneration (AMD) although there are approved on-label treatments available for AMD. Avastin represents a less expensive option and is reimbursed in Italy for AMD treatment precisely because of its effectiveness at a lower cost.
Richard Bergstrom of the EFPIA has predicted that one potential consequence of endorsing off-label use of drugs as a cost-saving measure could be less-than-optimal outcomes for patients. He also argued that ultimately this approach could discourage pharmaceutical companies from developing new drugs and testing new indications in existing drugs.
- Pharma Times Industry groups slam Italian off-label rule change