Draft guidelines that once finalized will implement new rules on pricing and reimbursement negotiations in Italy reveal that drug companies may have to disclose confidential information relating to the prices of their products in other EU member states.
Italy: Pharma May Have To Disclose Confidential Info Under New Pricing Rules
Drug companies have their last chance to negotiate which documents and information Italy’s regulator, AIFA, will be entitled to request of them when they submit pricing and reimbursement applications.

More from Health Technology Assessment
A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.
An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.
Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.
Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.
More from Market Access
Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
Democrats opposed the nomination because they believe Mehmet Oz will not defend Medicaid from spending cuts. His pledge to continue lowering drug costs in Medicare and Medicaid did not offset the concerns.
An analysis of Medicare Part D and other data found that more than one-third of all pharmacy spending went through pharmacies owned by Cigna, CVS Health, Humana or UnitedHealth Group.