Italy vs. Big Pharma
Italy reimburses off-label bevacizumab use in ophthalmology – pharma complains to the European Commission.
Eight months ago, the Italian medicines authority, the Agenzia Italiana del Farmaco (AIFA) made a decision: to reimburse patients with wet age-related macular degeneration (AMD) who were treated with bevacizumab. There’s no doubt that the drug works in wet AMD, with the CATT trial broadly describing its safety and efficacy profile relative to ranibizumab (1). There is a slight problem: the drug is being used off-label: bevacizumab’s approved indications are entirely oncological and not ophthalmological (2). You can see the attraction to AIFA – it is less expensive than the EMA-approved alternatives, and austerity-hit Italy needs to save money.
Understandably, representatives of the pharmaceutical industry are unimpressed. Healthcare payers are increasing pressure on pharma companies to reduce the cost of medicines, and AIFA’s move might herald copycat moves by other EU states. In fact, in the UK, the co-chair of the NHS Clinical Commissioners group, Amanda Doyle, is campaigning for the UK Government’s Department of Health and NHS England to “remove the current barriers” to off-label use of bevacizumab for the treatment of wet AMD (3).
Three trade federations – the European Confederation of Pharmaceutical Entrepreneurs, the European Federation of Pharmaceutical Industries and Associations, and the European Association for Bioindustries – have filed a complaint against Italy with the European Commission (4). They claim that the AIFA’s decision infringes on European law and could potentially compromise patient safety.
Italy certainly appears to up for the fight. In February 2014, the Italian competition authority, the Autorità Garante della Concorrenza e del Mercato (AGCM), accused Roche and Novartis (who hold the EU marketing authorizations for bevacizumab and ranibizumab, respectively) of contriving to restrict competition in favor of the more expensive treatment.
Novartis has issued a statement that it “fully supports the complaint… which highlights the discrepancy between Italian rules on off-label use of medicines and the EU’s pharmaceutical legislation” (5).
- DF Martin et al. “Ranibizumab and bevacizumab for neovascular age-related macular degeneration”, N Engl J Med, 364, 1897–1908 (2011). PMID: 21526923.
- Roche Products Limited. Summary of Product Characteristics. Avastin 25mg/ml concentrate for solution for infusion (November 27, 2014). bit. ly/avastinsmpc. Accessed March 01, 2015.
- NHSCC, “Doctors unite in seeking support for commissioning safe and effective eye care services that will save the NHS millions”, bit.ly nhscc. Accessed March 01, 2015.
- EUCOPE, EuropaBio, EFPIA, “Non-compliance of Italian rules on off-label use of medicines with the union acquis – complaint in the context of article 258 TFEU”, (2015). Available at: bit.ly/1AzknJn. Accessed March 01, 2015.
- The Wall Street Journal. “Pharma files complaint against Italy for reimbursing off-label prescribing”, (2015). Available at: on.wsj. com/17dPgFU. Accessed March 01, 2015.
I have an extensive academic background in the life sciences, having studied forensic biology and human medical genetics in my time at Strathclyde and Glasgow Universities. My research, data presentation and bioinformatics skills plus my ‘wet lab’ experience have been a superb grounding for my role as a deputy editor at Texere Publishing. The job allows me to utilize my hard-learned academic skills and experience in my current position within an exciting and contemporary publishing company.
