European pharma lobby says 'non' to French funding for off-label Avastin

The French government recently said "oui" to Roche's ($RHHBY) cancer drug Avastin as a cheap, off-label treatment for the blinding eye disease wet age-related macular degeneration (AMD). And that has prompted a resounding "non" from the pharma industry, which is none too pleased with the country's latest move.

A European industry organization filed a formal complaint with the European Commission, arguing that French regulators' decision to reimburse Avastin as a therapy for AMD violates the EU approval process for meds and "compromises their standard of quality, safety and efficacy and could put patients' health at risk." Drugs should only be prescribed off-label in certain situations where there is a "concrete medical need," the trade group said in a statement, and only after a drug's safety and risks have been taken into account.

"It is simply not acceptable for policy makers concerned with the size of healthcare spending to introduce legislation that not only contradicts EU law, but also puts the overall EU regulatory system aimed at guaranteeing the highest patient safety standards at risk," Richard Bergström, director general of the European Federation of Pharmaceutical Industries and Associations (Efpia), said in a statement. The European Commission should "address this public health issue urgently and preserve those safeguards that have been put in place," he added.

Marisol Touraine

French officials are strongly defending their decision to back Avastin for AMD. Last year, the government named Avastin as a substitute for its pricier counterpart, Novartis ($NVS) and Roche's eye drug Lucentis. Putting Avastin on the official reimbursement list for AMD "will achieve significant savings," France's minister of health Marisol Touraine said in a statement, an attractive prospect given the rising costs of prescription drugs in Europe. Lucentis costs 30 times more than Avastin in France, lawmakers pointed out last year, and switching patients over to the cheaper therapy could save the country €200 million ($273 million) a year.

France is not the only country trying to switch patients over to the cheaper therapy. Last year, the Italian government said it would cover Avastin as a treatment for AMD, instead of Lucentis, as a way to cut costs. The country in December also slapped Roche and Novartis with a €180 million fine ($221.6 million) for allegedly conspiring to increase sales for Lucentis by pushing patients toward the pricier drug.

Perhaps unsurprisingly, Roche is railing against the French government's decision to reimburse Avastin. The company did not conduct any clinical trials to test Avastin for treating the eye disease, a company spokeswoman told POLITICO. Lucentis, on the other hand, was specifically developed for use in the eye. Who will have the last word in the Avastin-Lucentis debate remains to be seen.

- read the statement
- get the French Health Ministry's statement (in French) (PDF)
- here's the POLITICO story

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