LONDON – The row over European governments sanctioning off-label use of drugs to cut their pharmaceuticals bills is escalating after the lower house of the French parliament voted in favor of a law that would allow off-label use even if on-label treatments are available.
The draft law references the use of Roche AG's cancer drug Avastin (bevacizumab) for treating wet age-related macular degeneration (AMD).
The vote in France follows a similar legislation in Italy, voted through on June 9, permitting Avastin to be used instead of Lucentis (ranibizumab) in AMD.
The European Confederation of Pharmaceutical Entrepreneurs (Eurocope) claims France's draft law jeopardizes patient safety and challenges European Union (EU) regulatory standards. "The proposed plan conflicts with EU law and poses a significant impediment to our highly innovative members," said Alexander Natz, Eurocope director general.
While it supports off-label use in some circumstances – for example, in pediatrics – if no on-label product is available, Eurocope is concerned that European doctors are being pushed to prescribe off-label medicines to reduce spending. "Promoting off-label use purely for economic reasons puts patients at unnecessary risk," it said. Lucentis is up to 40 times more expensive in some markets than Avastin.
Eurocope said the move also will undermine the innovative potential of all pharmaceutical companies in Europe, and claimed small biotechs developing orphan drugs will be particularly affected.
After being voted through by the lower house in the National Assembly, the proposal now has to pass through the upper house of parliament, the Sénat. It could also be reviewed by France's Constitutional Court.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) also has been campaigning against the new law in Italy and the proposal in France. Those changes represent a "material breach" of the pan-European approval framework operating under the EMA and call into question the European Commission's competence to approve drugs centrally, EFPIA said.
Speaking after the French vote, Richard Bergström, director general of EFPIA said, "This is a serious public health issue, which the European Commission must address urgently before it becomes more widespread."
Natz, too, called on the commission "to stop national developments infringing EU law."
The commission is standing back for now, claiming it has no powers to regulate off-label use of the drugs it approves. While the drugs approvals system is centralized, all matters relating to the operation and administration of health care are the responsibility of member states.
However, the commission is concerned about the issue and currently is scoping a review, which is due to begin later in the year. (See BioWorld Today, June 13, 2014.)
NEW GUIDE TO PHARMACOGENETICS
The EMA has published a new guide to pharmacogenetics, providing an overview of how to design and conduct studies that aim to investigate how individual genetic variants affect response to a drug.
The guide includes methods for identifying genetic variants and recommendations for analysis and reporting any observed impact on either therapeutic effect or adverse drug response.
The advice on pharmacogenetics forms part of the EMA's broader Guide on Methodology Standards in Pharmacoepidemiology, which was updated on July 14.
EMA DRUG APPROVALS STEADY
Thirty-nine drugs were recommended for marketing authorization by the EMA in the first half of 2014, compared with 44 in first half of 2013 and 33 in first half of 2012.
The EMA said that figure included a number of new products with potential to meet unmet medical needs, to treat diseases for which no treatments were previously available or to bring significant added benefit to patients over existing therapies. Most notably, it gave the nod to PTC Therapeutics Inc.'s Translarna (ataluren), the first drug to be approved for treating muscular dystrophy.
Among the approvals are two cancer treatments, Glaxosmithkline plc's Mekinist (trametinib) and Roche's Gazyvaro (obinutuzumab), the anti-inflammatory drug Entyvio (vedolizumab) from Takeda Pharmaceutical Co. Ltd. and Bristol-Myers Squibb Co.'s anti-infective Daklinza (daclatasvir).
More than two in three of the companies getting approvals in the first six months of the year had scientific advice during the development phase. That is a significant increase compared with the first half of 2013, when one in two applicants had received scientific advice.
Confirming the trend observed in the past few years, the number of treatments for rare diseases is steadily increasing, providing treatments for patients who often have only few or no options. Overall, eight orphan drugs were recommended for approval. That number includes three medicines for which the EMA recommended conditional approval but whose applications were withdrawn by the sponsor prior to a final decision by the European Commission. Conditional approval allows for early patient access to drugs that fulfill unmet medical needs or address life-threatening diseases. That mechanism was used for PTC's Translarna.
Two of the approvals, Daklinza and Janssen's Sylvant (siltuximab), followed an accelerated assessment.