EU And Pharma Industry Debate Off-Label Use of Meds

In order to cut national healthcare bills, cash-strapped European governments want to reimburse patients who use drugs that aren’t approved for their particular conditions. However, pharmaceutical companies aren’t too keen about this, arguing that prescribing medicines for so-called off-label use could not only harm patients, but also break EU law.

Off-label prescriptions are neither illegal nor uncommon in Europe, however the decision to set restrictions on use is in the hands of national regulators. Although the European Medicines Agency (EMA) doesn't keep official records on off-label use, it is seen most commonly in fields of oncology, pediatrics, and ophthalmology, the Wall Street Journal reported.

So far, countries in the EU that have allowed off-label use of drugs are as follows:

• France's National Assembly passed a law last Wednesday, which allows the government to reimburse off-label medicine as an attached amendment to its social-security budget.  France’s new law will potentially save the country as much as €200 million a year
• Italy was the forerunner in June, allowing the EU National Health System to pay for the cancer drug Avastin to treat age-related macular degeneration (AMD), an eye disease that can result in blindness. The EMA hasn't approved Avastin for treating AMD.

Pharma Concerns

The pharmaceutical industry as a whole is worried that these latest moves by France and Italy are more driven by finances, rather than the medical needs and protection of patients. They fear it will create a domino effect across the continent and further encourage off-label use simply to control costs. In the past four years, several EU countries including Spain, Italy, France, Greece, and Ireland have had to cut their health-care spending.

With the countries’ decisions to encourage off-label prescriptions, Roche told the Wall street Journal that all they can do is “inform the medical community including physicians and patients about the known risks associated with the off-label uses of our medicines."

The EU says it plans to launch a more in-depth study on off-label prescription use later this year, in an effort to evaluate legal and scientific considerations.

The Avastin debate

One particular drug at the center of the “off-label” debate is Roche’s Avastin. In fact, Roche, who designed its drug Lucentis for the specific purpose of AMD treatment, argues that Avastin is not a good alternative for AMD simply because it was manufactured for cancer.

However, in a U.S. government-funded head-to-head study of Avastin and Lucentis in 2012, the data found these two drugs performed almost identically in clinical studies. Paul A. Sieving, director of the National Eye Institute, even concluded that, “Results of this clinical trial provide evidence that long-term treatment with either drug results in a robust and lasting improvement in vision.”

The study did find that patients taking Avastin suffered from complications at a slightly higher rate than those taking Lucentis. Scientists who led the study said they were unsure why this happened, saying more research was needed.

The issue lies in the fact that drug companies are less likely to invest in clinical trials for inexpensive drugs because they won’t be big financial players in the market, the WSJ says.