UEMS survey highlights accessibility disparities, inconsistent policies for anti-VEGF treatment across Europe

A survey conducted across the 28 EU countries and Switzerland by the European Union of Medical Specialists highlighted a diverse and uneven scenario of anti-VEGF treatment in Europe in terms of numbers, prices, rules and policies.

“These results paint a clear picture, and this is in itself an important achievement. From here, we know what has to be addressed,” Marko Hawlina, MD, PhD, vice president of the ophthalmology section of the European Union of Medical Specialists (UEMS), said.

A first set of questions investigated treatment accessibility and reimbursement policies. An extreme variability in the number of injections administered per year in individual countries was found, from the lowest ratio of 500 per million population to the top level of 8,800 per million population.

“This is a huge gap we were not entirely aware of, which reflects the gap between countries with wealthy economies and substantial investments in health care and countries with weaker economies and substantial cuts in public spending,” Hawlina said.

Although an average optimal treatment number is difficult to establish, it might be assumed that in those countries where the ratio is approaching or more than 8,000 injections per million, there is some degree of overtreatment. The optimal ratio is probably in the range of 5,500 to 7,000 per million, which is the average found in a number of countries with wealthy economies and efficient health care systems, although with new indications, this number may continue to rise, Hawlina said. On the other hand, a ratio of less than 1,000 injections per million highlights a situation of severe undertreatment in a great proportion of Europe and should urgently be addressed.

“It is possible that some patients are treated in private centers at their own expenses. However, the countries with the lowest ratio are the lower-income countries where you would expect the cheaper drug, Avastin (bevacizumab, Genentech/Roche), to be approved to have more patients treated at a lower cost. But this is not always the case. Some countries do not allow Avastin although they do not provide the sufficient basic number of on-label drugs,” Hawlina said.

Lucentis (ranibizumab, Genentech/Novartis), Eylea (aflibercept, Regeneron/Bayer) and Avastin appear to be used in a similar proportion in all countries, according to the results of the questionnaire. However, approval and reimbursement policies vary a great deal, particularly in regard to Avastin.

“Some countries no longer allow the use of Avastin off label, in some it is allowed but not reimbursed, and some countries differentiate the prescription of one or the other of the drugs based on the visual prognosis. Basically, Eylea or Lucentis can only be used in patients with a good prognosis, whereas Avastin is suggested if poor or no visual improvement is expected. Countries with wealthier economies reimburse Lucentis or Eylea for all. Other countries reimburse Lucentis but not Eylea, some Lucentis and Eylea but not Avastin,” Hawlina said.

Co-payment and safety regulations

Another question in the survey asked what the possibilities are in case full reimbursement is limited to a certain number of patients.

In most EU countries, no private payment for anti-VEGF treatment or co-payment for the drug is allowed in public hospitals and health centers. Only three countries would allow patients to buy the drug in a pharmacy or pay for it in the center itself.

“With budgets that cover half or less than half of what is needed, waiting lists get longer and longer, and treatment is inappropriately delayed. Whether and how often patients resort to private centers or to traveling abroad for treatment is something beyond the scope of our survey, as we only included centers with national insurance contracts,” Hawlina said.

The last set of questions was related to the requirements of the centers performing anti-VEGF injections in terms of aseptic measures, equipment and technology. Eleven countries do not have specific regulations. Each center can apply its individual protocol for asepsis and acquire or not acquire the technology that is normally used for diagnosis and assessment of macular conditions. Only three countries require aseptic injection rooms, while about one-third of them require that fluorescein angiography is performed; optical coherence tomography is mandatory in most countries.

“Again, a diverse situation. This is another issue that we need to address to guarantee patient’s safety and avoid endophthalmitis and other complications,” Hawlina said.

Bottom line is cost

According to Hawlina, there are major concerns highlighted by the survey. Harmonizing practices within Europe is one of the goals of UEMS, and the next step will involve designing strategies to ensure equal access to anti-VEGF treatment throughout Europe.

“There should be some political pressure to have more patients treated, if not with the expensive approved drugs, at least with the cheaper drug. Avastin is not inferior to Lucentis, according to the CATT study, and countries that cannot afford the approved treatments should weigh the risk of using a drug off label against the consequences of not treating enough patients.

Vision impairment might become a much higher burden in the future,” Hawlina said.

On the other hand, given the fact that the universal right to health care is a founding principle of Europe, nobody should be forced to resort to expensive private practices to be treated.

The bottom line of the problem is the high price of approved anti-VEGF drugs and the lack of control on pricing policies.

“Although the price of Lucentis has decreased slightly, it is still 10 times more than Avastin in many countries. Major companies negotiate better prices with high-income countries that have higher numbers, while smaller countries with a lower population or low income countries are in a much worse position to negotiate the same price. Beyond the laws of the market, collaborative strategies between companies and governments are needed, and the goal of an accessible price across Europe should be pursued,” Hawlina said.

In order to cut costs but at the same time provide full access to treatment, governments should have legislation to promote off-label use of Avastin in the framework of safe practice, thus taking the responsibility of the public interest and accepting any liability that may accrue.

“Governments should take responsibility off the shoulders of individual doctors. Studies have shown good results, and the risk is reasonable,” Hawlina said. – by Michela Cimberle

Click here to read the entire issue of Ocular Surgery News Europe Edition, January 2015.

Marko Hawlina, MD, PhD, can be reached at Eye Hospital, University Medical Centre Ljubljana, 1000 Ljubljana, Slovenia; +386-31-365-600; email: marko.hawlina@gmail.com.

Disclosure: Hawlina has no relevant financial disclosures.