Global NotebookFrom OSN Europe

Anachronistic health care policies, bureaucracy limit access to therapy for macular disease in Italy

Only a limited number of hospitals are currently allowed to administer anti-VEGF injections, but they cannot meet the demand.

Due to insufficient funding, dysfunctional organization and bureaucratic redundancy, patients with age-related macular degeneration and other macular diseases are often undermonitored and undertreated in Italy. A recent survey carried out in one of the wealthiest and best served regions of northern Italy showed that the average number of injections administered per patient per year is only three.

“As president of the Italian Society of Ophthalmology (SOI), I have informed the Italian Medicines Agency (AIFA) and the Healthcare Commission that we are in a critical situation of not being able to provide patients with adequate care,” Matteo Piovella, MD, an OSN Europe Edition Board Member, said. “Strategies to increase the number of injections from three to seven and guarantee access to care must be prioritized.”

Categorization of anti-VEGFs

Anti-VEGFs are still included by Italian health authorities in the specific H category, which is indicative of experimental drugs or drugs still undergoing post-approval safety surveillance.

Matteo Piovella, MD

Matteo Piovella

“This makes, of course, no sense for intravitreal anti-VEGFs, which have gone through extensive testing and clinical use over more than 10 years. They are administered by nurses in some countries, and these extra precautions are unjustified,” Piovella said.

Because category H drugs are purchased and used exclusively by hospitals and are not available in public pharmacies, access to anti-VEGF injections is limited.

“Hospitals are overloaded and cannot meet the demand,” Piovella said. “Due to these limitations, only 200 out of 7,000 ophthalmologists in Italy currently perform intravitreal injections. We are far from being able to provide patients with regular monitoring, assessment and re-treatment when needed.”

In addition, because category H drugs are included in a data system for monitoring potential harmful effects, doctors are required to fill out lengthy forms for each injection.

“This takes at least 15 minutes when the AIFA website works, which is not always the case,” Piovella said.

Further hurdles derive from reimbursement policies. Anti-VEGF drugs have been included in the so-called file F, which encompasses innovative drugs assigned to selected centers by central health authorities. This has created disparities among hospitals and dysfunctional distribution of patient load.

“In Milan, the Sacco hospital has been assigned 6 million and can perform 6,000 injections per year, while the Ospedale Maggiore has been assigned 25,000, which is the equivalent of 25 injections per year. The largest hospital in town is unable to provide intravitreal injections, while a smaller hospital has an overload of patients with the consequent risks of not being able to properly schedule appointments and monitor patients because there is no time,” Piovella said.

The SOI is pressing health authorities to reclassify anti-VEGFs into category A, making them available and reimbursable to every physician and patient.

“This would mean a lot in terms of supporting the right of accessing treatment. Currently, we are the only country in Europe where the number of intravitreal injections is decreasing, while the demand is exponentially increasing,” Piovella said.

Qualified staff, technology needed

Another important point is to provide national health service ambulatory centers with the qualified staff and technology for the diagnosis and monitoring of maculopathies.

“Early diagnosis and quick access to treatment, within 2 weeks, are crucial factors for saving vision. We need the support of easily accessible diagnostic centers equipped with OCT technology to alleviate the burden of hospital departments. Currently, there are multiple appointments and unacceptable delays between eye examination by a general ophthalmologist and OCT examination in the hospital and between OCT examination and treatment,” Piovella said.

The growing epidemic of AMD is progressively going to double the cost of eye care in Italy.

“It may sound like an unbearable burden, but the perception changes dramatically when you realize that ophthalmology currently represents only 1% of the total health care budget. We have cost-effective technologies and treatments that can improve the vision and life of so many patients. Our government must help create the conditions for us to use them,” Piovella said. – by Michela Cimberle

Disclosure: Piovella reports no relevant financial disclosures related to this article.

Due to insufficient funding, dysfunctional organization and bureaucratic redundancy, patients with age-related macular degeneration and other macular diseases are often undermonitored and undertreated in Italy. A recent survey carried out in one of the wealthiest and best served regions of northern Italy showed that the average number of injections administered per patient per year is only three.

“As president of the Italian Society of Ophthalmology (SOI), I have informed the Italian Medicines Agency (AIFA) and the Healthcare Commission that we are in a critical situation of not being able to provide patients with adequate care,” Matteo Piovella, MD, an OSN Europe Edition Board Member, said. “Strategies to increase the number of injections from three to seven and guarantee access to care must be prioritized.”

Categorization of anti-VEGFs

Anti-VEGFs are still included by Italian health authorities in the specific H category, which is indicative of experimental drugs or drugs still undergoing post-approval safety surveillance.

Matteo Piovella, MD

Matteo Piovella

“This makes, of course, no sense for intravitreal anti-VEGFs, which have gone through extensive testing and clinical use over more than 10 years. They are administered by nurses in some countries, and these extra precautions are unjustified,” Piovella said.

Because category H drugs are purchased and used exclusively by hospitals and are not available in public pharmacies, access to anti-VEGF injections is limited.

“Hospitals are overloaded and cannot meet the demand,” Piovella said. “Due to these limitations, only 200 out of 7,000 ophthalmologists in Italy currently perform intravitreal injections. We are far from being able to provide patients with regular monitoring, assessment and re-treatment when needed.”

In addition, because category H drugs are included in a data system for monitoring potential harmful effects, doctors are required to fill out lengthy forms for each injection.

“This takes at least 15 minutes when the AIFA website works, which is not always the case,” Piovella said.

Further hurdles derive from reimbursement policies. Anti-VEGF drugs have been included in the so-called file F, which encompasses innovative drugs assigned to selected centers by central health authorities. This has created disparities among hospitals and dysfunctional distribution of patient load.

“In Milan, the Sacco hospital has been assigned 6 million and can perform 6,000 injections per year, while the Ospedale Maggiore has been assigned 25,000, which is the equivalent of 25 injections per year. The largest hospital in town is unable to provide intravitreal injections, while a smaller hospital has an overload of patients with the consequent risks of not being able to properly schedule appointments and monitor patients because there is no time,” Piovella said.

The SOI is pressing health authorities to reclassify anti-VEGFs into category A, making them available and reimbursable to every physician and patient.

“This would mean a lot in terms of supporting the right of accessing treatment. Currently, we are the only country in Europe where the number of intravitreal injections is decreasing, while the demand is exponentially increasing,” Piovella said.

Qualified staff, technology needed

Another important point is to provide national health service ambulatory centers with the qualified staff and technology for the diagnosis and monitoring of maculopathies.

“Early diagnosis and quick access to treatment, within 2 weeks, are crucial factors for saving vision. We need the support of easily accessible diagnostic centers equipped with OCT technology to alleviate the burden of hospital departments. Currently, there are multiple appointments and unacceptable delays between eye examination by a general ophthalmologist and OCT examination in the hospital and between OCT examination and treatment,” Piovella said.

The growing epidemic of AMD is progressively going to double the cost of eye care in Italy.

“It may sound like an unbearable burden, but the perception changes dramatically when you realize that ophthalmology currently represents only 1% of the total health care budget. We have cost-effective technologies and treatments that can improve the vision and life of so many patients. Our government must help create the conditions for us to use them,” Piovella said. – by Michela Cimberle

Disclosure: Piovella reports no relevant financial disclosures related to this article.