The therapeutic program for patients with the most severe form of age-related macular degeneration (AMD), which quickly leads to blindness, may not work in practice due to the low valuation proposed by the National Health Fund, ophthalmologists believe.
The program is to enter into force on May 19, 2010 under an earlier ordinance of the Minister of Health.
Unfortunately, the solutions proposed by the National Health Fund will not allow for its implementation. Due to the low pricing, the ampoule of the drug used in the program would have to be divided into four parts, and currently it can only be divided into two. In practice, this would have to lead to administering to patients a dose significantly lower than the therapeutic norm, or it would force hospitals to pay a significant amount for treatment. In such a situation, hospitals will not be able to sign contracts with the National Health Fund and treat patients who have been waiting for eye-saving therapy for five months, told PAP the national ophthalmology consultant Prof. dr hab. Jerzy Szaflik.
As PAP found out in the press office of the National Health Fund, public consultations regarding this program continued until Friday, May 14. The decision on its final shape will be made by the president of the National Health Fund in the coming days.
Macular degeneration (AMD) is considered the leading cause of vision loss in people over 50 in developed countries. The disease affects a small fragment of the retina – the so-called the spot, which is located at the back of the eyeball and is responsible for sharp and precise vision of details and colors. What patients with AMD see is vague in the central field and significantly distorted, e.g. they see a stain instead of a face, they cannot see what is happening in front of them on the street, and therefore are more prone to accidents, they have a problem with reading, walking up and down stairs, and even simple housework like preparing meals.
One million people suffer from AMD in Poland. Approx. 10-15 percent of them has a more dangerous form of the disease, the so-called wet AMD, which in the most severe cases can lead to loss of vision even within a few weeks. About 7 thousand people fall into this form in Poland. people per year.
Exudative AMD is caused by the appearance of pathological vessels under the retina. Their fragile and leaky walls ooze blood and fluid, which lead to edema or subretinal hemorrhage, destroying the macula.
One drug is approved for the treatment of this form – ranibizumab (trade name Lucentis) – which inhibits the formation of new blood vessels (angiogenesis). This method inhibits the development of the disease, and in 30 percent of patients it even leads to an improvement in vision. However, it needs to be applied early before it becomes seriously damaged.
The drug is expensive (about PLN 4 per ampoule) and has so far been used in a few Polish patients as part of the benefit with the consent of the payer – for treatment they had to receive individual consent from the head of the NHF department. However, since January 2010, they have lost this opportunity because treatment of the wet form of AMD was not included in the guaranteed benefits package.
Ophthalmologists, headed by the national ophthalmology consultant prof. Jerzy Szaflik and patients for years have been striving to create a therapeutic program that would increase the access of this group of patients to a medication that saves eyesight. In July 2007, Szaflik submitted to the Ministry of Health an application for the implementation of the program developed by him and his associates. After nearly three years, on April 7, 2010, the Minister of Health issued a regulation on its adoption.
However, ophthalmologists believe that it may turn out to be a purely formal act. As assessed in his letter to the Minister of Health, Prof. dr hab. Andrzej Stankiewicz, head of the Ophthalmology Clinic of the Military Medical Institute in Warsaw and president of the AMD Association, the proposed valuation of this service at PLN 1050 is unacceptable to service providers – it does not even cover the cost of the drug used in treatment, which is currently four times higher !. This, according to a specialist, will prevent doctors from implementing the program.
Stankiewicz also reminded that due to the amendment to the basket act, patients with the wet form of AMD have no chance of starting treatment with ranibizumab for almost half a year, and some had to stop the therapy (PAP).