Potential in the treatment of neovascular Age-related Macular Degeneration and Diabetic Macular Edema in Poland. The population needs and access to therapy.
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Authors
Objectives:
The aim of this study was to investigate the situation of patients with
neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema
(DME) in Poland, in terms of health needs and availability of treatment.
Methods:
We collected data on the epidemiology of both diseases from the
literature, as well as statistical data and data on medical services provided
obtained from the National Health Fund.
Results:
Based on available data, it is difficult to precisely estimate the
actual number of patients with AMD and DME in Poland. In 2021, in Poland over
130 000 patients used any medical service settled according to the ICD-10
codes: H35.0, H35.8 or H36.0. About 26% with AMD and 19% with DME required
hospitalization. Despite the fact that
in recent years the number of patients in the Drug Program offering access to
best therapeutic standards (aflibercept or ranibizumab, and then also with
brolucizumab) has been increasing, it is still a small percentage of those who
could be treated.
Conclusions: The analysis of data
regarding the implementation of the AMD and DME treatment program in Poland
indicates a large untapped potential. Despite the existence of a possibly large
number of patients only a small number receives treatment.
1. Introduction
Neovascular Age-related Macular Degeneration (nAMD)
and Diabetic Macular Edema (DME) have a significant impact on patient morbidity
in Poland, substantially reducing quality of life and placing a burden on the
national budget. The treatment for both ophthalmic diseases aims to slow their
progression and prevent vision loss. The gold standard in Poland, as in the
rest of Europe, involves anti-vascular endothelial growth factor (anti-VEGF)
drugs administered directly to the patient's eye: aflibercept, ranibizumab, and
brolucizumab [1,2]. The high costs of these modern therapies necessitated the
creation of a dedicated health service, known as a “drug program” (DP), which
guarantees cost-free treatment for eligible patients. Initially, there were
separate programs for each condition, but in 2022 they were merged into a
single, coherent program. Drug programs are contracted by hospitals and are a
popular method in Poland for providing patients access to the most expensive
medications.
A serious problem
in the treatment of retinal diseases in Poland is the low level of public
awareness regarding ophthalmic conditions. A significant proportion of Poles
with vision problems do not seek medical help, with 32% of Poles having never
visited an ophthalmologist [3]. As a result, the true epidemiology is
underestimated, making it difficult to assess whether the drug programs (DPs)
are fulfilling their role.
The aim of this study was to determine the current
prevalence of AMD and DME in Poland and to understand the characteristics of a
well-treated patient. Summarizing the potential needs for treating both
diseases based on population requirements provides useful insights that can
help guide future steps toward improving patient care.
2. Materials and Methods
A structured desk review was conducted on the research
and documents related to nAMD and DME in Poland from March 2023 to April 2024,
including current practice guidelines, evaluation reports, and epidemiology.
Additionally, some peer-reviewed studies dedicated to diseases coded H35.0,
H35.3, H35.8, and H36.0 (in the International Classification of Diseases, Tenth
Edition, ICD-10) were evaluated. In this classification, there is no specific
code for macular edema, including diabetic macular edema, and patients may be
diagnosed with diabetic retinopathy, other specified retinal disorders, or
non-proliferative retinopathy and retinal vascular changes. The most recent
data regarding ophthalmology in the country was collected from National Health
Fund (NHF). National data was also balanced against external sources such as
the United Nations and the American Academy of Ophthalmology.
3. Results
Epidemiology
DME indicates
diabetic macular edema; nAMD, neovascular age-related macular degeneration.
Figure 1. Estimated number of patients with DME and nAMD in Poland
The actual extent
of the epidemic of retinal diseases is difficult to estimate based on available
data. However, depending on the source, in 2021 there were approximately
180,000 to 232,000 patients with DME and about 109,000 to 130,000 patients with
nAMD in Poland [3-6]. The actual magnitude of patients is difficult to
estimate even for experts. The number of alleged cases of DME in Poland varies
between 50,000 and 200,000, depending on the expert, and the number of patients
with nAMD is estimated to be around 150,000 [7,8].
Based on the
average occurrence of AMD in Europe and the United Nations' population
forecasts for Poland, it is estimated that the number of patients with AMD in
the country will increase significantly, reaching approximately 360,000 cases
by 2055 [3]. Approximately 36,000 neovascular cases are expected within this
group, based on the rule that around 10% of all AMD cases are associated with
retinal swelling due to the accumulation of serous fluid [9].
The incidence of
DME increases with the duration of diabetes. The number of diabetics in Poland
is growing by approximately 2.5% annually. In 2018, there were 2.9 million
adults diagnosed with diabetes (one in eleven Poles). One-third of these
individuals had macular degeneration, and 300,000 required treatment [8-13].
The rising number of patients with diabetes indicates a parallel increase in
the number of DME cases. According to the national consultant in ophthalmology,
DME affects 14% of diabetic patients in Poland. Experts estimate this results
in approximately 10,000 new cases per year [8,14]. These estimates align with a
large meta-analysis dedicated to the projected number of DME cases by region,
published in 2021 by the American Academy of Ophthalmology. The study
highlighted increasing trends in this disease in Europe: in 2020, there were
3.16 million DME cases on the continent, which is expected to rise to 3.51
million by 2030 and reach 3.63 million by 2045 [15].
Diagnosed
cases
In 2021, in
Poland, slightly over 130,000 patients used medical services for conditions
coded according to ICD-10 as H35.0, H35.8, or H36.0. This means that only about
55% to 70% of people suffering from DME are diagnosed. The situation was even
worse for patients with AMD; out of approximately 1.3 million patients (both
dry and neovascular), fewer than 200,000 used medical services—representing
just 15% to 18% of the entire estimated population affected by this condition
(Table S1, supplementary data). Considering that about 30% of AMD cases in
Poland are at an advanced stage, it is evident that a significant portion of
the Polish population with this disease does not benefit from treatment at all
[3].
Hospitalizations
Of the diagnosed
patients (main or associated diagnosis), approximately 26% with AMD and 19%
with DME resulted in hospitalization (Figure 2a). Every eighth hospitalization
of a patient with AMD, and every third with DME, falls under the
diagnosis-related group (DRG) B84, which covers small vitreoretinal procedures
where most hospitalized patients undergo recombinant protein injections (Figure
2b). Additionally, in 2020, over 13,000 hospitalized DME patients
underwent photocoagulation.
Note: a) No data available for 2021-2022 b) No data for 2021. For 2022, the
National Health Fund reported data for DME only for H36.0 and did not precise
the numbers of recombined proteins injections.
AMD indicates age-related macular degeneration; DME, diabetic macular edema; DRG, diagnosis-related group; ICD-10, International Classification of Diseases, tenth edition.
The number of
hospitalizations in 2020 slightly decreased, likely due to the COVID-19
pandemic, but the trend for small vitreoretinal procedures, including
recombinant protein injections, continued to rise. This increase was
particularly notable in the number of AMD hospitalizations, which reached
nearly 14,000 in 2022, 1.6 times the number from 2020. The trend for DME was
harder to determine due to changes in the disease-assigned codes reporting by
the NHF. However, the overall trends in Poland are not optimistic, especially
given the increasing aging of the population (the rate of Poles aged 65+ in
2060 is expected to be 18.5% higher than it was in 2013) [3].
Drug Programs
In 2015, the B.70
drug program for patients with nAMD was implemented in Poland, allowing
affected individuals to be treated according to the best therapeutic standards
with aflibercept or ranibizumab, and later with brolucizumab. For DME, no
active substances were nationally reimbursed until 2021. Treatment was
conducted only within the DRG B84 group (small vitreoretinal procedures) in
hospital settings. However, this approach was burdensome for ophthalmology
centers because recurrent injections (approximately 32,000 in 2019) required
patient hospitalization each time [7]. Finally, in 2021, the B.120 drug program
was created, based on bevacizumab, aflibercept, and dexamethasone, and
soon expanded to include ranibizumab. In mid-2022, both drug programs (B.70 and
B.120) were merged, and since then, patients with both diseases have been
treated under a single program (retaining the B.70 number), with two separate
subgroups: nAMD and DME [16].
Participation in
the program requires meeting strict criteria (Figure S1, supplementary data).
Inclusion to the DP provides the patient with regular injections of the drug
and control of the effectiveness of the therapy, which has a significant impact
on the achieved results. However, access to the DP B.70 is not easy and varies
from region to region [13]. In 2022, nationwide, only 5% of facilities signed a
contract with the NHF for the implementation of the program (nAMD and DME).
Qualification and therapy take place in selected ophthalmology facilities, but
they are not evenly distributed across the country: in four (out of sixteen)
voivodeships is aggregated 40% of contractors and 46% of contracted amount of
money [17,18].
In March 2023, a
total of 192 centers serviced contracts under DP B.70, with a total value
exceeding PLN 260 million. The voivodeships (territorial entities in Poland)
with the highest activity in the treatment of patients in the program were
Silesian (15 facilities with contracts totaling PLN 42 million), Lower Silesian
(19 facilities with contracts totaling PLN 27 million), and Mazovian (the
largest number of centers, 20, with contracts totaling over PLN 23 million).
The Opole and Warmian-Masurian voivodeships were the least active, with five
facilities contracted for just over PLN 4 million and six facilities contracted
for PLN 6 million, respectively [18]. Even considering that the
number of patients in those voivodeships is lower due to a smaller overall
population, access to treatment is more restricted, partly because of the long
distances to the nearest ophthalmologist. Uneven access to treatment in the DP
forces patients to seek care in other, often distant, provinces: more than 70%
of patients treated in the Mazovia Province do not actually live there,
resulting in financial and time burdens due to the need for travel. Ultimately,
only about 70% of patients in Poland receive free treatment for nAMD as part of
NHF-financed care, while the remaining 30% opt for more accessible but paid
treatment within the private healthcare sector [13].
The number of
patients included in the DP is a small percentage of those who, according to
epidemiological data, meet the eligibility criteria for it. In the case of DME,
467 and 5,906 patients were included in DP in 2021 and 2022, respectively, out
of an estimated 16,600 to 22,700 potentially eligible patients
[3,7,19,20]. For nAMD, there were 30,014 and 36,786 patients included in
DP in 2021 and 2022, respectively (Figure 3).
Note: In
2022 no data of new involved patients.
AMD indicates age-related macular degeneration; DME, diabetic macular edema.
Patients are
qualified for treatment under PL B.70 with the participation of the
Coordinating Team for the Treatment of Retinal Diseases, composed of
ophthalmology specialists and operating at each center that provides
qualification for the program [21]. The average time interval to start
treatment under PL B.70 for both AMD and DME is approximately 8 days. The
longest waiting times are in the Warmian-Masurian and Silesian voivodeships (20
and 17 days, respectively), while the shortest waiting times are in the
Podlaskie, Lesser Poland, and Holy Cross Provinces (1 to 3 days). Waiting time
does not depend on the average number of patients per treatment provider: in
the Pomeranian Province, only 5 patients wait to start treatment, while in
Kujawsko-Pomorskie, as many as 225 patients wait. In both regions, the average
number of patients per facility involved in B.70 is around 160 [22].
The percentage of
rejected applications to the DP in 2022 was 14%. The highest rejection rate was
in the Lubuskie Voivodeship at 24%, while the lowest was in the Mazovian
Voivodeship at 5% [23]. The main reasons for not qualifying for the
program are advanced eye lesions (76% of rejection cases in nAMD and 48% in
DME) and low visual acuity (68% and 36%, respectively). In the case of DME,
unregulated diabetes is also a common reason for disqualification (32%).
Patients with both diseases who do not meet the conditions for inclusion are
treated outside the DP: half are treated under small vitreoretinal procedures
(DRG B84), while the other half are treated in the private sector. [13,24]
(Table 1).
Table 1. Number of hospitalizations related to recombined
protein injections among patients non-qualified to the program
|
Years |
||||
2016 |
2017 |
2018 |
2019 |
2020 |
|
Number of
hospitalizations related to recombined protein injection |
2 757 |
8 433 |
18 243 |
33 351 |
35 465 |
Percentage of
these hospitalizations among all hospitalizations in the DRG B84 group |
32% |
55% |
80% |
88% |
92% |
Patients treated
outside the program include those who do not meet the eligibility criteria as
well as those who have been excluded from it. Between 2017 and 2019, an average
of around 3,000 patients per year left the program, while this number almost tripled
between 2020 and 2021. This increase is likely due to the COVID-19 pandemic and
the difficulties in maintaining the continuity of injections and frequent
check-ups (every third doctor cites this as a reason for patient exclusion).
Additionally, the main reasons for discontinuation are a decrease in visual
acuity (68%) and permanent structural changes in the eye (48%) [13]. There
are also cases of patient exclusion due to the absence of visible signs of
active disease for at least 4 months, eliminating the need for further
injections. When these patients' conditions deteriorate, they must undergo the
entire qualification procedure for the program again. Unfortunately, some do
not reapply due to the burdensome nature of the process.[13].
In 2022, the
intravitreal injection service was positively recommended by the President of
the Polish Agency for Health Technology Assessment and Tariff System to become
a guaranteed outpatient specialist care service. This greatly simplifies
treatment, as numerous ambulatory care units improve the accessibility of
injections for patients while maintaining a comparable safety level for the
procedure. Moreover, some of the public payer's expenses incurred in hospital
treatment can be transferred to ambulatory care units. [25]. This
allows for a reduction in spending that is already heavily burdening the
national budget. The total costs of drugs used in the B.70 and B.120 programs
have been gradually increasing over the years, along with the rise in the
number of patients involved and medications used. Additionally, there is an
increase in non-drug services, including outpatient visits, diagnostics, and
qualifications (Figure 4).
Figure 4. Number of patients using drugs, services and procedures in drug programs B.70 and B.120
The total cost of
the programs (all components) increased from nearly PLN 200 million in 2019 to
almost PLN 290 million in 2022. However, it should be noted that the number of
beneficiaries increased from 25,000 to 43,000 during this period. The average annual
cost of treatment for an individual participant in the B.70 program from 2019
to 2021 ranged between PLN 7,000 and PLN 8,000, while the combination of
programs in 2022 reduced the average cost to PLN 6,600. Drug costs account for
approximately 53% of the total program cost each year (Figure 5).
Figure 5. Total costs of drug programs B70 and B120 components and average cost of individual participant per year
4. Discussion
Awareness of eye
diseases in Poland remains low. Achieving a satisfactory level of treatment for
retinal diseases will be challenging in a society where only one in five Poles
has heard of AMD and only one in nine is aware of DME [3]. According to the
Health Care Institute, 32% of Poles have never visited an ophthalmologist, and
an equal proportion feel ashamed and uncomfortable about their condition in
front of others [3]. Education aimed at raising awareness and supporting
patients with retinal diseases, as well as preventing them from feeling
socially excluded, seems necessary.
In 2022, nationwide, only 5% of facilities signed a
contract with the National Health Fund for the implementation of the DP B.70
[13]. Difficulties related to accessing facilities performing intravitreal
injections within the DP were particularly noticeable during the COVID-19
pandemic when the number of patients excluded from the program increased
significantly. From 2017 to 2019, an average of 3,200 patients left the program
annually. However, during the pandemic years of 2020-2021, the number of
excluded patients rose to nearly 8,900 per year. The primary reason for
exclusion was failing to appear before the attending physician at two
consecutive checkpoints specified by the program, resulting in the refusal of
further cost-free treatment [16,26].
Despite a
relatively large number of ophthalmologists (1.07 per 10,000 inhabitants),
there is a severe lack of optometrists in Poland, causing significant
organizational problems in the prevention and diagnosis of eye diseases [27].
Patients are referred to specialists too late, often in the advanced stage of
macular edema [13]. In a survey commissioned by Retina AMD
Poland association, as many as 24% of doctors pointed to organizational
difficulties resulting from a large number of patients [13]. A significant
difficulty in treating patients under the program was the high degree of
complexity of the qualification procedures - gradually simplified after the
program was introduced [26]. Ophthalmology facilities, inexperienced in
servicing patients under drug programs (DP B.70 was the first and so far the
only drug program for patients with ophthalmological issues), implemented and
developed the program more slowly than multi-specialty facilities that had been
using DPs for a long time in other medical fields. This contributed to
inequalities in access to treatment across the country and partially explains
the low percentage of diagnoses compared to epidemiological data.
In 2019, the
recombinant protein injection procedure as part of the DRG was priced at PLN
616-724, depending on whether it was performed as a one-day treatment or as
part of hospitalization. The cost of an anti-VEGF intravitreal injection in the
ambulatory mode within the DP is approximately PLN 380 [7]. The administration
of drugs within the DP significantly reduces the costs of treating retinal
diseases in Poland, so it should be aimed at the widest possible coverage of
patients with DME and nAMD with this form of treatment.
Unfortunately,
patients with AMD and DME face significant challenges due to inefficiencies in
the Polish healthcare system. Factors such as long waits for ophthalmologists,
flaws in prevention programs, excessive bureaucracy in drug programs, and other
systemic issues often pose serious barriers to effective treatment. While the
Polish third-party payer (NHF) and the Ministry of Health may theoretically
save on treatment costs, the long-term consequences result in high social
costs.
5. Conclusion
The analysis of
data regarding the implementation of the AMD and DME treatment program in
Poland indicates significant untapped potential. Despite the large number of
potential patients, only a small fraction receives treatment. This can be
attributed to factors such as low public awareness of the disease and
underdiagnosis. Access to the best available medical technologies and treatment
opportunities is currently fragmentary and unevenly distributed. There is an
urgent need to improve access to AMD and DME treatment in Poland.
Close cooperation among health market analysts, the public payer, and ophthalmologists is essential for the optimal allocation of financial and medical resources, ensuring effective treatment for patients suffering from retinal edema in Poland.
Notes:
All authors declare that there are no conflicts of interests.
All authors declare that this research did not receive any funding for the research.
6. Supplementary Data
Table S1. Number of diagnosed patients, with at least
one service ICD-10 H35.0, H35.3, H35.8 or H36.0 settled
|
Years |
||||
2017 |
2018 |
2019 |
2020 |
2021 |
|
Number of
diagnosed cases of H35.0, H35.8, H36.0 (DME as a main diagnosis) |
130 788 |
132 648 |
138 787 |
113 890 |
131 787 |
Number of
diagnosed cases of H35.3 (AMD as a main diagnosis) |
161 546 |
174 186 |
188 033 |
170 892 |
199 861 |
Note: Numbers of AMD cases constitute both, dry and neovascular form
AMD indicates age-related macular degeneration; DME,
diabetic macular edema; ICD-10, International Classification of Diseases, tenth
edition.
Source: “Open Data” Portal.
National Health Fund [cited: 10.03.2023] Available from: https://dane.gov.pl/pl/dataset/2557 https://dane.gov.pl/pl/dataset/2557
Figure S1. The main criteria for patients for drug
program participation
AMD indicates
age-related macular degeneration; BCVA best corrected visual acuity; CNV,
choroidal neovascularization; DME diabetic macular edema; DXM, dexamethasone;
HbA1c, glycated hemoglobin; nAMD, neovascular age-related macular degeneration;
OCT, optical coherence tomography.
Source: Ministry of Health. Drug
Program B.70 [cited: 22.07.2023] Available from: https://www.gov.pl/web/zdrowie/obwieszczenia-ministra-zdrowia-lista-lekow-refundowanych
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