by The WAIT index of the European Federation of Pharmaceutical Industries (EFPIA) is indicative of the reimbursement time for a new treatment in Greece compared to the European average, as it shows that our country is lagging far behind.
Despite the fact that the billing and reimbursement times for innovative drugs have improved considerably in recent years in our country, the 58% new treatments available in Greece – including oncology and orphan drugs for rare diseases – is in a limited state of availability or reimbursement, as indicated, among other things, by a report on the availability of new innovative treatments in Europe.
At the same time, the average availability of new innovative treatments in Europe in 2022that’s enough 45%.
The above conclusions are included in research to estimate the WAIT index (Waiting to Access Innovative Therapies), conducted annually by the European Federation of Pharmaceutical Industries (EFPIA) with the aim of measuring the degree of patient access to new innovative therapies, among 37 European countries.
I. The research concerns medicines that have been approved by the EMA within the past 4 years of each year of publication evaluating 2 main sub-indicators:
A) the availability of new innovative treatments (in this search, those who had an approval date from the European Medicines Agency during the period 2018-2022) by country
b) the time that elapses from the date of their approval by the European Medicines Agency (European Medicines Agency, EMA) until the start date of their reimbursement by health systems
Results of this year’s survey in Europe
According to the survey, 168 drugs who received marketing authorization over the 2018-2021 period, on average 76 drugs were available in European countries included in the study (Graph 1).
The average availability of new innovative drugs in Europe is estimated at 45% for the year 2022 (50% for oncology drugs and 39% for orphan drugs).
Figure 1. Degree of availability of new innovative medicines in Europe
Thus, the average time of compensation health systems in the European Union has been estimated at 517 days, 6 days higher than the corresponding average time obtained during the same survey last year (Graph 2) (526 days for oncology drugs and 625 days for orphan drugs).
Figure 2. Time between central approval (EMA) and inclusion of innovative medicines in the reimbursement list
Greece: high availability, unequal access and delay in the compensation period
The first general conclusion of the study is the great disparities between EU countries both in availablity of drugs as well as time which acts as an intermediary between the approval of the EMA and the inclusion of the drugs in the compensation system.
In Greece in 2022 about 54% drugs approved by the EMA between 2018 and 2021 are available for Greek patients. Our country shows availability slightly above EU average (47%) and lies roughly between Western and Northern European countries and Central and Eastern European countries (Figure 1).
The relative index of oncology and orphan drugs is valued higher and about him 70% and 56%respectively and this shows that in terms of serious diseases, patients in our country have access to medication concerning serious and threatening illnesses.
While the availability of new drugs appears satisfactory compared to the relative average, the majority of reimbursed drugs appear to be limited (1) and not complete (2) availability.
In particular, the 58% new medicines available in Greece (compared to the European average 31%), is in the status limited availability or compensation (66% and 68% of oncology and orphan drugs, respectively) primarily reflecting drugs available through the Electronic pre-approval system (SIP) (Chart 3).
This image of the availability of drugs in us reveals them inequalities in patient access to new treatments in Greece.
“The system and associated procedures they do not offer universal access treatments, patient access being at the initiative of the attending physician, whether or not new drugs belong to categories that can be made available by SIP, the drug administration regime, the specific therapeutic categories to which the patients may belong“, comment the researchers.
Graph 3. Number of drugs in full and limited availability regime
On the contrary, while in availablity new treatments, Greece is around the EU average, at clearing time of a new treatment, the country seems lags behind of the average time in the EU as this is calculated equal to 674 days (against 517 days in EU countries).
It should be noted that the average availability and average time to reimbursement of new medicines in this year’s survey are affected by the huge delays appeared in our country in the two years 2018-2019while it is certain that the investigations of the following years will be positively affected by the improvement of the compensation grids of the last period in the country as shown by a recently published study ii, but also the experience of the functioning of the competent commissions (EAAFAX and Negotiation), especially last year.
In addition to the above, the research analyzes the factors that shape the availability and timing of inclusion of new drugs in the compensation framework, which fall into the following categories:
a) time to market authorization (MA), b) pricing and reimbursement procedures, c) procedures for assessing the value of new medicines d) health system limitations and resources, and e) existence of approval procedures at regional rather than national level.
The analysis for Greece
In addition to the factors of categories a and e which do not concern Greece, in the remaining categories there is considerable room for improvement in the country, despite the fact that in the process pricing and compensation schedules – mainly – have improved quite a bit the last years.
The attention of health policy should be directed primarily to financing of pharmaceutical care which is characterized by serious distortions and the inability of the system to meet the needs of patients.
As evidenced by a recent survey by the Institute for Economic and Industrial Research (IOBE) for the year 2021 iii, the public pharmaceutical expenditure per capita in the country is significantly lower than the European average (€243 compared to €321), while the private sector largely exceeds the corresponding average size (€200 compared to €135).
“At 33% the financing of pharmaceutical expenditure by the pharmaceutical industry”
This discrepancy is attributed to the fact that in 2021 non-hospital pharmaceutical expenditure half financed (50.4%) by public funds, of which 33.3% financed by the pharmaceutical industry (through mandatory discounts and returns) and the 16.4% of patients and hospital pharmaceutical expenses are also financed by 50% of the health system and the rest of the industry.
It is clear that the position of the country in the availability of new innovative treatments is attributed mainly to the existence of the SIP (about 58% of the drugs available) and the financing of 37% and 13% of the total expenditure by industry and the patients, respectively.
Nevertheless, health policy interventions are needed to reduce inequities in patient access to treatment and increase public funding in combination with supply and demand control measures reduce burdens on industry and patients.
Finally, it is important to continue the positive and effective work evaluation procedures and negotiation, in order to further improve the average reimbursement time for new drugs.
1. Reimbursed drugs are considered limited availability:
a) in specific subpopulations of their approved indications,
b) on a case-by-case basis for each patient usually after relevant request and approval and
c) temporarily pending the decision to include them in the positive list
2. For the majority of countries, full availability is considered as the inclusion of medicines in the positive reimbursement list.
i European Federation of Pharmaceutical Industries, EFPIA (2023). EFPIA Patients WAIT Indicator 2022 survey. Available at: https://www.efpia.eu/media/677293/efpia-patient-wait-indicator-final-report.pdf
ii Chantzaras, A., Margetis, A., Kani, C., Koutsiouris, V., & Bacopoulou, F. (2022). Time to Health Technology Assessment of New Medicinal Products in Greece. Value in Health, 25(12), S342.
iii Institute for Economic and Industrial Research (2021). The pharmaceutical market in Greece: facts and figures. Available at http://iobe.gr/docs/research/RES_05_A_23062022_REP_GR.pdf
Source: Gianna Soulaki / iatropedia.gr
