Poland rises from 21st to 20th place in European WAIT survey

Poland again improved its score in the W.A.I.T. survey in terms of accessibility to innovative drugs, moving up one place and ranking 20th among the 36 European countries surveyed, with a score of 41 percent of available therapies. We are separated from the European average of 43 percent by two countries - Slovenia (42 percent) and Finland (43 percent). Recall that a year ago Poland rose from 25th to 21st place with a score of 36 percent. Today, 69 out of 167 innovative drug technologies are reimbursed in Poland, but as much as 83 percent of them are reimbursed only to a limited group of patients. This result is worse than a year ago by as much as 5 p.p., when the restrictions were at 78 percent. The time from registration to reimbursement, on the other hand, has shortened - from 827 days a year ago to 804 days in the current survey, but this is still one of the worst results a in the entire list. Only four countries are behind us - Serbia, Bosnia, Turkey and Malta.

Poland moves up one "notch"

Poland is steadily improving its score in the W.A.I.T. (Waiting to Access Innovative Therapies) survey, which celebrates its 20th anniversary this year. It is the largest analysis of access to innovative drugs and a measure of waiting times in European countries. The results of the survey have been published since 2004 by the European Federation of Pharmaceutical Industries and Associations. Poland recorded a historic advance in last year's ranking - we moved from 25th to 21st place. At that time, 59 out of 168 therapies were reimbursed in our country. This year, with 69 out of 167 reimbursed therapies, we rank 20th among 36 European countries. The podium is unchanged - Germany remains the leader with 147 available therapies, followed closely by Italy (129) and Austria (126). Poland is ahead of Hungary and Slovakia, among others, but our other neighbor, the Czech Republic, for example, ranks as high as 7th in the W.A.I.T. list.

- Access to innovative drug technologies in Poland is improving. Similar information was provided by updated data announced in May from the Access GAP platform, which analyzes access to innovative therapies and diagnostic solutions in the Visegrad countries. According to them, the Czech Republic is also well ahead of Slovakia, Poland and Hungary, respectively. Poland's good result in the W.A.I.T. list proves that we are moving in the right direction and, thanks to positive reimbursement decisions, we are catching up in terms of Polish patients' access to innovative therapies. At the same time, a detailed analysis of the W.A.I.T. results shows that older drugs are still more likely to enter reimbursement in Poland. Of the 69 drugs included in the W.A.I.T. analysis that are reimbursed in Poland, only 8 had registration in 2022, and the rest in earlier years. This means that we are not using the full potential of innovation, and Polish patients benefit from new drugs when... they are no longer new," says Michal Byliniak, CEO of the Association of Innovative Pharmaceutical Companies INFARMA.

More drugs available in Poland, but... with more restrictions

The percentage of reimbursed drugs in Poland with restrictions for certain groups of patients has increased by as much as 5 percentage points. It is now as high as 83 percent (last year's figure was 78 percent), and only Cyprus (96 percent) and Bosnia (100 percent) have worse results than Poland. In comparison, in Slovenia the proportions are exactly the opposite - 80 percent of drugs are available without restrictions and only 20 percent for specific patient groups.

- Each advance of Poland in the charts of patients' access to innovative therapies is gratifying and, at the same time, prompts analysis of indicators that need improvement. Of particular concern in the W.A.I.T. study is the percentage of drugs reimbursed for certain groups of patients, which for Poland is extremely high and completely out of line with European standards. This means that only a fraction of patients who may benefit from a particular therapy have access to it. Thus, the therapy is registered in Poland, almost at your fingertips, but... in practice inaccessible to many patients. The right direction of change should therefore be to provide Polish patients with fuller access to medical innovations, thereby leveling the playing field for longer and better quality of life for patients," stresses Agnieszka Grzybowska-Zalewska, President of the Board of the Association of Employers of Innovative Pharmaceutical Companies INFARMA

25 of the 69 innovative drug technologies available in Poland are oncology drugs.
As many as 92 percent of them are reimbursed for a limited group of patients. The situation is similar
in rare diseases, where we have 20 drugs, 95 percent of which are reimbursed with limitations, and in non-oncological rare diseases, where 14 therapies are available, but 93 percent with limitations.

More therapies with limitations and late availability due to multiple barriers

Poland has slightly improved the score in terms of the waiting time of Polish patients for reimbursement from the time of registration. Last year it was 827 days, today it is 804 or 23 days shorter. Only patients in Serbia, Bosnia and Turkey are waiting longer for innovative life-saving drugs. We are ahead of Romania and Bulgaria, among others, and we do not even come close to the rest of the Visegrad countries (Czech Republic: 498 days, Slovakia: 577 days, Hungary: 650 days). By comparison, a patient in Germany can be the beneficiary of a new therapy after just 126 days after registration, in Denmark after 169 days and in Austria after 283.

The W.A.I.T. indicator shows that disparities persist in the time it takes for patients to gain access to innovative drugs, so that patients in one European country can wait more than six times longer for the same drugs than patients in a neighboring country.

The reasons for unavailability and delays, examined in a report compiled by Charles River Associates (CRA), are multifactorial. Even before a drug is approved in Europe, slow regulatory processes can extend the time it takes for new drugs to reach patients.

Delays and barriers to access are often caused by a combination of factors. For example, the speed of health technology assessments, different reimbursement processes, or additional layers of regional and local decision-making processes. Duplicative or inconsistent evidence requirements can also cause delays or lack of accessibility. For example, different countries, HTA bodies and payers may require different study endpoints, or some accept actual evidence while others do not.

The use of external reference pricing (ERP) also causes delays and lack of accessibility. Many countries do not begin national pricing and reimbursement processes until they have access to reimbursement decisions from several other European countries.

What's more, data from EFPIA's European Access Hurdles Portal show that the majority (71 percent) of the total time between EMA approval and reimbursement occurs after the submission of a pricing and reimbursement (P&R) application. The remaining 29 percent occurs before the P&R application is submitted.

- The reasons why Europeans have to wait for access to new drugs are almost always a combination of factors. They vary by therapy area and country. Therefore, access issues cannot be solved by EU innovation legislation, but require action by multiple actors, including member states, to make progress. Whatever the reason, we are ready to play our part in reducing the time it takes for patients to gain access to the medicines we discover, develop and deliver," stresses Nathalie Moll, EFPIA Director General.

Similar barriers and the need for action at the national level are recognized by INFARMA, which has long drawn the attention of the Health Ministry to the legislative changes needed to reverse this negative trend, recalling them in its response to the MZ's communication in a recent letter.

- Based on our analysis and the results of reports compiled by EFPIA, it seems clear that reducing the problem of excessively long patient waiting times to the issue of when companies submit their reimbursement applications is a vast oversimplification that does not bring us any closer to solving this problem. Poland has the longest waiting time in the EU, and this seems to be the moment to ask whether a strategy based on the assumption that we want everything, fast and cheapest with the CBR steadily moving away from the statutory 17 percent is an effective approach and, above all, a good one for patients. The barriers are numerous and very complex and we presented the needed changes in the reimbursement process in detail in a letter to the Ministry of Health, which was met with a quick response and, we are very pleased, we are now in talks on the subject," says Michal Byliniak, INFARMA CEO.

The process of applying for reimbursement and setting the price of a drug in Poland, according to the experience of INFARMA member companies, is one of the most costly such proceedings in Europe (costs of preparing HTA analyses, fees for submitting applications, fee for preparing verification analysis, costs associated with the need to fulfill the condition of availability of the product on the market, etc.). At the same time, it is an extremely complex proceeding conducted in a legal environment that is unpredictable as to the outcome of the proceedings, destabilizing decisions after they are issued, imposing unnecessary and, as the recent amendment to the law shows, even irrational and unenforceable obligations on applicants on pain of numerous penalties.

Both the innovation industry and EU policymakers have long recognized this problem and have taken initiatives to counter it. One such solution is the introduction of the Joint European Clinical Assessment (JCA). The regulation went into effect at the beginning of January 2022 and will take effect in just eight months for advanced therapy drugs and new cancer drugs. Starting in 2028, the JCA will also cover orphan drugs, and from 2030 it will already cover all new products registered by the EMA. This solution introduces many mechanisms and tools that can realistically improve and level the playing field for access to medicines in EU countries (including identification of new technologies, scientific advice, common methodology). However, the condition for success is real implementation of the procedures in all EU countries.

There is a need for a faster pace of closing the gaps in access to innovative therapies in Poland and a strong push for innovation in the EU

The results of the W.A.I.T. study show, for another year, inequality in access to innovative treatment in different European countries with different reimbursement systems and GDP ratios. The difference in access to innovative medicines between the best-performing country and the worst is 84 percent in the 4-year cohort and 80 percent for longer time frames.

The data also indicate the need to improve the rate at which medical innovations are made available so that the European Union can respond to current health challenges, including an aging population and alarming predictions of rising cancer rates. Meanwhile, the average availability rate of innovative therapies in the European Union has fallen from 45 percent to 43 percent, and the average waiting time for a new drug on the European market has increased by 14 days to 531 days.

The health challenges facing EU countries are becoming more serious and unsolved problems are becoming bigger barriers. We are in the midst of the first reform of pharmaceutical law in 20 years and the finale of the legislative work will take place during the Polish presidency.

- The decisions that will be made with the Polish government's participation will determine whether the EU will once again be a globally competitive region that provides a strong impetus for innovation, clinical research, training of the best human resources and equitable access to modern treatment regardless of country of residence. Keeping in mind how important it is in Poland to accelerate the pace of closing the gaps to already registered therapies, the Polish government should not lose sight of the broader perspective of economic and health benefits for our society, which is also a fundamental pillar of the country's and the EU's drug security," stresses Agnieszka Grzybowska-Zalewska, INFARMA CEO.

This year's W.A.I.T. data covers 36 countries (including 27 from the European Union), and 167 innovative drugs with central marketing authorization between 2019 and 2022 were analyzed. The study was conducted with a one-year delay to allow countries to include these drugs in the public reimbursement list, meaning that availability data is accurate as of Jan. 5, 2024.

Source: press release