Antal Zemplényi, PhD, President of the ISPOR Hungary Chapter

Hungary implemented mandatory Health Technology Assessment (HTA) methodologies starting from 2004, including cost-effectiveness analysis to support pricing and reimbursement decisions of new pharmaceuticals and later expanded this to medical devices as well. Due to the expiry of the current guidance at the end of 2020, the College of Healthcare Professionals (an institution of Health Care State Secretariat of the Ministry of Human Capacities) established a Guideline Revision Working Group to update the local “Guideline on Health Economic Evaluations.” The Hungarian Health Economics Association (that also serves as the ISPOR Hungary Chapter) took part in the Working Group and actively participated in developing new recommendations for a revised cost-effectiveness threshold (CET) in Hungary. Substantial changes were made on 4 major topics in the guidance:

Clarifying the Rules for Choosing the Relevant Comparator

In several former economic evaluations, manufacturers happened to choose technologies as comparators that were only available in compassionate use or in named patient programs at the time of submission. Since these technologies cannot be considered standard therapies in Hungary and their respective cost-effectiveness analysis have not undergone the local critical appraisal procedure, they are not supposed to be used as comparators of new technologies.

Adding Specific Recommendations for the Evaluation of Medical Devices (MD)

The previous guidelines focused mainly on the assessment of pharmaceutical technologies. The recommendations have been amended to adapt a more holistic view and cover some specificities of medical devices, such as:

1. In the assessment of the effectiveness and cost-effectiveness of the MDs, the learning curve should be considered.
2. For MDs where the number of interventions performed influences outcomes, relative effectiveness and safety should be determined in high-volume centers with licensed health professionals.
3. For MDs with multiple indications, full HTA may not be necessary for each possible indication; cost-effectiveness results for the most common indications can be generalized to indications with similar expected health benefits.

Updating the Cost-effectiveness Threshold (CET)

With economic growth in Hungary, the current threshold (3xGDP per capita; EUR 44,845 in 2019) has surpassed the constant thresholds in Western European countries (eg NICE thresholds in the UK correspond to 22,785 EUR and 34,178 EUR in 2019 in actual exchange rate), while the GDP per capita in Hungary is about 40% of that in the UK. Hungary uses a single CET, which is not appropriate to reflect healthcare priorities. For these reasons, the baseline CET was lowered and equity considerations regarding severity and rarity of the diseases were introduced.

It was recommended that Hungary should also apply multiple CETs in the range of 1.5 to 3 times GDP per capita with stratification according to the relative QALY gain of the new technology (severity factor). In addition, multiple CETs in the range of 3 to 10 times GDP per capita is recommended for technologies in rare diseases (rarity factor).

Strengthening the Transparency of the HTA Documents

Two important recommendations were included in the guidelines to improve transparency of the local reimbursement procedure:

• To ensure transparency in the decision-making process, it is required that the authors of the economic evaluation report the sponsor of the study and whether they have received a financial or in-kind contribution from the manufacturers or their competitors.
• To ensure the reusability of the evaluations and to better inform patients and health care providers, the submitter of the analysis is advised to make the HTA report publicly available and searchable without any confidential information on the price of the health technology under evaluation.

Detailed recommendations from the Hungarian Health Economics Association on which elements of the HTA report should be made publicly available are still being developed with the involvement of a wide range of stakeholders.

The new guidelines are still to be published, but they have been approved by the Ministry of Human Resources.