The EU HTA regulation anchors a uniform clinical assessment of new therapies in Europe and has consequences for access to new therapies in Austria.
We as the pharmaceutical industry want a high-quality, streamlined and transparent process. The cooperation of all actors in the health system at the national level is crucial to ensure the early availability of new therapies in Austria
Mag. Alexander Herzog, Secretary General of PHARMIG
Vienna (OTS) – The upcoming EU Health Technology Assessment (HTA) Regulation 2025 presents Austria with groundbreaking challenges and at the same time opens up new opportunities for access to new therapies. This is because an HTA aims to evaluate the benefits of innovative therapies and provide the basis for subsequent pricing and reimbursement decisions. Although the regulation is intended to regulate a uniform framework for assessment at the European level, the handling of the joint clinical assessments lies in the hands of the member states. The legal aspects resulting from this for the hospital and private practice sector in Austria were the focus of an information event organized by PHARMIG at the beginning of March.
„We as the pharmaceutical industry want a high-quality, streamlined and transparent process. The cooperation of all actors in the health system at the national level is crucial to ensure the early availability of new therapies in Austria
“, explains Alexander Herzog, Secretary General of PHARMIG, in view of the fact that the national implementation of the EU HTA regulation in Austria has not yet been fully developed. Herzog believes it is important that national committees that are involved in the HTA process do not stand in the way of modern medical care for patients and thus points out a warning to the upcoming medication evaluation board.
Although the EU HTA Regulation makes a joint clinical assessment mandatory at the European level, the regulation leaves open which national institutions are responsible for applying the HTA assessments. During the discussion event, in view of the lack of regulations, Univ. Prof. Dr. Karl Stöger, expert in medical law at the Institute for Constitutional and Administrative Law at the University of Vienna, for additional national regulations to provide clarity.
When asked from the audience what role the medication evaluation board plays in the hospital sector within the framework of the EU HTA regulation, Stöger replied: “The European Union is concerned with ensuring that existing HTA processes are recorded. New ones don’t have to be created, but they can be created. The new assessment board will carry out processes equivalent to an HTA and make recommendations. But it is not the only committee with HTA tasks in Austria.”
Regardless of this, Stöger makes it clear that the use of drugs in hospitals must be based on the state of the art: “If there is a joint clinical assessment, I have a scientific document that says how a specific drug or health technology should be evaluated. This means that it cannot be ignored at the national level.” This means that decision-makers in the hospital have to deal with the results of the joint clinical assessment “in a balanced way,” says Stöger. However, there is no requirement for compliance.
According to Dr. Gisela Ernst from the Institute for European Law and International Law at the Vienna University of Economics and Business, it must be clear that the HTA only serves as a decision-making aid for the health technology to be evaluated in the national healthcare system: “Decisions that go beyond this, for example in connection with procurement, price , use and reimbursement remain unaffected by the clinical assessment from an EU law perspective, as they do not represent national HTAs, but are downstream from them. The HTA process therefore ends as soon as these decisions are involved.
“The question, which is essential for the inpatient area, as to whether there are national HTAs that can result in an evaluation of therapies according to prescription, plays a subordinate role in the office-based area,” says MMag.a Dr. Birgit Schrattbauer, Department of Labor – and business law, labor and social law department at the Paris-Lodron University in Salzburg. The reimbursement code is already an established instrument with which the insured person’s access to medicines is controlled at the expense of the health insurance company.
According to Schrattbauer, what is more important is what opportunities would arise from inclusion in the reimbursement code, especially for therapies that are already used in hospitals. “For example, the de facto predominant use in hospitals is not an exclusion criterion for the reimbursement of a drug in private practice if it can or is already used outside of hospitals according to applicable standards,” the legal expert states. This is an important perspective for patients, especially when it comes to cancer drugs.
At the event, patient representatives and health policy representatives welcomed the fact that the HTA regulation could enable increased availability of therapies, especially those that expand the treatment spectrum in Austria. The feedback from the audience also unanimously emphasizes the significant advantages that patient expertise in HTA processes can offer for treatment in Austria, especially for people with serious or rare diseases. This makes effective cooperation between politicians, authorities, hospital authorities, patient organizations and the pharmaceutical industry all the more important for the planning and implementation of the process at the national level.
About PHARMIG: PHARMIG is the voluntary interest group of the Austrian pharmaceutical industry. The association currently has around 120 members (as of March 2024), who cover a good 95 percent of the medication market. PHARMIG and its member companies stand for the best possible security of supply of medicines in the healthcare system and ensure social and medical progress through quality and innovation.
Questions & Contact:
PHARMIG – Association of the Austrian Pharmaceutical Industry
Peter Richter, BA MA MBA
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peter.richter@pharmig.at
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