Drug pricing and reimbursement in the inpatient sector in Austria: Approaches for a transparent and evidence-based process taking into account international experience

Duration: April 2018 – November 2018
Suggested by: Representatives of federal states
Language: German (with English abstract)
Publication: LBI-HTA Project report No. 109:  https://eprints.aihta.at/1183

Background:
The Austrian healthcare system is facing increasing challenges. One of the biggest challenge is the constantly increasing expenditures on medicines, which is in particular due to the aging population and the introduction of new and cost-intensive medicines, such as oncological treatments. Austria is one of the first countries in Europe to use a new oncology drug, resulting in high drug prices. The dual financing system for the outpatient and inpatient sector in Austria is further exacerbating the problem of high-priced medicines, especially for hospital drugs. Decisions in the hospital sector are largely independent of the outpatient sector for which a kind of positive list (reimbursement codex / EKO) exists. However, inpatient medicine therapies often have long-term effects on follow-up treatments in the outpatient sector, which is of great importance, especially for high-priced medicines. In addition, the processes regarding the pricing of drugs and reimbursement of costs vary between outpatient and inpatient sector, as well as between the individual hospital (-associations) within different federal states. Both can lead to unequal decisions and consequently to unequal availability of medicines between outpatient and inpatient care, as well as at hospital level between the individual federal states [1].

The pricing and reimbursement process of the outpatient sector is carried out uniformly throughout Austria, including recommendations of the Therapeutic Products Evaluation Commission (Heilmittel-Evaluierungs-Kommision, HEK). The HEK takes pharmacological, medical-therapeutic and health economic aspects into account [2]. In comparison, the decision about the procurement and use of medicines in the inpatient sector is performed by the drug commissions of the regional hospital authorities. Systematic evaluations and uniform methodological evaluation standards are currently not applied [1].

Against this background, hospital operators and payers started initiatives to develop a uniform nationwide process for pricing and drug reimbursement for the hospital sector.

Project objectives:
In a first step, the actual situation of the pricing and reimbursement process as well as the methods of benefit assessments and pharmacoeconomic evaluations used in Austria will be described (inpatient and outpatient sector).

Furthermore, the pricing and reimbursement processes of some countries, which have standardised evaluation methods for the processes in the inpatient and/or outpatient sector (e.g. Northern European countries such as Belgium and the Netherlands, Canada, etc.), are described and the strengths and weaknesses of the Austrian system are compared and analysed against this background.

Based on this, the main objective of the project is to identify possibilities for an Austrian-wide uniform process of pricing and reimbursement of medicines for the inpatient sector, which methodically fulfils the state-of-the-art in benefit and health economic evaluation and takes into account the Austrian framework conditions and existing processes (e.g. HEK). The main objective is to develop a transparent and evidence-based process.

A special focus should be placed on orphan drugs, as the pricing and reimbursement processes for orphan drugs may differ from those for other drugs and because these medicines are particularly costly [3].

The aim of the project is NOT to set out a final process of pricing and reimbursement for the inpatient sector. Rather, scenarios for an evaluation process for the inpatient sector are to be presented.

Research questions:

1. How is the reimbursement of medicines in the outpatient sector regulated? What is the course of time (drug approval - reimbursement decision - duration of decision-making - publication)? Which methodological steps are carried out with regard to the benefit assessment and pharmacoeconomic evaluation? What is the legal basis of the process? What is the reimbursement decision based on (HTA included)? To what extent are contingent reimbursement agreements (e.g. Managed Entry Agreements, Risk Sharing Agreements) taken into account? What are the strengths and weaknesses of the process?
2. How is drug reimbursement regulated in the inpatient sector? What is the course of time (drug approval - reimbursement decision - duration of decision-making - publication)? On what legal and methodological basis is the process for the inpatient sector based? What is the reimbursement decision based on (HTA included)? What are the strengths and weaknesses of the process?
3. What is the financing of medicines in other countries (outpatient and/or inpatient sector)? What is the course of time (drug approval - reimbursement decision - duration of decision-making - publication)? How are the pricing and reimbursement processes methodically carried out in other countries (e.g. benefit assessment, pharmacoeconomic assessment)? On which legal basis are the processes in other countries based? What is the reimbursement decision based on (HTA included)? To what extent are contingent reimbursement agreements (e.g. Managed Entry Agreements, Risk Sharing Agreements) taken into account? What are the strengths and weaknesses of processes in other countries?
4. How could an Austrian-wide uniform pricing and reimbursement process for the inpatient sector, which methodically fulfils the state-of-the-art in benefit and health economic evaluation and takes into account the Austrian framework conditions, as well as already existing processes (e.g. HEK), look like? What changes/improvements based on the experiences of other countries are necessary to create a transparent and evidence-based process?
5. How do the pricing and reimbursement processes for orphan drugs differ from those for other drugs in Austria and in other countries? How could these deviations be taken into account in the Austrian processes for the inpatient sector?

Methods:

1. Literature analysis
   • Literature search:
   • Search strategy: Literature search
   • Type of literature: Political reports, guidelines, legal texts, manuals of ministries/organidsations/institutions, peer-reviewed journal articles, posters, presentations, etc.
   • Search locations: Websites of the European Commission/Ministries/Associations/Institutions (e.g. WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies), Website of EUnetHTA, Google Scholar, Medline, etc.
   • Publication period: 2008 – 2018
   • Language: German, English
   • Information synthesis:
   • Level of detail of information: Step 1: macro level - transnational information (e.g. reviews), Step 2: if information is missing at the macro level à micro/country level
   • Qualitative synthesis of information
   • Grid design: Clustering of information/countries
   • Strengths and weakness profils
2. Expert interviews
   • E.g. qualitative guideline interviews or expert interviews - if necessary - depending on the level of detail of the information available from selected literature in order to gather detailed information about the processes and methods.
   • No exact social science content analysis

Procedure:

• For answering research questions 1 and 2 national literature (and, if necessary, expert interviews) will be used.
• To answer research question 3, literature from other countries (and, if necessary, expert interviews) will be used.
• To answer research question 4, the information from the first three research questions will be used and combined with each other. For example, solution approaches/improvement suggestions can be developed based on the strengths of other countries' processes.
• To answer research question 5, attention is paid to orphan drugs both in Austrian literature and in the literature of other countries, as these drugs are often treated separately in many countries.

Time schedule:

References:

1.         Zimmermann N, Vogler S (2009) Krankenhaus-Pharma-Bericht Österreich. Available via http://whocc.goeg.at/Literaturliste/Dokumente/CountryInformationReports/PHIS_Hospital_Pharma_AT_Report_deutsch.pdf. Cited 2018/17/04

2.         Hauptverband der Sozialversicherungen Österreich (2018) Erstattungskodex - EKO. Available via http://www.hauptverband.at/cdscontent/load?contentid=10008.637165&version=1515485239. Cited 2018/16/04

3.         Adkins EM, Nicholson L, Floyd D, et al. Oncology drugs for orphan indications: how are HTA processes evolving for this specific drug category? Clinicoecon Outcomes Res. 2017;9:327–42.