gms | German Medical Science

Background: Germany introduced the Early Benefit Assessment (EBA) in 2011 as a Health Technology Assessment (HTA) for newly licensed medicines. The British NICE assesses newly licensed drugs with the Single Technology Appraisal (STA). Both the EBA and STA are embedded in national decision making processes. In Germany the result of the Early Benefit Assessment is used alongside the European reference price to set reimbursement rates for newly licensed medicines. In the UK based on the results of the STA, NICE decides whether the newly licensed medicines will be available, available for specific indications, available for research or not available within the National Health System (NHS). Therefore, both HTA processes influence their specific health care settings and service provision. This contribution focuses on the comparison of the general methods, the commons and differences between the two HTAs processes. Also considered are the implications of the differences between the general methods for the assessment of specific drugs. The level of prescribing of newly licensed drugs is compared between Germany and the UK. Additionally we aimed to put the prescribing data into context with the assumed incidence and prevalence data from the specific national HTAs.

Materials and Methods: For the comparison of the general methods the relevant legal documents and official documents of the participating HTA bodies Federal Joint Committee, IQWIG and NICE were screened for the process procedures using the amended categories of the report „Ensuring value for money in health care: the role of health technology assessment in the European Union“ from the European Observatory on Health Systems and Policies. The first five newly licensed drugs (Ticagrelor, Cabazitaxel, Fingolimod, Eribulin and Retigabin) with both an Early Benefit Assessment and a STA from NICE were compared in detail using the patient-intervention-comparator-outcome (PICO) approach. Prescribing data of eight drugs with both a completed EBA and a STA on 31.12.2013 is obtained from the AOK PLUS for Saxony representing German data and prescribing data from Wales is obtained from the Welsh Analytical Prescribing Support Unit (WAPSU) representing UK data. The obtained prescribing data covers a time frame from 01.01.2010 to 31.12.2013 and is quarterly presented in defined daily doses. Prescribing density is shown by defined daily doses per 1000 patients insured. The covered target population links real patient numbers based on prescription data with the anticipated patient numbers published within the specific HTAs.

Results: Both HTA processes are embedded in official decision making processes and underlie a two-stage decision process. A formal assessment process is outlined for both. The STA is a full health economic assessment, whereas the cost effectiveness is not assessed within the EBA: The quality of the used health economic data in the British Fingolimod and Retigabin assessments were poor. The same high standards as for clinical trial data should be sought. An important difference for the assessment process itself is the fact that the comparator for the Early Benefit Assessment has to be licensed for the indication assessed. For the STA this is not the case. Subgroups were formed more frequently within the EBA process than within the STA (Fingolimod, Cabazitaxel, Abiraterone and Eribulin). No general patterns could be seen as such that one process leads to constant more favourable appraisals results for the drugs than the other. The prescribing patterns of the assessed drugs differ greatly. All drugs had been prescribed in Saxony before the results of the Early Benefit Assessments were published. Only in 2/8 cases new drugs had been prescribed in Wales before the NICE assessments were published. In 6/8 cases drugs had been prescribed earlier in Saxony than in Wales. In 5/8 cases drugs have a higher (up to tenfold) prescribing density in Saxony than in Wales. The Hepatitis C treatments Boceprevir and Telaprevir have a higher prescribing density in Wales. Retigabin is not marketed in Germany anymore, hence no prescribing occurred. The prescribing patterns of the assessed drugs do not reflect prior assumption in the Health Technology Assessments neither in Saxony nor in Wales as the treated target population varies between <1% and >350%.

Conclusion: For a comparability of the HTA processes within the European Union the agreement among European HTA agencies whether a comparator needs to be licensed for the assessed indication is essential. The quality of the health economic data used needs to improve. The Early Benefit Assessment seems to influence prescribing patterns less than the STA from NICE. There is no correlation between the assumed target population and real usage patterns.