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When Cochlear implants (CI) were first introduced, only postlingually, profoundly hearing impaired individuals were implanted unilaterally. As experience grew, eligibility was followed by prelingual deaf children, and a second contralateral CI was being considered. Due to surgical and technological improvements, eligibility criteria for CI are now shifting, encompassing patients with more residual hearing. We aimed to explore, ex ante, whether such shift is warranted.
Methods
A dynamic, population-based Markov modeling study was conducted. Model parameters were based on available evidence, expert opinion, and calibration. The model mimics Dutch demographic development in three age categories over a period of 20 years. Impact of changing eligibility was explored in terms of number of CI recipients, costs, quality of life and cost-effectiveness from a societal perspective.
Results
If those with severe hearing loss would qualify and opt for CI similar to those with profound hearing loss, this would lead to a fourfold increase of CI recipients (from 8,815 to 35,630) over a 20 year period, resulting in an increase in costs (EUR 550 million) and QALYs (54,000), with an Incremental Cost Utility Ratio of EUR 10,771/QALY (2.5–97.5 percentiles: 1,252–23,171).
Conclusions
Results suggest that expected health gains could be such, that the investment may be considered cost-effective against the backdrop of currently prevailing criteria. However, for this, a substantial increase in operating capacity, follow-up care and rehabilitation are required. Further inquiries are needed to investigate whether such increased capacity can be achieved, to ensure equitable access to those services.
In 2007, the National Healthcare Institute (ZIN) initiated conditional financing (CF) of expensive hospital drugs as an example of conditional reimbursement schemes (CRS). CF is a 4-year procedure encompassing initial HTA assessment (T = 0) followed by additional data collection via outcomes research (separately assessing appropriate use & cost-effectiveness in routine practice) and re-assessment (T = 4). This study aims to review performance and experiences with CF in the Netherlands to date.
METHODS:
All dossiers for drugs that underwent the full CF procedure were reviewed. Using a standardized data abstraction form, two researchers independently extracted information on procedural, methodological and decision-making aspects (that is, related to implemented outcomes research, evidence assessment and appraisal). A scoring algorithm was used to assess all three aspects.
RESULTS:
Fourty-seven candidates were nominated for CF; fourty-four underwent T = 0 assessments and eleven T = 4 assessments. The procedure extended beyond 4 years for 10/11 candidates. For the eleven candidates, applicants clearly defined study designs and data collection methods for outcomes research proposals addressing 16/22 research questions posed in T = 0 reports. ZIN provided discussion points and recommendations regarding research proposals for 18/22 research questions. Applicants implemented recommendations fully in 8/22 cases and partially in 12/22. Sufficient data was available at T = 4 to answer 15/22 research questions posed at T = 0. However, discussion points remained regarding implemented outcomes research for all eleven candidates at T = 4. ZIN advised to continue reimbursement for nine candidates and to stop reimbursement for two. For six of the nine candidates, reimbursement was continued on the basis of conditions relating to additional evidence generation beyond T = 4.
CONCLUSIONS:
Theoretically, CF provides a valuable option for enabling quick but conditional access to medicines in the Netherlands. However, procedural, methodological and decision-making considerations related to scheme design and implementation may affect its value in decision-making practice.
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