Belgian guidelines for economic evaluations: second edition.

OBJECTIVES: The aim of this study was to present the updated methodological guidelines for economic evaluations of healthcare interventions (drugs, medical devices, and other interventions) in Belgium. METHODS: The update of the guidelines was performed by three Belgian health economists following feedback from users of the former guidelines and personal experience. The updated guidelines were discussed with a multidisciplinary team consisting of other health economists, assessors of reimbursement request files, representatives of Belgian databases and representatives of the drugs and medical devices industry. The final document was validated by three external validators that were not involved in the previous discussions. RESULTS: The guidelines give methodological guidance for the following components of an economic evaluation: literature review, perspective of the evaluation, definition of the target population, choice of the comparator, analytic technique and study design, calculation of costs, valuation of outcomes, definition of the time horizon, modeling, handling uncertainty and discounting. We present a reference case that can be considered as the minimal requirement for Belgian economic evaluations of health interventions. CONCLUSIONS: These guidelines will improve the methodological quality, transparency and uniformity of the economic evaluations performed in Belgium. The guidelines will also provide support to the researchers and assessors performing or evaluating economic evaluations.

Should chronic hepatitis B be treated as early as possible?

OBJECTIVES: We studied the cost-effectiveness of tenofovir and entecavir in e antigen positive (CHBe+) and negative (CHBe-) chronic hepatitis B. METHODS: Using a multicenter survey including 544 patients we measured patient quality of life and attributable costs by clinical disease stage. Natural disease progression was studied in 278 patients in a single center. A Markov model was constructed to follow hypothetical cohorts of treated and untreated 40-year-old CHBe+ and CHBe- patients and 50-year-old patients with compensated cirrhosis. RESULTS: We did not find an improvement in quality of life when viral load was reduced under treatment. Transition rates to liver cirrhosis were found to be age-dependent. Assuming equal effectiveness, tenofovir dominates the entecavir strategy because of its lower price in Belgium. The incremental cost-effectiveness ratio (ICER) of tenofovir after 20 years is more favorable for treating Caucasian cirrhotic patients (mean ICER €29,000/quality-adjusted life-year [QALY]) compared with treating non-cirrhotic patients (mean ICER €110,000 and 131,000/QALY for CHB e+ and e-, respectively). Within the non-cirrhotic patients the ICER decreases with increasing cohort starting age from 30 to 50 years. CONCLUSIONS: Results of long-term models for tenofovir or entecavir treatment of CHB need to be interpreted with caution as long-term trials with hard end points are lacking. Especially the effect on HCC remains highly uncertain. Based on cost-effectiveness considerations such antiviral treatment should be targeted at patients with cirrhosis or at risk of rapid progression to this disease stage.

Cost-effectiveness of hepatitis A vaccination for adults in Belgium.

Hepatitis A vaccination targeting adults (or adult risk-groups like e.g. travellers, health care workers, soldiers or teachers) could be considered an alternative to a universal infant or adolescent vaccination program in low endemic countries. We estimated the current disease burden of hepatitis A in Belgium, and evaluated whether adult vaccination is cost-effective. We used a Markov cohort model to simulate the costs and effects of (1) vaccination of adults and (2) serological screening of adults and vaccination of susceptibles and compared these with the current situation. The results indicated that these expanded vaccination strategies are not cost-effective in the epidemiological circumstances of a typical low-endemic western country. In order to gain 1 quality-adjusted life year the health care payer would have to pay 185,000€ for vaccination and 223,000€ for screening and vaccination of seronegatives. For adult vaccination to be cost-effective, risk-groups would need to be exposed to a force of infection that is 3.5-4 times higher than currently estimated in the general population; or the total costs of vaccination would have to drop with approximately 75%.

A cost-utility analysis of transcatheter aortic valve implantation in Belgium: focusing on a well-defined and identifiable population.

BACKGROUND: Patients with severe aortic stenosis and coexisting non-cardiac conditions may be at high risk for surgical replacement of the aortic valve or even be no candidates for surgery. In these patients, transcatheter aortic valve implantation (TAVI) is suggested as an alternative. Results of the PARTNER (Placement of AoRTic TraNscathetER Valve) trial comparing the clinical effectiveness of TAVI with surgical valve replacement and standard therapy were published. The authors assessed the cost-effectiveness of TAVI in Belgium. METHODS: A Markov model of incremental costs, effects (survival and quality of life) and incremental cost-effectiveness of TAVI was developed. The impact on survival, number of events and quality of life was based on the PARTNER trial. Costs per event were context specific. RESULTS: In high-risk operable patients, even if the minor differences in 30-day and 1-year mortality are taken into account, the incremental cost-effectiveness ratio (ICER) remains on average above €750 000 per quality-adjusted life-year (QALY) gained (incremental cost: €20 400; incremental effect: 0.03 QALYs). In inoperable patients, an ICER of €44 900 per QALY (incremental cost: €33 200; incremental effect: 0.74 QALYs) is calculated, including a life-long extrapolation of the mortality benefit. This result was sensitive to the assumed time horizon. The subgroup of anatomically inoperable patients had better outcomes than medically inoperable patients, with ICERs decreasing more than €10 000/QALY. CONCLUSIONS: It is inappropriate to consider reimbursement of TAVI for high-risk operable patients. Reimbursing TAVI in inoperable patients in essence is a political decision. From an economic perspective, it would be prudent to first target patients that are inoperable because of anatomical prohibitive conditions. In the search for evidence, the authors identified non-published negative results from a randomised controlled TAVI trial. The study sponsor should be more willing to share this information to allow balanced evaluations and policy recommendations. Payers should require these data before taking reimbursement decisions.

Provider volume and short term complications after elective total hip replacement: an analysis of Belgian administrative data.

The relationship between provider volume and short term complications after an elective total hip replacement was studied on Belgian hospital discharge administrative database from 2004. The analysis included 11 856 patients. Hospitals were classified in low-volume (< or = 60/interventions per year), medium volume (61-110) or high volume (>110). Surgeons were labelled low-volume (< or = 6), medium volume (7-20) or high volume (>20). After adjustment for age, sex, principal diagnosis and comorbidity, surgeon volume was much more predictive of short term complications than centre volume. Patients treated by small volume surgeons (respectively medium volume surgeons) had a 43% higher odds of complications than patients operated by high volume surgeons (respectively 37%). Despite some limitations, Belgian administrative hospital discharge databases can be used to assess the volume outcome relationship for orthopaedic surgery. The study has emphasized the need to closely monitor individual performance, for hospitals and surgeons. Providers requiring further auditing can be effectively identified with funnel plots used routinely in quality control programs.

International comparison of orthotic brace prices.

This study compared market prices (i.e. third-party reimbursement and patient co-payment) of prefabricated neck, wrist and knee braces in Belgium, France, the Netherlands, Ontario (Canada) and the UK. Data were collected through contacts with health authorities, health insurance funds, manufacturers and distributors. Market prices varied substantially between countries, indicating that manufacturers adapt their price setting strategy to the policy environment and the structure of the brace market of a country. Belgian prices tended to exceed prices in other countries for the selected neck, wrist and knee braces. There seems to be scope for reducing Belgian prices of selected braces.

Reforming the Belgian market for orthotic braces: what can we learn from the international experience?

OBJECTIVES: This article aims to review regulation governing outpatient orthotic braces (neck, wrist and knee braces) in France, the Netherlands and Sweden with a view to reforming the Belgian market. METHODS: Information about the regulatory framework was derived from an analysis of legal texts and a survey completed by national experts. RESULTS: Strategies to keep down prices include public procurement in Sweden, maximum prices in France, and exclusion of expensive braces from reimbursement in the Netherlands. Reimbursement is linked to a medical indication or a chronic condition in France, the Netherlands and Sweden. To gain reimbursement, the cost-effectiveness of orthotic braces needs to be demonstrated in France and the Netherlands. Orthotic braces tend to be initially prescribed by a specialist physician and distributed by orthotists, medical equipment shops and/or community pharmacies. CONCLUSIONS: Extensive government intervention exists in the outpatient orthotic brace market in the countries studied. Our recommendations to reform the Belgian market for prefabricated orthotic braces are to separate reimbursement for service provision from reimbursement for braces; to set prices by means of a tendering process or an international price comparison; and to make reimbursement conditional on effectiveness and cost-effectiveness of braces.

Do tariffs and prices correspond with costs? A case study of orthotic braces.

OBJECTIVES: The Belgian third-party payer wishes to set reimbursement tariffs at a level that reflects the costs of orthotic braces. This article aims to calculate production and distribution costs of a prefabricated hard neck and knee brace and to explore whether Belgian tariffs and actual retail prices correspond with estimated costs of these two braces. METHODS: The cost model considered manufacturing costs, general overheads, research and development costs, warehousing costs, profit and distribution margins. Data were gathered from manufacturers, a production site visit, desk research, a decomposition of finished products and stakeholder interviews. The price year was 2007. RESULTS: The cost model estimated a retail price of euro55-euro150 for the neck brace, depending on assumptions. The estimated retail price for the neck brace was lower than the reimbursement tariff of euro194 and the actual retail price of euro241. The estimated retail price of euro331-euro694 for the knee brace was lower than the actual retail price of euro948. CONCLUSIONS: Actual retail prices and reimbursement tariffs for a neck brace and a knee brace exceeded prices based on estimated costs. Therefore, there appears to be scope for reducing tariffs.