Belgian methodological guidelines for pharmacoeconomic evaluations: toward standardization of drug reimbursement requests.

OBJECTIVE: To develop methodological guidelines for pharmacoeconomic evaluation (PE) submitted to the Belgian Drug Reimbursement Committee as part of a drug reimbursement request. METHODS: In 2006, preliminary pharmacoeconomic guidelines were developed by a multidisciplinary research team. Their feasibility was tested and discussed with all stakeholders. The guidelines were adapted and finalized in 2008. RESULTS: The literature review should be transparent and reproducible. PE should be performed from the perspective of the health-care payer, including the governmental payer and the patient. The target population should reflect the population identified for routine use. The comparator to be considered in the evaluation is the treatment most likely to be replaced. Cost-effectiveness and cost-utility analyses are accepted as reference case techniques, under specific conditions. A final end point-as opposed to a surrogate end point-should be used in the incremental cost-effectiveness ratio (ICER). For the calculation of quality-adjusted life-years (QALYs), a generic quality-of-life measure should be used. PE should in principle apply a lifetime horizon. Application of shorter time horizons requires appropriate justification. Uncertainty around the ICER should always be assessed. Costs and outcomes should be discounted at 3% and 1.5%, respectively. CONCLUSION: The current guidelines are the result of a constructive collaboration between the Belgian Health Care Knowledge Centre, the National Institute for Health and Disability Insurance and the pharmaceutical industry. A point of special attention is the accessibility of existing Belgian resource use data for PE. As PE should serve Belgian health-care policy, they should preferably be based on the best available data.

Cost-effectiveness of human papillomavirus vaccination in Belgium: do not forget about cervical cancer screening.

OBJECTIVES: The cost-effectiveness of adding a human papillomavirus (HPV) vaccination program in 12-year-old females to the recommended cervical cancer screening in Belgium is examined. Moreover, the health and economic consequences of a potential decline in screening uptake after initiation of a HPV vaccination program are investigated. METHODS: A static Markov model is developed to estimate the direct effect of vaccination on precancerous lesions and cervical cancers. RESULTS: Vaccination is estimated to avoid 20 percent of the cervical cancers occurring in a 12-year-old girls' cohort and to cost 32,665 euro per quality-adjusted life-year (QALY) gained (95 percent credibility interval [CrI]: 17,447 euro to 68,078 euro), assuming a booster injection after 10 years, a limited duration of protection and discounting costs and effects at 3 percent and 1.5 percent, respectively. Assuming lifelong protection, HPV vaccination is estimated to cost 14,382 euro (95 percent CrI: 9,238 euro to 25,644 euro) per QALY gained, while avoiding 50 percent of the cervical cancer cases. In the base-case, a 10 percent reduction in screening compliance after vaccination obliterates the effect of vaccination on cervical cancer cases avoided, whereas further declines in the level of screening compliance even turned out to be detrimental for the cohort's health, inducing a mean loss in QALYs and life-year gained compared with the situation prevaccination. CONCLUSIONS: An HPV vaccination program should only be considered if the level of screening after vaccination can be maintained.

Trastuzumab in early stage breast cancer: a cost-effectiveness analysis for Belgium.

OBJECTIVES: Although trastuzumab is traditionally used in metastatic breast cancer treatment, studies reported on the efficacy and safety of trastuzumab in adjuvant setting for the treatment of early stage breast cancer in HER2+ tumors. We estimated the cost-effectiveness and budget impact of reimbursing trastuzumab in this indication from a payer's perspective. METHODS: We constructed a health economic model. Long-term consequences of preventing patients to progress to metastatic breast cancer and side effects such as congestive heart failure were taken into account. Uncertainty was handled applying probabilistic modeling and through probabilistic sensitivity analyses. RESULTS: In the HERA scenario, applying an arbitrary threshold of euro30000 per life-year gained, early stage breast cancer treatment with trastuzumab is cost-effective for 9 out of 15 analyzed subgroups (according to age and stage). In contrast, treatment according to the FinHer scenario is cost-effective in 14 subgroups. Furthermore, the FinHer regimen is most of the times cost saving with an average incremental cost of euro668, euro-1045, and euro-6869 for respectively stages I, II and III breast cancer patients whereas the HERA regimen is never cost saving due to the higher initial treatment costs. CONCLUSIONS: The model shows better cost-effectiveness for the 9-week initial treatment (FinHer) compared to no trastuzumab treatment than for the 1-year post-chemotherapy treatment (HERA). Both from a medical and an economic point of view, the 9-week initial treatment regimen with trastuzumab shows promising results and justifies the initiation of a large comparative trial with a 1-year regimen.

Recommended structure for reporting economic evaluation on pharmaceuticals in Belgium.

Pharmaco-economic evaluations become more important for the reimbursement of pharmaceuticals, and will be obligatory for new pharmaceutical drugs for which an added therapeutic value is claimed and a price premium is proposed by the manufacturer. Therefore, it is important to guide purchasers and providers of pharmaceutical care in their efforts related to the evaluation process. Standard Report Format can support the quality, transparency and exhaustiveness of the data submitted. A multidisciplinary task force developed a Standard Report Format for pharmaco-economic evaluations in Belgium.