About Smart & Bi
We guide through various steps of access
- feasibility analyses of reimbursement submission
- compilation of the reimbursement dossier
- compilation of the price dossier
- advice on pre-submission approaches
- risk sharing and managed entry schemes
- budget impact assessments (BIA)
- health technology and relative effectiveness assessment / appraisal of cost-effectiveness
- description of the disease burden and (unmet) medical need
- further procedural assistance
- stakeholder mapping and interaction
- early dialogue
- data management / biostatistics / business intelligence
Scope
Our areas of expertise extend to:
- innovative medicinal products
- orphan drugs
- biologicals, including biosimilars
- hospital and retail environment
Customers
We provided since our start services for:
- nearly 70 projects
- more than 20 multinational pharmaceutical organisations
- We can work in close collaboration with various other service providers who have complementary expertise
- active collaboration in Step-Wiser – one-stop shop organisation for healthcare business consulting in Belgium and Europe
- active international collaboration on market access, regulatory submission, HTA and health-economic projects within dedicated Dutch-Belgian network
- academic organisations for external expertise
- We can work in close collaboration with various other service providers who have complementary expertise
Most recent
Publications
Publications
Van Wilder Philippe (Vrije Universiteit Brussel and SMART&BI), Mabilia Valentina (Milieu Ltd.), Kuipers Cavaco Yoline (Milieu Ltd.) and McGuinn Jennifer (Milieu Ltd.)
Report on behalf of the European Parliament.
Towards a harmonised EU Assessment of the Added Therapeutic Value of Medicines.
Study for the ENVI Committee. Directorate-General for Internal Policies.
June 2015 Available via: http://www.europarl.europa.eu/thinktank/en/document.html?reference=IPOL_STU(2015)542219
Van Wilder PB, Bormans VV, Dupont AG. Relative efficacy and effectiveness assessment of new pharmaceuticals in three EU member states: current practices and outcome agreement between Belgium, the Netherlands and France. Eur J Clin Pharmacol 2013, DOI 10.1007/s00228-013-1577-6
Van Wilder P. Advanced therapy medicinal products and exemptions to the Regulation 1394/2007: how confident can we be? An exploratory analysis. Front. Pharmacol. 3:12. doi: 10.3389/fphar.2012.00012
Dupont A, Van Wilder P. Access to orphan drugs despite poor quality of clinical evidence. Brit. J. Of Clin. Pharmacol 2011, 71 (4): pp. 488-496.
Van Wilder P, Zhu Q, Veraverbeke N. Identifying and rewarding pharmaceutical innovation: application in a EU member state. Drug Information Journal 2010, 44 (3): pp. 317-323.
Cleemput I, Van Wilder P. History of health technology assessment in Belgium. Int. J. of Technology Assessment in Health Care 2009, 25 (1): pp. 1-6.
Cleemput I, Van Wilder P, Belgian Methodological Guidelines for Pharmacoeconomic Evaluations: Toward Standardization of Drug Reimbursement Requests. Value in Health 2009; 12 (4): pp. 441-449
Van Wilder P, Dupont A. Reimbursement of medicines in Belgium: role of evidence-based medicine. Acta Clinica Belgica 2009, 64 (2): pp. 120-128.
Van Wilder P, Dupont A. Introducing evidence based medicine (EBM) in reimbursement procedures: does it affect the outcome? Value in Health 2008; 11 (4): pp. 784-787.
Van Wilder PB, Bormans VV, Dupont AG. Relative efficacy and effectiveness assessment of new pharmaceuticals in three EU member states: current practices and outcome agreement between Belgium, the Netherlands and France. Eur J Clin Pharmacol 2013, DOI 10.1007/s00228-013-1577-6
Van Wilder P. Advanced therapy medicinal products and exemptions to the Regulation 1394/2007: how confident can we be? An exploratory analysis. Front. Pharmacol. 3:12. doi: 10.3389/fphar.2012.00012
Dupont A, Van Wilder P. Access to orphan drugs despite poor quality of clinical evidence. Brit. J. Of Clin. Pharmacol 2011, 71 (4): pp. 488-496.
Van Wilder P, Zhu Q, Veraverbeke N. Identifying and rewarding pharmaceutical innovation: application in a EU member state. Drug Information Journal 2010, 44 (3): pp. 317-323.
Cleemput I, Van Wilder P. History of health technology assessment in Belgium. Int. J. of Technology Assessment in Health Care 2009, 25 (1): pp. 1-6.
Cleemput I, Van Wilder P, Belgian Methodological Guidelines for Pharmacoeconomic Evaluations: Toward Standardization of Drug Reimbursement Requests. Value in Health 2009; 12 (4): pp. 441-449
Van Wilder P, Dupont A. Reimbursement of medicines in Belgium: role of evidence-based medicine. Acta Clinica Belgica 2009, 64 (2): pp. 120-128.
Van Wilder P, Dupont A. Introducing evidence based medicine (EBM) in reimbursement procedures: does it affect the outcome? Value in Health 2008; 11 (4): pp. 784-787.
Relevant abstracts & posters
USE OF FACTOR ANALYSIS TO OBTAIN INDEPENDENT HEALTH PERFORMANCE INDICATORS. Van Wilder PB, Bormans VV, Leemans EJ. Abstract & poster 17th annual European ISPOR congress Amsterdam.
A LUMP SUM REIMBURSEMENT OF PHARMACEUTICALS IN HOSPITALS IN BELGIUM: ASSESSING THE ADVERSE EFFECTS Arickx F, Soete E, Van Haeren E, Bormans V. Value in Health, vol 12(7), 2009. Abstract & poster annual European ISPOR Congress.
PUBLIC TENDERING FOR OFF PATENT PHARMACEUTICALS IN BELGIUM – THE SIMVASTATIN CASE Van Haeren E, Arickx F, Soete E, Bormans V, Mortier M, Leveque F. Value in Health , vol 12(7), 2009. Abstract & poster annual European ISPOR Congress.
THE BELGIAN REIMBURSEMENT PROCEDURE (BRP): ARE ADDED THERAPEUTIC VALUE (ATV) AND ICER AFFECTING THE DRUG REIMBURSEMENT DECISION (DRD)? Verplanken P, Arickx F, Bormans V, Soete E, Annemans L, Robays H, Van Wilder P. Value in Health, vol 11(6), 2008. Abstract & poster annual European ISPOR Congress.
A LUMP SUM REIMBURSEMENT OF PHARMACEUTICALS IN HOSPITALS IN BELGIUM: ASSESSING THE ADVERSE EFFECTS Arickx F, Soete E, Van Haeren E, Bormans V. Value in Health, vol 12(7), 2009. Abstract & poster annual European ISPOR Congress.
PUBLIC TENDERING FOR OFF PATENT PHARMACEUTICALS IN BELGIUM – THE SIMVASTATIN CASE Van Haeren E, Arickx F, Soete E, Bormans V, Mortier M, Leveque F. Value in Health , vol 12(7), 2009. Abstract & poster annual European ISPOR Congress.
THE BELGIAN REIMBURSEMENT PROCEDURE (BRP): ARE ADDED THERAPEUTIC VALUE (ATV) AND ICER AFFECTING THE DRUG REIMBURSEMENT DECISION (DRD)? Verplanken P, Arickx F, Bormans V, Soete E, Annemans L, Robays H, Van Wilder P. Value in Health, vol 11(6), 2008. Abstract & poster annual European ISPOR Congress.
Dissertation
Van Wilder P. Market access of innovative medicinal products: assessment of their relative therapeutic value. Dissertation to obtain the degree of Doctor in Pharmaceutical Science (December 17, 2014).