Predictors for reimbursement of oncology drugs in Belgium between 2002 and 2013

Pauwels, Kim; Huys, Isabelle; Nys, Katelijne De; Casteels, Minne; Simoens, Steven

doi:10.1586/14737167.2015.1047347

Cited by 12 publications

(11 citation statements)

References 20 publications

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“…As well, there are likely other factors even within the economic domain that may play larger roles in the formation of the final funding recommendation, including clinical outcomes, uncertainty, and drug price [ 33 ]. While some studies have examined the predictors of type of funding recommendation, which included both economic and clinical variables [ 22 , 33 – 35 ], to the best of our knowledge, no other studies have attempted to examine the association between the issues the economic reviewers have identified and the final funding recommendation. This is an area for further research, including exploring causal models to take the results beyond associations.…”

Section: Discussionmentioning

confidence: 99%

Methodological Issues in Economic Evaluations Submitted to the Pan-Canadian Oncology Drug Review (pCODR)

Masucci

Beca

Sabharwal³

et al. 2017

PharmacoEconomics Open

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BackgroundPublic drug plans are faced with increasingly difficult funding decisions. In Canada, the pan-Canadian Oncology Drug Review (pCODR) makes funding recommendations to the provincial and territorial drug plans responsible for cancer drugs. Assessments of the economic models submitted by pharmaceutical manufacturers are publicly reported.ObjectivesThe main objective of this research was to identify recurring methodological issues in economic models submitted to pCODR for funding reviews. The secondary objective was to explore whether there exists any observed relationships between reported methodological issues and funding recommendations made by pCODR’s expert review committee.MethodsPublicly available Economic Guidance Reports from July 2011 (inception) until June 2014 for drug reviews with a final funding recommendation (N = 34) were independently examined by two authors. Major methodological issues from each review were abstracted and grouped into nine main categories. Each issue was also categorized based on perception of the reviewer’s actions to manage it.ResultsThe most commonly reported issues involved costing (59% of reviews), time horizon (56%), and model structure (36%). Several types of issues were identified that usually could not be resolved, such as quality of clinical data or uncertainty with indirect comparisons. Issues with costing or choice of utility estimates could usually be addressed or explored by reviewers. No statistically significant relationship was found between any methodological issue and funding recommendations from the expert review committee.ConclusionsThe findings provide insights that can be used by parties who submit or review economic evidence for continuous improvement and consistency in economic modeling, reporting, and decision making.Electronic supplementary materialThe online version of this article (doi:10.1007/s41669-017-0018-3) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Methodological Issues in Economic Evaluations Submitted to the Pan-Canadian Oncology Drug Review (pCODR)

Masucci

Beca

Sabharwal³

et al. 2017

PharmacoEconomics Open

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“…Consequently, differences in HTA recommendations have been the subject of extensive research. [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] Studies qualitatively assessing recommendations for groups of drugs in several HTA jurisdictions report that a series of sources contribute to observed differences. These sources can be roughly divided into two categories.…”

Section: Introductionmentioning

confidence: 99%

“…The inclusion of explanatory variables in univariate and multivariable models varies widely, and results are simultaneously variable and sometimes contradictory. [12][13][14][15][16][17] The inclusion of practice-related factors is rare. 18 Importantly, overall HTA recommendations are the result of very different practices in international HTA jurisdictions.…”

Section: Introductionmentioning

confidence: 99%

Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations

et al. 2020

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Background: Health technology assessment (HTA) plays an important role in reimbursement decision-making in many countries, but recommendations vary widely throughout jurisdictions, even for the same drug. This variation may be due to differences in the weighing of evidence or differences in the processes or procedures, which are known as HTA practices. Objective: To provide insight into the effects of differences in practices on interpretation of intercountry differences in HTA recommendations for conditionally approved drugs. Methods: HTA recommendations for conditionally approved drugs (N = 27) up until June 2017 from England/Wales, France, Germany, the Netherlands, and Scotland were included. Recommendations and practice characteristics were extracted from these five jurisdictions and this data was validated. The effect of nonsubmissions, resubmissions, and reassessments; costeffectiveness assessments; and price negotiations on changes in the percentage of negative recommendations and the interpretation of intercountry differences in HTA outcomes were analyzed using Fisher exact tests. Results: The inclusion of cost-effectiveness assessments led to significant increases in the proportion of negative recommendations in England/Wales (from 4% to 50%, P,.01) and Scotland (from 21% to 71%, P,.01). The subsequent inclusion of price negotiations led to significant reductions in the proportion of negative recommendations in England/ Wales (from 50% to 14%, P,.01), France (from 31% to 3%, P=.012), and Germany (from 34% to 0%, P,.01). Results indicated that the inclusion of nonsubmissions and resubmissions might affect Scottish negative HTA recommendations (from 7% to 21%), but this effect was not significant. No significant effects were observed in the Netherlands, possibly owing to sample size. Conclusion: Variations in HTA practices between international jurisdictions can have a substantial and significant impact on conclusions about recommendations by HTA bodies, as exemplified in this cohort of conditionally approved products. Studies comparing international HTA recommendations should carefully consider possible practice variations between jurisdictions.

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“…This finding is consistent with other literature that demonstrates the influence of clinical uncertainty [28,33] and clinical superiority [28-30, 32, 40] on funding recommendations in Belgium, Canada, Poland, the UK, and Wales. The number of alternative treatments has also been shown to be important in Australia and Belgium [32,43].…”

Section: Discussionmentioning

confidence: 99%

“…Some cross-country variations are explained by considerations of therapeutic value [24], disease severity [25] and economic considerations [22,26,27]. Clinical considerations have been shown to be significant predictors of funding recommendations in Canada, the UK and Poland [28][29][30][31], with clinical uncertainty being significant in Belgium and Wales [32,33] and not significant in Scotland [34]. Cost effectiveness was a significant influence on funding recommendations in all countries except Wales [33].…”

Section: Introductionmentioning

confidence: 99%

Cost Effectiveness of a Pharmacist-Led Information Technology Intervention for Reducing Rates of Clinically Important Errors in Medicines Management in General Practices (PINCER)

et al. 2014

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Background Most Canadian provinces and territories rely on the pan-Canadian Oncology Drug Review (pCODR) to provide recommendations regarding public reimbursement of cancer drugs. The pCODR review process considers four dimensions of value-clinical benefit, economic evaluation, patient-based values and adoption feasibility-but they do not define weights for individual decision criteria or an acceptable threshold for any of the criteria. Given this implicit review process, it is of interest to understand which factors appear to carry the most weight in pCODR recommendations using a revealed preferences approach. Methods Using publicly available decision summaries (n = 91) describing submissions and resulting recommendations 2011-2017, we extracted ten attributes that characterized each submission. Using logistic regression, we identified statistically significant attributes and estimated their relative impact in final recommendations.Results Clinical aspects appear to carry the greatest weight in the decision to reject or not reject, along with aspects of patient value (treatments with no alternatives were less likely to be rejected). Cost effectiveness does not appear to play a role in the initial decision to reject or not reject but is critical in full versus conditional approvals. There is evidence of a maximum acceptable threshold of around $Can140,000 per quality-adjusted life-year (QALY) gained. Conclusion A set of factors driving pCODR recommendations is identifiable, supporting the consistency of the review process. However, the implicit nature of the review process and the difficulty of extracting and interpreting some of the attribute levels used in the analysis suggests that the process may still lack full transparency. Key PointsWe characterize the pan-Canadian Oncology Drug Review (pCODR) process as two stages: a decision to reject or not reject, followed by a decision to recommend full or condition approval (conditional on non-rejection).Clinical aspects appear to carry the greatest weight in the decision to reject or not reject, whereas value for money had the greatest weight in full versus conditional approvals. Notwithstanding pCODR's implicit review process, there appears to be an identifiable and consistent set of factors driving pCODR recommendations.

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Predictors for reimbursement of oncology drugs in Belgium between 2002 and 2013

Abstract: Evidence-based medicine still plays a role in Belgian reimbursement decision-making. In order to allow transition towards value-based medicine and avoid spending money on products with limited incremental benefit, therapeutic need at patient level need to be taken into account.

Cited by 12 publications

References 20 publications

Methodological Issues in Economic Evaluations Submitted to the Pan-Canadian Oncology Drug Review (pCODR)

Methodological Issues in Economic Evaluations Submitted to the Pan-Canadian Oncology Drug Review (pCODR)

Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations

Cost Effectiveness of a Pharmacist-Led Information Technology Intervention for Reducing Rates of Clinically Important Errors in Medicines Management in General Practices (PINCER)

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