Multiple Criteria Decision Analysis for HTA across four EU Member States: Piloting the Advance Value Framework

Angelis, Aris; Linch, Mark; Montibeller, Gilberto; Molina-López, Teresa; Zawada, Anna; Orzel, K.; Arickx, Francis; Espín, Jaime; Kanavos, Panos

doi:10.1016/j.socscimed.2019.112595

Cited by 29 publications

(37 citation statements)

References 68 publications

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“…Because AHDH is a chronic condition, this lack of robust long-term clinical studies represents an important gap in the evidence base, and additional evidence from non-randomized and observational studies may be required to inform policy and clinical decision making. Further, policy decisions about which therapies are most appropriate may need to consider additional relevant factors, which may include burden of disease, therapeutic impact, safety profile, and socioeconomic impact [114]. For individual patients, the choice between treatments should reflect shared decision-making between the clinician and patient, with consideration of the patient's values, preferences, and individual circumstances, as well as the potential risks and benefits of the treatment options [115].…”

Section: Plos Onementioning

confidence: 99%

Pharmacologic treatment of attention deficit hyperactivity disorder in adults: A systematic review and network meta-analysis

et al. 2020

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Background Attention deficit hyperactivity disorder (ADHD) affects approximately 3% of adults globally. Many pharmacologic treatments options exist, yet the comparative benefits and harms of individual treatments are largely unknown. We performed a systematic review and network meta-analysis to assess the relative effects of individual pharmacologic treatments for adults with ADHD. Methods We searched English-language published and grey literature sources for randomized clinical trials (RCTs) involving pharmacologic treatment of ADHD in adults (December 2018). The primary outcome was clinical response; secondary outcomes were quality of life, executive function, driving behaviour, withdrawals due to adverse events, treatment discontinuation, serious adverse events, hospitalization, cardiovascular adverse events, and emergency department visits. Data were pooled via pair-wise meta-analyses and Bayesian network meta-analyses. Risk of bias was assessed by use of Cochrane's Risk of Bias tool, and the certainty of the evidence was assessed by use of the GRADE framework. Results Eighty-one unique trials that reported at least one outcome of interest were included, most of which were at high or unclear risk of at least one important source of bias. Notably, only 5 RCTs were deemed at overall low risk of bias. Included pharmacotherapies were methylphenidate, atomoxetine, dexamfetamine, lisdexamfetamine, guanfacine, bupropion, mixed

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Section: Plos Onementioning

confidence: 99%

Pharmacologic treatment of attention deficit hyperactivity disorder in adults: A systematic review and network meta-analysis

et al. 2020

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“…75,76 A recent MCDA pilot study in collaboration with European HTA bodies revealed how the application of quantitative decision analysis in combination with decision conferencing could take place by adopting a clean slate approach without the use of economic evaluations. 27 A number of evaluation criteria were incorporated in each jurisdiction's value model and decision-maker value preferences were elicited during the decision conferences, including performance scores and criteria weights. Following the estimation of the drugs' overall benefits, a subsequent consideration of drug costs enabled the demonstration of value for money in the form of estimated "cost per unit of value" ratios.…”

Section: Recommendations On the Use Of Quantitative Decision Analysis And Decision Conferencingmentioning

confidence: 99%

“…[16][17][18][19][20] Besides the generation of guidelines for the conduct of MCDA in HTA, 21,22 a number of empirical studies have been conducted in collaboration with decision makers to test and advance these methods in practice. [23][24][25][26][27]…”

Section: Introductionmentioning

confidence: 99%

ICER Value Framework 2020 Update: Recommendations on the Aggregation of Benefits and Contextual Considerations

2020

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The Institute for Clinical and Economic Review (ICER) in the United States recently published a 2020 update to its value assessment framework. We are commenting on the method by which the benefits of health interventions are integrated, relating to contextual considerations and other factors relevant to an intervention's value. We start by discussing the theoretical foundations of decision analysis and its extension to multiple criteria decision analysis (MCDA). Then we provide a detailed, evidence-based response to some of the claims made by ICER with regard to the use of MCDA methods and stakeholder engagement. Finally, we provide a number of recommendations on the use of quantitative decision analysis and decision conferencing that could be of relevance to the ICER methodology. Overall, we agree that some of the proposed changes by ICER are moving in the right direction toward improving transparency in the value assessment process, but these changes are probably inadequate. We advocate that more serious attention should be paid to the use of quantitative decision analysis together with decision conferencing for the construction of value preferences via group processes for the integration of an intervention's various benefit components.

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“…[26][27][28][29] A number of empirical studies have been conducted, often simulating different HTA settings [30][31][32][33] or by involving and eliciting the preferences of real decision makers and evaluators across different settings. [34][35][36][37] Still, a number of challenges relating to the appropriate use of such methods and their integration with policy-making have been raised that would be critical for MCDA implementation. 38,39 Although MCDA approaches have been explored in the context of product development and treatment selection, fewer studies exist compared with the drug approval context.…”

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confidence: 99%

“… 26 – 29 A number of empirical studies have been conducted, often simulating different HTA settings 30 – 33 or by involving and eliciting the preferences of real decision makers and evaluators across different settings. 34 – 37 Still, a number of challenges relating to the appropriate use of such methods and their integration with policy-making have been raised that would be critical for MCDA implementation. 38 , 39 …”

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confidence: 99%

Early Health Technology Assessment during Nonalcoholic Steatohepatitis Drug Development: A Two-Round, Cross-Country, Multicriteria Decision Analysis

et al. 2020

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Background. The assessment of value along the clinical development of new biopharmaceutical compounds is a challenging task. Complex and uncertain evidence has to be analyzed, considering a multitude of value preferences from different stakeholders. Objective. To investigate the use of multicriteria decision analysis (MCDA) to support decision making during drug development while considering payer and health technology assessment (HTA) value concerns, by applying the Advance Value Framework in nonalcoholic steatohepatitis (NASH) and testing for the consistency of the results. Design. A multiattribute value theory methodology was applied and 2 rounds of decision conferences (DCs) were organized in 3 countries (England, France, and Germany), with the participation of national key experts and stakeholders using the MACBETH questioning protocol and algorithm. A total of 51 health care professionals, patient advocates, and methodologists, including (ex-) committee members or assessors from national HTA bodies, participated in 6 DCs in the study countries. Target Population. NASH patients in fibrosis stages F2 to 3 were considered. Interventions. The value of a hypothetical product profile was assessed against 3 compounds under development using their phase 2 results. Outcome Measures. DC participants’ value preferences were elicited involving criteria selection, options scoring, and criteria weighting. Results. Highly consistent valuation rankings were observed in all DCs, always favoring the same compound. Highly consistent rankings of criteria clusters were observed, favoring therapeutic benefit criteria, followed by safety profile and innovation level criteria. Limitations. There was a lack of comparative treatment effects, early evidence on surrogate endpoints was used, and stakeholder representativeness was limited in some DCs. Conclusions. The use of MCDA is promising in supporting early HTA, illustrating high consistency in results across countries and between study rounds.

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Multiple Criteria Decision Analysis for HTA across four EU Member States: Piloting the Advance Value Framework

Cited by 29 publications

References 68 publications

Pharmacologic treatment of attention deficit hyperactivity disorder in adults: A systematic review and network meta-analysis

Pharmacologic treatment of attention deficit hyperactivity disorder in adults: A systematic review and network meta-analysis

ICER Value Framework 2020 Update: Recommendations on the Aggregation of Benefits and Contextual Considerations

Early Health Technology Assessment during Nonalcoholic Steatohepatitis Drug Development: A Two-Round, Cross-Country, Multicriteria Decision Analysis

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