Description of the use of multicriteria to support pricing and reimbursement decisions by European health technology assessment bodies

Abstract

Background Heterogeneity in drug access throughout Europe may be influenced by differences in drug-assessment strategies. The EUnetHTA’s assessment core model (EUnetHTA-core) and the EVIDEM’s multicriteria framework are reference methodologies in this context, the latter including a wider compromise between non-contextual and contextual criteria. Compliance of 37 European Health Technology Assessment bodies (HTAb) with EUnetHTA-core has been reported, but the use of EVIDEM by this HTAb is still unknown. Methods To describe the uptake and use of multicriteria approaches to evaluate drug value by European HTAb using EVIDEM as reference framework, a multicriteria framework was obtained based on EVIDEM model. The criteria used for drug appraisal by HTAb was extracted from the EUnetHTA report, and completed through search of websites, publications and HTAb reports. Use of EVIDEM assessment model in 37 European HTAb has been described semi-quantitatively and summarized using an alignment heatmap. Results Aligned, medium or misaligned profiles were seen for 24,3%, 51,4% and 24,3% of HTAb when matching to EVIDEM dimensions and criteria was considered. HTAb with explicit responsibilities in providing specific advice on reimbursement showed more aligned profiles on contextual and non-contextual dimensions. Conclusions EUnetHTA’s core model is limited in assessing medicines while EVIDEM’s framework provides contextual dimension used by some HTAb in Europe that can be escalated to other agencies. Most of the 37 European HTAb have room to broaden their contextual assessment tools, especially when social and medical perception of need requires to be explicit to support payer’s decision on reimbursement.

Early Access to Medicines: Use of Multicriteria Decision Analysis (MCDA) as a Decision Tool in Catalonia (Spain)

“…MCDA has been used in a diverse range of health care decisions and levels [18,32]. At the macro level, it has been mostly used by HTA bodies to rank and set priorities among therapeutic alternatives and inform reimbursement decisions [20][21][22][23]25,33], and it has also has been proposed for the benefit-risk assessment to support marketing…”

“…MCDA has been used in a diverse range of health care decisions and levels [ 18 , 32 ]. At the macro level, it has been mostly used by HTA bodies to rank and set priorities among therapeutic alternatives and inform reimbursement decisions [ 20 , 21 , 22 , 23 , 25 , 33 ], and it has also has been proposed for the benefit–risk assessment to support marketing authorisation [ 34 ]. At lower decision levels, MCDA has been used to inform hospital decision making to incorporate medicines into the hospital formulary [ 24 ] and also to support shared decision making involving the patient’s voice [ 35 ].…”

“…Multicriteria decision analysis (MCDA) enables a holistic assessment by a systematic, transparent and explicit consideration of multiple aspects beyond the traditional criteria used by HTA [ 18 , 19 , 20 ]. This methodology has been used to support different types of decisions and at different levels and contexts: to set priorities by HTA among alternatives at the national level or by PTC in the hospital setting, to support decision making about pricing and reimbursement or to assist clinical decisions in specific areas such as oncology or orphan drugs [ 21 , 22 , 23 , 24 , 25 , 26 , 27 ]. The Evidence and Value: impact on decision making (EVIDEM) is a reflective MCDA approach that provides an adaptable framework that has been used in a variety of healthcare settings to support the deliberative process.…”

“…The Evidence and Value: impact on decision making (EVIDEM) is a reflective MCDA approach that provides an adaptable framework that has been used in a variety of healthcare settings to support the deliberative process. The framework provides a structured consideration of criteria and a standardised process promoting the reflection of the stakeholders while sharing their diverse perspectives [ 20 , 21 , 28 ].…”

Reporting reimbursement price decisions for onco-hematology drugs in Spain

“…Besides a lack of elements to check consistency between price and value, the literature remains inconclusive about the factors that Health Technology Assessment Bodies (HTAb) are using to make their decisions on value and how the payers are deciding and reporting price decisions, especially when applying managed entry agreements ( 20 ). Recent studies ( 21 ) show that EVIDEM’s framework provides a complete and suitable value assessment framework, including contextual dimensions, and it has been progressively adopted by some HTAb in Europe. Additionally, differences may exist in the concept of value between payers and patients: while payers are generally focused on objective clinical outcomes to determine reimbursement conditions, the importance of patient preferences is not clear ( 22 , 23 ).…”