Pilot approach to analyzing patient and citizen involvement in health technology assessment in four diverse low- and middle-income countries.

BACKGROUND: In low- and middle-income countries (LMICs) striving to achieve universal health coverage, the involvement of different stakeholders in formal or informal ways in health technology assessment (HTA) must be culturally and socially relevant and acceptable. Challenges may be different from those seen in high-income countries. In this article, we aimed to pilot a questionnaire for uncovering the context-related aspects of patient and citizen involvement (PCI) in LMICs, collecting experiences encountered with PCI, and identifying opportunities for patients and citizens toward contributing to local decision- and policy-making processes related to health technologies. METHODS: Through a collaborative, international multi-stakeholder initiative, a questionnaire was developed for describing each LMIC's healthcare system context and the emergence of opportunities for PCI relating to HTA. The questionnaire was piloted in the first set of countries (Brazil, Indonesia, Nigeria, and South Africa). RESULTS: The questionnaire was successfully applied across four diverse LMICs, which are at different stages of using HTA to inform decision making. Only in Brazil, formal ways of PCI have been defined. In the other countries, there is informal influence that is contingent upon the engagement level of patient and citizen advocacy groups (PCAGs), usually strongest in areas such as HIV/AIDS, TB, oncology, or rare diseases. CONCLUSIONS: The questionnaire can be used to analyze the options for patients and citizens to participate in HTA or healthcare decision making. It will be rolled out to more LMICs to describe the requirements and opportunities for PCI in the context of LMICs and to identify possible routes and methodologies for devising a more systematic and formalized PCI in LMICs.

Barriers and facilitators of exploiting the potential of value-added medicines.

INTRODUCTION: Pharmaceutical research and development (R&D) is costly and only a minority of patients can access innovative medicines due to affordability constraints. Value-added medicines (VAMs) can offer potential benefits at significantly lower R&D costs. AREAS COVERED: VAMs may address different health care needs and problems, including off-label use of medicines, poor patient adherence, problems related to polypharmacy, need for home and/or personalized health care services. However, several barriers prevent societies from maximizing the benefits of incremental innovation related to VAMs. Generic manufacturers have limited budget and experience to demonstrate the value of new VAMs. Current market exclusivity options do not efficiently exclude freeridership and do not guarantee a return on investment for VAM innovators. Value propositions of VAMs are limitedly consistent with current HTA frameworks, consequently, incremental innovation is not acknowledged, nor rewarded with differential pricing by payers. Moreover, VAMs are often perceived solely as generic medicines by prescribers. EXPERT OPINION: Current practices may need to be reconsidered to exploit the full societal benefit of VAMs, including more efficient policies to guarantee market exclusivity for incremental innovation, acknowledgment of a fair price premium based on a specific value framework and the acceptance of low-cost evidence generation methods.

Health economic assessment of Gd-EOB-DTPA MRI versus ECCM-MRI and multi-detector CT for diagnosis of hepatocellular carcinoma in China.

Limited data exists in China on the comparative cost of gadolinium ethoxybenzyl diethylenetriamine magnetic resonance imaging (Gd-EOB-DTPA-MRI) with other imaging techniques. This study compared the total cost of Gd-EOB-DTPA-MRI with multidetector computed tomography (MDCT) and extracellular contrast media-enhanced MRI (ECCM-MRI) as initial imaging procedures in patients with suspected hepatocellular carcinoma (HCC). We developed a decision-tree model on the basis of the Chinese clinical guidelines for HCC, which was validated by clinical experts from China. The model compared the diagnostic accuracy and costs of alternative initial imaging procedures. Compared with MDCT and ECCM-MRI, Gd-EOB-DTPA-MRI imaging was associated with higher rates of diagnostic accuracy, i.e. higher proportions of true positives (TP) and true negatives (TN) with lower false positives (FP). Total diagnosis and treatment cost per patient after the initial Gd-EOB-DTPA-MRI evaluation was similar to MDCT (¥30,360 vs. ¥30,803) and lower than that reported with ECCM-MRI (¥30,360 vs. ¥31,465). Lower treatment cost after initial Gd-EOB-DTPA-MRI was driven by reduced utilization of confirmatory diagnostic procedures and unnecessary treatments. The findings reported that Gd-EOB-DTPA-MRI offered higher diagnostic accuracy compared with MDCT and ECCM-MRI at a comparable cost, which indicates Gd-EOB-DTPA-MRI could be the preferred initial imaging procedure for the diagnosis of HCC in China.

Health economic evaluation of Gd-EOB-DTPA MRI vs ECCM-MRI and multi-detector computed tomography in patients with suspected hepatocellular carcinoma in Thailand and South Korea.

OBJECTIVE: The effectiveness of treatment decisions and economic outcomes of using gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid-enhanced magnetic resonance imaging (Gd-EOB-DTPA-MRI) were compared with extracellular contrast media-enhanced MRI (ECCM-MRI) and multi-detector computed tomography (MDCT) as initial procedures in patients with suspected hepatocellular carcinoma (HCC) in South Korea and Thailand. METHODS: A decision-tree model simulated the clinical pathway for patients with suspected HCC from the first imaging procedure to a confirmed treatment decision. Input data (probabilities and resource consumptions) were estimated and validated by clinical experts. Costs for diagnostic alternatives and related treatment options were derived from published sources, taking into account both payer's and hospital's perspectives. RESULTS: All experts from Korea and Thailand agreed that Gd-EOB-DTPA-MRI yields the highest diagnostic certainty and minimizes the need for additional confirmatory diagnostic procedures in HCC. In Korea, from the payer's perspective, total cost was USD $3087/patient to reach a confirmed treatment decision using Gd-EOB-DTPA-MRI (vs $3205/patient for MDCT and $3403/patient for ECCM-MRI). From the hospital's perspective, Gd-EOB-DTPA-MRI incurred the lowest cost ($2289/patient vs $2320/patient and $2528/patient, respectively). In Thailand, Gd-EOB-DTPA-MRI was the least costly alternative for the payer ($702/patient vs $931/patient for MDCT and $873/patient for ECCM-MRI). From the hospital's perspective, costs were $1106/patient, $1178/patient, and $1087/patient for Gd-EOB-DTPA-MRI, MDCT, and ECCM-MRI, respectively. CONCLUSIONS: Gd-EOB-DTPA-MRI as an initial imaging procedure in patients with suspected HCC provides better diagnostic certainty and relevant statutory health insurance cost savings in Thailand and Korea, compared with ECCM-MRI and MDCT.