Evidence-based Health Technology Assessment Research Articles

PNS62 Keeping up with the Rest of the World or Setting a New PACE: China’S Expansion into Evidence-Based Health Technology Assessment in Healthcare Policy-Making

Despite the absence of institutionalising Health Technology Assessment (HTA), the Chinese government has set up clear goals to strengthen the national pharmacoeconomic evaluation capabilities and capacity so that a standardised HTA process can be integrated in drug pricing and reimbursement policy-making. This study aims to discuss the opportunities and challenges posed by the evolution of HTA in China and explore tangible solutions to succeed when the need for robust clinical and pharmacoeconomic evidence increases. Literature and policy documents were reviewed. Expert opinions via quantitative survey (n=60) and semi-structured in-depth qualitative interviews (n=10) were utilised to explore the recent evolution of HTA in China, during which payers were probed on details of policy trends, evidence requirements, and ways for global manufacturers to stay ahead of the curve. China has made significant progress in integrating HTA in the pricing and reimbursement policy-making processes, which can be seen in recent National Reimbursement Drug List (NRDL) and National Essential Drug List (NEDL) updates. Payers have highlighted the importance of developing robust clinical & economic evidence package to support national listing and price negotiation of high cost, high value drugs. Specifically, four types of evidence should be clearly demonstrated, namely clinical necessity, incremental clinical value vs. standard of care, robust pharmacoeconomic evaluation (cost-effectiveness and budget impact) and drug international reference prices/global sales information. In addition, in order to enable swift access of much needed innovative assets, the government is also actively exploring the possibility of ad-hoc review of an innovative drug upon company proactive submission. When it comes to pricing and reimbursement decisions, China is rapidly moving from an expert consensus-based evaluation framework to an evidence-based framework. Robustness in demonstrating clinical necessity, clinical and economic value are likely have a great impact on both likelihood and speed of access in China.

Pharmaceutical companies’ views on a health technology assessment (HTA) entity in Saudi Arabia

Saudi Arabia is undergoing a massive healthcare transformation to fulfill its new, national “Vision 2030.” To align with this objective, Saudi Arabia is establishing a new, independent and evidence-based health technology assessment (HTA) entity to help it maximize health gains through efficient use of resources. This study was designed to ascertain how pharmaceutical companies perceive the creation of such a national HTA entity in Saudi Arabia; what they think about it and expect from it. To achieve the study’s aim, we held a workshop in Riyadh, Saudi Arabia, lasting four and a half hours and hosted by the Saudi Ministry of Health (MOH). We invited 16 market access directors and managers from different multinational pharmaceutical companies to discuss the establishment of a national HTA entity. The findings from the workshop were structured around three axes: vision and remit; HTA method; and implementation and practical considerations. Overall, the pharmaceutical company participants were positive about HTA’s value for the Saudi healthcare system and expressed willingness to adapt to meet its future requirements.

What local experts expect from a health technology assessment (HTA) entity in Saudi Arabia: workshop conclusions

ABSTRACT Objectives Saudi Arabia is undergoing a massive health-care transformation to fulfill its new, national ‘Vision 2030.’ To align with this objective, Saudi Arabia is establishing a new, independent and evidence-based health technology assessment (HTA) entity to help it maximizes health gains through efficient use of resources. This study was designed to ascertain how local experts perceive the creation of such a national HTA entity in Saudi Arabia; what they think about it and expect from it. Methods To achieve study aim, we held two workshops in Riyadh, Saudi Arabia, each lasting three and a half hours and each hosted by the Saudi Ministry of Health (MOH). We invited 26 local experts from a variety of professional backgrounds to discuss the establishment of a national HTA entity. Results The findings from experts workshops were structured around four axes, namely vision and remit; services provided and technologies covered; process and method; and implementation and practical considerations. Conclusion This paper discusses the findings of the local experts convened at the workshops relative to their expectations for and views about a national HTA entity within Saudi Arabia.

An Evidence Framework for Off-Patent Pharmaceutical Review for Health Technology Assessment in Emerging Markets

ObjectiveThis article introduces an Evidence Framework for Off-Patent Pharmaceutical Review (EFOR), which establishes value-based criteria in a template that manufacturers use to provide evidence showing how their products meet those criteria. Health authorities in emerging markets can then use the evidence presented in the EFOR to evaluate off-patent pharmaceuticals (OPPs) in a consistent, transparent, and evidence-based manner to support policy decisions, including pricing, reimbursement, formulary listing, and drug procurement. MethodsA literature search found no multi-criteria evidence framework for evaluating OPPs in emerging markets. An International Outcomes Research Board (IORB) of academia and industry experts conducted extensive research, meetings, and workshops to define high-priority criteria to incorporate into an evidence-based health technology assessment (HTA) tool using the multi-criteria decision analysis (MCDA) technique. The resulting framework was further tailored for country-specific needs in workshops in three emerging countries (Kazakhstan, Vietnam, and Indonesia). ResultsThe IORB defined nine criteria four categories (Product, Manufacturing, Service, and Value Assessment), which OPP manufacturers can use to provide evidence for reimbursement and health policy decision making. Then the IORB developed the EFOR as a base case document, which can be adapted and used as a template by health authorities in emerging countries. ConclusionsEmerging countries have a significant need for an HTA tool that balances affordability with accurate evidence showing the value differentiation of OPPs. The value attributes in this setting often are different from those in developed markets, which emphasize new products and have high regulation and manufacturing standards. The EFOR is an easy-to-use, adaptable framework that emerging countries can use to increase the consistency, transparency, and effectiveness of drug decision making. The open source EFOR is available as Supplemental Materials.

Applying Multi-Criteria Decision Analysis (MCDA) Simple Scoring as an Evidence-based HTA Methodology for Evaluating Off-Patent Pharmaceuticals (OPPs) in Emerging Markets

Off-patent pharmaceuticals (OPPs) represent more than 60% of the pharmaceutical market in many emerging countries, where they are frequently evaluated primarily on cost rather than with health technology assessment. OPPs are assumed to be identical to the originators. Branded and unbranded generic versions can, however, vary from the originator in active pharmaceutical ingredients, dosage, consistency formulation, excipients, manufacturing processes, and distribution, for example. These variables can alter the efficacy and safety of the product, negatively impacting both the anticipated cost savings and the population’s health. In addition, many health care systems lack the resources or expertise to evaluate such products, and current assessment methods can be complex and difficult to adapt to a health system’s needs. Multicriteria decision analysis (MCDA) simple scoring is an evidence-based health technology assessment methodology for evaluating OPPs, especially in emerging countries in which resources are limited but decision makers still must balance affordability with factors such as drug safety, level interchangeability, manufacturing site and active pharmaceutical ingredient quality, supply track record, and real-life outcomes. MCDA simple scoring can be applied to pharmaceutical pricing, reimbursement, formulary listing, and drug procurement. In November 2015, a workshop was held at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting in Milan to refine and prioritize criteria that can be used in MCDA simple scoring for OPPs, resulting in an example MCDA process and 22 prioritized criteria that health care systems in emerging countries can easily adapt to their own decision-making processes.

P155 Lessons Learned: Applying Grade Methodology To Evidence-Based Health Technology Assessment Within A Managed Care Setting

BackgroundHealth technology assessment (HTA) within the context of a managed care organisation requires rigorous evidence assessment completed in a timely and efficient manner. A modified version of the GRADE evidence...

Evidence-based practice and health technology assessment: a call for anesthesiologists to engage in knowledge translation

How often have senior leaders in your hospital asked you to cut drug and equipment costs? Can we justifiably afford depth of anesthesia monitoring equipment for each operating room? Based on the benefits and risks, is the routine use of inhaled nitric oxide properly justified in patients who experience difficulty in weaning from cardiopulmonary bypass? Healthcare in North America is clearly at a crux. On the one hand, there is the pressing need to do all that we can to justify the increasing costs and efforts expended to implement new drugs, technologies, and techniques into practice. On the other hand, we need to respect that we cannot (and should not) ‘‘do it all’’, especially if the new techniques or technologies will achieve only marginal benefits at best and at greater risk and cost compared with the existing status quo. There is a limit in terms of available resources: money, space, human resources, time, and effort. Evidence-based health technology assessment (EBHTA) is not necessarily a means for cost-cutting, since the best available evidence may suggest that the newest most expensive option is truly the best option, and that the payback is worth the incremental costs required. Thus, EB-HTA provides guidance to ensure that resources are not wasted and that every dollar expended improves value for money. Evidence-based medicine (EBM) is formally defined as the ‘‘conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients’’. To practice EBM, all relevant highquality evidence should be sought, even when it does not say what we want it to say. Evidence-based medicine provides tools for filtering and interpreting clinical evidence so that we are less prone to being duped by biased or misleading information that can be cleverly cloaked as scientific evidence. For example, we can use pre-filtered evidence or apply the tips set out by the users’ guides to the medical literature to improve our objectivity in determining: