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Concept: Technology assessment

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In recent times, the use of health technologies in the diagnosis and treatment of diseases experienced considerable and accelerated growth. The goal of the present study was to describe the designated pilot MCDM (Multiple Criteria Decision Making) model for priority setting of health technology assessment in Iran.

Concepts: Time, Decision theory, Decision making software, Philosophy of science, Technology, Neolithic, Technology assessment, Multi-criteria decision analysis

26

Abstract Objective: To investigate the evolving use and expected impact of pay-for-performance (P4P) and risk-based provider reimbursement on patient access to innovative medical technology. Methods: Structured interviews with leading private payers representing over 110 million commercially-insured lives exploring current and planned use of P4P provider payment models, evidence requirements for technology assessment and new technology coverage, and evolving relationship between the two topics. Results: Respondents reported rapid increases in the use of P4P and risk-sharing programs, with roughly half of commercial lives affected three years ago, just under two-thirds today, and an expected three-quarters in three years. All reported well-established systems for evaluating new technology coverage. Five of nine reported becoming more selective in the past three years in approving new technologies; four anticipated that in the next three years there will be a higher evidence requirement for new technology access. Similarly, four expected it will become more difficult for clinically appropriate but costly technologies to gain coverage. All reported planning to rely more on these types of provider payment incentives to control costs, but didn’t see them as a substitute for payer technology reviews and coverage limitations; they each have a role to play. Limitations: Interviews limited to nine leading payers with models in place; self-reported data. Conclusion: Likely implications include a more uncertain payment environment for providers, and indirectly for innovative medical technology and future investment, greater reliance on quality and financial metrics, and increased evidence requirements for favorable coverage and utilization decisions. Increasing provider financial risk may challenge the traditional technology adoption paradigm, where payers assumed a “gatekeeping” role and providers a countervailing patient advocacy role with regard to access to new technology. Increased provider financial risk may result in an additional hurdle to the adoption of new technology, rather than substitution of provider- for payer-based gatekeeping.

Concepts: Risk, Technology, Finance, Technology assessment, Money, Credit card

11

The long path from initial research on oligonucleotide therapies to approval of antisense products is not unfamiliar. This lag resembles those encountered with monoclonal antibodies, gene therapies, and many biological targets and is consistent with studies of innovation showing that technology maturation is a critical determinant of product success. We previously described an analytical model for the maturation of biomedical research, demonstrating that the efficiency of targeted and biological development is connected to metrics of technology growth. The present work applies this model to characterize the advance of oligonucleotide therapeutics. We show that recent oligonucleotide product approvals incorporate technologies and targets that are past the established point of technology growth, as do most of the oligonucleotide products currently in phase 3. Less mature oligonucleotide technologies, such as miRNAs and some novel gene targets, have not passed the established point and have not yielded products. This analysis shows that oligonucleotide product development has followed largely predictable patterns of innovation. While technology maturation alone does not ensure success, these data show that many oligonucleotide technologies are sufficiently mature to be considered part of the arsenal for therapeutic development. These results demonstrate the importance of technology assessment in strategic management of biomedical technologies.

Concepts: DNA, Medicine, Model organism, Therapy, Classification of Pharmaco-Therapeutic Referrals, Technology, Innovation, Technology assessment

6

Over the period 1987-1991 an inter-disciplinary five-country group developed the EuroQol instrument, a five-dimensional three-level generic measure subsequently termed the ‘EQ-5D’. It was designed to measure and value health status. The salient features of its development and its consolidation and expansion are discussed. Initial expansion came, in particular, in the form of new language versions. Their development raised translation and semantic issues, experience with which helped feed into the design of two further instruments, the EQ-5D-5L and the youth version EQ-5D-Y. The expanded usage across clinical programmes, disease and condition areas, population surveys, patient-reported outcomes, and value sets is outlined. Valuation has been of continued relevance for the Group as this has allowed its instruments to be utilised as part of the economic appraisal of health programmes and their incorporation into health technology assessments. The future of the Group is considered in the context of: (1) its scientific strategy, (2) changes in the external environment affecting the demand for EQ-5D, and (3) a variety of issues it is facing in the context of the design of the instrument, its use in health technology assessment, and potential new uses for EQ-5D outside of clinical trials and technology appraisal.

Concepts: Time, Epidemiology, Clinical trial, Evaluation, Future, Economics, Past, Technology assessment

3

Recent changes to the regulatory landscape of pharmaceuticals may sometimes require reimbursement authorities to issue guidance on technologies that have a less mature evidence base. Decision makers need to be aware of risks associated with such health technology assessment (HTA) decisions and the potential to manage this risk through managed entry agreements (MEAs).

Concepts: Decision making, Risk, Decision theory, Risk management, Uncertainty, Technology, Neolithic, Technology assessment

3

Introducing new health technologies, including medical devices, into a local setting in a safe, effective, and transparent manner is a complex process, involving many disciplines and players within an organization. Decision making should be systematic, consistent, and transparent. It should involve translating and integrating scientific evidence, such as health technology assessment (HTA) reports, with context-sensitive evidence to develop recommendations on whether and under what conditions a new technology will be introduced. However, the development of a program to support such decision making can require considerable time and resources. An alternative is to adapt a preexisting program to the new setting.

Concepts: Scientific method, Medicine, Decision making, Science, Decision theory, Technology, Decision engineering, Technology assessment

2

Rapid reviews are of increasing importance within health technology assessment due to time and resource constraints. There are many rapid review methods available although there is little guidance as to the most suitable methods. We present three case studies employing differing methods to suit the evidence base for each review and outline some issues to consider when selecting an appropriate method.

Concepts: Scientific method, Evaluation, Evaluation methods, Technology assessment

1

Some countries make considerable effort to involve patients and patient groups in their health technology assessment (HTA) processes; others are only just considering or are yet to consider patient involvement in HTA.

Concepts: Health care provider, Patient, Illness, Technology, Technology assessment

1

Authors from the Canadian Agency for Drugs and Technologies in Health (CADTH) presented an analysis of submissions to the Common Drug Review (CDR) between 2004 and February 3, 2016 for drugs for rare disorders (disorders with a prevalence of <50 per 100,000).

Concepts: Epidemiology, Disease, Illness, Prevalence, Technology, Rare disease, Ontario, Technology assessment

1

When data needed to inform parameters in decision models are lacking, formal elicitation of expert judgement can be used to characterise parameter uncertainty. Although numerous methods for eliciting expert opinion as probability distributions exist, there is little research to suggest whether one method is more useful than any other method. This study had three objectives: (i) to obtain subjective probability distributions characterising parameter uncertainty in the context of a health technology assessment; (ii) to compare two elicitation methods by eliciting the same parameters in different ways; (iii) to collect subjective preferences of the experts for the different elicitation methods used.

Concepts: Evaluation, Risk, Decision theory, Probability, Expert, Subroutine, Expert witness, Technology assessment