The double burden of communicable and noncommunicable diseases is a major threat to the Indian public health system. AYUSH, an acronym for Ayurveda, Yoga and Naturopathy, Unani, Siddha, Sowa-Rigpa, and Homeopathy, represents the Indian system of medicine recognized by the Government of India. Mainstreaming of AYUSH is one of the key strategies of the Indian government for tackling increasing disease burden through initiatives such as AYUSH wellness centers, telemedicine, and quality control measures for medications in the AYUSH system of medicine. Such investment of resources in health systems may require economic evaluations. However, such evaluations are lacking in the AYUSH system, except for a few in homeopathy and yoga. In the absence of evidence from economic evaluations, researchers and decision makers are guided mostly by clinical efficacy while formulating healthcare strategies. In view of the increasing use of AYUSH across the country, economic evaluations of the AYUSH system are the need of the hour to aid healthcare decision making.

Performance-based managed entry agreements (PB-MEAs) might allow patient access to new medicines, but practical hurdles make competent authorities for pricing and reimbursement (CAPR) reluctant to implement PB-MEAs. We explored if the feasibility of PB-MEAs might improve by better aligning regulatory postauthorization requirements with the data generation of PB-MEAs and by active collaboration and data sharing. Reviewers from seven CAPRs provided structured assessments of the information available at the European Medicines Agency (EMA) Web site on regulatory postauthorization requirements for fifteen recently authorized products. The reviewers judged to what extent regulatory postauthorization studies could help implement PB-MEAs by addressing uncertainty gaps. Study domains assessed were: patient population, intervention, comparators, outcomes, time horizon, anticipated data quality, and anticipated robustness of analysis. Reviewers shared general comments about PB-MEAs for each product and on cooperation with other CAPRs. Reviewers rated regulatory postauthorization requirements at least partly helpful for most products and across domains except the comparator domain. One quarter of responses indicated that public information provided by the EMA was insufficient to support the implementation of PB-MEAs. Few PB-MEAs were in place for these products, but the potential for implementation of PB-MEAs or collaboration across CAPRs was seen as more favorable. Responses helped delineate a set of conditions where PB-MEAs may help reduce uncertainty. In conclusion, PB-MEAs are not a preferred option for CAPRs, but we identified conditions where PB-MEAs might be worth considering. The complexities of implementing PB-MEAs remain a hurdle, but collaboration across silos and more transparency on postauthorization studies could help overcome some barriers.

Health technology assessment conducted to inform decisions during technology development (development-focused or DF-HTA) has a number of distinct features compared with HTA conducted to inform reimbursement and usage decisions. In particular, there are a broad range of decisions to be informed related to the development of a technology; multiple markets and decision makers to be considered; a limited (and developing) evidence base; and constrained resources for analysis. These features impact upon methods adopted by analysts. In this paper, we (i) set out methods of DF-HTA against a timeline of technology development; (ii) provide examples of the methods’ use; and (iii) explain how they have been adapted as a result of the features of DF-HTA. We present a toolkit of methods for analysts working with developers of medical technologies. Three categories of methods are described: literature review, stakeholder consultation, and decision analytic modeling. Literature review and stakeholder consultation are often used to fill evidence gaps. Decision analytic modeling is used to synthesize available evidence alongside plausible assumptions to inform developers about price or performance requirements. Methods increase in formality and complexity as the development and evidence base progresses and more resources are available for assessment. We hope this toolkit will be used in conjunction with the framework of features of DF-HTA presented in our earlier article in order to improve the clarity and appropriateness of methods of HTA used in DF-HTA. We also seek to contribute to a continuing dialogue about the nature of, and the best approach to, DF-HTA.

In Brazil, there is no consensus on the concept of hospital-based health technology assessment (HB-HTA). There is great variability in the existing models and difficulty in evaluating their results—whether in respect of clinical decisions, quality of care, and hospital policy and management or in respect of optimizing the use of resources. This study aims to discuss the experiences of HB-HTA, its integration into the regulatory system for the adoption of new technologies into the Brazilian public (SUS) (Unified Health System), and its main challenges. During a workshop, a panel of specialists in HTA and/or HB-HTA was formed, representative of four different perspectives: (i) Health services and health technology assessment units, (ii) Academia, (iii) Secretary of State for Health, and (iv) the Federal SUS sector. This was followed by discussion, a preliminary consensus, contributions from the audience, a plenary session, and a final consensus. HB-HTA is not institutionalized, nor is it part of the regulation system for the adoption of new technologies in the SUS. The main challenges are the difficulties in creating qualified teams, financial support, and sustainability. The work of these bodies in respect of the evaluation of new technologies deserves further studies analyzing the relationship between the pressure for adoption from the hospital team and industry professionals and legal rulings. It is necessary to strengthen HB-HTA culture and implement this policy in hospital management, making assessment bodies a part of managerial and decision-making processes in hospitals, and develop regional collaborative networks and a national network of HTA.

This study aimed to evaluate manufacturers’ perceptions of the decision-making process for new drug reimbursement and to formulate implications in operating a health technology assessment system. In 2019, we conducted a questionnaire survey and a semistructured group interview for domestic (n = 6) and foreign manufacturers (n = 9) who had vast experience in introducing new medicines into the market through a health technology assessment. Representatives of manufacturers indicated that disease severity, budget impact, existence of alternative treatment, and health-related quality of life were relevant criteria when assessing reimbursement decisions. Compared with domestic manufacturers, foreign manufacturers were risk takers when making reimbursement decisions in terms of adopting a new drug and managing pharmaceutical expenditure. However, foreign manufacturers were risk-averse when evaluating new drugs with uncertainties based on real-world data such as clinical effectiveness. Based on manufacturers’ perceptions of the decision-making process for new drug reimbursement, there is room for improvement in health technology assessment systems. Explaining the underlying reasons behind their decisions, unbiased participation by various stakeholders and their embedded roles in the decision-making process need to be emphasized. However, the measures suggested in this study should be introduced with cautions. The process of health technology assessment might be a target for those who undermine the system in pursuit of their private interests.