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The insurability of innovative pharmaceutical cancer technologies.

ABSTRACT: The scientific literature, including several papers published in the IJHPR, has raised the issue of the spiraling cost of cancer treatment, including that of cancer drugs and other technologies such as gene and cell therapies. In this perspective, we review three criteria for insurability and show that they may not be met.First, the uncertain trends in the cost of innovative pharmaceutical and other cancer technologies make the maximum possible loss per event very difficult to predict and to manage in terms of insurer solvency. Second, the uncertainty of the price, the period that a drug or other cancer care technology will be administered and the number of individuals that will need the technology makes it difficult to predict future insurance premiums and whether they will be affordable to the target population. Third, public coverage needs to be consistent with societal values. However, pressure to limit public coverage will gradually increase as the possibilities of innovative pharmaceutical cancer technologies expand, thus transferring the burden onto commercial insurance. This is a phenomenon that is virtually impossible to predict accurately, but which will certainly undermine the status of health as a social good.We conclude that the financial risk arising from the use of innovative pharmaceutical cancer technologies fails to meet the aforementioned criteria, thus raising questions as to the sustainability of commercial insurance for cancer treatment and suggesting the need for the state to take greater responsibility for covering this financial risk in the future.

SUBMITTER: Greenberg SB

PROVIDER: S-EPMC7751103 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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The insurability of innovative pharmaceutical cancer technologies.

Greenberg Shuli Brammli SB Dotan Einat E Arazi Rachel R

Israel journal of health policy research 20201221 1

The scientific literature, including several papers published in the IJHPR, has raised the issue of the spiraling cost of cancer treatment, including that of cancer drugs and other technologies such as gene and cell therapies. In this perspective, we review three criteria for insurability and show that they may not be met.First, the uncertain trends in the cost of innovative pharmaceutical and other cancer technologies make the maximum possible loss per event very difficult to predict and to man ...[more]

PMID: 33342428

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Project description:There is no decision-making framework in the early-adoption stage of novel surgical technologies, putting the quality of health care and resource allocation of the health care system at risk. To investigate relevant weighted criteria that decision-makers may use to make an informed decision for the early adoption of innovative surgical technologies. This multi-institutional decision analytical modeling study used a mixed-methods multicriteria decision analysis (MCDA) and had 2 phases. First, a panel of 12 experts validated decision criteria in the literature and identified additional criteria. Second, 33 Canadian experts prioritized the main criteria (domains) using the composition pairwise-comparison weight-elicitation method (analytical hierarchy process model) and ranked their subcriteria using the direct-ranking elicitation method (Likert scale). Data were analyzed, and response consistency was estimated using the consistency ratio. Analysis of variance was used to assess for significant differences between expert responses. The MCDA was conducted at McGill University between 2021 and 2023. Data were collected nationally by inviting experts in Canada. Criteria domain weights and subcriteria rankings. Priority vectors, which are priority scores analyzed and prioritized from expert responses, were used to rank criteria domains and subcriteria for decision-making on adopting new innovative surgical technologies. A total of 45 experts (33 male [73.3%] and 12 female [26.7%]) were invited with different levels of education (22 experts with MD or equivalent, 13 experts with master's degree, and 12 experts with PhD degree) and years of experience (4 experts with <10, 12 experts with 11-20, 18 experts with 21-30, and 11 experts with >30 years). Surgeon experts (23 individuals) were from all surgical disciplines, and nonsurgeon experts (22 individuals) were administrative officers in surgical device procurement, health technology assessment experts, and hospital directors. A total of 7 domains and 44 subcriteria were identified. The MCDA model found that clinical outcomes had the highest priority vector, at 0.429, followed by patients and public relevance (0.135). Hospital-specific criteria (priority vector, 0.099), technology-specific criteria (priority vector, 0.092), and physician-specific criteria (priority vector, 0.087) were the next most highly ranked. The lowest priority vectors were for economic criteria, at 0.083, and finally policies and procedures, at 0.075. There was consensus in the responses (consistency ratio = 0.006), and there were no statistically significant differences between expert responses. This study weighted priority criteria domains in importance and established ranked subcriteria for decision-making of early adoption of surgical technologies. Putting these criteria into a framework may help surgeons and decision-makers make informed decisions for the early adoption of new surgical technologies.

Project description:BackgroundThe reimbursement of new technologies in inpatient care is not always linked to a requirement for evidence-based evaluation of patient benefit. In Germany, every new technology approved for market was until recently eligible for reimbursement in inpatient care unless explicitly excluded. The aim of this work was (1) to investigate the type of evidence that was available at the time of introduction of 25 innovative technologies and how this evidence evolved over time, and (2) to explore the relationship between clinical evidence and utilization for these technologies in German inpatient care.MethodsThis study combined different methods. A systematic search for evidence published between 2003 and 2017 was conducted in four bibliographic databases, clinical trial registries, resources for clinical guidelines, and health technology assessment-databases. Information was also collected on funding mechanisms and safety notices. Utilization was measured by hospital procedures captured in claims data. The body of evidence, funding and safety notices per technology were analyzed descriptively. The relationship between utilization and evidence was explored empirically using a multilevel regression analysis.ResultsThe number of included publications per technology ranges from two to 498. For all technologies, non-comparative studies form the bulk of the evidence. The number of randomized controlled clinical trials per technology ranges from zero to 19. Some technologies were utilized for several years without an adequate evidence base. A relationship between evidence and utilization could be shown for several but not all technologies.ConclusionsThis study reveals a mixed picture regarding the evidence available for new technologies, and the relationship between the development of evidence and the use of technologies over time. Although the influence of funding and safety notices requires further investigation, these results re-emphasize the need for strengthening market approval standards and HTA pathways as well as approaches such as coverage with evidence development.

Project description:IntroductionAccess to innovative pharmaceuticals is thought to be associated with several exogenous factors related to the local legal or financial framework of pharmaceutical reimbursement. Our aim was to describe the association between the outcome of the reimbursement procedure on innovative pharmaceutical submissions in Hungary and several potential explanatory variables related to the legal or financial framework of reimbursement procedures, such as the submission implying a need for a legal act to conclude on a positive decision; having a risk-sharing agreement (RSA) in place at the time of submission; the aim of the submission and expenditure on individual funding requests.MethodsPublicly available administrative announcements of the Hungarian National Health Insurance Fund Manager were used to construct the analysis dataset including all concluded procedures between 1 January 2018 and 7 June 2021, complemented with information on the overall aim of the submission (new compound or new indication). Logistic regression models were used to estimate odds ratios while adjusting for potential confounding.ResultsNeeding a legislative change as a proxy of involving high-level decision makers to reimburse had a lower (OR = 0.05, CI95%:0.02-0.11), whereas having an RSA had a statistically significant higher chance of a positive decision (OR = 3.49, CI95%:1.56-7.82). In contrast, neither the overall purpose of the submission (OR = 1.32, CI95%:0.65-2.69), nor the average biennial expenditure on individual funding requests exceeding 200 million HUFs (OR = 1.04, CI95%:0.92-1.19) had a statistically significant association with the decision.ConclusionsThis study quantitatively demonstrated that the need for legal acts to conclude on a positive decision decreases, whereas having an RSA for the particular product increases the likelihood of a positive reimbursement decision in Hungary. The role of other factors remain unclear. Our findings suggest that the legal requirements and RSAs play key roles in the reimbursement of innovative pharmaceuticals and can be viewed as potential areas of policy interventions in expanding access to these products, although the feasibility of such interventions need strong commitment from decision-makers, as well as implying increased autonomy to the entities involved in reimbursement procedures. Further research is needed to assess the impact of endogenous and exogenous factors in a coherent framework.

Dataset Information

The insurability of innovative pharmaceutical cancer technologies.

Publications

The insurability of innovative pharmaceutical cancer technologies.

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