Points of View Implications from a Japanese paper on cost-effectiveness analysis
A Case Study of Calculating the Cost of Nursing Care from a Social Standpoint- -A Case Study of Calculating the Cost of Nursing Care from a Social Standpoint

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Yuki Miura, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute

SUMMARY

  • To date, the cost-effectiveness evaluation system has not included the cost of long-term care, but there is growing interest in its analysis and evaluation. For this reason, we investigated how the cost of care was calculated for papers conducted based on academic research, regardless of whether or not they were subject to the same system, and presented individual case studies.
  • The survey method used Pubmed to investigate papers with cost-effectiveness analysis of pharmaceuticals contributed from 2014 to 2023, and the search terms "cost effectiveness analysis," "japan," and "societal perspective" (all AND conditions) The search terms were "cost effectiveness analysis," "Japan," and "societal perspective" (all AND conditions).
  • The number of cost-effectiveness analysis papers published in Japan during the period under review was 854 based on the search words, and the number of papers that included the societal perspective (a perspective that considers a wider range of costs) was 55, or 6.4% (55/854), a similar ratio compared to other countries. In this study, we focused on 10 of these cost-calculating cases.
  • In the analysis that included public care, all of the cases corresponded to interventions for the treatment of specific diseases, and the costs related to institutional care such as special nursing homes were services available under the long-term care insurance system, and these were included in the analysis.
  • The cases in which informal care costs were calculated were cases in which the caregiver's time measurement referred to other diseases or estimates based on expert opinion (presumed to be cases in which data varied widely or there were no credible data), and we considered that the lack of reporting as a source of information was an issue.
  • For public care costs, the calculated results were included in the costs, and informal care costs included the utility value of the patient's family and time loss, but only the utility value of the family was included in the evaluation under the analysis guidelines, and further discussion will be needed on the treatment of indirect costs to be included in the analysis.
  • It is suggested that uncertainty may arise in parameter selection for estimating care costs (especially informal care costs) due to the lack of information sources, and it is important to obtain outcomes at the clinical trial stage, utilize databases, and accumulate reports and studies to supplement the databases.

1. Introduction

Data containing content related to evaluation based on nursing care costs were submitted in the materials used for the approval review of Recanemab (product name: RekenbiⓇ intravenous infusion, hereinafter referred to as Rekenbi )1). In response to this, the Central Social Insurance Medical Council (hereinafter referred to as "Chuikyo") held various discussions on the handling of data related to the reduction of nursing care costs in a joint meeting of the Chuikyo NHI Special Committee on Drug Pricing and the Special Committee on Cost-Effectiveness Evaluation, and it was decided that the handling of data related to the reduction of nursing care costs would be discussed in the cost-effectiveness evaluation system, and the results of the discussions are as follows The results of the discussions were included in the draft of the 2024 Cost-Effectiveness Evaluation System Reform (Draft) 2). In the draft, it was noted that the cost-effectiveness evaluation system has not yet included nursing care costs in the analysis, that the results of the analysis including nursing care costs are not included in the final evaluation draft, and that the current situation and technical issues related to the analysis of nursing care costs were examined, The report also stated that the results of the analysis, including the cost of long-term care, would not be included in the final draft evaluation. The system is based on the analysis from the standpoint of public health care, and if a manufacturer or distributor wishes, it is allowed to submit an analysis that includes public long-term care costs (the analysis results are not included in the final evaluation draft).

In Japan's cost-effectiveness evaluation system, the cost of care was treated as a proposed requirement for items that fall under ethical and social considerations when cost-effectiveness evaluation was introduced on a trial basis, and has been positioned as described above. In the Draft Framework for Reform of the Cost-Effectiveness Evaluation System in FY2022, it was stated that the study group will continue to conduct research on the handling of public long-term care costs with reference to efforts in other countries, and will consider the issue in the future based on the progress of the research3). The extensive efforts of the National Institute for Health and Care Excellence (NICE) in the U.K. to include public care costs in cost-effectiveness analyses are also reflected in the examples of the Guidance on the Evaluation of Medical Technologies1, 4) and the Guidance on the Evaluation of Highly Specialized Technologies (HST) for Rare Diseases1, 4). (HST) evaluation guidance for rare diseases5, 6). In addition, among the value flowers of ISPOR (InternationalSociety for Pharmacoeconomics and OutcomesResearch; International Society for Pharmacoeconomics and Outcomes Research), family spillovers are the impact of family caregiving (family The importance of family spillovers in the value flowers of the Society for Pharmacoeconomics and Outcomes Research; International Society for Healthcare Economics and Outcomes Research has been demonstrated. In the future, there is growing interest in technical issues related to the analysis of long-term care costs in Japan.

One of the technical issues is the problem of utilizing the Long-Term Care Insurance Comprehensive Database (hereafter referred to as "Long-Term Care DB"). The Chuikyo discussed issues related to the analysis of the Long-Term Care DB. In Japan, the Long-Term Care DB was launched in 2013, and third-party provision began in 2008. Subsequently, consolidated analysis with the NDB (Database of Receipt Information and Information on Specified Health Checkups) began in October 2020, and with the DPC database in 20227). The use of data from the Long-Term Care DB and LIFE (Scientific Long-Term Care Information System Data) 8) linked to various databases for cost-effectiveness evaluation has increased the possibility of reflecting the actual cost of long-term care based on ADL (Activities of Daily Living; activities of daily living) that reflect treatment in actual clinical practice. The possibility of reflecting the actual situation of ADLs (Activities of Daily Living) in actual clinical practice is increasing. On the other hand, there are still issues with the use of long-term care DBs. These include the number of caregivers to be used for cost-effectiveness analysis, data coverage issues such as the identification of health conditions, and the time required from the accumulation of information to its use. In the latter case, a certain amount of time is required for a new drug to be approved and placed on the insurance list before it is distributed to the market and reflects the results of its administration. Under the current cost-effectiveness evaluation system, the results of a company's analysis must be submitted within a period of time such as nine months after a drug is listed on the insurance market and designated as an item9). Because the parameters for the analysis must be selected within this limited time frame, some of the parameters that have been changed in the reanalysis10) have reported new data that are important for the calculation of the incremental cost-effectiveness ratio (ICER; incremental cost-effectiveness ratio), and the cost of long-term care in Japan has been estimated to be about $3.5 billion ( 11). 11), further accumulation of case studies is necessary for the estimation of care costs in Japan, in addition to the enrichment of content and acceleration of public disclosure, including the consolidation of publicly available official data. The Analytical Guidelines for Cost-Effectiveness Evaluation in the Central Social Insurance Medical Council, Third Edition (hereafter, Analytical Guidelines, Third Edition) 12) recommends the use of a database of receipts in Japan that reflects actual clinical practice in estimating the cost of each health condition when calculating costs, but health conditions on the receipts However, this recommendation does not apply in cases where it is difficult to define health conditions on the receipts, or where there is not sufficient accumulation of data at the time of evaluation, making it difficult to conduct the estimation12). In such cases, cost data can be collected by using articles, surveys of medical records, receipts, or questionnaires on actual medical treatment, or by model analysis based on expert opinions. However, no analysis including the cost of public long-term care has been reported so far in the cost-effectiveness evaluation system. One of the reasons for the scarcity of evaluation cases in this system is that the selection is based on the addition of usefulness and the forecast of the market size at the peak time, and there are also analysis results for items that were not included in the system.

This paper investigates how the cost of care was calculated in domestic cost-effectiveness analysis cases, regardless of whether or not they were subject to the cost-effectiveness evaluation system, and introduces individual cases. We discuss the consistency with the guidelines and consider the uncertainty of the parameters for the treatment of long-term care costs.

Survey Methodology

Since there are no examples of analysis results that include nursing care costs in the reports of Japan's cost-effectiveness evaluation system, we will conduct a search for papers conducted as academic research. The DB for conducting the article search was Pubmed, and articles in which cost-effectiveness analyses of pharmaceuticals contributed from 2014 to 2023 were targeted for investigation (screening method is described below).

The study period was set for 10 years from 2014, when the pilot introduction of cost-effectiveness assessment in Japan began. As mentioned earlier, the extraction of papers that include cost-effectiveness analysis, including social position in Japan, is necessary for the purpose of investigating the importance of evaluating the multifaceted value of pharmaceuticals, the state of evaluation in other countries, and the results of analysis of the cost of care, as specified in the third edition of the Analytical Guidelines for Cost-Effectiveness Evaluation in Japan (see Table 113) ). Therefore, when searching for articles in pubmed, "cost effectiveness analysis," "japan," and "societal perspective" (both AND conditions) were set as search terms. Under these conditions, out of 55 hit papers (as of January 1, 2024), 10 papers were included in the analysis, excluding those analyzed outside Japan, analyses of vaccines and medical examinations, and insurance guidance and surgical procedures and systematic reviews that fall under categories other than medical devices and drugs such as artificial joints (Figure 1).

Henceforth, "social position" and "position considering broader costs" will be treated as synonyms, and public health care costs will not be mentioned in the analysis results.

Table 1: Positions of analysis and the range of costs included in the analysis.
Fig. 1 Subjects of analysis and screening methods and results

Results

The percentage of cost-effectiveness analyses conducted in Japan that included a societal perspective (a position that considers broader costs) was determined by the presence or absence of the search term "societal perspective. The number of reports that did not include the search term "societal perspective" ("cost effectiveness analysis" AND "japan") was 854, while the number of reports that included "societal perspective" was 55, or 6.4% (55 reports ÷ 854 reports) (Figure 1). In the U.S. (search term: usa), which, like Japan, allows analysis of societal perspective as an additional analysis in its guidelines, the rate was 6.6% (471 reports / 7,150 reports), in Australia (search term: australia), 6.4% (213 reports / 3,306 reports), and in the U.K. (search term: united kingdom), 4.4% (55 reports / 854 reports): united kingdom) was 4.4% (222 reports / 5,033 reports).

Analyses that include social positions (positions that consider broader costs) are included in this study. In addition to the analysis of the public health care position, we will discuss only those parts of the analysis that fall under additional analysis. For the public care position, the scope of costs was defined as "public care costs," while for the position that considers broader costs, "informal care14) costs" and "lost productivity of the patients themselves" were added to "public care costs" (Table 2).

Table 2 Scope of costs of care and productivity among analyses including social standpoints and number of applicable papers (10 papers in total)

The 10 papers that included the social position (the position that considers broader costs) included 3 papers that included public care costs in the analysis, 3 papers that included informal care costs in the analysis, and 7 papers that included the patient's own productivity loss in the analysis. The following sections will provide examples of the costs and parameters used in the analysis of public care costs and informal care costs that correspond to long-term care costs.

In the case of denosumab vs. alendronic acid in osteoporosis in elderly Japanese women at high risk of fracture (PMID: 30159632), the cost of using a nursing home was included as a public care cost, and the parameter Reward for Nursing Care (2015) 15) was cited. They were.

In the case of denosumab vs. oral alendronic acid in osteoporosis (PMID: 28210776), the annual cost of care after hip fracture was annualized from the Japanese long-term care insurance system's $3,600/month limit for nursing home care for those requiring 5 years of care, the rate of long-term care14%16, 17) and fracture mortality estimated based on a 25% risk. In addition, family salary losses from caring for hip fracture patients during hospitalization and after discharge were included based on the findings of Kondo et al. 18). Since there are no data on caregiver time related to care after hip fracture in Japan, we estimated costs based on studies19) on direct social and informal care for dementia in Asia and other parts of the world.

For the case of recanemab in early Alzheimer's disease (PMID: 37188886), public and informal care costs were included in the analysis. Decreased quality of life for caregivers (assuming one caregiver) according to the severity of the dementia patient was cited by Mesterton et al. 20). Caregiver costs were assessed in in-home and institutional care settings, and public caregiver costs were estimated by supplementing the MHLW study21) with the Asada et al. report22) , respectively. Parameters for informal care costs for caregivers in in-home care (by severity of illness) were taken from the reports by Sado et al. 23) and Asada et al. 22). Note that informal care costs for caregivers in institutional care were not included in the analysis.

In the case of ranibizumab biosimilar in age-related macular degeneration with neovascularization (PMID: 37171557), (1) costs related to accompanying patients to medical appointments and (2) costs related to routine care were included, both of which were calculated based on the Basic Survey of Wage Structure and expert opinion, and caregiver productivity Losses included.

In the cases where productivity losses were included in the analysis, the majority of these costs were calculated by multiplying the results of the Basic Survey on Wage Structure by the time spent in absenteeism and presenteeism due to illness (health status and severity).

We cross-checked care-related (public care costs and informal care costs) costs and their parameters with the Analytical Guidelines, Third Edition12) based on academic papers in Japan. Public long-term care costs included fees for facilities used within the scope of long-term care insurance, etc. The parameters were estimated based on cases citing past papers and the level of care.

For informal care costs, both cost and utility values were included in the analysis. Only in the case of dementia, the reduction in quality of life of the patient's family was included. Depending on the patient's health status (including severity of illness), the analysis included a decrease in caregiver productivity based on time spent caring for the patient in cases where family care was required. However, reports on time spent for caregiver care were not based on parameter selection based on surveys and studies conducted for the same disease in cases of osteoporosis and age-related macular degeneration.

Conclusion and Discussion

This paper presents a case study of a paper that included the cost of care in the analysis for a drug that was not covered by the cost-effectiveness evaluation system and included a social position (a position that considers a broader range of costs). Since the cost-effectiveness evaluation system has not accumulated any analysis cases that include nursing care costs, we collected articles published in Japan regardless of whether the drug is designated as an item under the system or not, and included those cases that were calculated from a social standpoint in the cost-effectiveness analysis that corresponded to the survey. The cost of immunization in Japan is about the same as that in other countries. It should be noted that this may be attributed to the fact that there were some cases in Japan where the analysis was conducted from a social standpoint in the evaluation of the cost-effectiveness of vaccinations, and that there was a large amount of noise caused by search methods when only pharmaceutical products were targeted.

Since the method and data source for calculating the cost of care is not based on consultation between corporate analysis and public analysis as in the cost-effectiveness evaluation system with respect to the validity of the analytical model and parameters used in the analysis, and once we disregard it here, the breakdown of costs analyzed from the standpoint of public care were all based on the Analytical Guidelines, 3rd ed. (12).

Turning to the estimation of long-term care costs, public long-term care costs and informal care costs were incorporated into the analysis as long-term care costs, although the scope of costs differed depending on the position of analysis. In the analysis of public long-term care costs from the standpoint of public care, all of the cases corresponded to specified diseases24), and costs related to the use of facilities such as special nursing homes for the elderly are services available under the long-term care insurance system, and these costs were included in the analysis.

Although there were cases in which informal care costs were calculated in the present case studies, there were cases in which caregiver time measurement referred to dementia, which is a different disease, and estimates based on expert opinion (we assume that the data varied widely or that there were no credible data), and the lack of reporting as a source of information was We considered that there were issues; as pointed out in Urwin's report examining issues related to informal caregiver time measurement25), a number of caregiver time measurement issues remained, which could lead to uncertainty when calculating informal care costs.

The following is a discussion of informal care costs in terms of their consistency with the Analytic Guidelines, Third Edition12). The Guidelines allow for consideration of the impact on quality of life values on family members and other caregivers and nurses if actual data are available. In addition, if it is clear that productivity loss due to nursing or caregiving by family members or other caregivers is not attributable to the caregiver, it may be included as a cost under the same conditions and treatment as the productivity loss of the caregiver. However, it does not allow for the inclusion in costs of reduced productivity losses that occur indirectly through improved outcomes. Therefore, for informal care costs, only quality of life values for which actual data are available are to be included in the analysis. In this case study, costs based on time estimates related to family caregiver care were included. Only costs were included for public care costs, while informal costs were evaluated for outcomes based on quality of life, and the analysis was conducted for caregiver productivity losses, which were not included in the evaluation. 46 analyses from 51 countries. In the aggregate, the guidelines included direct costs to family members and caregivers in 73% of the analyses, while non-health outcomes were considered in only 40%. Further discussion will be needed on the extent to which the analysis should be included in Japan's cost-effectiveness evaluation system.

Next, we will discuss the results of the analysis of long-term care costs and the allowance for uncertainty by referring to examples from other countries. The UK HTA agency NICE and the Australian HTA agency PBAC (Pharmaceutical Benefits AdvisoryCommittee) require cost-effectiveness data to be submitted for decision-making on insurance benefits and include long-term care-related costs in their analyses. reported in the past that care-related costs were frequently taken into account in reimbursement decisions in its evaluation guidance for rare diseases6), while NICE states that decisions on rare diseases, medical technologies for children, and innovations are to be made with acceptance of great uncertainty. The major difference between Japan and the US is that the results of HTA may or may not be involved in insurance reimbursement, and the treatment of uncertainty in Japan may differ depending on whether the cost of care is assessed under the NHI drug price system, the cost-effectiveness evaluation system, or the NHI price revision system. In any case, public long-term care costs are highly analyzable in Japan at this point, and the use of information from the long-term care DB is expected to reduce the uncertainty associated with parameter selection during evaluation. On the other hand, for items that are subject to the cost-effectiveness evaluation system, while company analysis must be conducted within 9 months, there are time factors that arise in data accumulation and parameters that cannot be covered even by the long-term care DB. In the case study6) of HST14 (target disease: lipodystrophy) of NICE, UK, reported in the past, it is estimated that 1.67 caregivers are needed based on the survey results. Thus, in some cases the number of caregivers is used in the analysis, but these information cannot be obtained in the current Nursing Care DB. We believe that research on information sources that complement public databases such as the Long-Term Care DB and receipt data should be continued.

In addition, the incorporation of health-related quality of life of patients and their families/caregivers (especially the EQ-5D, a preference-based scale, etc.) and the ZBI27) (Zarit caregiver Burden Interview), which is used to measure caregiver burden, in the clinical trial phase, in situations where rapid analysis is required The cost-effectiveness evaluation system in Japan, in particular, has been a source of uncertainty for many years. In particular, since Japan's cost-effectiveness evaluation system targets medical technologies with large financial impact, minimizing uncertainty and improving the speed of analysis could be a very important perspective. Japan's ratio of EQ-5D included in clinical trials was 8.7%, a high level compared to other countries where medical technology evaluation is conducted. 28) Obtaining not only utility values but also cost-related indicators such as EQ-5D at the clinical trial stage may be an important corporate effort to ensure that the various values of pharmaceutical products are evaluated. This will be an important corporate effort to ensure that the various values of pharmaceuticals are evaluated. We hope that as the study of a new value-based drug pricing system progresses, companies will be able to enjoy incentives based on outcomes, and that a cycle of case accumulation and evaluation will continue.

Reference data 1 List of survey targets

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