Points of View Current status of evaluation and utilization of labor productivity outcomes in pharmaceuticals

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Yosuke Nakano, Senior Researcher, Research Institute for Pharmaceutical Industry Policy
Mariko Hirozane, Researcher, Pharmaceutical Policy, Graduate School of Pharmaceutical Sciences, The University of Tokyo
Mariko Hirozane, Visiting Associate Professor, Pharmaceutical Policy, Graduate School of Pharmaceutical Sciences, The University of Tokyo
Associate Professor, Health and Social Medicine Unit, Yokohama City University School of Medicine
Naka Igarashi

Introduction

In 2018, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) proposed 12 elements in the value assessment of medical technologies, including pharmaceuticals ¹⁾. One of these factors is "productivity. Productivity itself is not new, and has long been considered in the form of productivity loss when calculating the cost-effectiveness of medical technologies. However, its frequency is not high, and the evaluation of its value is not yet generalized. In this paper, we focus on the value factor of productivity (especially labor productivity), and investigate the current status of evaluation and utilization of labor productivity outcomes in pharmaceuticals.

2. What is labor productivity?

When a person's own labor productivity declines due to physical illness, it can result in reduced working hours due to tardiness or leaving early, reduced concentration or work stoppages during working hours, or absenteeism or absence from work. If these conditions are not corrected, they may result in retirement. Darius et al. reported a 50% decrease in productivity in approximately 50% of migraine patients in the U.S. ²⁾. Treatment of the disease not only improves the patient's own long-term quality of life, but also helps society as a whole avoid economic losses through improved labor productivity.

This decline in labor productivity can be divided into two categories: Absenteeism, in which the patient takes time off or leaves work due to illness, and presenteeism, in which the patient continues to work while feeling unwell. Generally, when evaluating labor productivity, a survey on Absenteeism and Presenteeism is conducted using a questionnaire. According to a U.S. survey, presenteeism accounts for approximately 60% of economic losses due to illness, and is said to be a more serious problem than absenteeism ^.3), ⁴⁾

Various tools have been developed to assess work productivity, and one of the most common is the Work Productivity and Activity Impairment Questionnaire (WPAI). The WPAI is a questionnaire that assesses the extent to which work time and productivity were impaired during the past seven days. Based on the impairment and lost time, the degree of impairment and loss of efficiency are calculated as percentages ⁽ %), as shown in Figure 1.) In addition, there is an improved version that can ask questions about the status of "study" for those who are not yet employed (students), and it is also used as a tool to measure productivity for those who are not in the workforce.

Other assessment tools include the HPQ (Health and Work Performance Questionnaire), the WLQ (Work limitations questionnaire), and disease-specific questionnaires such as the MIDAS (Migraine Disability Assessment) for migraine headaches. Disability Assessment ⁽ MIDAS) for migraine headaches as disease-specific questionnaires.)

3. Current status of labor productivity outcome (WPAI) evaluation in clinical trials

In light of the current situation described above, we first conducted a survey on the number of studies that set outcome measures on labor productivity in clinical trials of pharmaceutical products, as well as on the target diseases. This survey was conducted using the WPAI, one of the representative tools for labor productivity outcomes described above, and a search was conducted using the ClinicalTrials.gov clinical trial registration system operated by the National Institutes of Health (NIH) of the U.S. and other organizations, using the following conditions.

The search conditions in the database were as ^follows6).

3-(1). Number of tests with labor productivity indicator WPAI

The number of clinical trials extracted by the search condition a) (all the clinical trials that matched the subject period, intervention method, etc. were 26,145 in total) was further narrowed down by the search condition b). From these, 158 trials were screened by using the search condition b). 158 trials were excluded from the description of Outcome Measures (endpoints), except for the WPAI. Finally, 120 trials (about 0.46% of the total) were selected as trials that assessed labor productivity outcomes with WPAI. The number of trials per year did not change significantly, although there was a slight increase in the last five years (Figure 2). Comparing the countries in which clinical trials were conducted, there were fewer trials conducted in Japan (41) than in the U.S. and five European countries. Of these 41, 38 were global clinical trials.

3-(2). Comparison of the number of studies by target disease

Figure 3 shows the number of trials by target disease. Psoriasis accounted for the largest number of trials (15), followed by Crohn's disease and rheumatoid arthritis. The top three diseases were all autoimmune related. Looking at the overall extracted diseases, many of them were accompanied by symptoms such as pain, itching, and poor physical condition, suggesting that WPAI may be more likely to be used in such diseases.

It should be noted, however, that the survey was limited to WPAI and did not comprehensively identify diseases (e.g., mental illness and cancer) that could affect employment and labor productivity. In addition, diseases for which disease-specific questionnaires are mainly used (e.g., migraine headaches) have not been fully confirmed.

4. Examples of Utilization of Work Productivity Outcomes

Next, we investigated and examined how labor productivity outcomes are actually utilized.

First, we classified the methods of utilizing labor productivity outcomes into three broad categories as shown in Figure 4. Each method is used for different purposes, and the examples and issues involved are described below.

4-(1). Clinical Trials Demonstrate Effects of Improvement in Labor Productivity

By obtaining data on labor productivity outcomes in clinical trials and demonstrating improvement, it is possible to present this as an element of the usefulness of the drug. As shown in Table 1, one example of this case is a company publicly announcing the improvement in labor productivity outcomes obtained in a Phase III clinical trial (clinical trial) and communicating the usefulness of the drug in terms of labor productivity in Japan. In other cases, the following reports are also available.

As for the acquisition of data on labor productivity outcomes, clinical studies are being conducted in Japan to evaluate such outcomes not only in clinical trials, as shown in the examples in Table 1, but also after marketing ⁹⁾.

In the case of clinical trials, the presence or absence of significant differences from the comparator group is also indicated, which may make the usefulness of the data easier to understand for healthcare professionals who are familiar with clinical trial data. In addition, since the usefulness of pharmaceuticals in terms of labor productivity itself is not fully recognized, this is a useful method in terms of communicating this to society as a whole. However, even if the labor productivity index were to improve by 20%, it is difficult to understand what this improvement would mean. Future research will be needed to clarify the clinical significance of this improvement and to apply it to reimbursement and pricing.

4-(2)． Productivity loss is calculated and taken into account in the cost-effectiveness assessment

From a health economic perspective, productivity loss is calculated as a cost other than medical costs related to treatment, and may be included in the calculation of the incremental cost-effectiveness ratio (ICER), which is a cost-effectiveness indicator. The method for considering productivity loss has already been described in Policy Research Institute News No. 52, "How to Handle Productivity Loss in Health Economic Evaluation" ⁽¹⁰⁾, so a detailed explanation is omitted from this report. The total cost (productivity loss) is calculated by multiplying the total labor productivity loss hours obtained from the WPAI and other survey forms mentioned above by the average hourly wage (or daily wage). In addition, within this News No. 5210), the Netherlands is discussed as an example of a country where productivity loss is taken into account. The report analyzes the results of 394 evaluations (from 2007 to August 2017) published by CVZ, the Dutch HTA agency, and finds that 23 (5.8%) of the evaluations actually incorporated productivity losses in their analysis. This Dutch case study confirms that even under systems that allow productivity losses to be considered within cost-effectiveness, they are only practically implemented in some drugs due to the difficulty of the methodology and other reasons. On the other hand, the report suggests that incorporating productivity losses into cost-effectiveness calculations can compensate for the actual increase in healthcare costs by reducing productivity losses, and that the calculation of productivity losses is meaningful when the target patients are of working age.

In addition, the analytical guideline for cost-effectiveness evaluation institutionalized in Japan from April 2019 also clearly states the possibility of its consideration as follows: "(Original) If the introduction of the technology to be evaluated has a direct impact on productivity, the analysis should be conducted from the standpoint of considering broader costs, and productivity losses may be included in the costs. . may be taken into account." ^{(Id. at 11)}. NICE in the U.K., which takes the position of "health care payer and does not consider productivity losses," has also considered the reduction in productivity losses of caregivers through reduced assistance in its appraisals. There are various issues to be addressed, such as whether or not to take the employment rate into account, the age at which productivity loss should be included, and whose wages should be used for the conversion. Since there is no clear "right answer" for these issues, it is important to clearly state what assumptions were used in the calculation.

4-(3). Demonstrate social impact using medical costs and productivity losses, etc.

A final method of utilization is to show the degree of social impact by calculating and comparing the productivity loss mentioned above with the additional medical costs if the drug is used. In other words, it is a way to estimate and quantitatively show the level of economic benefit that would be obtained if the drug were introduced to the country. Recently, there have been a number of such cases. For example, estimates for Erenumab, a drug to control the onset of migraine headaches, for Germany show additional medical costs of €5.86bn and productivity losses of €14.35bn (Table 2). In other words, the productivity loss is much larger than the additional medical costs, and the Value Invest Ratio for society is approximately 2.5 ^{(Table 2)}. Unpaid work refers to work done at home, such as housework and childcare, and productivity losses related to this unpaid work are also calculated and incorporated.

In Japan, a cost-benefit analysis was proposed as one of the methods in a health economic evaluation study on the introduction of routine vaccination in 2010, in which the cost of vaccination was considered as a "cost" and the productivity loss associated with the reduction in medical costs and treatment of infectious diseases and the productivity loss associated with the worsening of patients' conditions and early death as "benefits" and compared The actual evaluation of vaccines is usually based on cost-effectiveness analysis and cost-effectiveness analysis. Although actual vaccine evaluations were conducted using conventional cost-effectiveness analysis and cost-only comparisons (without incorporating the loss of early mortality), the basic concept of the method has some commonalities with the value investment ratio.

Although this method is not yet generally recognized, it seems to have the advantage of making the social benefits easier to understand from a health policy or public perspective. It is a new way of showing value, as it allows us to look at the cost of introducing a new drug from the perspective of investment rather than cost, and it is one way of approaching the simple question of how much economic benefit the drug will bring back to society.

5. Summary

So far, we have discussed the current status of Work Productivity Outcome Assessment in Clinical Trials (WPAI) and the utilization of WPAI. We were able to confirm the characteristics of diseases for which WPAI is frequently used in clinical trials. We have also identified three major methods of utilizing WPAI, and discussed each of them using case examples.

Measuring labor productivity outcomes using WPAI and other methods is considered important in showing the intrinsic value of the drug. It is also hoped that WPAI will become more widely used as a tool to reflect patients' own evaluations from the viewpoint of drug development.

On the other hand, there are still some issues in its evaluation and utilization. Although it is very meaningful to show the effect of improvement in labor productivity of pharmaceuticals through clinical trial data, it is difficult under the current system in Japan to directly reflect the effect of such improvement in, for example, drug prices. In addition, when productivity loss is calculated and utilized, it is easily influenced by the population age of the target patients. For diseases that affect mainly the working generation and diseases that affect mainly the retired generation (elderly), productivity loss is greater for the former, and even the same level of lost time is likely to vary by disease. Furthermore, the amount of productivity loss varies greatly depending on the range of costs and time period taken into account when calculating productivity loss, so the issue will be how to calculate highly convincing estimates.

Looking at new trends, opportunities to utilize real-world data for obtaining labor productivity outcomes are expanding.

In Japan, there are a number of services that enable QOL and labor productivity outcomes to be obtained through the use of smartphone applications (Table 3). All of these services use apps provided by various companies. kencom ¹³⁾ and Pep up PRO ¹⁴⁾ and 15) are health support service apps targeting subscribers to specific insurance associations, while harmo channel ^{16) is} an electronic medication diary and PHR that can be used regardless of where the subscription is The apps are the basis of the system. Both systems will enable the acquisition of PRO data (patient-reported outcomes) in the real world and its utilization for surveys and research. Through these tools, data on labor productivity outcomes (e.g., WPAI) in patients using specific drugs can be easily obtained through smartphones and other devices. Although the target patient population varies with each service, labor productivity outcomes can be obtained at a much lower cost and more efficiently than in clinical research, making it possible to utilize the data for different purposes.

Increasingly, a wide variety of data are being requested after a drug is launched, including QOL and labor productivity, as well as additional usefulness and effectiveness in actual clinical practice. The source of the requests is not limited to the government side, but additional data may also be requested from the frontline side, such as hospitals and clinicians. It is impossible to respond to diverse data needs only through pre-market clinical trials, and such services are highly valuable as tools for collecting post-marketing data.

If labor productivity outcomes such as WPAI discussed in this paper are also a type of PRO, it is expected that the expansion of such digitally-enabled services in the future will lead to more evaluation of pharmaceutical outcomes by patients themselves.

Finally, the improvement of labor productivity through pharmaceuticals can contribute to the long-term improvement of patients' own quality of life and the avoidance of economic losses for society as a whole. In order for the "value of improving labor productivity," which is one of the various values of pharmaceuticals, to be properly evaluated, it is desirable that it first be widely understood by society as a whole.

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