Policy Research Institute page Workshop on the Value of Drugs: Considering the Value of Drugs and Their Evaluation from the Perspective of the Public and Patients" was held by the Policy Research Institute
On October 20, 2021, the "Value of Drugs Workshop: Thinking about the Value of Drugs and Their Evaluation from the Perspective of the Public and Patients" was held in an online format, hosted by the Policy Research Institute. More than 560 participants from member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ) attended the workshop.
Plenary Discussion
Introduction
The pharmaceutical industry must continue to create innovative drugs and deliver them to patients as quickly as possible. However, in order to achieve this, it is important that the various values of pharmaceuticals created as a result of innovation are properly evaluated, and this is an issue that must be considered not only from the perspective of the pharmaceutical industry, but also from the perspective of the public and patients.
Therefore, the Policy Research Institute has planned a workshop titled "Thinking about the value of pharmaceuticals and their evaluation from the viewpoints of the public and patients. Through lectures and discussions by prominent experts and specialists, we hope that the workshop provided participants with an opportunity to deepen their understanding of issues and solutions from the viewpoints of the public and patients, and to think together about what we in the pharmaceutical industry can and should do.
Workshop Overview
Session (1) focused on the theme of "Various Values of Pharmaceuticals," and began with a report by Yosuke Nakano, Senior Researcher of the Policy Research Institute, on his research on "Consideration of Various Values of Pharmaceuticals and Results of Public Survey" ( Fig. 1 ). Then, Dr. Naka Igarashi, Associate Professor of Health and Social Medicine Unit, Yokohama City University School of Medicine and Visiting Associate Professor of Pharmaceutical Policy Studies, Graduate School of Pharmaceutical Sciences, University of Tokyo, gave a lecture on "The Value of Pharmaceuticals in Light of the Coronary Disaster and New Drug Trends" ( Figure 2 ).
Figure 1 "Elements of Social Value" to be surveyed
Source: Research Paper No. 76 (March 2021), Pharmaceutical and Industrial Policy Research Institute
*Excerpts from slides by Yosuke Nakano, Senior Research Fellow, Policy Research Institute
Figure 2: Key points in organizing and evaluating Value
*Excerpts from slides by Dr. Naka Igarashi, Associate Professor, Yokohama City University and Visiting Associate Professor, Graduate School of the University of Tokyo
In Session (2), on the theme of "Evaluation of the Value of Pharmaceuticals from the Perspective of the Public and Patients," Akiko Yoshida, Senior Researcher, National Institute for Policy Studies, presented "Major Issues in the Evaluation of the Value of Pharmaceuticals in Japan" ( Fig. 3), followed by a presentation by Dr. Yoshida, Representative Director of the Institute for Medical Development and Infrastructure Research (IDIEB), and Dr. Igarashi Naka, Visiting Associate Professor, Graduate School of Pharmaceutical Sciences, University of Tokyo. Next, Dr. Kyoko Imamura, Representative Director of the Institute for Medical Development Infrastructure and Visiting Professor of IT Healthcare Social Collaboration, Graduate School of Pharmaceutical Sciences, University of Tokyo, presented "The Current Status of PPI (Patient and Public Participation) in Japan and the Significance of PPI in Value Evaluation" ( Figure 4), and Dr. Naomi Sakurai, President of Cancer Solutions, presented "How Do You Measure the Value of Medical Care" ( Figure 5). ( Figure 5), on "How to Measure the Value of Medical Care.
Fig. 3 Main issues in the evaluation of "value of pharmaceutical products" in Japan
*Excerpts from slides by Dr. Akiko Yoshida, Senior Researcher, National Institute for Policy Studies
Fig. 4 Patient Involvement in PARADIGM
Excerpts from slides by Dr. Kyoko Imamura, Representative Director of the Institute for Medical Development Fundamental Research and Visiting Professor of the Graduate School of the University of Tokyo
Figure 5: You can't just take one thing out of the equation
Excerpt from the slide of Ms. Naomi Sakurai, President and Representative Director of Cancer Solutions, Inc.
Finally, based on the two sessions, Mr. Imamura (moderator), Mr. Igarashi, and Ms. Sakurai discussed the following issues.
| (1) | What are the important values for the public and patients among various values? |
| (2) | What should be done to ensure that important values for the public and patients are recognized? (Issues and approaches) |
| (3) | What should the pharmaceutical industry do? 2. |
Here is a brief introduction of the points discussed during the plenary discussion.
1. among the various values, what are the important values for the public/patients?
Based on the results of a public survey on the various values of medicines conducted during the epidemic of novel coronavirus infection (COVID-19) (many people considered the value of "reducing the burden on healthcare professionals" important), Mr. Igarashi stated, "If the survey had been conducted before the COVID-19 epidemic, the perspective of 'reducing the burden on healthcare professionals' would have been more important. If the survey had been conducted prior to the COVID-19 epidemic, it is assumed that the perspective of "reducing the burden on healthcare professionals" would not have emerged as an important value. In other words, the value of pharmaceuticals can change depending on the times and social environment, and it is necessary to determine the important values for the public and patients in accordance with the "current trends.
Mr. Sakurai shared his opinion that in considering "important values for the public and patients," it is necessary for patients to consider the value of pharmaceuticals from the patients' viewpoint and then return to the public's viewpoint (objective viewpoint) to see how their claims are seen from the outside. Also, in relation to the earlier public survey, given the current situation in which many people have a history of COVID-19, "If we conducted a survey limited to people with a history of the disease and their families, might another 'important value' emerge?" He also raised the question, "What is the value of a survey limited to people with a history of morbidity and their family members?
Dr. Imamura stated that COVID-19 is an acute infectious disease and that it is easy to obtain the data necessary to evaluate its value, and since sequelae after COVID-19 infection are also considered problematic, he hoped that future surveys and research would be developed in Japan as well.
What should be done to ensure that important values for the public and patients are recognized?
Mr. Igarashi advised that, in discussions on various value evaluations, we should clarify where the problem lies (in the product, in the evaluation index, or in both) in cases where evaluation is difficult under the existing framework, so as not to cause the misunderstanding that we are discussing a value evaluation that is favorable to pharmaceutical companies. The participants also discussed the importance of the workshop as well as other activities to promote the development of a framework to address the issues. He also argued that there is a wide range of venues for discussing the value and evaluation of pharmaceutical products, including this workshop, and that we need to make progress in the discussion at this time when there are concrete examples of COVID-19 treatments and vaccines and dementia drugs that are of great interest to people.
Mr. Sakurai mentioned that he recently received a detailed and easy-to-understand explanation from the European Medicines Agency (EMA) about the approval process of vaccines based on the COVID-19 case, which is a familiar story to us, and he was impressed by the development story of the vaccine developed and approved in an extremely short period of time and realized the product value We shared that the story was familiar to us and that we were impressed by the story of the development and approval of the vaccine in a very short period of time and realized the value of the product. On the other hand, he also commented that he felt frustrated as a citizen that there is no opportunity to share such information in Japan due to advertising regulations and other reasons.
In addition, he commented that discussions on the NHI drug price system and cost-effectiveness evaluation system tend to compare Japan with Europe and the U.S., but that Japan should consider its own unique system, taking into account the country's characteristics (a well-developed nursing care system and a super-aged society). In conjunction with this, Mr. Igarashi stated that there is an effort to create a QOL measurement index that takes advantage of such Japanese characteristics, and that useful data originating in Japan against the backdrop of a super-aging society could be disseminated overseas.
Dr. Imamura commented that the evaluation of the value of pharmaceutical products in Japan tends to be directed toward physicians, and that the approach should take into account the evaluation of patients as end users, with the patient's voice being included from the early stages of research and development.
What should the pharmaceutical industry do?
Dr. Igarashi advised that it is impossible to quantify all the various values, but it is also incorrect to say that there is no value if it cannot be quantified, and that it is desirable to make concrete proposals from where one can. He also stressed the importance of unifying the pharmaceutical industry's intention as to which value to claim first, and to proceed one by one while investing resources intensively in this area.
Mr. Sakurai mentioned that when the cost-effectiveness evaluation system was introduced, he hoped that light would finally shine on areas that had not been illuminated (allowing patients to participate in value evaluation), but that this did not happen. He encouraged pharmaceutical companies to take on new challenges without being bound by the rules of the regulatory authorities. He also suggested that, in promoting patient participation in drug development, pharmaceutical companies should first read their own protocols to see if the language, expressions, etc. are truly easy for patients to understand.
Mr. Imamura concluded by saying that although there may be various issues, there is nothing that cannot be done, and he hopes that pharmaceutical companies and the pharmaceutical industry will take even a single initiative to address them.
Concluding Remarks
After the workshop, we received feedback from the participants in the form of a questionnaire. The workshop as a whole received a high evaluation (90% of the respondents were "satisfied" or more), and the organizers were very pleased to hear from many of the participants that the workshop "made me realize" something or "gave me an opportunity to think". We hope to apply the lessons learned and suggestions from this workshop in our future research and studies.
Finally, I would like to take this opportunity to thank all the speakers and others who contributed to the workshop, as well as all the participants, for their hard work and cooperation.
( Yosuke Nakano and Akiko Yoshida, Senior Researchers, Pharmaceutical and Industrial Policy Research Institute)