Biosimilar, towards sustainable social security system and hospital management

“Hospital Management and Biosimilar in the Era of High-priced Drugs”

Biologics are innovative and therapeutic products. However, it is extremely costly, has a significant effect on economy of hospital management and social security. In this time, we would report the panel discussion with healthcare experts how to deal with high-priced drugs in the future.

“Hospital Management and Biosimilar in the Era of High-priced Drugs”

~Deloitte’s Proposal for Protecting Sustainable Health Insurance System~

October 6th 2017, the Deloitte Tohmatsu Group hold an emergency panel discussion on “Hospital Management and Biosimilar in the Era of High-priced Drugs: Deloitte’s Proposal for Protecting Sustainable Health Insurance System”. 

Biologics are innovative and therapeutic products. However, it is extremely costly, has a significant effect on economy of hospital management and social security. 

In this time, we would report the panel discussion with healthcare experts how to deal with high-priced drugs in the future.



The panel discussion was conducted to aggressively discuss on the biosimilar with healthcare experts as the panelists. The panelists were specialized in four types; a public welfare administration (policy maker), a hospital manager, a prescribing physician, and a pharmacist (pharmacy department).

Why this panel discussion was held ~ Raising an issue by Deloitte~

At the beginning, Noriyuki Watanabe, Partner, Deloitte Touche Tohmatsu LLC, Risk Advisory Division, Healthcare Unit,  explained the purpose of the panel discussion.

He mentioned that the Deloitte has raised an issue on how to approach “protecting the safety of people and patients” and “passing on the universal health insurance system towards the next generation”. 

That was the reason Japan has faced issues which the universal health insurance system will be protected due to aging of population.

In this panel discussion, the panelists were expressed their expectation and aim; "Contribute to change the future of Japan".

  •  Tokyo University of Pharmacy and Life Sciences, pharmaceutical Department, Pharmaceutical Regulatory Laboratory, Professor (ex- government officer, Ministry of Health, Labour and Welfare):
    Kouichi Masuyama (chairperson)
  •  Tochigi Cancer Center, Executive Director and Vice-president:
    Iwao Ozawa
  •  Yokohama City University Medical Center, Gastrointestinal Center, Professor (Vice-president):
    Chikara Kunisaki
  •  Mitsui Memorial Hospital, Department of Rheumatology, Manager:
    Akitake Suzuki
  •  St. Marianna University School of Medicine, Gastrointestinal and Liver Internal Medicine Division, Associate Professor:
    Nobuyuki Matsumoto
  •  Kameda Medical Center, Medical Administration Division, Pharmaceutical Management Department, Manager:
    Ryokan Funakoshi
  •  Deloitte Tohmatsu Consulting Co., Ltd., Manager(ex-medical officer, Ministry of Health, Labour and Welfare):
    Masato Homma
  •  Deloitte Touche Tohmatsu LLC, Senior Manager:
    Daisuke Yuzuki (facilitator)


Keynote Speech

“Ten years of history for the 80% usage of generic medicines: what the system has left behind”

Koichi Masuyama, chairperson, in the keynote speech gave an interesting lecture on background of launching approach for biosimilar of his idea and necessary countermeasure, as well as experience involved in established a system to promote the usage of generic medicines at the time of working in the Ministry of Health, Labor and Welfare.

Outline of the lecture:

  •  What can we do to control medical expenses from the viewpoint of pharmaceutical regulatory? -Experience with generic medicines and biosimilar
  •  "Guidelines for ensuring quality, safety and effectiveness of biosimilar "
  •  Different from generic medicines? Examples of issues with biosimilar (BS)



Main Part: Discussion

[Theme(1): What is remaining issue and achievement for the 80% usage of generic medicines?]

<Key opinions of panelists>

Matsumoto: “At the time, St. Marianna University School of Medicine was first to introduce generic products, however, some of physicians appealed for using of original products because of their own paper. In the meantime, the manager in pharmaceutical department was leading their staffs based on the evidence. I believe that there is necessary for the leadership in the hospital.”

Suzuki: “The accumulation of 10 years of time has led to product’s reliability. I believe that various approaches have effectively worked as introducing of electronic medical records reduced the mental barrier to prescribe generic medicines, as well as the health insurance union distributed the pamphlets about generic medicines for patients.

Kunisaki: “The timing of introduction on generic medicines was late at university hospital. There were some concerns regarding results of collaborative research with other health facilities, however, it was gradually disappeared our resistance according to increasing using of generic medicines. At the beginning, the generic medicines was prescribed with consultation by prescribed physician, in meantime, the pharmaceutical department has been leading to make a decision.


[Theme(2): Expectations for biosimilar in the era of high-priced drugs and issues on expansion]

The panelists introduced the current situation and issues that high-priced drugs have an effect on economy of hospital management.

They also described the specific factors not promoting the expanding of biosimilar such as “no financial benefits for the patients linked to the reimbursement system for high medical expenses and subsidy system for intractable diseases”, “Different formulation from genetic medicines” and “not explicitly stated problems in the guidelines”.

The panelists from prescribing physicians gave lectures on actual issues in the clinical setting.

<Key opinions of panelists>

Ozawa:  “There is almost no margin on drug prices with the consumption tax, although the drug price revision does not change the purchase price. High-priced drugs not only increase the inventory value but also have a large effect on cash flow, causing deterioration of management. Nowadays, the pharmaceutical department and the finance division are conducting trial calculations of in-hospital drug costs, and adoption of generic medicines."

Funakoshi: “The operation costs related to biologics are growing up since there are almost no margin on drug prices for high-priced biologics, and required to purchase refrigerators. It is also difficult to control inventory for new patients because it is not recommended for patients using the previous medicines. It is a factor for not promoting because of lack of statement using biosimilar in the guidelines. However, physicians gradually supported it since pharmacists have provided evidence in Europe such as NICE and EMA etc. Therefore, it is necessary to estimate the treatment cost for each patients because some patients’ out of pocket of medical expenses would possibility increase due to shifting from high-cost medical expense benefit to biosimilar.”

Matsumoto: “There is a prejudice that the sugar chain structure affects the efficacy, although there might be no difference in effect of biosimilar because efficacy of the antibody drugs is related to the epitope structure.

Suzuki: “The patients sometimes reject to be suggested using it along with the cases in Europe. There are various factors not to progress with clinical practices such as less benefit to the patients qualified high-cost medical expense benefit, low awareness, and the anxiety of biosimilar.


 [Theme (3): What we can do to maintain the universal health insurance system in the future]

The panelists aggressively exchanged their opinions on two major points: "short-term approach under the current system" and "long-term approach to maintain the universal health insurance system."

The conclusion would help to solve this theme as conducting the meeting with all stakeholders in the hospital and the discussion cross-department.

<Comments from panelists>

Ozawa: “We reduced the number of previous products in the hospital because the G-CSF biosimilar was plugged in regimen as recommended medicines for improving prescription rate. It might be necessary for the patients to understand, think, and make choices on personalized medicine and advanced care planning and the contents of medical treatment for their future.

Kunisaki: “It will be a great benefit to both patients and hospitals, if biosimilar could significantly reduce costs because of high-priced of biologics. I felt that it is also necessary to efforts by pharmaceutical companies for launching products with guaranteed efficacy and safety.”

Suzuki: “It is highly respected about the actual live voices by patients with the same disease. I think that the patient groups would promote to increase the number of usage of biosimilar in the future. The residence of biosimilar by the patients could reduce due to connect with the other patients when the physicians recommends.

Funakoshi: I felt that it was necessary to work together not only physicians and pharmacist but also all staffs in the hospital. 

In addition, evaluations after prescription should be also shared with patients which it might be a different flow."

Matsumoto: “It was very useful to provide information to the patients who disseminate information with deep knowledge. I realized that it is necessary all people, healthcare professionals and patients to have the awareness of being as player in order to maintain the universal health insurance system, because the lack of benefits to the patients could cover by high-cost medical expense benefit and subsidy system for intractable diseases.


Summary of chairperson

It is difficult to promote the approach like generic medicines which the patient have less out-of-pocket of medical expenses, under the present system (high-cost medical expense benefit). I think that it is necessary for the patients and their family to provide information on possibility of crisis of universal health insurance and also passing it towards the next generation. It is suggested that the biosimilar will be introduced in the field where easily progress, because it is supposed not to immediately make the effectiveness in order to various issues to aggressively use in the clinical practice. 

In that case, it is important for the pharmacist to be responsible for collecting medicine information and providing information to physicians. 

I hope that Deloitte will continue to provide opportunities considering how to approach on biosimilar as well as providing high-quality health.


Summary of Deloitte

It was successful panel discussion which make us realize that the healthcare professionals have accumulated with experience of generic medicines over a decade in Japan.

It is natural that the public welfare administration and hospital management usually require economic efficiency.

It is also supposed that the prescribing physician is in a position to consider the therapeutic benefits and the financial burden for the patient.

However, the present prescribing physicians have a sense for both quality of health and economic/finance of balance, and also recognized that the continuity of social security systems and hospital management is as important as aggressive use of new therapeutically effective medicines. There is a major issue that prescribed biosimilar have no merit of patients with certain diseases.

The purpose of this panel discussion was discussed with experts “what we can do from tomorrow”, even though there are two timeframes; "what we can do for the time being” and "design and establish the desirable system".

According to the outcomes to be summarized by the chairman, Masuyama, we, Deloitte believe that the pharmaceutical department should have their responsibility for supporting hospital management and prescribing physicians in the future.

In addition, it was mentioned in the panel discussion which it should be prepared the system for introducing biosimilar including in the medical affairs division to estimate patient treatment costs.

In this line, the focus group discussion made us realize that the issues which occurred in hospital should be achieved the healthcare professionals to think carefully for the patients, because it could be not solved one stakeholders.

The Deloitte Tohmatsu Group would like to disseminate information to the healthcare professionals, we will select theme and panelists for the next opportunity based on obtained valuable opinions in this time, in order to business continuity and development for healthcare industries.


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