Trend and Future Perspective of Patient Support Program (PSP) in Japan- Round-table discussion with Deloitte Tohmatsu, Salesforce and Takeda Pharmaceuticals -

Trend of Patient Support Program (PSP) in Japan

Takayuki Tao
Director, Life Science & Healthcare,
Deloitte Tohmatsu Consulting LLC: 
The discussion today is about the current situation and outlook of patient support program (“PSP”) in Japan from the perspective of different players, including Takeda as a pharmaceutical company, Salesforce as a solution platform provider, and Deloitte as a consulting firm.

To begin with, how do you see the situation and trend related to PSP in Japan?

Tien Nguyen
Head, Patient Service, Japan Pharma Business Unit
Takeda Pharmaceutical Company Limited: 
I cannot speak on behalf of any other pharma companies. However, what I can say with confidence is that Takeda is demonstrating significant investment and unwavering commitment to PSP. Our PSP offerings covers rare diseases, gastrointestinal diseases, and neuroscience. Our experience is that PSP is still in initial stage here in Japan compared to other more PSP matured countries. Although the awareness has been slowly increasing due to the initiatives from the players in our industry, the awareness of these pharma sponsored services are very low among Health Care Professionals (“HCPs”), Health Care Organizations (“HCOs”) and patients. Beyond raising awareness, we also need to establish a clear value proposition in the minds of our key stakeholders (HCPs, HCOs and Patients) and build the infrastructure to bring all of our services and programs to life. This doesn’t happen overnight. It takes a lot of efforts and I think that the way to move the needle is for our industry and our partners to drive this agenda collectively and proactively.

Tao / Deloitte: What do you think are reasons behind the slow-moving situation? HCPs are aware of PSP and its value to some extent but do not seem to be very keen to explain the program to their patients.

Nguyen / Takeda: One of the biggest bottlenecks is the regulatory environment in this space. Our end users are patients and caregivers, but in principal, it is only the treating HCPs who can recommend and inform PSP for patients treated with our products to their patients. During the limited time of consultation, HCPs’ main role is to diagnose/treat patients. Therefore they do not have much time to explain PSP, and patients tend to not receive this information. This additional “task” can be perceived as burdensome as HCPs are already time constrained. Although some HCPs think they should introduce services like PSP, they are hesitant to inform their patients.

Tao / Deloitte: Hayata-san, you are ex-MR and currently, at Salesforce, you are offering Health Cloud and other PSP solutions to pharmaceutical companies. What do you think, from your perspective, about the trend and awareness on PSP among HCPs and patients in Japan?

Kazuaki Hayata
Senior Manager, Industries Transformation, Healthcare & Life Sciences Industry
Salesforce Japan Co., Ltd. : 
Although the level of interest, the amount of investment and actions vary depending on companies, almost everyone is interested in PSP in order to increase patient satisfaction. I see this attitude as a big change. Some started working on patient support initiatives even with limited investment with the agile mindset. I am hoping that these moves could potentially bring about transformation in the industry.

One thing I often hear pharmaceutical companies debating is how they can think about ROI (Return on Investment) of PSP.

Nguyen / Takeda: At Takeda, our approach to PSP goes beyond traditional financial metrics such as ROI. We recognize that the true returns of PSP are not monetary. Instead, they lie in being close to patients, enhancing adherence, and ultimately achieving better outcomes. Our investments in PSP are oriented towards long-term benefits, as the positive clinical outcomes we strive for cannot be attained overnight. They differ from short-term, easily measurable ROI indicators. We prioritize the sustained well-being of patients, improved clinical outcomes and ensuring patients are having an optimal experience while on our therapies. The impact of PSP extends far beyond immediate financial gains. We leverage the insights gained from our services to continuously innovate, improve and provide meaningful services for patients.

Wataru Hamaguchi
Partner, Life Science & Healthcare
Deloitte Tohmatsu Consulting LLC: 
There are clearly two different views on PSP. One is to see them as a source of business growth. If not directly linking PSP with profit growth, companies want to leverage insights gained from PSP, or hope that the improved adherence leads to more sales. As a business organization, they want to balance PSP with profits. The other group regards PSP as pure social contributions, considering them as not directly relevant to business.

Nguyen / Takeda: Diverse perspectives on PSP can coexist within the same organization, influenced by departmental variations and leadership approaches.

It is important to note that TOMO® exclusively cater to patients who have already been prescribed our medications. Therefore, the objective of TOMO® is not to drive drug sales or encourage patients to consume medications that are unsuitable for their condition or switch therapies unnecessarily. Rather, TOMO® is designed to complement the use of our drugs, serving as a supportive component alongside the prescribed therapy. Our aim is to empower patients in making informed decisions regarding their treatment and medications while keeping them motivated throughout the process. By promoting adherence, we can enhance clinical outcomes. Hence, the interpretation of PSP returns, whether profit-driven or not, depends on one's perspective.

Tao / Deloitte: As you mentioned, the level of understanding of purpose and value of PSP is still in initial stages in Japan, what is your suggestion to pharmaceutical companies trying to establish PSP in Japan?

Nguyen / Takeda: Although the concept of PSP is in its initial stages in Japan and local evidence is not fully available yet. There is compelling evidence that substantiates the efficacy and value of PSP if we look overseas to more PSP matured countries. Extensive research spanning a decade reveals that patients enrolled in well-designed PSP can achieve significant improvements in therapy persistence and adherence, which can increase humanistic and clinical outcomes . From our perspective, PSP are not a “nice to have”, but a “need to have”. For any pharmaceutical company contemplating the implementation of PSP within the Japanese market, our recommendation is to place trust in the wealth of evidence and data accumulated over a decade. These valuable insights solidify the significance and efficacy of PSP, making them a compelling strategic choice for optimizing patient care and outcomes.

Difference in Market Environment between Japan and Other Countries

Tao / Deloitte: You were promoting PSP in another county and came to Japan in 2022, what are the differences between the market in Japan and the rest of the world?

Nguyen / Takeda: Making direct comparisons between Japan and “the rest of the world” is challenging due to varying levels of market maturity. While certain markets are advanced, it is reasonable to assume that others may still be in their early days. Also, we don’t have data on PSP on every single country to make a valid statement and medical environments differ country by country. However, when drawing a comparison to the more developed markets in Europe, it’s evident that Japan lags behind in terms of PSP implementation and advancement.

Hayata / Salesforce: Pharmacovigilance is a big issue in Japan. Collecting information on the safety of drugs from patients is quite a sensitive, touchy area. We at Salesforce recognize this as a challenge when developing PSP in this market.

Hamaguchi / Deloitte: One of the biggest differences between Japan and the US / Europe is patients’ attitude. Patients in Japan do not aggressively search for information on drugs and treatments, nor monitor their health. They are satisfied, knowing that they comply with their physicians’ treatment. Even if PSP can help them have a better quality of life, patients do not proactively look for support. This is partly because we have well established insurance and healthcare systems, and longer life expectancy. We need to change this mindset, however. We need to encourage patients to be proactive in managing their own health.

Tao / Deloitte: Deloitte’s research last year shows that, while 40% in the US are monitoring their health using mobile apps and devices, only 10% of Japanese people do the same. The difference is significant.

Nguyen / Takeda: That is very surprising. I don’t have the European data top of mind, but I want to believe that its much higher than 10% for sure. Digital health is a fast-growing industry with rapid adoption. There are more than 350,000 health apps available looking to measure everything from daily steps to menstrual cycles. This is a strong indication that there is a high demand for such products. Personally, I have been consistently using a variety of health apps in the past 8 years to keep track of my health data. Most people I know in my generation are doing the same, at different levels of course. Perhaps it’s a cultural difference?

Having said that, I want to share a personal experience related to this. I recently saw my General Practitioner (“GP”) for migraines in here in Japan. I was put on a new therapy and my GP advised me to download a health app to track various factors, including my dietary intake, temperature, weather conditions, and other relevant variables whenever I experience symptoms. She wanted me to show her my health data in the next consultation so she can make informed assessments regarding the efficacy of my medication and evaluate the appropriate dosage frequency. Perhaps there is a shift going on in Japan as well?

Tao / Deloitte: What do you think are the most effective ways for patients to understand the value of PSP? Would it be through HCPs or do you think is there any channels we can leverage?

Nguyen / Takeda: In Japan, regulatory constrains restricts pharmaceutical companies to have direct communications with patients. Our primary channel for raising awareness and sharing information about PSP is through the treating HCPs. However, it is crucial that the HCP recognizes the value of PSP and recalls this information during consultations to inform the patient about the available PSP. We are of course open to explore any other legitimate channels to inform patients.

Hayata / Salesforce: When reaching out to end users, municipal governments can play a role, too. Some of them are encouraging their citizens to use PSP as part of their health management.

Hamaguchi / Deloitte: We can think about two approaches to raising awareness. One is top-down - it would be a powerful driver if PSP becomes part of the clinical reimbursement.

The other approach is more bottom-up based on patients’ desire. If the number of patients who are willing to be on PSP increase to reach a critical mass, others will follow on and HCPs will need to change their mindset and behavior as well.

Nguyen / Takeda: As the current regulatory environment restricts direct communication between pharmaceutical companies and patients, it may be necessary to address and reevaluating the existing regulations?

By potentially creating new avenues or ease the restrictions, we can: 1. Less rely on HCPs to inform patient about PSP, 2. empower patients, enhance their understanding, and promote more proactive engagement in their healthcare journey.

Tao / Deloitte: Software as a Medical Device (SaMD) is a good example here. Many pharmaceutical companies are trying to promote SaMD to authorities to advocate higher reimbursement. Perhaps, we should do the same for PSP.

TOMO®: Reactions of Users and Future Perspectives

Tao / Deloitte: Takeda launched its patient support program for rare diseases in 2021, and for GI and neuroscience in April 2022. How are the reactions so far?

Nguyen / Takeda: According to feedback surveys, patients enrolled in our programs consistently express high levels of satisfaction. Among the diverse range of services available, what resonates most with them is the human engagement and personalized support provided by our dedicated case managers. Case managers are dedicated nurses who support patients through our outsourced call center. Patients value our genuine care for them as individuals, recognizing our commitment to their overall well-being extends beyond medication support. Patients endure numerous concerns and challenges that extend beyond the medical needs, including life plans, family relationships, and financial implications. As some patients goes through an emotional rollercoaster, being heard and understood by a compassionate case manager is highly valued, someone who is impartial and separate from their immediate circle of family and friends.

Hamaguchi / Deloitte: How do you collaborate with stakeholders and key opinion leaders?

Nguyen / Takeda: When we launch new initiatives or programs, we always ensure to listen to our key stakeholders’ voices. Primarily patients, HCPs and regulators. To understand and solve the pain points in a compliant manner. Their insights and guidance remain invaluable in shaping our programs.

Tao / Deloitte: What are the challenges in running TOMO®? For example, how do you treat adverse events when they are captured through TOMO®?

Nguyen / Takeda: We are highly vigilant when it comes to adverse events. In the case of TOMO®, our call center operations are outsourced, and we have established a robust structure to ensure prompt reporting of any adverse events by our dedicated case managers to Takeda. When it comes to websites and mobile apps, we limit the use of free text input. However, we are actively exploring the utilization of advanced technologies to effectively detect and identify potential adverse events. By harnessing the power of these cutting-edge tools, we aim to enhance our ability to monitor and respond to adverse events.

Tao / Deloitte: What are your visions or plans for TOMO® going forward?

Nguyen / Takeda: Our vision is to build a patient-centric ecosystem. Our ultimate aim is to provide the best possible patient experience, which in turn leads to improved clinical and humanistic outcomes. Insights derived from our programs helps us to understand the pain points of patients and how we can continuously improve our service offering.

Tao / Deloitte: We are here and Salesforce is here to support and implement your strategies. We can accelerate the momentum of PSP for better lives for patients in Japan as we work closely with one another. Thank you very much for your insights around PSP today and look forward to further collaboration in this space.