Astellas Pharma US, Inc. is committed to providing patients, customers, community and employees with a bright future by Changing Tomorrow. As a responsible corporate citizen, it's important we crystalize our stance on important issues impacting the healthcare industry and pharmaceutical innovation.

Read our stance on important patient-relevant topics below. Read all of our corporate policy and positioning statements here.

 

Position on Expanded Access to Investigational Medicines

Astellas is committed to making our medicines available to patients in the most efficient manner to address their unmet medical needs. The general approach is through the conduct of clinical trials and subsequent registration and commercialization of our products. However, Astellas recognizes that patients with serious or life-threatening diseases may have exhausted all of their available treatment options, may not qualify for a clinical trial and may seek access to investigational medicines.

 

Background

Astellas is committed to making our medicines available to patients in the most efficient manner to address their unmet medical needs. The general approach is through the conduct of clinical trials and subsequent registration and commercialization of our products. However, Astellas recognizes that patients with serious or life-threatening diseases may have exhausted all of their available treatment options, may not qualify for a clinical trial and may seek access to investigational medicines.

Our Position

Astellas commits to establishing expanded access plans for investigational medicines and patients that satisfy the following conditions:

  1. The disease or condition being studied is serious or life-threatening
  2. The patient has exhausted all available treatment options
  3. The provision of expanded access does not delay, interfere or compromise the completion of the clinical trial process and registration of the medicine
  4. The medicine is in active clinical development and not available on the commercial market
  5. Patient is ineligible for clinical trials
  6. There is sufficiently robust preliminary safety and efficacy data including dosing information
  7. The potential benefit to the patient outweighs the risks
  8. The patient’s physician, the institutional review board/ethics committee and regulatory authority have authorized the provision of the investigational drug

The decision to provide the medicine to a patient will be made by Astellas based on a fair and impartial evaluation of the requests that meet the conditions described above. This decision will be made in a timely manner to be responsive to the patient’s needs but with appropriate consultation and discussions with Astellas medical and clinical teams, the patient’s physician, regulatory authorities and outside experts. As a general guideline, a response will be provided to expanded access requests within 7 days of receipt if not sooner.

This procedure will be implemented in compliance with local regulations in the country where expanded access is requested. Expanded Access programs will be targeted for countries where active clinical development is underway and registration of the medicine is planned. Generally once a medicine is approved and on the market in a country, the expanded access program will no longer be available.

Astellas provides information on Expanded Access programs appropriately.*Patients should speak with their physicians in regards to seeking eligibility and access to the Astellas Expanded Access Programs.

*Information on Expanded Access protocols can be found at Astellas EAPs. Further information on Expanded Access programs at Astellas can be provided through the following contact. 

Contact Information for physicians:
・E-mail: [email protected]
・TEL for physicians in the US: 800-727-7003
・Physicians outside the US: Call local Astellas office (https://www.astellas.com/en/worldwide/)

References

  • Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results by PhRMA (June, 2015)
  • BIO Principles on Expanded Access to Investigational, Unapproved Medicines (April, 2015)
  • A vision towards a life sciences strategy for Europe by EFPIA (2014)

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Position on Patient Organization Engagement

Patient organizations play an active role in representing the patient voice to society and the healthcare community. Patient organizations are an important stakeholder for Astellas.

 

Background

Patient organizations play an active role in representing the patient voice to society and the healthcare community. Patient organizations are an important stakeholder for Astellas.

Our Position

Astellas believes that engaging with patient organizations has the potential to advance our ability to develop effective medical treatments by better understanding the patient’s perspective and desired outcomes and enriching our understanding of the broader healthcare environment. By working together and developing long-term relationships with patient organizations, we can achieve our shared objective of improving the experiences and outcomes for patients and caregivers.

Patient organizations work with patients and caregivers and possess a unique knowledge of their unmet needs. Astellas respects the immense value these insights can offer to help Astellas better understand the patient journey. For example, where appropriate and possible, we will work with patient organizations to enhance our research and development quality. Astellas is currently engaging in efforts to include patient input in the optimal design and execution of clinical trials and identification of additional relevant endpoints important to patients.

Astellas believes that we can build trust with patients and other relevant stakeholders and deliver even more value within the healthcare ecosystem through working with patient organizations. For example, we strive to help patients and their caregivers better understand and manage their conditions by supporting the critical work by patient organizations to improve the health literacy of their members.

Patient engagement requires working together with integrity, in a transparent, ethical and professional manner. Astellas accomplishes this when relationships are based on an independent, mutually respectful, authentic and trustworthy foundation. Astellas is committed to pursuing the development of these meaningful relationships and transparent interactions with patient organizations in compliance with the relevant laws, local regulations, and rules and guidelines of the innovative pharmaceutical industry.

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Position on Value + Pricing of Medicines

Astellas contributes to improving the health of people around the world by providing innovative medicines to patients. We do this by investing in leading-edge research and development for innovative medicines and by supporting patients to the access to the medicines they need.

Astellas engages with many stakeholders in the healthcare community to find ways to meet the dual imperatives of working towards affordable access for patients while maintaining proper incentives for companies required to sustain the promise of future innovative medicines.

 

Background

Astellas contributes to improving the health of people around the world by providing innovative medicines to patients. We do this by investing in leading-edge research and development for innovative medicines and by supporting patients to the access to the medicines they need.

Astellas engages with many stakeholders in the healthcare community to find ways to meet the dual imperatives of working towards affordable access for patients while maintaining proper incentives for companies required to sustain the promise of future innovative medicines.

Our Position

Astellas believes that the price of medicines should be a fair reflection of the value they bring to patients, healthcare systems, and society as a whole. Improved patient outcomes in mortality, morbidity and quality of life are our first and foremost priorities. However, we also believe that when determining the value of medicines, stakeholders must take into consideration: the novelty of the science; the strength and quality of the evidence; the clinical benefits relative to existing treatments; the economic benefits for both patients and healthcare systems; and the ability of healthcare systems to provide broad access to patients. Throughout the research and development process, we engage with a range of relevant stakeholders, including healthcare providers, payers and patients, to gain diverse perspectives on these and other factors.

Astellas understands affordability of medicines is one factor that can impact patients’ access to medicines. We work with a broad array of healthcare stakeholders to develop sustainable solutions to address issues of affordability. As part of this, we explore various pricing and access solutions, such as patient access initiatives and value-based approaches to the pricing of our medicines, both of which take into consideration a variety of factors, including geographic and socio-economic circumstances.

Astellas is committed to working with stakeholders to find durable solutions that enable patients to have affordable access to our medicines, while still enabling us to invest in innovative new medicines.

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Position on Access to Health

Advances continue to be made in technology and medicine that address unmet medical needs. However, there still remain barriers for many people who have difficulty accessing the healthcare they need due to the lack of available treatments, poverty, healthcare system challenges and insufficient healthcare information.

 

Background

Advances continue to be made in technology and medicine that address unmet medical needs. However, there still remain barriers for many people who have difficulty accessing the healthcare they need due to the lack of available treatments, poverty, healthcare system challenges and insufficient healthcare information.

Our Position

Astellas' raison d'être is to contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Guided by this corporate philosophy, our main efforts to expand Access to Health lie in discovering, developing and providing innovative medicines for patients. Astellas also works to advance Access to Health by engaging in initiatives in areas where improvements are needed for healthcare. To improve Access to Health, Astellas has identified four areas where we can leverage our strengths, technologies and expertise to contribute to better global health. These areas are “creating innovation”, “enhancing availability”, “strengthening healthcare system” and “improving health literacy”.

1. Creating Innovation

  • Innovative medicines to satisfy unmet medical needs
    Astellas’ primary contribution to improve global health is creating innovative medicines and medical solutions in therapeutic areas with a high level of unmet medical needs and delivering them to patients around the world.
  • Social benefit-driven research and development
    Astellas endeavors to accelerate social benefit-driven research and development, i.e., to research and develop products for diseases which Astellas believes have high unmet medical needs but have been neglected or less prioritized for commercial reason. These activities include drug discovery research, formulation development and new indications for existing products for patients suffering from such diseases.

2. Enhancing Availability

  • Management of Intellectual Property (IP) 
    Astellas believes that IP protection of research and development results is essential to continuously creating new drugs and technologies. At the same time, we acknowledge that some developing countries need special consideration. Astellas commits to not file nor enforce patents in select countries with significant economic challenges considering the importance of improving Access to Health. These select countries will be decided by referring to those designated as Least Developed Countries (LDCs)1 defined by the United Nations or Low Income Countries (LICs)2 defined by the World Bank.
  • Expanded access to investigational medicines
    The general approach for making our medicines available to patients in need is through the conduct of clinical trials and subsequent registration and commercialization of our products. However, Astellas recognizes that patients with serious or life-threatening diseases may have exhausted all of their available treatment options, may not qualify for a clinical trial and may seek access to investigational medicines. As appropriate, Astellas commits to establishing expanded access plans for investigational medicines and patients that satisfy certain defined conditions in compliance with local regulations.
  • Supply chain management
    An effective and responsibly managed supply and distribution system is essential to ensure that high-quality products get to the right patients at the right time. Astellas is committed to ensuring the reliable supply of high-quality, safe and effective medicine to patients and customers. Astellas maintains strict quality standards and effective supply chain management to ensure the safety and continued availability of our products.
  • Patient assistance/access program
    In some markets, Astellas will implement programs which enable patients, who meet predetermined criteria, to obtain assistance in gaining access to select Astellas’ medicines. These programs should include a fair and transparent application process, rational criteria and an effective distribution mechanism relevant for the local market needs.

3. Strengthening Healthcare System

  • Improving medical infrastructure, services and quality of care
    Astellas seeks to contribute to improvements in the healthcare system through initiatives that benefit public health, enhance the quality of healthcare being provided, and bring overall value to patients, other stakeholders, and the healthcare system as a whole. Our goal through these efforts is to make a lasting improvement in local capacity.
  • Technology transfer including capacity building
    Astellas will contribute to the appropriate transfer of technology important to the production of medicines through collaboration with the public and/or private sector. Capacity building including sharing of know-how, training and education in manufacturing and quality management of medicines will be considered to strengthen local healthcare system.

4. Improving Health Literacy

  • Increasing awareness and patient support
    Astellas seeks to improve health literacy in the community and believes it is important to undertake initiatives to raise awareness and provide education that will help patients to prevent diseases, or get proper diagnosis and treatment. Astellas works, within many different regulatory environments, to provide appropriate information and opportunities for patients, families, caregivers and other stakeholders as appropriate to understand diseases and the proper use of pharmaceutical products. In addition, Astellas supports patient groups working to improve health literacy for patients. Interacting with patient groups also helps us to better understand the needs of patients.

Each of these initiatives helps facilitate Access to Health. At the same time, we believe that these initiatives will lead to enhancement of our enterprise value. In order to develop these activities, Astellas considers working with relevant partners where appropriate and will continue to work with and maintain a close dialogue with stakeholders.

References

  1. LDCs defined by United Nations 
  2. LICs defined by the World Bank 
  3. Policy on Social Contribution
  4. Position on Expanded Access to Investigational Medicines
  5. Position on Intellectual Property in Developing Countries

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