Contributors Participating in Society

Access to Healthcare Management

PharmaEssentia follows the framework of the 2024 Access to Medicine Index (ATMI). Under good access to healthcare governance, the company provides product development rooted in scientific innovation. By increasing medicine accessibility, accelerating the promotion of drug certification acquisition, and market distribution, PharmaEssentia helps more MPN patients obtain better treatment with Besremi, thereby improving their quality of life. Even though PharmaEssentia is not currently listed in the ATMI Report, we remain committed to promoting Access to Medicine by adhering to the ATMI framework and indicator processes. We conduct independent assessments and descriptions of the results in accordance with this commitment.

Actions on Access to Healthcare

We are committed to providing high-quality medications to more patients whose medical needs are currently unmet. Through innovative research and development efforts, and by accelerating drug certification with market supply chain partners, we can meet the needs of more patients requiring solutions. Additionally, we are considering how to implement reasonable pricing strategies to reduce the burden of healthcare costs, demonstrating the cost-effectiveness of Besremi through cost analysis.

Action 1: Committed to providing high-quality medicines to more patients whose medical needs are currently unmet.

• Compassionate Use Therapy

  

• Accelerating Drug Registration

  BESREMi® has obtained marketing authorization in over 40 countries globally. Through the establishment of subsidiaries and partnerships with strategic partners, PharmaEssentia continues to expand its global market share, providing new options for the treatment of rare diseases and reducing the burden of such treatments.

  

• Product Delivery

  Given the different regulations on drug packaging and labeling in various countries, PharmaEssentia collaborates with local stakeholders. In countries like the USA, Germany, and Japan, PharmaEssentia has signed outsourcing manufacturing contracts with local manufacturers who comply with GMP standards to enhance the smooth delivery of products. Additionally, measures are taken to combat counterfeiting.

• Patient Support Program

  Establishing a Patient Support Program, including a website, professional medical education, and customer service center, to provide patients with convenience support from insurance information and self-pay discount programs to medication guidance and ongoing medication ordering processes, and assisting patients in reducing out-of-pocket financial burden.

• Product Donation

  We actively collaborate with governments and the academic community to make an impact. During the severe COVID-19 pandemic, considering patient needs, PharmaEssentia donated medication to the Health and Welfare Department’s Shuang Ho Hospital for clinical use in treating mild to moderate COVID-19 patients. Out of 22 patients, 21 successfully recovered and were discharged after their test results changed from positive to negative. Based on this success, PharmaEssentia invited National Taiwan University Hospital to lead a Phase III multicenter clinical trial of P1101 for treating COVID-19, aimed at providing treatment options for mild to moderate cases. Although the pandemic subsided and the trial was not completed, PharmaEssentia will continue to adhere to its patient-centered philosophy and spirit, investing in research and collaborating with medical professionals to provide drug donations for independent clinical research based on clinical needs, accelerating the expansion of the drug’s potential benefits to help more patients in need.

Action 2: Responsible Pricing Strategy, Creating Medical Value and Cost-Effectiveness

• Equitable Access to Healthcare Strategy and Outcomes: Enhancing product medical efficiency

  BESREMi® has been incorporated into the guidelines of the European LeukemiaNet (ELN) since 2021, and into the National Comprehensive Cancer Network (NCCN) guidelines, a globally authoritative cancer clinical treatment standard in the United States, since 2022. In 2023, it was further elevated in the NCCN guidelines. Regardless of the treatment previously received by patients or whether they belong to high-risk groups, BESREMi® can be used as the first-choice medication for treating adults with Polycythemia Vera (PV).

  

• Improving New Drug Affordability: Fair and Reasonable Pricing

  When pricing our drugs, patient interests are our top priority. We take into consideration various factors, such as the investment in research and development, the number of patients who would benefit from the treatment during the patent period, the pricing of competing products, expected profits, third-party insurance claims, and health insurance coverage provided by regulatory authorities. We then use these factors to determine a fair price, taking into account the ability of different countries to afford the medication, their level of economic development, and the cost of manufacturing the drug. We also refer to the WHO Guideline on Country Pharmaceutical Pricing Policies published by the World Health Organization to determine reasonable and fair drug prices.

  

PharmaEssentia contributes to health outcomes across various stages of the Patient Journey, including disease awareness and screening, MPN diagnosis confirmation and treatment, as well as comprehensive patient care post-treatment, providing holistic support.

Disease Awareness and Screening

PharmaEssentia not only continues to invest in ongoing professional education for healthcare professionals in the countries where its products are marketed but also supports healthcare professionals in conducting patient education events. Additionally, in accordance with local laws, online websites are established in the marketing countries.

Diagnosis and Treatment

In addition to being included in national and international treatment guidelines, PharmaEssentia conducts ongoing professional education for healthcare providers in the countries where its products are marketed. This is aimed at enhancing their understanding, diagnosis, treatment, and care of MPN. PharmaEssentia also collaborates with medical associations in the marketing countries and internationally to host seminars and continuously publish significant research findings. For example, in 2023, Panco hosted 17 seminars for healthcare professionals and patients to enhance understanding of diseases and medication treatment options, thereby enhancing professional medical knowledge. These events had a total of approximately 700+ participants.

Comprehensive Patient Cycle Care

Management Approach on Access to Healthcare

PharmaEssentia adheres to a patient-centered approach, and plans various actions and support programs to implement access to medicine and meet patients' health-related needs. Through activities such as health education, financial and medical support, academic exchanges and more, we provide patients with a comprehensive and integrated plan that covers every stage of their treatment.For patients already using BESREMi, a series of health promotion activities have been planned to extend their medication duration and improve overall treatment outcomes. By promoting local Healthcare and social participation to expand our external social influence.

Empowerment Programs along the Value Chain

• Constructing Value Chain Empowerment Program

  PharmaEssentia actively participates in empowerment programs and key activities at every stage of the value chain, such as establishing an innovation research center utilizing artificial intelligence for new drug development, helping the American MPN Research Foundation to establish a clinical trial search tool, setting up patient support programs in Taiwan, the USA, and Japan, and enhancing drug accessibility for financially needy patients, gradually expanding to other countries. For patients already using BESREMi, a series of health promotion activities are planned to extend their medication period and perfect the overall treatment process.

• Cross-Value Chain Empowerment Activities Engaging Community Co-Learning

  PharmaEssentia aspires to be a pioneer driving industry growth and has always been committed to participating in community co-learning and sharing initiatives. For example, the plant manager was invited to speak at the "Innovative Pharmaceutical Industry Chain Link International Competitiveness Promotion Project" seminar to exchange practical GMP process change management, promoting industry quality enhancement and to BIO Asia–Taiwan 2023, the largest biotech exhibition in Asia and a key industry exchange platform, to discuss biotechnology techniques and trends, fostering learning and sharing in the biotechnology field. The director of the Sustainability Center was invited to the "Biomedical Products Industry Low Carbon Transformation Initiative - Green Manufacturing Technology and Carbon Reduction Practice Community" to share experiences in promoting sustainable development, fostering co-operation and symbiosis in the biotech industry, while also offering a summer internship program to cultivate new industry talent. To date, the company's operations have not caused any negative impacts on the local community.

  

  

This year's sponsored public welfare activities include the Jane Goodall Institute, Bay Voice Orchestra New Year's Concert, and Digital Humanity Association, with the following project sponsorship details:

In 2023, we sponsored public welfare activities, including the International Jane Goodall Institute for Biodiversity Advocacy Activities, the Digital Humanitarian Association's Rural Elderly Health Promotion, and the OneSong Orchestra New Year Charity Concert for promotion of local culture. The following project sponsorship details are outlined as below:

               【Annual implementation of Corporate Sustainable Development _2023】

 Since 2016, we have been providing long-term sponsorship for the Asia Myeloproliferative Neoplasms International Conference (MPN Asia). To date, six successful conferences have been held, spanning four cities across Asia. These conferences have brought together top international experts, scholars, and clinical physicians to engage in profound interaction and academic exchange regarding the research and treatment of blood disorders.

  Continued support for the CHIA-YI MPN Center and the Taiwan Myeloproliferative Neoplasms Association (TMPNA) in providing services to patients with myeloproliferative neoplasms, implementing patient education and support activities in the Taiwan region. 

  Sponsoring the One Song’s New Year Concert for five consecutive years, supporting cultural and artistic development, and promoting a new ecosystem of inclusiveness and mutual benefit in response to UN SDGs 8 and 11. 

  Ongoing sponsorship of the Digital Humanitarian Association's Rural Health Promotion Philanthropy, supporting local health aging through digital technology-enabled remote medical care models, and actively caring for vulnerable groups in response to UN SDGs 3, 4, 5, 8, 10, 11, 13, and 17. 

  Sponsorship of the Jane Goodall Institute's Hope Box Biodiversity Public Welfare Project, contributing efforts to the protection and sustainable use of biodiversity for the benefit of human health. This aligns with UN SDGs 3, 4, 13, 15, the Convention on Biological Diversity (CBD), and the World Health Organization's (WHO) health advocacy. 

  The subsidiary, Panco, establishes the patient education interactive platform "MPN iCare ", providing educational information to patients and their families. In 2023, a total of 17 seminars were held to enhance the understanding of the disease and drug treatment choices for healthcare professionals, patients, and others, with a total participation of approximately 700+ people.  Assistance was also provided to TMPNA for organizing World MPN Day educational lectures and the first members' meeting. 

  The U.S. subsidiary initiated patient support activities through “BESREMi.com and the SOURCE program”, offering a comprehensive range of services including insurance support and the convergence of educational resources for patients. 

   The new drug Ropeginterferon alfa-2b (Ropeg) is listed as a treatment option for polycythemia vera (PV) in adults, and in May of 2023, it was upgraded to the preferred drug for PV_2A category patients in the United States NCCN Guidelines. 

  The company has applied the new product Ropeginterferon alfa-2b (P1101) in the Compassionate Use program since 2017, benefiting a total of 43 patients in 4 countries as of the end of 2023. 

  In July of 2023, the factory director of the Taichung plant was invited to speak at BIO Asia–Taiwan 2023, sharing insights on biotechnology technology exchange and trends, contributing to the learning and sharing of scientific and technological developments in the biotechnology field and enhancing the company's visibility.

  In August of 2023, the Director of Sustainability Center was invited to the DCB "Biomedical Product Industry Low Carbon Transformation Promotion Plan - Green Manufacturing Technology and Carbon Reduction Practice Symposium," sharing the company's journey and practical experiences in promoting sustainable development, contributing to collaboration and mutual growth in the biotechnology industry. 

  In October of 2023, the factory director of the Taichung plant was invited to share experience on GMP process change management and practices in the "Innovative Pharmaceutical Industry Chain International Competitiveness Enhancement Project," contributing to the continuous improvement of product quality and positive impact in compliance with regulatory requirements in the pharmaceutical industry.