Prioritizing Patient Access

 

 

Biogen is committed to continuously adapting our thinking and approaches to pricing and access. Our pioneering work in neuroscience requires us to keep pace with an increasingly ambiguous and changing environment to ensure that patients have access to our breakthrough therapies.

 

 


 

 

Access to Treatments

To ensure that new, innovative therapies are commercially available to the patients who need them, we comply with government regulations. After pivotal clinical trials are completed, therapies with positive results must then be approved by a regulatory authority – such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Working towards expanding access to treatments both before and after a therapy's potential regulatory approval is one of our top priorities. We create broader access to our therapies through both public and private healthcare systems.


Affordability Access:
Biogen may offer financial assistance or help to secure reimbursement in public and private healthcare programs for patients who are otherwise unable to access our medications. We follow pricing principles that allows us to determine the value of our therapies in terms of clinical outcomes, improvements in daily living and quality of life, and whether the medicine advances clinical practice and/or addresses a high unmet medical need.

 

Learn more about our access programs.

 

 


 

 

Pharmacovigilance

Biogen is committed to the safety of our patients and safe use of our products in all countries we serve. We support patients by monitoring the safety of Biogen investigational and marketed products, over the lifecycle of the products, through the science of Pharmacovigilance (PV).


PV refers to the monitoring, reviewing, evaluating and communicating of information on the safety of pharmaceutical products. PV is conducted through a comprehensive and rigorous set of activities focused on the detection, assessment, understanding and prevention of adverse effects or other product-related problems. PV activities are conducted in collaboration with team members located around the world, who provide expertise regarding regional and country-specific regulatory requirements.

 

 


 

 

Clinical Trials

While clinical trials are an essential part of the drug development process because they are designed to answer specific research questions related to the safety and efficacy of a potential drug, all patients are encouraged to carefully consider the risks prior to participation. In most cases, the drugs being investigated in clinical trials are not yet approved by regulatory agencies. We are grateful to the patients, healthy volunteers, healthcare providers, hospitals and clinics that participate in testing our investigational drugs.


Learn more about patient safety and our approach to clinical trials and hear directly from a patient involved in a clinical trial.

 

 


 

 

Expanded Access Programs

To provide patients with access to drugs that have not yet become commercially available, we have occasionally been able to offer Expanded Access Programs (EAPs). These programs are intended to help provide access to investigatitional drugs for patients who have unmet medical needs while regulatory approval processes and reimbursement negotiations are still underway.


By the end of 2019, SPINRAZA was approved in over 50 countries with formal reimbursement in 40 countries, including China. Prior to commercial availability, in order to bridge the gap between positive data readout and formal reimbursement, Biogen offered an Expanded Access Program to treat 800+ patients in over 40 countries to provide patients with the earliest access possible to this innovative therapy. Biogen continues to support patients in countries without formal reimbursement via our Expanded Access Programs today.


At Biogen, we’re deeply inspired by the courage and resilience of all of our patients, and we will continue to work tirelessly to solve societal problems and create access to innovation.

 

 


 

 

Our Approach to Pricing and Access

Our pricing and access actions are guided by a clear and transparent series of principles:

  • Value to patients
  • Present and future benefits to society
  • Fulfilling our commitment to innovation
  • Evolution towards value-based health care
  • Affordability and sustainability

Finding solutions to improve the affordability of innovations is one of our key priorities. We believe all healthcare stakeholders have a shared responsibility to ensure that patients have equitable access to new, innovative medicines. We recognize that geographic location and economic circumstances can greatly affect a patient’s ability to pay for medicines, which is why we work with local healthcare systems that can deliver breakthrough therapies quickly and efficiently to patients everywhere. To accomplish this, we may alter our approach to accessibility and pricing depending on a country’s economic situation and healthcare infrastructure.


Two key examples of such approaches include:

  • Launching an SMA-focused individual patient access program in lower-middle- and lower-income countries to bring medical education and treatment to SMA patients in need. Although the initial focus is in India, we hope to expand the pilot program to other countries in the future.
  • Collaborating with the Brazilian Ministry of Health to implement an inaugural risk-sharing agreement to ensure broad access to SMA Patients. Learn more about the Pioneering Access Program in Brazil.

 

 

 

 

Product Stewardship

We comply with all applicable regulations and minimize adverse health, safety, environmental and social impacts of our products while maximizing their benefits and value through their full life cycle. To this end, we are investing in serialization technology to protect our products from counterfeits and improve patient safety. To ensure that patients are receiving safe, quality products, Biogen has instituted anti-counterfeiting policies and guidelines in place to protect patients.


Biogen believes transparency is an important part of our ongoing collaboration with the healthcare community, helping to build a community of trust and respect with healthcare professionals, patients, industry peers, stockholders and the public. Learn more about our Transparency Reporting.

 

 


 

 

Supply Chain Responsibility

Biogen’s Code of Business Conduct, Human Rights Position Statementand Anti-Slavery and Human Trafficking Statement establish the principles and practices of ethical business to which we expect all of our suppliers, business partners and employees to adhere. In addition, our commitment to inclusive sourcing and procurement practices is represented in our supplier diversity program.

 

 


 

 

Health Equity

At Biogen, we are committed to understanding and addressing the issue of health disparities and inequity in the disease areas we treat for underserved patient populations. We advanced health equity goals for our clinical trials and maintained our expanded access program to treat patients in over than 40 countries to help better meet the needs of underserved patients globally. Our approach to Health Equity is a multi-pronged strategy, focusing on the following strategic pillars:

  • Patient Engagement & Education
  • Increasing Underserved Patient Representation in Clinical Trials
  • Expanding Medical Publications for Underserved Patients
  • Engagement of Key Medical Experts
  • Access to Our Therapies for Underserved Patients

We’re committed to supporting underserved and vulnerable populations both now and in the future, and we have made it a priority to support underserved populations throughout the entire product lifecycle. Being a pioneer in health equity means doing much more than simply translating our product information into different languages, but rather developing an understanding of how culture and history affect healthcare decisions and access.


In 2019, Biogen created an internal, cross-functional Advisory Council focused on reaching underserved patient populations to ensure alignment before starting new projects.  Biogen also created a new goal, above the industry average, to increase representation of Black and Latinx patients in clinical trials. Biogen also worked with trusted organizations to participate in six community health events drawing over 1,700 attendees across the U.S.  The focus of these community events was to engage directly with the general public, listen to their level of understanding and awareness, and provide resources to support education. Attendee survey data indicated the majority of participants are somewhat or very interested and willing to participate in a clinical trial, indicating an opportunity to further engage, educate and drive underrepresented patients to clinical trials sites.


Additionally, this year Biogen worked with an MS Advisory Board of neurologists from across the U.S., many of whom have found that the majority of patients that come to them are from underserved populations. We have worked closely with our partners to identify how best to raise awareness and education for the specific demographics they are seeing, with the goal to create a more equitable and health literate MS population.


By taking a holistic and contextualized approach to health equity, we continue to strive to be nimble and adaptable to rapidly changing patient populations. Through our work with advocacy groups we are continuously partnering, learning and sharing best practices.


Learn more about our access programsfinancial assistance and pricing principles.

 

 


 

 

Patient Advocacy

Biogen Government Affairs was active in a number of initiatives in 2019 to support patient access. The Massachusetts state team worked to increase the number of other states participating in newborn screening (NBS) implementation for SMA. Three more states – Kansas, Mississippi and Wisconsin – recently began screenings, bringing the total number to 13. Four more states expected to begin screening by early 2020 (Connecticut, New Hampshire, Colorado and Wyoming).


Also in 2019, Biogen’s own Cherié Butts, Medical Director in Digital & Quantitative Medicine, was appointed by the Baker Administration to serve on Massachusetts' Economic Development Planning Council (EDPC), comprised of 36 appointees including state legislators, Executive Secretariats, and municipal leaders, along with small business owners and entrepreneurs, leaders from business sectors and higher education. Biogen is the sole large biopharma company on the Council and brought together a cross-functional group to generate specific recommendations for the state to consider. Cherié was also recognized by BioSpace on their 10 Prominent African American Life Science Leaders List.