Positions & Policy
- Pricing philosophy
- Public policy
At Biogen, we have the opportunity and responsibility to bring transformative treatments to patients. We recognize that prices for and access to treatments are chief concerns for patients, providers, payers, and policy makers; and we work with all parties to help ensure that patients are not denied access to a life-changing therapy.
The creation of breakthrough medicines requires billions of dollars in research and large teams of people – often working for decades – to bring them to patients. However, there is no guarantee that even with these investments we will be successful in having a new drug approved.
When we are successful, it is imperative we ensure that patients can access new treatments, a process that involves complex negotiations with governments, regulatory agencies, third party payers, pharmaceutical benefit managers, pharmacies, and hospitals throughout the world. Further, we must demonstrate to physicians and payers the benefits and value of our treatments. In the end, the price of a given product is only one of many factors that impacts patient access – and we recognize our responsibility within this complex healthcare ecosystem to work collaboratively with all parties for the benefit of patients globally.
A critical part of ensuring access to our medicines is also the work we do years in advance of the introduction of a new therapy. We engage with our stakeholders, including governments, regulatory agencies and private payers, so they are prepared for the introduction of new breakthrough medicines. This work is essential to creating and supporting sustainable health systems for the long term.
Today, Biogen’s products help thousands of patients around the world with multiple sclerosis (MS) -- and we are committed to potentially transformative R&D programs to tackle the most debilitating of diseases, such as Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS), spinal muscular atrophy, and neuropathic pain. This focus on research has led us on a 20-year journey, from introducing one of the first disease modifying treatments for MS to seeking ways to reverse or repair the impact of the disease. As a company, we recognize that our ongoing commitment to bringing transformative therapies to patients also requires that we ensure that patients globally have access to them.
Learn more about our pricing philosophy
As we consider the prices of our products, we strive to achieve an appropriate balance among the following three key principles:
- Clinical Value: we must understand the intrinsic clinical value of the product and what it is able to provide to patients in terms of altering the course of disease, generating positive health outcomes, and improving quality of life.
- System Impact: we must evaluate the impact a therapy has on the entirety of the health care system, including the financial implications on payers and patients.
- Stakeholder Returns: we must recognize the need to fund Biogen’s entire research enterprise at all levels – from basic research that advances scientific understanding to clinical development of new treatments – while at the same time providing sufficient returns to those shareholders who have invested in us and recognize the importance of ground breaking research even if it never results in a treatment.
In following these principles, we also work to reflect the needs of our stakeholders – patients, physicians, payers, investors and future generations who count on us for life-changing therapies. We take into account a range of additional factors, including the following considerations:
- Revenue from marketed therapies fuels research for serious and complex medical conditions with few or no treatment options. In the past decade nearly 25% of our revenues have been reinvested directly into research and development.
- We seek to have a net positive impact on society, balancing the benefits our therapies bring to patients with serious diseases and the very real pressures on healthcare budgets.
- We work to remove barriers to access, ensuring that patients are able to receive our therapies. In 2014 alone, we provided over $1 billion in patient financial assistance and free drug programs.
The diverse stakeholders involved in enabling patient access to our therapies often rely upon different methodologies and evidence requirements for assessing the value of our medicines. Here are some of the ways we seek to address stakeholder needs:
Understanding Payers’ Interests
We initiate conversations with payers and Health Technology Assessment (HTA) authorities early in the drug development process. These conversations have yielded great insights into the perceived value of the products in our development pipeline and the types of evidence needed to help increase their potential for acceptance for reimbursement. Maintaining an open dialogue enables us to make well-informed decisions at every stage in the development process.
Supporting Clinical Research with Social Data
Over the past few years we have taken an innovative approach to integrate patient access considerations into our research and development design. With payers making reimbursement contingent upon data that can take years to collect, we have incorporated evidence-driven strategies into our product development programs and have implemented these strategies earlier in the development cycle. This process allows us to generate data that can help advance regulatory approval for our therapies and satisfy expectations of payers, pricing reimbursement authorities and HTA organizations.
Listening to Voices of Those Affected
We are engaged in continuous dialogue with many patient advocacy groups. These organizations provide a critically important voice in the health care system, representing the interests of patients and families affected by disease. We partner with patient advocacy organizations to better understand the needs and challenges facing patients and to help patients access improved treatments and services.
Supporting Patients in Need
We offer several forms of financial assistance programs to patients.
In the U.S., our Patient Services team helps patients navigate the often complex reimbursement process and puts them in touch with agencies that can help them secure the financial assistance they need. We also offer copay assistance to eligible patients and a free drug program to those patients who are unable to access our therapies in any other way. In 2014 alone, Biogen provided financial assistance valued at more than $1 billion in the form of free drug and insurance copayment support, infusion assistance, and charitable contributions. Learn more about supporting patients.
We make significant investments of time and capital over many years to bring new therapies to patients. When we are successful in those endeavors, we have a limited period of time – granted through patents or other intellectual property (IP) protections – to generate sufficient revenue from that innovation to keep our research engine moving forward in search of the next treatment or cure. Once products are no longer covered by IP, regulatory frameworks provide the foundation for generic or biosimilar versions of therapeutic products to enter the market at reduced costs for the benefit of all future generations.
Biosimilars are similar, but not identical, versions of their originator biologic counterparts. Biogen continues to make progress in biosimilar development through Samsung Bioepis, our joint venture with Samsung Biologics. In 2014 we established a new business unit focused specifically on the commercialization of biosimilar products. Our first biosimilar products will be anti-TNF product candidates that treat conditions such as rheumatoid arthritis. In 2016, the European Commission approved BENEPALI® (etanercept), the first etanercept biosimilar referencing Enbrel®, for use in the European Union. BENEPALI marks the first approval in the European Union for the joint venture.
We believe that it is the responsibility of all health care stakeholders to ensure that patients have access to and receive high-quality, efficient medical care. Our efforts in biosimilars enable us to offer an alternative for payers and health systems to reduce the burden of treatment costs after innovator IP protections expire. We have made a significant commitment to biosimilars and believe our expertise in protein engineering and biologics manufacturing will continue to advance high-quality treatments and provide patients with confidence in our high quality biosimilar products. Learn more about biosimilars at Biogen.