Patient Advocacy at Alkermes
We have developed and now manufacture and commercialize proprietary medicines for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder - disease areas with vulnerable patient populations who are often treated in public health and criminal justice settings where systemic inequities are pervasive.
We champion approaches to treatment that recognize the multitude of factors that affect outcomes for patients, caregivers and communities, and are committed to patient and community engagement, disease education and awareness and advocacy for policies that support equitable access to treatment options. Patient advocacy and community engagement are core to our mission. Regular engagements with policymakers and leaders in the patient advocacy community allow us to better understand their perspectives and goals. Learnings from these interactions help to inform our business activities, including in respect to clinical trials, policy and advocacy. Across our endeavors, we are purposeful about staying connected to the reality of living with these complex conditions. We actively seek input from patients and advocates early in our drug development process to help identify unmet patient needs and inform our research. These engagement efforts help us design clinical trials and programs with specific patient outcomes in mind. We continue to consult with patients during the drug development process and beyond, so that patient perspectives continue to inform the development and lifecycle management of our products.
Driven by our patient-centered ethos, we advocate for, among other things, improved access to medicines and other forms of treatment. However, we also understand that access to treatment options addresses only a portion of the needs of the patients, families and communities for whom we develop our medicines. We are committed to working with the people affected by addiction, serious mental illness and cancer, and the organizations that support them, to better understand the complex system of care for these diseases and to achieve our common goal of improving outcomes for these patients and their caregivers.
Oncology Patient Advocacy Summit
In the fall of 2021, as part of our commitment to incorporating patient voices and perspectives into our drug development efforts, we hosted a virtual patient advocacy summit, as a means of gathering members of the cancer advocacy and survivor community. Attendees participated in a series of discussions that provided insights about the patient experience in oncology clinical trials and factors that contribute to recruitment, enrollment and retention. These critical patient insights helped inform elements of the ongoing ARTISTRY clinical development program and related patient communications materials.
Alkermes believes that every patient deserves quality care, and we are committed to collaborating with policymakers and other industry stakeholders to preserve and enhance access to medicines. We strive to price our medicines in a responsible manner that facilitates broad access. We also offer programs, such as Patient Assistance Programs and Co-Pay Savings Programs, to provide support to eligible patients who are prescribed our medicines. In 2021, more than 20,000 patients participated in our Co-Pay Savings Programs.
Early Access Policy
Alkermes endeavors to make safe and effective medicines by conducting rigorous clinical trials and obtaining marketing approval from regulatory authorities, including the FDA. Participation in one of our clinical trials is the optimal way for patients to gain access to our investigational medicines prior to regulatory approval. However, we understand that some patients may not be able to participate in a clinical trial. If early data from our clinical trials suggest that an investigational treatment might offer benefits for patients facing serious or lifethreatening conditions, Alkermes has a policy under which patients may be eligible to receive access to an investigational medicine outside of the context of a clinical trial. Additional details, including eligibility criteria, can be found in the Alkermes Early Access Policy, a copy of which is available on the Early Access page of the Research & Development section of the Company’s website.