For eligible patients, compassionate use can be a powerful and potentially life-saving program. However, implementation is often easier said than done. Such programs require specific policies and governance structures, strategic partnerships, and a user-friendly request system.
In this guide, we’ll help you navigate compassionate use, improve patient outcomes, and maximize the impact of these programs. Whether you’re part of a pharmaceutical company, hospital, or advocacy group, these valuable insights will help you implement and manage your compassionate use programs effectively.
What is compassionate use?
Compassionate use (also known as expanded or managed access) allows patients with life-threatening illnesses to gain early access to medications that haven’t been approved for use in their jurisdiction. For example, a cancer patient with no other treatment options who cannot be enrolled in a clinical trial might be able to access medication that is still in the investigatory phase and not otherwise widely available to patients.
Why are compassionate use programs important?
Compassionate use programs not only expand treatment options for patients but also benefit approval processes by providing real-world data on effectiveness and safety. By bringing relief to patients in the most dire circumstances and enabling the development of revolutionary treatments, there is no doubt that compassionate use programs improve the entire healthcare system.
4 tips to improve your compassionate use program
Although compassionate use programs have a myriad of benefits, they’re governed by global regulations and require careful oversight and strict compliance. Additionally, requests for access often require a quick turnaround time. The decision whether to treat a patient facing the final stages of an illness must be made in a matter of days, if not hours. As a result, these programs must carefully balance oversight against speed.
Keep these tips in mind as you optimize your compassionate use program:
- Standardize the application process. Standardizing the application process can help to expedite the review and approval process. Assemble a dedicated team to create a comprehensive application and handle compassionate use requests.
- Create guidelines. Establish clear guidelines for patients and healthcare professionals to follow when accessing and administering investigational treatments. This includes ensuring compliance with regulatory requirements and taking ethical considerations into account.
- Foster strong partnerships. Build relationships with patient advocacy groups and other stakeholders to increase awareness and support for compassionate use initiatives, as well as to collaborate on research and development efforts.
- Emphasize patient-centered care. Ensure that each patient’s needs and preferences are taken into account when determining their eligibility for investigational treatments. This involves providing comprehensive education and support services to patients and their families.
To further streamline the process, leverage technology. The right compassionate use solution will inform decision-making and allow you to treat patients with life-threatening conditions as soon as possible.
How Bonterra can facilitate your compassionate use program
Bonterra Managed Access (formerly CyberGrants) allows healthcare providers to submit requests for medication along with relevant test results and supporting documentation in the best format to facilitate a quick review process.
When a request is submitted, Managed Access automatically assigns it to the necessary approvers based on the medication requested, the location, and a variety of other factors. For a request with a short response window, manual routing and management can waste critical time that patients simply might not have. Managed Access eliminates this problem by automatically routing the request to the necessary stakeholders so they can review and approve it in a timely manner. In some cases, the medication can even be shipped on the same day!
Additionally, in the event that further information is needed, supplementary documents can be quickly submitted through our system, eliminating costly back-and-forth with healthcare providers. Every step of this process is tracked through Managed Access and can be made available for compliance and audit purposes.
The future of compassionate use
The Bonterra team is passionate about using technology to improve lives and drive maximum social impact. Although Managed Access is one of many ways we achieve that goal, it has an immediate, tangible impact on individuals fighting life-threatening illnesses. We’re proud we can help make that process quicker and simpler.
However, we know we can always do more. We’re continually investigating ways to further streamline the process, including how to facilitate re-supply requests in a way that makes submissions easier, approvals faster, and enables tracking to create a complete record from the original request through all re-supplies. We’re looking forward to working closely with the pharmaceutical industry to continue to make our platform even better and improve the lives of patients everywhere.
A final note about compassionate use
A commitment to compassionate use means having policies, end-to-end processes, and systems in place to manage requests in a prompt, fair, and efficient manner. If you’re ready to tap into the power of a compassionate use program, request a personalized walkthrough of Managed Access today.
