From Patient Access to Real World Data – Early Access Programs Offer Compelling Results
What is an EAP?
Early Access Programs (EAPs), also referred to as Compassionate Use, Managed Access Programs or Expanded Access Programs, are a pathway by which pharma and biopharmaceutical companies provide investigational new drugs (INDs) to patients with serious conditions. Often, patients have exhausted their approved therapies and cannot participate in a clinical trial. These pathways offer a direct channel from the manufacturer to the patient outside of the clinical trial space and before the commercial launch of the drug.
Clinical Trials v. EAPs
Historically, clinical trials were the only way patients could obtain access to pre-approved drugs. Clinical trials often take place in only a select number of countries, and have very specific eligibility criteria that might include gender, age, type of disease, stage of disease, treatment history, etc. These guidelines limit the number of patients who can gain access to a new drug.
EAPs offer an alternative to those patients who are not able to participate in a clinical trial for various reasons. In most countries, there is an established named patient supply process for fulfilling demand if the medicine is not commercially available. In different scenarios, the physician, manufacturer or a 3rd party can sponsor/initiate the program.
What are the benefits of EAPs?
EAPs can be uniquely designed and offer a number of compelling benefits.
- Patient Access: Compliantly enable access to your medicine for patients who can benefit and would otherwise not be treated.
- Increased Physician Experience: Allow healthcare providers in future commercial markets to become familiar with the product before it is commercialized, increasing uptake at launch.
- Ongoing Access: Provide continued access to clinical trial patients after trial closure rather than using an Open-Label Extension (OLE), ultimately reducing CRO costs.
- Real World Data: Collect real-world evidence on your medicine, as well as continued safety data, which can help support registration or reimbursement negotiations, especially with rare diseases.
Tanner Pharma Group partners with companies to run access programs across the globe. Tanner’s approach to these programs is unique because of the operating model we employ, giving physicians and their patients a much more personalized access experience. Tanner has a track record of finding solutions, even in very difficult scenarios, to get medicine to patients based on their specific needs — no matter their location.
If you’re looking for an experienced partner to help navigate and manage the access space, reach out to us today to start the conversation.