Managed Access Programs provide access to an investigational medical product when patient enrollment in a clinical trial isn’t possible. The programs are also known as Expanded or Extended Access, Treatment IND, or compassionate use studies.
Peggy Schrammel, Vice President, Managed Access Programs, at Parexel, told Outsourcing-Pharma.com that the company’s expanded program “helps biopharmaceutical companies bridge the gap between product development and launch in delivering life-saving treatments in challenging circumstances.”
“Demands are increasing on biopharmaceutical companies developing treatments for unmet diseases to make them available to select patients even before the drug is labeled, packaged and fully commercialized,” she said.
While these demands are not new, “they are more frequent today, driven by an unprecedented public awareness of the various stages and status of product development,” said Schrammel. “This awareness extends beyond the medical community and patient advocacy groups to patients and their families themselves.”
Patients may lack access to treatments for various reasons. Schrammel explained, “They may be ineligible for an ongoing trial, trials may not yet have begun or regulatory or reimbursement processes are still ongoing.”
Often, a physician or patient requests access because an alternative therapy isn’t available and the risk posed by the disease or condition is greater than the risk of participating in a Managed Access Program.
However, as Schrammel explained, these programs can be complex. Factors that add to this complexity include, identifying suitable patients and treating physicians; managing a limited drug supply; ensuring scalability; and initiating start-up in an expedited time period.
The new program was designed based on customer and physical feedback, which Schrammel said was critical, particularly around the company’s enabling technology.
“We have developed technology specific to Managed Access Programs that supports patient identification and management of requests, as well as physician enrollment, drug supply management, and resource determination,” she explained. “Physician feedback was critical to help us create a simple and intuitive experience for physicians so that they can quickly request access for patients in urgent need.”