Impact of Accelerated Approval: Focus on Medications for Rare Diseases, Oncology, and Alzheimer's Disease
Pricing: Free for Members and $30 for Non-Members
In 1992, the U.S. Food and Drug Administration (FDA) established the Accelerated Approval Program to provide early access to medications for patients with serious and life-threatening conditions that fill an unmet need. The drug approval process for accelerated approval uses surrogate endpoints or intermediate clinical endpoints for approval that may reasonably predict the clinical benefit of the drug. The risk of using surrogate endpoints is that they may not represent a clinically meaningful outcome. This presents a challenge to payers who are managing very high-cost therapies with uncertain clinical effectiveness, especially when looking at medications used to treat rare diseases, cancer, and Alzheimer's Disease.
This session will discuss the accelerated approval process and how the therapeutic agents approved by this pathway may be managed. The session will also focus on three therapeutic areas that are impacted by the accelerated approval pathway – rare diseases, cancer, and Alzheimer's Disease.
Pharmacists who practice in managed care settings.
At the completion of this activity, participants should be able to:
- Describe the accelerated approval pathway and how it differs from a traditional drug approval pathway.
- Summarize the impact of drugs approved through the accelerated approval pathway on formulary management.
- Explain how the accelerated approval pathway impacts medications used for rare diseases, cancer, and Alzheimer’s Disease from a managed care perspective.
Yuqian Liu, PharmD
Sr. Director, Specialty Clinical Solutions
Magellan Rx Management
Simone Ndujiuba, PharmD, BCOP
Director, Clinical Strategy and Innovation, Oncology
Magellan Rx Management
Financial Relationship Disclosures
|Faculty/Reviewer/Planner||Reported Relevant Financial Relationships|
|Employee: Magellan Rx Management|
Employee: Magellan Rx Management
Speaker: Janssen Pharmaceuticals
Disclosed no relevant financial relationships.
|Disclosed no relevant financial relationships.|
- AMCP Staff have disclosed no relevant financial relationships.
- If applicable, relevant financial relationships have been mitigated and documented.
- Content has undergone a peer review to ensure content validity.
The Academy of Managed Care Pharmacy (AMCP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
ACPE UAN:0233-0000-23-001-H99-P • Activity Type: Knowledge-Based
Contact Hours: 1.25
Release Date: March 22, 2023 • Expiration Date: December 31, 2024
Activity Fee: Free for Members and $30 for Non-Members
Participants should claim continuing pharmacy education (CPE) credit for this home study activity only if they have not claimed credit for the live activity presented at AMCP 2023. CPE credit will be processed through the AMCP Learn portal and reported directly to CPE Monitor. Please allow 72 hours for processing and posting in your NABP account.
To receive credit for an online activity you must:
- Review the full content of the activity.
- Successfully complete the post-test (required to pass with a score of 70% or higher, it may be taken a maximum of three times).
- Complete a specific activity evaluation.
- 1.25 ACPEThe Academy of Managed Care Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
- 1.25 Certificate of Completion
System Requirements Courses and learning activities are delivered via your Web browser and Acrobat PDF. For all activities, you should have a basic comfort level using a computer and navigating websites. View the minimum technical and system requirements for continuing education online learning activities