• Clinician Perspectives on the Regulatory Review of Tavneos (avacopan)

  • The National Kidney Foundation (NKF) and Vasculitis Foundation (VF) are partnering together to better understand clinicians’ perspectives regarding the regulatory review of Tavneos (avacopan), a treatment option approved in October 2021 for ANCA-associated vasculitis (in combination with glucocorticoids). Briefly, the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has proposed withdrawing Tavneos (avacopan) from the market based on:

    1) FDA’s assessment that new information  raises questions about whether Tavneos (avacopan) has been shown to be effective for its approved use, and

    2) FDA’s concerns about data integrity and accuracy of statements in the original application for approval.

    Tavneos (avacopan) remains on the market during the review process. Treatment decisions regarding whether to initiate or continue Tavneos (avacopan) therapy should be made using a shared-decision-making approach and considering individual clinical circumstances.

    This survey is intended to assess clinicians' awareness, sentiment, and patient care implications regarding CDER’s proposal.

    This survey should take approximately 15 minutes to complete.

    You can pause and return to the survey at any time.


     

  • Section 1: Awareness & Clinical Understanding

  • 1. How familiar are you with the FDA/CDER proposal to withdraw Tavneos (avacopan) from the market?*
  • 2. How did you learn about the FDA/CDER proposal? (Select all that apply)*
  • 3. Which of the following issues cited by the FDA regarding Tavneos (avacopan) do you consider to be most compelling? (Select all that apply)*
  • 4. How would you describe your current perspective of Tavneos’ risk/benefit profile in the patients with preserved GFR (i.e., eGFR ≥60 mL/min/1.73m2)?*
  • 5. How would you describe your current perspective of Tavneos’ risk/benefit profile in patients with reduced GFR (eGFR <60mL/min/1.73m2)?*
  • 6. Please rate your level of agreement with the FDA’s statement that “Tavneos (avacopan) has not been shown to be effective for its approved use”.*
  • 7. Please rate your level of agreement with the FDA’s statement that “the application that resulted in FDA approval [of Tavneos(avacopan)] contained untrue statements of material fact”.*

  • Section 2: Potential Impact on Clinical Practice

  • 8. How has this development changed your approach to using Tavneos (avacopan) for managing ANCA-associated vasculitis?*
  • 9. Are you currently initiating (or do you plan to initiate) Tavneos (avacopan) in new patients?*
  • 12. How would you describe your current perspective regarding the continued availability of Tavneos (avacopan) as a treatment for ANCA-associated vasculitis?*
  • 13. When making treatment decisions for patients with ANCA-associated vasculitis, how do you typically weigh real-world evidence(RWE) compared with randomized clinical trial (RCT) data?*
  • 14. Do you feel a Risk Evaluation & Mitigation Strategy (REMS) program should be created for Tavneos (avacopan)?*

  • Section 3: Patient Communication

  • 16. How are you discussing this recent development regarding Tavneos (avacopan) with your patients?*
  • 17. How would you rate your level of comfort discussing this topic with patients?*
  • 18. What information or resources would be helpful to facilitate your conversations with patients? (Select all that apply.)*

  • Section 4: Trust & Regulatory Confidence

  • Rows

  • Section 5: Educational Needs & Forward-Looking Questions

  • 20. What guidance would help you most with navigating this situation while caring for patients? (Select all that apply.)*

  • Section 6: General Demographic Information

  • 23. Please specify your discipline:*
  • 24. Please specify your specialty practice area:*
  • 25. How many years have you been practicing in your specialty area?*
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