Immediate Market Feedback and Global Clinical Impact of the FDA’s Revocation of Avastin in Metastatic Breast Cancer

Continuing the tradition of providing you with timely market feedback, OBR and MDoutlook are pleased to share results from MDoutlook’s most recent Quick Poll. This survey was fielded among MDoutlook’s global network of 53,000 cancer physicians to gauge the clinical impact of the recent FDA decision to revoke marketing authorization of bevacizumab (Avastin®) in HER-2 negative metastatic Breast Cancer.

Quick Poll Methodology and Respondents’ Geographic Distribution

• On Friday, November 18, 2011, the U.S. Federal Drug Administration (FDA) revoked its regulatory approval concerning the use of bevacizumab (Avastin®) in HER-2 negative metastatic breast cancer
• In response to this action, Genentech announced it was moving forward with a new clinical trial including biomarkers to try to identify those most likely to benefit from receiving bevacizumab.
• Medicare subsequently announced it would continue covering the cost of bevacizumab for this indication
• This Global Quick Poll was launched at 8 a.m. Eastern Time on Saturday, November 19^th to gauge the immediate response of the oncology community to this news
• Only cancer physicians who treat breast cancer were targeted for this Quick Poll
• 232 responses were received by Tuesday, November 22^nd at 8 a.m. EST

–        59% of responses were from US (39 states)
–        36% of responses from EU
–        Overall respondents were from 24 different countries
–        No financial compensation was provided to the participants

FDA’s Action Will Severely Limit the Usage of Bevacizumab in the Treatment of HER-2 Negative Metastatic Breast Cancer

Key Conclusions

• Overall usage of bevacizumab (BEV) in metastatic breast cancer (mBC) will be cut in half following the FDA’s revocation of its label extension in mBC

–      Expected to reduce by 2/3 in US
–      Outside of US will still decrease by 1/3

• Similar proportional decreases seen in heavy users of bevacizumab (those who use it in >50% of their relevant patients) (data not shown)

Insurance / Payer Coverage of Bevacizumab for Metastatic Breast Cancer Will Have Significant Role in the Decision Making Process

Key Conclusion

• Standard payer coverage of bevacizumab in mBC will be a key driver for its future use, especially in the U.S

–      Nearly half of US oncologists rate payer coverage as an extremely important decision driver
–      One in three oncologists outside the US also see as an extremely important factor

There is a High Amount of Interest in a Biomarker-Driven Trial for Bevacizumab in Metastatic Breast Cancer

Key Conclusion

• Nearly 7 out of 8 oncologists are interested & willing to refer patients to the new clinical trial for bevacizumab in HER-2neg mBC.
• Geographic location has no impact on the willingness to refer patients to this new clinical trial

Overall Conclusions

• The FDA’s actions will have a dramatic impact on the usage of bevacizumab in HER-2 negative metastatic breast cancer

−     Usage in the US will decrease by two-thirds
−     Usage outside of the US will decrease by one-third

• Insurance / Payer coverage will be a key component of the oncologist’s decision process on whether or not to use bevacizumab for breast cancer

−     More important in the US than in other locations but still of importance everywhere
−     This is of the utmost importance to between 1/3 (Ex-US) and 1/2 (US) of oncologists

• Although usage of bevacizumab in practice will be strongly decreased, most oncologists are still interested in the concept of using bevacizumab for metastatic breast cancer and will refer patients to a new clinical trial for it

Final Thoughts

MDoutlook Quick Polls are a fast way of measuring expected acceptance of clinical data post major medical meetings, and perhaps can be used to make some assumptions about adoption amongst providers. In today’s information hungry environment, the speed at which these polls can be conducted and analyzed are advantageous for market planning and “pressure testing” acceptance of data amongst key stakeholders.

Submitted by Robert Stephan, PhD, Sr. Dir. Medical Services and Jan Heybroek, President, The Arcas Group