Minutes of June 19, 2001 Meeting
OPEN SESSION
Baltimore Convention Center
Baltimore, Maryland
Attendees
Frank J. Papatheofanis, MD
Chairperson
Barbara J. McNeil, MD
Vice-Chairperson
Janet Anderson
Executive Secretary
Voting Members
Carole R. Flamm, MD
Jeffrey C. Lerner, PhD
Michael Manyak, MD
Donna C. Novak, MBA
Steven Guyton, MD
Guests
Arnold J. Krubsack, PhD
Jeff Abrams, MD
Industry Representative
Michael S. Klein, MBA
HCFA Representative
Sean R. Tunis, MD
The Diagnostic Imaging Panel met on June 19, 2001, to discuss the use of Positron Emission Technology (PET) in the diagnosing and staging of breast cancer. The meeting began with a reading of the conflict of interest statement, and the call to order.
Charge to Panel. The chairman presented the charge to the Panel, to advise Health Care Financing Administration (HCFA) on the quality of the evidence concerning the use of PET in diagnosing and staging breast cancer.
Presentation of Questions. A HCFA representative presented the Panel with the five questions for consideration relating to different indications for the use of PET. He emphasized to the Panel that if the answer to any question was yes, HCFA would also ask the Panel to assess the size of effect utilizing a seven-point scale laid out by the Executive Committee (EC).
Presentation of Blue Cross/Blue Shield TEC Assessment. David Samson presented a summary of the Technology Evaluation Center (TEC) assessment, stating that TEC considered evidence relating to the use of PET for four indications: 1) initial diagnosis of breast cancer; 2) initial staging of lymph nodes; 3) detection of locoregional or distant metastases recurrence; 4) and evaluating response to therapy. These indications yielded the following conclusions: For indication one, there is incomplete data on the full spectrum of patients, but risk-benefit tradeoffs do not appear acceptable in the intermediate to higher prevalence group; for indication two, diagnostic performance data is sparse with poor studies, and risk-benefit tradeoffs do not appear acceptable; for indication three there are sparse and insufficient data and no concordance or discordance related to PET's accuracy; for indication four there are only heterogeneous studies with small patient pools, and substantial potential for undertreatment. Following Mr. Samson's presentation, he responded a number of questions from the Panel.
Scheduled Public Comments. The Panel heard from three scheduled speakers, Sam Gambhir, MD, David Rollo, MD and Steven Larson, MD.
Dr. Gambhir's conclusions were that FDG-PET has a biochemical basis that will continue to reinforce the accuracy of the test in various clinical settings. He encouraged the Panel to not focus exclusively on breast cancer literature. He further encouraged the Panel to focus on the needs of underserved women, particularly those with dense breasts, asserting that unlike conventional imaging techniques, PET is unaffected by density of breasts.
Dr. Rollo spoke as a representative of the National Electrical Manufacturing Association. He encouraged the Panel to take into consideration the full spectrum of information presented, and to consider that the Federal Government has made improved diagnosis and treatment of breast cancer a national priority. He encouraged the Panel to take a flexible approach in making its recommendations, rather than a specific indication-by-indication decision. Dr. Rollo presented an example of PET success from personal clinical experience.
Dr. Larson spoke as a representative of the American Society of Clinical Oncology (ASCO). He read a statement from the president of ASCO on FDG-PET for breast cancer diagnosis and staging. Dr. Rollo then summarized an abstract that will be presented to the Society of Nuclear Medicine later this year.
Open Public Comments. Peter Conti, MD, a representative from the Society of Nuclear Medicine (SNM), American College of Radiology (ACR) read a statement from that group, recommending that the use of PET be approved at the discretion of the referring physician in the diagnosis of known or suspected recurrent or metastatic disease for the purpose of restaging patients with breast cancer.
Richard Wahl, MD mentioned a study that he is conducting, and encouraged the Panel to support the ACR SNM position.
Ms. Kim Pierce, breast cancer survivor and member of the National Breast Cancer Coalition, presented a petition with over 1,000 signatures encouraging HCFA to cover PET. She related her own personal experience, and encouraged HCFA to make PET available to the women who need it.
Irv Weinberg, MD asked the Panel to consider the effect of their decision on emerging technologies for physiologic and biochemical imaging of breast disease.
Abass Alavi, MD gave the Panel a brief history of PET, and pointed out that 25 years later PET's role was still being argued, while MR was approved in two or three years. He also stated his belief that PET would be effective, especially for metastatic cancer.
Open Panel Discussion. The Panel held a lengthy discussion concerning the use of PET in various indications. A great deal of focus went to the issue of dense breasts, and how PET is more effective at assessing women with dense breast tissue than other modalities, although there may be little in the published literature to support that.
A representative from the Agency for Healthcare Research and Quality explained how the five questions before the Panel were devised, after which there was further discussion of the issue of dense breasts, and other issues related to PET application.
Final Panel Recommendations. The Panel voted on the following six questions:
1) Is there adequate evidence that PET can improve health outcomes when used to decide whether to perform a biopsy in patients with an abnormal mammogram or palpable mass? The Panel voted unanimously in the negative.
2) Is there adequate evidence that PET can improve health outcomes by leading to earlier and more accurate diagnosis of breast cancer compared to short interval mammographic, vis-a-vis three to six months follow-up in patients with low suspicion findings on mammography and other routine imaging procedures? The Panel voted unanimously in the negative.
3) Is there adequate evidence that PET improves health outcomes when used to decide whether to perform axillary lymph node dissection? The Panel voted unanimously in the negative.
4) Is there adequate evidence that PET improves health outcomes as either an adjunct to, or replacement for, standard staging tests in detecting locoregional occurrence or distant metastases recurrence? (There was extensive discussion before the question was called to a vote, particularly separating the adjunct to and replacement considerations) The question was then changed to: Is there adequate evidence that PET improves health outcomes as an adjunct to standard staging tests in detecting locoregional recurrence or distant metastases/recurrence when results from other tests are inconclusive? The Panel voted affirmatively, with five votes in the affirmative and one abstention. (At the request of HCFA Medical Officer Mitchell Burken, MD, the Panel discussed the level of effectiveness of PET in this indication, but was unable to reach consensus on which level had been established.)
5) Is there adequate evidence that PET improves health outcomes as a replacement for standard staging tests in detecting locoregional recurrence or distant metastases recurrence? The Panel voted unanimously in the negative.
6) Is there adequate evidence that PET can improve health outcomes by providing either a more accurate or earlier determination of tumor response to treatment compared to the use of conventional response criteria which may rely upon clinical exam and/or standard imaging tests, i.e., CT, MR or bone scan? The Panel voted unanimously in the negative.
Closing Remarks. The Chairman informed the panelists and the public that in all likelihood, these recommendations will face ratification by the EC, since Benefits Improvement Protection Act does not take effect until October 1, 2001.
Adjournment. The meeting adjourned at 3:56 p.m.
I certify that I attended the meeting
of the Diagnostic Imaging Panel
on June 19, 2001, and that these minutes
accurately reflect what transpired.
_________________________________
Janet Anderson
Executive Secretary, HCFA |
I approve the minutes of this meeting
as recorded in this summary.
______________________________
Frank J. Papatheofanis, MD, PhD, MPH
Chairperson
