Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

What is the comparative effectiveness of new modalities or approaches to breast imaging, compared to standard approaches, to screen for, diagnose, plan treatment or follow up patients with breast cancer? New modalities include digital tomosynthesis, positron emission mammography (PEM), molecular breast imaging (MBI), and computed tomography of the breast (breast CT; still in development and not yet approved for marketing). New approaches use existing technology and include contrast-enhanced, full field digital mammography and diffusion-weighted imaging with magnetic resonance imaging (DWI-MRI).

An update of an AHRQ report on noninvasive diagnostic tests for breast cancer is underway, but it focuses solely on screening and on more established technologies, such as mammography, MRI, and ultrasound. The proposed report would focus on newer technologies and approaches, as well as additional uses. Because the literature may be limited, a technical brief that both reviews the new technologies and applications and that proposes a framework for assessing their use may be the best approach.

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

Newer technologies and approaches (listed in item 1) versus standard approaches for the following uses related to breast cancer:

• Screening for breast cancer, especially among women at high risk or with dense breasts
• Resolving equivocal screening cases
• Presurgical planning, to identify multifocal and multicentric disease
• Evaluating the impact of neoadjuvant therapy during or after treatment
• Surveillance following treatment

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

All women undergoing screening for breast cancer, as well as patients with breast cancer.

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

1. Women at high risk of disease, including BRCA mutations carriers and others with family histories that elevated the risk of breast cancer.
2. Follow-up after breast cancer treatment
3. Women with dense breasts, using the Breast Imaging Reporting and Data System (BIRADS) categorization.

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

• Longer overall survival, due to earlier detection and potentially more effective treatment
• Longer recurrence-free survival, due to earlier detection and potentially more effective treatment
• Reduction in unnecessary biopsies, due to a reduction in false positive results

Describe any health-related risks, side effects, or harms that you are concerned about.

• Exposure to larger doses of radiation, from increased use of tests that require radiation
• Unnecessary biopsies and mastectomies, if for example, additional lesions are found in the ipsilateral breast. However, this is an already controversial with regard to MRI.
• Undergoing multiple tests, some of which may not provide any incremental value.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Cancer

AHRQ Priority Populations

• Minority groups
• Women
• Elderly

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

• Breast cancer affects a large number of women in the United States, both those who have the design and those at elevated risk who must undergo increased screening beginning at an earlier age
• There is controversy regarding the appropriate use and response to imaging tests such as MRI for pre-surgical planning; the uncertainty is likely to increase with the proliferation of new imaging modalities and procedures.
• Health plans want to support the use of the most effective compendium of tests that will improve patient outcomes.
• Breast cancer risk increases with age, so is likely to have a significant impact on the Medicare population.
• The new technologies need to be evaluated separately for each indication, e.g., screening, diagnosis, treatment planning, follow-up.
• Potential increases in radiation exposure by a radiosensitive organ, namely the breast, need to be evaluated carefully.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

Many sessions of the 2010 annual meeting of the Radiological Society of North America focused on these new breast imaging modalities and approaches, with some comparisons to established technologies and uses. The preferred uses of these technologies have yet to be established, especially compared to existing practices, although many possibilities were mentioned. The Blue Cross Blue Shield Plans have focused on the appropriate use of breast imaging modalities for over a decade. As with patients and clinicians, the Plans support the use of those technologies most likely to improve patient outcomes. The results of the proposed research would provide BCBS Plan decision-makers with information for medical policies decision-making

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

It is not clear which imaging technologies are most effective for each breast cancer-related indicators, and what the relative benefits and risks are. Providers will soon make decisions about whether or not to invest in the new modalities.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

BlueCross BlueShield Plan Medical Directors will use the results in the development of medical policies.

Describe the timeframe in which an answer to your question is needed.

There is an urgent need for this topic to be addressed quickly—within 12 months. Because imaging often requires major expenditures to acquire new equipment, it is hard to revise course if and when new information is released. This area is on the cusp of major developments

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

This question will address choices for women at high risk for breast cancer and those with dense breasts for whom mammography performs more poorly than for the general population of women. It will disproportionately affect older women, who are more likely to have breast cancer. Ideally, it will also provide information that is useful to African American women, who experience worse outcomes from breast cancer than white women.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

BlueCross BlueShield Plan Medical Directors will use the results in the development of medical policies.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program

BlueCross BlueShield Plans routinely use information issued by the EHC. The BlueCross BlueShield Association Technology Evaluation Center is an Evidence-based Practice Center of AHRQ. BCBS EPC staff were consulted in the preparation of this nomination. This topic nomination was based on input from the BlueCross BlueShield Plan Medical Directors.