Topic Suggestion

1. What is the decision or change you are facing or struggling with where a summary of the evidence would be helpful?

We are interested in understanding the importance of subclinical lymphedema in the management of lymphedema post-breast cancer treatment. Providers/Payers are looking to understand which diagnostic tools have the highest specificity in diagnosing subclinical lymphedema.

The following diagnostic tools are mentioned in publications:

• Tape measure has been mentioned in publications as a method to assess lymphedema, but tape measure can’t detect subclinical lymphedema.  By the time tape measurement detects increased volume, patient has clinically already developed lymphedema.  Tape measurement also lacks inter-rater reliability and there is no consensus on thresholds to detect lymphedema.
• Perometry is often cited in publications, but it is not FDA cleared for measurement of lymphedema, the equipment is expensive, cumbersome and not supported in the USA – therefore it is not commonly used.
• Bioimpedance spectroscopy (BIS) can detect changes in extracellular fluid before obvious clinical symptoms occur allowing earlier intervention such as compression sleeve and preventing functional impairment.
• 20-30% of cancer survivors will develop lymphedema. More than 5 million patients suffer from lymphedema. The annual cost of lymphedema is well over $7 billion.

2. Why are you struggling with this issue?

Breast cancer survivors’ rate recurrence of their cancer as their number one concern, but their second concern is developing chronic lymphedema.

Breast cancer guidelines require clinicians to monitor for lymphedema, but there is no summary of the evidence recognizing importance of subclinical lymphedema and recommended diagnostic tools based on diagnosis of subclinical lymphedema.

Payers are not covering technologies such as bioimpedance and have questioned the importance of detecting subclinical lymphedema.  As a result, patients are not being diagnosed at subclinical level causing delayed treatment.  As lymphedema progresses treatment becomes more complex and costly.

3. What do you want to see changed? How will you know that your issue is improving or has been addressed?

We want to see payers and providers understand the importance of subclinical lymphedema and how best to diagnose subclinical lymphedema. We will know the issue is improving when breast cancer patients at high risk of developing lymphedema are proactively being monitored for subclinical lymphedema.

4. When do you need the evidence report?

Sun, 12/01/2019

5. What will you do with the evidence report?

A report would inform clinical decision-making for patients, payers and providers.

(Optional) About You

What is your role or perspective?

Manufacturer working with provider and payer community on coverage for technologies used to detect and monitor subclinical lymphedema

If you are you making a suggestion on behalf of an organization, please state the name of the organization.

ImpediMed

May we contact you if we have questions about your nomination?

Yes