Lymphoseek

The information on this web site is intended for use only by healthcare professionals in the United States.

Reimbursement & Formulary

Formulary Kit and Downloads

Formulary Kit and Downloads

Get the information you need to help make Lymphoseek® part of your facility’s formulary. Download and print either the entire Formulary Kit or individual sections.


OR

Download Individual Sections

Cover Letter:
This letter highlights the components of the Formulary Kit for Lymphoseek.

FDA Approval Letter:
Read the letter issued by the US Food and Drug Administration approving the New Drug Application (NDA) for Lymphoseek.

Clinical Summary:
This document provides important and meaningful information about the role of lymphatic mapping and sentinel lymph node biopsy—and the use of Lymphoseek—in helping to assist in the localization of lymph nodes draining a primary tumor site in patients with clinically node negative breast cancer, melanoma, and squamous cell carcinoma of the oral cavity. Specific information related to Lymphoseek includes product indication, recommended dosing and administration, pharmacokinetics, clinical data, publication summary, and safety profile.

Coding Information Sheet—CPT, HCPCS, and ICD-10-CM:
This reference sheet for physicians features relevant Product, Procedure, and Diagnosis coding information that may be applicable for billing purposes.

Lymphoseek Package Insert:
Access the FDA-approved full Prescribing Information for Lymphoseek.

Material Safety Data Sheet:
The MSDS lists important health and safety precautions for the preparation, handling, and use of Lymphoseek.

Ordering Information:
Get the information you need to order Lymphoseek for your facility—right at your fingertips. Find more information on how to order Lymphoseek.

Reimbursement Kit and Downloads

Reimbursement Kit and Downloads

The Lymphoseek Reimbursement Kit was designed as a resource guide for physicians and administrators seeking to submit claims for the use of Lymphoseek and to help troubleshoot any potential issues with payors. Download and print either the entire Reimbursement Kit or individual sections.


OR

Download Individual Sections

Cover Letter:
This letter provides an overview of available resources to help with the reimbursement process for Lymphoseek.

Clinical Summary:
This document provides important and meaningful information about the role of lymphatic mapping and sentinel lymph node biopsy—and the use of Lymphoseek—in helping to assist in the localization of lymph nodes draining a primary tumor site in patients with clinically node negative breast cancer, melanoma, and squamous cell carcinoma of the oral cavity. Specific information related to Lymphoseek includes product indication, recommended dosing and administration, pharmacokinetics, clinical data, publication summary, and safety profile.

Coding Information Sheet—CPT, HCPCS, and ICD-10-CM:
This reference sheet for physicians features relevant Product, Procedure, and Diagnosis coding information that may be applicable for billing purposes.

Letter of Medical Necessity for Prior Authorization (letter template):
Customize this letter template to request prior authorization approval of Lymphoseek from your patient’s payor/provider. Personalized sections are clearly marked so that you can insert your patient’s clinical and policy—related information.

Letter of Medical Necessity for Claim Review (letter template):
If a previously submitted claim for Lymphoseek has been denied, you can use this letter template to request a claim reevaluation. Personalized sections are clearly marked so that you can customize the letter and launch the appeals process in a timely manner.

This document provides important and meaningful information about the role of lymphatic mapping and sentinel lymph node biopsy—and the use of Lymphoseek—in helping to assist in the localization of lymph nodes draining a primary tumor site in patients with clinically node negative breast cancer, melanoma, and squamous cell carcinoma of the oral cavity. Specific information related to Lymphoseek includes product indication, recommended dosing and administration, pharmacokinetics, clinical data, publication summary, and safety profile.

*Indication

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

  • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
  • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

Please see full Prescribing Information.

To report suspected adverse reactions, contact Navidea Biopharmaceuticals, Inc. at 1-800-476-5270 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.