[Please note – providers should be sure to follow individual payers’ requirements for preparing
and submitting letters of medical necessity. Although this template letter is intended to support a
request for coverage, providers may need to comply with additional payer-specific requirements.
Providers are responsible for customizing the letter to reflect the unique background and
diagnosis of a particular patient, as well as the special requirements of the particular payer
involved. The provider is responsible for ensuring the medical necessity of the procedure.]
[insert physician or practice letterhead]
[insert date]
[insert Medical Director Contact name]
[insert Payer organization name]
[insert Street address]
[insert City, State, Zip Code]
RE: [insert patient name]
Date of Birth: [insert patient’s DOB]
Policy ID/Group Number: [insert policy ID/Group number]
Policy Holder: [insert policy holder’s name]
Dear [insert payer medical director/contact name]:
I am a(n) [breast surgeon/oncologist/etc.] writing on behalf of my patient, [insert patient name], to
request prior authorization approval and to document the medical necessity of Lymphoseek®
(technetium Tc 99m tilmanocept) Injection to assist in the localization of lymph nodes draining a primary
tumor site in patients with breast cancer or melanoma.
As there is no HCPCS product code to report Lymphoseek® for the localization of lymph nodes draining a
primary tumor site, I am submitting this prior authorization request under HCPCS code A4641
[Radiopharmaceutical, diagnostic, not otherwise classified] (for Lymphoseek®)and CPT code [Insert
procedure code used] (for the procedure). This letter and the enclosed references provide support for
approval of this prior authorization request.
On March 13, 2013, Lymphoseek® was approved by the FDA for the lymphatic mapping with a hand-held
gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with
breast cancer or melanoma.1
The safety and efficacy of Lymphoseek® for the localization of lymph nodes draining a primary tumor site
were evaluated and assessed in two open-label, multicenter, single arm, within-subject active comparator
trials of patients with melanoma or breast cancer.1,2,3 In Phase 3 clinical trials, Lymphoseek® on average,
was present in 97% (range 94%-100%) of resected and histopathology confirmed lymph nodes.1
Lymphoseek® localized an average of 2.4 lymph nodes per patient.1
In clinical trials, no serious adverse reactions were reported during clinical trials with Lymphoseek®. The
most common adverse reactions in clinical trials (n = 542 patients) were:1



Injection site irritation: 0.6%; n = 3 of 542
Injection site pain: 0.2%; n = 1 of 542
Other adverse reactions were uncommon, and of mild severity and short duration
Diagnostic efficacy was determined by the number of histology-confirmed lymph nodes detected by
Lymphoseek®. Lymphoseek® (50 mcg; 0.5 mCi) was injected into patients at least 15 minutes prior to the
scheduled surgery, and blue dye was injected shortly prior to initiation of the surgery. Intraoperative
lymphatic mapping was performed using a hand-held gamma detection probe followed by excision of
lymph nodes identified by Lymphoseek®, blue dye, or the surgeon’s visual and palpation examination. The
resected lymph nodes were sent for histopathology evaluation.1
In Study One, of 179 patients who received Lymphoseek®, 94 (53%) had known or suspected breast
cancer and 85 (48%) had known or suspected melanoma. The median age was 59 years (range 20 to 90
years) and most (72%) were women.1
In Study Two, of 153 patients who received Lymphoseek, 77 (50%) had known or suspected breast
cancer and 76 (50%) had known or suspected melanoma. The median age was 61 years (range 26 to 88
years) and most (68%) were women.1
For additional information, please visit Lymphoseek.com or call Navidea at 1-800-476-5270.
[Mr./Ms./Mrs.] [insert patient’s last name] is a [insert age] year old [female/male] who has [breast
cancer/malignant melanoma] (ICD-9-CM [insert ICD-9 codes]). [Mr./Ms./Mrs.] [insert patient’s last
name] presented to me on [insert date] with [details such as physical exam results and clinical
impressions]. [Mr./Ms./Mrs.] [insert patient’s last name] is a candidate for Lymphoseek® (technetium Tc
99m tilmanocept) injection to assist in the localization of lymph nodes draining a primary tumor site in
patients with breast cancer or melanoma. [If other localization products were used or considered prior to
Lymphoseek®, would add: Other therapies [tried/considered] as part of the localization of [Mr./Mrs./Ms.]
[insert patient’s last name]’s lymph nodes included [describe other products]. However, [provide
rationale for using Lymphoseek® as compared to comparator products, or why it was used following a
comparator product].]
I request confirmation that this procedure is a covered benefit based on medical necessity, and that
associated fees will be covered. Thank you for your review of this information and for your coverage
consideration. If you have any questions or require additional information, please contact me at [insert
physician’s contact information].
Sincerely,
[Physician Signature]
[Physician’s full name]
[Address]
[Telephone number]
Indication
Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a handheld gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients
with 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.
The most common adverse reactions are injection site irritation and/or pain (<1%).
References:
1. LYMPHOSEEK Injection Package Insert. Dublin, OH: Navidea Biopharmaceuticals, Inc., Dublin OH;
February 2013.
2. Sondak VK, King DW, Zager J, et al Combined analysis of Phase III trials evaluating
[99mTc]Tilmanocept and vital blue dye for identification of sentinel lymph nodes in clinically
node-negative cutaneous melanoma. Ann Surg Oncol 2013;20:680-8.
3. Wallace AM, Han LK, Povoski SP, et al. Comparative evaluation of [99mTc] Tilmanocept for
sentinel node mapping in breast cancer patients: results of two phase 3 trials. Ann Surg Oncol.
2013; doi 10.1245/s10434-013-2887-8.