Ordering and Reimbursement Resources for PYLARIFY®

PYLARIFY® Availability

PYLARIFY® is Available Nationwide

Looking for a PYLARIFY® imaging site near your postal code? LEARN MORE

Find the nearest PYLARIFY® center to you

For information about ordering PYLARIFY® for your imaging site, and how to get started, contact PYLARIFY®
Customer Support at 1-800-964-0446 1-8‌00-9‌64-0446 M-F 8:30 am-8:00 pm ET, or email cspyl@lantheus.com.

Please refer to the map below for the production site nearest you.

Looking for a PYLARIFY® imaging site near your postal code? LEARN MORE

Delivery time and delivery area may vary. For more information about ordering
PYLARIFY® outside available cities, please call 1-800-964-04461-8‌00-96‌4-0446.

Available Now

Alabama, Birmingham
Arizona, Phoenix
Arkansas, Little Rock
California, Culver City
California, Gilroy
California, Loma Linda
California, Sacramento
California, San Francisco
Colorado, Denver
Florida, Fort Lauderdale
Florida, Jacksonville
Florida, Tampa
Georgia, Atlanta
Illinois, Chicago
Illinois, Romeoville
Iowa, Davenport
Kentucky, Louisville
Louisiana, Covington
Massachusetts, Boston
Massachusetts, Haverhill
Michigan, Detroit
Minnesota, Minneapolis
Missouri, Columbia
Missouri, Kansas City
Nevada, Las Vegas
New Jersey, Hackensack
New Jersey, Totowa
New Mexico, Albuquerque
New York, Albany
North Carolina, Raleigh
Ohio, Oakwood Village
Oregon, Portland
Puerto Rico, San Juan
South Carolina, Columbia
Tennessee, Gray
Tennessee, Knoxville
Tennessee, Nashville
Texas, Dallas
Texas, Houston
Utah, Salt Lake City
Virginia, Sterling
Washington, Seattle
West Virginia, Morgantown
Wisconsin, Milwaukee

Iowa, Davenport
Kentucky, Louisville
Louisiana, Covington
Massachusetts, Boston
Massachusetts, Haverhill
Michigan, Detroit
Minnesota, Minneapolis
Missouri, Columbia
Missouri, Kansas City
Nevada, Las Vegas
New Jersey, Hackensack
New Jersey, Totowa
New Mexico, Albuquerque
New York, Albany
North Carolina, Raleigh

Ohio, Oakwood Village
Oregon, Portland
Puerto Rico, San Juan
South Carolina, Columbia
Tennessee, Gray
Tennessee, Knoxville
Tennessee, Nashville
Texas, Dallas
Texas, Houston
Utah, Salt Lake City
Virginia, Sterling
Washington, Seattle
West Virginia, Morgantown
Wisconsin, Milwaukee

Planned Future Sites

Florida, Sanford
Missouri, Kansas City
Missouri, St. Louis
New York, Albany
North Carolina, Winston-Salem
Ohio, Cleveland
Oklahoma, Tulsa
Pennsylvania, Philadelphia
Texas, Houston
Washington, Spokane

Delivery time and delivery area may vary. For more information about ordering
PYLARIFY® outside available cities, please call 1-800-964-04461-8‌00-96‌4-0446.

Reimbursement Resources

For questions relating to reimbursement for patients, providers, and payers, please call or download the resources below

Reimbursement Hotline:

844-339-851484‌4-33‌9-8514

Reimbursement Support includes:

Billing, Coding, and Claims Information for PYLARIFY® (piflufolastat F 18) injection and related procedures
Coverage for Specific Payers: We can assist with claims and coverage issues for PYLARIFY® and related procedures with your local and regional payers
Radiology Benefit Managers (RBMs): While payers pay your claims, many have handed coverage off to their RBM partners. These partners develop clinical coverage guidelines that will determine what procedures will be approved—we can provide support to establish coverage and assist in pre-authorization of claims with the RBMs you deal with
Benefit Investigation: The Hotline will verify patient insurance benefits, including deductible and copayments, any prior authorization requirements, and determine any possible coverage restrictions such as to network or place of service
Prior Authorization (PA) Assistance: If PA is required, we will work with providers on submitting a request for prior authorization and assist in appealing a denied request for approval
Appeal/Peer-to-Peer Assistance: When a claim is denied, we offer assistance on appealing the denial with the payer

Reimbursement Resources

PYLARIFY® Coding and Billing Guide: Includes PYLARIFY® billing codes (NDC, Diagnosis/ICD 10 code[s], CPT, HCPCS [J-code, A-code]), as well as details about PYLARIFY® access and reimbursement support services

Download Coding and Billing Guide

PYLARIFY® Access & Reimbursement Best Practices Guide: Includes recommendations for inquiring with a patient’s payer prior to administration, managing expectations for cost and coverage, steps to take upon potential denials, and reimbursement scenarios/cases

Download Access & Reimbursement Guide

Patient Resources

Patient Brochure: Includes information on prostate cancer, an overview on how PYLARIFY® can help create an optimal treatment plan as well as what to expect when having a PET scan

Download Patient Brochure

How to Use PYLARIFY® PYLARIFY AI™

INDICATION & IMPORTANT
SAFETY INFORMATION

PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

INDICATION

with suspected metastasis who are candidates for initial definitive therapy.
with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

IMPORTANT SAFETY INFORMATION

Contraindications

None.

Warnings and Precautions

Risk of Image Misinterpretation

Imaging interpretation errors can occur with PYLARIFY imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Hypersensitivity Reactions

Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks

Diagnostic radiopharmaceuticals, including PYLARIFY, expose patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies with PYLARIFY. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug Interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY in prostate cancer. The effect of these therapies on performance of PYLARIFY PET has not been established.

To report suspected adverse reactions for PYLARIFY, call 1-800-362-26681-80‌0-36‌2-2668 or contact FDA at 1-800-332-10881-800-FDA-1088 or www.fda.gov/medwatch.

For important risk and use information about PYLARIFY Injection, please see Full Prescribing information.

Reference

FDA clearance letter for aPROMISE X. Food and Drug Administration. April 29, 2022.