Frequently asked questions about radioligand therapy (RLT)

What is radioligand therapy (RLT)?

Radioligand therapy (RLT) is a type of radiation therapy that is injected or infused. RLT combines a targeting compound or ligand, which binds to a specific marker with a radioisotope, creating what is called a radioligand, to locate and destroy cancer cells.

The ligand directs the radioisotope to the target cancer cells expressing the specific marker, even when they have spread throughout the body, to deliver radiation directly to these cancer cells.

How does RLT work?

RLT works by first binding to specific biomarkers on cancer cells and then delivering radiation precisely to the targeted cancer cells. This unique mechanism of action aims to damage or destroy target cancer cells or cells of the tumor microenvironment with the goal of limiting impact on nearby healthy cells.

How is RLT administered?

RLT is administered as an injection or intravenous (IV) infusion at treatment centers trained to safely handle radioactive materials.

What roles are needed to structure an RLT program?

An RLT program typically requires communication, planning, and coordination among a multidisciplinary team (MDT) involving multiple specialties and individuals, with each member of the team helping to fulfill specific roles to streamline the process and deliver quality patient care. 

Individual practices and responsibilities for RLT may vary on the basis of institutional organization and available resources, but will typically include a medical oncologist, radiation oncologist, radiation technicians, and nursing staff.

What components make up RLT?

There are 4 key components that make up RLT:

1. Radioisotope

2. Targeting ligand

3. Chelator

4. Linker 

These components all work together in a cohesive unit to deliver targeted radiation to cancer cells in the body with the goal of limiting impact on nearby healthy cells.

What are “theranostics” or the theranostic approach?

Theranostics refers to the pairing of a diagnostic and a therapeutic radiopharmaceutical to target the same biomarker for both imaging and treatment. Combining “therapy” and “diagnostics” into a “theranostic pair” offers a precision medicine approach to treating cancer.

How does the theranostic approach work?

A diagnostic imaging agent is introduced first; it binds to specific markers on cancer cells, allowing doctors to “see” the tumors on imaging scans and determine eligibility for the paired therapy. A therapeutic agent is then used to “treat” the cancer by delivering targeted radiation to those same cancer cell targets, treating the disease with potentially limited damage to healthy cells.

How many patients have been treated with Novartis RLTs?

Nearly 50,000 patients with cancer have been treated with Novartis RLTs since 2018. With the number of patients eligible for treatment expected to grow in the coming years, particularly in breast, lung, and ovarian cancer, Novartis remains committed to bringing RLT to those patients right when they need it.

How many RLTs are approved for use?

Novartis offers 2 RLTs, which have treated nearly 50,000 patients to date. The first of these 2 RLTs was approved in 2018.

How many RLT clinical trials is Novartis working on?

Novartis has 18 clinical and preclinical trials investigating multiple isotopes, ligands, and combinations in numerous tumor types and therapeutic areas, including breast, prostate, lung, and pancreatic cancer.

Where does Novartis produce RLTs?

There are 3 Novartis manufacturing sites currently operating in the US: Millburn, NJ; Indianapolis, IN; and Carlsbad, CA. Novartis is working on increasing production to ensure continued access to RLTs, with sites planned to open in Denton, TX, in 2028 and Winter Park, FL, in 2029.

How many doses of RLT can Novartis produce?

In 2024, Novartis reached an RLT production capacity of 250,000 doses. Novartis was the first company to build the first fully automated production line specifically designed for RLT manufacturing.

What RLT treatment sites are close to my office?

There are over 850 RLT treatment sites across the United States. 90% of patients eligible for RLTs live within 30 miles of a treatment site. You can contact a Novartis representative for help with finding RLT treatment centers closest to your patients. You can also call Novartis Patient Support™ at 1-844-638-7222, Monday through Friday, 8 AM-8 PM ET, for additional information.

How long does it take for RLTs to be delivered?

Novartis is making sure our RLT treatments get to patients as quickly as possible, with 99% on-time delivery within 5 days of ordering.

Who can help my office with the referral process and reimbursement for RLTs?

Novartis Patient Support team can help guide you and your patients through the referral process and financial assistance, including coverage, acquisition, administration, and reimbursement. You can start the process by submitting a Start Form.

What is WAC, AWP, and ASP?

WAC, AWP, and ASP are pricing benchmarks. Understanding the different pricing benchmarks is important for reimbursement.

• WAC (or invoice) represents the manufacturer's list price for a drug to wholesalers or direct purchasers, but does not include discounts or rebates

• AWP is published by third-party sources of pricing data, but does not represent an actual price paid. Often estimated as a 20% mark-up applied to manufacture WAC

• ASP is the manufacturer's average price to all purchasers, net of applicable discounts, chargebacks, and rebates for drugs

What is a JW/JZ modifier and when should they be used?

JW and JZ modifiers are Medicare billing codes applied to drugs payable under Medicare Part B that are described as a “single-dose” container or “single-use” package.

• JW modifier is required on all claims to report the amount of drug discarded or not administered. The modifier should only be used for claims that bill single-dose container drugs

• JZ modifier is required on all claims when there are no discarded amounts. The modifier should only be used for claims that bill for single-dose container drugs