PRRT – FDA Approves Lutathera®, What’s Next?

The FDA approval of Lutathera®, a peptide receptor radionuclide therapy (PRRT), on January 26, 2018 signals a new era in treatment options for the neuroendocrine cancer community.  It has also raised a host of questions including:

  • What exactly is this treatment?
  • Where do I go to get PRRT?
  • Will my insurance cover this therapy?


What is PRRT?

PRRT is a form of targeted treatment comprised of a targeting molecule which carries a radioactive component. Once administered through infusion drip (IV) into the bloodstream, the targeting molecule binds to a specific receptor on tumor cells, and is then internalized into the target cells, where the radioactive component destroys the tumor cells from within.


Where is PRRT with Lutathera® being offered in the United States?

The sites most likely to offer PRRT under the new FDA approval will be those that offered PRRT through the Expanded Access Program (EAP).  A total of 41 sites in Arizona, California, Colorado, Florida, Georgia, Illinois, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New York, North Carolina, Pennsylvania, South Carolina, Texas, Utah, Virginia, and the State of Washington participated in the EAP compassionate use program.  See a list of EAP sites here: Click on the plus sign next to Contacts and Locations.  With the FDA approval of Lutathera® the Expanded Access Program has closed to new participants; those enrolled prior to the FDA approval will still be able to complete the 4 treatment cycles as part of the Expanded Access Program.


Which sites, both those that offered EAP and new sites, will offer PRRT with Lutathera® first?

It is a complex process for any institution to begin treating NET patients under the new FDA approval. Physicians and nuclear medicine departments need a variety of permissions in their institutions before these treatments can begin.  The amount of time it takes for an institution to come onboard varies.  Additionally, institutions need to decide how many patients they will treat weekly and ensure that the institution can accommodate these patients (for example, each patient requires a separate room with access to an isolated (non-public) bathroom).

Currently, Lutathera® is manufactured in Italy and flown to the United States.  Given the transportation time and half-life of Lutathera®, patients in the EAP program are only treated on Wednesday, Thursday and Friday.  Beginning later this year, Lutathera® will also be manufactured in New Jersey, opening additional days for PRRT treatments.

It is anticipated that within a year between 60 and 70 sites in the United States could be offering PRRT with Lutathera®.


Will my insurance cover PRRT with Lutathera®?

This is a question NET patients are asking every day.  At this time, there is no guarantee that all insurance companies will cover all aspects of PRRT, although it is hoped that the various institutions administering the treatment will assist patients in getting insurance coverage.  The best course of action is to work with your provider on obtaining prior authorization or pre-determination to determine whether your insurance is recognizing and covering Lutathera®. While the process of private insurance companies evaluating and deciding on coverage of new therapies varies by company, CMS (Center of Medicare and Medicaid Services) covers FDA approved drugs, as long as they are used on label.  It is possible that some aspects of the bill will be covered, such as the amino acid infusion that is used to protect a patient’s kidneys during this treatment, the cost of medical personnel involved in the treatment, etc., while other costs, such as Lutathera®, may not be covered.  It is also possible that some institutions will choose to wait to offer PRRT with Lutathera® until insurance companies have decided on coverage.


The Carcinoid Cancer Foundation will continue to update the NET community about where PRRT with Lutathera® is available and any other relevant information.  We will create a blog post similar to the one we created about where the Gallium 68 PET/CT scan with NETSPOT is being offered that we will update as we receive new information.

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