Since we shared the news of the FDA’s January 26, 2018 approval of peptide receptor radionuclide therapy, PRRT, with Lutathera (lutetium Lu 177 dotatate), more information has become available for the neuroendocrine tumor community, including updates about coverage and reimbursement; information about patient assistance programs being offered by Advanced Accelerator Applications (AAA), the manufacturer of Lutathera; new patient materials from Advanced Accelerator Applications; and locations where the treatment is currently being offered.
Scroll down for a state-by-state list of where PRRT with Lutathera is being offered as well as details from each institution where available. We will be adding details as they are received as well as additional locations as more institutions offer the treatment. Check back often!
Infographic, Key Facts about PRRT: Click here for the complete infographic which describes how PRRT works, who might benefit from it, how it is administered, etc: https://www.carcinoid.org/wp-content/uploads/2018/07/PRRT_Infographic_Final-2018-07-24.pdf
Many NET patients have asked “What is the insurance/billing code for PRRT?” At the current time, because Lutathera is a newly approved therapy, and until the Centers for Medicare and Medicaid Services (CMS) issues a product-specific billing code, institutions must use a temporary code. A permanent billing code is expected to be issued by January 2019. These codes help facilitate the reimbursement process for institutions.
As of July 1, 2018, there is a pass through code for Lutathera (this code is only for the medication, not for anything else involved in the treatment) for Medicare patients treated in hospital outpatient facilities, when used as per the FDA approval of the medication, also described as on-label. This code is C9031.
For Medicare patients, there should be coverage for on-label use of Lutathera, based on historical precedent with other newly approved medicines. If a doctor prescribes the medicine for off-label use, meaning for patients or conditions not included in the FDA approved indication, Medicare requires that the treatment is listed in compendia or supported by at least 2 peer-reviewed publications. This process is uncertain and requires a lot of work from the physicians and their staff.
For patients with private insurance, it could take several months for private (commercial) insurance companies to develop written policies regarding coverage of the PRRT procedure. In many cases, while payers are developing policies, patients are considered on a case-by-case basis. It is generally recommended that patients ask their insurance company for a pre-determination, versus prior authorization, although this does not guarantee coverage. Prior authorization is a quick and simple process (typically a few hours or days), where the physician submits some basic information regarding the patient and intended use of the treatment, and the insurance company confirms if the treatment meets certain criteria set by the insurance plan. In a pre-determination process, however, the insurance company looks at the design of the benefit plan and checks any newly approved drug lists, which can improve the likelihood of coverage. This process often takes a bit longer (a few weeks) compared to a prior authorization, and might include a peer review with the physician, depending on the individual insurance company or plan.
Patient Assistance Programs:
All patient assistance programs offered by AAA are administered by a third-party provider. The process for patient assistance must begin with the physician/health care provider. There are website and contact #s for physicians to access the forms and ask questions (insert link to updated AAAPatientConnect Brochure). Please work with your health care provider to apply for these programs. Any requests for verification of information or other inquiries will be sent only to the submitting physician, not the patient.
For patients with private (commercial) insurance, there is a co-pay assistance program. The level of co-pay assistance is determined based on the patient’s household income. Patients need to speak with their physicians and/or nurses about applying. The form must be completed and signed by both the doctor and patient. Patients cannot complete or submit this form on their own.
For patients who do not have private insurance, Medicare or Medicaid or other insurance, the Lutathera drug will be free; however, there will still be costs for the anti-nausea medication and amino acids given at the time of each treatment. There may be additional institutional costs including medical personnel and patients must work this out with the institution administering their treatment.
For Medicare patients, there will be automatic coverage for on-label use of Lutathera. If the doctor goes off-label, meaning prescribing the treatment for NET patients not included in the FDA approval (for example, pheochromocytoma and paraganglioma patients and lung neuroendocrine tumor patients as lung NETs are technically not gasteroenteropancreatic NETs), Medicare might not cover the treatments.
Advanced Accelerator Applications, AAA, has a new website regarding PRRT with Lutathera for both patients and providers: https://lutathera.com/. This website is intended for US residents only, there is a separate link for Non-US residents. There is also a separate section within the site for Healthcare Providers.
New Publications from Advanced Accelerator Applications:
- A Fact Sheet with basic “quick” info on Lutathera/PRRT, https://www.carcinoid.org/wp-content/uploads/2018/07/AAA_Lu177_US_0058_LUTATHERA_lutetitum_Lu177_dotatate_Patient_Fact-Sheet_Final-July-2018.pdf
- A brochure giving high level information on Patient Assistance Programs available through AAA PatientCONNECT™ , https://www.carcinoid.org/wp-content/uploads/2018/07/AAA_AAAPC_US_0012_AAAPC_Patient_Brochure_Final-July-2018.pdf
- A brochure with information about Lutathera, including some details regarding administration and follow up procedures and other helpful hints (including a brief mention of Patient Assistance Programs available via AAA PatientCONNECT™), https://www.carcinoid.org/wp-content/uploads/2018/07/AAA_Lu177_US_0057_LUTATHERA_lutetitum_Lu177_dotatate_Patient_Brochure_Final-July-2018.pdf
- A Journey of Hope: Moving Toward a Brighter Future in Neuroendocrine Tumor (NET) Treatment. A must-read about five neuroendocrine tumor patients, each with different experiences with Peptide Receptor Radionuclide Therapy (PRRT). With a foreword, “Hope is Like Air,” by neuroendocrine cancer specialist Eric Liu, MD, general surgeon, Rocky Mountain Cancer Centers, Denver, Colorado. https://www.carcinoid.org/wp-content/uploads/2018/04/A-Journey-of-Hope-Moving-Toward-a-Brighter-Future-in-Neuroendocrine-Tumor-NET-Treatment_2.pdf
National Comprehensive Care Network (NCCN) Oncology Guidelines: The most recent version of the NCCN Guidelines for Neuroendocrine and Adrenal Tumors (Version 2.2018, May 4, 2018) includes a new section entitled “Principles of Peptide Receptor Radionuclide Therapy (PRRT) with 177-LU-DOTATE1-4” beginning on page 56. You can register for a free account and access the guidelines here, https://www.nccn.org/professionals/physician_gls/default.aspx.
Animation from Advanced Accelerator Applications about PRRT with Lutathera (click below to watch)
STATE-BY-STATE LIST OF LOCATIONS OFFERING PRRT WITH LUTATHERA
It is not necessary for a patient to see a UCLA physician in order to be referred there for PRRT. Orders for PRRT are accepted from any licensed MD or DO within the United States. International patients do need to have a US physician refer them to UCLA for PRRT. If a patient would like to transfer their care to UCLA or would like to see an oncologist specializing in NET, it is recommend they contact Nicole Pope at the Santa Monica UCLA Oncology group, 310-829-5471. Dr. Randy Hecht is one of the highly recommended oncologists from this group, specializing in patients with NET.
To schedule an appointment at UCLA an order is needed from a physician. Once the order is faxed to UCLA (see below), either patients or referring providers’ offices can call to schedule a consult. A consult is always required prior to scheduling the therapy dates. During the consult, UCLA doctors discuss the therapy process and answer any questions the patient may have, and UCLA coordinators will schedule the entire 4 therapy cycles.
Phone number: To schedule an appointment or ask questions call the main scheduling line at 310-794-1005.
Fax number: 310-267-0227
Insurance questions: For questions regarding insurance, patients or doctors’ offices can call the main UCLA scheduling line above. If coordinators are not able to answer the caller’s questions, then they will transfer the caller to the billing staff. For orders from non-UCLA providers, patients must provide demographic information, insurance cards, and backup medical documentation. Authorization (when required) is needed for the initial pre-therapy consult visit. UCLA coordinators can also provide referring physicians’ offices with the billing codes necessary to request authorization (when required).
Additional Information: UCLA participated in the investigational (Expanded Access Protocol) study that helped make this an FDA-approved therapy and treated more than 30 patients during the investigational study.
All PRRT candidates must first be seen by one of the Mayo GI oncologists. Requests should be for a GI oncology consult for PRRT with Drs. Pashtoon Kasi, Dr. Kabir Mody or Dr. Gerardo Colon-Otero. A patient can request this or have his/her physician request the GI oncology consult.
Once seen by a Mayo GI oncologist, the physician will determine if the patient meets all the necessary requirements and is a candidate for PRRT. Then Mayo will go about scheduling the patient for the treatment.
Phone number: 904-953-0863
Fax number: 904-953-0896
Insurance questions can be answered at the phone number above. The same person patients speak to regarding booking the consult will review their insurance information with them to see if it is in or out of network etc.
Northwestern prefers that patients wishing to have PRRT schedule an appointment with one of the oncologists there (see below) to be evaluated for their symptoms, etc. Northwestern can then set up the PRRT treatment if recommended. Northwestern is still in the process of firming up its policy regarding PRRT for NET patients at their institution.
Northwestern oncologists with whom NET patients can make an appointment are: Al B. Benson III, MD; Mary Mulcahy, MD; Deva Mahalingam, MD; Aparna Kalyan, MD; and Sheetal Kircher, MD.
Phone: 312-695-0990 (for patients who wish to schedule an appointment with an oncologist) Patients should have their medical information available (i.e., name of your local oncologist) so that Northwestern can retrieve your medical records before your appointment. If you have questions, patients can also leave a message at this number for the team nurse.
Insurance questions: 312-695-0990 (If there is anything more specific please leave a message for the team nurse and Northwestern can have one of their financial assistance members contact you.)
Patients who wish to be considered for PRRT at Rush University should make an appointment with Dr. Xavier Keutgen in Rush’s NET clinic. The treatment schedule is handled by the Nuclear Medicine Department who will reach out to patients for scheduling times once Dr. Keutgen has approved them for PRRT and ordered treatment.
Telephone number for appointments with Dr. Keutgen: 312-942-5500
Fax number: 312-563-2228
For information regarding insurance questions, please contact:
Carmen Rodriguez | Administrative Manager
1725 W. Harrison Street
Suite 250 | Chicago, IL 60612
T: 312-563-2095| F: 312-563-2096
The University of Chicago Medicine often collaborates with outside offices for treatment of patients receiving PRRT. If patients are not currently established at UChicago Medicine, an initial consultation with one of the GI oncologists needs to be made. The leading UChicago Medicine GI oncologist treating patients with PRRT is Dr. Chih-Yi Liao. If patients prefer that their appointments outside PRRT treatments be received at a local facility, UChicago Medicine will coordinate care with their local provider. However, patients must have a follow-up with a UChicago Medicine GI oncologist prior to each PRRT appointment.
Patients’ insurance may require a referral. However, if a patient is currently under the care of another physician, a UChicago Medicine GI oncologist will communicate treatment recommendations to patients’ local provider. Patients can make appointments directly, as well.
For patients with commercial insurance, UChicago Medicine works with Advanced Accelerator Applications Patient CONNECT™ for financial assistance. Patients complete a form that is submitted to Advanced Accelerator Applications Patient CONNECT™. Once insurance coverage is confirmed, Lutathera is ordered for a patient’s initial PRRT treatment.
For insurance questions, contact LaKeisha Rattler 773-702-0436 or Melissa Rios 773-834-2914.
Telephone: 773-702-6149 to make an appointment with Dr. Chih-Yi Liao at UChicago Medicine
The University of Iowa NET team works closely with referring physicians and self-referred patients. All physician- and self-referred patient will require a consultation with one of Iowa’s two neuroendocrine oncologists (Thomas O’Dorisio, MD and Joseph Dillon, MD). Prior to this initial consultation, the following information and materials are required: 1) most recent clinic note from primary care physician or medical oncologist; 2) most recent CT/MRI report and CD; 3) report and CD of most recent 68Ga-DOTATATE PET; and 4)most recent pathology report and tissue block (or 8-10 unstained slides). If any of these required materials are unavailable, we will schedule appropriate CT/MRI and/or 68Ga-DOTATATE PET for the first visit.
University of Iowa Neuroendocrine Tumor Clinic: Director: Thomas M. O’Dorisio, MD; Co-director: Joseph Dillon, MD; Co-director: James R. Howe, MD; Medical Oncology: Chandharika Chandrasekharan, MD
Phone: 319-356-4200 (patients or referring physicians can request an appointment); Choose option 3, ask for Ms. Molly Becker or NET scheduler
Fax: 319-384-9874; Attention Ms. Kimberly Miller, NET nurse coordinator
Insurance questions: Handled at the time of scheduling the initial scheduling, 319-356-4200, option 3
Iowa has a NET clinic for children and adolescents; referrals can be made to M. Sue O’Dorisio, MD, 319-356-3595. Information and materials needed at the first visit are listed above.
Mayo Clinic Hospital requires at least 1 visit with 1 of the members of the NET team to determine eligibility for PRRT and to ensure that all the necessary studies have been done prior to proceeding such as receptor imaging (ideally gallium 68 DOTATATE PET). Mayo also wants to make sure that kidney and liver function is adequate and that patients understand the logistics of the treatment, the benefits and the risks. Patients who have not been treated at Mayo Clinic are able to have PRRT there but must have at least 1 visit with a NET team physician first.
Patients can initiate the process by calling the New Registration office for medical oncology. Providers can formally request an appointment and Dr. Thor Halfdanarson is happy to take questions from providers via his email (will generally not respond to patients he has not seen via email but promptly gets back to providers).
Phone, New Registration Office for Medical Oncology: ,507-284 -4137
The staff in the New Registrations Office can address initial questions. Insurance issues directly related to PRRT will probably not be addressed until Mayo places the orders for the treatment and preauthorization is obtained.
Samuel H. Mehr, MD is head of the CHI Health Creighton University Theranostics Center and is available to consult with any patient with a neuroendocrine tumor diagnosis considering PRRT. Dr. Mehr sees patients at CHI West Omaha Imaging, 17201 Wright Street, Suite 100, Omaha, Nebraska 68130-2042.
Patients or referring physicians may schedule the initial consultation. When the initial appointment is made, patients will be asked to have all medical records forwarded to Dr. Mehr.
During the initial visit, Dr. Mehr reviews the patient’s medical records, explains the treatment options for neuroendocrine tumors (including PRRT), performs a physical examination, and arranges for required diagnostic laboratory and imaging examinations.
Dr. Mehr will manage the patient’s care during the entire course of PRRT.
Questions regarding coordination and insurance should be addressed to Jill Shepherd, 402-717-4760.
Nebraska Cancer Specialists has partnered with Samuel H. Mehr, MD to provide Peptide Receptor Radionuclide Therapy (PRRT). Dr. Mehr is program director of the CHI Health Creighton University Medical Center Theranostics program, and has recently affiliated with Nebraska Cancer Specialists to provide this service in a community oncology setting. Dr. Mehr consults with patients who have a neuroendocrine tumor diagnosis that are considering PRRT. Patient swill have a brief consult with a medical oncologist from Nebraska Cancer Specialists specializing in neuroendocrine tumors.
Patients, or their referring physician, may schedule the initial consultation. In order to provide complete care, a copy of the patient’s medical records will be requested by Nebraska Cancer Specialists.
During the initial consultation visit, Dr. Mehr will review the patient’s medical records, explain treatment options for neuroendocrine tumors (including PRRT), perform a physical examination, and arrange for the required laboratory and diagnostic imaging.
Dr. Mehr, in collaboration with the medical oncologist, will manage the patient’s care during the entire course of PRRT. The patient will return to the care of their referring physician after completing PRRT treatment, and is welcome to receive any supportive treatments with Nebraska Cancer Specialists or with his/her referring oncologist.
The location of the Nebraska Cancer Specialists Theranostics Center is: 17201 Wright Street, Suite 200, Omaha, Nebraska 68130-2042.
Please direct any questions regarding coordination and insurance coverage to Annie Rudloff, Program Director, at (531) 444-1227.
Anyone with low or intermediate grade GI or pancreatic neuroendocrine cancer is eligible to get PRRT (per the FDA approved indication) as long as they have progressed on some other therapy, have adequate kidney function and there is uptake on an octreoscan or Gallium-68 Dotatate scan. Patients with lung NETs are not covered by the FDA indication. Patients from anywhere can come to Roswell Park and see Dr. Renuka Iyer to determine if they meet these criteria. Patients should expect to have an up-to date gallium/octreoscan (within the past 6 months), recent lab work to include creatinine, and know their last dose of either Sandostatin or Somatuline Depot (if they are taking it) in order to initially qualify for PRRT. If patients do not have a recent Gallium-68 PET/CT or octreotide scan, they can have that at Roswell prior to their appointment. A one-time appointment with Dr. Iyer is necessary in order for Roswell to screen and process insurance authorization. Pending that approval, there will be a second appointment in the nuclear medicine department to get clearance and schedule the treatments.
The number to call for an appointment is 716-845-2300 or online www.roswellpark.org/become-a-patient.
Patients can enter the Roswell system by physician referral or by self-referral. Most patients have their information faxed over to 716-845-7104 or call 716-845-2300 with a referral specifically for PRRT. If Roswell determines that something else is needed, the Roswell coordinator may contact the patient and ask to have those tests to make the visit productive.
The PRRT/ neuroendocrine nurse coordinator is Jennifer Pangelinan. She can be reached at 716-845-4005 to answer questions. She does not schedule any appointments, so appointments should be scheduled through 716-845-2300 or online roswellpark.org/become-a-patient. PRRT is scheduled after a consultation with Dr. Iyer, an insurance verification and a clearance from the nuclear medicine doctor. Treatments are also dependent on lab work, so those may be repeated prior to scheduling treatment.
Fax number: 716-845-7104
Financial Counselors are available to assist with questions about insurance coverage and other barriers to treatment at 716-845-4782.
Meet the neuroendocrine cancer team at Roswell Park here: https://www.roswellpark.org/cancer/neuroendocrine-carcinoid.
New York City:
Mount Sinai has a team consisting of physicians, nurses and coordinators managing and coordinating neuroendocrine tumor patients who would need PRRT. This team meets monthly to discuss the medical indication and determine the eligible patients for PRRT. Outside referring physicians are sent an eligibility check list to be sent back to Mount Sinai to determine the PRRT indication for the individual patient. Patients are encouraged to have consultations with and be followed by the Carcinoid and Neuroendocrine Tumor Team at Mount Sinai.
For all patients who are referred from outside Mount Sinai, the contact numbers for PRRT coordinators are 212-241-6969 (Wendy Bourne-Marcel) or 212-241-7888 (Vanessa Grinnel). All patients who are referred for consideration for PRRT are scheduled for a single visit consultation with the Nuclear Medicine Division to definitively establish eligibility for treatment.
The first contact will be with the coordinators as detailed above and the following step will be submission of the completed check list which will be sent by the coordinators to the referring physicians.
Fax number: 212-831-2851
Insurance questions: Mt. Sinai has a dedicated insurance process for PRRT with Lutathera. This can be discussed when patients are found eligible for treatment.
The treatment regimen consists of a total of 4 IV administrations every 8 weeks ± 1 week (this interval can be extended in case of toxicity). Patients must fulfill the eligibility criteria which include but are not limited to a positive result on a somatostatin specific imaging study e.g. Gallium-68 PET/CT, an ECOG (Eastern Cooperative Oncology Group) Performance Status of 1 or 0, and good organ function status based on blood tests (all requirements are specified on the eligibility check list). All patients will be followed based on laboratory tests every 2-3 weeks after every therapy cycle to monitor possible blood and organ toxicity.
NET patients receiving PRRT at Duke must have seen a medical oncologist at Duke for a consultation and continue to see them or their physician extender during the time they are receiving PRRT. Generally, that would be Michael Morse, MD. who specializes in the management of neuroendocrine tumors. A patient or their physician can call to make a new patient visit with Dr. Morse.
Dr. Morse will see patients as a new consultation and then he and his staff will review the case with Dr. Wong or Borges-Neto of Nuclear Medicine. If all are in agreement that PRRT is appropriate, they will coordinate any required additional testing, insurance approvals, and subsequent scheduling of the first PRRT treatment. If a person has additional questions prior to scheduling the first PRRT treatment, a clinic appointment will also be scheduled with the Nuclear Medicine team.
Phone: 919-660-9673 for GI New Patient Coordinator for appointments
Patients who wish to have PRRT at Ohio State University Comprehensive Cancer Center – The James Cancer Hospital must first be seen by a physician there. Patient records must be faxed to OHSU before making an appointment, fax: 614-293-3112. For questions or to make an appointment to see a physician, call 614-293-8629.
Patients do not need to regularly see an OHSU physician. But, generally speaking, the outside referring physician should be able to provide the same level of care and follow-up as would an OHSU physician. The process is as follows: The referring physician should contact Adam Brown at email@example.com, or (503) 494-2875 to initiate this referral. He will send over the order form and a specific template for the items needed at OHSU (clinic notes, pathology slides, imaging, and labs) for screening. These items will be evaluated by a Nuclear Medicine physician and the patient will be discussed at the OHSU NET multidisciplinary tumor board. If everyone is in agreement, then they can proceed with PRRT without being seen by an OHSU physician.
If not, then the patient would need to be seen by an OHSU physician, Dr. Rodney Pommier, first. Patients can make appointments by contacting 503-494-5501. Physician referrals should contact 503-494-6812. Instructions on how to make an appointment with Dr. Pommier will be given to the referring physician directly.
Phone: Questions about the PRRT program at OHSU, including scheduling questions should be directed to Adam Brown, the NM/PET Supervisor, at brownada@ohsu or (503) 494-2875
Insurance questions: Please direct to Adam Brown (contact information above)
For kidney protection as part of the overall PRRT treatment, OHSU offers and utilizes the compounded amino acids, L-Lysine and L-Arginine, which cause little to no nausea providing a much more comfortable patient experience.
Patients seeking an appointment need to have their physician request the appropriate forms, which the physician then completes. After UPMC reviews these forms an appointment can be made. Physicians can obtain these forms by writing to firstname.lastname@example.org or calling 412-647-7259. If you are a patient and have questions, please also call 412-647-7259.
Ms. Susan Cork at email@example.com, 713-341-3203 or Ms. Amber Gonzales at firstname.lastname@example.org, 713-341-3246
Salt Lake City:
It is preferred that any patient seeking treatment from outside of Carilion Clinic have a referral from his/her own physician to Dr. David A. Buck’s practice to arrange for an initial consultation and evaluation for appropriateness of treatment. Dr. Buck’s office number is 540-981-7377. He is President of Blue Ridge Oncology and his fax number is 540-981-8528. Besides Dr. Buck, one of his partners, Dr. Bret Adams, will begin seeing patients seeking PRRT.
Regarding insurance, all patients need to have predetermination. Blue Ridge Oncology should be able to assist with some of the insurance questions
WASHINGTON, STATE OF
Patients may be referred to Virginia Mason for PRRT therapy while continuing to receive NET care with their primary oncologist. After an initial visit with Dr. Hagen Kennecke, Medical Oncology, to determine eligibility and suitability for PRRT, patients are scheduled for up to four outpatient treatments. Prior functional imaging with NETSPOT (Gallium-68 Dotatate) is required within the past 12 months or will be scheduled at Virginia Mason to help determine eligibility. A pre-treatment visit and labs are required to assess tolerance of PRRT and response. When required, the Virginia Mason team will ensure that the timing of PRRT therapy is coordinated with monthly somatostatin analogue therapy injections, which may be continued at the current dose and schedule as required and administered under the direction of the primary oncologist.
For referrals to see Dr. Hagen Kennecke at the Virginia Mason Cancer Institute, please follow this process:
Outside referrals are directed here: https://www.virginiamason.org/for-clinicians
An online referral form is available at the link as well. That team quick-registers the patients, and sends the records to the Hematology-Oncology Team.
Non-urgent nursing and referral-related questions can be directed to:
Breanne Senior, Nurse, 206-223-6193, Breanne.Senior@virginiamason.org
Applications for reimbursement for PRRT and NETSPOT will be assisted by Virginia Mason and will be initiated by the Medical Oncology Program.
At Virginia Mason, PRRT is administered by a team of nurses, pharmacists, nuclear medicine physicians, medical oncology and nuclear medicine technicians. Medical Oncology is generally to primary point of contact with the responsibility to coordinate multidisciplinary care. All cases are reviewed by a multidisciplinary tumor board to ensure the appropriateness of PRRT therapy and cancer clinical trials for NETs are offered. The NET team includes healthcare professionals in hepatobiliary surgery, gastroenterology, endocrinology, nuclear medicine, nursing, medical oncology, radiation oncology, and interventional-radiology.
In order to more easily manage patients’ care, patients must be seen by a Medical College of Wisconsin, MCW, oncologist (Dr. Thomas, Dr. Ritch, Dr. George, Dr. Alqwasmi).
Appointments with a physician: Call Gail Laschen, Cancer Center FMLH, 414-805-6849
PRRT appointments/questions: Call Nuclear Medicine/PET Department, 414-805-3771
Insurance questions: Call Patient Financial Services Department 414-777-1013