Pancreas/Pancreas-Kidney/Pancreatic Islet Cell Transplantation
DESCRIPTION
Pancreas transplantation is intended for insulin dependent diabetics to restore endogenous insulin secretion and normal glucose metabolism. Control of metabolic glucose is intended to prevent, halt, or reverse the secondary complications of insulin dependent diabetes mellitus (IDDM). Pancreas transplantation is not generally viewed as life-saving treatment; however, in a small subset of individuals who experience life-threatening complications from IDDM, pancreas transplantation may be considered lifesaving.
Transplant candidates include: 1) IDDM cases with renal failure receiving a cadaveric simultaneous pancreas/kidney transplant (SPK); 2) IDDM cases receiving a pancreas transplant at some time after a kidney transplant (pancreas after kidney, i.e., PAK) from either a cadaveric or living-related donor; and 3) non-uremic IDDM cases with severely disabling and potentially life-threatening diabetic problems, receiving a pancreas alone (PTA).
Individuals with chronic pancreatitis can experience intractable pain that can be relieved only with a total or near total pancreatectomy, although this treatment will cause the individual to become an insulin dependent diabetic. Autologous islet transplantation has been considered as a technique to prevent this associated morbidity. A suspension of isolated islet cells taken from the resected pancreas specimen is injected into the portal vein of the liver, where the cells function as a free graft.
The FDA approved allogeneic pancreatic islet cell transplantation using donislecel-jujn (Lantidra™) in June 2023 for the treatment of type 1 diabetes in adults who are unable to approach target hemoglobin A1c due to repeated episodes of severe hypoglycemia despite intensive diabetes management and education.
POLICY
Combined pancreas-kidney transplantation is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Pancreas transplantation alone is considered medically necessary if the medical appropriateness criteria are met. (See Additional Information for definitions.) (See Medical Appropriateness below.)
Pancreas transplantation after a prior kidney transplant is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Pancreas re-transplantation is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Autologous pancreatic islet cell transplantation as an adjunct to a total or near total pancreatectomy is considered medically necessary.
Repeated laboratory tests and procedures to address changes in condition and for continued transplant listing are considered medically necessary.
Multiple laboratory tests and work-up procedures for the sole purpose of repeat evaluation at multiple transplant centers will be considered not medically necessary.
Allogeneic pancreatic islet cell transplantation using an FDA-approved cellular therapy product donislecel-jujn (i.e., Lantidra) is considered investigational.
Islet transplantation with donislecel-jujn in all other situations is considered investigational.
Pancreas re-transplantation after two or more failed pancreas transplants is considered investigational.
MEDICAL APPROPRIATENESS
BCBST approval is required prior to transplantation.
Pancreas transplantation is considered medically appropriate if ALL the following criteria are met:
Procedure is indicated for ANY ONE of the following:
Combined pancreas-kidney transplantation for the treatment of diabetes mellitus in individuals who are insulin-dependent with uremia
Pancreas transplantation alone for treatment of insulin-dependent diabetes mellitus (IDDM) with ANY ONE of the following:
Severely disabling and potentially life-threatening metabolic complications due to labile diabetes as evidenced by documentation in chart notes or hospitalization for diabetic ketoacidosis
Hypoglycemia unawareness that persists despite optimal medical management, as evidenced by documentation in chart notes or emergency room visits
Pancreas transplantation after a prior kidney transplant in individuals with insulin dependent diabetes
Pancreas re-transplantation after a failed primary pancreas transplant
Documentation supports ALL of the following:
NOTE: Potential contraindications are subject to the judgment of the transplant center
Clinical information submitted for determination of medical appropriateness criteria is dated within the last 7 months
Adequate cardiopulmonary status
No other irreversible end-stage disease not attributed to kidney disease
No untreated systemic infection making immunosuppression unsafe, including chronic infection
No known current malignancy
No history of malignancy with a moderate to high risk of recurrence
Documentation of compliance with present medical management
No major psychiatric history likely to result in non-adherence
No psychosocial conditions or chemical or alcohol dependency affecting ability to adhere to therapy
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Severe metabolic complications include conditions such as ketoacidosis, hypoglycemic events, and infection. Hypoglycemic unawareness includes profound hypoglycemia without the usual warning signs such as palpitations, sweating, tremors, dizziness, tingling, and / or blurred vision.
There is inadequate data to permit scientific conclusion regarding the health outcomes associated with pancreas re-transplantation after two or more failed pancreas transplants or for allogeneic pancreatic islet cell transplantation.
SOURCES
American Diabetes Association. 4. Comprehensive medical evaluation and assessment of comorbidities: Standards of medical care in diabetes-2023. Retrieved October 20, 2023 from https://diabetesjournals.org.
American Diabetes Association. 9. Pharmacologic approaches to glycemic treatment: Standards of medical care in diabetes-2023. Retrieved October 20, 2023 from https://diabetesjournals.org.
BlueCross BlueShield Association. Evidence Positioning System. (10:2023). Islet Transplantation for Chronic Pancreatitis and Donislecel-jujn for Type 1 Diabetes (7.03.12). Retrieved October 20, 2023 from www.bcbsaoca.com/eps/. (60 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (9:2023). Allogeneic Pancreas Transplant (7.03.02). October 20, 2023 from www.bcbsaoca.com/eps/. (34 articles and/or guidelines reviewed)
Boggi, U., Baronti, W., Amorese, G., Pilotti, S., Occhipinti, M., Perrone, V., et al. (2022). Treating type 1 diabetes by pancreas transplant alone: a cohort study on actual long-term (10 years) efficacy and safety. Transplantation, 106 (1), 147–157, doi: 10.1097/TP.0000000000003627. (Level 2 evidence)
Bramis, K., Gordon-Weeks, A., Friend, P., Bastin, E., Burls, A., Silva, M., & Dennison, A. (2012). Systematic review of total pancreatectomy and islet autotransplantation for chronic pancreatitis. British Journal of Surgery, 99, 761-766. (Level 1 evidence)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for pancreas transplants (260.3). Retrieved February 25, 2015 from http://www.cms.gov/.
Kopp, W.H., Verhagen, M.J., Blok, J.J., Huurman, V.A., de Fijter, J.W., de Koning, E.J., et al. (2015). Thirty years of pancreas transplantation at Leiden University Medical Center: long-term follow-up in a large Eurotransplant center. Transplantation, 99 (9), e145-e151. (Level 4 evidence)
Lablanche, S., Vantyghem, M. C., Kessler, L., Wojtusciszyn, A., Borot, S., Thivolet, C., et al. (2018). Islet transplantation versus insulin therapy in patients with type 1 diabetes with severe hypoglycaemia or poorly controlled glycaemia after kidney transplantation (TRIMECO): a multicentre, randomised controlled trial. The Lancet. Diabetes & Endocrinology, 6 (7), 527–537, doi: 10.1016/S2213-8587(18)30078-0. (Level 1 evidence)
National Health Services (NHS). (2022). Pancreas transplantation: patient selection. Retrieved October 20, 2023 from http://www.odt.nhs.uk/transplantation/tools-policies-and-guidance/.
National Institute for Health and Clinical Excellence. (2015, August; last updated August 2022). Type 1 diabetes in adults: diagnosis and management. Retrieved September 14, 2022 from www.nice.org.uk/guidance.
National Institute of Health. National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Pancreatic islet transplantation. Retrieved September 15, 2020 from www.diabetes.niddk.nih.gov.
Organ Procurement and Transplantation Network. (2023, September). Policy 11: allocation of pancreas, kidney-pancreas, and islets. Retrieved October 20, 2023 from https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf#nameddest=Policy_11.
Seal, J., Selzner, M., Laurence, J., Marquez, M., Bazerbachi, F., McGilvray, I., et al. (2015). Outcomes of pancreas transplantation after simultaneous kidney-pancreas transplantation are comparable to pancreas after kidney transplantation alone. Transplantation, 99 (3), 623-628. (Level 4 evidence)
Winifred S. Hayes, Inc. Evidence Analysis Research Brief. (2023, October). Donislecel-jujn (Lantidra; CellTrans Inc) for treatment of type 1 diabetes. Retrieved October 20, 2023 from www.Hayesinc.com/subscribers, (9 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 5/1985
MOST RECENT REVIEW DATE: 3/1/2024
ID_BA
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