Performed in conjunction with pancreatectomy for chronic pancreatitis, autologous islet transplantation is proposed to reduce the likelihood of insulin-dependent diabetes. Allogeneic islet cell transplantation with donislecel-jujn is also being investigated as a treatment or cure for patients with type 1 diabetes.
For individuals with chronic pancreatitis undergoing total or near-total pancreatectomy who receive autologous pancreas islet transplantation, the evidence includes nonrandomized studies and systematic reviews. Relevant outcomes are overall survival (OS), change in disease status, medication use, resource utilization, and treatment-related morbidity. Autologous islet transplants are performed in the context of total or near-total pancreatectomies to treat intractable pain from chronic pancreatitis. The procedure appears to decrease significantly the incidence of diabetes after total or near-total pancreatectomy in patients with chronic pancreatitis. Also, this islet procedure is not associated with serious complications and is performed in patients who are already undergoing a pancreatectomy procedure. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals with type 1 diabetes who receive allogeneic pancreas islet transplantation with donislecel-jujn, the evidence includes single-arm prospective trials conducted at a single study site without strict protocols demonstrating insulin independence for over 1 year in a majority of participants, with mean insulin independence of approximately 5 years, resulting in Food and Drug Administration approval of donislecel for adults who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education and for use in conjunction with concomitant immunosuppression. Additional well-designed studies are required to determine the effects of allogeneic islet transplantation in patients with type 1 diabetes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Autologous pancreas islet transplantation may be considered medically necessary as an adjunct to a total or near-total pancreatectomy in individuals with chronic pancreatitis.
Allogeneic islet transplantation using an FDA-approved cellular therapy product (donislecel-jujn [ie, Lantidra]) is considered investigational for the treatment of type 1 diabetes.
Islet transplantation with donislecel-jujn is considered investigational in all other situations.
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CPT |
48160 |
Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells |
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0584T |
Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; percutaneous |
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0585T |
Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; laparoscopic |
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0586T |
Islet cell transplant, includes portal vein catheterization and infusion, including all imaging, including guidance, and radiological supervision and interpretation, when performed; open |
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ICD-10-PCS |
3E033U0 |
Percutaneous administration, peripheral vein, pancreatic islet cells, autologous |
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3E0J3U0 |
Percutaneous administration, biliary and pancreatic tract, pancreatic islet cells, autologous |
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3E0J7U0 |
Administration via natural or artificial opening, biliary and pancreatic tract, pancreatic islet cells, autologous |
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3E0J8U0 |
Endoscopic administration via natural or artificial opening, biliary and pancreatic tract, pancreatic islet cells, autologous |
| HCPCS | G0341 | Percutaneous islet cell transplant, includes portal vein catheterization and infusion |
| G0342 | Laparoscopy for islet cell transplant, includes portal vein catheterization and infusion | |
| G0343 | Laparotomy for islet cell transplant, includes portal vein catheterization and infusion | |
| S2102 | Transplant, islet cell tissue, allogeneic | |
| J3590 | Unclassified biologics | |
| C9399 | Unclassified drugs or biologicals |
Only adult subjects were enrolled in donislecel-jujn (Lantidra) clinical studies, although clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. Risks of donislecel-jujn infusion in pregnancy have not been assessed.
There are risks associated with the infusion procedure and long-term immunosuppression. There is no evidence of donislecel-jujn benefit for individuals whose diabetes is well-controlled with insulin therapy or for those with hypoglycemic unawareness who are able to prevent current repeated severe hypoglycemic events (neuroglycopenia requiring active intervention from a third party) using intensive diabetes management (including insulin, devices, and education).
Repeated intraportal islet infusions are not recommended in patients who have experienced prior portal thrombosis, unless the thrombosis was limited to second- or third-order portal vein branches. There is no evidence to support donislecel-jujn for individuals with liver disease, renal failure, or who have received a renal transplant.
Islet transplantation does not supplant future whole pancreatic transplantation (see policy 7.03.02).
A specific target of HbA1c cannot be provided for all patients, as the target can be different based on age, duration of diabetes, and diabetic complications.
"Current repeated episodes" indicates risk within 1 year of the intended transplantation and is not related to events more than 1 year prior to the intended transplantation.
In autologous islet transplantation during the pancreatectomy procedure, islet cells are isolated from the resected pancreas using enzymes, and a suspension of the cells is injected into the portal vein of the patient's liver.1, Once implanted, the beta cells in these islets begin to make and release insulin.
Allogeneic islet transplantation potentially offers an alternative to whole-organ pancreas transplantation in patients with type 1 diabetes.2, In the case of allogeneic islet cell transplantation, cells are harvested from a deceased donor's pancreas, processed, and injected into the recipient's portal vein. Islet transplantation has generally been reserved for patients with frequent and severe metabolic complications who have consistently failed to achieve control with insulin-based management. Allogeneic transplantation may be performed in the radiology department.
In 2000, a modified immunosuppression regimen increased the success of allogeneic islet transplantation. This regimen is known as the "Edmonton protocol."
The U.S. Food and Drug Administration (FDA) regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation Title 21, parts 1270 and 1271. Allogeneic islet cells are included in these regulations. Donislecel-jujn (Lantidra™), a first-in-class deceased donor-derived allogeneic pancreatic islet cellular therapy product, was approved by the FDA 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.3
