Medical Policy: 07.03.09
Original Effective Date: November 2009
Reviewed: October 2017
Revised: October 2016
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Achievement of insulin dependence with resultant decreased morbidity and increased quality of life is the primary health outcome of pancreas transplantation. Transplantation of the pancreas is a treatment method for patients with insulin dependent diabetes mellitus. Pancreas transplantation can restore glucose control and is intended to prevent, halt or reverse the secondary complications from diabetes mellitus. Replacement of the pancreas may be performed alone, following a kidney transplant, or simultaneously with a kidney transplant.
Pancreas transplant alone (PTA) may be indicated for patients with uncontrolled type 1 diabetes mellitus (i.e. abnormal hemoglobin A1c, inability to maintain blood glucose levels in a normal range) but adequate renal function. The purpose of PTA is to restore glucose control and is intended to prevent, halt or reverse the secondary complications from diabetes such as retinopathy, neuropathy, or end-stage renal disease.
Pancreas transplant is not typically used for the treatment of individuals with type 2 diabetes mellitus. Individuals with type 2 produce some insulin, however for unknown reasons the body is unable to use it effectively. While in general there is no simple laboratory test to distinguish between type 1 and type 2 diabetes mellitus, C-Peptide levels are often used to verify insulinopenia, in combination with a documented clinical exam and/or insulin sensitivity and resistance testing. Identifying individuals with type 2 diabetes mellitus who are candidates for pancreas transplant can be challenging. C-peptide levels increase in the presence of renal disease and there is limited information regarding C-peptide levels for defining the type of diabetes in study subjects with ESRD.
Typically a person with type 2 diabetes mellitus has a normal C-peptide level. A fasting C-peptide level that is ≤ 110% of the lower limit of normal of the laboratory’s measurement method and a concurrently obtained fasting glucose of ≤ 225 mg/dL is indicative of insulinopenic type 2 diabetes mellitus.
Pancreas transplantation has been proposed to achieve insulin independence in persons with type 2 diabetes mellitus. Although the evidence in the peer reviewed medical literature is limited pancreas transplantation is an alternative treatment for insulin dependent individuals with type II diabetes mellitus.
For individuals who have insulin dependent diabetes and severe complications who receive pancreas transplant alone, the evidence includes registry studies. Data from international and national registries have found that graft and patient survival rates after pancreas transplant alone have improved over time (e.g. 3 year survival of 95%). The evidence is sufficient to determine that pancreas transplant alone results in meaningful improvements in net health outcomes.
Kidney failure is a major complication of diabetes mellitus and, as a result, most potential pancreas transplant recipients are also uremic. Due to poor five year survival rate of individuals with diabetes mellitus who are on dialysis, kidney transplantation is the treatment of choice for patients with diabetes mellitus who have end stage renal disease (ESRD) and are on dialysis.
Individuals with type 1 diabetes mellitus and impending or established ESRD who have minimal or limited secondary complications of diabetes mellitus are considered optimal candidates for kidney transplantation. Simultaneous pancreas-kidney (SPK) transplant is performed to correct complications of type 1 diabetes mellitus and renal failure with reliance on dialysis. In individuals with type 1 diabetes mellitus who have had a successful kidney transplantation to correct previous uremia, PAK is performed to improve quality of life by: 1) eliminating the need for exogenous insulin and its associated difficulty controlling glucose levels; and 2) to limit secondary diabetic complications, including retinopathy, neuropathy, nephropathy and vasculopathy.
There are some data on outcomes in patients with type 2 compared with type 1 diabetes. In 2011, Sampaio et. al. published an analysis of date from the United Network for Organ Sharing (UNOS) database. The investigators compared outcomes in 6141 patients with type 1 diabetes and 582 patients with type 2 diabetes who underwent SPK between 2000 and 2007. In adjusted analyses, outcomes were similar between the two groups. After adjusting for other factors such as body weight, dialysis time, and cardiovascular comorbidities, type 2 diabetes was not associated with an increased risk of pancreas or kidney graft failure or mortality compared with type 1 diabetes.
Evidence in the scientific published medical literature supports simultaneous pancreas-kidney (SPK) and pancreas-after-kidney (PAK) transplantation as an appropriate therapeutic intervention of individuals with diabetes mellitus who require or have previously had a kidney transplant. The evidence includes case series and registry studies. Data from national and international registries have found relatively high patient survival rates. SPK and PAK is a well-established and accepted method of treatment for these individuals. The evidence is sufficient to determine that SPK and PAK transplantation results in a meaningful improvement in net health outcomes.
The last four decades have seen a significant and progressive improvement in outcomes for pancreas transplantation. Improvements in immunosuppression, surgical technique and post-transplant management have all contributed to better graft survival. However, despite refinements in surgical technique, technical failure is defined by the International Pancreas Transplant Registry as graft loss secondary to vascular thrombosis, bleeding, anastomotic leaks or infection/pancreatitis and is responsible for more than 50% of all pancreas grafts lost in the first 6 months following transplantation. Thrombosis accounts for more than one-half of these technical failures, and may be influenced by donor and recipient factors, preservation and ischemic injury, immunological issues and surgical technique.
The decision to retransplant the pancreas after an early graft failure is complex. Prior to proceeding with retransplantation, a careful analysis of the factors contributing to the technical failure must be undertaken and reversible risk factors must be addressed. Surgical issues leading to thrombosis such as improper suturing of the vascular anastomosis, poor positioning of the allograft or inadequate hemostasis may be the primary cause of graft thrombosis. However, there may be no obvious surgical cause for graft loss identified. Reconfirming the tissue typing with the original donor and evaluating the patient for hypercoagulable state should be considered prior to attempting retransplantation in order to guide anticoagulation and immunosuppression management for the second graft.
Following appropriate evaluation for the causes of graft thrombosis, repeat pancreas transplantation may be considered, although the optimal timing for retransplantation remains somewhat controversial. From a surgical perspective, retransplanting in the early post-pancreatectomy period may be preferable because extensive adhesions have not yet formed, this facilitates placing the new graft in the same anatomic site as the prior transplant. Some previous studies suggest that immediate retransplantation is associated with similar graft and patient survival as primary transplants, others indicate that this approach is associated with higher incidence of post-operative complications and rejection leading to premature loss of the second graft.
For individuals who have had a prior pancreas transplant who still meet criteria for a pancreas transplant who receive pancreas retransplantation, the evidence includes case series and registry studies. Although there are no standard guidelines regarding multiple pancreas transplants, each transplant center has its own guidelines based on experience. National data and data reported from specific transplant centers have generally found similar graft and patient survival rates after pancreas retransplantation compared with initial transplantation. The evidence is sufficient to determine that pancreas retransplantation results in meaningful improvement in net health outcomes.
Based on the medical literature pancreas transplant may be considered medically necessary in patients who are undergoing, or have undergone, kidney transplantation for renal failure. It may also be considered medically necessary as a stand-alone treatment in patients with hypoglycemia unawareness and labile diabetes, despite optimal medical therapy and in whom severe complications have developed. The evidence suggest that transplantation can restore glucose control and prevent, halt or reverse the secondary complications from diabetes mellitus. Pancreas transplant alone (PTA), simultaneous pancreas-kidney (SPK) and pancreas-after-kidney (PAK) is well established and accepted methods of treatment for these individuals. The evidence is sufficient to determine that these transplant procedures result in a meaningful improvement in net health outcomes.
In 2014, the American Diabetes Association issued a position statement regarding type 1 diabetes through the life span, which included recommendations regarding pancreas transplants.
Successful pancreas transplantation has been demonstrated to be efficacious in significantly improving the quality of life of people with diabetes, primarily by eliminating the need for exogenous insulin, frequent daily blood glucose measurements, and many of the dietary restrictions improved by the disorder. Transplantation can also eliminate the acute complications of diabetes.
In 2013 the American Society of Transplantation issued a 3rd edition guideline on transplantation infectious diseases that includes criteria for transplantation for HIV infected individuals. The criteria for transplantation for HIV infected individuals for kidney/pancreas transplants includes the following:
In 2016 the following is the allocation policies of the Organ Procurement and Transplantation Network for the Allocation of Pancreas and Kidney-Pancreas:
Each candidate registered on the pancreas waiting list must meet one of the following requirements:
Each candidate registered on the kidney-pancreas waiting list must be diagnosed with diabetes or have pancreatic exocrine insufficiency with renal insufficiency.
Kidney-Pancreas Waiting Time Criteria for Candidates at Least 18 Years Old
If a kidney-pancreas candidate is 18 years or older on the date the candidate is registered for kidney-pancreas, then the candidate begins to accrue waiting time once the candidate has met all of the following conditions:
Note: The OPTN Contractor may not modify the maximum allowable BMI to exceed 30mg/m2
Prior approval is required.
See also Medical Policy 07.03.01 Pancreatic Islet Cell Transplant
Pancreas transplant alone (PTA) may be considered medically necessary in patients who have insulin-dependent diabetes mellitus with severe disabling and life threatening hypoblycemic unawareness due to labile diabetes despite optimal medical management.
Pancreas transplant after a prior kidney transplant (PAK) may be considered medically necessary in patients with insulin-dependent diabetes.
Simultaneous pancreas-kidney transplant (SPK) may be considered medically necessary in insulin-dependent diabetics with impending or established renal failure.
Pancreas transplant alone (PTA), pancreas transplant after prior kidney transplant (PAK), or simultaneous pancreas-kidney transplant (SPK) performed for any other conditions not listed above will be considered not medically necessary.
Pancreas transplant alone (PTA), pancreas after kidney (PAK) or simultaneous pancreas-kidney (SPK) retransplantation after a failure of the primary graft may be considered medically necessary provided the individual meets the transplant criteria above.
Candidates for pancreas transplant alone should additionally meet 1 of the following severity of illness criteria:
In addition, most pancreas transplant patients will have type 1 diabetes mellitus. Those transplant candidates with type 2 diabetes mellitus, in addition to being insulin dependent, should also not be obese (body mass index (BMI) should be 32 kg/m2 or less).
Although there are no standard guidelines regarding multiple pancreas transplants, the following information may aid in case review:
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