Medical Policy

This document addresses pancreas alone transplantation or combined pancreas/kidney transplantation. Both procedures involve the replacement of mal- or non-functioning organs with healthy organs from a deceased or living human donor into a single recipient.

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

 Note: Members must meet the disease specific criteria as well as the General Individual Selection criteria below for the transplantation to be considered medically necessary.

Medically Necessary:

Simultaneous deceased-donor pancreas/kidney transplant (SPK) is considered medically necessary for individuals with insulin dependent diabetes mellitus (IDDM) who have end-stage renal disease.

Simultaneous deceased-donor pancreas and living-donor kidney transplant (SPLK) is considered medically necessary for individuals with insulin dependent diabetes mellitus who have end-stage renal disease.

Pancreas transplant alone (PTA) either deceased or living-donor segmental is considered medically necessary for individuals who have insulin dependent diabetes mellitus with severe disabling and documented life threatening hypoglycemic unawareness due to labile diabetes which persists despite optimal medical management.

Pancreas after kidney transplant (PAK) is considered medically necessary for individuals with insulin dependent diabetes mellitus.

One pancreas alone, one pancreas after kidney or one simultaneous pancreas/kidney (SPK or SPLK) re-transplantation after failure of the primary graft is considered medically necessary provided the individual meets the transplant criteria above.

Investigational and Not Medically Necessary:

Pancreas transplantation is considered investigational and not medically necessary for all other applications.

A third or subsequent pancreas alone, pancreas after kidney or SPK or SPLK transplantation is considered investigational and not medically necessary in all cases.

Note: For multi-organ transplant requests, criteria must be met for each organ requested. In those situations, an individual may present with a concurrent medical condition which would be considered an exclusion or a comorbidity that would preclude a successful outcome, but would be treated with the other organ transplant. Such cases will be reviewed on an individual basis for coverage determination to assess the member's candidacy for transplantation.

General Individual Selection Criteria

In addition to having the clinical indications above, the member must not have a contraindication as defined by the American Society of Transplantation in Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation (2001) listed below.

Absolute Contraindications- for Transplant Recipients include, but are not limited to, the following:

1. Metastatic cancer
2. Ongoing or recurring infections that are not effectively treated
3. Serious cardiac or other ongoing insufficiencies that create an inability to tolerate transplant surgery
4. Serious conditions that are unlikely to be improved by transplantation as life expectancy can be finitely measured
5. Demonstrated individual nonadherence, which places the organ at risk by not adhering to medical recommendations
6. Potential complications from immunosuppressive medications are unacceptable to the individual
7. Acquired immune deficiency syndrome (AIDS) (diagnosis based on Centers for Disease Control and Prevention [CDC] definition of CD4 count, 200 cells/mm³) unless the following are noted:
   1. CD4 count greater than 200 cells/mm³ for greater than 6 months
   2. HIV-1 RNA undetectable
   3. On stable anti-retroviral therapy greater than 3 months
   4. No other complications from AIDS (for example, opportunistic infection, including aspergillus, tuberculosis, coccidioidomycosis, resistant fungal infections, Kaposi’s sarcoma or other neoplasm)
   5. Meeting all other criteria for pancreas or pancreas/kidney transplantation.

Steinman, Theodore, et al. Guidelines for the Referral and Management of Patients Eligible for Solid Organ Transplantation. Transplantation. Vol. 71, 1189-1204, No. 9, May 15, 2001.

This document describes clinical studies and expert recommendations, and explains whether pancreas alone transplantation or combined pancreas/kidney transplantation are appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Pancreas transplantation replaces a non-working pancreas with a healthy one, usually to help people with severe cases of type 1 diabetes not controlled by medical treatment. It can be done alone or with a kidney transplant when the person has severe kidney disease along with diabetes. There are different types: doing both pancreas and kidney at the same time from a deceased donor (SPK), a pancreas from a deceased donor and a kidney from a living donor (SPLK), pancreas transplant alone (PTA), or doing the pancreas transplant after a kidney transplant (PAK). These surgeries aim to improve blood sugar control, reduce or eliminate the need for insulin, and prevent serious diabetes complications. Each option has pros and cons. These include risks from surgery and the need for lifelong medicines to prevent organ rejection. While pancreas transplants can improve quality of life and health for many, better studies are needed for some situations to fully understand the long-term benefits.

What the Studies Show

Pancreas transplants have been shown to improve blood sugar control and quality of life in people with type 1 diabetes. In SPK, people often live longer and have better health outcomes than those who only get a kidney transplant. Some studies show people with both a pancreas and kidney transplant have fewer diabetes-related complications and better blood sugar levels. In PTA, people can stop insulin and avoid low blood sugar episodes, but long-term success varies. For PAK, outcomes are also generally good when done in carefully chosen people. Living-donor segmental pancreas transplants are rare, but may offer good results in select cases. A second transplant after failure of a first graft, called retransplantation, is also sometimes successful. Most people who get pancreas transplants survive at least 1 year, and many keep their transplant working for 5 years or longer. Transplants can help lower hemoglobin A1c (HbA1c, a marker of long-term blood sugar control), improve cholesterol, and reduce risks of heart problems. However, these benefits come with risks such as infection, organ rejection, or side effects from immunosuppressive drugs. Experts agree that these transplants can help, but must be used wisely. Some newer transplant methods or combinations need more research to be sure they improve health.

When is Pancreas or Pancreas/Kidney Transplant Clinically Appropriate?

Pancreas or pancreas/kidney transplant may be appropriate in these situations:

• SPK is appropriate for people with insulin-dependent diabetes and end-stage kidney disease
• SPLK is appropriate for people with insulin-dependent diabetes and end-stage kidney disease
• PTA is appropriate for people with insulin-dependent diabetes and life-threatening low blood sugar that cannot be controlled with standard treatment
• PAK is appropriate for people with insulin-dependent diabetes who have already received a successful kidney transplant
• Re-transplantation (SPK, SPLK, PTA, or PAK) may be appropriate after graft failure if the person still meets transplant criteria

When is this not Clinically Appropriate?

Pancreas transplant is not clinically appropriate in other cases. This includes situations where the person does not meet the transplant criteria, or if the person is seeking a third or later pancreas or pancreas/kidney transplant. This is because there is not enough evidence showing that more than two pancreas transplants help people live longer or feel better. In some people, other medical problems like advanced cancer, serious infections, or heart disease may make the surgery too risky. Pancreas transplantation is not clinically appropriate in scenarios other than those listed above.

(Return to Description/Scope)

Summary

Pancreas transplantation, particularly simultaneous pancreas-kidney (SPK), pancreas after kidney (PAK), and pancreas transplant alone (PTA), have demonstrated both high short- and long-term recipient and graft survival rates, with studies highlighting over 90% 1-year survival across transplant types. Large-scale registry and cohort data, including those from the Scientific Registry of Transplant Recipients (SRTR), International Pancreas Transplant Registry (IPTR), and Organ Procurement and Transplantation Network (OPTN), support favorable outcomes, though recent propensity-matched analyses suggest previous SPK survival benefits may reflect selection bias. Quality-of-life and metabolic improvements, including sustained glycemic control and reduced cardiovascular risk, are well-documented. Emerging procedures such as simultaneous pancreas-living donor kidney (SPLK) show promise, and living-donor segmental pancreas transplants appear feasible in select cases. Clinical recommendations from major societies, including the American Diabetes Association (ADA), the First World Consensus Conference on Pancreas Transplantation (FWCCPT), and the Banff Pancreas Transplantation Multidisciplinary Report (BPTMR), emphasize the selective use of transplantation, particularly in individuals with type 1 diabetes and severe glycemic instability or concurrent renal failure, while underlining the need for lifelong immunosuppression and individualized post-transplant management strategies.

Discussion

Survival Outcomes

Evidence from registry data and cohort studies demonstrates favorable recipient and graft survival across all pancreas transplant types. Recent large-scale analyses have refined understanding of survival outcomes, with propensity-matched studies suggesting that survival advantages previously attributed to SPK may reflect recipient selection rather than procedural benefits.

Recipient Survival

Scientific Registry of Transplant Recipients (2022) data for individuals in the U.S. who underwent deceased-donor pancreas transplantation during 2020 showed 1-year recipient survival rates of 98.9% (95% confidence interval [CI], 97.8% to 99.5%) for SPK, 99.1% (95% CI, 94.2% to 99.9%) for PAK, and 100% (95% CI, not estimable) for PTA. The International Pancreas Transplant Registry (Gruessner, 2022) reported that worldwide recipient survival at 1 year for primary deceased-donor transplants occurring between 2016 and 2020 was 96.9% for SPK recipients, 96.3% for PAK recipients, and 98.3% for PTA recipients.

Perosa and colleagues (2025) reported outcomes from a 25-year, single-center experience with 1073 consecutive pancreas transplants in Brazil, including 593 SPK transplants, 331 PAK transplants, 149 PTA, and 101 retransplants. Overall 1-year recipient survival exceeded 90% for primary PTA and PAK and 85% for SPK or retransplantation. Progressive refinements in surgical technique reduced pancreatic graft vascular thrombosis from 9.5% in the early era (1996 to 2007) to 2.1% in the most recent era (2018 to 2021) for SPK recipients.

Data on long-term survival after SPK were published by Parajuli and colleagues (2020). The authors reported on 291 individuals who received an SPK between 1986 and 1993. A total of 39 of 291 individuals (13.4%) had a functional pancreas allograft as of October 31, 2018, which was at least 25 years after transplantation. All of these had the same indication for SPK, namely long-standing diabetic nephropathy, and all but one had been diagnosed with type 1 diabetes.

Choksi and colleagues (2025) reported outcomes from 500 SPK recipients with type 1 diabetes followed for up to 10 years. Recipient survival was 97% at 1 year, 93% at 5 years, and 87% at 10 years. Among 108 deaths with identified cause, 52% were due to major adverse cardiovascular events, 21% to malignancy, and 16% to infection, highlighting the importance of cardiovascular risk management in this population.

Propensity-matched analyses have provided important context for interpreting survival outcomes. Catarinella and colleagues (2025) analyzed 3679 SPK and 3679 matched kidney transplant alone recipients using real-world electronic health records from over 150 healthcare organizations worldwide. In unmatched comparisons, SPK recipients showed significantly lower mortality (hazard ratio [HR] 0.76, 95% CI, 0.71 to 0.83). However, after propensity score matching, survival probabilities became virtually identical (HR 1.00, 95% CI, 0.91 to 1.11), suggesting that historical survival signals were largely attributable to selection bias. Similarly, Budhiraja and colleagues (2025) analyzed 22,545 transplant recipients from the Scientific Registry of Transplant Recipients (2014 to 2023) and found no significant difference in overlap-weighted 5-year recipient survival (SPK 86% vs. kidney transplant alone 87%) or 10-year survival (SPK 71% vs. kidney transplant alone 74%). However, subgroup analysis identified a survival benefit for SPK among recipients with type 1 diabetes and body mass index under 30 (adjusted HR 1.37 for kidney transplant alone, 95% CI, 1.04 to 1.81).

A meta-analysis of studies on outcomes after SPK in individuals with end-stage kidney disease and type 2 diabetes was published by Cao and colleagues (2022). The authors identified nine cohort studies published through May 2021 and six of these were included in a meta-analysis of survival rates. Pooled recipient survival rates at 1 year, 3 years, and 5 years were 98% (95% CI, 96% to 100%), 95% (95% CI, 91% to 99%), and 91% (95% CI, 87% to 96%), respectively.

Ventura-Aguiar and colleagues (2023) published an analysis of 301 individuals from Spain who received a pancreas transplant, with or without a kidney transplant. Of the 301 study participants, there were 241 (80.1%) SPKs, 56 (18.6%) PAKs, and four (1.3%) PTAs. The median follow-up period was 3.2 years and the maximum follow-up was 5.6 years. A total of 282 recipients (93.7%) survived from the date of transplantation until the end of the study, with estimated 1-year, 3-year, and 5-year recipient survival rates of 98.7%, 96.1%, and 94.4%, respectively. There were 19 (6.3%) individuals who died during the study period. The deaths were due to infection in 10 individuals (52.6%), vascular disease in 4 individuals (21.1%), sudden death in 2 individuals (10.5%), gastrointestinal hemorrhage in 2 individuals (10.5%), and a road traffic accident in 1 individual (5.3%).

Boggi and colleagues (2022) reported on 66 individuals with type 1 diabetes who underwent PTA and had at least 10 years of follow-up. A total of 61 of 66 individuals survived 10 years after PTA, for a survival rate of 92.4%. Among the 5 individuals who died, causes of death were infectious disease in 2 cases and cardiovascular disease in the other 3 cases.

Assfalg and colleagues (2025) evaluated outcomes for SPK using rescue allocation organs in the Eurotransplant region. Among 1504 SPK recipients (2013 to 2021), multivariable analyses demonstrated no significant differences in recipient mortality between standard allocation and rescue allocation modes (HR 1.37 to 1.48, p=not significant). Rescue allocation organs, characterized by higher donor age and longer cold ischemia time, achieved non-inferior outcomes while reducing waitlist times. Donor age was the only donor-related parameter significantly associated with inferior pancreas and kidney graft survival.

For retransplantation, Gasteiger and colleagues (2018) reported on 52 pancreas retransplantations performed at a single center, with 1-year and 5-year recipient survival rates of 96% and 89%, respectively. Organ Procurement and Transplantation Network (OPTN) data through January 6, 2025 showed that for individuals who underwent repeat PTA between 2008 and 2015, the 1-year recipient survival rate was 96.4% (95% CI, 92.1% to 98.4%) and the 5-year survival rate was 84.0% (95% CI, 78.6% to 88.2%). For individuals who underwent repeat SPK, the 1-year survival rate was 100% (95% CI, 100% to 100%) and the 5-year survival rate was 71% (95% CI, 55.4% to 82.0%).

Graft Survival

Scientific Registry of Transplant Recipients (2022) data showed 1-year graft survival rates of 95.7% (95% CI, 94.2% to 96.8%) for SPK, 93.4% (95% CI, 86.9% to 96.7%) for PAK, and 95.6% (95% CI, 87.5% to 98.5%) for PTA among individuals who underwent deceased-donor pancreas transplantation in 2020.

Data from the International Pancreas Transplant Registry provide evidence to support the efficacy of PAK in carefully selected individuals with diabetes who have previously received a successful kidney transplant. The 1-year graft survival rate (defined as total freedom from insulin therapy, normal fasting blood glucose concentrations, and normal or only slightly elevated HbA1c) is 77.5%.

In the Perosa and colleagues (2025) study, 1-year death-censored graft survival was 97% for SPK-kidney and 90% for SPK-pancreas, compared to 75% for all subgroups of solitary pancreas transplants. Among 111 solitary pancreas transplant and SPLK individuals with systematic donor-specific antibody monitoring, de novo donor-specific antibody development was associated with significantly higher immunological pancreas loss (relative risk [RR], 5.07). Individuals with persistent or increased donor-specific antibody levels demonstrated higher rates of acute rejection (100% vs. 63.2%) and antibody-mediated rejection (47.4% vs. 10.5%) with inferior long-term pancreas survival (26.9% vs. 73.1%) compared to those with decreased or cleared donor-specific antibodies.

The meta-analysis by Cao and colleagues (2022) reported pooled pancreas graft survival rates at 1 year, 3 years, and 5 years of 91% (95% CI, 86% to 95%), 86% (95% CI, 78% to 94%), and 81% (95% CI, 78% to 84%), respectively.

In the Ventura-Aguiar and colleagues (2023) study, 246 of 301 (81.7%) pancreas grafts survived from transplantation date to the end of the study. Estimated 1-year, 3-year, and 5-year graft survival rates were 87.8%, 84.9%, and 83.0%, respectively.

Among individuals with PTA in the Boggi and colleagues (2022) study, of the 61 individuals who were alive at the 10-year follow-up, 35 (57.4%) had optimal graft function, defined as normoglycemia and insulin independence. An additional 2 individuals had good graft function, which included HbA1c levels below 7%, no severe hypoglycemia, more than a 50% reduction in insulin use, and restoration of clinically significant C-peptide production.

In the Choksi and colleagues (2025) study, death-censored graft survival was 87% at 1 year, 84% at 5 years, and 80% at 10 years. Predictors of graft failure included female sex, elevated triglycerides, and higher HbA1c levels at follow-up.

For retransplantation, Gasteiger and colleagues (2018) reported a 1-year graft survival rate of 79% after a median follow-up of 65 months. Parajuli and colleagues (2019) found that individuals who underwent pancreas retransplantation after graft failure had better kidney outcomes than those without retransplantation. After a mean follow-up of 8-9 years post-SPK, the death-censored kidney graft failure rate was 24% among individuals with pancreas retransplantation compared to 48% among those without.

Quality of Life and Metabolic Benefits

Successful pancreas transplantation has been demonstrated in multiple case series studies to significantly improve the quality of life of people with type 1 diabetes. Benefits include eliminating the need for exogenous insulin, frequent daily blood glucose measurements, and many of the dietary restrictions imposed by the disorder. Transplantation can also eliminate the acute complications commonly experienced by individuals with type 1 diabetes, such as hypoglycemia and hyperglycemia.

Choksi and colleagues (2025) provided comprehensive longitudinal metabolic data in 500 SPK recipients followed for up to 10 years. HbA1c significantly decreased from pretransplant 8.5% to 5.9% at 3 years (mean difference [MD], 2.76, 95% CI, 2.38 to 3.15) and remained significantly lower than pretransplant at 10 years despite modest increases. Lipid profiles improved significantly: triglycerides decreased by 0.45 mmol/L at 5 years and 0.51 mmol/L at 10 years, total cholesterol decreased by 0.36 mmol/L at 5 years and 0.63 mmol/L at 10 years, and high-density lipoprotein increased by 0.20 mmol/L at 3 years. Insulin sensitivity (measured by quantitative insulin sensitivity check index) improved from 0.305 at 1 month to 0.339 at 3 years and remained improved at 10 years, though values remained below the normal range, likely reflecting ongoing effects of immunosuppression. Despite significant long-term weight gain, these metabolic improvements support an overall cardiovascular risk benefit.

Catarinella and colleagues (2025) reported that SPK recipients maintained significantly lower HbA1c levels throughout follow-up compared to matched kidney transplant alone recipients (6.23% vs. 6.58% after matching), reflecting sustained physiologic glycemic control and high probability of insulin independence. While this metabolic advantage did not translate into measurably improved survival in the matched cohort, the authors concluded that SPK provides durable metabolic benefits that support individualized use for quality-of-life improvement.

The evidence from the peer-reviewed literature supports the efficacy and use of a well-matched living-donor kidney in SPLK procedures. Such transplants offer the potential benefits of shorter waiting time, expansion of the organ donor pool, and improved short-term and long-term renal graft function. SPLK has the advantage of being a single procedure in contrast to the standard living-donor kidney transplant followed by PAK; in addition, SPLK in general leads to better early and long-term renal graft function.

Recommendations

The FWCCPT (Boggi, 2021) developed evidence-based recommendations using systematic literature review, GRADE methodology, and Delphi consensus requiring 85% agreement. Key recommendations include:

1. SPK transplantation improves quality of life and long-term survival compared to current medical treatment for people on the waitlist and compared to other transplant options (Grade 2B).
2. Preemptive SPK transplant is associated with improved outcomes when compared to SPK transplant performed in individuals undergoing dialysis (Grade 2B).
3. PAK transplantation clearly improves quality of life due to superior renal graft survival and improved metabolic control (Grade 2B).
4. PTA is not associated with an increased long-term risk of death compared with people remaining on the waiting list (Grade 2B).
5. Successful PTA provides normal or near normal glucose levels and therefore is superior to current medical therapies for hypoglycemia and hyperglycemia (Grade 2B).
6. Renal failure post-PTA is uncommon if pretransplant estimated glomerular filtration rate is 60 mL/min/1.73 m² or greater (Grade 2B).

The ADA (2025) recommendations on pancreas transplantation are as follows:

Successful pancreas and islet transplantation can normalize glucose levels and mitigate microvascular complications of type 1 diabetes. However, people receiving these treatments require lifelong immunosuppression to prevent graft rejection and/or recurrence of autoimmune islet destruction. Given the potential adverse effects of immunosuppressive therapy, pancreas transplantation should be reserved for people with type 1 diabetes undergoing simultaneous kidney transplantation, following kidney transplantation, or for those with recurrent ketoacidosis or severe hypoglycemia despite optimized glycemic management.

The 2022 PBTMR (Drachenberg, 2024) provides the international standard diagnostic framework for pancreas transplant pathology. Key recommendations included: pancreas transplant biopsy is strongly recommended when there is exocrine graft dysfunction or clinical suspicion of rejection; in SPK transplantation, pancreas biopsy is indicated when there is pancreas dysfunction, particularly when kidney biopsy is negative; and donor-derived cell-free DNA is potentially useful for longitudinal monitoring after the early post-transplant phase.

Post-Transplant Management Considerations

A Cochrane systematic review of steroid avoidance or withdrawal in pancreas and pancreas-kidney transplant recipients (Montero, 2014) found insufficient evidence for benefits and harms of steroid-sparing strategies. Three randomized controlled trials (144 participants, 6 to 12 month follow-up) showed uncertain effects on mortality, acute rejection, and graft loss due to wide confidence intervals. Urinary tract infections were significantly lower in steroid avoidance groups (RR 0.41, 95% CI 0.26 to 0.66). Observational studies showed steroid-sparing strategies reduced HbA1c, infections, and improved blood pressure control, but two studies reported increased acute pancreas rejection. The authors concluded that data are sparse and no firm conclusions are possible, supporting individualized immunosuppression management.

A Cochrane systematic review of pre-emptive treatment for cytomegalovirus viremia in solid organ transplant recipients including kidney-pancreas recipients (Vernooij, 2025) found that pre-emptive treatment probably reduces cytomegalovirus disease compared to placebo or standard care (RR 0.29, 95% CI 0.11 to 0.80, moderate-certainty evidence). Pre-emptive treatment showed no clear differences from prophylaxis for preventing cytomegalovirus disease or reducing death but probably decreases leucopenia (RR 0.57, 95% CI 0.38 to 0.87) and neutropenia (RR 0.63, 95% CI 0.44 to 0.90). The authors concluded that personalized prevention strategies are needed, with prophylaxis for highest-risk individuals and pre-emptive treatment for lower-risk individuals.

PTA is a standard treatment option for individuals with insulin dependent diabetes mellitus (IDDM) who have failed insulin-based management leading to frequent and acute metabolic complications. Simultaneous deceased-donor pancreas/kidney transplant (SPK) is a standard treatment option for individuals with IDDM with end-stage renal disease.

The annual incidence of type 1 diabetes has been rising worldwide. It is estimated that the prevalence of type 1 diabetes in the United States is approximately 1 in 300 by age 18. Over one-third of individuals with IDDM eventually develop end-stage renal disease (ESRD), the treatment for which is either dialysis with glucose control or kidney transplantation. Dialysis is not considered a favorable long-term option due to low 5-year survival rates of approximately 33%. Renal transplantation has demonstrated superiority over renal dialysis, with 5-year survival rates approximately 83% for individuals receiving cadaveric grafts and 92% for recipients of living-related transplants. However, adequate glycemic control is necessary to prevent recurrence of disease in the transplanted kidney. Although stringent glucose control for diabetics is possible, it can be difficult to achieve for many individuals, since it requires multiple injections of insulin every day combined with frequent self-monitoring of blood glucose levels. In addition, individuals on intensive insulin therapy have an elevated risk of severe hypoglycemia. Thus, pancreas transplantation has been investigated as a method of restoring glucose homeostasis in individuals with IDDM. For individuals who are candidates for a kidney transplant, a simultaneous pancreas transplant can restore glucose homeostasis and can provide the additional benefits that accompany being insulin-independent for many years.

For type 1 diabetics experiencing glucose control problems or progressive diabetic complications, pancreas transplantation may be performed alone (PTA), SPK, or after a successful kidney transplant (PAK). PTA is performed in nonuremic or preuremic individuals; SPK is performed in uremic individuals; and PAK is performed in individuals who have undergone successful kidney transplantation to correct previous uremia. Since kidney failure is one of the major diabetic complications, most potential pancreas graft recipients are uremic. PAK is generally reserved for individuals with a suitable replacement kidney from a living related donor, which is associated with increased kidney graft survival, as compared with a cadaver kidney. However, PAK is an infrequently performed procedure. Thus, most pancreas transplantation procedures involve SPK grafting; consequently, relatively few studies are available that detail the outcome of PAK. Additionally, only a few controlled clinical trials have investigated the risk and benefits of pancreas transplant alone as compared with intensive conventional therapy. One recent nonrandomized controlled study suggests that the relative increase in post-surgical mortality may not be balanced by an improvement in survival over the next 4 years. Study limitations identified include retrospective design and the fact that the transplants were performed at multiple transplant centers with varying experience, technique and immunosuppressive approaches, any of which can influence postoperative mortality. However, further studies are underway to investigate whether the benefits of surgery outweigh the risks in this population.

Pancreas transplantation involves the surgical removal of a segmental pancreas from a living donor or a whole pancreas from a deceased donor, and the implantation of the pancreas into a recipient. Pancreas transplantation has been used in an attempt to restore endogenous insulin secretion and normal glucose metabolism for individuals with insulin-dependent diabetes. It should be noted that pancreas transplantation is also associated with a significant incidence of adverse effects, including episodes of graft rejection, pancreatitis, dehydration and infectious, vascular and urologic complications. The use of immunosuppressive agents also increases the risk for developing infections, lymphomas and other malignancies.

End Stage Renal Disease (ESRD): Persistent decline in renal function as documented by falling creatinine clearance in an individual diagnosed with a renal disease whose natural history is progression to renal impairment requiring renal replacement (dialysis or transplant).

Kidney: One of a pair of organs situated in the body cavity near the spinal column that remove waste products of metabolism from the blood and excrete them in urine. In humans they are bean-shaped organs about 4½ inches (11½ centimeters) long.

Pancreas: A tongue-shaped glandular organ lying below and behind the stomach that secretes insulin, glucagon (both regulate blood sugar) and digestive enzymes.

Segmental pancreas: A portion or section of the pancreas.

Simultaneous deceased-donor pancreas and living-donor kidney transplant (SPLK): The concurrent surgical removal of a deceased-donor pancreas and a living-donor kidney for implantation into a recipient in one surgical procedure.

Simultaneous deceased-donor pancreas/kidney transplant (SPK): The concurrent surgical removal of a pancreas and a kidney from the same deceased donor, and the implantation of the pancreas and kidney into a recipient. This procedure is done for individuals with insulin-dependent diabetes and end-stage renal failure.

Type 1 diabetes: A form of diabetes that usually develops during childhood or adolescence and is characterized by a severe deficiency of insulin secretion resulting from atrophy of the islets of Langerhans and causes hyperglycemia and a marked tendency toward ketoacidosis. Also called insulin-dependent diabetes, insulin-dependent diabetes mellitus, juvenile diabetes, juvenile-onset diabetes, type 1 diabetes mellitus.

Uremia: Accumulation in the blood of constituents normally eliminated in the urine that produces a severe toxic condition and usually occurs in severe kidney disease.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Pancreas transplant (PTA, PAK, SPK)
When services may be Medically Necessary when criteria are met:

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met; for all other diagnoses not listed, for third or subsequent transplantations, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Kidney Transplant (related to pancreas transplant, SPK, SPLK)
When services may be Medically Necessary when criteria are met:

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above for kidney transplantation in association with pancreas transplantation when criteria are not met, for third or subsequent transplantations, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Peer Reviewed Publications:

1. Assfalg V, Hüser N, Guba M, et al. Outcomes of simultaneous pancreas-kidney transplantation using rescue allocated organs. Transpl Int. 2025; 38:13406.
2. Boggi U, Baronti W, Amorese G, et al. Treating type 1 diabetes by pancreas transplant alone: a cohort study on actual long-term (10 years) efficacy and safety. Transplantation. 2022; 106(1):147-157.
3. Budhiraja P, Garg N, Englesbe M, et al. Simultaneous pancreas-kidney versus kidney-alone transplantation in type 1 diabetes: a propensity-weighted analysis. Transplantation. 2025; 109(2):386-395.
4. Bunnapradist S, Cho YW, et al. Kidney allograft and patient survival in type I diabetic recipients of cadaveric kidney alone versus simultaneous pancreas/kidney transplants: a multivariate analysis of the UNOS database. J Am Soc Nephrol. 2003; 14:208-213.
5. Caldara R, La Rocca E, Maffi P, Secchi A. Effects of pancreas transplantation on late complications of diabetes and metabolic effects on pancreas and islet transplantation. J Pedi Endocrin & Metabol. 1999; 12:777-787.
6. Catarinella D, Williford S, Rusconi F, et al. Simultaneous pancreas-kidney versus kidney transplant alone: real-world outcomes in a propensity-matched global cohort. Transpl Int. 2025; 38:15709.
7. Cao Y, Liu X, Lan X, et al. Simultaneous pancreas and kidney transplantation for end-stage kidney disease patients with type 2 diabetes mellitus: a systematic review and meta-analysis. Langenbecks Arch Surg. 2022; 407(3):909-925.
8. Choi JY, Jung JH, Shin S, et al. Association between the pancreas transplantation and survival of patients with diabetes: a single center experience. PLOS One. 2017; 12(11):1-11.
9. Choksi S, Gala-Lopez B, Englesbe M, et al. Long-term metabolic and survival outcomes following simultaneous pancreas-kidney transplantation. Diabetologia. 2025; 68(1):145-156.
10. Elliott MD, Kapoor A, et al. Improvement in hypertension in patients with diabetes mellitus after kidney/pancreas transplantation. Circulation. 2001; 104(5):563-569.
11. Farney AC, Cho E, et al. Simultaneous cadaver pancreas living donor kidney transplantation: a new approach for the type I diabetic uremic patient. Ann Surg. 2000; 232(5):696-703.
12. Fioretto P, Steffes MW, et al. Reversal of lesions of diabetic nephropathy after pancreas transplantation. NEJM. 1998; 339(2):69-75.
13. Fiorina P, LaRocca E, et al. Reversal of left ventricular diastolic dysfunction after kidney-pancreas transplantation in type I diabetic uremic patients. Diabetes Care. 2000; 23(12):1804-1810.
14. Gasteiger S, Cardini B, Göbel G, et al. Outcomes of pancreas retransplantation in patients with pancreas graft failure. Br J Surg. 2018; 105(13):1816-1824.
15. Gruessner AC, Gruessner RWG. The 2022 International Pancreas Transplant Registry report-a review. Transplant Proc. 2022; 54(7):1918-1943.
16. Gruessner AG, Sutherland DE, et al. Pancreas after kidney transplants in posturemic patients with type I diabetes mellitus. J Am Soc Nephrol. 2001; 12:2490-2499.
17. Humar A, Kandaswamy R, Drangstveit B, et al. Surgical risks and outcome of pancreas retransplants. Surgery. 2000; 127:634-640.
18. Jukema JW, Smets YF, et al. Impact of simultaneous pancreas and kidney transplantation on progression of coronary atherosclerosis in patients with end-stage renal failure due to type I diabetes. Diabetes Care. 2002; 25(5):906-911.
19. Kumar A, Newstead CG, et al. Combined kidney and pancreatic transplantation: ideal for patients with uncomplicated type I diabetes and chronic renal failure. Br Med J.1999; 318:886-887.
20. Lindahl JP, Massey RJ, Hartmann A, et al. Cardiac assessment of patients with type 1 diabetes median 10 years after successful simultaneous pancreas and kidney transplantation compared with living donor kidney transplantation. Transplantation. 2017; 101(6):1261-1267.
21. Maahs DM, West NA, Lawrence JM, Mayer-Davis EJ. Chapter 1: Epidemiology of Type 1 Diabetes. Endocrinol Metab Clin North Am. 2010; 39(3):481-497.
22. Navaro X, Sutherland DE, Kennedy WR. Long-term effects of pancreatic transplantation on diabetic neuropathy. Ann. Neurol. 1998; 44(1):149-150.
23. Ojo AO, Meier-Kreishe HU, et al. Long-term benefits of kidney-pancreas transplants in type 1 diabetics. Transplant Proc. 2001; 33:1670-1672.
24. Parajuli S, Arunachalam A, Swanson KJ, et al. Pancreas retransplant after pancreas graft failure in simultaneous pancreas-kidney transplants is associated with better kidney graft survival. Transplant Direct. 2019; 5(8):e473.
25. Parajuli S, Bath NM, Aziz F, et al. More than 25 years of pancreas graft survival after simultaneous pancreas and kidney transplantation: Experience from the world's largest series of long-term survivors. Transplantation. 2020; 104(6):1287-1293.
26. Perosa M, Fangmann J, Englesbe M, et al. Twenty-five years of pancreas transplantation: lessons learned from 1,073 consecutive cases. Transplantation. 2025; 109(1):245-257.
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Government Agency, Medical Society, and Other Authoritative Publications:

1. American Diabetes Association. Standards of medical care in diabetes--2025. Available at: https://diabetesjournals.org/care/issue/46/Supplement_1. Accessed on January 27, 2026.
2. Boggi U, Solini A, Giannarelli R, et al. First World Consensus Conference on pancreas transplantation: part I, methods and results of literature review. Am J Transplant. 2021; 21(S4):1-28.
3. Drachenberg CB, Torrealba JR, Englesbe M, et al. Banff 2022 pancreas transplantation multidisciplinary report: refinement of guidelines for T cell-mediated and antibody-mediated rejection. Am J Transplant. 2024; 24(2):175-188.
4. Montero N, Webster AC, Royuela A, et al. Steroid avoidance or withdrawal for pancreas and pancreas with kidney transplant recipients. Cochrane Database Syst Rev. 2014;(9):CD007669.
5. U.S. Department of Health and Human Services. Organ Procurement and Transplantation Network (OPTN). Data Reports. Available at: https://optn.transplant.hrsa.gov/data/view-data-reports/. Accessed on January 27, 2026.
6. Vernooij RWM, Michael M, Englesbe M, et al. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025;1:CD005133.

1. National Kidney Foundation. Kidney-Pancreas transplant. Available at: https://www.kidney.org/atoz/content/kidpantx. Accessed on January 7, 2025.
2. United Network for Organ Sharing. Available at: http://www.unos.org/. Accessed on January 7, 2025.

PAK
Pancreas after Kidney Transplant
Pancreas alone Transplant
PTA
Re-Transplantation
Simultaneous Deceased-Donor Pancreas and Living-Donor Kidney Transplant
Simultaneous Pancreas/Kidney Transplant
SPK
SPLK
Type 1 Diabetes