Islet Transplantation for Chronic Pancreatitis and Donislecel-jujn for Type 1 Diabetes

POLICY NUMBER

A.7.03.12

DESCRIPTION

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.

Islet 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. 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. 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 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.

POLICY

No benefits will be provided for a covered transplant procedure or a transplant evaluation unless the Member receives prior authorization through Case Management from Blue Cross & Blue Shield of Mississippi.

Autologous pancreas islet transplantation may be considered medically necessary as an adjunct to a total or near total pancreatectomy in individuals with chronic pancreatitis. Autologous pancreas islet cell transplantation is a specialized procedure that may require referral to an out of network facility.

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.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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 the Allogeneic Pancreas Transplant medical policy).

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.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/2001: Approved by Medical Policy Advisory Committee (MPAC).

3/6/2002: Prior authorization through Case Management added.

4/18/2002: Type of Service and Place of Service deleted.

5/29/2002: Code Reference section updated.

10/25/2005: Code Reference section updated, CPT code 48146 deleted from covered codes, ICD-9 Procedure codes 52.51 - 52.59, 52.6, 52.86 deleted from covered codes, HCPCS codes G0341 and G0342 added to covered codes.

1/4/2007: Policy reviewed, investigational statement per allogeneic transplant for type 1 diabetes added.

1/9/2007: Code reference section updated. CPT codes 0141T, 0142T, 0143T, G0343, and S2102 added to the non-covered codes. CPT codes G0341 and G0342 moved to non-covered.

4/23/2009: Policy reviewed, no changes.

07/15/2010: Policy description updated to include information regarding autologous islet transplantation. Policy statement unchanged.

08/02/2011: Policy reviewed; no changes.

07/17/2012: Policy reviewed; no changes.

10/23/2013: Policy reviewed; no changes.

06/17/2014: Policy reviewed; description updated regarding primary risk factors for chronic pancreatitis. Policy statement unchanged.

08/27/2015: Code Reference section updated for ICD-10. Removed deleted CPT codes 0141T, 0142T, and 0143T.

10/01/2015: Policy reviewed; no changes to policy statements. Policy Guidelines updated to add medically necessary and investigative definitions.

06/01/2016: Policy number A.7.03.12 added.

09/20/2017: Policy description updated regarding FDA regulations. Policy statements unchanged.

09/04/2018: Policy description updated regarding individuals with type 1 diabetes. Policy statements unchanged.

09/13/2019: Policy reviewed; no changes.

12/20/2019: Code Reference section updated to add new CPT codes 0584T, 0585T, and 0586T effective 01/01/2019.

09/18/2020: Policy description updated to remove information regarding chronic pancreatitis and type 1 diabetes. Policy statements unchanged.

12/28/2021: Policy description updated regarding islet cell products. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

11/16/2022: Policy reviewed. Medically necessary policy statement updated to change "islet cell transplantation" to "islet transplantation" and "patients" to "individuals." Added statement that islet transplantation is considered investigational in all other situations.

02/15/2024: Policy title changed from "Islet Transplantation" to "Islet Transplantation for Chronic Pancreatitis and Donislecel-jujn for Type 1 Diabetes." Policy description updated regarding islet cell transplantation and Donislecel-jujn (Lantidra™). Policy statement revised to state that allogeneic islet transplantation using an FDA-approved cellular therapy product (donislecel-jujn [ie, Lantidra]) is considered investigational for the treatment of type 1 diabetes. Revised statement to state that islet transplantation with donislecel-jujn is considered investigational in all other situations. Policy Guidelines updated regarding donislecel-jujn (Lantidra) clinical studies.

12/05/2024: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.03.12

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Investigational Codes

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