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L.5.01.476
Symlin (pramlintide acetate)
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Symlin (pramlintide) is a synthetic form of human amylin, a hormone that is secreted with insulin from pancreatic beta cells that contributes to glucose control during the postprandial period. Pramlintide regulates postprandial glucose levels by slowing gastric emptying, decreasing postprandial glucagon concentrations, and promoting satiety.
Symlin (pramlintide) is a subcutaneous injection that is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy.
Prior authorization is required.
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Initial Criteria
Symlin (pramlintide) may be considered medically necessary for individuals who meet ALL of the following criteria:
The individual is ≥15 years of age;
The individual has a documented diagnosis of type 1 or type 2 diabetes mellitus;
The prescriber is or has consulted with a board certified endocrinologist;
Effective glycemic control (defined as HBA1C ≤7%) has not been achieved after at least 3 months use of insulin;
The individual has current use of prandial insulin therapy as evidenced by pharmacy claims history or use of an insulin pump;
The individual does not have any contraindication(s) to therapy with the requested agent; AND
The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage (i.e.,
60 mcg prior to each meal for type 1 diabetes;
120 mcg prior to each meal for type 2 diabetes).
Length of Approval: 6 months
Renewal Criteria
Symlin (pramlintide) may be considered for renewal when ALL of the following criteria are met:
The individual has previously been approved for therapy through BCBSMS PA process;
The individual has documented clinical improvement (i.e., reduction in A1c);
The individual has current use of prandial insulin therapy as evidenced by pharmacy claims history or use of an insulin pump;
The individual does not have any contraindication(s) to therapy with the requested agent; AND
The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage (i.e., 60 mcg prior to each meal for type 1 diabetes; 120 mcg prior to each meal for type 2 diabetes).
Length of Approval: 12 months
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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.
01/01/2014: New policy added.
07/23/2015: Code Reference section updated for ICD-10.
05/04/2016: Policy Guidelines updated to add medically necessary and investigative definitions.
05/31/2016: Policy number L.5.01.476 added.
06/13/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
02/07/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug name to the top of the policy. Added statement that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Sources section updated. Effective 01/01/2019.
11/01/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications. Policy section updated to add that prior authorization is required. Medically necessary statement updated with additional criteria. Added renewal criteria. Policy Exceptions updated to remove FEP and State Health Plan members. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders." Sources updated.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
03/20/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Initial and renewal criteria updated regarding a documented diagnosis of type 1 or type 2 diabetes mellitus, contraindications to therapy, and dose requirements. Sources updated.
American Diabetes Association Professional Practice Committee; 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes—2025. Diabetes Care 1 January 2025; 48 (Supplement_1): S181–S206. https://doi.org/10.2337/dc25-S009
Symlin prescribing information. AstraZeneca Pharmaceuticals LP.December 2019. Last accessed January 2025.
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