Diabetes Mellitus

Diabetes mellitus (commonly referred to as diabetes) is a chronic (long-term) medical condition characterized by high blood glucose (sugar). This may be because the pancreas (an organ in the belly) does not make enough insulin (a hormone), or because the body is not responding to insulin the way it should. Insulin helps glucose get into cells in the body, giving it energy. With diabetes, sugar builds up in the blood because the body stops responding to insulin, or because there is not enough of it.

Types of Diabetes

• Type 1 diabetes - the pancreas makes no insulin, or a very small amount
• Type 2 diabetes - cells in the body do not respond to insulin the way it should; sometimes, thepancreas also does not make enough insulin

Diabetes is usually managed by eating healthy foods, getting plenty of exercise, and sometimes medicines. Medicines are used to either control blood sugar, or to lower the chance of problems that can happen in the future because of diabetes. These medications can be insulin itself, or medications that help the body make more insulin or help insulin do its job.

Symlin (pramlintide acetate)

Symlin (pramlintide acetate) is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.

Definitions

"Insulin" is a hormone produced by the beta cells in the pancreas. It facilitates the entry of glucose into cells for energy production. Insufficient insulin leads to a high blood glucose level, a condition known as diabetes. Oral and injectable medications can help increase insulin production, enhance the body's sensitivity to insulin, and decrease blood sugar levels.

"Type 1 Diabetes" is an autoimmune condition where the pancreas's beta cells are unable to produce sufficient insulin, leading to elevated blood glucose levels. Patients with Type 1 diabetes often require daily insulin injections to regulate their blood glucose.

"Type 2 Diabetes" is a metabolic disorder characterized by insufficient insulin production or insulin resistance in the body cells. It is more common than Type 1 and often managed through lifestyle changes, non-insulin medications, and, if necessary, insulin injections.

"Blood Glucose" is the primary sugar found in the bloodstream, serving as the body's main energy source. Chronic high blood glucose levels can lead to complications from blood vessel damage.

"Hemoglobin A1c (HbA1c)" is a blood test that measures average blood glucose levels over the past 2 to 3 months. It is also referred to as the A1C or glycosylated hemoglobin test. Various factors, such as age, ethnicity, certain conditions, and pregnancy, can affect A1C results.

"Hyperglycemia" is the medical term for high blood glucose. It can occur due to inadequate fasting (fasting hyperglycemia) or post-meal (postprandial hyperglycemia).

"Hypoglycemia" is a condition characterized by abnormally low blood glucose, typically less than 70 mg/dL. Symptoms include hunger, nervousness, dizziness, confusion, and in severe cases, unconsciousness. Immediate treatment involves consuming carbohydrate-rich foods or using injectable glucagon for severe cases.

Medical Necessity Criteria for Authorization

The Plan considers SymlinPen (Pramlintide) medically necessary when ALL the following criteria are met:

1. The member has a diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus; AND
2. The member has ONE of the following:
   • failed to achieve desired glucose control despite receiving optimal insulin therapy, including mealtime insulin; or
   • has been receiving SymlinPen (Pramlintide) for at least 3 months AND has demonstrated a reduction in A1c (hemoglobin A1c) since starting this therapy.

If the above prior authorization criteria are met, SymlinPen (Pramlintide) will be approved for 12 months.

Experimental or Investigational / Not Medically Necessary

SymlinPen (Pramlintide) for any other indication is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven.

References

1. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins—Obstetrics. ACOG Practice Bulletin No. 190: Gestational diabetes mellitus. Obstet Gynecol. 2018;131(2):e49-e64.
2. American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin No. 201: Pregestational diabetes mellitus. Obstet Gynecol. 2018;132(6):e228-e248. doi:10.1097/AOG.0000000000002960
3. American Diabetes Association (ADA). Standards of medical care in diabetes–2021. DiabetesCare. 2021;44(suppl 1):S1-S232.
4. American Diabetes Association (ADA). Standards of medical care in diabetes–2021. Diabetes Care. 2021;44(suppl 1):S1-S232. https://care-diabetesjournals-org.libproxy.unm.edu/content/44/Supplement_1. Accessed January 13, 2021.

References

1. American Diabetes Association Professional Practice Committee, Draznin, B., Aroda, V. R., Bakris, G., Benson, G., Brown, F. M., Freeman, R., Green, J., Huang, E., Isaacs, D., Kahan, S., Leon, J., Lyons, S. K., Peters, A. L., Prahalad, P., Reusch, J., & Young-Hyman, D. (2022). 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes- 2022. Diabetes care, 45(Suppl 1), S125–S143. https://doi.org/10.2337/dc22-S009.
2. Blumer I, Hadar E, Hadden DR, et al. Diabetes and pregnancy: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2013;98(11):4227-4249.
3. Davies MJ, D'Alessio DA, Fradkin J, et al. Management of hyperglycemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018;41(12):2669-2701. doi:10.2337/dci18-0033
4. Garber AJ, Handelsman Y, Grunberger G et al. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm 2020 executive summary. Endocr Pract. 2020; 26:107-139. [PubMed 32022600]
5. Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2020 clinical practice guideline for diabetes management in chronic kidney disease. Kidney Int. 2020;98(supp 4):S1-S115. doi:10.1016/j.kint.2020.06.019
6. LeRoith D, Biessels GJ, Braithwaite SS, et al. Treatment of diabetes in older adults: an Endocrine Society* clinical practice guideline. J Clin Endocrinol Metab. 2019;104(5):1520-1574. doi:10.1210/jc.2019-00198
7. Symlin (pramlintide) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2019.
8. Clinical Guideline Revision / History InformationOriginal Date: 6/29/2023Reviewed/Revised: 4