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L.5.01.438
Admelog (lispro)
Apidra (glulisine)
Humalog (lispro)
Humalog Mix (lispro protamine, lispro)
Humulin 70/30 (regular insulin, NPH)
Humulin N (NPH)
Humulin R (regular insulin)
Lyumjev (lispro-aabc)
Novolin 70/30 (regular insulin, NPH)
Novolin N (NPH)
Novolin R (regular insulin)
Novolog (aspart)
Novolog Mix 70/30 (aspart protamine, aspart)
Relion R (regular insulin)
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.
Insulin is used in the treatment of patients with diabetes of all types. The need for insulin depends upon the balance between insulin secretion and insulin resistance. All patients with type 1 diabetes need insulin treatment permanently, unless they receive an islet or whole organ pancreas transplant; many patients with type 2 diabetes will require insulin as their beta cell function declines over time. There are various forms of insulin including regular, NPH, rapid-acting, mixes, and long-acting insulin.
Based on a review of data, there is no advantage to using one non-long acting insulin product (such as Admelog, Humalog, Humulin, or Apidra) over the Novolog or Novolin family of products.
Note: This policy only addresses the coverage of non-long acting insulin products. This policy does not apply to the long-acting insulin products (i.e. Lantus, Levemir, Tresiba). This policy does not apply to Humulin U-500.
Prior Authorization is required.
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Novolog and Novolin family of non-long acting insulin products are available without prior authorization.
Other non-long-acting insulin products (i.e., Admelog, Apidra, Humalog, Humulin, etc.) may be considered medically necessary when one or more of the following criteria are met:
There is clinical evidence that the use of Novolog or the Novolin family of products will be ineffective for the individual;OR
The individual's medical history supports that the use of Novolog or the Novolin family of products causes an adverse reaction for the patient.
The use of non-long-acting insulin products other than the Novolog or Novolin family of products is considered not medically necessary if the above individual selection criteria are not met.
Lyumjev (lispro-aabc) is considered not medically necessary on all Blue Cross and Blue Shield of Mississippi formularies as other formulary alternatives are available for the treatment of diabetes mellitus.
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.
Medication failure is defined as disease progression despite maximally tolerated dose (≥3 months use) as appropriate for disease state being treated. Experience of common side effects of medication will not be considered medication failure for the purpose of this review.
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 Medically Necessary, “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.
11/20/2014: New policy added. Approved by Medical Policy Advisory Committee. Effective 01/01/2015.
08/28/2015: Medical policy revised to add ICD-10 codes.
06/09/2016: Policy number L.5.01.438 added. Policy Guidelines updated to add medically necessary and investigative definitions.
02/12/2019: Policy updated to add product.
06/30/2020: Policy description and statement updated to add Admelog as a non-long acting insulin product.
10/19/2020: Added drug names to the top of the policy. Added statement to perform a formulary drug search on the 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. Policy section updated to add that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Added statement that Lyumjev (lispro-aabc) is considered not medically necessary on all Blue Cross and Blue Shield of Mississippi formularies as other formulary alternatives are available for the treatment of diabetes mellitus. Policy Exceptions updated. Policy Guidelines updated to define medication failure and to change "Nervous/Mental Conditions" to "Mental Health Disorders." Sources updated. Code Reference section updated to remove ICD-10 diagnosis codes.
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 updated to add Humalog Mix (lispro protamine, lispro), Humulin 70/30 (regular insulin, NPH), Novolin 70/30 (regular insulin, NPH), and Novolog Mix 70/30 (aspart protamine, aspart) to the list of products. Policy description updated regarding products addressed in this policy. Policy section updated to add statement that prior authorization is required. Revised policy statements to state the following: 1) The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. 2) Novolog and Novolin family of non-long acting insulin products are available without prior authorization. Sources updated.
Admelog prescribing information. Sanofi-Aventis U.S. LLC. September 2023. Last accessed November 2024.
Apidra prescribing information. Sanofi-Aventis U.S. LLC. July 2023. Last accessed November 2024.
Humalog prescribing information. Eli Lilly and Company. August 2024. Last accessed November 2024.
Humulin N prescribing information. Eli Lilly and Company. January 2024. Last accessed November 2024.
Humulin R prescribing information. Eli Lilly and Company. June 2023. Last accessed November 2024.
Lyumjev prescribing information. Eli Lilly and Company. October 2024. Last accessed November 2024.
Novolin N prescribing information. Novo Nordisk. November 2022. Last accessed November 2024.
Novolin R prescribing information. Novo Nordisk. November 2022. Last accessed November 2024.
Novolog prescribing information. Novo Nordisk. February 2023. Last accessed November 2024.
Weinstock RS. General principles of insulin therapy in diabetes mellitus. UptoDate, Connor RF (Ed)®, Wolters Kluwer. https://www.uptodate.com/contents/general-principles-of-insulin-therapy-in-diabetes-mellitus (Accessed November 18, 2024).
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