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Rapid to Intermediate Acting Insulin Prior Authorization Program Summary
Policy Number: PH-1160
This program applies to Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Admelog® (insulin lispro) Injection |
To improve glycemic control in adult and pediatric patients with diabetes mellitus |
Rapid-Acting Insulins |
1 |
Apidra® (insulin glulisine) Injection |
To improve glycemic control in adults and pediatric patients with diabetes mellitus |
Rapid-Acting Insulins |
2 |
Fiasp® (insulin aspart) Injection |
To improve glycemic control in adult and pediatric patients with diabetes mellitus |
Rapid-Acting Insulins |
3 |
Humalog®, Humalog Junior®, Insulin Lispro, Insulin Lispro Junior Injection |
To improve glycemic control in adults and children with diabetes mellitus |
Rapid-Acting Insulins |
4 |
Humalog® Mix 50/50 (50% insulin lispro protamine/50% insulin lispro) Injection |
To improve glycemic control in adult and pediatric patients with diabetes mellitus |
NPH-Lispro Combinations |
14 |
Humalog® Mix 75/25, Insulin Lispro Protamine/Insulin Lispro (75/25) Injection |
To improve glycemic control in adult and pediatric patients with diabetes mellitus |
NPH-Lispro Combinations |
13 |
Humulin® 70/30 (70% human insulin isophane/30% regular human insulin) Injection |
To improve glycemic control in adults with diabetes mellitus |
NPH-Regular Combinations |
11 |
Humulin® N (human isophane insulin) Injection |
To improve glycemic control in adult and pediatric patients with diabetes mellitus |
Intermediate-Acting Insulins |
9 |
Humulin® R (regular human insulin) Injection |
To improve glycemic control in adult and pediatric patients with diabetes mellitus |
Short-Acting Insulins |
7 |
Novolin® 70/30, Insulin aspart protamine/insulin aspart Injection |
To improve glycemic control in adults and pediatric patients with diabetes mellitus |
NPH-Regular Combinations |
12 |
Lyumjev® (insulin lispro-aabc) Injection |
To improve glycemic control in adults with diabetes mellitus |
Rapid-Acting Insulins |
5 |
Novolin® N, ReliOn® N (human isophane insulin) Injection |
To improve glycemic control in adult and pediatric patients with diabetes mellitus |
Intermediate-Acting Insulins |
10 |
Novolin® R, ReliOn® R (regular human insulin) Injection |
To improve glycemic control in adult and pediatric patients with diabetes mellitus |
Short-Acting Insulins |
8 |
NovoLog®, Insulin Aspart Injection |
To improve glycemic control in adults and pediatric patients with diabetes mellitus |
Rapid-Acting Insulins |
6 |
NovoLog® Mix 70/30, Insulin aspart protamine/insulin aspart Injection |
To improve glycemic control in patients with diabetes mellitus |
NPH – NovoLog Combination |
15 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Overview |
The American Diabetes Association Standards of Medical Care in Diabetes recommend the following therapy for type 1 diabetes mellitus:(16)
For type 2 diabetes mellitus, the American Diabetes Association recommends the following:(16)
The American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) 2023 algorithm for type 2 diabeties recommends the overall goal of insulin therapy is to achieve glycemic control after failure of noninsulin antihyperglycemic agents. Glycemic targets should be individualized, although an A1C of 6.5% to 7% for persons on insulin is recommended for most patients. Although A1C is a key measure, insulin titration requires use of multiple glycemic parameters including fasting blood glucose (FBG), premeal or 2-hour postprandial blood glucose, and data from continuous glucose monitoring (CGM), when available. In general, targets for fasting and premeal glucose are <110 mg/dL without hypoglycemia and can be individualized based on a person’s comorbidities and clinical status. The use of CGM is recommended for persons treated with insulin to optimize glycemic control while minimizing hypoglycemia.(17) Given that type 2 diabetes is a progressive disease, many individuals will require >1 antihyperglycemic medication to achieve their individualized A1C target over the course of the disease. Clinicians should consider multiple factors when selecting the second agent, including presence of overweight or obesity, hypoglycemia risk, access/cost, and presence of severe hyperglycemia. Patients often present with >1 of these factors, so using a patient-centered, shared decision-making approach is important. The order that medications are listed in the algorithm denotes the suggested preference hierarchy for selection. In those patients with overweight or obesity and the additional goal of weight loss, dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP/GLP-1 RA), GLP-1 RA, or sodium glucose cotransporter 2 inhibitor (SGLT2i) class are preferred options. Persons with a history of hypoglycemia, at high risk of hypoglycemia, and/or at risk for severe complications from hypoglycemia should preferentially be initiated with an agent associated with low risk for hypoglycemia, including GLP-1 RA, SGLT2i, dual GIP/GLP-1 RA, thiazolidinedione (TZD), or dipeptidyl peptidase-4 inhibitor (DPP-4i).(17) Patients with symptomatic hyperglycemia and/or an A1C >10% suggestive of marked insulin deficiency should start basal insulin to improve glycemia as quickly as possible. Basal insulin can be initiated with or without initiation and titration of a GLP-1 RA if the patient is not already on this class of agents. Some patients with severe hyperglycemia may need simultaneous initiation of bolus insulin. Clinicians should be cognizant that combination of incretin-based therapies is not recommended (ie, DPP-4i with GLP-1 RA or dual GIP/GLP-1 RA). Antihyperglycemic medications should be titrated to the maximally tolerated dose to achieve the individualized A1C goal, and additional antihyperglycemic agents should be considered in a timely fashion to avoid therapeutic inertia. If the A1C is >9% or >1.5% above goal, greater than 2 antihyperglycemic agents may need to be initiated at once.(17) Basal with or without prandial insulin treatment may be needed as initial therapy if the A1C is >10% and/or glucose values are >300 mg/dL, combined with catabolic symptoms, such as weight loss. If symptomatic hyperglycemia is present, a GLP-1 RA alone is not recommended as it requires titration and may delay glucose control. The goal of initial intensive insulin therapy for symptomatic hyperglycemia is to reduce glucose levels safely and promptly. After improved glycemic control is achieved with short-term insulin therapy, especially with a new diagnosis of DM, a role for noninsulin antihyperglycemic agents could be considered. For most persons who need intensification of glycemic control and who are already undergoing 3 to 4 oral therapies, a GLP-1 RA or GIP/GLP-1 RA should be the initial choice, if not already in use. If glycemic targets are not achieved with these therapies, basal insulin should be added alone or as a basal insulin/GLP-1 RA combination injection. Stepwise addition of prandial insulin at 1 to 3 meals is recommended if additional glycemic control is required. The dose of basal insulin can be based on A1C levels at the time of initiation. For an A1C <8%, basal insulin can be started at 0.1 to 0.2 U/kg/day and for an A1C >8%, 0.2 to 0.3 U/kg/day can be considered. Analog insulins, including detemir, glargine, or degludec are preferred over human insulins such as neutral protamine Hagedorn (NPH) to reduce hypoglycemia.(17) |
Safety |
All rapid to intermediate-acting insulin agents have the following contraindications:(1-15)
|
REFERENCES
Number |
Reference |
1 |
Admelog prescribing information. Sanofi-Aventis US, LLC. August 2023. |
2 |
Apidra (insulin glulisine [rDNA origin] injection) solution for injection. Sanofi-Aventis. November 2022. |
3 |
Fiasp prescribing information. Novo Nordisk Inc. June 2023. |
4 |
Humalog, Humalog Kwikpen, Humalog Junior Kwikpen, Humalog Tempo Pen (insulin lispro injection [rDNA origin] solution for subcutaneous injection). Eli Lilly and Company. July 2023. |
5 |
Lyumjev, Lyumjev Kwikpen, Lyumjev Junior Kwikpen, Lyumjev Kwikpen prescribing information. Eli Lilly and Company. October 2022. |
6 |
NovoLog (insulin aspart [rDNA origin] injection) solution for subcutaneous use. Novo Nordisk, Inc. February 2023. |
7 |
Humulin R (insulin human injection [rDNA origin]) solution for subcutaneous injection. Eli Lilly and Company. June 2022. |
8 |
Novolin R (human insulin injection [rDNA origin]). Novo Nordisk, Inc. November 2022. |
9 |
Humulin N (insulin [rDNA origin] isophane suspension). Eli Lilly and Company. June 2022. |
10 |
Novolin N (human insulin isophane suspension injection) suspension. Novo Nordisk. November 2022. |
11 |
Humulin 70/30 (70% human insulin isophane suspension and 30% human insulin injection (rDNA origin). Eli Lilly and Company. June 2022. |
12 |
Novolin 70/30 (70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection, [rDNA]). Novo Nordisk. November 2022. |
13 |
Humalog Mix 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection (rDNA origin). Eli Lilly and Company. July 2023. |
14 |
Humalog Mix 50/50 (50% insulin lispro protamine suspension and 50% insulin lispro injection [rDNA origin]). Eli Lilly and Company. July 2023. |
15 |
NovoLog 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection. Novo Nordisk Inc. February 2023. |
16 |
American Diabetes Association, 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2023. Diabetes Care 1 January 2023; 46 (Supplement_1): S140–S157. https://doi.org/10.2337/dc23-S009. |
17 |
Samson, S. L., Vellanki, P., Blonde, L., et. al. (2023). American association of clinical endocrinology consensus statement: Comprehensive type 2 diabetes management algorithm – 2023 update. Endocrine Practice: Official Journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists, 29(5), 305–340. https://doi.org/10.1016/j.eprac.2023.02.001 |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
|
insulin aspart inj soln ; insulin aspart soln cartridge ; insulin aspart soln pen-injector |
100 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
|
insulin aspart prot & aspart (human) inj ; insulin aspart prot & aspart sus pen-inj |
(70-30) 100 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
Apidra ; Apidra solostar |
insulin glulisine inj ; insulin glulisine soln pen-injector inj |
100 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
|
insulin lispro prot & lispro inj ; insulin lispro prot & lispro sus pen-inj |
(50-50) 100 UNIT/ML ; (75-25) 100 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
Admelog ; Admelog solostar |
Insulin Lispro Inj ; insulin lispro inj soln ; insulin lispro soln pen-injector ; insulin lispro subcutaneous soln |
100 ; 100 UNIT/ML ; 200 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
insulin aspart inj soln ; insulin aspart soln cartridge ; insulin aspart soln pen-injector |
100 UNIT/ML |
Health Insurance Marketplace |
|
insulin aspart prot & aspart (human) inj ; insulin aspart prot & aspart sus pen-inj |
(70-30) 100 UNIT/ML |
Health Insurance Marketplace |
|
insulin lispro prot & lispro inj ; insulin lispro prot & lispro sus pen-inj |
(50-50) 100 UNIT/ML ; (75-25) 100 UNIT/ML |
Health Insurance Marketplace |
Admelog ; Admelog solostar |
Insulin Lispro Inj ; insulin lispro inj soln ; insulin lispro soln pen-injector ; insulin lispro subcutaneous soln |
100 ; 100 UNIT/ML ; 200 UNIT/ML |
Health Insurance Marketplace |
Apidra ; Apidra solostar |
insulin glulisine inj ; insulin glulisine soln pen-injector inj |
100 UNIT/ML |
Health Insurance Marketplace |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||||||||||||||||||||
PA |
Non-Preferred Insulin Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: 12 months *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required. |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
ALBP _ Commercial _ CSReg _ Rapid_to_Intermediate_Acting_Insulin_PA _ProgSum_ 10-01-2024 _
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