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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 |
4/1/2023 |
|
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Admelog® Injection |
To improve glycemic control in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus |
Rapid-Acting Insulins |
1 |
Apidra® Injection |
To improve glycemic control in adults and pediatric patients with diabetes mellitus |
Rapid-Acting Insulins |
2 |
Fiasp® 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 Injection |
To improve glycemic control in 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 patients with diabetes mellitus |
NPH-Lispro Combinations |
13 |
Humulin® 70/30 Injection |
To improve glycemic control in adult patients with diabetes mellitus |
NPH-Regular Combinations |
11 |
Humulin® N Injection |
To improve glycemic control in adult and pediatric patients with diabetes mellitus |
Intermediate-Acting Insulins |
9 |
Humulin® R 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® Injection |
To improve glycemic control in adults with diabetes mellitus |
Rapid-Acting Insulins |
5 |
Novolin® N, ReliOn® N |
To improve glycemic control in adult and pediatric patients with diabetes mellitus |
Intermediate-Acting Insulins |
10 |
Novolin® R, ReliOn® R 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:
For type 2 diabetes mellitus, the American Diabetes Association recommends the following:
The American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) algorithm for type 2 diabetics recommends starting insulin therapy if the patient has an A1c greater than 9% and is having hyperglycemia symptoms. Patients with recent-onset type 2 diabetes or who have mild hyperglycemia (A1c less than 7.5%), lifestyle therapy plus antihyperglycemic monotherapy (preferably with metformin) is recommended. Patients who present with an A1c greater than 7.5% should be started initially on metformin plus another agent, one of which is insulin. Patients taking two oral antihyperglycemic agents who have an A1c greater than 8 and/or long-standing type 2 diabetes are less likely to reach their target with a third oral antihyperglycemic agent. Although adding a GLP-1 receptor agonist as the third agent may lower hyperglycemia, eventually many patients will still require insulin. When insulin becomes necessary, a single daily dose of basal insulin should be added to the regimen. Dosage should be adjusted at regular and at short intervals to achieve the glycemic goal. Patients whose glycemia remains uncontrolled while receiving basal insulin in combination with oral agents or GLP-1 receptor agonists may require mealtime insulin to cover postprandial hyperglycemia.(17) |
REFERENCES
Number |
Reference |
1 |
Admelog prescribing information. Sanofi-Aventis US, LLC. December 2020. |
2 |
Apidra (insulin glulisine [rDNA origin] injection) solution for injection. Sanofi-Aventis. December 2020. |
3 |
Fiasp prescribing information. Novo Nordisk Inc. September 2022. |
4 |
Humalog, Humalog Kwikpen, Humalog Junior Kwikpen, Humalog Tempo Pen (insulin lispro injection [rDNA origin] solution for subcutaneous injection). Eli Lilly and Company. November 2019. |
5 |
Lyumjev, Lyumjev Kwikpen, Lyumjev Junior Kwikpen, Lyumjev Kwikpen prescribing information. Eli Lilly and Company. August 2021. |
6 |
NovoLog (insulin aspart [rDNA origin] injection) solution for subcutaneous use. Novo Nordisk, Inc. October 2021. |
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 2019. |
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 2019. |
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. April 2021. |
13 |
Humalog Mix 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection (rDNA origin). Eli Lilly and Company. November 2019. |
14 |
Humalog Mix 50/50 (50% insulin lispro protamine suspension and 50% insulin lispro injection [rDNA origin]). Eli Lilly and Company. November 2019. |
15 |
NovoLog 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection. Novo Nordisk Inc. April 2021. |
16 |
American Diabetes Association. Pharmacologic Approaches to Glycemic Treatment: Standards of medical care in diabetes-2022. Available at https://diabetesjournals.org/care/issue/45/Supplement_1 |
17 |
AACE/ACE Comprehensive Type 2 Diabetes Management Algorithm (2020) Executive Summary. Available at: https://pro.aace.com/pdfs/diabetes/AACE_2019_Diabetes_Algorithm_03.2021.pdf |
OBJECTIVE PRIOR AUTHORIZATION
The intent of the Rapid to Intermediate Acting Insulin prior authorization criteria is to encourage use of cost-effective preferred Rapid to Intermediate Acting insulin agents over the non-preferred Rapid to intermediate Acting insulin agents. The program will also support a quantity limit of 100 mL of preferred and non-preferred insulin agent per 30 days.
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Preferred Status |
Effective Date |
|
||||||
Admelog ; Admelog solostar ; Humalog ; Humalog junior kwikpen ; Humalog kwikpen ; Humalog tempo pen ; Lyumjev ; Lyumjev kwikpen ; Lyumjev tempo pen |
insulin lispro inj soln ; insulin lispro soln cartridge ; insulin lispro soln pen-inj w/transmitter port ; insulin lispro soln pen-injector ; insulin lispro-aabc inj ; insulin lispro-aabc soln pen-inj ; insulin lispro-aabc soln pen-inj w/transmit port ; insulin lispro-aabc soln pen-injector |
100 UNIT/ML ; 200 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 |
|
|
Fiasp ; Fiasp flextouch ; Fiasp penfill ; Novolog ; Novolog flexpen ; Novolog flexpen relion ; Novolog penfill ; Novolog relion |
insulin aspart (with niacinamide) inj ; insulin aspart (with niacinamide) sol pen-inj ; insulin aspart (with niacinamide) soln cartridge ; insulin aspart inj soln ; insulin aspart soln cartridge ; insulin aspart soln pen-injector |
100 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
Humalog mix 50/50 ; Humalog mix 50/50 kwikpen ; Humalog mix 75/25 ; Humalog mix 75/25 kwikpen |
insulin lispro prot & lispro inj ; insulin lispro prot & lispro sus pen-inj ; insulin lispro protamine & lispro inj |
50 UNIT/ML ; 75 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
HUMULIN 70/30 ; HUMULIN 70/30 KWIKPEN |
insulin nph & regular susp pen-inj ; insulin nph isophane & regular human inj |
70 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
HUMULIN N ; HUMULIN N KWIKPEN |
insulin nph (human) (isophane) inj ; insulin nph (human) (isophane) susp pen-injector |
100 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
HUMULIN R |
insulin regular (human) inj |
100 UNIT/ML ; 500 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
Humulin r u-500 (concentr |
Insulin Regular (Human) Inj 500 Unit/ML |
500 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
HUMULIN R U-500 (CONCENTR ; NOVOLIN R RELION |
insulin regular (human) inj |
100 UNIT/ML ; 500 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
Humulin r u-500 kwikpen |
Insulin Regular (Human) Soln Pen-Injector 500 Unit/ML |
500 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
HUMULIN R U-500 KWIKPEN ; NOVOLIN R FLEXPEN RELION |
insulin regular (human) soln pen-injector |
100 UNIT/ML ; 500 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
NOVOLIN 70/30 ; NOVOLIN 70/30 FLEXPEN ; NOVOLIN 70/30 FLEXPEN REL ; NOVOLIN 70/30 RELION |
insulin nph & regular susp pen-inj ; insulin nph isophane & regular human inj |
70 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
NOVOLIN N ; NOVOLIN N FLEXPEN ; NOVOLIN N FLEXPEN RELION ; NOVOLIN N RELION |
insulin nph (human) (isophane) inj ; insulin nph (human) (isophane) susp pen-injector |
100 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
NOVOLIN R |
insulin regular (human) inj |
100 UNIT/ML ; 500 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
NOVOLIN R FLEXPEN |
insulin regular (human) soln pen-injector |
100 UNIT/ML ; 500 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
Novolin r flexpen ; Novolin r flexpen relion |
Insulin Regular (Human) Soln Pen-Injector 100 Unit/ML |
100 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
Novolog mix 70/30 ; Novolog mix 70/30 prefill ; Novolog mix 70/30 relion |
insulin aspart prot & aspart (human) inj ; insulin aspart prot & aspart sus pen-inj |
70 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Admelog ; Admelog solostar ; Humalog ; Humalog junior kwikpen ; Humalog kwikpen ; Humalog tempo pen ; Lyumjev ; Lyumjev kwikpen ; Lyumjev tempo pen |
insulin lispro inj soln ; insulin lispro soln cartridge ; insulin lispro soln pen-inj w/transmitter port ; insulin lispro soln pen-injector ; insulin lispro-aabc inj ; insulin lispro-aabc soln pen-inj ; insulin lispro-aabc soln pen-inj w/transmit port ; insulin lispro-aabc soln pen-injector |
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 |
Fiasp ; Fiasp flextouch ; Fiasp penfill ; Novolog ; Novolog flexpen ; Novolog flexpen relion ; Novolog penfill ; Novolog relion |
insulin aspart (with niacinamide) inj ; insulin aspart (with niacinamide) sol pen-inj ; insulin aspart (with niacinamide) soln cartridge ; insulin aspart inj soln ; insulin aspart soln cartridge ; insulin aspart soln pen-injector |
100 UNIT/ML |
Health Insurance Marketplace |
Humalog mix 50/50 ; Humalog mix 50/50 kwikpen ; Humalog mix 75/25 ; Humalog mix 75/25 kwikpen |
insulin lispro prot & lispro inj ; insulin lispro prot & lispro sus pen-inj ; insulin lispro protamine & lispro inj |
50 UNIT/ML ; 75 UNIT/ML |
Health Insurance Marketplace |
HUMULIN 70/30 ; HUMULIN 70/30 KWIKPEN |
insulin nph & regular susp pen-inj ; insulin nph isophane & regular human inj |
70 UNIT/ML |
Health Insurance Marketplace |
HUMULIN N ; HUMULIN N KWIKPEN |
insulin nph (human) (isophane) inj ; insulin nph (human) (isophane) susp pen-injector |
100 UNIT/ML |
Health Insurance Marketplace |
HUMULIN R |
insulin regular (human) inj |
100 UNIT/ML ; 500 UNIT/ML |
Health Insurance Marketplace |
Humulin r u-500 (concentr |
Insulin Regular (Human) Inj 500 Unit/ML |
500 UNIT/ML |
Health Insurance Marketplace |
HUMULIN R U-500 (CONCENTR ; NOVOLIN R RELION |
insulin regular (human) inj |
100 UNIT/ML ; 500 UNIT/ML |
Health Insurance Marketplace |
Humulin r u-500 kwikpen |
Insulin Regular (Human) Soln Pen-Injector 500 Unit/ML |
500 UNIT/ML |
Health Insurance Marketplace |
HUMULIN R U-500 KWIKPEN ; NOVOLIN R FLEXPEN RELION |
insulin regular (human) soln pen-injector |
100 UNIT/ML ; 500 UNIT/ML |
Health Insurance Marketplace |
NOVOLIN 70/30 ; NOVOLIN 70/30 FLEXPEN ; NOVOLIN 70/30 FLEXPEN REL ; NOVOLIN 70/30 RELION |
insulin nph & regular susp pen-inj ; insulin nph isophane & regular human inj |
70 UNIT/ML |
Health Insurance Marketplace |
NOVOLIN N ; NOVOLIN N FLEXPEN ; NOVOLIN N FLEXPEN RELION ; NOVOLIN N RELION |
insulin nph (human) (isophane) inj ; insulin nph (human) (isophane) susp pen-injector |
100 UNIT/ML |
Health Insurance Marketplace |
NOVOLIN R |
insulin regular (human) inj |
100 UNIT/ML ; 500 UNIT/ML |
Health Insurance Marketplace |
NOVOLIN R FLEXPEN |
insulin regular (human) soln pen-injector |
100 UNIT/ML ; 500 UNIT/ML |
Health Insurance Marketplace |
Novolin r flexpen ; Novolin r flexpen relion |
Insulin Regular (Human) Soln Pen-Injector 100 Unit/ML |
100 UNIT/ML |
Health Insurance Marketplace |
Novolog mix 70/30 ; Novolog mix 70/30 prefill ; Novolog mix 70/30 relion |
insulin aspart prot & aspart (human) inj ; insulin aspart prot & aspart sus pen-inj |
70 UNIT/ML |
Health Insurance Marketplace |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
|||||||||
PA |
Non-preferred insulin agents will be approved when ONE of the following is met:
Length of Approval: 12 months |
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.
Commercial _ PS _ Rapid to Intermediate Acting Insulin Prior Authorization _ProgSum_ 4/1/2023