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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® 
(insulin lispro)

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®
(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 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
(70% human insulin isophane/30% regular human insulin)

Injection

To improve glycemic control in adult patients 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:

  • Most individuals with type 1 diabetes should be treated with multiple daily injections of prandial and basal insulin, or subcutaneous insulin infusion
  • Most individuals with type 1 diabetes should use rapid-acting insulin analogs to reduce hypoglycemia risk.
  • Individuals with type 1 diabetes should receive education on how to match mealtime insulin doses to carbohydrate intake, fat and protein content, and anticipated physical activity.(16)

For type 2 diabetes mellitus, the American Diabetes Association recommends the following:

  • First-line therapy depends on comorbidities, patient-centered treatment factors, and management needs and generally includes metformin and comprehensive lifestyle modification.
  • The early introduction of insulin should be considered if there is evidence of ongoing catabolism, if symptoms of hyperglycemia are present, or when A1C levels or blood glucose levels are very high.
  • A patient-centered approach should be used to guide the choice of pharmacological agents. Consider the effects on cardiovascular and renal comorbidities, hypoglycemia risk, impact on weight, cost and access, risk of side effects, and patient preferences.(16)

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

Preferred Agents

Non-Preferred Target Agents

Stand-Alone Agents

Rapid, Regular

Fiasp (insulin aspart) Insulin Aspart
Novolin R (regular human insulin)
NovoLog (insulin aspart)

 

Rapid, Regular

Admelog (insulin lispro)
Apidra (insulin glulisine)
Humalog (insulin lispro)
Humalog Junior Kwikpen (insulin lispro)
Humalog Kwikpen U200 (insulin lispro)
Humalog Tempo (insulin lispro)
Humulin R U-100 (regular human insulin)
Insulin Lispro
Insulin Lispro Junior Kwikpen
Insulin Lispro Kwikpen
Lyumjev (insulin lispro-aabc)
Lyumjev Tempo (insulin lispro-aabc)

Rapid, Regular

Humulin R U-500 (regular human insulin concentrated)
Relion R (regular human insulin)

 

Mix, NPH

Insulin aspart protamine/insulin aspart
Novolin N (human insulin NPH)
Novolin 70/30 (70% human insulin isophane suspension/30% human insulin)
NovoLog 70/30 (70% insulin aspart protamine/30% insulin aspart)

 

Mix, NPH

Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro)
Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin lispro)
Humulin N (human insulin isophane suspension)
Humulin 70/30 (70% human insulin isophane suspension/30% human insulin)
Insulin Lispro Protamine/Insulin Lispro Kwikpen (75/25)

 

Non-preferred insulin agents will be approved when ONE of the following is met: 

  1. BOTH of the following:
    1. The requested agent is a rapid insulin AND
    2. Information has been provided that the patient is currently using an insulin pump that has an incompatibility with all preferred rapid insulin agents that is not expected to occur with the requested agent OR
  2. The request is for Humalog Mix 50/50 AND ONE of the following:
    1. The patient is currently using Humalog Mix 50/50 AND the prescriber states the patient is at risk if switched to a different insulin OR
    2. The patient has tried and had an inadequate response to all preferred insulin mix agents OR
  3. BOTH of the following:
    1. The requested agent is a rapid, regular, mix, or NPH insulin AND
    2. ONE of the following:
      1. The patient has an intolerance or hypersensitivity to all preferred insulin agents of the same type (rapid or regular, mix or NPH) that is not expected to occur with the requested agent OR
      2. The patient has an FDA labeled contraindication to all preferred insulin agents of the same type (rapid or regular, mix or NPH) that is not expected to occur with the requested agent OR
  4. Information has been provided that the patient has a physical or a mental disability that would prevent him/her from using all preferred insulin agents OR
  5. The patient is pregnant

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