Prior Authorization Guideline

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Valerie Todd
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1 Prior Authorization Guideline Guideline: PC (CO) - Insulin Delivery Systems Therapeutic Class: Hormones and Synthetic Substitutes Therapeutic Sub-Class: Insulin Delivery Systems Client: CO Approval Date: 8/2/2004 Revision Date: 6/6/2006

Substitutes Therapeutic Sub-Class: Insulin Delivery

2 I. BENEFIT COVERAGE Table 1. Formulary status Non-Formulary Products (Cartridges) Humulin insulin cartridge (all products: 50/50, 70/30, NPH [N], Regular [R]) Novolin insulin cartridge (all products: 70/30, N, R) Humalog cartridge (insulin lispro) Humalog Mix 75/25 or 50/50 PFS** (insulin-npl/lispro) Apidra cartridge (insulin glulisine) Lantus cartridge (insulin glargine) Levemir cartridge (insulin glargine) NovoLog cartridge (insulin aspart) NovoLog Mix 70/30 cartridge (insulin aspart protamine /insulin aspart) ** PFS = prefilled disposable syringe Formulary Products (Vials) Humulin (human insulin, all products except insulin cartridges and prefilled insulin pens) Velosulin BR (human regular insulin buffered) Novolin (human insulin, all products except insulin cartridges and prefilled insulin pens) Novolin Innolet insulin dosers (NPH, 70/30) Humalog (insulin lispro) Humalog Mix 75/25 (Insulin NPL/lispro) NovoLog (insulin aspart) NovoLog Mix 70/30 (insulin aspart protamine /insulin aspart) Lantus (insulin glargine) General Information 1. Insulin cartridges and insulin dosers will not be provided to patients for the sole purpose of convenience. Insulin cartridges or insulin dosers may be provided to patients who have a visual or physical disability that prevents the use of an insulin vial and syringe. Short-acting insulin cartridges (e.g. regular insulin, insulin lispro) or insulin dosers (e.g. regular insulin) may be provided for patients who have intensive insulin regimens. Intermediate and combination insulin cartridges (e.g. NPH, 70/30, insulin-npl/lispro) or insulin dosers (e.g. NPH) may only be provided to patients who have a visual or physical disability that prevents the use of an insulin vial and syringe. 2. Prefilled disposable insulin pens are not covered, with the exception of the insulin- NPL/lispro (Humalog 75/25 and 50/50) prefilled disposable insulin pen, which are not available as cartridges. 3. The reusable insulin pen device is considered DME, part of the medical benefit. 4. Approval of these products also includes approval of insulin pen needles. II. INDICATIONS A. FDA Approved Indications 1-11 Insulin is indicated for the management of diabetes mellitus III. GUIDELINE

cartridge (insulin lispro) Humalog Mix 75/25 or 50/50 PFS** (insulin-npl/lispro) Apidra cartridge (insulin glulisine) Lantus cartridge (insulin glargine) Levemir cartridge (insulin glargine) NovoLog

3 A. Short or Rapid-Acting Insulin Cartridges Regular insulin, Humalog, or NovoLog cartridges (NOT the prefilled disposable pens) may be approved except when excluded as a plan benefit, based on one of the following criteria: 1. The patient has visual impairment (unable to use formulary insulin vial and syringe). 2. The patient has physical impairment (unable to use formulary insulin vial and syringe). 3. The patient has an intensive insulin regimen that requires at least three injections a day of short- or rapid-acting insulin therapy. The patient must test blood glucose at least twice a day and be able to adjust and self-administer insulin to meet blood glucose changes, diet changes, and exercise changes. B. Intermediate-, Long-Acting, and Mixed Insulin Cartridges Humulin/Novolin NPH, 70/30, 50/50 cartridges, Humalog Mix 75/25, 50/50 (prefilled disposable pens), NovoLog Mix 70/30 cartridges, or Lantus cartridges may be approved except when excluded as a plan benefit, based on one of the following criteria. 1. The patient has visual impairment (unable to use formulary insulin vial and syringe). 2. The patient has physical impairment (unable to use formulary insulin vial and syringe). C. Non-formulary Insulin Cartridges/Dosers 1. Apidra cartridges will be approved except when excluded as a plan benefit based on both of the following: a. Documented history of failure or intolerance to Humalog and Novolog. b. One of the following: -AND- (1) The patient has visual impairment (unable to use formulary insulin vial and syringe). (2) The patient has physical impairment (unable to use formulary insulin vial and syringe) 2. Levemir cartidges will be approved except when excluded as a plan benefit based on both of the following:

The patient has physical impairment (unable to use formulary insulin vial and syringe). 3.

4 a. Documented history of failure or intolerance to Lantus b. One of the following: -AND- (1) The patient has visual impairment (unable to use formulary insulin vial and syringe). (2) The patient has physical impairment (unable to use formulary insulin vial and syringe) Summary Tables Table 2. Short-Acting Insulin Cartridges (Must Meet One Criterion) Approval criteria Regular insulin Insulin lispro Visual impairment X X Physical Impairment X X Intensive Insulin Regimen (requires 3 X X VI. AVAILABILITY 1-11 Table 3. Intermediate-, Long-Acting And Mixed Insulin Cartridges (Must Table 4: meet Availability one criterion) of Insulin Products

(2) The patient has physical impairment (unable to use formulary insulin vial and syringe) Summary Tables Table 2.

5 Humalog X X X Humalog Mix 50/50 X Humalog Mix 75/25 X X Lantus X X Levemir X X** X X Novolin R X X Novolin N X X X Novolin 70/30 X X X NovoLog X X X NovoLog Mix 70/30 X X X * PFS = prefilled disposable syringes VII. BACKGROUND A. Description The metabolic effect of insulin delivered by pen compared to syringe is unclear. Studies show no significant difference in surrogate outcomes when the pen is compared to the syringe. 12 The studies, however, are of short duration, with small sample sizes. They are not powered to study morbidity and mortality. The studies comparing pen and pump were conducted in the late 1980s on older pump models. 12 Definitive conclusions cannot be made, although these older studies favor the pump for surrogate outcomes. Studies comparing more recent models of the pump have not been conducted. The pen is the preferred device among patients, although the questionnaires used to assess their preference are not validated. 12 IX. REFERENCES 1. Novolin N InnoLet Prescribing Information. Available at: Accessed May 3, Novolin 70/30 InnoLet Prescribing Information, Novo-Nordisk. Available at: Accessed May 3, Apidra Product Information. Sanofi Aventis. July Levemir Product Information. Novo Nordisk. June Humulin R Patient Product Information. Eli Lilly. Available at: Accessed May 3, Humulin N Pen Patient Product Information. Available at: Accessed May 3, Humulin 70/30 Pen Patient Product Information. Available at: Accessed May 3, Humalog Prescribing Information. Eli Lilly. Available at: Accessed May 3, Humalog Mix 75/25 Prescribing Information. Eli Lilly. Available at: Accessed May 3, NovoLog Prescribing Information. Novo Nordisk. Available at: NovoLog Mix Prescribing Information. Novo Nordisk. Available at:

Studies show no significant difference in surrogate outcomes when the pen is compared to the syringe. 12 The studies, however, are of short duration, with small sample sizes.

6 12. CCOHTA. Insulin Pen-fill Formulations. No. 29. January Available at: Accessed April 21, This Prior Authorization Guideline represents the recommendation of Prescription Solutions Pharmacy and Therapeutics (P&T) Committee. It is based upon the P&T Committee s review of the available evidence as of the date of drafting or revision of this Prior Authorization Guideline. It is subject to updating from time to time, based upon changes in scientific knowledge and information. This Prior Authorization Guideline is intended as a resource for making coverage decisions for Health Plan members, but it does not replace an individualized case-by-case review and medical necessity determination for each Health Plan member. Copyright 2005 by Prescription Solutions. All rights reserved. This Prior Authorization Guideline is intended for use by Prescription Solutions and Health Plan employees and applicable contracted providers and practitioners only. The information contained in this Prior Authorization Guideline is confidential and proprietary to Prescription Solutions and shall not be used, reproduced, or transferred in whole or in part without Prescription Solutions prior written consent.

Prior Authorization Guideline

Prior Authorization Guideline Guideline: PC - Apidra, Levemir Therapeutic Class: Hormones and Synthetic Substitutes Therapeutic Sub-Class: Antidiabetic Agents Client: CA, CO, NV, OK, OR, WA and AZ Approval