Basal Insulin Drug Class Prior Authorization Protocol

Transcription

1 Basal Insulin Drug Class Prior Authorization Protocol Line of Business: Medicaid P&T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Drugs Requiring Prior Authorization Review: Levemir (insulin detemir), Levemir FlexTouch (insulin detemir), Toujeo SoloStar (insulin glargine), Tresiba Flextouch (insulin degludec) Formulary Alternatives: Basaglar KwikPen (insulin glargine), Lantus (insulin glargine), Lantus SoloStar (insulin glargine) Criteria: A. Drugs: Levemir 1. Diagnosis: Diabetes Mellitus I or II Criteria: Must meet all of the following requirements: a. Failure or clinically significant adverse effects to Lantus or Basaglar. b. Must have an HbA1c greater than 7 percent after 3 months (90 consecutive days) of treatment with Lantus or Basaglar. Specialist: N/A

2 2. Diagnosis: Gestational Diabetes Criteria: May be approved with a confirmed diagnosis. Specialist: N/A a. Recent pharmacy claims within 180 days of request. B. Drugs: Levemir FlexTouch 1. Diagnosis: Diabetes Mellitus I or II Criteria: Must meet all of the following requirements: a. Failure or clinically significant adverse effects to Lantus or Basaglar. b. Failure or clinically significant adverse effects to Levemir vial. c. Must have an HbA1c greater than 7 percent after 3 months (90 consecutive days) of treatment with alternatives. Specialist: N/A 2. Diagnosis: Gestational Diabetes Criteria: Must meet 1 of the following requirements: a. Failure or significant adverse effects to Levemir vial. b. Documented dexterity or vision issues.

3 Specialist: N/A C. Drugs: Toujeo Solostar, Tresiba Flextouch 1. Diagnosis: Diabetes Mellitus I or II Criteria: Must meet all of the following requirements: a. Failure or clinically significant adverse effects to Lantus or Basaglar. b. Must have an HbA1c greater than 7 percent after 3 months (90 consecutive days) of treatment with Lantus or Basaglar. Specialist: Endocrinologist

4 Clinical Justification: American Diabetes Association (ADA) Standards of Medical Care in Diabetes January 2018 Basal insulin alone is the most convenient initial insulin regimen, beginning at 10 units per day or units/kg/day, depending on the degree of hyperglycemia. Basal insulin is usually prescribed in conjunction with metformin and sometimes once additional noninsulin agent. When basal insulin is added to antihyperglycemic agents in patients with type 2 diabetes, long-acting basal analogs (U-100 glargine or detemir) can be used instead of NPH to reduce the risk of symptomatic and nocturnal hypoglycemia. Longer-acting basal analogs (U-300 glargine or degludec) maybe additionally convey a lower hypoglycemia risk compared with U-100 glargine when used in combination with oral antihyperglycemic agents. While there is evidence for reduced hypoglycemia with newer, longer-acting basal insulin analogs, people without a history of hypoglycemia are at decreased risk and could potentially be switched to human insulin safely. Thus, due to high costs of analog insulins, use of human insulin may be a practical option for some patients, and clinicians should be familiar with its use.

5 References: 1. Levemir (insulin detemir) [package insert]. Plainsboro, NJ: Norvo Nordisk; Toujeo SoloStar (insulin glargine) [package insert]. Bridgewater, NJ: Sanofi-Aventis; 2015.

6 3. Tresiba Flextouch (insulin degludec) [package insert]. Plainsboro, NJ: Norvo Nordisk; Basaglar KwikPen (insulin glargine) [package insert]. Indianapolis, IN: Lilly USA; Lantus (insulin glargine) [package insert]. Bridgewater, NJ: Sanofi-Aventis; Garber, AJ, Abrahamson MJ, et al. Endocrine Practice, Vol 24(1), January American Diabetes Association. Standards of Medical Care in Diabetes Diabetes Care, January 2018, Volume 41, Supplement 1. Change Control Date Change 02/21/2018 Updated 2018 ADA Guidance