HARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES

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1 Generic Brand HICL GCN Exception/Other INSULIN REGULAR, HUMAN AFREZZA 37619, 37622, 37623, 38923, 37624, 42833, 38918, GUIDELINES FOR USE 1. Is the member currently taking the requested medication (within the last 180 days) as indicated on the MRF or claims history? If yes, continue to #2. If no, continue to #4. 2. Has the member's pulmonary function (e.g. spirometry) been assessed within the last 365 days? If yes, continue to #3. this medication requires pulmonary function testing (e.g. spirometry) within the past 365 days. Your provider did not indicate that pulmonary function testing was completed and therefore your 3. Has there been a decrease in pulmonary function of at least 20% or more from baseline? this medication requires pulmonary function testing (e.g. spirometry) and demonstration that lung function has not declined more than 20% from baseline for continuation of therapy. Your provider indicated that you have had a decline of 20% or greater from baseline and therefore your If no, continue to # Has the member had a previous trial of at least 30 days duration and tried/failed or is intolerant to at least one rapid-acting insulin (e.g. Novolog, Humalog, Apidra)? If yes, continue to #6. If no, continue to #5. Page 1

2 5. Is the member physically or functionally unable or unwilling to administer injectable insulin? If yes, continue to #6. this medication is only approved after a previous trial of a rapid acting injectable insulin (e.g. Novolog, Humalog, Apidra) or if the member is physically or functionally unable or unwilling to administer injectable insulin. Your provider did not indicate that you have tried or alternatively are unwilling or unable to try one of these insulins and therefore your 6. Is the member 18 years of age or older? If yes, continue to #7. this medication is only covered for members 18 years of age and older. Your provider indicated that you are under the age of 18 and therefore your 7. Does the member have Type 1 Diabetes? If yes, continue to #8. If no, continue to #9. 8. Will the member be using a long acting insulin (e.g. Lantus, Levemir, or Tresiba) along with Afrezza? If yes, continue to #11. this medication is only covered in Type I Diabetes patients who will be using Afrezza in combination with a long acting insulin (e.g. Lantus, Levemir, Tresiba). Your provider did not indicate that you will be using a long acting insulin and therefore your request was not approved. 9. Does the member have Type II Diabetes? If yes, continue to #10. DENIAL TEXT: Per your health plan's Afrezza (insulin regular, human) guideline, this medication is only covered in Type 1 Diabetes patients who will be using Afrezza along with a long acting insulin or Type 2 Diabetes patients who had inadequate control, intolerance or contraindications to at least 2 oral diabetes medications. Your provider did not indicate that you have Type 1 or Type 2 Diabetes and therefore your Page 2

3 10. Has the member had inadequate control, intolerance or contraindications to at least 2 oral antidiabetic medications such as metformin, glyburide, or Januvia? If yes, continue to #11. DENIAL TEXT: Per your health plan's Afrezza (insulin regular, human) guideline, this medication is only covered in Type 2 Diabetes patients who have had inadequate control, intolerance or contraindications to at least 2 oral diabetes medications such as metformin, glyburide, or Januvia. Your provider did not indicate that you have had inadequate control, intolerance or contraindications to at least 2 oral diabetes medications and therefore your 11. Does the member have a diagnosis of lung disease (such as asthma or COPD) as evidenced by a detailed medical history, physical examination, and spirometry (FEV1)? this medication is only provided in members that do not have lung disease such as asthma or COPD as confirmed by medical history, physical examination and pulmonary function testing (e.g. spirometry). Your provider indicated that you have a lung disease such as asthma or chronic obstructive pulmonary disease (COPD) and therefore your If no, continue to #12. Page 3

4 12. Does the member currently smoke or has the member smoked within the past 180 days? this medication is only provided for members that have not smoked within the last 6 months Your provider indicated that you have smoked within the previous 6 months and therefore your If no, approve for 12 months by GPID as follows: (The quantity limits are hard-coded) Please use status code #056. Requests for products on formulary with a restriction, please use the approval text provided. (PAC NOTE: Please reference the quantity limit listed below for the requested product when completing the free text of the approval letter.) APPROVAL TEXT: Your request for Afrezza has been approved for a 12-month period with a quantity limit of units per 30 days. Requests for products not on formulary, please use the approval text provided. PAC NOTE: Please reference the quantity limit listed below for the requested product when completing the free text of the approval letter. APPROVAL TEXT: Your request for Afrezza has been approved for a 12-month period with a quantity limit of units per 30 days at your highest cost-share tier. Refer to your Harvard Pilgrim ID card for the amount you pay for drugs on that tier. 4 unit cartridges (90) (GPID 37619): QL 180/30 days 8 unit cartridges (90) (GPID 37621): QL 180/30 days 12 unit cartridges (90) (GPID 38918): QL days 4 unit cartridges (60) and 8 unit cartridges (30) (GPID 37622): QL 450/30 days 4 unit cartridges (30) and 8 unit cartridges (60) (GPID 37623): QL 450/30 days 8 unit cartridges (60) and 12 unit cartridges (30) (GPID 38923): QL 450/30 days 8 unit cartridges (30) and 12 unit cartridges (60) (GPID TBD): QL 450/30 days 4 unit cartridges (90) and 8 unit cartridges (90) (GPID 37624): QL 540/30 days 4 unit cartridges (60) and 8 unit cartridges (60) and 12 unit cartridges (60) (GPID 42833): QL 540/30 days Page 4

5 RATIONALE To ensure appropriate use of AFREZZA for the treatment of Type 1 and Type 2 Diabetes. Injectable insulins offer the best value and have an extensive track record of clinical experience. Inhaled insulin is a rapid acting prandial insulin that has been shown to improve A1C in adult patients with type 1 or type II diabetes mellitus when used in combination with a basal insulin and/or an oral antidiabetic medication(s). For patients with type I diabetes, an insulin regimen consisting of a basal and a prandial insulin is the standard of care. Inhaled insulin has a boxed warning for the risk of acute bronchospasm and is contraindicated in patients with asthma or COPD. Because of these reasons, a prior authorization guideline is used to ensure that inhaled insulin is used safely and effectively in patients who cannot tolerate or do not respond to injectable rapid-acting insulin. FDA APPROVED INDICATIONS AFREZZA is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Important limitations of use: In patients with type 1 diabetes, must use with a long-acting insulin Not recommended for the treatment of diabetic ketoacidosis Not recommended in patients who smoke REFERENCES Afrezza package insert. Mannkind Corporation. Danbury, CT. September Created: 01/08/15 Effective: 10/01/18 Client Approval: 07/18/18 P&T Approval: 09/27/18 Page 5

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