DIABETES MEDICATIONS

Transcription

1 CLINICAL POLICY DIABETES MEDICATIONS Policy Number: PHARMACY T2 Effective Date: January 1, 2016 Table of Contents CONDITIONS OF COVERAGE... COVERAGE RATIONALE... BENEFIT CONSIDERATIONS... BACKGROUND... REFERENCES... POLICY HISTORY/REVISION INFORMATION... Page Related Policies: Drug Coverage Guidelines The services described in Oxford policies are subject to the terms, conditions limitations of the Member's contract or certificate. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage enrollees. Oxford reserves the right, in its sole discretion, to modify policies as necessary without prior written notice unless otherwise required by Oxford's administrative procedures or applicable state law. The term Oxford includes Oxford Health Plans, LLC all of its subsidiaries as appropriate for these policies. Certain policies may not be applicable to Self-Funded Members certain insured products. Refer to the Member's plan of benefits or Certificate of Coverage to determine whether coverage is provided or if there are any exclusions or benefit limitations applicable to any of these policies. If there is a difference between any policy the Member s plan of benefits or Certificate of Coverage, the plan of benefits or Certificate of Coverage will govern. CONDITIONS OF COVERAGE Applicable Lines of Business/Products Benefit Type Referral Required (Does not apply to non-gatekeeper products) Authorization Required (Precertification always required for inpatient admission) Precertification with Medical Director Review Required Applicable Site(s) of Service (If site of service is not listed, Medical Director review is required) Special Considerations This policy applies to Oxford Commercial plan membership 2,3 Pharmacy No Yes 1,2 No Other 1 Providers must call Oxford's Pharmacy Benefit Manager (PBM) to obtain precertification. 2 This policy applies to New York Connecticut plans products only. 3 This policy does not apply to New Jersey plans products. 1

2 COVERAGE RATIONALE JANUVIA Januvia will be approved based on the following criteria: 1) Member has a history of a three month trial** resulting in a therapeutic failure, or a contraindication, or an intolerance to all of the following (document dates Member received each medication): a) Onglyza (saxagliptin) b) Tradjenta (linagliptin) c) Nesina (alogliptin) JANUMET OR JANUMET XR Janumet of Janumet XR will be approved based on the following criteria: 1) Member has a history of a three month trial* ** resulting in a therapeutic failure, or a contraindication, or an intolerance to all of the following (document dates Member received each medication. (Trial of Kombiglyze XR is required to be after 1/1/2010. Trial of Jentadueto is required to be after 5/1/2011. Trial of Kazano is required to be after 1/1/2013.*): a) Kombiglyze XR (saxagliptin-metformin extended-release) b) Jentadueto (linagliptin-metformin) c) Kazano (alogliptin/metformin) INVOKANA AND JARDIANCE Invokana Jardiance will be approved based one of the following criteria: 1) History of failure, contraindication or intolerance to one of the following: a) Metformin b) Sulfonylurea (e.g. glimepiride) c) Thiazolidinedione (e.g., pioglitazone) or 2) Both of the following: a) Member is currently on therapy with Invokana or Jardiance is requesting continuation of the same therapy; b) One of the following: 1. Member has not received a manufacturer supplied sample at no cost as a means to establish as a current user of Invokana or Jardiance; or 2. Both of the following: i. Member has received a manufacturer supplied sample at no cost as a means to establish as a current user of Invokana or Jardiance; ii. History of failure, contraindication, or intolerance to one of the following: a. Metformin b. Sulfonylurea (e.g. glimepiride) c. Thiazolindinedione (e.g., pioglitazone) FARXIGA Farxiga will be approved based on both of the following criteria: 1) Member has a history of a three month trial** resulting in a therapeutic failure, or a contraindication, or an intolerance to one of the following: 2

3 a) Metformin b) Sulfonylurea (e.g. glimepiride) c) Thiazolidinedione (e.g. rosiglitazone) 2) Member has a history of a three month trial** resulting in a therapeutic failure, or a contraindication, or intolerance to both of the following: a) Invokana b) Jardiance XIGDUO XR Xigduo XR will be approved based on the following criterion: 1) History of a three month trial** resulting in a therapeutic failure, or a contraindication, or intolerance to Invokana. TRULICITY Trulicity will be approved based on the following criteria: 1) History of a three month trial** resulting in a therapeutic failure, contraindication, or intolerance to two of the following (list reason for therapeutic failure, contraindication, or intolerance): a) Bydureon b) Byetta c) Tanzeum d) Victoza GLYXAMBI Glyxambi will be approved based on the following criteria: 1) History of a three month trial** resulting in therapeutic failure, contraindication or intolerance to all of the following: a) One of the following i. Metformin ii. Sulfonylurea (e.g. glimepiride) iii. Thiazolidinedione (e.g. pioglitazone) b) Jardiance (empagliflozin); c) Tradjenta (linagliptin) Authorization will be issued for 12 months. ** For Connecticut business, only a 30 day trial will be required. BENEFIT CONSIDERATIONS Some states mate benefit coverage for off-label use of medications for some diagnoses or under some circumstances. Some states also mate usage of other Compendium references. Where such mates apply, they supersede language in the benefit document or in the notification criteria. This policy applies to New York Connecticut plans products only. This policy does not apply to New Jersey plans products. 3

4 Supply limits may be in place. BACKGROUND Farxiga (dapagliflozin), Invokana (canagliflozin), Januvia (sitagliptin), Jardiance (empagliflozin), Tradjenta (linagliptin), Onglyza (saxagliptin), Nesina (alogliptin) are indicated as an adjunct to diet exercise to improve glycemic control in adults with type 2 diabetes mellitus. Janumet (sitagliptin/metformin), Janumet XR (sitagliptin/metformin extended-release) are indicated as an adjunct to diet exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin metformin/metformin extended-release is appropriate. Kombiglyze XR (saxagliptin/metformin extended-release) is indicated as an adjunct to diet exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin metformin is appropriate. Jentadueto (linagliptin/metformin) is indicated as an adjunct to diet exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin metformin is appropriate. Kazano (alogliptin/metformin) is indicated as an adjunct to diet exercise in patients to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both alogliptin metformin is appropriate. Invokamet (canagliflozin/metformin), Xigduo XR (dapagliflozin/metformin extended-release) are sodium-glucose co-transporter 2 (SGLT2) inhibitors biguanide combination medications indicated as an adjunct to diet exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing metformin or a SGLT-2 inhibitor or in patients already being treated with both a SGLT-2 inhibitor metformin. Bydureon (exenatide extended-release), Byetta (exenatide), Tanzeum (albiglutide), Trulicity (dulaglutide), Victoza (liraglutide) are glucagon-like peptide-1 (GLP-1) receptor agonists indicated as adjunct to diet exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyxambi (empagliflozin/linagliptan) is a combination sodium-glucose co-transporter 2 (SGLT2) inhibitor dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin linagliptin is appropriate. If a member has a prescription for metformin, a sulfonylurea, or a thiazolidinedione has a prescription for Invokana or Jardiance in the claims history within the previous 12 months, the claim for Invokana, Farxiga or Jardiance will automatically process. Members currently on Invokana or Jardiance as documented in claims history will be allowed to continue on their current therapy. If a member has a prescription for Glyxambi in the claims history within the previous 12 months, the claim for Invokana or Jardiance will automatically process. Members new to therapy will be required to meet the coverage criteria above. REFERENCES The foregoing Oxford policy has been adapted from an existing UnitedHealthcare Pharmacy Clinical Pharmacy Program that was researched, developed approved by the UnitedHealth Group National Pharmacy & Therapeutics Committee. 1. American Diabetes Association; Executive Summary: Stards of Medical Care in Diabetes 2012, Diabetes Care 2012:35:S4-S Januvia package insert. Merck CO. Inc. Whitehouse Station, New Jersey. April

5 3. Janumet package insert. Merck CO. Inc. Whitehouse Station, New Jersey. April Janumet XR prescribing information. Merck & Co., Inc., Whitehouse Station, New Jersey. February Jardiance prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. August Jentadueto prescribing information. Boehringer-Ingelheim Pharmaceuticals, Inc. Ridgefield, Connecticut. January Kazano prescribing information. Takeda Pharmaceutical America, Inc. Deerfield, IL. January Kombiglyze Package Insert, Bristol Myers Squibb, Princeton, New Jersey. March Nesina prescribing information. Takeda Pharmaceuticals America, Inc. Deerfield, IL. January Onglyza package insert. Bristol Myers Squibb, Princeton, New Jersey. February, Traejenta Prescribing Information. Boehringer-Ingelheim Pharmaceuticals, Inc. Ridgefield, Connecticut. January Invokana prescribing information. Janssen Pharmaceuticals, Inc. Titusville, NJ. May Farxiga prescribing information. Bristol Myers Squibb, Princeton, New Jersey. January Jardiance prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. August Xigduo XR prescribing information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. October Byetta prescribing information. AstraZeneca Pharmaceuticas LP. Wilmington DE. August Bydureon prescribing information. AstraZeneca Pharmaceuticas LP. Wilmington DE. May Tanzeum prescribing information. GlaxoSmithKline. Wilmington, DE. April Trulicity prescribing information. Eli Lilly Company. Indianapolis, IN. October Victoza prescribing information. Novo Nordisk. Plainsboro, NJ. April Glyxambi prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. January POLICY HISTORY/REVISION INFORMATION Date 01/01/2016 Action/Description Added reference link to policy titled Drug Coverage Guidelines Revised coverage rationale o Added language to indicate Glyxambi will be approved based on history of a three month trial** resulting in therapeutic failure, contraindication or intolerance to all of the following: One of the following 5

6 Date Action/Description - Metformin - Sulfonylurea (e.g. glimepiride) - Thiazolidinedione (e.g. pioglitazone) Jardiance (empagliflozin) Tradjenta (linagliptin) **Only a 30 day trial will be required for Connecticut plan members o Changed authorization approval timeframe from 60 months to 12 months Updated supporting information to reflect the most current background information references Archived previous policy version PHARMACY T2 6