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Prior Authorization Bone Modifiers – Teriparatide Products - Forteo® (Teriparatide Injection for Subcutaneous Injection), Teriparatide Injection for Subcutaneous Use

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Prior Authorization Bone Modifiers – Teriparatide Products - Forteo® (Teriparatide Injection for Subcutaneous Injection), Teriparatide Injection for Subcutaneous Use Cigna National Formulary Coverage Policy Prior Authorization Bone Modifiers – Teriparatide Products - Forteo® (teriparatide injection for subcutaneous injection), Teriparatide injection for subcutaneous use Table of Contents Product Identifer(s) National Formulary Medical Necessity ................ 1 33906 Conditions Not Covered....................................... 4 Background .......................................................... 4 References .......................................................... 5 Revision History ................................................... 6 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. National Formulary Medical Necessity Cigna covers Teriparatide products (Forteo®) as medically necessary when the following criteria are met for FDA Indications or Other Uses with Supportive Evidence: Prior Authorization is recommended for prescription benefit coverage of teriparatide products. All approval(s) are provided for 2 years in duration unless otherwise noted below. For the indication of hypoparathyroidism, because of the specialized skills required for evaluation and diagnosis of individuals treated with teriparatide as well as monitoring for adverse events and long-term efficacy, approval requires teriparatide to be prescribed by or in consultation with a physician who specialized in the condition being treated. In the approval indication, as appropriate, an asterisk (*) is noted next to the specified gender. In this context, the specified gender is defined as follows: men are defined as individuals with the biological traits of a man, regardless of the individual’s gender identity or gender expression. FDA Indication(s) 1. Glucocorticoid-Induced Osteoporosis – Treatment. Approve for 2 years if the individual meets the following criteria (A, B, and C): A) Individual is either initiating or continuing systemic glucocorticoids; AND Page 1 of 7 Cigna National Formulary Coverage Policy: PA Bone Modifiers – Teriparatide Products - Forteo, Teriparatide Note: An example of a systemic glucocorticoid is prednisone. B) Individual meets ONE of the following (i, ii, iii, or iv): i. Individual has tried zoledronic acid injection (Reclast); OR ii. Individual has tried at least one oral bisphosphonate or oral bisphosphonate-containing product and meets one of the following (a, b, or c): Note: Examples of oral bisphosphonate products include Fosamax® (alendronate tablets and oral solution), Fosamax® Plus D (alendronate/cholecalciferol tablets), Actonel® (risedronate tablets), Atelvia® (risedronate delayed-release tablets), and Boniva® (ibandronate tablets). a) Individual has experienced inadequate efficacy to oral bisphosphonate therapy after a trial duration of 12 months as determined by the prescriber; OR Note: An example of an inadequate efficacy is ongoing and significant loss of bone mineral density (BMD) or a lack of a BMD increase. b) Individual has had an osteoporotic fracture or fragility fracture while receiving oral bisphosphonate therapy; OR c) Individual has experienced significant intolerance to an oral bisphosphonate; OR Note: Examples of significant intolerance include severe gastrointestinal related adverse events, severe musculoskeletal related adverse events, or a femoral fracture. iii. Individual cannot take an oral bisphosphonate due to one of the following circumstances (a, b, or c): a) Individual cannot swallow or has difficulty swallowing; OR b) Individual cannot remain in an upright position post oral bisphosphonate administration; OR c) Individual has a pre-existing gastrointestinal (GI) medical condition; OR Note: Examples of pre-existing gastrointestinal medical conditions include esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying (stricture, achalasia). iv. Individual meets one of the following conditions (a, b, or c): a) Severe renal impairment; OR Note: An example of severe renal impairment is a creatinine clearance < 35 mL/min. b) Chronic kidney disease (CKD); OR c) Individual has had an osteoporotic fracture or a fragility fracture; AND C) Use of teriparatide exceeding 2 years during a individual’s lifetime, approve if the individual is at high risk for fracture as determined by the prescriber. Note: Examples of high risk for fracture include a previous osteoporotic fracture or fragility fracture, receipt of medications that increase the risk of osteoporosis, advanced age, and very low bone mineral density. 2. Osteoporosis – Treatment for a Postmenopausal Individual. Approve for 2 years if the individual meets the following criteria (A, B, and C): A) Individual meets ONE of the following conditions (i, ii, or iii): i. Individual has had a T-score (current or at any time in the past) at or below -2.5 at the lumbar spine, femoral neck, total hip, and/or 33% (one-third) radius (wrist); OR ii. Individual has had an osteoporotic fracture or a fragility fracture; OR iii. Individual meets both of the following (a and b): a) Individual has low bone mass; AND Note: An example of low bone mass includes a T-score (current or at any time in the past) between -1.0 and -2.5 at the lumbar spine, femoral neck, total hip and/or 33% (one-third) radius (wrist). b) Prescriber determines the individual is at high risk for fracture; AND B) Individual meets ONE of the following (i, ii, iii, or iv): i. Individual has tried ibandronate injection (Boniva) or zoledronic acid injection (Reclast); OR ii. Individual has tried at least one oral bisphosphonate or oral bisphosphonate-containing product and meets one of the following (a, b, or c): Note: Examples of oral bisphosphonate products include Fosamax® (alendronate tablets and oral solution), Fosamax® Plus D (alendronate/cholecalciferol tablets), Actonel® (risedronate tablets), Atelvia® (risedronate delayed-release tablets), and Boniva® (ibandronate tablets). a) Individual has experienced inadequate efficacy to oral bisphosphonate therapy after a trial duration of 12 months as determined by the prescriber; OR Page 2 of 7 Cigna National Formulary Coverage Policy: PA Bone Modifiers – Teriparatide Products - Forteo, Teriparatide Note: An example of an inadequate efficacy is ongoing and significant loss of bone mineral density (BMD) or a lack of a BMD increase. b) Individual has had an osteoporotic fracture or fragility fracture while receiving oral bisphosphonate therapy; OR c) Individual has experienced significant intolerance to an oral bisphosphonate; OR Note: Examples of significant intolerance include severe gastrointestinal related adverse events, severe musculoskeletal related adverse events, or a femoral fracture. iii. Individual cannot take an oral bisphosphonate due to one of the following circumstances (a, b, or c): a) Individual cannot swallow or has difficulty swallowing; OR b) Individual cannot remain in an upright position post oral bisphosphonate administration; OR c) Individual has a pre-existing gastrointestinal (GI) medical condition; OR Note: Examples of pre-existing gastrointestinal medical conditions include esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying (stricture, achalasia). iv. Individual meets one of the following conditions (a, b, or c): a) Severe renal impairment; OR Note: An example of severe renal impairment is a creatinine clearance < 35 mL/min. b) Chronic kidney disease (CKD); OR c) Individual has had an osteoporotic fracture or a fragility fracture; AND C) Use of teriparatide exceeding 2 years during a individual’s lifetime, approve if the individual is at high risk for fracture as determined by the prescriber. Note: Examples of high risk for fracture include a previous osteoporotic fracture or fragility fracture, receipt of medications that
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