Sunflower Health Plan FORTEO, Teriparatide (Recombinant) Form

Teriparatide (Forteo®, Bonsity®) is a recombinant human parathyroid hormone (PTH) analog. FDA Approved Indication(s) Forteo and Bonsity are indicated: • Postmenopausal osteoporosis (PMO): For the treatment of postmenopausal women with osteoporosis at high risk for fracture* or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Forteo and Bonsity reduce the risk of vertebral and nonvertebral fractures. • Male osteoporosis: To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture* or who have failed or are intolerant to other available osteoporosis therapy. • Glucocorticoid-induced osteoporosis (GIO): For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture* or who have failed or are intolerant to other available osteoporosis therapy. __________________ *High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that teriparatide is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Osteoporosis (must meet all): 1. Diagnosis of PMO, GIO, or male osteoporosis and one of the following (a or b): a. Member is at very high risk for fracture as evidenced by one of the following (i, ii, or iii): i. Recent osteoporotic fracture (within the past 12 months); ii. Bone mineral density (BMD) T-score at hip or spine ≤ -3.0; iii. BMD T-score at hip or spine ≤ -2.5 AND major osteoporotic fracture (i.e., hip, spine, forearm, wrist, humerus); Page 1 of 10 CLINICAL POLICY Teriparatide b. Member has completed a 3-year trial of bisphosphonate therapy* (see Appendix B; alendronate is preferred) at up to maximally indicated doses, unless one of the following (i-v): i. All bisphosphonates are contraindicated; ii. Clinically significant adverse effects are experienced to both IV and PO formulations (see Appendix E) iii. Member has experienced a loss of BMD while receiving bisphosphonate therapy; iv. Member has experienced a lack of BMD increase after ≥ 12 months of bisphosphonate therapy; v. Member experienced an osteoporotic fracture or fragility fracture while receiving bisphosphonate therapy; *Prior authorization may be required for bisphosphonates 2. Age ≥ 18 years or documentation of closed epiphyses on x-ray; 3. If request is for brand Forteo or Bonsity, member must use teriparatide (generic Forteo), unless contraindicated or clinically significant adverse effects are experienced; 4. One of the following (a or b): a. For PMO, failure of Prolia® or Tymlos® at up to maximally indicated doses, unless clinically significant adverse effects are experienced or both are contraindicated*; *Prior authorization may be required for Prolia and Tymlos b. If request is for continuation of cumulative PTH analog therapy beyond 2 years, provider attestation that member remains at or has returned to having a high risk for fracture (e.g., history of osteoporotic fracture or multiple risk factors for fracture, see Appendix D) and that the risk versus benefit of continued therapy has been reviewed with the member; 5. Dose does not exceed both of the following (a and b): a. 20 mcg per day; b. 1 pen every 28 days. Approval duration: Medicaid/HIM – 6 months Commercial – 6 months or to the member’s renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 or 2): 1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: Page 2 of 10 CLINICAL POLICY Teriparatide CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. II. Continued Therapy A. Osteoporosis (must meet all): 1. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B); 2. Member is responding positively to therapy; 3. If request is for continuation of cumulative PTH analog therapy beyond 2 years, provider attestation that member remains at or has returned to having a high risk for fracture (e.g., history of osteoporotic fracture or multiple risk factors for fracture, see Appendix D) and that the risk versus benefit of continued therapy has been reviewed with the member; 4. If request is for brand Forteo or Bonsity, member must use teriparatide (generic Forteo), unless contraindicated or clinically significant adverse effects are experienced; 5. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. 20 mcg per day; b. 1 pen every 28 days. Approval duration: Medicaid/HIM – 12 months Commercial – 6 months or to the member’s renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 or 2): 1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or Page 3 of 10 CLINICAL POLICY Teriparatide 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key BMD: bone mineral density FDA: Food and Drug Administration GIO: glucocorticoid-induced osteoporosis PMO: postmenopausal osteoporosis PTH: parathyroid hormone Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent and may require prior authorization. Drug Name Dosing Regimen Dose Limit/ Maximum Dose PTH analog therapy Tymlos (abaloparatide) Treatment: PMO 80 mcg SC QD Receptor activator of nuclear factor kappa-B (RANK) ligand inhibitor Prolia (denosumab) Treatment: PMO, GIO, male osteoporosis 60 mg SC once every 6 months IV bisphosphonates ibandronate (Boniva®) Treatment: PMO 3 mg IV every 3 months Treatment: PMO, GIO, male osteoporosis 5 mg IV once a year 80 mcg/day - 2 year total lifetime 60 mg/dose 3 mg /3 months 5 mg/year zoledronic acid (Reclast®) Oral bisphosphonates alendronate (Fosamax®) Fosamax® Plus D (alendronate / cholecalciferol) Treatment: PMO, GIO, male osteoporosis 10 mg PO QD or 70 mg PO once Treatment: PMO, male osteoporosis 70 mg alendronate /2800 IU vitamin D3 or 70 mg alendronate /5600 IU vitamin D3 PO once weekly 70 mg/week 70 mg / 5600 IU/ week Page 4 of 10 CLINICAL POLICY Teriparatide Drug Name Dosing Regimen risedronate (Actonel®, Atelvia®) ibandronate (Boniva) Actonel: Treatment: PMO, GIO, male osteoporosis Atelvia: Treatment: PMO See prescribing information for dose. Treatment: PMO 150 mg PO once monthly Dose Limit/ Maximum Dose Varies 150 mg/month Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity • Boxed warning(s): none reported Appendix D: General Information • The FRAX tool is readily available and incorporates multiple clinical risk factors that predict fracture risk, largely independent of BMD. Clinical risk factors in FRAX include age, sex, body mass index (BMI), smoking, alcohol use, prior fracture, parental history of hip fracture, use of glucocorticoids, rheumatoid arthritis, secondary osteoporosis, and femoral neck BMD, when available. FRAX predicts the 10-year probability of hip fracture and major osteoporotic fracture (hip, clinical spine, humerus, or forearm). FRAX designation of high risk of fracture is defined as 10-year major osteoporotic fracture probability ≥ 20% or hip fracture probability ≥ 3%. • The 2019 Endocrine Society clinical practice guidelines include patient profiles representing examples of high and very high fracture risk: o High risk: T-score of minus 2.5 or below, or prior hip or vertebral fracture, or high fracture probability by the fracture risk assessment tool (FRAX) (10-year probability of major osteoporotic fracture ≥ 20%, or 10-year probability of hip fracture ≥ 3%) o Very high risk: T-score of minus 2.5 or below and 1 or more fractures, or multiple vertebral fractures, or severe vertebral fracture. Appendix E: IV/PO Bisphosphonates: Examples of Contraindications and Adverse Effects Bisphosphonates Oral Formulations IV Formulations Contraindications Hypocalcemia Increased risk of aspiration Hypersensitivity to product component Inability to stand/sit upright for at least 30 minutes Creatinine clearance < 35 mL/min or evidence of acute renal impairment X X X X - X - X - X Page 5 of 10 CLINICAL POLICY Teriparatide Bisphosphonates Oral Formulations X Esophagus abnormalities which delay emptying such as stricture or achalasia Clinically significant warnings or adverse side effects Pregnancy Eye inflammation Acute renal failure Osteonecrosis of the jaw Atypical femoral shaft fracture Drug interactions (product-specific) Severe or incapacitating musculoskeletal pain X X X X X X X IV Formulations - X X X X X X X V. Dosage and Administration Indication PMO, GIO, male osteoporosis 20 mcg SC QD Dosing Regimen Maximum Dose 20 mcg/day up to 2 years cumulative PTH analog use lifetime VI. Product Availability Drug Name Teriparatide (Forteo) Multi-dose prefilled pen (containing 28 daily doses of 20 mcg): Availability 600 mcg/2.4 mL Teriparatide (Bonsity) Multi-dose prefilled pen (containing 28 daily doses of 20 mcg): 620 mcg/2.48 mL VII.