TYMLOS, Abaloparatide Form

Abaloparatide (Tymlos®) is a human parathyroid hormone (PTH)-related peptide analog. FDA Approved Indication(s) Tymlos is indicated: • For the treatment of postmenopausal women with osteoporosis (PMO) at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Tymlos reduces the risk of vertebral fractures and nonvertebral fractures. • To increase bone density in men with osteoporosis at high risk for fracture or patients 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 Tymlos is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Osteoporosis (must meet all):

1. Diagnosis of PMO 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); b. Member has completed a 3-year trial of bisphosphonate therapy (see Appendix B; generic alendronate is preferred) at up to maximally indicated doses, unless one of the following (i-v): Prior authorization may be required for bisphosphonates
   i. All bisphosphonates are contraindicated; ii. Clinically significant adverse effects are experienced to both IV and PO formulations (see Appendix D); Page 1 of 8

   CLINICAL POLICY Abaloparatide 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;

2. Age ≥ 18 years or documentation of closed epiphyses on x-ray;
   3. Member has not received ≥ 2 years cumulative abaloparatide therapy;
   4. Dose does not exceed both of the following (a and b):
      a. 80 mcg per day;
      b. 1 pen every 30 days. Approval duration: 6 months (2 years cumulative abaloparatide use lifetime) B. Other diagnoses/indications (must meet 1 or 2):
3. 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
4. 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):

5. 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. Member has not received ≥ 2 years cumulative abaloparatide therapy;
   4. If request is for a dose increase, new dose does not exceed both of the following (a and b):
      a. 80 mcg per day;
      b. 1 pen every 30 days. Approval duration: 12 months (2 years cumulative abaloparatide use lifetime) Page 2 of 8

   CLINICAL POLICY Abaloparatide B. Other diagnoses/indications (must meet 1 or 2):

6. 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

7. 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 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 IV bisphosphonates ibandronate (Boniva®)
   Treatment: PMO 3 mg IV every 3 months 3 mg/3 months zoledronic acid (Reclast®) Treatment: PMO, male osteoporosis 5 mg/year 5 mg IV once a year Oral bisphosphonates alendronate (Fosamax®) Treatment: PMO, male osteoporosis 10 mg PO QD or 70 mg PO once weekly 70 mg/week Page 3 of 8

   CLINICAL POLICY Abaloparatide Drug Name Dosing Regimen Fosamax® Plus D (alendronate / cholecalciferol) risedronate (Actonel®, Atelvia®) ibandronate (Boniva®)
   Treatment: PMO, male osteoporosis 70 mg alendronate /2800 IU vitamin D3 or 70 mg alendronate /5600 IU vitamin D3 PO once weekly
   Actonel: Treatment: PMO, male osteoporosis 5 mg PO QD or 35 mg PO once weekly or 75 mg PO QD taken on two consecutive days each month or 150 mg PO once monthly Atelvia: Treatment: PMO 35 mg PO once weekly Treatment: PMO 10 mg PO QD or 70 mg PO once weekly Dose Limit/ Maximum Dose 70 mg / 5600 IU/ week Actonel: 5 mg/day 35 mg/week 150 mg/month Atelvia: 35 mg/week 70 mg/week 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): known hypersensitivity to Tymlos • Boxed warning(s): none reported Appendix D: 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 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) X X X X

   • X X X X X X X Page 4 of 8 X
   • X
   • X
   • X X X X X X

   CLINICAL POLICY Abaloparatide Bisphosphonates
   Severe or incapacitating musculoskeletal pain Oral Formulations X IV Formulations X V. Dosage and Administration
   Indication PMO, male osteoporosis Dosing Regimen 80 mcg SC QD Maximum Dose 80 mcg/day up to 2 years cumulative PTH analog use lifetime VI. Product Availability
   Single-patient-use prefilled pen: 3,120 mcg/1.56 mL (30 daily doses of 80 mcg) VII.