EVENITY, Romosozumab-aqqg Form

Romosozumab-aqqg (Evenity®) is a sclerostin inhibitor.
FDA Approved Indication(s) Evenity is indicated for the treatment of osteoporosis in postmenopausal (PMO) women at high risk for fracture. __ High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
Limitation(s) of use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. 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 Evenity is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Osteoporosis (must meet all):

1. Diagnosis of PMO 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) iii. Member has experienced a loss of BMD while receiving bisphosphonate therapy; Page 1 of 7

   CLINICAL POLICY Romosozumab-aqqg 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 ≥ 12 months cumulative romosozumab therapy;
   4. Dose does not exceed both of the following (a and b):
      a. 210 mg per month;
      b. 2 prefilled syringes per month. Approval duration: 6 months (limited to 12 months cumulative romosozumab 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 ≥ 12 months cumulative romosozumab therapy;
   4. If request is for a dose increase, new dose does not exceed both of the following (a and b):
      a. 210 mg per month;
      b. 2 prefilled syringes per month.
      Approval duration: 6 months (limited to 12 months cumulative use lifetime) Page 2 of 7

   CLINICAL POLICY Romosozumab-aqqg 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 GIO: glucocorticoid-induced osteoporosis PMO: postmenopausal osteoporosis 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 for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen Dose Limit/ Maximum Dose IV bisphosphonates ibandronate (Boniva)
   zoledronic acid (Reclast®) 5 mg IV once a year
   3 mg IV every 3 months. 3 mg/3 months 5 mg/year Oral bisphosphonates alendronate (Fosamax®) Fosamax® Plus D (alendronate / cholecalciferol) 10 mg PO QD or 70 mg PO once
   70 mg/week 70 mg alendronate /2800 IU vitamin D3 or 70 mg alendronate /5600 IU vitamin D3 PO once weekly 70 mg / 5600 IU/ week Page 3 of 7

   CLINICAL POLICY Romosozumab-aqqg Drug Name Dosing Regimen risedronate (Actonel®, Atelvia®) Dose Limit/ Maximum Dose Actonel: 5 mg/day 35 mg/week 150 mg/month Actonel: 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: 35 mg PO once weekly
   150 mg PO once monthly Atelvia: 35 mg/week ibandronate (Boniva®)
   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): hypocalcemia; known hypersensitivity to Evenity • Boxed warning(s): potential risk of myocardial infarction, stroke, cardiovascular death 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) Severe or incapacitating musculoskeletal pain X X X X

   • X X X X X X X X X
   • X
   • X
   • X X X X X X X V. Dosage and Administration
     Indication PMO Dosing Regimen 210 mg (2 prefilled syringes) SC once every month Maximum Dose 210 mg/month up to 12 months cumulative use Page 4 of 7

   CLINICAL POLICY Romosozumab-aqqg VI. Product Availability
   Prefilled syringe: 105 mg/1.17 mL
   VII.