ATELVIA, Risedronate Sodium ACTONEL, Risedronate Sodium Form

Risedronate IR (Actonel®) and risedronate DR (Atelvia®) are oral bisphosphonates. FDA Approved Indication(s) Actonel and Atelvia is indicated for: • Treatment and prevention of osteoporosis in postmenopausal women (PMO). Actonel is addditionally indicated for:
• Treatment and prevention of glucocorticoid-induced osteoporosis (GIO). • Treatment to increase bone mass in men with osteoporosis. • Treatment of Paget’s disease of bone. Limitation(s) of use: Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. 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 Actonel and Atelvia are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Osteoporosis (must meet all):

1. Prescribed for one of the following (a or b): a. Treatment or prevention of PMO or GIO; b. Treatment of male osteoporosis;
2. Age ≥ 18 years or documentation of closed epiphyses on x-ray;
   
   3. Failure of a 12-month trial of generic alendronate at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;
3. If request is for Atelvia, prescribed for PMO;
   5. If request is for brand Actonel or Atelvia, member must use generic risedronate, unless contraindicated or clinically significant adverse effects are experienced;

4. Request meets one of the following (a or b): a. Actonel: Dose does not exceed all of the following (i, ii, iii, and iv): i. 5 mg per day; ii. 35 mg per week; Page 1 of 8

   CLINICAL POLICY Risedronate iii. 150 mg per month; iv. 1 tablet per day;
   b. Atelvia (PMO treatment only): Dose does not exceed both of the following (i and ii):
   i. 35 mg per week; ii. 1 tablet per week. Approval duration: Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Paget’s Disease (must meet all):

   1. Request is for Actonel;
   2. Diagnosis of Paget’s disease of the bone;
   3. Age ≥ 18 years or documentation of closed epiphyses on x-ray;
   4. If request is for brand Actonel, member must use generic risedronate, unless contraindicated or clinically significant adverse effects are experienced;
5. Failure of ≥ 12-month trial of generic alendronate at maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced;
6. Dose does not exceed both of the following (a and b):
   a. 30 mg per day;
   b. 1 tablet per day.
   Approval duration: 2 months C. Other diagnoses/indications (must meet 1 or 2):
7. 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
8. 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):

9. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; Page 2 of 8

   CLINICAL POLICY Risedronate 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 a dose increase, request meets one of the following (a or b): a. Actonel: Dose does not exceed all of the following (i, ii, iii, and iv): i. 5 mg per day; ii. 35 mg per week; iii. 150 mg per month; iv. 1 tablet per day;
      b. Atelvia (PMO treatment only): Dose does not exceed both of the following (i and ii):
      i. 35 mg per week; ii. 1 tablet per week. Approval duration: Medicaid/HIM – 12 months Commercial – 12 months or duration of request, whichever is less B. Paget’s Disease (must meet all):
10. Currently receiving Actonel via Centene benefit or member has previously met initial approval criteria;
11. Two months have elapsed since the completion of previous therapy with Actonel;
    3. Member is responding positively to therapy;
    4. If request is for a dose increase, new dose does not exceed both of the following (a and b) a. 30 mg per day;
       b. 1 tablet per day. Approval duration: 2 months C. Other diagnoses/indications (must meet 1 or 2):
12. 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

13. 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.
    Page 3 of 8

    CLINICAL POLICY Risedronate 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 FDA: Food and Drug Administration GIO: glucocorticoid-induced osteoporosis PMO: postmenopausal osteoporosis IR: immediate release DR: delayed release 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 40 mg/day 70 mg/week alendronate (Fosamax®) • Treatment: PMO, male osteoporosis 10 mg PO QD or 70 mg PO once weekly • Treatment: GIO 5 mg PO QD or 10 mg PO QD in postmenopausal women not receiving estrogen • Prevention: PMO
    5 mg PO QD or 35 mg PO once weekly • Paget’s disease: 40 mg PO QD for 12 months 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): abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia; inability to stand/sit upright for at least 30 minutes; hypocalcemia; hypersensitivity • Boxed warning(s): none reported V. Dosage and Administration
    Drug Name
    risedronate (Actonel) Indication PMO treatment and prevention Male osteoporosis treatment Dosing Regimen 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 35 mg PO once weekly Maximum Dose 5 mg/day 35 mg/week 150 mg/month 35 mg/week Page 4 of 8

    CLINICAL POLICY Risedronate Drug Name
    Indication GIO treatment and prevention Paget’s disease Dosing Regimen 5 mg PO QD 30 mg PO QD for 2 months risedronate (Atelvia) PMO treatment 35 mg PO once weekly Maximum Dose 5 mg/day 30 mg QD not to exceed 2 months 35 mg/week VI. Product Availability
    Drug Name risedronate (Actonel) risedronate (Atelvia) Availability
    Tablets: 5mg, 30 mg, 35 mg, 75 mg, 150 mg Delayed-release tablet: 35 mg VI.