CurrentmhnPolicy CP.PMN.100

Risedronate (Actonel, Atelvia)

Medical necessity and prior authorization criteria for risedronate products (Actonel, Atelvia) for treatment/prevention of osteoporosis, Paget's disease, and related indications applicable to Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyRisedronate (Actonel, Atelvia)

Policy CodePolicy CP.PMN.100

Change TypeAnnual reviews and targeted revisions (2023-2026)

Effective Date03.01.18

Next Review Date

Key ActionSubmit documentation supporting that the member has met all approval criteria when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

Added requirement that request does not exceed health plan-approved quantity limit, if applicable.

Added generic redirection to continuation of therapy requests; references reviewed and updated.

Clarified Actonel dose limit per week and per month; added redirection to generic risedronate; added criteria to ensure Atelvia is prescribed for PMO per PI; clarified failure of 'generic' alendronate is preferred; references reviewed and updated.

Paget's disease initial criteria - revised alendronate trial duration from 6 months to 12 months to align with other bisphosphate policies; references reviewed and updated.

Added step therapy bypass for IL HIM per IL HB 5395.

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

12 monthsstandard approval duration

≥18minimum age

12-month

Coverage Criteria

A. Osteoporosis — Initial Therapy

Covered when ALL of the following are met:

Osteoporosis Initial Criteria: 1) Prescribed for treatment or prevention of postmenopausal osteoporosis (PMO) or glucocorticoid-induced osteoporosis (GIO), or for 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 (Illinois HIM requests are exempt from step therapy per IL HB 5395); 4) If request is for Atelvia, prescribed specifically 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; 6) Request does not exceed health plan‑approved quantity limit, if applicable; 7) Dosing limits: either (a) Actonel — dose does not exceed all of: i. 5 mg per day; ii. 35 mg per week; iii. 150 mg per month; iv. 1 tablet per day; or (b) Atelvia (PMO treatment only) — dose does not exceed both of: i. 35 mg per week; ii. 1 tablet per week.

See dosing and maximum dose information in the Dosage and Administration section for product‑ and indication‑specific regimens.

B. Paget's Disease — Initial Therapy

Covered when ALL of the following are met:

Paget's Initial Criteria: 1) Request is for Actonel; 2) Diagnosis of Paget's disease of 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 a ≥ 12‑month trial of generic alendronate at maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced (Illinois HIM requests are exempt from step therapy per IL HB 5395); 6) Request does not exceed health plan‑approved quantity limit, if applicable; 7) Dose limit: dose does not exceed 30 mg per day and 1 tablet per day.

Paget's dosing regimen and maximum dose: Actonel 30 mg PO daily for up to 2 months (see Dosage and Administration).

II.A Continued Therapy — Osteoporosis

Covered when ALL of the following are met:

Osteoporosis Continued Therapy: 1) Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria, or (b) currently receiving medication and enrolled in a state/product with continuity‑of‑care regulations; 2) Member is responding positively to therapy; 3) If request is for brand Actonel or Atelvia, member must use generic risedronate unless contraindicated or clinically significant adverse effects are experienced; 4) Request does not exceed health plan‑approved quantity limit, if applicable; 5) If request is for a dose increase, dosing limits are the same as initial therapy: either (a) Actonel — dose does not exceed all of i. 5 mg per day; ii. 35 mg per week; iii. 150 mg per month; iv. 1 tablet per day; or (b) Atelvia (PMO only) — dose does not exceed both of 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.

II.B Continued Therapy — Paget's Disease

Covered when ALL of the following are met:

Paget's Continued Therapy: 1) Currently receiving Actonel via Centene benefit or member has previously met initial approval criteria; 2) Two months have elapsed since completion of previous Actonel therapy; 3) Member is responding positively to therapy; 4) If request is for brand Actonel, member must use generic risedronate unless contraindicated or clinically significant adverse effects are experienced; 5) Request does not exceed health plan‑approved quantity limit, if applicable; 6) If request is for a dose increase, new dose must not exceed 30 mg per day and 1 tablet per day.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider supplies sufficient documentation demonstrating efficacy and safety. Such documentation must align with the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or with evidence of coverage documents.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage rules that supersede this policy.

Coding and Limits

Glucocorticoid daily dose threshold

Glucocorticoid daily dose threshold>= 7.5 mg prednisone equivalent

ContextUsed to define glucocorticoid-induced osteoporosis (GIO) treatment eligibility for Actonel when patients are on systemic glucocorticoids.

Source dosing exampleActonel dosing for GIO: 5 mg PO daily (maximum 5 mg/day).

Approval duration / quantity

Commercial approval duration12 months or duration of request, whichever is less

Medicaid/HIM approval duration12 months

Quantity limit requirement

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Actonel, Atelvia, and risedronate. These agents are medically necessary only when all applicable policy criteria are met and the provider submits supporting documentation.

Prior authorization required for Actonel, Atelvia, and risedronate

Documentation Required

Documentation Required to Support Medical Necessity

Provider must submit documentation (such as office chart notes, laboratory results, imaging, or other relevant clinical information) that supports the member has met all applicable approval criteria. Failure to submit sufficient documentation or to demonstrate that the member meets the criteria may result in denial of the request.

Examples: office chart notes, lab results, x-ray reports, medication history

Definitions

GIO — Glucocorticoid‑induced osteoporosis

DefinitionGlucocorticoid‑induced osteoporosis (GIO): treatment indication for Actonel when patients are on systemic glucocorticoids (>= 7.5 mg prednisone or equivalent daily).

Actonel dosing for GIO5 mg PO daily (maximum 5 mg/day).

PMO — Postmenopausal osteoporosis

Primary FDA indicationPostmenopausal osteoporosis (PMO) is the primary FDA indication for both Actonel and Atelvia.

Atelvia dosing (PMO)35 mg PO once weekly (maximum 35 mg/week).

Actonel dosing (PMO)Options include 5 mg PO daily, 35 mg PO once weekly, 75 mg PO on two consecutive days each month, or 150 mg PO once monthly (maximums apply).

Background

Risedronate (both immediate‑release and delayed‑release formulations) are oral bisphosphonates indicated for the treatment and prevention of postmenopausal osteoporosis. Actonel (risedronate) additionally has labeled indications including glucocorticoid‑induced osteoporosis, male osteoporosis, and Paget’s disease of bone. Duration of bisphosphonate therapy should be periodically re‑evaluated, as the optimal treatment duration is not firmly established.

Revision History

2018-03-01policy_effective

Policy became effective.

2022-10-10template_changes

Template changes applied to other diagnoses/indications and continued therapy section; Paget's disease initial criteria later revised in Nov 2022.

2022-11-02annual_review

1Q 2023 annual review: Paget's disease initial criteria revised—alendronate trial duration changed from 6 months to 12 months to align with other bisphosphate policies; references reviewed and updated.