CurrentCentenePolicy CP.PMN.100

Risedronate (Actonel, Atelvia) coverage

Defines medical necessity, prior authorization, and coverage criteria for risedronate products (Actonel and Atelvia) for Centene lines of business including Commercial, HIM, and Medicaid; applies to prescribers requesting coverage for treatment of osteoporosis, Paget's disease, and related indications.

Policy Summary

PayerCentene

PolicyRisedronate (Actonel, Atelvia) coverage

Policy CodePolicy CP.PMN.100

Change TypeQuantity limit requirement added (1Q2026)

Effective DateMar 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation showing indication, age, 12‑month generic alendronate trial (unless contraindicated), dosing limits, and product details.

SourceLink

POLICY UPDATE CHANGES

Added quantity limit requirement (1Q2026)

Dose limitsDose limits specified

≥18 yrsMinimum age/closed epiphyses

12-monthRequired alendronate trial

12 moStandard approval duration

5–150 mgActonel formulations

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Risedronate (Actonel, Atelvia)

Initial Therapy Criteria

Covered when ALL of the following are met

Osteoporosis initial therapy

Indication: Prescribed for one of the following: (a) treatment or prevention of postmenopausal osteoporosis (PMO) or glucocorticoid-induced osteoporosis (GIO), OR (b) treatment of male osteoporosis
Age ≥ 18 years OR documentation of closed epiphyses on x-ray
Step therapy: Failure of a 12-month trial of generic alendronate at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced (Note: Illinois HIM requests are exempt from this step therapy requirement per IL HB 5395)
Atelvia-specific: If request is for Atelvia, prescribed for postmenopausal osteoporosis (PMO)
Brand restriction: If request is for brand Actonel or Atelvia, member must use generic risedronate unless contraindicated or clinically significant adverse effects are experienced
Quantity limits: Request does not exceed health plan-approved quantity limit, if applicable
Dose limits: Request meets one of the following dosing limits: (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: (i) 35 mg per week; (ii) 1 tablet per week

Paget's Disease — Initial Therapy Criteria

Covered when ALL of the following are met

Paget's initial therapy

Product: Request is for Actonel
Diagnosis of Paget's disease of the bone
Age ≥ 18 years OR documentation of closed epiphyses on x-ray
Brand restriction: If request is for brand Actonel, member must use generic risedronate unless contraindicated or clinically significant adverse effects are experienced
Step therapy:

Non‑FDA approved indications that are not specifically addressed in this policy are not covered unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid), or unless coverage is supported by the member’s evidence of coverage document.

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

Product Codes and Age/Key Attributes

Product codes (not specified)NDC

NDC	Not specified in this partial document

Age

Age requirementAge ≥ 18 years OR documentation of closed epiphyses on x‑ray

Applies toAll initial and continued therapy criteria for Osteoporosis and Paget's disease reference this age requirement

Evidence locationAge criterion stated in initial therapy (Osteoporosis) and Paget's disease criteria

Prior Authorization, Documentation, and Step Therapy Requirements

Prior Authorization

Prior authorization requirements

Prior authorization requires submission of documentation that the member meets the specified criteria for indication, age, step therapy (failure of a 12-month trial of generic alendronate unless contraindicated), dosing limits, and use of generic risedronate before brand when applicable.

Indication (PMO, GIO, male osteoporosis, or Paget's where specified)
Age ≥ 18 years or documentation of closed epiphyses on x‑ray
Evidence of failure of a 12‑month trial of generic alendronate unless contraindicated
Adherence to product-specific dose limits and generic risedronate use when applicable

Prior Authorization

Prior authorization and approval duration

Prior authorization approvals must reflect documented prior bisphosphonate use and comply with stated approval-duration and quantity rules; requests must not exceed the health plan‑approved quantity limit when applicable.

Clinical Background on Risedronate

Risedronate is available as immediate‑release (Actonel) and delayed‑release (Atelvia) oral bisphosphonate formulations. Actonel (immediate‑release) is indicated for treatment and prevention of postmenopausal osteoporosis, and additionally for glucocorticoid‑induced osteoporosis, treatment of male osteoporosis, and Paget’s disease of bone. Atelvia (delayed‑release 35 mg) is indicated for the treatment and prevention of postmenopausal osteoporosis. Optimal duration of bisphosphonate therapy is not definitively established; periodic re‑evaluation of ongoing therapy is recommended and low‑risk patients may consider discontinuation after 3 to 5 years.

Definitions and Clinical Terms

GIO (glucocorticoid‑induced osteoporosis)

DefinitionGIO = glucocorticoid‑induced osteoporosis

Indication in policyActonel (risedronate) indicated for treatment and prevention of glucocorticoid‑induced osteoporosis (GIO) per product dosing guidance

Reference guidelineACR 2022 guideline for prevention and treatment of GIO cited in references

PMO (postmenopausal osteoporosis)

DefinitionPMO = postmenopausal osteoporosis

Policy useRequests for Atelvia are limited to PMO; Actonel also includes PMO treatment and prevention

Product dosing

Policy Summary

PayerCentene

PolicyRisedronate (Actonel, Atelvia) coverage

Policy CodePolicy CP.PMN.100

Change TypeQuantity limit requirement added (1Q2026)

Effective DateMar 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation showing indication, age, 12‑month generic alendronate trial (unless contraindicated), dosing limits, and product details.

SourceLink

On This Page

Failure of ≥ 12-month trial of generic alendronate at maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced (Note: Illinois HIM requests are exempt per IL HB 5395)

Quantity limits: Request does not exceed health plan-approved quantity limit, if applicable

Dose limits: Dose does not exceed both: (a) 30 mg per day; and (b) 1 tablet per day

Document prior bisphosphonate trials (e.g., generic alendronate) per policy criteria

Comply with approval-duration expectations (standard review and durations noted in policy history)

Do not exceed plan‑approved quantity limits (added requirement 1Q2026)

Step Therapy

Step therapy (alendronate trial)

A trial of at least 12 months of generic alendronate at maximally indicated doses is required prior to approval of risedronate for osteoporosis unless contraindicated or clinically significant adverse effects are experienced.

Illinois HIM requests are exempt from the step therapy requirement per IL HB 5395 as of 1/1/2026

Step Therapy

Step therapy and generic redirection

Policy history documents redirection to generic risedronate and a preference that members fail generic alendronate before receiving brand Actonel or Atelvia; step therapy bypass for IL HIM was added per IL HB 5395.

1Q2024–1Q2025 edits added redirection to generic risedronate and clarified preference for failure of generic alendronate
Step therapy bypass for Illinois HIM per IL HB 5395 included in recent template updates

Documentation Required

Required supporting clinical documentation

Providers must submit supporting clinical documentation such as office chart notes, laboratory results, or other clinical information demonstrating that the member meets all approval criteria.

Include documentation of indication, age (or closed epiphyses), prior alendronate trial details, and response to therapy as applicable

Documentation Required

Product and strength documentation

Document the specific product formulation and strength being requested (Actonel tablet strengths or Atelvia delayed‑release 35 mg) on the prior authorization submission.

Actonel tablet strengths: 5 mg, 30 mg, 35 mg, 75 mg, 150 mg
Atelvia: delayed‑release tablet 35 mg

Denial Risk

Documentation requirement — risk of denial

Failure to submit required documentation (office notes, labs, or other clinical information) supporting that the member meets all approval criteria may result in denial of the request.

Ensure prior alendronate trial information and dose/quantity details are included to avoid denial

Billing Rule

Quantity limit exceedance — potential denial

Requests that exceed the health plan‑approved quantity limit may be denied; ensure the requested quantity is within the plan‑approved limit.

Quantity‑limit requirement was added in the 1Q2026 annual review and must be observed for approvals

Actonel and Atelvia dosing regimens include PMO‑specific schedules per Dosage and Administration section

IR / DR abbreviations

IRIR = immediate release

DRDR = delayed release

Product examplesActonel is immediate‑release risedronate; Atelvia is delayed‑release risedronate (35 mg weekly)

Osteoporosis clinical guidance (selected society references)

Endocrine SocietyEndocrine Society pharmacological management guideline for postmenopausal osteoporosis cited (Shoback et al.; Eastell et al.)

AACE/ACEAmerican Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guideline (Camacho et al., 2020) cited

ACPAmerican College of Physicians living guideline for pharmacologic treatment to prevent fractures in adults cited (Qaseem et al., 2024)