mhn alendronate coverage update Prior Auth

Coverage Criteria

Initial Therapy - Osteoporosis

Covered when ALL of the following are met for Osteoporosis (Initial Approval):

Osteoporosis initial approval: 1. Diagnosis of postmenopausal osteoporosis (PMO) or male osteoporosis; 2. Age ≥ 18 years or documentation of closed epiphyses on x-ray; 3. Failure of a 12-month trial of formulary/preferred generic alendronate at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced; 4. Request does not exceed health plan-approved quantity limit, if applicable; 5. Dose does not exceed one of the following: a. Binosto 70 mg (1 tablet) per week; b. Fosamax Plus D 70 mg/5600 IU (1 tablet) per week; c. Alendronate oral solution 70 mg (1 bottle) per week.

Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Continuation Therapy - Osteoporosis

Covered when ALL of the following are met for Continued Therapy (Osteoporosis):

Osteoporosis continued therapy: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria, or member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Request does not exceed health plan-approved quantity limit, if applicable; 4. If request is for a dose increase, the new dose does not exceed one of the following: a. Binosto 70 mg (1 tablet) per week; b. Fosamax Plus D 70 mg/5600 IU (1 tablet) per week; c. Alendronate oral solution 70 mg (1 bottle) per week.

Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Other Diagnoses/Indications

Other diagnoses/indications:

Other indications pathway: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, refer to the appropriate no-coverage or non-formulary policy for the relevant line of business; 2. If the requested use (diagnosis, age, dosing) is not specifically listed under section III and criterion 1 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 HIM, CP.PMN.53 for Medicaid).

See listed policy cross-references for line-of-business specific guidance.

Requests for uses that are not FDA‑approved and are not specifically addressed in this policy will generally be excluded from coverage. Such requests may be considered only if the provider submits sufficient clinical documentation of efficacy and safety consistent with the Health Plan’s applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or as allowed by the member’s evidence of coverage.

Coverage under this policy is subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, the evidence of coverage, certificate of coverage, policy, or contract of insurance). The policy provides medical necessity guidance to assist coverage decisions and benefit administration but does not guarantee payment; providers must follow applicable Health Plan administrative policies and state or federal requirements when seeking authorization.

Alendronate products must not be used in patients with any of the listed contraindications. Specifically, do not approve therapy for members with esophageal abnormalities that delay emptying (e.g., stricture or achalasia), those who have an inability to sit or stand upright for at least 30 minutes, documented hypocalcemia, or a history of hypersensitivity to alendronate. Additionally, because of aspiration risk, Binosto and alendronate oral solution should not be used in patients with an increased risk of aspiration. Requests for these patients would be considered not medically necessary.

Coding & Key Values

inv-07: Maximum weekly dose

Maximum weekly dose70 mg/week

Binosto dosing70 mg (1 tablet) per week

Fosamax Plus D dosing70 mg/5600 IU (1 tablet) per week

Alendronate oral solution dosing70 mg (1 bottle) per week

inv-08: Minimum age

Minimum age requirementAge ≥ 18 years

Alternate documentationDocumentation of closed epiphyses on x-ray accepted

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for osteoporosis therapies (Binosto, Fosamax Plus D, alendronate oral solution). Provider must submit supporting documentation such as office chart notes, relevant laboratory results, imaging (e.g., DXA, x-ray showing closed epiphyses when applicable), and prior medication history demonstrating trials and outcomes. Requests that exceed health plan-approved quantity limits will be reviewed and may be denied; verify the member’s plan quantity limit before submission.

Affected products: Binosto, Fosamax Plus D, alendronate oral solution
Acceptable documentation examples: office chart notes, lab results (e.g., calcium), DXA or x-ray reports, medication fill history, documentation of adverse events or contraindications to alendronate
Verify plan quantity limits prior to PA submission

Step Therapy

Step Therapy Requirement and IL HIM Bypass

Step therapy: a 12-month trial of a formulary/preferred generic alendronate (PDL product) at up to maximally indicated doses is required prior to approval, unless there is documentation of a contraindication or clinically significant adverse effects. For requests subject to Illinois Health Insurance Marketplace (HIM) rules, the step therapy requirement is bypassed per IL HB 5395 effective 1/1/2026. When applicable, document prior use, dates, doses, reason for discontinuation, or contraindication.

Initial Therapy

Covered when ALL of the following are met for Osteoporosis (Initial Approval):

Osteoporosis initial approval (duplicate): 1. Diagnosis of postmenopausal osteoporosis (PMO) or male osteoporosis; 2. Age ≥ 18 years or documentation of closed epiphyses on x-ray; 3. Failure of a 12-month trial of formulary/preferred generic alendronate at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced; 4. Request does not exceed health plan-approved quantity limit, if applicable; 5. Dose does not exceed one of the following: a. Binosto 70 mg (1 tablet) per week; b. Fosamax Plus D 70 mg/5600 IU (1 tablet) per week; c. Alendronate oral solution 70 mg (1 bottle) per week.

Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy (Osteoporosis):

Osteoporosis continued therapy (duplicate): 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria, or member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Request does not exceed health plan-approved quantity limit, if applicable; 4. If request is for a dose increase, the new dose does not exceed one of the following: a. Binosto 70 mg (1 tablet) per week; b. Fosamax Plus D 70 mg/5600 IU (1 tablet) per week; c. Alendronate oral solution 70 mg (1 bottle) per week.

Approval duration: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Step Therapy Requirements

Step	Requirement
1	Must trial a formulary/preferred drug list (PDL) generic alendronate for 12 months at up to maximally indicated doses prior to approval unless contraindicated or clinically significant adverse effects are experienced.

Jurisdiction	Step therapy detail / Bypass
General	Step therapy required: failure of a 12-month trial of formulary/preferred generic alendronate at up to maximally indicated doses prior to approval (unless contraindicated or intolerant).
Illinois HIM	Per IL HB 5395 (effective 1/1/2026), the step therapy requirements do not apply for Illinois HIM requests (step therapy bypass permitted).

Quantity Limits

inv-25: Binosto, Fosamax Plus D, Alendronate oral solution

Quantity limit requirementRequests for Binosto, Fosamax Plus D, and alendronate oral solution must not exceed the Health Plan-approved quantity limit, if applicable

Policy change note1Q 2026 review added the requirement re: Health Plan-approved quantity limit

Impact on prior authorizationPrior authorization may include verification that request does not exceed plan-approved quantity limit

inv-26: Alendronate

Quantity limit requirement for alendronateAlendronate use must not exceed the Health Plan-approved quantity limit when applicable

Policy update1Q 2026 annual review added the quantity limit requirement

Background

Alendronate is an oral bisphosphonate therapy indicated for the treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis. Clinical guidance notes that optimal treatment duration is not definitively established; for patients at lower fracture risk, discontinuation after approximately 3–5 years may be appropriate based on clinical judgment.

Definitions

inv-19: PMO

DefinitionPostmenopausal osteoporosis (PMO)

AbbreviationPMO = postmenopausal osteoporosis

Context of usePMO is an approved diagnosis for treatment with alendronate products under this policy

inv-20: Health Plan

Definition'Health Plan' means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan's affiliates

ScopePolicy decisions and benefit administration are subject to the Health Plan's coverage documents and administrative policies

Revision History

10.19.23annual review (1Q2024)

Clarified that failure of a 'generic' alendronate is preferred (template/references reviewed and updated).

10.22.24annual review (1Q2025)

Added alendronate oral solution to the policy and clarified redirection to a formulary/preferred drug list (PDL) generic alendronate product (references reviewed and updated).

10.16.25annual review (1Q2026)Latest

OpenPayer

Alendronate (Binosto, Fosamax Plus D)

Coverage Criteria

Coding & Key Values

Provider Actions & Prior Authorization

Initial Therapy

Continuation Therapy

Step Therapy Requirements

Quantity Limits

Background

Definitions

Revision History