CurrentEmblemHealthPolicy N/A

Medicare Advantage Medical Utilization Review Policy

Medicare Advantage utilization review policy governing medical-benefit coverage and prior authorization recommendations for ibandronate injection (Boniva IV) for treatment of osteoporosis in postmenopausal women and senile osteoporosis in males, including dosing and situations not recommended for coverage.

Policy Summary

PayerEmblemHealth

PolicyMedicare Advantage Medical Utilization Review Policy

Policy CodePolicy N/A

Change TypeRevised criteria (04/10/2023)

Effective DateApr 10, 2023

Next Review Date

Key ActionPrior authorization is recommended; approve when the patient meets the policy Criteria and Dosing and document T-scores, fracture history or trial/intolerance to oral bisphosphonates.

SourceLink

POLICY UPDATE CHANGES

Policy incorporates Medicare NCDs and LCDs and companion articles for coding guidance; reference lists of HCPCS/ICD-10 in companion articles are for reference only.

2Covered Indications (major)

1Not Recommended Indications (major)

1Typical initial approval duration (years)

Coverage Summary

Ibandronate injection (Boniva IV) is indicated for treatment of osteoporosis in postmenopausal women and for senile osteoporosis in males. This Medicare Advantage utilization review policy aligns with applicable Medicare NCDs/LCDs and companion local coverage articles and provides medical-benefit coverage criteria and prior authorization recommendations for Boniva IV. Prior authorization is recommended for medical-benefit coverage and approvals are provided when patients meet the Criteria and Dosing. Effective and last review date: 04/10/2023.

Quick facts

T-score threshold<= -2.5 (osteoporosis threshold); low bone mass defined as between -1.0 and -2.5

Oral bisphosphonate trial duration12 months (trial duration as determined by the prescriber)

Typical initial approval duration1 year (typical initial approval)

Medical Necessity Criteria and Dosing

Osteoporosis Treatment for a Postmenopausal Patient (Initial Approval)

Approve for 1 year if the patient meets the following criteria (A and B):

ALL of the following

A) The patient meets ONE of the following conditions
- i: The patient has had a T-score (current or at any time in the past) at or below -2.5 at the lumbar spine, femoral neck, total hip, and/or 33% (one-third) radius (wrist); OR hipT-score <= -2.5
- ii: The patient has had an osteoporotic fracture or a fragility fracture
- iii: Prescriber determines that the patient is at high risk for fracture; AND patient has low bone masslow bone mass: T-score between -1.0 and -2.5
  Low bone mass example: T-score (current or at any time in the past) between -1.0 and -2.5 at the lumbar spine, femoral neck, total hip and/or 33% radius (wrist).

Dosing (Postmenopausal and Senile Male Osteoporosis)

ALL of the following

Postmenopausal dosing: Approve 3 mg IV once every 3 months3 mg IV q3 months
Senile osteoporosis in male patients dosing: Approve IV once every 3 months, 2 mg2 mg IV q3 months

Senile Osteoporosis in Male Patients (Initial Approval)

Approve for 1 year if the patient meets ONE of the following criteria (A or B):

ANY of the following

A: The patient cannot tolerate an oral bisphosphonate
Example: patient cannot swallow or has difficulty swallowing.
B: The patient has a medical contraindication to oral bisphosphonate
Examples include inability to remain upright post-dose or pre-existing GI condition (esophageal lesions, ulcers, stricture, achalasia) where IV therapy is warranted.

Conditions Not Recommended for Approval

ANY of the following

1: Osteoporosis prevention (preventative services) — not covered by Medicare
Medicare coverage of preventative services is limited by statute and prevention of osteoporosis is not covered by Medicare.
2: Circumstances not listed in the Recommended Authorization Criteria

Provider Actions & Billing

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for medical-benefit coverage; approval is recommended when the patient meets the conditions of coverage in the Criteria and Dosing. Approvals are provided for the durations noted (typically 1 year).

Documentation Required

Document fracture, T-score, or trial/intolerance to oral bisphosphonate

Providers should document T-scores (current or historical), history of osteoporotic/fragility fracture, prescriber assessment of fracture risk and low bone mass, and evidence of trial/failure/intolerance/contraindication to oral bisphosphonates.

Coding Guidance

Relevant HCPCS/ICD-10 coding guidance referencedmixed

No codes listed

Background & Evidence

Ibandronate injection is indicated for the treatment of osteoporosis in postmenopausal women. The policy incorporates and aligns with Medicare coverage guidance (NCDs/LCDs) and related local coverage articles, and it provides recommended authorization criteria, dosing guidance, and coding/billing references to support medical-benefit coverage decisions.

Reference	Source
Boniva IV prescribing information	Genentech/Roche; January 2022
LCD / Local Coverage Article referenced	LCD L33394 and Local Coverage Article A52421 (accessed April 10, 2023)

Low bone mass: T-score between -1.0 and -2.5 at the lumbar spine, femoral neck, total hip, and/or 33% radius (wrist).

Osteoporotic/fragility fracture: Fracture occurring from low-level trauma associated with decreased bone strength; used as a qualifying criterion for treatment.

Medicare Determinations

Effective Date	Name	Number	Type
2015-10-01	Coverage of Drugs and Biologicals, for Label and Off-Label Uses	L33394	LCD
2015-10-01	Ibandronate Sodium (Boniva) Related to LCD L33394	A52421	Local Coverage Article

Revision History

2023-04-10material_revisionLatest

Updated criteria for postmenopausal osteoporosis to require T-score <= -2.5, or prior fracture, or low bone mass; added criteria allowing coverage after trial of oral bisphosphonate with inadequate response or intolerance, or prior trial of Boniva IV or Reclast. Historic revisions moved examples into notes, changed wording from 'prescribing physician' to 'prescriber', and adjusted phrasing for inadequate efficacy and intolerance.

03/08/2021non_material_revision

Brand name of Boniva removed from the policy title; incorporated osteoporotic/fragility fracture examples into notes related to inadequate efficacy or intolerance to oral bisphosphonate therapy.

B) The patient meets ONE of the following

i: The patient has tried at least one oral bisphosphonate and has experienced inadequate efficacy to oral bisphosphonate therapy after a trial duration of 12 months as determined by the prescribertrial duration 12 months
Examples of inadequate efficacy: ongoing and significant loss of bone mineral density (BMD), lack of a BMD increase, and/or an osteoporotic/fragility fracture.
ii: The patient has experienced significant intolerance to an oral bisphosphonate
Examples of significant intolerance include severe gastrointestinal-related adverse events, severe musculoskeletal-related adverse events, or a femoral fracture.
iii: The patient has a medical contraindication to oral bisphosphonate
Examples include inability to remain upright post-dose, pre-existing GI conditions (esophageal lesions, ulcers, or abnormalities delaying esophageal emptying such as stricture or achalasia), or inability to swallow.
iv: The patient has tried ibandronate injection (Boniva IV) or zoledronic acid injection (Reclast)
v: The patient has had an osteoporotic fracture or a fragility fracture