CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Teriparatide (parathyroid hormone) for osteoporosis - Coverage Criteria

Policy governing coverage criteria for teriparatide therapy for members with osteoporosis (postmenopausal, primary/hypogonadal in men, and glucocorticoid-induced) when approval criteria are met; applies to Neighborhood Health Plan of Rhode Island Medicaid population.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTeriparatide (parathyroid hormone) for osteoporosis - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2020

Next Review DateApr 1, 2021

Key ActionSubmit prior authorization with documentation of pre-treatment T-score or fragility fracture history and prior bisphosphonate trial or contraindication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsusual initial authorization duration

24 monthsmaximum cumulative therapy

medicaidscope

yesuses FRAX

Coverage Criteria for Teriparatide

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Postmenopausal osteoporosis

Authorization of 12 months may be granted to postmenopausal members with osteoporosis when ANY of the following criteria are met:

Postmenopausal criteria: 1) Documentation that the member has a history of fragility fractures; OR 2) Documentation that the member has a pre-treatment T-score ≤ -2.5; OR 3) Osteopenia (pre-treatment T-score > -2.5 and < -1) with a high pre-treatment FRAX fracture probability (see Appendix B); OR 4) The member has failed treatment with or is intolerant to previous injectable osteoporosis therapy (e.g., zoledronic acid, denosumab); OR 5) The member has had an oral bisphosphonate trial of ≥1 year duration or has a contraindication to oral bisphosphonate therapy (see Appendix A).

Meet any listed item

Primary/hypogonadal osteoporosis (men)

Authorization of 12 months may be granted to male members with primary or hypogonadal osteoporosis when ANY of the following criteria are met:

Men's osteoporosis criteria: 1) Documentation that the member has a history of an osteoporotic vertebral or hip fracture; OR 2) Documentation that the member meets BOTH of the following: (a) has had an oral or injectable bisphosphonate trial of ≥1 year duration OR has a contraindication to oral bisphosphonates; AND (b) pre-treatment T-score ≤ -2.5 OR treatment FRAX fracture probability (see Appendix B).

Either fracture history OR both bisphosphonate trial/contraindication and low T-score/FRAX

Glucocorticoid-induced osteoporosis

Authorization of 12 months may be granted for members with glucocorticoid-induced osteoporosis when ALL of the following criteria are met:

Glucocorticoid-induced criteria: 1) Documentation of an oral or injectable bisphosphonate trial of ≥1 year duration OR a contraindication to oral bisphosphonates (see Appendix A); 2) Documentation that the member is currently receiving or will be initiating glucocorticoid therapy at an equivalent dose for ≥3 months; 3) Documentation that the member has a history of a fragility fracture; AND 4) The member meets ANY of: pre-treatment T-score ≤ -2.5 OR osteopenia (pre-treatment T-score > -2.5 and < -1) with a high pre-treatment FRAX probability (see Appendix B).

All items required; internal any for T-score/FRAX

Continuation Therapy

Authorization of up to 12 months may be granted for continuation when ALL the following are met:

Continuation: 1) If the member has not been previously approved by Neighborhood, clinician must submit documentation that initial criteria are met; AND 2) Documentation that the member has not received more than 24 months of parathyroid hormone therapy in their lifetime.24 months lifetime

Both required

All indications for teriparatide that are not listed in the EDA‑Approved Indication section — including uses outside treatment of postmenopausal osteoporosis, men with primary or hypogonadal osteoporosis, and glucocorticoid‑induced osteoporosis — are considered experimental/investigational and are not covered.

Use of teriparatide for any indication not included in the EDA‑Approved Indication section is considered not medically necessary / experimental and is not a covered benefit.

Definitions and Coding Thresholds

FRAX thresholds

FRAX major osteoporotic fracture threshold10-year major osteoporotic fracture risk ≥20%

FRAX hip fracture threshold10-year hip fracture risk >3%

Glucocorticoid adjustment — major fractureMultiply estimated major osteoporotic fracture risk by 1.15 if glucocorticoid treatment >7.5 mg prednisone equivalent/day

Glucocorticoid adjustment — hip fractureMultiply estimated hip fracture risk by 1.2 if glucocorticoid treatment >7.5 mg prednisone equivalent/day

FRAX calculation resource10-year probability calculation tool: https://www.sheffield.ac.uk/FRAX

High FRAX fracture probability (definition)

Definition of high FRAX probabilityHigh FRAX fracture probability defined as 10-year major osteoporotic fracture risk ≥20% or hip fracture risk >3%

Glucocorticoid users — adjustment recommendedMultiply FRAX major osteoporotic fracture risk by 1.15 and hip fracture risk by 1.2 when glucocorticoid treatment >7.5 mg prednisone equivalent/day

FRAX tool reference10-year probability calculation tool available at the Sheffield FRAX website

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals are typically granted for 12 months when approval criteria are met; continuation approvals are granted per the continuation criteria (see Continuation of Therapy).

Initial authorizations typically up to 12 months
Continuation approvals subject to continuation criteria (up to 12 months)

Step Therapy

Bisphosphonate Trial Requirement

Policy requires documentation of a trial and failure of, or intolerance to, an oral bisphosphonate of at least 1 year duration or an injectable bisphosphonate, or documentation of a contraindication to oral bisphosphonates. This applies to postmenopausal women, men with primary or hypogonadal osteoporosis, and glucocorticoid‑induced osteoporosis.

Oral bisphosphonate trial ≥ 1 year OR injectable bisphosphonate trial ≥ 1 year
Or documented intolerance to bisphosphonates or contraindication to oral bisphosphonates
Applies across postmenopausal, male primary/hypogonadal, and glucocorticoid‑induced osteoporosis populations

Documentation Required

Required Documentation

Submit documentation of required baseline data to support the request. Lack of these documents may result in denial.

Pre‑treatment T‑score (e.g., ≤ -2.5) and/or documentation of osteopenia with high FRAX probability (see appendices)
History of fragility fracture (e.g., osteoporotic vertebral or hip fracture) when applicable
Documentation of prior bisphosphonate trial duration (≥1 year) or intolerance/contraindication to bisphosphonates
For glucocorticoid‑induced osteoporosis: evidence of current or planned chronic glucocorticoid use (dose and expected duration)
For continuation requests: documentation of prior approval and total lifetime duration of parathyroid hormone therapy (must not exceed 24 months)

Denial Risk

Basis for Denial

Requests missing required baseline documentation or bisphosphonate trial information may be denied. Examples that may lead to denial include absent pre‑treatment T‑score or FRAX data, no history of fragility fracture when claimed, or no documentation of a ≥1‑year bisphosphonate trial or a valid contraindication/intolerance.

Missing pre‑treatment T‑score or FRAX fracture probability
No documentation of history of fragility fracture when applicable
No documentation of prior bisphosphonate trial duration (≥1 year) or no documented intolerance/contraindication

OpenPayer

Teriparatide (parathyroid hormone) for osteoporosis - Coverage Criteria

Coverage Criteria for Teriparatide

Definitions and Coding Thresholds

Provider Requirements and Authorization Process

Background

Revision History