ModifiedCignaPolicy IP0330

Teriparatide (parathyroid hormone analogs) coverage policy

Coverage policy governing medical necessity, authorization, reauthorization, duration, and exclusions for teriparatide parathyroid hormone analog injections for Cigna-administered benefit plans.

Policy Summary

PayerCigna

PolicyTeriparatide (parathyroid hormone analogs) coverage policy

Policy CodePolicy IP0330

Change TypeAdded Bonsityremoved chronic hypoparathyroidismproduct strength revisions

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, BMD or fracture history, and trial or intolerance to a bisphosphonate as required.

SourceLink

POLICY UPDATE CHANGES

Chronic Hypoparathyroidism: This condition of approval was removed.

Added Bonsity to coverage policy.

Updated product availability and concentrations for Forteo and Teriparatide (various mcg/volume changes).

Updated wording from 'documented failure, contraindication, or intolerance' to 'tried and cannot take' in individual/family plans preferred product table.

Added 'patient with glucocorticoid-induced osteoporosis (GIO)' exception.

24 monthsmaximum initial cumulative therapy duration

up to 12 monthsreauthorization approval duration

4products named in overview

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.

Excludedconcurrent therapy stance

2 yearsrecommended maximum lifetime use

Medical Necessity & Coverage Criteria

Glucocorticoid-Induced Osteoporosis - Treatment

Covered when ALL of the following are met

GIO initial criteria: A. Initiating or continuing chronic systemic glucocorticoids (for example, prednisone).

GIO initial criteria: B. ONE of the following: (i) Failure to at least ONE oral or IV bisphosphonate unless contraindicated or intolerant (examples: alendronate, ibandronate, risedronate, zoledronic acid) — failure may include osteoporotic/fragility fracture while on bisphosphonate therapy, ongoing significant loss of BMD, or lack of BMD increase; OR (ii) Individual is at very high risk for fracture (examples: recent fracture within past 12 months, fractures while on approved osteoporosis therapy, multiple fractures, fractures while on drugs causing skeletal harm e.g., long-term glucocorticoids, very low T-score e.g., < -3.0, high risk for falls or history of injurious falls, very high FRAX probability e.g., major >30% or hip >4.5%).

GIO initial criteria: C. Total cumulative therapy with parathyroid hormone analogs will not exceed 24 months. An exception can be made for individuals who remain at or have returned to high risk for fracture (examples: prior osteoporotic/fragility fracture, receipt of medications that increase osteoporosis risk, advanced age, or very low BMD).<= 24 months

GIO initial criteria: D. Preferred/non-covered product criteria is met per the product tables (refer to policy product tables).

Osteoporosis Treatment for Postmenopausal Women

Covered when ALL of the following are met

Postmenopausal osteoporosis initial criteria: A. ONE of the following conditions: (i) BMD T-score ≤ -2.5 at the lumbar spine, femoral neck, total hip and/or 33% radius (wrist); OR (ii) History of an osteoporotic or fragility fracture; OR (iii) BOTH: low bone mass (T-score between -1.0 and -2.5) AND prescriber determines the individual is at high risk for fracture (for example, FRAX 10-year probability for major osteoporotic fracture ≥20% or hip fracture ≥3%).

Postmenopausal osteoporosis initial criteria: B. ONE of the following: (i) Failure to at least ONE oral or IV bisphosphonate unless contraindicated or intolerant (examples: alendronate, ibandronate, risedronate, zoledronic acid) — failure may include osteoporotic/fragility fracture while on bisphosphonate therapy, ongoing significant loss of BMD, or lack of BMD increase; OR (ii) Individual is at very high risk for fracture (examples listed in policy).

Postmenopausal osteoporosis initial criteria: C. Total cumulative therapy with parathyroid hormone analogs will not exceed 24 months (exceptions possible if individual remains at or has returned to high risk for fracture).<= 24 months

Osteoporosis - Men with Primary or Hypogonadal Osteoporosis

Covered when ALL of the following are met

Men with primary or hypogonadal osteoporosis initial criteria: A. ONE of the following conditions: (i) BMD T-score ≤ -2.5 at the lumbar spine, femoral neck, total hip and/or 33% radius; OR (ii) History of an osteoporotic or fragility fracture; OR (iii) BOTH: low bone mass (T-score between -1.0 and -2.5) AND prescriber determines the individual is at high risk for fracture (for example, FRAX 10-year probability for major ≥20% or hip ≥3%).

Men with primary or hypogonadal osteoporosis initial criteria: B. ONE of the following: (i) Failure to at least ONE oral or IV bisphosphonate unless contraindicated or intolerant (examples: alendronate, ibandronate, risedronate, zoledronic acid); OR (ii) Individual is at very high risk for fracture (examples listed in policy).

Men with primary or hypogonadal osteoporosis initial criteria: C. Total cumulative therapy with parathyroid hormone analogs will not exceed 24 months (exceptions may be granted if individual remains at or has returned to high fracture risk).<= 24 months

Reauthorization Criteria

Covered for continuation when ALL of the following are met

Reauthorization beyond 24 months: A. The initial medical necessity criteria for the relevant osteoporosis indication (GIO, postmenopausal, or men’s primary/hypogonadal osteoporosis) are met.

Reauthorization beyond 24 months: B. The individual remains at or has returned to a high risk for fracture (for example, prior osteoporotic/fragility fracture, receipt of medications that increase osteoporosis risk, advanced age, or very low BMD).

Reauthorization beyond 24 months: C. The prescriber has determined the potential benefit of continued therapy outweighs the risk.

Reauthorization duration: Reauthorization approvals may be granted up to 12 months when criteria are met.

Summary coverage logic and limits

Key coverage-related rules and clinical alignments present in this section

Lifetime duration limit: Use of teriparatide for more than 2 years during a patient’s lifetime should only be considered if the patient remains at or has returned to having a high risk for fracture.>2 years

Safety consideration: osteosarcoma signal in animal data and limited human data beyond 2 years.

Clinical guideline alignment: Teriparatide is recommended in clinical guidelines for GIO and postmenopausal osteoporosis often after trial of other agents or for patients at very high fracture risk or intolerant of oral therapy.

References include ACR 2022, Endocrine Society 2019, AACE/ACE 2020, Bone Health and Osteoporosis Foundation 2022.

Product selection and plan-specific criteria: Policy updated to add Bonsity and revise product strengths; preferred product tables and plan-specific language (e.g., 'tried and cannot take' for individual/family plans and a GIO exception) affect prior authorization and product preference.

Any other use of teriparatide products is considered experimental, investigational, or unproven. Examples explicitly listed in the policy include: concurrent use with other osteoporosis medications (for example, denosumab/Prolia, oral bisphosphonates such as alendronate or risedronate, intravenous bisphosphonates such as zoledronic acid/Reclast or IV ibandronate, calcitonin nasal spray, abaloparatide/Tymlos, and romosozumab/Evenity), osteoporosis prevention (use in patients without substantial bone loss), acute post-surgical hypoparathyroidism, and hypoparathyroidism caused by calcium-sensing receptor mutations.

Chronic hypoparathyroidism has been removed as a condition of approval in this policy excerpt; the revision notes state: Chronic Hypoparathyroidism: This condition of approval was removed.

Use of teriparatide for osteoporosis prevention and concurrent use with other osteoporosis medications is considered not medically necessary/experimental or unproven. The policy explains teriparatide has not been studied for prevention and the benefits and risks in that population are unknown, and it lists concurrent therapy examples that are excluded.

The policy advises against teriparatide use in patients with baseline risk factors for osteosarcoma, noting an increased incidence of osteosarcoma in animal studies and limited long‑term human data. It states there are limited data evaluating risk beyond 2 years of use and that use beyond 2 years during a patient’s lifetime should only be considered if the patient remains at or has returned to high risk for fracture.

Product Codes, Formulations, and Clinical Thresholds

Named products/formulationsmixed

Bonsity 560 mcg/2.24 mL	teriparatide subcutaneous injection (brand listed)
Forteo 560 mcg/2.24 mL	teriparatide subcutaneous injection (brand listed)
Teriparatide 560 mcg/2.24 mL	teriparatide subcutaneous injection (generic listed)
Teriparatide 620 mcg/2.48 mL	teriparatide subcutaneous injection (Alvogen listed)

Referenced drug products and prescribing informationmixed

NDC and specific billing codes not listed in this excerpt

Product prescribing information and product strengths referenced (Forteo, Bonsity, Teriparatide brands)

BMD T-score

Diagnostic osteoporosis thresholdBMD T-score ≤ -2.5 at lumbar spine, femoral neck, total hip, or 33% radius

Low bone mass (osteopenia)T-score between -1.0 and -2.5

Site examples specifiedLumbar spine, femoral neck, total hip, and 33% (one-third) radius (wrist)

FRAX 10-year probability

FRAX major osteoporotic fracture threshold10-year probability ≥ 20%

FRAX hip fracture threshold10-year probability ≥ 3%

Prior Authorization, Documentation & Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for teriparatide products. Initial approvals are granted up to 24 months (cumulative lifetime with parathyroid hormone analogs) for osteoporosis indications; reauthorization approvals may be granted up to 12 months. Prior authorization requirements were updated to reflect addition of Bonsity and revised product strengths; check employer vs individual/family plan criteria for product-specific rules.

Initial approval: up to 24 months total cumulative therapy with parathyroid hormone analogs (abaloparatide or teriparatide) for osteoporosis indications.
Reauthorization: up to 12 months for all indications.
Policy updated to add Bonsity and to update Forteo/Teriparatide product strengths and associated criteria.

Denial Risk

Concurrent Therapy Exclusion

Requests for concurrent use of teriparatide with other osteoporosis medications are considered not covered. Concurrent therapy increases safety concerns and is listed as an exclusion in the policy.

Clinical Background

Teriparatide products are parathyroid hormone (PTH 1-34) analogs indicated for treatment of glucocorticoid-induced osteoporosis (GIO), to reduce fracture risk in postmenopausal women at high risk for fracture, and to increase bone mass in men with primary or hypogonadal osteoporosis. Clinical thresholds used in the policy to define high fracture risk include recent fragility fracture (for example within 12 months), very low BMD (e.g., T‑score < -3.0), and elevated FRAX 10‑year probabilities (examples cited include major osteoporotic fracture ≥ 20% or hip fracture ≥ 3%). The policy aligns with guideline-recommended positioning of teriparatide—typically after failure, intolerance, or contraindication to bisphosphonates or when patients are at very high fracture risk—and specifies a cumulative therapy limit of up to 24 months for parathyroid hormone analogs unless reauthorization criteria are met.

Definitions & Clinical Thresholds

High risk for fracture

Definition — high risk for fracturePatients with history of osteoporotic fractures, multiple risk factors for fracture, or who have failed or are intolerant to other osteoporosis therapy

Example risk factorsRecent fracture within 12 months, fractures while on therapy, multiple fractures, drugs causing skeletal harm, very low BMD

Clinical relevanceHigh-risk designation used to determine eligibility for teriparatide and exceptions to step therapy or duration limits

Lifetime use limit

Lifetime use limit — general ruleUse of teriparatide for more than 2 years during a patient's lifetime should only be considered if the patient remains at or has returned to high risk for fracture

RationaleLimited long-term safety data and osteosarcoma signal in animal studies

Policy Summary

PayerCigna

PolicyTeriparatide (parathyroid hormone analogs) coverage policy

Policy CodePolicy IP0330

Change TypeAdded Bonsityremoved chronic hypoparathyroidismproduct strength revisions

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, BMD or fracture history, and trial or intolerance to a bisphosphonate as required.

SourceLink

On This Page

Postmenopausal osteoporosis initial criteria: D. Preferred product criteria is met per the product tables included in the policy.

Men with primary or hypogonadal osteoporosis initial criteria: D. Preferred product criteria is met per the product tables included in the policy.

Operational revisions reflected in product tables and prior authorization requirements.

Use in risk determination

FRAX probabilities cited as examples when prescriber determines high fracture risk

Very low T-score example

Example of very low T-scoreT-score < -3.0 (explicit example of very low BMD used to define very high fracture risk)

Context of useListed as an example criterion for 'very high risk' in GIO and other osteoporosis indications

Impact on therapy decisionsMay qualify individual for teriparatide without bisphosphonate trial if considered very high risk

Examples of excluded concurrent medications: Prolia (denosumab), oral bisphosphonates (alendronate, risedronate, ibandronate), IV bisphosphonates (zoledronic acid, IV ibandronate), calcitonin nasal spray, Tymlos (abaloparatide), Evenity (romosozumab).
Use beyond 2 years in a patient's lifetime is discouraged and should only be considered for patients who remain at or have returned to high fracture risk.

Documentation Required

Required Clinical Documentation

Documentation must support the diagnosis, fracture risk, and prior therapy history. Provide objective data to substantiate medical necessity and any exceptions to step requirements.

Clinical documentation to include: relevant BMD T-scores (current or historical), history of osteoporotic or fragility fractures, FRAX score or other fracture-risk assessment when cited, and details of glucocorticoid exposure when applicable.
Document prior trials, failures, intolerances, or contraindications to alternative therapies (including specific bisphosphonates) and the dates/durations of those therapies.
If requesting therapy beyond policy limits (e.g., >24 months cumulative or >2 years lifetime), include rationale demonstrating persistent or recurrent high fracture risk.

Documentation Required

Product-Specific Substitution Documentation

For certain products and lines of business, the prescriber must document why an alternative branded or generic formulation cannot be used (product-specific substitution justification). Employer and individual/family plans have distinct criteria for preferred products.

Employer plans: documentation that the patient tried teriparatide 560 mcg/2.24 mL (generic for Forteo 560 mcg/2.24 mL) and cannot take it due to a formulation difference in inactive ingredients (e.g., dyes, fillers, preservatives) that would cause a significant allergy or serious adverse reaction.
Individual & Family plans: documentation that the patient has tried and cannot take Tymlos (abaloparatide) OR meets glucocorticoid-induced osteoporosis exception as specified in the plan tables.
For Alvogen teriparatide 620 mcg/2.48 mL, document trial of the 560 mcg/2.24 mL formulation and inability to take it due to inactive ingredient differences when applicable.

Documentation Required

Product Selection Documentation

Product selection must follow the preferred product criteria in the employer or individual/family plan tables; documentation should reflect the justification for selecting a non-preferred product when required.

Verify employer vs individual/family plan preferred product rules before submission.
When selecting a non-preferred product, provide documentation that meets the plan-specific criteria (for example, trial and inability to take the preferred agent or documented GIO exception for individual/family plans).
Receipt of sample product does not satisfy documentation or trial requirements.

Step Therapy

Bisphosphonate Trial Requirement (Step)

Step therapy requires trial and failure, intolerance, or contraindication to at least one oral or IV bisphosphonate for most osteoporosis indications prior to teriparatide, unless the patient meets high-risk criteria or other exceptions.

Accepted bisphosphonate trial options include: alendronate (Fosamax), ibandronate (Boniva; oral or IV), risedronate (Actonel/Atelvia), and zoledronic acid (Reclast) IV infusion.
Documentation must indicate the nature of the trial failure (e.g., fracture while on therapy, ongoing significant BMD loss, or lack of BMD increase) or intolerance/contraindication.
Clinical guidelines often recommend teriparatide after trial of bisphosphonates in various scenarios; exceptions exist for very high-risk patients where teriparatide may be appropriate without bisphosphonate trial.

Step Therapy

Clinical Guideline–Aligned Step Therapy

Policy aligns with clinical guidelines that place teriparatide after other agents in many scenarios but recognize use for very high-risk patients. Ensure clinical justification references guideline-based indications where relevant.

Guideline examples: ACR 2022 guidance for glucocorticoid-induced osteoporosis recommends teriparatide after trial of other agents in many situations.
Endocrine Society (2019), AACE/ACE (2020), and Bone Health and Osteoporosis Foundation guidance cite teriparatide as an option for very high-risk patients or those intolerant of oral therapy.
When using guideline-aligned exceptions (e.g., very high fracture risk), include objective evidence (recent fracture, very low T-score, high FRAX probability, multiple fractures, or fractures while on approved therapy).

Exception conditionsException can be made for individuals who remain at or return to high fracture risk (examples: prior osteoporotic fracture, medications increasing osteoporosis risk, advanced age, very low BMD)

GIO (Glucocorticoid-Induced Osteoporosis)

DefinitionGlucocorticoid-Induced Osteoporosis (GIO)

Indication contextGIO refers to osteoporosis associated with sustained systemic glucocorticoid therapy (daily prednisone equivalent ≥ 5 mg)

Policy useGIO is a covered indication when initiating/continuing chronic systemic glucocorticoids and other coverage criteria are met