CurrentCignaPolicy N/A

Bone Modifiers - Teriparatide Drug Quantity Management Policy - Per Days

Defines Cigna's drug quantity management limits and exception criteria for teriparatide products (Bonsity, Forteo/generic, and teriparatide pens) for covered health benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyBone Modifiers - Teriparatide Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeMaterial updates to approval duration and quantity limits (Bonsity added)

Effective DateN/A

Next Review DateApr 30, 2025

Key ActionRequest prior authorization for teriparatide products when dispensing above the quantity limits; approvals are issued for 1 year.

SourceLink

POLICY UPDATE CHANGES

Approval duration was changed from 2 years to 1 year.

New quantity limits for Bonsity 560 mcg/2.24 mL pen were added: 2.24 mL (1 pen) per 28 days at retail and 6.72 mL (3 pens) per 84 days at home delivery.

Policy updated to reflect existing quantity limits when a product is obtained via home delivery.

1 penRetail max / 28 days (560 mcg pens)

3 pensHome delivery max / 84 days (560 mcg pens)

20 mcg QDRecommended dose

>2 yearsUse beyond 2 years

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Coverage Criteria and Exceptions

Drug Quantity Limit Application and Exception Handling

Quantity limits apply; exceptions are covered as medically necessary when criteria are met

Quantity limit application: Quantity limit is specific to the chemical entity for all strengths combined; if the Drug Quantity Management rule is not met at the point of service, coverage will be determined by the criteria below; approvals are provided for 1 year in duration.See Drug Quantity Limits

Exceptions to the listed quantity limits are covered as medically necessary only when the specified criteria are met; any other exception is not medically necessary.

Any exception to the listed quantity limits that does not meet the specified criteria is considered not medically necessary. The policy specifies maximum retail and home delivery quantities for each teriparatide pen and states that exceptions to those limits are only covered when the documented criteria are met.

For the listed pen presentations — including the 560 mcg/2.24 mL pens (Bonsity and Forteo/generic) and the 620 mcg/2.48 mL teriparatide pen — no override is recommended. If a request exceeds the stated quantity limits and does not satisfy the exception criteria, coverage is considered not medically necessary.

Dosing and Coding Details

Drug NDC/HCPCS not listed in documentmixed

No codes listed

Teriparatide dosing

Recommended dose20 mcg subcutaneously once daily (QD)

Administration routeSubcutaneous (SC)

Use beyond 2 yearsConsider only if patient remains at or has returned to high fracture risk

Provider Responsibilities and Authorization Rules

Prior Authorization

Prior Authorization and Quantity Management

All approvals are provided for 1 year in duration. The Drug Quantity Management rule applies at the point of service; if the rule is not met for the requested medication at the point of service, coverage will be determined by the applicable plan criteria and may be denied.

Approvals duration: 12 months
Drug Quantity Management rule enforced at point of service
Exceptions and coverage determinations handled per policy and applicable benefit plan document

Documentation Required

Documentation and Review Expectations

Coverage determinations require consideration of the applicable benefit plan document, any relevant laws/regulations, related coverage policies and collateral materials, and the specific facts of the individual case. Medical directors have discretion to make individual coverage determinations when appropriate.

Clinical Background

Teriparatide (PTH 1-34) products are parathyroid hormone analogs indicated for treatment of glucocorticoid‑induced osteoporosis, postmenopausal osteoporosis in patients at high fracture risk, and to increase bone mass in men with primary or hypogonadal osteoporosis at high fracture risk. The recommended dosing for osteoporosis is 20 mcg subcutaneously once daily. Quantity limits in this policy reflect pen presentations that contain 28 daily doses of 20 mcg each (for example, 560 mcg/2.24 mL pens) and are intended to manage premature dose escalation while allowing standard daily dosing.

Key Definitions

High risk for fracture (definition)

Definition of high fracture riskHistory of osteoporotic fractures

Definition of high fracture riskMultiple risk factors for fracture

Definition of high fracture riskFailure or intolerance to other osteoporosis therapy

Initial Therapy Requirements

Initial dosing

Dosing and initial use

Standard dosing: Recommended dose is 20 mcg subcutaneously once daily for osteoporosis.20 mcg QD

Continuation and Duration of Therapy

Duration of Therapy

Continuation/total duration considerations

Duration guidance: Use of teriparatide for more than 2 years during a patient's lifetime for FDA‑approved indications should only be considered if the patient remains at or has returned to high risk for fracture.>2 years

Approvals under this policy are issued for 1 year.

Step Therapy and Overrides

Step	Requirement
1	No overrides/step therapy exceptions apply to the updated quantity limits for the 560 mcg/2.24 mL pens.

Product-Specific Quantity Limits

Bonsity quantity limits

Product and presentationBonsity 560 mcg/2.24 mL prefilled pen

Retail limit (28 days)2.24 mL (1 pen) per 28 days

Home delivery limit (84 days)6.72 mL (3 pens) per 84 days

Forteo (generic) quantity limits

Product and presentationForteo (generic) 560 mcg/2.24 mL prefilled pen (28 daily doses)

Retail limit (28 days)2.24 mL (1 pen) per 28 days

Home delivery limit (84 days)6.72 mL (3 pens) per 84 days

Dispensing Site and Home Delivery Rules

Billing Rule

Site-specific quantity limits: home delivery allows 3-pen (84 day) fills

Retail and home delivery dispensing have different maximum quantities: retail fills are limited to a 28-day supply (1 pen for the 560 mcg/2.24 mL presentations), while home delivery allows a 3-pen fill covering 84 days.

Bonsity and Forteo 560 mcg/2.24 mL pens: Retail = 2.24 mL (1 pen) per 28 days; Home delivery = 6.72 mL (3 pens) per 84 days.
Teriparatide 620 mcg/2.48 mL pen: Retail = 1 pen (2.48 mL) per 28 days; Home delivery = 3 pens (7.44 mL) per 84 days.