CurrentmhnPolicy CP.PHAR.282

Parathyroid Hormone (Natpara)

Defines medical necessity criteria, dosing limits, approval durations, exclusions, and billing codes for Natpara (parathyroid hormone) as adjunct therapy for hypocalcemia secondary to hypoparathyroidism across Commercial, HIM and Medicaid lines of business.

Policy Summary

Payermhn

PolicyParathyroid Hormone (Natpara)

Policy CodePolicy CP.PHAR.282

Change TypeRevised (auth durations updated)

Effective DateNov 16, 2016

Next Review Date

Key ActionProvider must submit office notes, lab results, or other clinical information supporting all approval criteria, including recent serum calcium and 25-hydroxyvitamin D levels.

SourceLink

POLICY UPDATE CHANGES

1Q 2026 annual review: updated initial and continued authorization durations from 6 months to 12 months; references reviewed and updated.

1Q 2024 annual review: added HCPCS code C9399; references reviewed and updated.

Multiple annual reviews (2022-2025) noted as 'no significant changes'; references updated.

1Covered FDA-approved indications

100Maximum daily dose (mcg)

3Lines of business

12/6Approval durations (pre-1Q2026)

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: Defines medical necessity criteria, dosing limits (maximum 100 mcg per day), approval durations, exclusions, and billing codes for Natpara (parathyroid hormone) as adjunct therapy for hypocalcemia secondary to hypoparathyroidism across Commercial, HIM and Medicaid lines of business. Status: CURRENT. Subject: Natpara (parathyroid hormone) coverage for hypoparathyroidism.

FDA approval and safety note: Natpara is FDA-approved as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Because of a potential risk of osteosarcoma, Natpara is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. Additional administrative notes: policy revisions document manufacturing discontinuation planning and code references.

Key thresholds and authorization info

Baseline serum calcium to start Natpara> 7.5 mg/dL

25-hydroxyvitamin D sufficiency≥ 50 nmol/L (≥ 20 ng/mL)

Target serum calcium during treatment8 to 9 mg/dL (goal: lower half of normal range)

Continuation monitoring windowRecent serum calcium within the last 90 days

Maximum daily dose100 mcg per day

Approval durationsMedicaid/HIM: 12 months; Commercial: 6 months or to member renewal date (updated to 12 months per 1Q2026 review)

Lines of businessCommercial, HIM, Medicaid

Initial Therapy Criteria

Initial therapy - Hypocalcemia Secondary to Hypoparathyroidism (must meet all)

Covered when ALL of the following are met:

Diagnosis and prescriber
- Diagnosis of hypocalcemia secondary to hypoparathyroidism
- Prescriber: Prescribed by or in consultation with an endocrinologist
- Age ≥ 18 years
Adjunct and labs before initiation

Continuation Therapy Criteria

Continuation/renewal criteria - Hypocalcemia Secondary to Hypoparathyroidism (must meet all)

Covered for continuation when ALL of the following are met:

Member continuity options
- Option A: Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Option B: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums CC.PHARM.03A and CC.PHARM.03B)
Evidence of response
- Response A:

Other Indications and Exclusions

Other diagnoses/indications; Diagnoses/Indications NOT authorized

If requested use is outside the covered indication or policy not updated for a recent label change (must meet one):

ref

Provider Actions

Prior Authorization

Prior authorization requirement

Natpara requires prior authorization and is covered only when the policy criteria are met. Approval durations vary by line of business: Medicaid/HIM approvals are 12 months; Commercial approvals were 6 months or to the member’s renewal date but were updated to 12 months in the 1Q2026 review.

Approval duration (Medicaid/HIM): 12 months
Commercial approval duration: previously 6 months or to member renewal date; updated to 12 months in 1Q2026 review

Documentation Required

Submit supporting documentation

Providers must submit clinical documentation supporting that the member meets all approval criteria, including recent laboratory results. Specifically provide office chart notes and lab results documenting recent serum calcium and 25-hydroxyvitamin D levels.

Applicable Codes

HCPCS / billing codes referencedHCPCS|other

J3590	Unclassified biologics (referenced for informational purposes only)
C9399	Unclassified drugs or biologicals (added 1Q 2024 review)

Clinical Evidence & Background

FDA approval indication: Natpara is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.

Manufacturing discontinuation note: Multiple annual reviews note that Takeda plans to discontinue global manufacturing of Natpara by the end of 2024.

Product presentation: Natpara is available in multiple-dose, dual-chamber glass cartridges in 25, 50, 75, and 100 mcg/dose presentations.

Safety concern and usage recommendation: The product carries a boxed warning for the potential risk of osteosarcoma; because of this risk, Natpara is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. Prescribers should confirm 25-hydroxyvitamin D stores are sufficient and serum calcium is above 7.5 mg/dL before initiating therapy. The Feb 2023 prescribing information and cited clinical guidelines are referenced for these recommendations.

Definitions

Sufficient 25-hydroxyvitamin D storesDefined as ≥ 50 nmol/L (≥ 20 ng/mL)

Target serum calciumDefined as the lower half of the normal range: 8 to 9 mg/dL

Revision History

1Q 2026 (P&T Approval Date = 02.26; Date = 11.06.25)material_revisionLatest

1Q 2026 annual review: updated initial and continued authorization durations from 6 months to 12 months; references reviewed and updated.

1Q 2024 (P&T Approval Date = 02.24; Date = 10.12.23)revision

1Q 2024 annual review: added HCPCS code C9399; references reviewed and updated.

1Q 2025 (P&T Approval Date = 02.25; Date = 12.02.24)historical_note

Policy Summary

Payermhn

PolicyParathyroid Hormone (Natpara)

Policy CodePolicy CP.PHAR.282

Change TypeRevised (auth durations updated)

Effective DateNov 16, 2016

Next Review Date

Key ActionProvider must submit office notes, lab results, or other clinical information supporting all approval criteria, including recent serum calcium and 25-hydroxyvitamin D levels.

SourceLink

On This Page

Natpara is prescribed as an adjunct to calcium supplements and active forms of vitamin D, unless contraindicated

Serum calcium baseline: Recent (dated within the last 30 days) serum calcium level is > 7.5 mg/dL> 7.5 mg/dL

25-hydroxyvitamin D: Recent (dated within the last 30 days) lab result shows sufficient 25-hydroxyvitamin D stores≥ 50 nmol/L (≥ 20 ng/mL)

Prior therapy failure and documentation

Failure of calcium/vitamin D: Failure of a 12-week trial of calcium supplements and active forms of vitamin D (e.g., calcitriol) at up to maximally indicated doses, unless contraindicated or clinically significant adverse events are experienced
Examples of failure include large swings in calcium, high risk of renal complications, hypercalciuria, nephrolithiasis, or poor absorption
Prescriber statement: Prescriber must indicate that the hypocalcemia is not well controlled with calcium supplements and active forms of vitamin D
See Appendix B examples

Dose limit: Dose does not exceed 100 mcg per day≤ 100 mcg/day

Per dosing and maximum dose guidance

Recent (dated within the last 90 days) serum calcium level is within 8-9 mg/dL

Target: lower half of normal range

Response B: Recent serum calcium level is > 9 mg/dL, and Natpara dose is being decreased> 9 mg/dL

Dose being decreased demonstrates response

Dose increase rule: If request is for a dose increase, new dose does not exceed 100 mcg per day≤ 100 mcg/day

Office chart notes documenting diagnosis and prior therapy
Recent serum calcium level (dated within the last 30 days for initiation; within last 90 days for continuation)
Recent 25-hydroxyvitamin D level showing sufficiency (≥ 50 nmol/L / ≥ 20 ng/mL)

Documentation Required

Endocrinologist involvement

Natpara must be prescribed by or in consultation with an endocrinologist. Include documentation of the endocrinologist’s involvement—either the prescription from an endocrinologist or clinical notes documenting the consultation and specialty of the prescribing provider.

Prescriber specialty indicated in prescription or office notes
Documentation of endocrinology consult if the prescriber is not an endocrinologist

Billing Rule

Dose limit enforcement

Claims for Natpara that exceed the policy maximum daily dose should be denied. The policy maximum dose threshold is 100 mcg per day.

Policy maximum dose: 100 mcg per day

1Q 2025 annual review: noted Takeda plans to discontinue global manufacturing of Natpara by the end of 2024; references reviewed and updated.

1Q 2022 - 1Q 2023historical_note

Multiple annual reviews (2022-2023) noted no significant changes; references reviewed and updated.