CurrentCentenePolicy CP.PHAR.282

Parathyroid Hormone (Natpara) (PDF)

Defines medical necessity criteria, dosing limits, approval durations, contraindications, and billing code guidance for Natpara (parathyroid hormone) for hypocalcemia secondary to hypoparathyroidism across Commercial, HIM, and Medicaid lines.

Policy Summary

PayerCentene

PolicyParathyroid Hormone (Natpara) (PDF)

Policy CodePolicy CP.PHAR.282

Change TypeRevised approval durations (1Q2026); coding added (C9399) in 1Q2024

Effective DateNov 16, 2016

Next Review Date

Key ActionSubmit office chart notes, labs, and documentation showing diagnosis, recent labs, prior therapy failure, and endocrinology involvement to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Updated initial and continued authorization durations from 6 months to 12 months during 1Q 2026 annual review.

Added HCPCS code C9399 to coding implications in 1Q 2024 annual review.

Annual reviews 1Q2022–1Q2025: no significant clinical changes; references updated; noted Takeda plans to discontinue global manufacturing of Natpara by end of 2024.

1Covered FDA Indication (hypoparathyroidism)

100 mcg/dayMaximum dose

≥30 daysRequired recent lab window (calcium, vitamin D)

12 months

Medicaid/HIM approval duration

12 monthsCommercial approval duration

Coverage Summary

Coverage stance: covered_with_criteria. This policy defines medical necessity criteria, dosing limits, approval durations, contraindications, and billing code guidance for Natpara (parathyroid hormone) when used for the FDA-approved indication of controlling hypocalcemia in patients with hypoparathyroidism as an adjunct to calcium and vitamin D. Use is limited because of the potential risk of osteosarcoma, and the policy notes a manufacturing discontinuation plan by the manufacturer (Takeda) while maintaining the coverage rules. Authorization durations were updated in the 1Q 2026 review.

Quick Facts / Policy Thresholds

Minimum serum calcium to initiate> 7.5 mg/dL

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

Target serum calcium on therapy8-9 mg/dL (goal: lower half of normal range)

Maximum Natpara dose100 mcg/day

Approval duration (Medicaid/HIM)12 months

Approval duration (Commercial)12 months

Initial Therapy — Hypocalcemia Secondary to Hypoparathyroidism (Medically Necessary)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of hypocalcemia secondary to hypoparathyroidism
Prescribed by or in consultation with an endocrinologist
Age ≥ 18 years
Natpara is prescribed as an adjunct to calcium supplements and active forms of vitamin D, unless contraindicated

Continuation Therapy / Renewal (Medically Necessary)

Covered when ALL of the following are met for members previously approved or currently receiving therapy:

ALL of the following

Member currently receiving medication via Centene benefit or member has previously met initial approval criteria OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations
Member is responding positively to therapy as evidenced by one of the following
- Recent (dated within the last 90 days) serum calcium level is within 8-9 mg/dL8-9 mg/dL
- Recent serum calcium level is > 9 mg/dL, and Natpara dose is being decreased

Other Diagnoses / Off-Label or Not-Specified Uses

If request does NOT meet the above criteria or is for a different indication:

ANY of the following

If the drug has a recent (within 6 months) label change not yet reflected in this policy, refer to applicable formulary/no-coverage or non-formulary policies per line of business (lists provided in policy)
If requested use is not specifically listed under section III and criterion above does not apply, refer to the off-label use policy for the relevant line of business (policy references provided)

Provider Actions and Prior Authorization Requirements

Prior Authorization

Submit documentation for medical necessity

Provider must submit office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria, including diagnosis, recent labs, documentation of prior therapy failure, and prescriber specialty.

Diagnosis of hypocalcemia secondary to hypoparathyroidism
Recent serum calcium and 25-hydroxyvitamin D results
Documentation of prior therapy trial/failure

Documentation Required

Required laboratory evidence prior to initiation

Provide recent laboratory evidence dated within the last 30 days: a serum calcium level > 7.5 mg/dL and a 25-hydroxyvitamin D result demonstrating sufficient stores (≥ 50 nmol/L, equivalent to ≥ 20 ng/mL).

Applicable Codes and Billing Guidance

Informational HCPCS / Billing Codes referencedHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Clinical Evidence & References

Key evidence sources include the Prescribing Information: Natpara Prescribing Information, February 2023, and guideline guidance such as the Management of hypoparathyroidism guidelines (J Clin Endocrinol Metab. 2016;101(6):2273-83) and subsequent updates. The FDA approved Natpara as an adjunct to calcium and vitamin D for control of hypocalcemia in hypoparathyroidism. The labeling and policy note a boxed warning for a potential risk of osteosarcoma, which limits use to patients not adequately controlled on calcium and active vitamin D. Annual reviews and reference updates (including a note that Takeda planned discontinuation of global manufacturing) are documented in the policy history.

Definitions and Background

Active forms of vitamin D: Examples include calcitriol (Rocaltrol). Policy requires Natpara to be prescribed as an adjunct to calcium supplements and active forms of vitamin D unless contraindicated, and documents that a 12-week trial of calcium plus active vitamin D at maximally indicated doses (or documented contraindication/adverse events) is required to demonstrate failure before Natpara is authorized. The goal of therapy is to achieve serum calcium within the lower half of normal range (approximately 8–9 mg/dL) and to reduce supplemental calcium and vitamin D requirements.

Revision History

02.26.2026annual_review_material_changeLatest

1Q2026 annual review updated initial and continued authorization durations from 6 months to 12 months; P&T Approval Date 02.26.2026.

01.2024coding_update

1Q2024 annual review added HCPCS code C9399 for informational billing guidance.

10.29.2021 - 02.25.2025annual_review_notes

Annual reviews 1Q2022–1Q2025 noted no significant clinical changes; references reviewed and updated. 1Q2025 review noted Takeda plans to discontinue global manufacturing of Natpara by the end of 2024 (policy maintained, not a coverage rule change).

Policy Summary

PayerCentene

PolicyParathyroid Hormone (Natpara) (PDF)

Policy CodePolicy CP.PHAR.282

Change TypeRevised approval durations (1Q2026); coding added (C9399) in 1Q2024

Effective DateNov 16, 2016

Next Review Date

Key ActionSubmit office chart notes, labs, and documentation showing diagnosis, recent labs, prior therapy failure, and endocrinology involvement to support medical necessity.

SourceLink

On This Page

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

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

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, unacceptable calcium-phosphate product, high risk of renal complications due to hypercalciuria or stones, nephrolithiasis, or poor absorption

Prescriber must indicate that the hypocalcemia is not well controlled with calcium supplements and active forms of vitamin D (see Appendix B examples)

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

Maximum dose per policy and product labeling

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

Documentation Required

Demonstrate failure of prior therapy

Document either a 12-week trial of calcium supplements plus active forms of vitamin D at up to maximally indicated doses showing inadequate control, or documentation that such a trial is contraindicated or discontinued due to clinically significant adverse events. Examples of failure include large swings in calcium, unacceptable calcium–phosphate product, high risk of renal complications from hypercalciuria or stones, nephrolithiasis, or poor absorption.

12-week trial of calcium + active vitamin D at maximally indicated doses (e.g., calcitriol)
Or documented contraindication or clinically significant adverse event preventing the trial
Examples: large calcium swings, hypercalciuria/renal stones, poor absorption

Prior Authorization

Prescriber specialty requirement

Prescription must be written by or in consultation with an endocrinologist as a condition of meeting the coverage criteria.

Billing Rule

Dose limit enforcement

Authorizations will not exceed dosing greater than 100 mcg per day; any request for a dose increase must result in a maintained dose at or below 100 mcg/day.

Prior Authorization

Approval duration

Initial and continued approvals are for 12 months for Medicaid and HIM; Commercial approvals are 12 months (policy updated during the 1Q 2026 annual review from the prior 6-month commercial duration to 12 months).

Medicaid/HIM: 12 months
Commercial: 12 months (updated from 6 months in 1Q 2026)