CurrentmhnPolicy CP.PHAR.282

Parathyroid Hormone (Natpara) — Coverage Criteria

Defines medical necessity and prior authorization criteria for Natpara (parathyroid hormone) for treatment of hypocalcemia due to hypoparathyroidism for Centene-affiliated health plans; applies to commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyParathyroid Hormone (Natpara) — Coverage Criteria

Policy CodePolicy CP.PHAR.282

Change TypeNo material change

Effective DateNov 16, 2016

Next Review DateFeb 25, 2025

Key ActionSubmit prior authorization with documentation of diagnosis, specialist involvement, relevant labs, trial of calcium and active vitamin D, and dosing information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18min patient age

100 mcg/daymax dose

6 monthsapproval duration

8–9 mg/dLcalcium target

Coverage Criteria for Natpara (parathyroid hormone)

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Initial criteria: 1. Diagnosis of hypocalcemia secondary to hypoparathyroidism; 2. Prescribed by or in consultation with an endocrinologist; 3. Age ≥ 18 years; 4. Natpara is prescribed as an adjunct to calcium supplements and active forms of vitamin D, unless contraindicated; 5. Recent (dated within the last 30 days) serum calcium level is > 7.5 mg/dL; 6. Recent (dated within the last 30 days) 25-hydroxyvitamin D ≥ 50 nmol/L (≥20 ng/mL); 7. 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 intolerant; 8. Dose does not exceed 100 mcg per day; 9. Prescriber must indicate that the hypocalcemia is not well controlled with calcium supplements and active forms of vitamin D.

Continuation/Renewal Criteria

Covered when ALL of the following are met

Continuation criteria: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria or is covered under continuity of care; 2. Member is responding positively to therapy as evidenced by either (a) recent (dated within the last 90 days) serum calcium within 8-9 mg/dL, or (b) recent serum calcium >9 mg/dL with Natpara dose being decreased; 3. If request is for dose increase, new dose does not exceed 100 mcg per day.

Other Indications / Label Changes

Process when indication not specifically covered

Other uses: 1. If this drug has undergone a label change within the last 6 months that is not yet reflected in this policy, follow applicable formulary or non‑formulary policies for the member's line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255 for formulary; CP.CPA.190, HIM.PA.103, CP.PMN.16 for non‑formulary); 2. For requested uses not listed in exclusions and not covered by item 1, refer to the off‑label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Dosage and Administration

Dosing and administration parameters included in the policy:

Dosing: Initial dosing: 50 mcg subcutaneously once daily; increase by 25 mcg every 4 weeks as needed.

See maximum dose node

Maximum dose: Do not exceed 100 mcg per day.

Non–FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid), or unless the use is supported by the member’s evidence of coverage documents.

Natpara is reserved for patients who cannot be well‑controlled on calcium supplements and active forms of vitamin D alone because of a boxed warning for a potential risk of osteosarcoma. Requests for Natpara should document that the patient is not adequately controlled on conventional therapy (calcium plus active vitamin D) or has a contraindication or intolerance to those therapies.

Policy and Billing Codes

Policy identifiersmixed

CP.PHAR.282

Policy reference number

HCPCS Codes (referenced)HCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Serum calcium

Initiation thresholdSerum calcium > 7.5 mg/dL (recent, within 30 days) required before starting therapy

Response targetTherapeutic goal: serum calcium within approximately 8–9 mg/dL (lower half of normal range)

Monitoring windowResponse evidence may be recent serum calcium within 90 days for continuation requests

25-hydroxyvitamin D

Required level before initiation25-hydroxyvitamin D ≥ 50 nmol/L (≥ 20 ng/mL) (recent, within 30 days)

Prescriber actionPrescriber should confirm 25-hydroxyvitamin D stores are sufficient prior to starting Natpara

DocumentationLab result must be submitted with prior authorization request to verify sufficiency

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit documentation confirming diagnosis of hypocalcemia secondary to hypoparathyroidism, specialist involvement (prescribed by or in consultation with an endocrinologist), age, prior adequate trials of calcium supplements and active vitamin D (12 weeks at maximally indicated doses unless contraindicated), recent labs (serum calcium >7.5 mg/dL and 25-hydroxyvitamin D ≥50 nmol/L [≥20 ng/mL] dated within 30 days for initiation), and dose does not exceed 100 mcg/day. Approval durations: Medicaid/HIM 6 months; Commercial 6 months or to member renewal date, whichever is longer.

Prior authorization required with documentation of diagnosis, endocrinology involvement, and supporting labs.
Provide office chart notes, lab results, or other clinical information to demonstrate criteria are met.

Step Therapy

Step Therapy / Therapeutic Alternatives

Natpara is approved only after failure of a 12-week trial of calcium supplements and active forms of vitamin D at up to maximally indicated doses unless contraindicated or clinically significant adverse events occur. Therapeutic alternatives (e.g., calcitriol, calcium carbonate, calcium citrate) should be considered and documented; see Appendix B for dosing and alternatives.

Step therapy: 12-week trial of calcium + active vitamin D required prior to Natpara unless contraindicated.
Therapeutic alternatives: calcitriol (up to 2 mcg/day), calcium carbonate (up to 3 g/day), calcium citrate (up to 3 g/day).

Denial Risk

Denial Triggers

Requests that do not meet the medical necessity criteria (e.g., diagnosis not hypocalcemia secondary to hypoparathyroidism, insufficient documentation of prior trials, missing required labs, dosing above 100 mcg/day, or requests for non‑FDA indications without appropriate off‑label justification) will be denied.

Denial triggers include: lack of documented failure of a 12-week trial of calcium and active vitamin D, missing recent serum calcium or 25-hydroxyvitamin D results, prescriber not an endocrinologist or no consultation documented, dose >100 mcg/day, or requests for non‑FDA indications without evidence per off‑label policies.

Billing Rule

Prior Authorization and Coding

When submitting claims for Natpara or similar parathyroid hormone products billed under unclassified codes, follow coding guidance and verify current coding sources prior to claim submission. Inclusion or exclusion of codes in this policy does not guarantee coverage.

HCPCS: J3590 — Unclassified biologics; C9399 — Unclassified drugs or biologicals
Providers should reference the most up-to-date professional coding guidance before submitting claims.

Billing Rule

Coding May Affect Coverage

Coding may affect coverage determinations. The presence or absence of specific codes in this clinical policy is informational only and does not ensure reimbursement. Verify codes and modifier use with current payer and billing resources.

Inclusion or exclusion of any codes does not guarantee coverage; check current coding guidance before claim submission.

Documentation Required

Required Documentation and Supporting References

Provider must submit documentation (office chart notes, lab results, and other clinical information) supporting that the member has met all applicable criteria. Ensure references and supporting literature (Natpara prescribing information, clinical guidelines, and relevant literature) are available in the medical record.

Required documentation: office notes, recent serum calcium and 25-hydroxyvitamin D results, documentation of prior therapy and response, and specialist consultation notes as applicable.
Supporting references to include Natpara Prescribing Information and relevant clinical guidelines (see References).

Background on Natpara and Clinical Context

Natpara (parathyroid hormone) is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Initial dosing for hypocalcemia secondary to hypoparathyroidism is typically 50 mcg subcutaneously once daily, with increases of 25 mcg every 4 weeks as needed, and a maximum recommended dose of 100 mcg per day.

Definitions and Key Safety Information

Natpara

Product descriptionNatpara: a parathyroid hormone product indicated as an adjunct to calcium and vitamin D to control hypocalcemia in hypoparathyroidism.

Indication contextUsed when hypocalcemia is not well controlled with calcium and active vitamin D alone (per policy limitations).

Regulatory statusFDA-approved indication: adjunct to calcium and vitamin D for hypoparathyroidism-related hypocalcemia.

Boxed warning

Boxed warning summaryNatpara carries a boxed warning for potential risk of osteosarcoma.

Clinical implicationDue to osteosarcoma risk, Natpara is reserved for patients not well-controlled on calcium and active vitamin D alone.

Contraindication noteContraindication includes hypersensitivity to any component of the product.

Dosing regimen

Initial dosing50 mcg subcutaneously once daily (SC QD)

Titration incrementIncrease by 25 mcg every 4 weeks as needed based on response

Administration routeSubcutaneous injection

Maximum dose

Maximum recommended doseDo not exceed 100 mcg per day

Policy limitContinuation and dose increase requests must ensure new dose does not exceed 100 mcg/day

Documented dosing rangePolicy documents dosing range for hypocalcemia secondary to hypoparathyroidism as 50–100 mcg/day