CurrentCentenePolicy N/A

Clinical Policy: Parathyroid Hormone (Natpara)

Policy governing medical necessity and coverage criteria for Natpara (parathyroid hormone) as adjunct therapy to calcium and vitamin D for hypocalcemia due to hypoparathyroidism for Centene lines of business.

Policy Summary

PayerCentene

PolicyParathyroid Hormone (Natpara) — Clinical/Medical Policy

Policy CodePolicy N/A

Change TypeClarified supply discontinuationcoding update

Effective Date11.16.16

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that Natpara is prescribed by or in consultation with an endocrinologist and that the member failed a 12‑week trial of calcium and active vitamin D with supporting labs.

SourceLink

POLICY UPDATE CHANGES

Noted that Takeda plans to discontinue global manufacturing of Natpara by the end of 2024.

Added HCPCS code C9399 to coding implications.

100 mcg/daymaximum daily dose allowed

7.5 mg/dLminimum serum calcium prior to initiation

8-9 mg/dLtreatment goal (serum calcium)

6 monthsapproval duration

J3590, C9399

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Coverage Criteria for Natpara (parathyroid hormone)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Approval: 1) Diagnosis of hypocalcemia secondary to hypoparathyroidism; 2) Prescribed by or in consultation with an endocrinologist; 3) Natpara prescribed as an adjunct to calcium supplements and active forms of vitamin D unless contraindicated; 4) Age >= 18 years; 5) Recent (within 30 days) serum calcium > 7.5 mg/dL; 6) Recent (within 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 clinically significant adverse events; 8) Prescriber attests that hypocalcemia is not well controlled with calcium and active vitamin D; 9) Dose does not exceed 100 mcg per day.

Items and numbering reflect policy language; documentation must be provided to support each item.

Continuation Therapy — Covered when ALL of the following for continued therapy are met

Covered when ALL of the following for continued therapy are met

Continued Therapy Path: Member meets one of the following: a) Currently receiving medication via the Centene benefit or previously met initial approval criteria; OR b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.

Either condition allows consideration for continuation.

Response to therapy: Member is responding positively as evidenced by a recent (within 90 days) serum calcium within 8-9 mg/dL; if the request is for a dose increase, the new dose must not exceed 100 mcg/day; if recent serum calcium is >9 mg/dL, the Natpara dose is being decreased.

Documentation of labs and dosing adjustments required.

Initial therapy (alternate/duplicate listing) — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial therapy: 1) Diagnosis of hypocalcemia secondary to hypoparathyroidism; 2) Treatment goal to achieve serum calcium in the lower half of the normal range (8–9 mg/dL) and to reduce calcium/vitamin D supplementation; 3) Evidence of failure or inability to maintain control with calcium and vitamin D (examples: swings in calcium, unacceptable calcium-phosphate product, hypercalciuria, nephrolithiasis, or malabsorption); 4) Appropriate dosing plan: initiate Natpara 50 mcg subcutaneously once daily and titrate by 25 mcg every 4 weeks up to a maximum of 100 mcg/day.

Dosing and failure examples follow policy recommendations.

Natpara was not studied in patients with hypoparathyroidism caused by calcium-sensing receptor mutations and therefore use in this population is limited. Additionally, Natpara was not studied in patients with acute post-surgical hypoparathyroidism; these settings are excluded from the evidence base supporting routine use. The product also carries a boxed safety concern (osteosarcoma risk) and is recommended only for patients who cannot be well controlled on calcium supplements and active forms of vitamin D alone.

Operationally, the policy notes that Takeda plans to discontinue global manufacturing of Natpara by the end of 2024. This is an important supply consideration for treatment planning and prior authorization timing but does not by itself change the clinical coverage criteria.

Use of Natpara for non–FDA–approved indications is not authorized under this policy unless the request is supported by sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace, and CP.PMN.53 for Medicaid). Providers must submit the required off‑label justification and supporting evidence for consideration.

Inclusion of HCPCS or other billing codes in this document is informational only and does not guarantee coverage. Requests lacking supportive clinical documentation or failing to meet the clinical criteria in this policy may be denied regardless of coding. Providers should ensure documentation demonstrates the diagnosis, prior therapy, relevant labs, prescriber specialty and dosing/titration plan required by the policy.

Coding References and Clinical Thresholds

HCPCS Codes referencedHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

inv-09: 25-hydroxyvitamin D requirement

25-hydroxyvitamin D requirement>= 50 nmol/L (20 ng/mL)

Timing of testRecent result within the last 30 days required

Action before initiationPrescriber should confirm sufficient 25-hydroxyvitamin D stores prior to starting Natpara

inv-10: Pre-initiation serum calcium threshold

Minimum pre-initiation serum calcium> 7.5 mg/dL

Timing of measurementRecent serum calcium dated within the last 30 days

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Natpara must be prescribed by or in consultation with an endocrinologist and used as an adjunct to calcium supplements and active forms of vitamin D. Requests must demonstrate the member meets all approval criteria (diagnosis, labs, prior therapies, dosing limits).

Prescriber specialty: endocrinologist or documented consultation with an endocrinologist
Natpara used as adjunct to calcium and active vitamin D (unless contraindicated)
Dose limit: does not exceed 100 mcg per day
Recent serum calcium within last 30 days > 7.5 mg/dL
Recent 25-hydroxyvitamin D within last 30 days ≥ 50 nmol/L (20 ng/mL)

Step Therapy

Step Therapy Requirement

A documented trial and inadequate control with calcium supplements and active forms of vitamin D is required prior to approval. The policy requires failure of a 12-week trial at maximally indicated or tolerated doses unless contraindicated or a clinically significant adverse event occurred.

Background on Natpara and Indication

Natpara (parathyroid hormone) is FDA‑indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Due to safety concerns, including a potential osteosarcoma risk, it is reserved for patients whose hypocalcemia cannot be adequately managed with calcium supplements and active forms of vitamin D alone.

Definitions and Examples

inv-22: Natpara indication and boxed warning — FDA indication and boxed warning for potential osteosarcoma risk

FDA indicationNatpara is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism

Boxed warningBoxed warning: potential risk of osteosarcoma

Contraindication notedContraindicated in patients with hypersensitivity to any component of the product

inv-23: Examples of failure of supplementation — swings in calcium, inability to maintain calcium-phosphate product, renal complications examples

Swings in calcium levelsMarked variability or 'swings' in serum calcium despite supplementation

Unacceptable calcium–phosphate product