CurrentCignaPolicy N/A

Natpara Medical Necessity Criteria

Defines Cigna's prior authorization and medical necessity criteria for Natpara (parathyroid hormone subcutaneous injection) for treatment of chronic hypoparathyroidism, including who may prescribe, required lab thresholds, duration of approval, and non-covered indications.

Policy Summary

PayerCigna

PolicyNatpara Medical Necessity Criteria

Policy CodePolicy N/A

Change TypeClarified / Revised (no material changes)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended for Natpara; ensure specialist involvement (endocrinologist or nephrologist) and document vitamin D/calcium status and required lab thresholds for approval.

POLICY UPDATE CHANGES

A nephrologist was added as a physician type that counts toward the specialist requirement.

Examples of response to Natpara therapy were moved to a Note for the 'Patient is Currently Receiving Natpara' criterion.

Policy history notes multiple annual revisions with 'No criteria changes' including 04/23/2025 review.

1Covered Indications (chronic hypoparathyroidism)

2Not Covered Indications listed

1 yrTypical approval duration

REMSREMS program required

Coverage Summary

Scope: This policy defines Cigna's prior authorization and medical necessity criteria for Natpara (parathyroid hormone subcutaneous injection) for the treatment of chronic hypoparathyroidism. Payer stance: covered_with_criteria. Drug: Natpara (parathyroid hormone). Covered indication: chronic hypoparathyroidism as an adjunct to calcium and vitamin D to control hypocalcemia. Typical approval duration: 1 year for the FDA‑approved chronic hypoparathyroidism indication. REMS requirement: Natpara is available only through a restricted REMS program (certified prescribers and certified pharmacies). Manufacturer discontinuation/availability note: the manufacturer planned to discontinue global manufacturing by the end of 2024 with limited availability thereafter (supply only for select patients until inventory is depleted or expired).

Key thresholds and quick facts

Serum calcium concentration (pre-initiation)> 7.5 mg/dL

Typical approval duration1 year

REMS program requiredREMS

Manufacturer discontinuation plannedManufacturer will discontinue global manufacturing by end of 2024 with limited availability thereafter

Medical Necessity Criteria

FDA-Approved Indication - Chronic Hypoparathyroidism

Approve for 1 year if the patient meets ONE of the following (A or B):

ONE of

A) Initial Therapy
- Patient cannot be well-controlled on calcium supplements and active forms of vitamin D alone
- Patient's 25-hydroxyvitamin D stores are sufficient (before initiating Natpara therapy) according to the prescriber
- Patient's serum calcium concentration is > 7.5 mg/dL before initiating Natpara therapy> 7.5 mg/dL

Provider Actions & Authorization

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Natpara; approvals provided for durations noted (1 year for chronic hypoparathyroidism).

Approval duration = 1 year

Documentation Required

Specialist involvement required for initial approval

Initial approval requires Natpara to be prescribed by or in consultation with a physician who specializes in the condition (endocrinologist or nephrologist).

endocrinologist
nephrologist

Applicable Codes

Drug (Natpara) - HCPCS/J-code not specifiedmixedCovered

No codes listed

Clinical Evidence & Definitions

≥50%Reduction in active vitamin D dose (pivotal responder criterion)

≥50%Reduction in oral calcium supplementation (pivotal responder criterion)

7.5–10.6 mg/dLAlbumin-corrected total serum calcium range (pivotal responder criterion)

Pivotal responder definition: ≥50% reduction from baseline in active vitamin D dose AND ≥50% reduction in oral calcium supplementation AND albumin-corrected total serum calcium between 7.5 mg/dL and 10.6 mg/dL.

REMS/boxed warning note: Natpara has a Boxed Warning for the potential risk of osteosarcoma; parathyroid hormone increased osteosarcoma incidence in rats (dose‑ and duration‑dependent) and a human risk could not be excluded. Natpara is available only through a restricted REMS program, and only certified healthcare providers can prescribe and only certified pharmacies can dispense Natpara.

Definition of REMS: Risk Evaluation and Mitigation Strategy; Natpara is available only through a restricted REMS program with certified prescribers and pharmacies.

Background

Background: Natpara is indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Limitations of use note that Natpara is recommended only for patients who cannot be well-controlled on calcium supplements and active forms of vitamin D alone. In the pivotal study, a responder was defined as an individual with ≥50% reduction from baseline in active vitamin D dose, ≥50% reduction from baseline in oral calcium supplementation, and an albumin-corrected total serum calcium concentration between 7.5 mg/dL and 10.6 mg/dL. Natpara carries a Boxed Warning for the potential risk of osteosarcoma based on animal data. Natpara is available only through a restricted REMS program. Manufacturer statement: Takeda announced it will discontinue global manufacturing of Natpara by the end of 2024 and will not re-commercialize it; after 2024 supply will be limited and provided until inventory is depleted or expired.

Definitions: REMS — Risk Evaluation and Mitigation Strategy; Natpara is available only through a restricted REMS program with certified prescribers and certified pharmacies.

Revision History

10/30/2024clarified

A nephrologist was added as a physician type that counts toward the specialist requirement.

prior to 04/24/2024revised

Examples of response moved to a Note for the "Patient is Currently Receiving Natpara" criterion.

04/23/2025revisedLatest

No clinical policy statement changes at latest review; multiple annual revisions with No criteria changes.