Palopegteriparatide (Yorvipath) (PDF)

Coverage Summary

Coverage stance: covered_with_criteria for Palopegteriparatide (Yorvipath) for hypoparathyroidism. Scope: defines medical necessity criteria, prior authorization requirements, dosing limits, approval durations, and exclusions for treatment of hypoparathyroidism in adults across Commercial, HIM, and Medicaid lines of business. Status: CURRENT. Effective date: 2024-12-01. Last review: 2024-11-25.

Initial Therapy - Hypoparathyroidism (must meet all)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of hypoparathyroidism
Prescribed by or in consultation with an endocrinologist
Age ≥ 18 years
At therapy initiation, Yorvipath is prescribed as an adjunct to calcium supplements and active forms of vitamin D (e.g., calcitriol), unless contraindicated or clinically significant adverse effects are experienced
Recent (dated within the last 30 days) albumin-corrected serum calcium level is ≥ 7.8 mg/dL>= 7.8 mg/dL
Must be dated within the last 30 days
Recent (dated within the last 30 days) serum 25-hydroxyvitamin D (25(OH)D) is within the laboratory defined normal range (e.g., 30-100 ng/mL, 75-250 nmol/L)Within laboratory defined normal range
Must be dated within the last 30 days
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 experienced12 weeks
Prescriber must indicate that hypocalcemia is not well controlled with calcium supplements and active forms of vitamin D; examples in Appendix B; for Illinois HIM requests the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395
Dose limits (both required)
- Dose does not exceed 30 mcg per day, administered as a single injection<= 30 mcg/day
- Dose does not exceed 2 pens per 28 days<= 2 pens/28 days

Continuation Therapy / Renewal - Hypoparathyroidism (must meet all)

Continued coverage when ALL of the following are met:

ALL of the following

ALL of the following
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- 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)
ALL of the following
- Albumin-corrected serum calcium in the normal range (e.g., 8.3 to 10.6 mg/dL)8.3-10.6 mg/dL

Other diagnoses/indications

When the requested use is not for FDA-approved hypoparathyroidism or policy is outdated due to recent label change:

ANY of the following

If drug had a recent label change within last 6 months not reflected in this policy, refer to formulary/no coverage/non-formulary policies per line of business (lists CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable)
If requested use is not listed under section III and criterion 1 above does not apply, refer to off-label use policy per line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Diagnoses/Indications Not Authorized

Coverage is NOT authorized for:

Non-FDA approved indications not addressed in this policy unless sufficient documentation of efficacy and safety is provided per off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53)

Applicable Codes

HCPCS / billing codes referencedHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Note: Inclusion of the unclassified HCPCS codes (e.g., J3590, C9399) is informational only and does not guarantee coverage; providers should follow current coding guidance and submit required documentation to support medical necessity.

Prior Authorization & Provider Requirements

Prior Authorization

Prior authorization required with criteria

Yorvipath requires prior authorization and is considered medically necessary only when the policy criteria are met. The prescriber must document prior failure of a 12-week trial of calcium supplements and active forms of vitamin D (e.g., calcitriol) at up to maximally indicated doses, or document a contraindication or clinically significant adverse events that preclude such therapy.

Documentation Required

Submit supporting documentation

Provider must submit supporting documentation such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria. For initiation criteria, recent labs must be dated within the last 30 days.

Recent labs for initiation must be dated within 30 days

Key Clinical Thresholds & Limits

Key thresholds

Albumin-corrected serum calcium (initiation)>= 7.8 mg/dL

Serum 25-hydroxyvitamin DWithin laboratory defined normal range (e.g., 30-100 ng/mL)

Albumin-corrected serum calcium (continuation goal)8.3 to 10.6 mg/dL

Elemental calcium while off conventional therapy<= 600 mg/day

Maximum daily dose<= 30 mcg/day

Maximum supply per 28 days<= 2 pens per 28 days

Clinical Evidence & Background

Background: Palopegteriparatide (Yorvipath) is a parathyroid hormone analog FDA-approved for the treatment of hypoparathyroidism in adults. Limitations: it has not been studied for acute post-surgical hypoparathyroidism, and the titration scheme was evaluated only in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL following calcium and active vitamin D therapy. Prescribers should follow the product labeling and prescribing information for dosing, monitoring, and administration details.

Evidence: Yorvipath Prescribing Information, Aug 2024; Phase 3 PaTHway trial results published 2023–2024 support efficacy and improvement in renal function.

Definitions:

Adjunct to calcium and active vitamin D — Yorvipath should be started while the patient remains on calcium supplements and active vitamin D unless contraindicated.

Independence from conventional therapy — no active vitamin D and elemental calcium supplementation ≤ 600 mg/day.

Policy Revision History

2026-01-01material_changeLatest

Added step therapy bypass for Illinois HIM per IL HB 5395; step therapy requirements do not apply for Illinois HIM requests as of 1/1/2026.

2025-07-17references_reviewed

References reviewed and updated.

2024-11-25material_change

Continued approval duration revised: Medicaid and HIM continued approval increased to 12 months (Commercial remains 6 months or to member renewal date).