CurrentUnitedHealthcarePolicy 2024 P 2358-1

Yorvipath (palopegteriparatide) prior authorization / medical necessity

UnitedHealthcare prior authorization and medical necessity criteria for Yorvipath (palopegteriparatide) for treatment of hypoparathyroidism in adults, including initial authorization, reauthorization, prescribing provider requirements, and program rules. Effective date governs utilization management for commercial pharmacy benefit.

Policy Summary

PayerUnitedHealthcare

PolicyYorvipath (palopegteriparatide) prior authorization / medical necessity

Policy CodePolicy 2024 P 2358-1

Change TypeNew prior authorization program

Effective DateMar 1, 2025

Next Review Date

Key ActionPrior authorization is required and will be approved only if all initial authorization criteria are met; authorization will be issued for 12 months.

POLICY UPDATE CHANGES

New prior authorization program created for Yorvipath (palopegteriparatide) with P&T approval dated 12/2024 and effective date 3/1/2025.

12 monthsAuthorization duration

Adults onlyCovered population

2Required pretreatment lab confirmations

Coverage Summary

Coverage stance: covered_with_criteria for Yorvipath (palopegteriparatide) prior authorization and medical necessity per policy number 2024 P 2358-1. Scope: UnitedHealthcare prior authorization and medical necessity criteria for treatment of hypoparathyroidism in adults under the commercial pharmacy benefit; effective date 2025-03-01.

Key clinical thresholds

Pretreatment albumin-corrected serum calcium< 8.5 mg/dL on ≥2 occasions separated by ≥2 weeks

Pretreatment intact PTH< 20 pg/mL on ≥2 occasions (2nd- or 3rd-generation immunoassay)

Required albumin-corrected serum calcium (on therapy / titration starting point)7.8-10.6 mg/dL

Serum 25(OH) vitamin D20-80 ng/mL

Calcium requirement for independence from conventional therapy< 600 mg/day supplemental calcium (and no active vitamin D)

Target albumin-corrected serum calcium for reauthorizationApproximately 8.3-10.6 mg/dL

Provider Actions & Program Rules

Prior Authorization

Prior authorization required

Prior authorization is required and will be approved only if all initial authorization criteria are met. Approvals issued under this program are valid for 12 months.

Documentation Required

Documentation of diagnostic labs

Document pretreatment diagnostic labs: albumin-corrected serum calcium and intact parathyroid hormone (PTH). Each value must be documented on at least two occasions separated by at least 2 weeks. Also provide evidence of current supplemental calcium and active vitamin D therapy and include the relevant lab ranges.

Documentation Required

Prescriber specialty requirement

Prescriptions for initial authorization and for reauthorization must be written by an endocrinologist or a nephrologist.

Prior Authorization

Reauthorization documentation

For reauthorization provide documentation of a positive clinical response, for example an albumin-corrected serum calcium in the normal range (approximately 8.3–10.6 mg/dL) or independence from conventional therapy (no active vitamin D and < 600 mg/day of supplemental calcium).

Billing Rule

Authorization duration

Approved authorizations are valid for 12 months.

Denial Risk

Not indicated for acute post-surgical hypoparathyroidism

Yorvipath was not studied for acute post-surgical hypoparathyroidism; use in that setting is outside the supporting studies and may be denied.

Clinical Evidence & References

Evidence summary: P&T approval date 12/2024 and program recorded as a new prior authorization program.

Key trials and sources cited include the Phase 2 placebo-controlled TransCon PTH trial (J Clin Endocrinol Metab. 2022) and the Phase 3 PaTHway trial (J Bone Miner Res. 2023), and the product package insert (Ascendis Pharma, August 2024).

12/2024P&T approval date

PaTHway P2 & P3Key trials cited (Phase 2 and Phase 3 PaTHway)

Aug 2024Package insert (Ascendis Pharma)

Background

Background: Yorvipath is a parathyroid hormone analog (PTH(1-34)) indicated for the treatment of hypoparathyroidism in adults. Conventional therapy consists of active vitamin D (e.g., calcitriol or alfacalcidol) and calcium supplementation.

Limitations: Yorvipath was not studied for acute post-surgical hypoparathyroidism. The titration scheme was evaluated only in adults who first achieved an albumin-corrected serum calcium of at least 7.8 mg/dL using calcium and active vitamin D therapy.

Definitions:

• Albumin-corrected serum calcium: Serum calcium adjusted for albumin concentration; policy specifies numeric thresholds for eligibility and reauthorization.

• Independence from conventional therapy: No active vitamin D required and 600 mg/day of supplemental calcium (policy defines independence as requiring no active vitamin D and < 600 mg/day of calcium).

Policy Summary

PayerUnitedHealthcare

PolicyYorvipath (palopegteriparatide) prior authorization / medical necessity

Policy CodePolicy 2024 P 2358-1

Change TypeNew prior authorization program

Effective DateMar 1, 2025

Next Review Date

Key ActionPrior authorization is required and will be approved only if all initial authorization criteria are met; authorization will be issued for 12 months.

On This Page

OpenPayer

Yorvipath (palopegteriparatide) prior authorization / medical necessity

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Provider Actions & Program Rules

Applicable Codes

Clinical Evidence & References

Background

Revision History