CurrentCignaPolicy N/A

Yorvipath (palopegteriparatide) prior authorization for hypoparathyroidism

Defines Cigna's prior authorization requirements and medical necessity criteria for coverage of Yorvipath (palopegteriparatide) for adults with chronic hypoparathyroidism, including prescriber specialty and baseline lab requirements.

Policy Summary

PayerCigna

PolicyYorvipath (palopegteriparatide) prior authorization for hypoparathyroidism

Policy CodePolicy N/A

Change TypeMaterial – adds nephrologist to specialist requirement

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document baseline labs (25‑OH vitamin D normal and albumin‑corrected serum calcium ≥7.8 mg/dL or ionized ≥4.4 mg/dL) and specialist prescription/consultation.

SourceLink

POLICY UPDATE CHANGES

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

Annual revision with no criteria changes noted for 09/03/2025.

1 yearinitial approval duration

Adultsindicated population

≥7.8 mg/dLcalcium threshold

Not studiedlimitation of use

Coverage and Medical Necessity Criteria

Policy Summary

PayerCigna

PolicyYorvipath (palopegteriparatide) prior authorization for hypoparathyroidism

Policy CodePolicy N/A

Change TypeMaterial – adds nephrologist to specialist requirement

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Initial and Ongoing Therapy Criteria

Covered when ONE of the following is met

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

A) Initial Therapy

a or b
- a) Albumin-corrected serum calcium: Albumin-corrected serum calcium concentration ≥ 7.8 mg/dL at baseline before initiating Yorvipath therapy.≥ 7.8 mg/dL
  Baseline measurement.
- b) Ionized serum calcium: Ionized serum calcium ≥ 4.4 mg/dL at baseline before initiating Yorvipath therapy.≥ 4.4 mg/dL
  Baseline measurement.

B) Currently Receiving Yorvipath: Patient cannot be well-controlled on calcium supplements and active forms of vitamin D according to the prescriber; patient has sufficient 25-hydroxyvitamin D stores (during Yorvipath therapy) according to the prescriber; patient is responding to Yorvipath therapy according to the prescriber (examples: reduction in oral calcium dose, reduction in active vitamin D dose, and maintenance of a stable albumin-corrected total serum calcium concentration).

All conditions i-iii must be met.

Yorvipath (palopegteriparatide) is considered not medically necessary for acute post-surgical hypoparathyroidism and for any other non-covered uses. This policy follows the product limitations noting Yorvipath was not studied in the acute post‑surgical hypoparathyroidism population, and therefore use in that setting is excluded from coverage.

Use of Yorvipath for acute post-surgical hypoparathyroidism is not medically necessary because the medication was not studied in patients with this condition. Providers should not expect coverage when the indication is acute post‑surgical hypoparathyroidism given the absence of supporting clinical trial data.

Provider Requirements, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for prescription benefit coverage of Yorvipath. Approvals are provided for the duration noted in the policy. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Yorvipath, initial approval requires Yorvipath to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., endocrinologist or nephrologist).

Approve for 1 year when criteria are met
Initial prescriber requirement: endocrinologist or nephrologist

Step Therapy

Step: inadequate control on calcium and active vitamin D

Requirement that the patient cannot be well-controlled on calcium supplements and active forms of vitamin D is part of the coverage criteria for both initial therapy and continuing therapy. The prescriber must document inadequate control on calcium and active vitamin D as part of the prior authorization request.

Initial Therapy and Continuing Therapy both require documentation that patient cannot be well-controlled on calcium supplements and active forms of vitamin D

Documentation Required

Baseline laboratory requirements before initiating Yorvipath

Obtain baseline laboratory tests within 2 weeks before the first Yorvipath dose. Specifically, confirm serum 25-hydroxyvitamin D (25[OH] vitamin D) is within the normal range and that albumin-corrected serum calcium is ≥ 7.8 mg/dL (alternatively, ionized serum calcium ≥ 4.4 mg/dL may be used per prescriber). Document these baseline values in the prior authorization submission.

Baseline labs within 2 weeks before first dose: serum 25(OH) vitamin D within normal range
Baseline albumin-corrected serum calcium ≥ 7.8 mg/dL OR ionized serum calcium ≥ 4.4 mg/dL

Denial Risk

Billing and Coding — Denial Risk

Claims submitted without covered diagnosis/procedure codes or without the appropriate covered codes will be denied per billing guidance. When billing, providers must use the most appropriate codes as of the date of service; services billed for conditions or diagnoses not covered under this policy will be denied.

Claims lacking covered codes or billed for non-covered diagnoses will be denied
Use most appropriate codes effective on date of service

Background and Indication

Yorvipath is a parathyroid hormone (PTH [1-34]) analog indicated for the treatment of hypoparathyroidism in adults. Limitations of use include that Yorvipath has not been studied for acute post‑surgical hypoparathyroidism. The published titration scheme was evaluated only in adults who first achieved an albumin‑corrected serum calcium of at least 7.8 mg/dL while on calcium and active vitamin D. Additionally, baseline laboratory confirmation is required: within 2 weeks before the first dose confirm serum 25‑hydroxyvitamin D is within the normal range and albumin‑corrected serum calcium is ≥ 7.8 mg/dL.

OpenPayer

Yorvipath (palopegteriparatide) prior authorization for hypoparathyroidism

Coverage and Medical Necessity Criteria

Coding and Baseline Lab Requirements

Provider Requirements, Prior Authorization, and Billing

Key Definitions

Background and Indication