CurrentmhnPolicy CP.PHAR.696

YORVIPATH (PDF)

Clinical policy governing medical necessity criteria, prior authorization requirements, dosing limits, continued therapy criteria, exclusions, and billing coding implications for palopegteriparatide (Yorvipath) across Commercial, HIM (health insurance marketplace), and Medicaid lines of business.

Policy Summary

Payermhn

PolicyYORVIPATH (PDF)

Policy CodePolicy CP.PHAR.696

Change TypeStep therapy bypass; approval duration extended; references updated

Effective DateDec 1, 2024

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria; labs must be dated within 30 days for calcium and 25(OH)D.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395

Extended continued approval duration from 6 to 12 months for Medicaid and HIM

References reviewed and updated

1Covered Indication (FDA-approved)

2Approval Durations (Medicaid/HIM vs Commercial)

30 mcg/dayMaximum Daily Dose

2 pens/28 daysMaximum Dispensed Quantity

Coverage Summary

Covered with criteria for the FDA-approved indication of hypoparathyroidism in adults; policy governs medical necessity, prior authorization, dosing limits, continuation criteria, and approval durations across Commercial, HIM, and Medicaid.

Approval Duration - Initial

Medicaid/HIM approval duration = 6 months

Commercial approval duration = 6 months or to the member's renewal date, whichever is longer

Continuation Therapy Criteria

Approval Duration - Continued Therapy

Medicaid/HIM approval duration = 12 months

Commercial approval duration = 6 months or to the member's renewal date, whichever is longer

Unproven / Exclusions

Other Diagnoses/Label Changes

If request does not meet above or recent label change:

If drug has recently (within the last 6 months) undergone a label change not reflected in this policy, follow formulary/no-coverage or non-formulary policies depending on formulary status (references: CP.CPA.190; HIM.PA.33; CP.PMN.255; HIM.PA.103; CP.PMN.16)

If requested use is not specifically listed under section III and criterion 1 above does not apply, refer to off-label use policy for relevant line of business (CP.CPA.09; HIM.PA.154; CP.PMN.53)

Diagnoses/Indications Not Authorized

Not covered unless off-label policy or evidence supports:

Non-FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09; HIM.PA.154; CP.PMN.53) or evidence of coverage documents

Applicable Codes

HCPCS codes (informational)HCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for requests for Yorvipath. The prior authorization must demonstrate that all clinical criteria are met and must include the prescriber specialty (prescribed by or in consultation with an endocrinologist) and documentation of a prior trial of calcium supplements plus an active form of vitamin D (e.g., calcitriol).

Documentation Required

Submit supporting documentation

Submit supporting documentation with the request, such as office chart notes, lab results, or other clinical information. Recent lab results for albumin-corrected serum calcium and serum 25-hydroxyvitamin D (25[OH]D) must be dated within the last 30 days. Examples of acceptable documentation include clinic notes detailing diagnosis and prescriber specialty, laboratory reports showing albumin-corrected serum calcium ≥ 7.8 mg/dL at initiation and 25(OH)D within the laboratory-defined normal range (e.g., 30–100 ng/mL), and prior treatment records documenting trials of calcium and active vitamin D.

Clinical Evidence & References

Key trials referenced: PaTHway phase 3 trials showing efficacy and safety (refs: PaTHway, 2023; 2024).

Prescribing information: Yorvipath Prescribing Information, August 2024.

Key thresholds

Albumin-corrected serum calcium (initiation minimum)≥ 7.8 mg/dL

Albumin-corrected serum calcium (target for response)8.3 to 10.6 mg/dL

Serum 25-hydroxyvitamin D (25(OH)D) targetWithin laboratory defined normal range (e.g., 30–100 ng/mL, 75–250 nmol/L)

Trial duration of calcium + active vitamin D prior to approval12 weeks at up to maximally indicated doses

Maximum dose30 mcg/day

Background

Palopegteriparatide (Yorvipath) is a parathyroid hormone analog and is FDA-approved for the treatment of hypoparathyroidism in adults.

Initiation and titration recommendations align with the prescribing information: confirm 25-hydroxyvitamin D stores are within the normal range and serum calcium is ≥ 7.8 mg/dL before starting; typical starting dose is 18 mcg SC once daily with titration in 3 mcg increments/decrements aiming to maintain serum calcium in the normal range without the need for active vitamin D or therapeutic calcium (> 600 mg/day); maximum dose is 30 mcg/day.

Revision History

2026-01-01policy change (added)Latest

Step therapy requirements do not apply for Illinois HIM requests per IL HB 5395 (added step therapy bypass for IL HIM).

2024-07-17policy change (revised)Latest

Continued therapy approval duration for Medicaid and HIM increased from 6 months to 12 months (extended continued approval duration to 12 months for Medicaid and HIM).

2024-08 / 2025-07-17references updated (revised)

Policy Summary

Payermhn

PolicyYORVIPATH (PDF)

Policy CodePolicy CP.PHAR.696

Change TypeStep therapy bypass; approval duration extended; references updated

Effective DateDec 1, 2024

Next Review Date

SourceLink

On This Page

Office chart notes
Laboratory reports dated within 30 days for albumin-corrected serum calcium and 25(OH)D
Prior treatment records showing trial of calcium + active vitamin D

Step Therapy

Step therapy requirement (12-week trial)

A 12-week trial of calcium supplements and active vitamin D at up to maximally indicated doses is required prior to approval unless contraindicated or clinically significant adverse events occur. Note the material change for Illinois HIM: step therapy requirements do not apply for Illinois HIM requests as of 2026-01-01 per IL HB 5395.

Documentation Required

Dose limit documentation for dose increase requests

For requests that would increase dose, document that the new dose does not exceed the maximums: 30 mcg per day (single injection) and no more than 2 pens per 28 days. Include clinical justification and supporting records when requesting a dose increase.

Maximum dose: ≤ 30 mcg/day (single injection)
Maximum dispensed quantity: ≤ 2 pens per 28 days
Provide clinical justification and supporting documentation for dose increase

Billing Rule

Use appropriate HCPCS for unclassified biologic/drug

When submitting claims, providers may use unclassified HCPCS codes J3590 or C9399 for informational purposes; inclusion of these codes does not guarantee coverage. Follow up-to-date coding guidance and recognize that use of these codes is informational only.

J3590 — Unclassified biologics
C9399 — Unclassified drugs or biologicals
Informational use does not guarantee coverage

Maximum quantity dispensed

≤ 2 pens per 28 days

Elemental calcium threshold (independence definition)≤ 600 mg/day

References reviewed and updated, including Yorvipath Prescribing Information and PaTHway trial publications; references list updated in policy.