Navepegritide (Yuviwel) — Coverage Criteria for Achondroplasia
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Defines medical necessity and prior authorization requirements for navepegritide (Yuviwel) for pediatric achondroplasia across applicable QualChoice lines of business (Commercial, ICHRA/HIM, Medicaid). Affects providers requesting coverage for initiation and continuation of therapy.
Criteria updated per prescribing information to include weight-based dosing and quantity limits.
Added requirement that Yuviwel is not prescribed concurrently with Voxzogo and any human growth hormone products for continued therapy.
ICHRA (health insurance marketplace/ICHRA) line of business was added.
Coverage Criteria for Yuviwel (navepegritide)
Non‑FDA indications not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient supporting evidence per the applicable off‑label use policies for the member's line of business (see referenced off‑label policies). Requests for uses outside the FDA‑approved indication should be routed through the insurer’s off‑label/formulary review process prior to coverage consideration.
Requests that fail to meet the documented diagnostic, age, radiographic, dosing, or documentation requirements are considered not medically necessary and may be denied. Examples include missing genetic confirmation of an FGFR3 mutation, absence of radiographic evidence of open epiphyses, lack of baseline annualized growth velocity or current weight documentation, or doses exceeding the weight‑based weekly dosing table and vial limits. Therapy that is prescribed concurrently with disallowed agents (any human growth hormone product or Voxzogo) will not meet coverage criteria and may result in denial.
Initial Therapy Criteria and Approval
Continued Therapy Criteria and Renewal
Coding, Age, and Dosing Summary
Quantity and Vial Limits
Provider Actions, Prior Authorization, and Documentation
Prior authorization required — 6‑month approvals
Yuviwel (navepegritide) requires prior authorization. Approvals are issued only when the request meets the applicable Initial or Continued Therapy criteria in this policy; approval duration is 6 months.
Off‑label and formulary routing — follow line‑of‑business policies
If the requested use, diagnosis, age, or dosing is not listed in this policy or the drug recently had a label change, route the request per the applicable formulary/non‑formulary or off‑label use policy for the member's line of business before coverage consideration.
- Refer to formulary/no‑coverage or non‑formulary policies when the drug recently had a label change (see list in policy).
- If the requested use is not listed in section III and criterion above does not apply, follow the off‑label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, or CP.PMN.53).
Required documentation to support approval
Submit supporting clinical documentation with the prior authorization request to show the member meets all criteria. Required items include office chart notes and objective data described in the criteria.
- Office chart notes or clinical progress notes documenting diagnosis and prescribing clinician (pediatric endocrinologist involvement).
- Radiographs showing open epiphyses at initiation and radiographs within 4 months for continuation.
- Genetic testing confirming FGFR3 mutation.
- Baseline annualized growth velocity calculated from standing height over the 6 months prior to request.
- Documentation of current weight in kilograms.
Documentation & concurrent therapy exclusions — denial risks
Requests lacking the required documentation or proposing concurrent use with disallowed agents will be denied. Denial triggers include missing confirmation of diagnosis/FGFR3 mutation, absent radiographs showing open epiphyses, missing baseline growth velocity or current weight, or concurrent prescription of any human growth hormone product or Voxzogo.
- Concurrent therapy exclusion: Yuviwel must not be prescribed concurrently with any human growth hormone products (e.g., Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Zomacton).
- Concurrent therapy exclusion: Yuviwel must not be prescribed concurrently with Voxzogo.
- Missing required documentation as listed (diagnosis confirmation, radiographs, baseline growth velocity, current weight) may result in denial.
Definitions and Diagnostic Criteria
Step Therapy and Formulary Routing
| Step | Rule / Action |
|---|---|
| 1 | If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy (e.g., new indication, age expansion, new dosing), route the request to the appropriate formulary or non‑coverage policy for the member's line of business: for formulary drugs use the no coverage criteria policies (CP.CPA.190 — commercial; HIM.PA.33 — ICHRA/marketplace; CP.PMN.255 — Medicaid); for non‑formulary drugs use the non‑formulary policies (CP.CPA.190 — commercial; HIM.PA.103 — ICHRA/marketplace; CP.PMN.16 — Medicaid). |
| 2 | If the requested use (diagnosis, age, dosing regimen) is not listed in Section III and criterion 1 does not apply, refer the request to the off‑label use policy for the member's line of business (CP.CPA.09 — commercial; HIM.PA.154 — ICHRA/marketplace; CP.PMN.53 — Medicaid) before considering coverage. |
Site of Care
No site‑of‑care restriction stated
The policy does not impose a site‑of‑care restriction; administration setting is not limited by this policy.
Background
Navepegritide (brand name Yuviwel) is a C‑type natriuretic peptide (CNP) prodrug indicated to increase linear growth in pediatric patients with achondroplasia. The policy supports its use in children with genetically confirmed achondroplasia (FGFR3 mutation) who have open epiphyses. Initiation and continued therapy require documentation of age, radiographic open growth plates, baseline and on‑therapy annualized growth velocity, and current weight, with dosing constrained to the weight‑based weekly dosing table and the policy’s vial limits.
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