CurrentCentenePolicy CP.PHAR.80

Vandetanib (Caprelsa) (PDF)

Policy governing medical necessity, prior authorization criteria, dosing limits, contraindications, and approval durations for vandetanib (Caprelsa) across Commercial, HIM, and Medicaid lines of business for treatment of medullary thyroid carcinoma and specified differentiated thyroid carcinoma uses.

Policy Summary

PayerCentene

PolicyVandetanib (Caprelsa) (PDF)

Policy CodePolicy CP.PHAR.80

Change TypeRevised (1Q 2026 annual review)

Effective DateOct 1, 2011

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets all approval criteria; prior authorization may be required for Lenvima or Nexavar as noted.

SourceLink

POLICY UPDATE CHANGES

1Q 2026 annual review: for DTC, added disease qualifiers of progressive and/or symptomatic, removed requirement for radioactive iodine therapy for oncocytic carcinoma, and revised status from 'not amenable' to 'refractory' per NCCN; added request does not exceed health plan-approved quantity limit; extended initial approval duration for Medicaid/HIM from 6 to 12 months.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

Clarified DTC be recurrent, advanced, or metastatic per NCCN and clarified 'must use' generic redirection language; removed lung cancer indication.

Extended/adjusted legacy approval durations and template changes applied to other diagnoses/indications in 2022-2024 reviews.

1FDA-approved indication (MTC)

1Off-label covered tumor type (DTC) with restrictions

18+Required minimum age

Coverage Summary

Policy subject: Vandetanib (Caprelsa). Coverage stance: covered_with_criteria. Scope: medical necessity, prior authorization criteria, dosing limits, contraindications, and approval durations for vandetanib across Commercial, HIM, and Medicaid lines of business for treatment of medullary thyroid carcinoma (MTC) and specified differentiated thyroid carcinoma (DTC) uses. Status: CURRENT.

Policy-level thresholds

Maximum daily dose300 mg/day

Minimum age≥ 18 years

Minimum prior exposure for continuation≥ 30 days

Product strengthsTablets: 100 mg, 300 mg

Prescriber requirementPrescribed by or in consultation with an oncologist

Initial Therapy Criteria

I. Initial Approval Criteria - A. Thyroid Cancer (must meet all)

Covered when ALL of the following are met:

ALL of the following

ONE of
- Recurrent, persistent, unresectable, or metastatic medullary thyroid carcinoma (MTC)
- Recurrent, persistent, unresectable, or metastatic differentiated thyroid carcinoma (DTC) (i.e., follicular, oncocytic carcinoma [Hurthle cell], or papillary thyroid carcinoma) (off-label)
Prescribed by or in consultation with an oncologist
Age ≥ 18 years≥ 18 years

Continuation / Renewal Criteria

II. Continuation/Renewal Criteria - A. Thyroid Cancer (must meet all)

Renewal covered when ALL of the following are met:

ALL of the following

Member is currently receiving medication via Centene benefit, or documentation supports that member has received Caprelsa for a covered indication for at least 30 days≥ 30 days
Member is responding positively to therapy
Member must use generic vandetanib, if available, unless contraindicated or clinically significant adverse effects are experienced
Request does not exceed health plan-approved quantity limit, if applicable

Other Indications & Exclusions

III. Other diagnoses/indications

If not listed above, must meet one of the following:

ANY of the following

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

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IV. Diagnoses/Indications NOT authorized

Applicable Codes & Product Availability

Product Availability / Dosage strengthsmixed

N/A	Tablets: 100 mg, 300 mg

Provider Actions & Billing

Prior Authorization

Prior authorization and documentation required

Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria. Prior authorization may be required for Lenvima (lenvatinib) or Nexavar (sorafenib) as noted.

Documentation Required

Prescriber specialty and evidence for off-label use

Caprelsa must be prescribed by or in consultation with an oncologist. For off-label use in differentiated thyroid carcinoma (DTC) when dosing or use is outside the FDA-approved regimen, the prescriber must submit supporting evidence from practice guidelines or peer‑reviewed literature.

Clinical Evidence & Guidelines

Primary evidence references: Caprelsa Prescribing Information; May 2025 and NCCN Thyroid Cancer Version 1.2025. Background: The FDA approves Caprelsa for symptomatic or progressive medullary thyroid cancer (MTC) that is unresectable locally advanced or metastatic, and NCCN guidance supports specific off‑label use criteria for differentiated thyroid carcinoma (DTC) that are incorporated into this policy.

Background

Vandetanib (Caprelsa) is an FDA‑approved kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer (MTC) that is unresectable locally advanced or metastatic. Use in indolent, asymptomatic, or slowly progressive disease should be carefully considered because of treatment‑related risks. This policy also includes off‑label coverage criteria for specified differentiated thyroid carcinoma (DTC) (follicular, oncocytic [Hurthle cell], and papillary) per NCCN guidance when the listed criteria (e.g., progression/symptoms, prior therapies) are met. Definitions: MTC = medullary thyroid carcinoma; DTC = differentiated thyroid carcinoma (follicular, oncocytic [Hurthle cell], papillary).

Revision History

02.26.2026revisedLatest

1Q 2026 annual review: For DTC, added disease qualifiers of progressive and/or symptomatic; removed requirement for radioactive iodine therapy for oncocytic carcinoma; revised DTC status language to 'refractory' per NCCN; added requirement that request does not exceed health plan‑approved quantity limit; extended initial approval duration for Medicaid/HIM from 6 to 12 months; references reviewed and updated. Highlighted as material.

05.22 (P&T Approval)revised

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less (material revision from Jan–May 2022 updates).

02.22 (P&T Approval)

Policy Summary

PayerCentene

PolicyVandetanib (Caprelsa) (PDF)

Policy CodePolicy CP.PHAR.80

Change TypeRevised (1Q 2026 annual review)

Effective DateOct 1, 2011

Next Review Date

Key ActionProvider must submit documentation supporting that the member meets all approval criteria; prior authorization may be required for Lenvima or Nexavar as noted.

SourceLink

On This Page

For follicular and papillary thyroid carcinoma: Disease is refractory to radioactive iodine therapy

For DTC

Disease is progressive and/or symptomatic
Failure of Lenvima (lenvatinib) or Nexavar (sorafenib), unless clinically significant adverse effects are experienced or both are contraindicated
Prior authorization may be required for Lenvima or Nexavar

Member must use generic vandetanib, if available, unless contraindicated or clinically significant adverse effects are experienced

Request does not exceed health plan-approved quantity limit, if applicable

Dose requirement

Dose does not exceed 300 mg per day≤ 300 mg/day
Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Dose increase

New dose does not exceed 300 mg per day≤ 300 mg/day
New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Coverage not authorized when:

Non-FDA approved indications not addressed in this policy unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents

Billing Rule

Quantity limit compliance

Requests must not exceed the health plan‑approved quantity limit, if applicable.

Denial Risk

Non-covered indications

Claims for non‑FDA approved indications that are not addressed in this policy may be denied unless there is sufficient documentation of efficacy and safety per the off‑label use policies or evidence of coverage documents.

1Q 2022 annual review: Clarified DTC be recurrent, advanced, or metastatic per NCCN; removed lung cancer indication; clarified oral oncology generic redirection language to 'must use' (material).

2022-2024 (multiple dates)revised

Template and administrative updates: extended/adjusted legacy approval durations and applied template changes to other diagnoses/indications; references reviewed and updated (non-material/administrative).