CurrentmhnPolicy CP.PHAR.80

Vandetanib (Caprelsa)

Defines medical necessity criteria, approvals, dosing limits, and documentation requirements for vandetanib (Caprelsa) for commercial, HIM, and Medicaid lines of business including initial and continuation criteria for medullary and differentiated thyroid carcinoma and programmatic billing/authorization notes.

Policy Summary

Payermhn

PolicyVandetanib (Caprelsa)

Policy CodePolicy CP.PHAR.80

Change TypeRevised/Clarified (annual reviews 2022-2026)

Effective DateOct 1, 2011

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria.

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; added persistent disease as a covered tumor type in 1Q2023.

Clarified generic redirection language to 'must use' for oral oncology agents.

References and nomenclature updated (e.g., 'Hurthle cell' to 'oncocytic carcinoma') and routine reference updates in annual reviews 2022-2025.

2Covered tumor types (MTC, DTC)

300 mg/dayMaximum daily dose

12 monthsTypical approval duration

≥18Minimum age (years)

Coverage Summary & Scope

coverage_stance: covered_with_criteria; scope_summary: Defines medical necessity criteria, approvals, dosing limits, and documentation requirements for vandetanib (Caprelsa) for Commercial, HIM, and Medicaid lines of business including initial and continuation criteria for medullary and differentiated thyroid carcinoma and programmatic billing/authorization notes.; status: CURRENT; subject: Vandetanib (Caprelsa); effective date: 2011-10-01; last_review date: 2026-02-26.

Key thresholds & quick facts

Maximum daily dose≤ 300 mg/day

Age requirement≥ 18 years

Minimum prior use for continuation≥ 30 days (documented current use)

Typical approval duration12 months (Medicaid/HIM; Commercial: 12 months or duration of request, whichever is less)

Covered tumor typesMedullary thyroid carcinoma (MTC); Differentiated thyroid carcinoma (DTC) — follicular, oncocytic (Hurthle cell), papillary

Initial Therapy Criteria

I. Initial Approval Criteria - A. Thyroid Cancer

Must meet all:

ALL of the following

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

Continuation / Renewal Criteria

II. Continuation/Criteria for Renewal - A. Thyroid Cancer

Must meet all:

ALL of the following

Currently receiving medication via Centene benefit, or documentation supports member has received Caprelsa for a covered indication for at least 30 days
Minimum prior use for continuation: ≥ 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

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Caprelsa (vandetanib) is subject to prior authorization per Centene policies. Prior authorization may also be required for Lenvima (lenvatinib) or Nexavar (sorafenib) when those agents are part of the DTC failure criteria.

Refer to off-label use policies as applicable: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), CP.PMN.53 (Medicaid).
Prior authorization may be required for Lenvima or Nexavar when used in DTC failure criteria (see therapeutic alternatives and notes).

Documentation Required

Submit supporting documentation

Submit supporting documentation demonstrating the member meets all approval criteria. Provide office chart notes, laboratory results, or other clinical information to substantiate the diagnosis, treatment history, and clinical status.

Product Availability & Codes

Product Availability (NDC not specified in policy)mixed

Tablet strengths

100 mg, 300 mg tablets (product availability)

Clinical Evidence & Regulatory Status

FDA approved indication: Caprelsa is indicated for the treatment of symptomatic or progressive medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease (Prescribing Information).

References: Caprelsa Prescribing Information May 2025; NCCN Thyroid Cancer guidelines and Drugs & Biologics Compendium.

Background

Background: Vandetanib (Caprelsa) is an FDA-approved kinase inhibitor indicated for symptomatic or progressive medullary thyroid cancer (MTC) in unresectable locally advanced or metastatic disease. Use in indolent, asymptomatic, or slowly progressing disease should only occur after careful consideration of treatment-related risks. The labeled maximum dose for MTC is 300 mg per day. Important safety considerations include contraindication in congenital long QT syndrome and boxed warnings for QT prolongation, torsades de pointes, and sudden death.

Definitions

MTCMedullary thyroid carcinoma

DTCDifferentiated thyroid carcinoma

Revision History & Policy Changes

02.26 (P&T); effective updates dated 10.23.25material_changeLatest

1Q 2026 annual review: For differentiated thyroid carcinoma (DTC) added disease qualifiers of progressive and/or symptomatic; removed requirement for radioactive iodine therapy for oncocytic carcinoma (Hurthle cell) and revised status wording per NCCN (not amenable → refractory); added request must not exceed health plan‑approved quantity limit if applicable; extended initial approval duration for Medicaid/HIM from 6 to 12 months.

01.20.22 (recorded) / 05.22 (P&T approval)material_change

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less (change recorded 01.20.22; P&T approval recorded 05.22).

Policy Summary

Payermhn

PolicyVandetanib (Caprelsa)

Policy CodePolicy CP.PHAR.80

Change TypeRevised/Clarified (annual reviews 2022-2026)

Effective DateOct 1, 2011

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria.

SourceLink

On This Page

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

Applies specifically to follicular and papillary histologies

For DTC must meet both: disease is progressive and/or symptomatic; failure of lenvatinib (Lenvima) or sorafenib (Nexavar) unless clinically significant adverse effects or contraindications

Failure of Lenvima or Nexavar unless adverse effects/contraindicated

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 OR dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence); prescribed regimen must be FDA-approved or recommended by NCCN<= 300 mg/day

Prescribed regimen must be FDA-approved or recommended by NCCN

I. Initial Approval Criteria - B. Other diagnoses/indications

If requested use not addressed or recent label change:

ANY of the following

If the drug has undergone a label change within the last 6 months not yet reflected in this policy, follow the formulary/no-coverage or non-formulary policy depending on formulary status (see referenced policies)
References CP.CPA.190, HIM.PA.33, CP.PMN.255 for no-coverage; CP.CPA.190, HIM.PA.103, CP.PMN.16 for non-formulary
If the requested use is NOT specifically listed under section III and the recent-label-change pathway does not apply, refer to the off-label use policy for the relevant line of business
References CP.CPA.09, HIM.PA.154, CP.PMN.53

Dose increase requirement: If request is for a dose increase, new dose does not exceed 300 mg per day OR new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)<= 300 mg/day

Prescribed regimen must be FDA-approved or recommended by NCCN

III. Diagnoses/Indications Not Authorized

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

Refer to off-label policies: CP.CPA.09, HIM.PA.154, CP.PMN.53

ref':

Office notes documenting diagnosis and clinical status
Relevant laboratory or imaging results
Documentation of prior tyrosine kinase inhibitor (TKI) failure (e.g., Lenvima or Nexavar) or documentation of contraindication/intolerability to those agents

Billing Rule

Quantity limit adherence

The requested quantity must not exceed the health plan-approved quantity limit. Requests should adhere to any plan-specific quantity limits in place.

Plan-specific quantity limits apply; verify the health plan's approved quantity limit prior to submission.

Documentation Required

Off-label evidence submission

For off-label use in differentiated thyroid carcinoma (DTC) or for doses exceeding standard limits, the prescriber must submit supporting evidence. Provide practice guideline recommendations or peer-reviewed literature that support the regimen and dose; prescribed regimens must be FDA‑approved or recommended by NCCN.

Citations from practice guidelines (e.g., NCCN) or peer-reviewed literature supporting the off-label indication or higher dose
Statement that the prescribed regimen is FDA‑approved or recommended by NCCN

1Q 2023 (02.23 P&T recorded; Date = 11.22.22)

Added persistent disease as a covered tumor type for DTC and clarified coverage for DTC is only when unamenable/refractory to radioactive iodine therapy (per NCCN); legacy Wellcare approval durations consolidated (historical note).

1Q 2022 annual review (P&T 02.22)material_change

Template and nomenclature updates including clarifying DTC be recurrent, advanced, or metastatic per NCCN and clarified oral oncology generic redirection language to 'must use'.

2022-2025 (annual reviews)non_material_update

Multiple non-clinical/template updates and routine reference/nomenclature updates (e.g., 'Hurthle cell' to 'oncocytic carcinoma'); described as 'no significant changes' across annual reviews.