CurrentCignaPolicy N/A

Oncology - Cometriq Prior Authorization Policy

Prior authorization policy for prescription benefit coverage of Cometriq (cabozantinib capsules) across Cigna-administered health benefit plans, defining FDA-approved and other supported indications, approval durations, and not medically necessary indications.

Policy Summary

PayerCigna

PolicyOncology - Cometriq Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revision (terminology clarified; prior requirements retained)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended for Cometriq; follow the listed criteria and requested documentation for approvals (typically granted for 1 year).

POLICY UPDATE CHANGES

Changed naming of Hürthle cell carcinoma to 'oncocytic carcinoma (formerly Hürthle cell carcinoma)' in differentiated thyroid carcinoma examples.

Non-Small Cell Lung Cancer: requirement that patient has recurrent, advanced, or metastatic disease and progressed on Gavreto or Retevmo was added previously (noted in history).

2FDA-approved indications covered

2Other supported indications listed

1Not medically necessary indications

Coverage Summary & Stance

Scope: Prior authorization policy for prescription benefit coverage of Cometriq (cabozantinib capsules) across Cigna-administered health benefit plans, defining FDA-approved and other supported indications, approval durations, and not medically necessary indications. Coverage stance: covered_with_criteria. Covered indications include the FDA-approved use for progressive, metastatic medullary thyroid carcinoma in adults (approve for 1 year for patients ≥ 18 years) and other supported uses with specified criteria: non-small cell lung cancer with RET gene rearrangement after progression on first-line RET inhibitors (approve for 1 year for patients ≥ 18 years) and differentiated thyroid carcinoma refractory to radioactive iodine in patients ≥ 12 years who have tried lenvatinib or sorafenib (approve for 1 year). Cometriq is considered not medically necessary for other uses including metastatic castration-resistant prostate cancer (mCRPC) based on negative COMET-1 results.

Not Medically Necessary / Exclusions

Not Medically Necessary

Cometriq is considered not medically necessary for ANY other use(s) including:

ANY of the following

Metastatic Castration-Resistant Prostate Cancer (mCRPC) based on COMET-1 results failing to meet primary endpoint (no statistically significant overall survival benefit)

The COMET-1 Phase III trial in men with metastatic castration-resistant prostate cancer showed that cabozantinib did not meet the primary endpoint of a statistically significant overall survival benefit versus prednisone (median OS 11.0 vs 9.8 months), and therefore Cometriq is considered not medically necessary for mCRPC.

Prior Authorization, Documentation & Billing Impact

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Cometriq; approvals are provided for the durations specified (typically 1 year).

Documentation Required

Document clinical criteria

For non‑FDA‑supported indications (e.g., NSCLC, differentiated thyroid carcinoma), document tumor genotype (for example, RET rearrangement), prior therapies (for example, progression on Gavreto or Retevmo; prior lenvatinib or sorafenib), and radioactive iodine refractory status where applicable.

Tumor genotype (e.g., RET rearrangement)
Prior therapies (e.g., progression on Gavreto or Retevmo; prior lenvatinib or sorafenib)
Radioactive iodine refractory status (for differentiated thyroid carcinoma)

Denial Risk

Not covered indications risk

Claims for Cometriq for indications not meeting the listed criteria (including metastatic castration‑resistant prostate cancer) are considered not medically necessary and may be denied based on available evidence (COMET‑1 failed to meet its primary OS endpoint).

Evidence & References

Evidence summary: The FDA prescribing information for Cometriq (Exelixis; August 2023) documents the indication for progressive, metastatic medullary thyroid cancer. NCCN guidelines reference cabozantinib for certain thyroid carcinoma subtypes and as a subsequent RET-directed therapy option in NSCLC after progression on first-line RET inhibitors. The COMET-1 trial demonstrated cabozantinib did not achieve a statistically significant overall survival benefit versus prednisone in mCRPC (median OS 11.0 vs 9.8 months).

Background & Guidelines

Cometriq (cabozantinib) is a small-molecule kinase inhibitor indicated for progressive, metastatic medullary thyroid cancer. NCCN guidance discusses its use: as a preferred option (category 1) along with vandetanib for recurrent or persistent medullary thyroid cancer that is locoregional or metastatic, and as a consideration for differentiated thyroid cancer subtypes (papillary, follicular, oncocytic) after progression on lenvatinib and/or sorafenib. For non-small cell lung cancer with RET gene rearrangements, NCCN recommends Cometriq as subsequent therapy following progression on first-line RET inhibitors (Retevmo or Gavreto). The FDA prescribing information is Cometriq capsules, Exelixis; August 2023, and the COMET-1 phase III study failed to show a statistically significant overall survival benefit in mCRPC (median OS 11.0 vs 9.8 months).

Revision History

2025-05-07reviewLatest

Non-Small Cell Lung Cancer: requirement that patient has recurrent, advanced, or metastatic disease and progressed on Gavreto or Retevmo was added previously (noted in history).

2024-06-12annual_revision

This was an earlier annual revision; no new criteria changes in 2025 review.

2023-06-07clarified