Cabozantinib (Cometriq/Cabometyx) — Coverage Criteria
Defines accepted indications, coverage criteria, exclusions, and coding for cabozantinib (Cometriq/Cabometyx) usage in cancer treatment and prior authorization processing for members.
Added new indication for pancreatic neuroendocrine tumors (pNET) and extra-pancreatic neuroendocrine tumors (epNET).
Updated maximum dosage form quantities in exclusion criteria.
Converted to new Evolent guideline template and replaced prior UM ONC_1237 policy.
Coverage criteria and indications
Hepatocellular Carcinoma (HCC)
Covered for hepatocellular carcinoma when ALL of the following are met
Kidney Cancer (Clear cell RCC)
Covered for renal cell carcinoma in specified settings
Policy states cabozantinib monotherapy is not supported as first-line treatment for IMDC favorable risk due to lack of Level 1 evidence
Pancreatic and Extra-Pancreatic Neuroendocrine Tumors
Covered for neuroendocrine tumors when ALL of the following are met
New indication for pNET/epNET added per policy history
Thyroid Cancer
Covered for thyroid cancer when ALL of the following are met
Requests for cabozantinib will be excluded (and may be denied) when any of the following apply: disease progression while taking Cometriq/Cabometyx (cabozantinib); dosing that exceeds single-dose limits (Cometriq >140 mg, Cabometyx >60 mg); or monthly quantity limits exceeded (Cometriq: 84 × 20 mg or 28 × 80 mg capsules per month; Cabometyx: 30 × 20 mg, 30 × 40 mg, or 30 × 60 mg tablets per month). Investigational or off‑label uses that lack sufficient supporting evidence (not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature) are also excluded.
Cabozantinib monotherapy is not supported as first‑line treatment for clear cell renal cell carcinoma in patients with IMDC favorable risk. The policy rationale cites a lack of Level‑1 evidence demonstrating superior outcomes for cabozantinib monotherapy compared with alternative agents or regimens recommended on Evolent Pathways. Requests for first‑line monotherapy in this subgroup should be evaluated against this position and may be considered not medically necessary.
Approved regimens and combinations
| Regimen | Indication / Line of therapy | Coverage status |
|---|---|---|
| {"text":"Cabometyx (cabozantinib) + nivolumab","status":""}|{"text":"First-line treatment for relapsed/metastatic clear cell renal cell carcinoma with intermediate or poor IMDC risk","status":"covered"}|{"text":"Covered","status":"covered"} | ||
| {"text":"Cabometyx (cabozantinib) monotherapy","status":""}|{"text":"Subsequent therapy (relapsed/metastatic clear cell RCC) for any IMDC risk; may be used as first-line monotherapy for intermediate/poor risk","status":"covered"}|{"text":"Covered with criteria","status":"covered"} | ||
| {"text":"Cabozantinib (Cometriq) monotherapy","status":""}|{"text":"Unresectable or metastatic medullary thyroid cancer; monotherapy for specified thyroid cancers (see Cabometyx row for papillary/follicular/Hurthle cell)","status":"covered"}|{"text":"Covered with criteria","status":"covered"} | ||
| {"text":"Cabometyx (cabozantinib) monotherapy — thyroid cancer (Cabometyx only)","status":""}|{"text":"Adult and pediatric ≥12 years with unresectable or metastatic papillary, follicular, or Hurthle cell thyroid cancer refractory to a VEGFR‑targeted therapy and not candidates for or refractory to radioactive iodine","status":"covered"}|{"text":"Covered with criteria","status":"covered"} |
Billing, HCPCS and quantity limits
| J8999 | cabozantinib |
Prior authorization, documentation, and exclusion triggers
Prior Authorization and Required Documentation
Prior authorization is required. Requests must be supported by FDA labeling, CMS-recognized compendia (e.g., NCCN), ASCO/NCCN clinical guidelines, or acceptable peer‑reviewed literature meeting CMS standards. Continuation requests may be approved only if the member has not experienced disease progression on cabozantinib, the medication was used within the last year without a lapse >30 days from an active authorization, and no additional medications are being added to the continuation request.
- Prior authorization required with clinical support from FDA labeling, recognized compendia/guidelines, or acceptable peer‑reviewed literature.
- Continuation approval conditional on: no disease progression on cabozantinib; prior use within last year without >30‑day lapse; no new medications added to the continuation request.
Step/Therapeutic Sequencing for RCC
Cabometyx (cabozantinib) monotherapy is not supported by this policy as preferred first‑line therapy for clear cell renal cell carcinoma (RCC) patients with favorable IMDC risk. Cabozantinib may be used first line for intermediate/poor risk disease (as monotherapy or with nivolumab) and as subsequent therapy for any risk category, but not as first‑line monotherapy for IMDC favorable risk due to lack of Level‑1 evidence.
- For first‑line clear cell RCC with favorable IMDC risk, cabozantinib monotherapy is not supported as preferred first‑line therapy.
Common Exclusion Triggers
Common exclusion triggers include documented disease progression while on cabozantinib, requests with dosing that exceed single‑dose limits (Cometriq 140 mg; Cabometyx 60 mg), and monthly quantity limits that exceed the specified maximums. Investigational or off‑label uses lacking sufficient evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature (e.g., reliance on case reports or abstracts without full peer‑reviewed publication) are excluded.
- Excluded when there is disease progression while taking cabozantinib.
- Excluded if dosing exceeds single‑dose limits: Cometriq 140 mg; Cabometyx 60 mg.
- Excluded if monthly supply exceeds limits: Cometriq 84 (20 mg) or 28 (80 mg) capsules/month; Cabometyx 30 (20 mg), 30 (40 mg) or 30 (60 mg) tablets/month.
- Excluded for investigational/off‑label indications not supported by CMS compendia or acceptable peer‑reviewed literature (case reports and abstracts without full publications generally insufficient).
First-line, second-line, and salvage therapy rules
first-line | second-line | salvage
Authorize based on line of therapy as specified below
Monotherapy not supported for IMDC favorable risk RCC first-line
Continuation requires no disease progression on cabozantinib and documentation per authorization requirements
Refer to exclusion criteria for dosing and quantity limits
Clinical background and drug overview
Cabozantinib (marketed as Cometriq and Cabometyx) is a targeted tyrosine kinase inhibitor with approved and guideline‑supported uses across multiple tumor types including renal cell carcinoma, hepatocellular carcinoma, thyroid cancer, and neuroendocrine tumors. Coverage under this policy is tied to FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidance, or acceptable peer‑reviewed literature and includes specific clinical constraints such as liver function requirements for HCC and IMDC risk stratification for RCC. Administrative and safety limits apply to dosing: single‑dose maxima (Cometriq 140 mg, Cabometyx 60 mg) and monthly formulation quantity limits (Cometriq: 84 × 20 mg or 28 × 80 mg capsules; Cabometyx: 30 × 20 mg, 30 × 40 mg, or 30 × 60 mg tablets) are enforced, and investigational or off‑label indications without sufficient evidence are excluded.
Key definitions and clinical classifications
Policy changes and history
Converted to new Evolent guideline template, replaced prior UM ONC_1237 policy, added indication for pancreatic and extra‑pancreatic neuroendocrine tumors (pNET/epNET), and updated maximum dosage form quantities in exclusion criteria.
Updated NCH verbiage to Evolent.
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