Tafinlar (dabrafenib) prior authorization criteria
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Defines UnitedHealthcare Pharmacy prior authorization/notification criteria for Tafinlar (dabrafenib) for members, including indications, age-based rules, and renewal requirements affecting prescribers and pharmacies.
No material clinical or coverage changes in this revision.
Coverage Criteria for Tafinlar (dabrafenib)
Initial Therapy — Melanoma
Covered when ALL of the following are met
Authorization issued for 12 months
Continuation Therapy — Reauthorization
Covered when ALL of the following are met
Authorization issued for 12 months
CNS Cancers — Initial Therapy
Covered when ALL of the following are met
Authorization issued for 12 months
NSCLC — Initial Therapy
Covered when ALL of the following are met
Authorization issued for 12 months
Thyroid Cancer — Initial Authorization
Covered when ANY of the following initial authorization pathways are met
Authorization issued for 12 months
Authorization issued for 12 months
Pediatric (<19 years) — Special Pathway
Patients less than 19 years of age
Authorization issued for 12 months; prescription will automatically process without coverage review for members under 19
Anaplastic Thyroid Cancer — Initial Authorization
Covered when ALL of the following are met
Differentiated Thyroid Carcinomas — Initial Authorization
Covered when ALL of the following are met
Hepatobiliary Cancers — Initial Authorization
Covered when ALL of the following are met
Authorization issued for 12 months
Histiocytic Neoplasms — Initial Authorization
Covered when ALL of the following are met
Authorization issued for 12 months
Solid Tumors (Tumor-agnostic) — Initial Authorization
Covered when ALL of the following are met
Authorization issued for 12 months
Epithelial Ovarian, Fallopian Tube, Primary Peritoneal Cancer — Initial Authorization
Covered when ALL of the following are met
Authorization issued for 12 months
Pancreatic and Ampullary Cancer — Initial Authorization
Covered when ALL of the following are met
Authorization issued for 12 months
Reauthorization — All Indications
Reauthorization covered when the following is met
Authorization issued for 12 months upon meeting this criterion.
Initial Therapy — Pancreatic / Ampullary Cancer
Covered when ALL of the following are met
Authorization issued for 12 months
Reauthorization — Pancreatic / Ampullary Cancer
Covered on reauthorization when the following is met
Authorization issued for 12 months
Initial Therapy — Hairy Cell Leukemia
Covered when ALL of the following are met
Authorization issued for 12 months
Reauthorization — Hairy Cell Leukemia
Covered on reauthorization when the following is met
Authorization issued for 12 months
Initial Therapy — Salivary Gland Tumor
Covered when ALL of the following are met
Authorization issued for 12 months
Reauthorization — Salivary Gland Tumor
Covered on reauthorization when the following is met
Authorization issued for 12 months
Initial Therapy — GIST
Covered when ALL of the following are met
Authorization issued for 12 months
Reauthorization — GIST
Covered on reauthorization when the following is met
Authorization issued for 12 months
Tafinlar (dabrafenib) is not indicated for the treatment of patients with wild-type BRAF solid tumors. Requests for coverage that do not document a BRAF V600 activating mutation (for example V600E or V600K where required) are outside the indications described in the clinical labeling and do not meet the coverage criteria.
For differentiated thyroid carcinomas (follicular, oncocytic, or papillary), coverage under the differentiated thyroid carcinoma pathway requires that the disease be refractory to radioactive iodine treatment. In addition, the criteria require that the patient have unresectable locoregional recurrent, persistent, or metastatic disease and symptomatic or progressive disease, and that the tumor is positive for a BRAF V600 mutation.
Coverage determinations are subject to applicable state statutory mandates and the member's individual benefit plan. State requirements or specific benefit plan language may supersede or further restrict coverage described in this policy.
On reauthorization, coverage is contingent on clinical evidence that the patient does not show evidence of progressive disease while on Tafinlar therapy. Documentation of disease progression during therapy is a basis for denying reauthorization.
Provider Actions, Prior Authorization & Documentation
Prior authorization required (age <19 exception)
Prior authorization/notification is required for Tafinlar (dabrafenib) under UnitedHealthcare Pharmacy Clinical Pharmacy Programs; prescriptions for members under 19 years of age will automatically process without coverage review. Authorizations are typically issued for 12 months when criteria are met.
- All requests for Tafinlar require prior authorization/notification except automated processing for members <19.
- Typical authorization duration: 12 months when approved.
Prior authorization and duration
Prior authorization must include documentation of the diagnosis, tumor BRAF V600E (or V600 where specified) mutation positivity, and documentation of combination use with Mekinist (trametinib) when the criteria specify combination therapy; approvals are issued for 12 months.
- Provide documented diagnosis per indication (e.g., melanoma, hepatobiliary, pancreatic, CNS, thyroid, ovarian, GIST).
- Provide tumor BRAF V600E mutation status when required by the indication.
- When the approval criteria require combination with Mekinist (trametinib), document intent to use the combination.
Prior authorization requirements
Prior authorization requests must document the specific diagnosis and disease stage or status required by the indication (e.g., unresectable, metastatic, locally advanced, recurrent), plus biomarker status and combination use where indicated; authorizations are typically for 12 months.
- Document disease extent required by the indication (e.g., metastatic, unresectable, locally advanced, recurrent, symptomatic or progressive).
- Document prior systemic therapy when the indication requires Tafinlar as subsequent-line treatment.
Combination preferred; single-agent allowed if not tolerated (NSCLC)
For NSCLC, the policy prefers Tafinlar be used in combination with Mekinist (trametinib); single-agent dabrafenib is allowed only if the combination is not tolerated.
- If combination is not tolerated, document intolerance to trametinib to support single-agent use.
Subsequent-line requirement
For hepatobiliary cancers and for tumor-agnostic solid tumor indications, Tafinlar is specified as subsequent-line (used after progression on or after systemic treatment); prior authorization should document prior systemic therapy and progression.
- Document prior systemic treatment and evidence of progression prompting subsequent-line use.
Utilization management and supply limits
Supply limits and other utilization management programs may apply to Tafinlar; the prior authorization/notification program is part of UnitedHealthcare’s utilization management and automated approval processes may be used.
- Be aware that supply limits may be in place and automated approval/re-approval processes vary by program.
Documentation must support diagnosis, disease stage, and combination intent
Documentation submitted with authorization requests must support the specific diagnosis, disease stage/status (e.g., unresectable, metastatic, locally advanced, recurrent), and the intent to use combination therapy with trametinib when the indication requires combination use.
- Include clinical notes, pathology or imaging reports that establish disease extent and indication-specific criteria.
- If combination therapy is required, include the treatment plan or prescriptions showing intent to use trametinib concurrently.
Required documentation: BRAF V600E status and combination intent
Required documentation includes confirmation of tumor BRAF V600E mutation status and, where specified, documentation of intent to use Tafinlar in combination with Mekinist (trametinib); reauthorization also requires evidence of no progressive disease while on therapy.
- Provide the BRAF V600E mutation test result (FDA‑approved test) for indications that require it.
- For reauthorization, provide evidence that the patient does not show progressive disease while on Tafinlar.
Program automation and documentation
UnitedHealthcare may approve initial or reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD‑10), and/or claim logic; automated approval and re‑approval processes vary by program.
- Ensure prior claim history and diagnosis coding accurately reflect the indication and prior therapies, as approvals may be processed using this information.
Incomplete requests if BRAF V600E status or required combination not documented
Requests that lack documentation of tumor BRAF V600 mutation positive status (for indications requiring it) or that fail to document required combination therapy with trametinib where specified will be considered incomplete and risk denial.
- Missing BRAF V600E mutation test results for indications that mandate it.
- Missing documentation of concurrent trametinib when the criteria require combination therapy.
Triggers for denial: missing biomarker, combination, or disease‑state documentation
Triggers for denial include lack of documentation of a BRAF V600E mutation when required, absence of the required combination therapy with Mekinist (trametinib) where specified, or failure to meet disease‑state requirements such as unresectable, metastatic, locally advanced, or progression criteria.
- No documented BRAF V600E mutation result for indications stating 'Cancer is positive for BRAF V600E mutation.'
- Failure to document combination use with trametinib when the criteria mandate combination therapy.
- Requests that do not demonstrate the disease extent required by the indication (e.g., not metastatic or unresectable as required).
Reauthorization denial trigger: progressive disease on therapy
Reauthorization may be denied if the patient shows evidence of progressive disease while on Tafinlar therapy; provide follow‑up documentation demonstrating lack of progression to support renewal.
- For reauthorization, include recent imaging or clinical assessments showing no evidence of progressive disease while on therapy.
Permitted Regimens and Combination Therapy
| Regimen | Indications / Notes | Coverage status |
|---|---|---|
| Dabrafenib ± trametinib | ||
| Melanoma (unresectable or metastatic); adjuvant melanoma involving lymph node(s) — combination with trametinib required for adjuvant; BRAF V600 mutation required; authorization issued for 12 months | ||
| Regimen | Typical requirement / clinical context | Coverage status |
|---|---|---|
| Dabrafenib (Tafinlar) + trametinib (Mekinist) | ||
| Used in most tumor-specific and tumor-agnostic indications (e.g., solid tumors, hepatobiliary, pancreatic/ampullary, ovarian/fallopian/primary peritoneal); BRAF V600E mutation required; often subsequent-line after prior systemic therapy where specified; authorization typically 12 months | ||
| Tumor type / setting | Combination required? | Coverage details |
|---|---|---|
| Central nervous system cancers (metastatic brain lesions, glioma) | ||
| Yes — used in combination with trametinib | ||
| Requires BRAF V600E mutation and combination with trametinib; authorization issued for 12 months |
Line of Therapy Designations
first-line
Top-level node indicating first-line use where specified
Some approvals are accelerated and contingent on confirmatory trials
second-line | subsequent-line
Top-level node indicating subsequent-line use where specified
Biomarker Requirements for Coverage
Definitions and References
Background on Dabrafenib (Tafinlar)
Background: Dabrafenib (Tafinlar) is a BRAF kinase inhibitor indicated for use in BRAF V600–mutant tumors. As a single agent it is indicated for unresectable or metastatic melanoma with a BRAF V600E mutation detected by an FDA‑approved test. In multiple other tumor types (including metastatic melanoma in combination with trametinib, metastatic NSCLC with BRAF V600E, anaplastic thyroid cancer with BRAF V600E and selected pediatric and adult solid tumors with BRAF V600E), Tafinlar is used in combination with trametinib (Mekinist) per the labeled and compendium‑recommended regimens. The NCCN Drugs and Biologics Compendium is cited in the policy as a reference supporting use across multiple indications.
Revision History
Policy effective date for the Tafinlar (dabrafenib) prior authorization criteria and related automation rules.
Clinical review completed for Tafinlar prior authorization criteria (last review date).
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