Prior authorization/notification required; pediatric auto-processing

Prior authorization/notification is required under UnitedHealthcare Clinical Pharmacy Programs (Program Number 2026 P 1062-17). Note: prescriptions for members under 19 years of age will automatically process without a coverage review and authorization will be issued for 12 months.

• Program Number: 2026 P 1062-17
• Members <19 years auto-process without coverage review
• Authorization when issued: 12 months

Prior authorization required; 12-month approval when criteria met

Prior authorization is required for Mekinist and, when the specified diagnostic and treatment criteria are met, approval will be issued for 12 months for the listed indications.

• Prior authorization is required for Mekinist for covered indications
• Authorization duration: 12 months when criteria are met

Prior authorization required for each cancer indication; 12‑month approvals

Prior authorization is required across the cancer indications listed and will be approved for 12 months when the specific diagnostic, biomarker, and treatment-context criteria for each indication are satisfied.

• Approvals contingent on meeting indication-specific criteria (diagnosis, biomarker, combination therapy where listed)
• Authorization issued for 12 months

Prior authorization processes may use automated claim-based approvals

UnitedHealthcare may use prior authorization/notification automation; initial approvals and reauthorizations can be granted based on prior claim/medication history, diagnosis codes (ICD‑10), and/or claim logic.

• Automated approvals/re-approvals vary by program or therapeutic class
• Approvals may be based solely on claim history, ICD‑10 codes, and/or claim logic

Initial authorization requires diagnosis and biomarker; reauthorization requires no progression

Initial authorization criteria require documentation of the indicated diagnosis; for many indications, positive BRAF V600 (V600E or V600K) mutation and use in combination with dabrafenib (Tafinlar) are required. Reauthorization requires no evidence of disease progression while on Mekinist therapy.

• Initial: diagnosis-specific criteria and BRAF V600 mutation positivity where specified
• Many indications: use in combination with Tafinlar (dabrafenib)
• Reauthorization: patient must not show evidence of progressive disease on Mekinist

Approved as subsequent-line therapy for hepatobiliary and solid tumors

For hepatobiliary cancers and for general solid tumors, Mekinist is approved only as subsequent-line therapy after progression on or after systemic treatment; documentation must support prior systemic therapy and disease progression.

• Hepatobiliary initial authorization requires use as subsequent treatment after progression on/after systemic therapy
• Solid tumors: approval requires prior progression and unresectable or metastatic disease

Step therapy/sequencing: follow indication-specific requirements

Coverage is driven by indication‑specific criteria and combination-use rules; the policy does not set a generalized step therapy sequence beyond requiring that listed criteria (including combination with dabrafenib where specified) be met.

• No uniform step sequence specified — follow indication-specific requirements
• Many indications require combination use with Tafinlar (dabrafenib)

Supply limits may apply

Supply limits may apply to Mekinist claims; providers should anticipate utilization controls and check claim adjudication responses for quantity restrictions.

• Supply limits may be in place

Submit FDA‑approved test documentation of BRAF V600 mutation when required

For labeled BRAF‑mutant indications, submit documentation of BRAF V600 mutation status (V600E or V600K) as detected by an FDA‑approved companion diagnostic when requesting authorization.

• Evidence of BRAF V600E or V600K mutation via FDA‑approved test is required where specified
• FDA companion diagnostic information is referenced by the policy

Required documentation: diagnosis, biomarker, prior therapy, disease status, and combination use

Documentation required with the authorization request must demonstrate the diagnosis, BRAF V600E mutation status when applicable, prior systemic treatment and progression when required, unresectable or metastatic disease when applicable, and evidence of concomitant use with Tafinlar (dabrafenib) for combination indications.

• Diagnosis consistent with the requested indication
• BRAF V600E mutation status when required
• Prior systemic therapy and progression for subsequent-line indications
• Unresectable or metastatic disease documentation when required
• Concomitant use with Tafinlar (dabrafenib) when listed

Claims-based authorization possible — ensure accurate claims and ICD‑10 coding

UnitedHealthcare may approve initial authorizations and reauthorizations based solely on previous claim/medication history, diagnosis codes (ICD‑10), and/or claim-driven rules; providers should ensure claims and diagnosis coding accurately reflect the clinical situation.

• Approvals may be granted based on prior claim/medication history and ICD‑10 codes
• Ensure accurate coding and prior-therapy claims to support authorization

Authorization duration is 12 months; state/federal/plan constraints may apply

Authorizations when granted are issued for 12 months. Coverage is also subject to state mandates, federal regulatory requirements, and the member's specific benefit plan, which may supersede or affect coverage.

• Authorization duration: 12 months
• State mandates, federal requirements, and member benefit plans may impact coverage

State mandates may supersede policy criteria — verify state requirements

Where applicable, state mandates may supersede the benefit document or notification criteria; verify state‑specific requirements because mandated coverage may alter authorization or coverage decisions.

• State mandates may apply and supersede policy language
• Check state-specific mandates for off-label coverage or compendium references

Denial risk: missing required BRAF mutation evidence or missing required combination therapy

Lack of documented BRAF V600E (or V600 where required) mutation for indications that require it, or failure to use Mekinist in combination with Tafinlar (dabrafenib) where the policy requires combination therapy, may result in denial of coverage.

• Denial trigger: missing required BRAF V600 mutation evidence
• Denial trigger: not using Mekinist with dabrafenib for combination-only indications

Reauthorization denial trigger: progression on therapy

If there is evidence of progressive disease while the patient is on Mekinist therapy, reauthorization will be denied — reauthorization requires absence of disease progression.

• Reauthorization denied if patient shows disease progression on Mekinist

Automated approval variability — ensure accurate claims and documentation

Automated approval and reapproval processes vary by program and therapeutic class; because approvals can be based on previous claim history and claim logic, missing or inaccurate claims data or diagnosis codes may lead to denial.

• Automated approvals vary by program/therapeutic class
• Missing or inaccurate claim/diagnosis data can cause denials when automation is used