UnitedHealthcare step therapy Mekinist Prior Auth

Coverage Criteria

Coverage criteria

Covered when meeting the following distinct criteria groups depending on patient category

Patients <19 years: Member is less than 19 years of age; authorization will be issued for 12 months.

Prescription automatically processes without coverage review for members under 19.

Unresectable or Metastatic Melanoma - Initial: Mekinist to be used in combination with Tafinlar (dabrafenib) AND one of: (1) documented contraindication or history of intolerance to Zelboraf (vemurafenib) plus Cotellic (cobimetinib); OR (2) provider attestation that the patient is not an appropriate candidate for Zelboraf plus Cotellic due to clinical status/comorbidities; OR (3) continuation criteria are met (see Continuation of Therapy).

Authorization will be issued for 12 months.

Continuation of Therapy: Patient is a continuation of therapy AND patient has not received a manufacturer supplied sample at no cost from a prescriber's office, or assistance from the Novartis Oncology Co‑Pay Savings Program (including sample cards redeemable at a pharmacy) or a 30‑day free trial from a pharmacy to establish current use; authorization will be issued for 12 months.

Patients initially established on therapy via manufacturer sample or co‑pay assistance must meet initial authorization criteria as if new to therapy.

Other Indications: Mekinist will be approved for other indications as allowed by the member's benefit, state mandates, and clinical rules.

Authorization typically issued for 12 months; state mandates and benefit plan terms may supersede.

Some state mandates may supersede this policy. Where applicable, state laws or benefit mandates for off‑label medication use or required compendium references take precedence over the criteria in this document. Providers must follow the member’s specific benefit plan coverage when state mandates or plan terms differ from this policy.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Mekinist (trametinib) when not a member <19 years of age or an allowed continuation. Approval requires Mekinist to be used in combination with Tafinlar (dabrafenib). Authorization will be issued for 12 months.

Mekinist (trametinib) must be prescribed in combination with Tafinlar (dabrafenib).
Authorization duration: 12 months.
PA required for members new to therapy (members currently on Tafinlar + Mekinist as documented in claims history may continue).

Step Therapy

Step Therapy Requirement

Step therapy requires members new to therapy to try Zelboraf (vemurafenib) + Cotellic (cobimetinib) prior to coverage of Tafinlar + Mekinist for unresectable or metastatic BRAF V600E/K melanoma. Members currently on Tafinlar + Mekinist per claims history are allowed to continue without meeting step requirements.

Initial Therapy Criteria

Initial therapy

Initial authorization conditions for Mekinist in melanoma

Initial Therapy - Melanoma: Mekinist must be used in combination with Tafinlar (dabrafenib).

AND member must meet ONE of the following: (1) documented contraindication or history of intolerance to Zelboraf (vemurafenib) plus Cotellic (cobimetinib); OR (2) provider attests patient is not an appropriate candidate for Zelboraf plus Cotellic due to clinical status/comorbidities; OR (3) continuation criteria (see Continuation of Therapy). Authorization will be issued for 12 months.

Continuation Therapy Criteria

Continuation of Therapy

Requirements for patients continuing Mekinist therapy

Continuation: Patient is a continuation of therapy; patient has not received a manufacturer supplied sample at no cost from a prescriber's office, any form of assistance from the Novartis Oncology Co‑Pay Savings Program (e.g., sample card redeemable at a pharmacy), or a 30‑day free trial from a pharmacy to establish current use of Mekinist.

If patient was established via such manufacturer sample or assistance, they must meet initial authorization criteria as if new to therapy. Authorization will be issued for 12 months.

Step Therapy Table

Step	Requirement	Exceptions / Notes
1	Members new to therapy must trial the Zelboraf (vemurafenib) + Cotellic (cobimetinib) combination prior to coverage of Mekinist (trametinib) when used in combination with Tafinlar (dabrafenib) for unresectable or metastatic BRAF V600E or V600K melanoma.	Applies to patients with unresectable or metastatic melanoma with documented BRAF V600E or V600K mutation; authorization issued for 12 months.
Step-failure/contraindication exception	Coverage may be granted without prior trial if there is documented contraindication or history of intolerance to Zelboraf + Cotellic, or if the provider attests the patient is not an appropriate candidate due to clinical status or comorbidities.	Provider must document the contraindication/intolerance or provide clinical attestation in the prior authorization request.
Continuation/other	Members currently on Tafinlar + Mekinist as documented in claims history are allowed to continue without meeting the step requirement.	Continuation approvals require documentation that the patient did not establish therapy via manufacturer samples, Novartis co-pay assistance, or a 30-day free pharmacy trial; authorization typically for 12 months.

Background and Definitions

Tafinlar (dabrafenib) plus Mekinist (trametinib) and Zelboraf (vemurafenib) plus Cotellic (cobimetinib) are approved BRAF/MEK inhibitor combination regimens for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. This program favors trial of the lower‑cost Zelboraf + Cotellic combination before authorizing Tafinlar + Mekinist for members who are new to therapy for unresectable or metastatic disease.

For members 19 years of age, prescriptions will automatically process without coverage review. Prior authorization is required for Mekinist when used in combination with Tafinlar for members who are not auto‑processed, unless the patient meets continuation criteria. Approval for initial therapy requires evidence of a prior trial of Zelboraf + Cotellic or documentation of a contraindication/intolerance or a provider attestation that the patient is not an appropriate candidate based on clinical status or comorbidities. Continuation of therapy is allowed when prior use is documented and the member did not rely on manufacturer samples, Novartis co‑pay assistance, or a pharmacy 30‑day free trial to establish current use.

Continuation of therapy — definition and continuation rules

DefinitionContinuation of therapy = ongoing therapy for members documented in claims history or prior users who meet continuation rules (i.e., patient is already receiving Tafinlar + Mekinist as shown in claims).

Continuation rule - manufacturer assistancePatient must not have received a manufacturer-supplied sample at no cost from the prescriber's office, Novartis co-pay savings assistance, or a 30-day free pharmacy trial to establish current use; if they have, they must meet initial authorization criteria as a new user.

OpenPayer

Step therapy program for Mekinist (trametinib)