CurrentColorado Rocky Mountain Health PlansPolicy N/A

Step therapy requirement for Mekinist (trametinib)

Defines step therapy coverage rules requiring prior use of Zelboraf (vemurafenib) + Cotellic (cobimetinib) before covering Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for unresectable or metastatic BRAF V600E/V600K melanoma; applies to members of UnitedHealthcare Pharmacy Clinical Pharmacy Programs under the payer.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy requirement for Mekinist (trametinib)

Policy CodePolicy N/A

Change TypeClinical scope clarified

Effective DateNov 1, 2025

Next Review DateAug 1, 2025

Key ActionRequire trial of Zelboraf (vemurafenib) + Cotellic (cobimetinib) for new-to-therapy members before covering Mekinist with Tafinlar unless an allowed exception is documented.

SourceLink

POLICY UPDATE CHANGES

Updated section on melanoma by specifying 'unresectable or metastatic'.

Updated background and references; no changes to clinical criteria in 8/2024 review.

12 monthsauthorization duration for approved requests

Step Therapyprogram type

BRAF V600E/Kmutation requirement referenced in indications

<19 auto-approve

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

members under 19 process

Coverage Criteria

inv-01: Initial and Continuation Therapy Criteria

Covered when ALL of the following are met for the specified groups

Age-based rule: Patients less than 19 years of age: Mekinist will be approved if member is <19; authorization issued for 12 months.age < 19

automatically processes without coverage review for members under 19

Unresectable or Metastatic Melanoma - Initial therapy: Mekinist must be used in combination with Tafinlar (dabrafenib) AND one of the following: (1) patient has a contraindication or history of intolerance to Zelboraf (vemurafenib) plus Cotellic (cobimetinib); OR (2) provider attests patient is not an appropriate candidate for Zelboraf + Cotellic; OR (3) continuation of therapy conditions apply.BRAF V600E or V600K mutation implied by indication

Authorization will be issued for 12 months.

Continuation of therapy: For continuation: member is an established user AND member has not received a manufacturer-supplied sample at no cost, or any form of assistance from the Novartis Oncology Co-Pay Savings Program, or a 30-day free trial from a pharmacy to establish current use; authorization issued for 12 months.claims history of current therapy

Patients established via samples or assistance must meet initial authorization criteria as new-to-therapy.

inv-02: Other Indications

Other oncology indications

Other Indications: Mekinist will be approved for other indications as referenced; authorization issued for 12 months.per plan/state mandates

State mandates, federal requirements, and the member-specific benefit plan may affect coverage; other policies/utilization management programs may apply.

State mandates and member-specific benefit plan terms may affect coverage for Mekinist. Some states mandate benefit coverage for off-label uses or require use of specific compendia; where such mandates apply they supersede the policy language. In addition, federal regulatory requirements and the member specific benefit plan coverage may also impact coverage criteria. Other policies and utilization management programs may also apply.

For members who are new to therapy, use of Mekinist (trametinib) in place of the preferred regimen requires documentation of an allowed exception. Specifically, the policy requires that the patient have either a contraindication or history of intolerance to Zelboraf (vemurafenib) plus Cotellic (cobimetinib), or a documented clinical justification from the prescriber attesting that the patient is not an appropriate candidate for the Zelboraf+Cotellic regimen.

Initial Therapy

inv-11: Initial Therapy

Initial therapy requirements for Mekinist in combination with Tafinlar

Initial therapy: Mekinist must be prescribed in combination with Tafinlar (dabrafenib) AND one of the following: documented contraindication or history of intolerance to Zelboraf (vemurafenib) plus Cotellic (cobimetinib); OR provider attestation that the patient is not an appropriate candidate for Zelboraf + Cotellic; OR meet continuation exception as documented.none

Authorization will be issued for 12 months; members under 19 auto-process per age criterion.

Continuation of Therapy

inv-12: Continuation of Mekinist

Continuation rules for members already on therapy

Continuation: Members currently on Tafinlar and Mekinist as documented in claims history will be allowed to continue therapy provided they have not been established via a manufacturer-supplied sample, Novartis Co-Pay Savings assistance, or a 30-day free trial used to establish current use; authorization issued for 12 months.claims history of current therapy

If member was established via samples or assistance, they must meet initial authorization criteria as if new-to-therapy.

Step Therapy Requirement

Step	Required prior therapy	Applies to	Coverage status
1
Zelboraf (vemurafenib) + Cotellic (cobimetinib)
Members new to therapy for unresectable or metastatic melanoma with BRAF V600E or V600K mutation
Coverage granted after requirement met

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Mekinist (trametinib) will only be approved when used in combination with Tafinlar (dabrafenib). Members currently on Tafinlar + Mekinist documented in claims may continue; members new to therapy must meet step therapy criteria.

Approval duration: 12 months
Combination required: Mekinist + Tafinlar

Step Therapy

Step Therapy Requirement

Members new to therapy must try Zelboraf (vemurafenib) + Cotellic (cobimetinib) prior to coverage of Mekinist unless an exception is documented. This step-therapy requirement applies to initial authorizations only; continuation criteria differ.

Step required for new-to-therapy members: Zelboraf + Cotellic prior to Mekinist

Definitions & Background

inv-10: unresectable or metastatic melanoma — definition to clarify clinical scope

DefinitionMelanoma that cannot be removed surgically or has spread to other parts of the body (unresectable or metastatic).

Relevant mutationsBRAF V600E or V600K mutation required by indication for Tafinlar + Mekinist in this setting.

Treatment combinations referencedTafinlar (dabrafenib) + Mekinist (trametinib) are indicated for unresectable or metastatic melanoma with BRAF V600E/V600K; Zelboraf (vemurafenib) + Cotellic (cobimetinib) is an alternative regimen for the same indication.

Step therapy implicationMembers new to therapy must try the Zelboraf + Cotellic combination prior to coverage of Tafinlar + Mekinist for unresectable or metastatic melanoma unless an allowed exception applies.

Continuation policy noteMembers currently on Tafinlar + Mekinist as documented in claims history may continue their therapy without meeting the step requirement.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy requirement for Mekinist (trametinib)

Policy CodePolicy N/A

Change TypeClinical scope clarified

Effective DateNov 1, 2025

Next Review DateAug 1, 2025

Key ActionRequire trial of Zelboraf (vemurafenib) + Cotellic (cobimetinib) for new-to-therapy members before covering Mekinist with Tafinlar unless an allowed exception is documented.

SourceLink

On This Page

Documentation Required

Required Documentation

Providers must document prior use of Zelboraf + Cotellic and either a contraindication or intolerance to that regimen, OR provide an attestation that the patient is not an appropriate candidate due to clinical status or comorbidities. For continuation requests, document prior authorization history and that the patient did not become established via free samples or manufacturer copay assistance.

Acceptable documentation: medical records showing trial and failure/intolerance to Zelboraf + Cotellic
Or: provider attestation describing clinical rationale why Zelboraf + Cotellic is inappropriate
For continuation: evidence patient is an established user not solely via manufacturer samples or copay assistance

Denial Risk

Denial Risk: Step Therapy Documentation

Failure to document a contraindication/intolerance or to provide the required attestation may result in denial of coverage for Mekinist. Lack of evidence of prior use of Zelboraf + Cotellic (or failure to meet continuation exceptions) is a denial trigger.

Denial triggers: missing documentation of prior Zelboraf + Cotellic trial
Missing contraindication/intolerance documentation or attestation
Evidence showing patient only received manufacturer sample or assistance to appear established

Tafinlar (dabrafenib) used in combination with Mekinist (trametinib) is indicated for treatment of patients with BRAF V600E or V600K mutated disease in settings such as unresectable or metastatic melanoma and certain metastatic NSCLC contexts; this policy focuses on use of Mekinist in combination with Tafinlar for unresectable or metastatic melanoma. The program is structured as a step therapy approach that encourages use of the alternative lower‑cost regimen Zelboraf (vemurafenib) plus Cotellic (cobimetinib) before approving Mekinist for new‑to‑therapy members, unless an allowed exception is documented. Authorization for approved requests is issued for 12 months, and coverage may be further shaped by applicable state mandates, federal requirements, and the member's benefit plan.