CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tafinlar (dabrafenib) — Coverage Criteria

Defines accepted indications, continuation and exclusion criteria, and authorization/management expectations for Tafinlar (dabrafenib) (often in combination with trametinib) for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTafinlar (dabrafenib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionObtain prior authorization; continuation requests are exempt from re-review if medication used within the last year, no disease progression or intolerance, and no additional medications are added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipleFDA/guideline indications

≥1 yrMinimum age

150 mgSingle dose max

180 / 120Monthly limits

12 moAdjuvant max duration

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.

Coverage criteria for Tafinlar (dabrafenib)

inv-01: Low Grade Glioma

Covered when ALL of the following are met for Low Grade Glioma

Low Grade Glioma: Tafinlar (dabrafenib) used in combination with Mekinist (trametinib) for members ≥1 year with low grade glioma harboring a BRAF V600E mutationage >= 1 year

inv-02: Melanoma

Covered when ANY of the following melanoma indications apply

Melanoma adjuvant: Tafinlar (dabrafenib) in combination with Mekinist (trametinib) as adjuvant treatment following complete resection for melanoma with BRAF V600E or V600K mutations

Adjuvant use: maximum duration limit applies per policy

Unresectable/metastatic melanoma: Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for unresectable or metastatic melanoma that is BRAF V600E or V600K mutation–positive

inv-03: Non-Small Cell Lung Cancer (NSCLC)

Covered when ALL of the following are met for NSCLC

NSCLC: Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for recurrent or metastatic BRAF V600E mutation–positive non–small cell lung cancer as first-line or subsequent therapy provided anti-BRAF targeted therapy was not previously used

inv-04: Solid Tumors with BRAF V600E (excluding colorectal cancer)

Covered when ALL of the following are met for other solid tumors

Solid tumors BRAF V600E: Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for adult or pediatric members ≥1 year with unresectable or metastatic solid tumors harboring a BRAF V600E mutation, excluding colorectal cancer, as subsequent therapyage >= 1 year

Excludes colorectal cancer

inv-05: Thyroid Cancer

Covered when ALL of the following are met for Thyroid Cancer

Thyroid cancer: Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for anaplastic, papillary, follicular, or Hürthle cell thyroid carcinoma that is BRAF V600E mutation–positive and radioactive iodine–refractory (if radioactive iodine would be appropriate) or unresectable/recurrent/metastatic

If radioactive iodine is appropriate, disease must be refractory

inv-06: Continuation Therapy

Continuation requests

Continuation requests are exempt from full policy review when: the requested medication was used within the last year AND the member has not experienced disease progression or intolerance to the requested medication AND no additional medications are being added to the continuation request

Coverage excludes use of Tafinlar (dabrafenib) for tumors that are wild‑type for BRAF. Therapy is not covered when there is documented disease progression while receiving any MEK inhibitor + BRAF inhibitor combination. For colorectal cancer, presence of KRAS or NRAS mutations is an exclusion. Prescriptions that exceed the approved dosing limits are not covered: single doses above 150 mg, or total monthly dispensing above 180 tablets of 50 mg or 120 tablets of 75 mg. Adjuvant use for melanoma following complete resection and regional lymph node dissection is limited to a maximum duration of 12 months; treatment beyond this duration is excluded. Finally, investigational or off‑label uses without sufficient evidence (see investigational criteria) are not eligible for coverage.

Off‑label or investigational use of Tafinlar (dabrafenib) is considered not medically necessary unless supported by sufficient evidence. Sufficient evidence is defined by the absence of conflict with CMS‑recognized compendia and the presence of acceptable peer‑reviewed literature that adequately represents the patient and cancer characteristics, the treatment regimen, and reports clinically meaningful outcomes (for example ASCO‑recommended thresholds such as hazard ratios < 0.80 and survival benefits for OS or PFS of at least 3 months).

When assessing investigational use, the strength of evidence should consider study design and quality: randomized data are preferred but well‑conducted non‑randomized trials with substantial subject numbers may be supportive; however, isolated case reports and meeting abstracts without full peer‑reviewed publications generally do not provide adequate evidence to support coverage.

Initial therapy criteria

inv-18: Initial therapy

Initial therapy criteria for NSCLC

NSCLC initial therapy: Tafinlar (dabrafenib) in combination with Mekinist (trametinib) may be used as first-line or subsequent line therapy for recurrent or metastatic BRAF V600E mutation–positive NSCLC provided anti-BRAF targeted therapy was not previously used

Continuation therapy and renewal rules

inv-19: Continuation therapy

Continuation therapy — exemption and related criteria

Continuation exemption: Requests for continuation therapy are exempt from full policy re-review if the medication was used within the last year AND there has been no disease progression or intolerance to the medication AND no additional medications are being added to the request

Provider actions, documentation, and authorization

Prior Authorization

Prior authorization required; continuation requests may be exempt

Prior authorization is required for Tafinlar (dabrafenib) requests. Continuation requests are exempt from full policy re‑review if the medication was used within the last year, the member has not experienced disease progression or intolerance to the requested medication, and no additional medications are being added to the continuation request.

Step Therapy

NSCLC sequencing: first‑line or subsequent if no prior anti‑BRAF therapy

For recurrent or metastatic BRAF V600E mutation‑positive NSCLC, dabrafenib in combination with trametinib may be used as first‑line or subsequent therapy provided anti‑BRAF targeted therapy was not previously used.

Documentation Required

Supporting evidence required

Medication use must be supported by one of the following: FDA‑approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Denial Risk

Denial triggers and common exclusion reasons

Requests risk denial when any exclusion criterion is met, including: wild‑type BRAF tumors; disease progression while on any MEK inhibitor + BRAF inhibitor combination; presence of KRAS or NRAS mutations in colorectal cancer; dosing above the single‑dose limit (dabrafenib 150 mg) or monthly tablet limits (180 × 50 mg or 120 × 75 mg); adjuvant melanoma treatment beyond 12 months; or investigational/off‑label use lacking sufficient supporting evidence.

Single dose limit: dabrafenib 150 mg
Monthly tablet limits: 180 (50 mg) tablets/month or 120 (75 mg) tablets/month
Adjuvant melanoma duration limit: >12 months is exclusion

Coding and per-dose limits

inv-09: Single dose limit — single dose max 150 mg

Single dose maximum per dose150 mg

inv-10: Monthly tablet limits — 180 (50 mg) tablets/month OR 120 (75 mg) tablets/month

Monthly limit (50 mg tablets)180 (50 mg) tablets per month

Monthly limit (75 mg tablets)120 (75 mg) tablets per month

inv-11: Adjuvant melanoma duration limit — Maximum 12 months

Adjuvant melanoma duration maximumMaximum 12 months when used as adjuvant treatment following complete resection

ContextApplies to adjuvant use after primary lesion resection and regional lymph node dissection

Quantity limits for Tafinlar (dabrafenib)

inv-20: Tafinlar (dabrafenib) — 180 (50 mg) tablets/month

Quantity limit for 50 mg tablets180 (50 mg) tablets per month

DrugTafinlar (dabrafenib)

inv-21: Tafinlar (dabrafenib) — 120 (75 mg) tablets/month

Quantity limit for 75 mg tablets120 (75 mg) tablets per month

DrugTafinlar (dabrafenib)

inv-22: Tafinlar (dabrafenib) — Single dose max 150 mg

Single dose maximum150 mg per dose

DrugTafinlar (dabrafenib)

Key definitions

inv-17: Wild-type BRAF — Tumors lacking activating BRAF V600 mutations; presence is an explicit exclusion for Tafinlar use.

DefinitionTumors lacking activating BRAF V600 mutations

Policy implicationPresence of wild-type BRAF is an explicit exclusion for Tafinlar use

Related exclusionRequests for Tafinlar in wild-type BRAF tumors will be denied per exclusion criteria

Background and drug information

Dabrafenib is a targeted BRAF inhibitor that is typically administered in combination with the MEK inhibitor trametinib for tumors harboring activating BRAF V600E or V600K mutations. This combination is used across multiple malignancies and settings addressed by this policy, including melanoma (adjuvant and unresectable/metastatic), non‑small cell lung cancer with BRAF V600E, selected thyroid carcinomas, low‑grade glioma in pediatric patients ≥1 year, and other BRAF V600E‑mutant solid tumors (with explicit exclusion of colorectal cancer).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTafinlar (dabrafenib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 31, 2024

Next Review DateN/A

SourceLink

On This Page