CurrentColorado Rocky Mountain Health PlansPolicy N/A

Gavreto (pralsetinib) prior authorization

Defines prior authorization and reauthorization clinical criteria for Gavreto (pralsetinib) for Colorado Rocky Mountain Health Plans members, including indications for NSCLC, thyroid cancers, and biliary tract cancers; applies to pharmacy benefit coverage determinations.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyGavreto (pralsetinib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2026

Next Review DateNov 20, 2025

Key ActionSubmit prior authorization demonstrating indication-specific clinical and molecular criteria (or note that members under 19 auto-process).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

age <19auto-approve pediatric

12 monthsauthorization duration

NCCN recognizedNCCN recognition

NSCLC/thyroid/biliaryprimary indications

Coverage Criteria for Gavreto (pralsetinib)

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Patients less than 19 years of age

Approval for patients under 19 years

Pediatric approval: (a) Patient is less than 19 years of age

Authorization will be issued for 12 months

NSCLC

Covered when ALL of the following are met:

NSCLC initial authorization: (1) Diagnosis of non-small cell lung cancer (NSCLC) AND (2) Disease is recurrent, advanced, or metastatic AND (3) Presence of RET rearrangement positive tumors

Authorization will be issued for 12 months

Thyroid carcinoma (various histologies)

Covered when ONE of the listed histology-specific groups is met:

Follicular or Papillary carcinoma: (a) Diagnosis of follicular or papillary carcinoma AND (b) Unresectable locoregional recurrent, persistent, or metastatic disease AND (c) Disease is RET gene-fusion positive AND (d) Disease is not amenable to radioactive iodine therapy

Oncocytic carcinoma: (a) Diagnosis of oncocytic carcinoma AND (b) Unresectable locoregional recurrent, persistent, or metastatic disease AND (c) Disease is RET gene-fusion positive

Medullary carcinoma: (a) Diagnosis of medullary carcinoma AND (b) Unresectable locoregional disease that is symptomatic or progressing, or recurrent, or with persistent distant metastases AND (c) Disease is RET-mutation positive

Anaplastic carcinoma: (a) Diagnosis of anaplastic carcinoma AND (b) Disease is stage IVA or IVB (locoregional) or metastatic AND (c) Disease is RET gene fusion positive

Thyroid reauthorization: Patient does not show evidence of progressive disease while on Gavreto therapy

Authorization will be issued for 12 months

Biliary tract cancers (gallbladder, cholangiocarcinoma)

Covered when ALL of the following are met for gallbladder or cholangiocarcinoma:

Diagnosis group: Either (a) Gallbladder cancer with resectable locoregionally advanced, unresectable, resected gross residual (R2), or metastatic disease OR (b) Cholangiocarcinoma with unresectable, resected gross residual (R2), or metastatic disease

Molecular requirement: Disease is positive for RET gene fusion mutation

Biliary reauthorization: Patient does not show evidence of progressive disease while on Gavreto therapy

Authorization will be issued for 12 months

NCCN recommended regimens

NCCN recognition: Drug has NCCN Drugs and Biologics Compendium Category of Evidence and Consensus of 1, 2A, or 2B

May be considered per compendium

Some states have mandates that may supersede the policy language for coverage or compendium use. For members who are 19 years of age, the prescription will automatically process without a coverage review, and authorization will be issued according to the standard duration noted elsewhere in this policy.

Provider Actions, Authorization and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Gavreto. Initial authorization criteria differ by indication (NSCLC, thyroid carcinomas, gallbladder/cholangiocarcinoma). Authorization is typically issued for 12 months when criteria are met.

Applies to initial and reauthorization requests; reauthorization requires no evidence of progressive disease while on therapy.
Initial authorization criteria vary by diagnosis (see denial triggers below for common failure points).

Denial Risk

Denial Risk — NSCLC Criteria Not Met

Denial may be triggered if the diagnosis is not non-small cell lung cancer (NSCLC) when approval is being sought under the NSCLC criteria, or if the NSCLC disease is not described as recurrent, advanced, or metastatic as required.

NSCLC initial-authorization requires: (1) diagnosis of NSCLC AND (2) disease that is recurrent, advanced, or metastatic AND (3) presence of RET rearrangement–positive tumor.

Denial Risk

Denial Risk — Thyroid Carcinoma Criteria Not Met

Denial may be triggered for thyroid carcinoma cases that do not meet the specific histology, disease extent, RET positivity, or radioactive iodine–related criteria.

Thyroid histologies covered include follicular, papillary, oncocytic, medullary, and anaplastic carcinomas — each has distinct requirements for unresectable/locoregional recurrent/persistent/metastatic disease and RET gene-fusion or RET-mutation positivity.
For follicular/papillary carcinoma: disease must be unresectable locoregional recurrent, persistent, or metastatic, RET gene-fusion positive, and not amenable to radioactive iodine.
For oncocytic carcinoma: disease must be unresectable locoregional recurrent, persistent, or metastatic and RET gene-fusion positive.
For medullary carcinoma: disease must be unresectable locoregional symptomatic/progressing, recurrent, or with persistent distant metastases and RET-mutation positive.
For anaplastic carcinoma: disease must be stage IVA/IVB locoregional or metastatic and RET gene-fusion positive.

Denial Risk

Denial Risk — Gallbladder / Cholangiocarcinoma Criteria Not Met

Denial may be triggered for gallbladder or cholangiocarcinoma cases that are not RET gene-fusion positive or that do not meet the listed disease-extent requirements.

Gallbladder criteria require diagnosis of gallbladder cancer with resectable locoregionally advanced, unresectable, resected gross residual (R2), or metastatic disease AND RET gene-fusion positivity.
Cholangiocarcinoma criteria require diagnosis of cholangiocarcinoma with unresectable, resected gross residual (R2), or metastatic disease AND RET gene-fusion positivity.

Note

Prior Approval and Automated Decisioning

Prior approval decisions may be based solely on previous claim or medication history, diagnosis codes (ICD-10), and/or claim logic; automated approval and re-approval processes may be used. Supply limits may apply.

Plan may use prior claims/medication history or ICD-10 diagnosis codes to approve initial or reauthorization requests without additional documentation.
Check for program-specific automated approval rules and any applicable supply limits when submitting requests.

Initial Authorization Criteria

Initial authorization

Initial authorization requires indication-specific clinical and molecular criteria.

NSCLC initial: Diagnosis of NSCLC; disease is recurrent, advanced, or metastatic; presence of RET rearrangement positive tumors

Authorization will be issued for 12 months

Thyroid initial groups: Meets one histology-specific group (follicular/papillary; oncocytic; medullary; anaplastic) with required disease extent and RET positivity and radioactive iodine criteria where specified

Biliary initial: Diagnosis of gallbladder or cholangiocarcinoma with specified disease extent AND disease is RET gene fusion positive

Authorization will be issued for 12 months

Definitions and Key Terms

RET fusion-positive / RET rearrangement positive — definition required for coverage.

DefinitionRET fusion-positive (RET rearrangement positive): presence of a RET gene rearrangement or fusion detected in tumor tissue; required molecular finding for coverage of listed indications (e.g., metastatic NSCLC, select thyroid cancers, biliary tract cancers).

Test specimenDetection is based on tumor tissue molecular testing (per the policy requirement for RET gene fusion/rearrangement).

Relevance to indicationsRequired for coverage in metastatic NSCLC, advanced/metastatic thyroid cancer (age ≥12 when systemic therapy indicated), and RET fusion–positive biliary tract cancers per NCCN recognition.

radioactive iodine-refractory — definition related to thyroid cancer eligibility.

DefinitionRadioactive iodine‑refractory: thyroid cancer that is not amenable to radioactive iodine therapy or is refractory when radioactive iodine would otherwise be appropriate.

ApplicabilityApplies to advanced or metastatic RET fusion–positive thyroid cancer patients 12 years and older who require systemic therapy (per the policy background).

Implication for coveragePatients must be radioactive iodine‑refractory (when radioactive iodine is appropriate) to meet the thyroid cancer coverage criteria where specified.

OpenPayer

Gavreto (pralsetinib) prior authorization

Coverage Criteria for Gavreto (pralsetinib)

Provider Actions, Authorization and Denial Triggers

Initial Authorization Criteria

Reauthorization / Continuation Criteria

Definitions and Key Terms

Background

Step Therapy / Supply Limits