CurrentAmbetter NevadaPolicy CP.PHAR.808

Clinical Policy: Gedatolisib (Revtorpyk)

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This policy governs prior authorization and medical-necessity coverage for gedatolisib (Revtorpyk) for Ambetter members, including commercial, HIM/ICHRA, and Medicaid lines of business. It primarily covers adults with HR-positive, HER2-negative, locally advanced or metastatic breast cancer without a detected PIK3CA mutation after progression on metastatic endocrine therapy.

Policy Summary

PayerAmbetter Nevada

PolicyGedatolisib (Revtorpyk)

Policy CodePolicy CP.PHAR.808

Change TypeNo material change

Effective DateDec 1, 202635d

Last ReviewNov 1, 20265d

Next Review DateN/A

Key ActionSubmit office chart notes, laboratory results, or other clinical information supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age

HR+/HER2−Required tumor profile

160 mgMaximum weekly dose

130 mgMinimum dose

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CurrentAmbetter NevadaPolicy CP.PHAR.808

Clinical Policy: Gedatolisib (Revtorpyk)

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Policy Summary

PayerAmbetter Nevada

PolicyGedatolisib (Revtorpyk)

Policy CodePolicy CP.PHAR.808

Change TypeNo material change

Effective DateDec 1, 202635d

Last ReviewNov 1, 20265d

Next Review DateN/A

Key ActionSubmit office chart notes, laboratory results, or other clinical information supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age

HR+/HER2−Required tumor profile

160 mgMaximum weekly dose

130 mgMinimum dose

6 or 12 mo.Approval duration

Coverage Criteria

Initial approval: breast cancer

Covered when ALL of the following are met.

Initial approval requirements

Clinical eligibility: The member has a diagnosis of breast cancer, the medication is prescribed by or in consultation with an oncologist, and the member is age 18 years or older.Age ≥ 18 years
Disease characteristics: The disease is HR-positive, HER2-negative, locally advanced or metastatic, and has no detected PIK3CA mutation.
Treatment regimen and prior therapy: The medication is prescribed in combination with fulvestrant, with or without Ibrance (palbociclib), and the disease has progressed on or after an endocrine-based therapy regimen in the metastatic setting.
Premenopausal status: If the member is a premenopausal female, the member has been treated with ovarian ablation or suppression.
Dose pathway
- Standard dose: The dose does not exceed 160 mg once weekly on Days 1, 8, and 15 of every 28-day cycle and is at least 130 mg per dose.130 mg ≤ dose ≤ 160 mg on Days 1, 8, and 15 every 28 days
- Evidence-supported off-label dose: The dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use, and the prescriber submits supporting evidence.

Continued therapy: breast cancer

Covered when ALL of the following are met.

Continued breast cancer therapy

Current treatment status: The member is currently receiving the medication through the Centene benefit, or documentation supports that the member is currently receiving Revtorpyk for breast cancer and has received it for at least 30 days.At least 30 days when documentation is used instead of current Centene benefit receipt
Clinical response: The member is responding positively to therapy.
Dose increase pathway
- Standard increased dose: The new dose does not exceed 160 mg once weekly on Days 1, 8, and 15 of every 28-day cycle and is at least 130 mg per dose.

Other diagnoses and indications

Other diagnoses or indications must meet ONE of the following pathways.

Alternative coverage pathway

Recent label change: The drug has undergone a label change within the last 6 months, such as a newly approved indication, age expansion, or new dosing regimen, that is not yet reflected in this policy. Refer to the applicable no-coverage-criteria or non-formulary policy based on formulary or PDL status and line of business.Within the last 6 months
Other off-label use: The requested use, including diagnosis, age, or dosing regimen, is not specifically listed under the diagnoses or indications for which coverage is not authorized, and the recent-label-change pathway does not apply. Refer to the applicable off-label use policy for the line of business.

Non-FDA-approved indications that are not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided under the applicable off-label use policy—CP.CPA.09 for commercial members, HIM.PA.154 for health insurance marketplace/ICHRA members, or CP.PMN.53 for Medicaid members—or under the applicable evidence of coverage documents.

Coding and Dose Parameters

HCPCS CodesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

HCPCS CodesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Standard weekly dose

Maximum doseDoes not exceed 160 mg once weekly

Dosing daysDays 1, 8, and 15

CycleEvery 28-day cycle

Minimum dose

Minimum doseAt least 130 mg per dose

Tolerance thresholdPatients unable to tolerate 130 mg per dose must permanently discontinue treatment

Application

Provider Requirements and Decision Points

Prior Authorization

Prior Authorization Required

Prior authorization is required. The provider must submit documentation demonstrating that all applicable approval criteria are met for Revtorpyk.

Submit documentation supporting diagnosis, prescribing requirements, clinical eligibility, treatment regimen, and applicable dosing criteria.

Step Therapy

Prior Metastatic Endocrine Therapy

For initial approval, the member’s breast cancer must have progressed on or after an endocrine-based therapy regimen in the metastatic setting.

Document prior metastatic endocrine-based therapy and disease progression after that therapy.

Policy Background

Gedatolisib (Revtorpyk) is a kinase inhibitor. This policy addresses its use with fulvestrant, with or without palbociclib (Ibrance), for adults with HR-positive, HER2-negative, locally advanced or metastatic breast cancer without a detected PIK3CA mutation after progression on at least one endocrine-therapy line in the metastatic setting.

Definitions

HR-positive

TermHR-positive

MeaningHormone receptor-positive disease

Receptor profileEstrogen receptor-positive and/or progesterone receptor-positive disease

HER2

AbbreviationHER2

Full termHuman epidermal growth factor receptor 2

Policy disease profileThe covered breast cancer indication requires HER2-negative disease

Initial Breast Cancer Therapy

Initial breast cancer therapy

Initial therapy requires ALL of the following breast cancer criteria.

Clinical eligibility: The member has a diagnosis of breast cancer, the medication is prescribed by or in consultation with an oncologist, and the member is age 18 years or older.Age ≥ 18 years
Disease characteristics: The disease is HR-positive, HER2-negative, locally advanced or metastatic, and has no detected PIK3CA mutation.
Treatment regimen and prior therapy: The medication is prescribed in combination with fulvestrant, with or without Ibrance (palbociclib), and the disease has progressed on or after an endocrine-based therapy regimen in the metastatic setting.

Continued Therapy

Continued therapy

Continued therapy is covered when ALL of the following criteria are met.

Continued breast cancer therapy

Current treatment status: The member is currently receiving the medication through the Centene benefit, or documentation supports that the member is currently receiving Revtorpyk for breast cancer and has received it for at least 30 days.At least 30 days when documentation is used instead of current Centene benefit receipt
Clinical response: The member is responding positively to therapy.
Dose increase pathway
- Standard increased dose:

Required Prior Therapy

Step	Required prior therapy	Coverage condition
1	At least one line of endocrine therapy in the metastatic setting before Revtorpyk	Disease has progressed on or after an endocrine-based therapy regimen in the metastatic setting.

Policy Summary

PayerAmbetter Nevada

PolicyGedatolisib (Revtorpyk)

Policy CodePolicy CP.PHAR.808

Change TypeNo material change

Effective DateDec 1, 202635d

Last ReviewNov 1, 20265d

Next Review DateN/A

Key ActionSubmit office chart notes, laboratory results, or other clinical information supporting that the member meets all approval criteria.

SourceLink

On This Page

130 mg ≤ new dose ≤ 160 mg on Days 1, 8, and 15 every 28 days

Evidence-supported off-label increase: The new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use, and the prescriber submits supporting evidence.

The minimum dose applies to the standard dosing pathway

FDA dosage regimen

Dose180 mg intravenously once weekly

ScheduleDays 1, 8, and 15 of a 28-day cycle

Treatment durationContinue until disease progression or unacceptable toxicity

Documentation Required

Clinical Documentation Required

The provider must submit clinical documentation supporting that the member meets all approval criteria. Acceptable supporting information may include office chart notes, laboratory results, or other relevant clinical records.

Include records supporting diagnosis, receptor status, HER2 status, disease stage, PIK3CA mutation status, prior therapy, and requested regimen.

Unsupported block type: documentation

Documentation Required

Continuation Therapy Documentation

For continued therapy, documentation must support that the member is currently receiving Revtorpyk through the Centene benefit or has received it for at least 30 days, and that the member is responding positively to therapy.

Document current or prior Revtorpyk therapy through the applicable benefit.
Document positive response to treatment.
For a dose increase, document compliance with the applicable dose parameters or provide guideline or peer-reviewed literature support for off-label dosing.

Denial Risk

Clinical Eligibility Not Met

Coverage may be denied when clinical eligibility requirements are not met, including requirements related to diagnosis, age, receptor status, disease setting, mutation status, combination therapy, or prior treatment.

Breast cancer diagnosis is required.
Member must be age 18 years or older.
Disease must be HR-positive, HER2-negative, locally advanced or metastatic, and without PIK3CA mutations.
Therapy must be prescribed by or in consultation with an oncologist and in combination with fulvestrant, with or without Ibrance.
Premenopausal females must have received ovarian ablation or suppression.

Denial Risk

Dose Outside Policy Parameters

Requests may be denied when the requested dose is outside the policy parameters and no qualifying clinical support is submitted.

Standard dose must not exceed 160 mg once weekly on Days 1, 8, and 15 of each 28-day cycle.
Standard dose must be at least 130 mg per dose.
For dose increases, the new dose must meet the same maximum and minimum parameters unless supported by practice guidelines or peer-reviewed literature for the relevant off-label use.

Denial Risk

Unaddressed Indication

Coverage is not authorized for non-FDA-approved indications that are not addressed by this policy unless sufficient documentation of efficacy and safety is submitted under the applicable off-label use policy or evidence of coverage document.

For Ambetter Nevada marketplace coverage, consult CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, or CP.PMN.53 for Medicaid, as applicable.
Submit evidence supporting efficacy and safety for the unaddressed indication.

Ovarian ablation/suppression

Surgical ablationSurgical oophorectomy

Radiation ablationOvarian irradiation

Medication-based suppressionLuteinizing hormone-releasing hormone (LHRH) agonists, including goserelin and leuprolide

Hormonal effectSuppression of ovarian estrogen production

Premenopausal status: If the member is a premenopausal female, the member has been treated with ovarian ablation or suppression.

Dose pathway

Standard dose: The dose does not exceed 160 mg once weekly on Days 1, 8, and 15 of every 28-day cycle and is at least 130 mg per dose.130 mg ≤ dose ≤ 160 mg on Days 1, 8, and 15 every 28 days
Evidence-supported off-label dose: The dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use, and the prescriber submits supporting evidence.

The new dose does not exceed 160 mg once weekly on Days 1, 8, and 15 of every 28-day cycle and is at least 130 mg per dose.

130 mg ≤ new dose ≤ 160 mg on Days 1, 8, and 15 every 28 days

Evidence-supported off-label increase: The new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use, and the prescriber submits supporting evidence.