CurrentCareSourcePolicy N/A

Torisel (temsirolimus) utilization management

Defines prior authorization, coverage criteria, dosing limits, and authorized indications for intravenous temsirolimus (Torisel) for CareSource members; applies to providers requesting medical benefit coverage.

Policy Summary

PayerCareSource

PolicyTorisel (temsirolimus) utilization management

Policy CodePolicy N/A

Change TypeAnnual revision with indication and disease-state updates

Effective DateN/A

Next Review DateDec 11, 2024

Key ActionObtain prior authorization and document oncologist involvement; approve for 1 year when the patient meets the listed criteria and dosing limits.

SourceLink

POLICY UPDATE CHANGES

Endometrial Carcinoma: Added requirement that the patient has either endometrial carcinoma or uterine perivascular epithelioid cell tumor (PEComa).

Renal Cell Carcinoma: Removed relapsed and metastatic from requirement that the patient has advanced disease.

Endometrial Carcinoma: Added 'advanced' and 'inoperable', and removed 'high-risk' from the disease-state requirement.

3indications with recommended authorization criteria

25 mgmaximum individual dose per infusion

1 yearstandard approval duration

kidney changeNCCN guidance note

Recommended Authorization Criteria

Initial Therapy (Renal Cell Carcinoma)

Covered when ALL of the following are met:

Renal Cell Carcinoma approval: Patient is ≥ 18 years of age; Patient has advanced disease; Torisel will be used as a single-agent; The medication is prescribed by or in consultation with an oncologist.Each individual dose must not exceed 25 mg IV no more frequently than once weekly.

Approve for 1 year.

Initial Therapy (Endometrial Carcinoma / Uterine PEComa)

Covered when ALL of the following are met:

Endometrial Carcinoma or Uterine PEComa: Patient is ≥ 18 years of age; Patient has advanced, recurrent, metastatic, or inoperable disease; Patient has ONE of: (i) endometrial carcinoma OR (ii) uterine perivascular epithelioid cell tumor (PEComa); Torisel will be used as a single-agent; The medication is prescribed by or in consultation with an oncologist.

Policy Summary

PayerCareSource

PolicyTorisel (temsirolimus) utilization management

Policy CodePolicy N/A

Change TypeAnnual revision with indication and disease-state updates

Effective DateN/A

Next Review DateDec 11, 2024

Key ActionObtain prior authorization and document oncologist involvement; approve for 1 year when the patient meets the listed criteria and dosing limits.

SourceLink

On This Page

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.

Each individual dose must not exceed 25 mg IV no more frequently than once weekly.

Initial Therapy (Soft Tissue Sarcoma)

Covered when ALL of the following are met:

Soft Tissue Sarcoma: Patient is ≥ 18 years of age; Patient has ONE of: (i) perivascular epithelioid cell tumors (PEComas) OR (ii) recurrent lymphangioleiomyomatosis OR (iii) recurrent angiomyolipoma OR (iv) non-pleomorphic rhabdomyosarcoma; Patient meets ONE of: (i) Torisel used as a single-agent OR (ii) Torisel used in combination with cyclophosphamide and vinorelbine; The medication is prescribed by or in consultation with an oncologist.Each individual dose must not exceed 25 mg IV no more frequently than once weekly.

Approve for 1 year.

Coverage of Torisel (temsirolimus) is not recommended for indications or uses that are not explicitly listed in the Recommended Authorization Criteria. The policy will not approve requests outside those specified criteria and will be updated if new published data support additional uses.

Authorized Regimens and Combinations

Regimen	Indication / Patient criteria	Prescriber requirement	Coverage status
Torisel (temsirolimus) single-agent
Soft tissue sarcoma: Patient is ≥ 18 years of age; Patient has ONE of: (i) Perivascular epithelioid cell tumors (PEComas) OR (ii) Recurrent lymphangioleiomyomatosis OR (iii) Recurrent angiomyolipoma OR (iv) Non-pleomorphic rhabdomyosarcoma; Approve for 1 year; each dose ≤ 25 mg IV no more frequently than once weekly.
Prescribed by or in consultation with an oncologist
Covered with criteria

Regimen	Indication / Patient criteria	Prescriber requirement	Coverage status
Torisel (temsirolimus) single-agent
Endometrial carcinoma or uterine PEComa: Patient is ≥ 18 years of age; Patient has advanced, recurrent, metastatic, or inoperable disease; Torisel will be used as a single-agent; Approve for 1 year; each dose ≤ 25 mg IV no more frequently than once weekly.
Prescribed by or in consultation with an oncologist
Covered with criteria

Dosing and Administration Limits

inv-05: Maximum single dose — 25 mg per infusion

Maximum single doseEach individual dose must not exceed 25 mg administered by intravenous infusion.

Applies to indicationsStated dosing limit applies to renal cell carcinoma, endometrial carcinoma/uterine PEComa, and specified soft tissue sarcoma indications.

Approval duration linked to doseApprovals are recommended for 1 year when criteria are met and dosing limits (≤25 mg per infusion) are followed.

inv-06: Dosing frequency — no more frequently than once weekly

Dosing frequencyDoses should be administered no more frequently than once weekly (each individual dose no more frequently than once a week).

Route of administrationIntravenous infusion — frequency restriction applies to IV dosing as specified.

Conjunction with approvalFrequency limit is part of the dosing constraints required for 1‑year approval when clinical criteria are met.

Prior Authorization, Documentation, and Review

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are recommended for up to 1 year when the patient meets the listed criteria for the specific indication and dosing. Requests for doses outside the established dosing in this policy will be considered on a case-by-case basis by clinician review (e.g., Medical Director or Pharmacist).

Approve for 1 year when criteria and dosing are met for the FDA‑approved and supported indications listed in this policy
Dose exceptions: clinician review required for requests outside established dosing (case-by-case)

Documentation Required

Required Documentation and Prescriber Specialty

Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Torisel, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist).

Required prescriber specialty: Oncology involvement (prescribed by or in consultation with an oncologist)
Documentation: Supportive clinical information must be provided to demonstrate the patient meets all indication-specific criteria (age, disease stage, single-agent vs combination use, and indication-specific diagnoses) and dosing limits

Denial Risk

Coverage Outside Criteria

Coverage is not recommended for requests that do not meet the Recommended Authorization Criteria contained in this policy. Criteria will be updated as new published data become available.

Requests outside the listed criteria are not recommended for approval

Place in Therapy

Line of Therapy

Line of therapy: Policy specifies approved indications (renal cell carcinoma; endometrial carcinoma/uterine PEComa; select soft tissue sarcomas) but does not explicitly define first-line versus later lines of therapy. Refer to indication-specific criteria and current NCCN guidance (note: NCCN no longer recommends Torisel for relapsed or stage IV renal cell carcinoma).

Refer to indication-specific criteria for dosing and approval duration (each dose ≤ 25 mg IV no more frequently than once weekly; approve for 1 year).

Key Terms

inv-12: mTOR inhibitor — definition and brief description

DefinitionmTOR inhibitor: A class of drugs that inhibit the mammalian target of rapamycin (mTOR) pathway; temsirolimus (Torisel) is an intravenous mTOR inhibitor.

Indicated useTorisel is indicated for the treatment of advanced renal cell carcinoma and has supportive evidence for select endometrial and soft tissue sarcoma indications.

AdministrationTemsirolimus (Torisel) is administered by intravenous infusion as described in the policy dosing sections.

Clinical Background

Temsirolimus (Torisel) is an intravenous mTOR inhibitor that works by inhibiting the mammalian target of rapamycin pathway and is indicated for treatment of advanced renal cell carcinoma. Clinical guidance and evidence also support select uses in endometrial carcinoma, uterine perivascular epithelioid cell tumors (PEComa), and certain soft tissue sarcomas. Prior authorization is recommended for medical benefit coverage; when the listed authorization criteria are met, approvals are typically issued for 1 year with dosing limits of ≤ 25 mg per infusion and no more frequently than once weekly.