CurrentEmblemHealthPolicy MG.MM.PH.173

Torisel (temsirolimus) Intravenous

Clinical coverage criteria for temsirolimus (Torisel) IV for treatment of advanced renal cell carcinoma and select other malignancies; applies to EmblemHealth/ConnectiCare medical benefit determinations and providers requesting authorization.

Policy Summary

PayerEmblemHealth

PolicyTorisel (temsirolimus) Intravenous

Policy CodePolicy MG.MM.PH.173

Change TypeRevisions to indication language and authorization duration

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that the patient meets the listed clinical criteria (e.g., diagnosis, age ≥18, disease status, and oncology prescribing/consultation).

SourceLink

POLICY UPDATE CHANGES

Initial Criteria for Renal Cell Carcinoma (RCC) revised to remove 'relapsed and Metastatic' from the patient disease descriptor.

Endometrial carcinoma criteria revised: removed 'high risk', added 'inoperable disease', and added requirement that diagnosis be either endometrial carcinoma or uterine PEComa.

Length of authorization increased from 6 months to 12 months (historical revision reflected).

25 mgper dose maximum

12 monthsauthorization duration

J9330HCPCS

00008-1179-xx

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.

≥18min patient age

Coverage Criteria

Initial Therapy - Covered Indications

Torisel may be considered medically necessary when any of the following selection criteria is met:

Covered indications

Renal Cell Carcinoma (RCC)
- Age: Patient is ≥ 18 years of age≥18 years
- Disease status: Patient has advanced disease
- Agent use: Torisel will be used as a single-agent
- Prescriber: The medication is prescribed by or in consultation with an oncologist

Renal Cell Carcinoma (RCC)

Age: Patient is ≥ 18 years of age≥18 years
Disease status: Patient has advanced disease
Agent use: Torisel will be used as a single-agent
Prescriber: The medication is prescribed by or in consultation with an oncologist

Other Uses with Supportive Evidence

Approve for the following non‑FDA–labeled indications when ALL listed criteria for that indication are met:

Other supported indications

Endometrial Carcinoma
- Age: Patient is ≥ 18 years of age≥18 years
- Disease status: Patient has recurrent, metastatic, or inoperable disease
- Agent use: Torisel will be used as a single-agent

Renewal Therapy

Coverage may be renewed when ALL of the following are met:

Renewal approval conditions

Continued eligibility: Patient continues to meet criteria in INITIAL APPROVAL CRITERIA
Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread
Toxicity: Absence of unacceptable toxicity from the drug (examples provided)
Examples include severe hypersensitivity/infusion reactions, hepatic impairment, hyperglycemia/glucose intolerance, infections, interstitial lung disease, hyperlipidemia, bowel perforation, renal failure, wound healing complications, intracerebral hemorrhage, proteinuria/nephrotic syndrome

Toxicity: Absence of unacceptable toxicity from the drug (examples provided)

Coverage for Torisel (temsirolimus) is subject to specific limitations. Use of Torisel is not medically necessary when any of the following conditions are present: the member has moderate to severe liver disease with total bilirubin > 1.5 x ULN; the drug is administered without recommended pretreatment medications (for example, diphenhydramine); the member demonstrates disease progression while on Torisel; Torisel is given concurrently with other chemotherapy agents; dosing exceeds the per-dose maximum of 25 mg; or the requested indication is not supported by CMS-recognized compendia or acceptable peer‑reviewed literature.

When one or more of the Limitations/Exclusions above apply, the request for Torisel will be judged not medically necessary and is likely to be denied or not reimbursed. Examples leading to exclusion include inadequate pretreatment to reduce infusion reactions, bilirubin above the specified threshold, concurrent chemotherapy use, exceeding the single‑dose limit of 25 mg, disease progression on temsirolimus, or indications lacking supporting compendia or literature.

Covered Regimens and Dosing

Indication	Permitted Regimens/Combinations	Coverage Status
Soft tissue sarcoma (PEComa, recurrent lymphangioleiomyomatosis, recurrent angiomyolipoma, non-pleomorphic rhabdomyosarcoma)
Torisel as a single‑agent OR Torisel in combination with cyclophosphamide and vinorelbine
Prescribed by or in consultation with an oncologist; patient ≥ 18 years

Dose	Route & Frequency	Infusion Time	Premedication	Duration/Stopping Criteria	Coverage Status
25 mg
Intravenous, once weekly
Infuse over 30 to 60 minutes
Diphenhydramine 25–50 mg IV given ~30 minutes prior to each dose
Continue until disease progression or unacceptable toxicity
Covered with criteria (see indications)

Coding

Applicable Procedure CodesHCPCSCovered

J9330

Injection, temsirolimus, 1 mg, 1 billable unit = 1 mg

Applicable NDCsNDCCovered

00008-1179-xx

Torisel 25 mg/ml injection

Applicable ICD-10 DiagnosesICD-10

C48.0	Malignant neoplasm of retroperitoneum
C48.1	Malignant neoplasm of specified parts of peritoneum
C48.2	Malignant neoplasm of peritoneum, unspecified
C48.8	Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C49.0	Malignant neoplasm of connective and soft tissue of head, face and neck
C49.10	Malignant neoplasm of connective and soft tissue of unspecified upper limb, including
C49.11	Malignant neoplasm of connective and soft tissue of right upper limb, including shoulder
C49.12	Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder
C49.20	Malignant neoplasm of connective and soft tissue of unspecified lower limb, including hip
C49.21	Malignant neoplasm of connective and soft tissue of right lower limb, including hip

1–10 of 32

1/4

Bilirubin (denial risk)

Bilirubin threshold> 1.5 x ULN is considered moderate to severe liver disease and may trigger denial

Policy impactUse is not medically necessary when bilirubin > 1.5 x ULN

Action for providersAssess baseline liver function tests prior to initiating Torisel; document bilirubin level in authorization request

Per-dose billable units

Per-dose billing units25 billable units per 7 days (1 billable unit = 1 mg); maximum single dose = 25 mg

Dose equivalence

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. The treating physician or primary care provider must submit clinical documentation demonstrating that the member meets the criteria for treatment (e.g., diagnosis, age ≥18, advanced or recurrent/metastatic/inoperable disease as applicable, use as single-agent unless combination allowed, and prescription by or in consultation with an oncologist). Requests without required documentation cannot be properly reviewed for preauthorization or post-payment review.

Document diagnosis and stage (e.g., RCC, endometrial carcinoma, PEComa, soft tissue sarcoma)
Confirm age ≥ 18 where required
Confirm advanced, recurrent, metastatic, or inoperable disease where required
Specify single-agent use or allowed combination regimen
Include treating or consulting oncologist name and rationale

Step Therapy

Line of Therapy

Informational

Informational: policy does not specify line‑of‑therapy sequencing.

RCC guidance: Policy no longer specifies first-line vs subsequent lines; criteria require advanced disease and single-agent use

Background

Temsirolimus (Torisel) is an inhibitor of the mammalian target of rapamycin (mTOR). It binds with high affinity to the intracellular immunophilin FKBP‑12, and the resulting complex inhibits mTOR kinase activity, which leads to cell‑cycle arrest in G1 and downstream antiproliferative effects. Temsirolimus is FDA‑approved for advanced renal cell carcinoma and is used off‑label in certain gynecologic and soft tissue malignancies. The recommended administration is 25 mg IV infused over 30–60 minutes once weekly until disease progression or unacceptable toxicity; patients should be premedicated (for example, with diphenhydramine 25–50 mg IV ~30 minutes prior to each dose) to reduce infusion reactions. Billing is per milligram (HCPCS J9330), with a per‑dose maximum of 25 billable units per 7 days (1 billable unit = 1 mg).

Torisel (temsirolimus) — key facts

Mechanism of actionBinds FKBP-12; the complex inhibits mTOR kinase causing G1 cell-cycle arrest and reduced tumor size

FDA-approved indicationApproved for treatment of advanced renal cell carcinoma

Non‑FDA uses noted in policyListed non‑FDA labeled indications include endometrial cancer and soft tissue sarcoma

Revision History

2025-02-10Annual review - RCC criteriaLatest

Initial criteria for Renal Cell Carcinoma (RCC) revised to remove 'relapsed and Metastatic' from the disease descriptor.

2024-01-02Annual review - Endometrial criteria and renewal

Endometrial carcinoma criteria revised to remove 'high risk', add 'inoperable disease', and require diagnosis be endometrial carcinoma or uterine PEComa; renewal criteria expanded to define disease response and list examples of unacceptable toxicity.

2023-04-17Policy revision - authorization length

Policy Summary

PayerEmblemHealth

PolicyTorisel (temsirolimus) Intravenous

Policy CodePolicy MG.MM.PH.173

Change TypeRevisions to indication language and authorization duration

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that the patient meets the listed clinical criteria (e.g., diagnosis, age ≥18, disease status, and oncology prescribing/consultation).

SourceLink

On This Page

Patient has ONE of the following: endometrial carcinoma OR uterine perivascular epithelioid cell tumor (PEComa)

Prescriber: The medication is prescribed by or in consultation with an oncologist

Soft Tissue Sarcoma

Age: Patient is ≥ 18 years of age≥18 years
Tumor types: Patient has ONE of: PEComas; recurrent lymphangioleiomyomatosis; recurrent angiomyolipoma; non-pleomorphic rhabdomyosarcoma
Agent use: Torisel will be used as a single-agent OR in combination with cyclophosphamide and vinorelbine
Prescriber: The medication is prescribed by or in consultation with an oncologist

Endometrial Carcinoma

Age: Patient is ≥ 18 years of age≥18 years
Disease status: Patient has recurrent, metastatic, or inoperable disease
Agent use: Torisel will be used as a single-agent
Histology: Patient has ONE of the following: endometrial carcinoma OR uterine perivascular epithelioid cell tumor (PEComa)
Prescriber: The medication is prescribed by or in consultation with an oncologist

Examples include severe hypersensitivity/infusion reactions, hepatic impairment, hyperglycemia/glucose intolerance, infections, interstitial lung disease, hyperlipidemia, bowel perforation, renal failure, wound healing complications, intracerebral hemorrhage, proteinuria/nephrotic syndrome

1 billable unit = 1 mg of temsirolimus

Administration frequency25 mg IV once weekly (per Dosage/Administration guidance)

No specific step-therapy or prior-agent sequencing is required by this policy. Coverage decisions are based on the clinical criteria met for the indicated diagnosis rather than prior use of other agents.

Documentation Required

Required Clinical Documentation

Submit all supporting clinical evidence with the authorization request or for post-payment review. EmblemHealth will use this documentation to determine medical necessity.

History and physical and relevant clinical notes
Pathology or diagnostic reports confirming diagnosis and disease extent
Prior treatment history and response (including progression on temsirolimus if applicable)
Chemotherapy regimen details if used in combination
Medication orders or prescriptions showing dose (single dose limit 25 mg) and planned administration schedule
Oncology consultation notes documenting rationale for temsirolimus

Denial Risk

Triggers for Denial

The following conditions may trigger denial of the request. Verify these items are addressed in the submission to avoid denial risk.

Bilirubin > 1.5 × ULN (moderate to severe liver disease)
Temsirolimus used without required premedication (e.g., diphenhydramine)
Evidence of disease progression while on temsirolimus
Concurrent use of temsirolimus with other chemotherapy when not allowed
Dosing that exceeds single dose limit of 25 mg
Indications not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature

Length of authorization increased from 6 months to 12 months.