CurrentAnthemPolicy CC-0101

Torisel (temsirolimus) — Medical Drug Clinical Criteria / Coverage Criteria

Clinical criteria governing prior authorization and medical necessity determinations for temsirolimus (Torisel) under the medical benefit, focused on renal cell carcinoma, select soft tissue sarcomas, and uterine/endometrial neoplasms; applies to Anthem members in North Carolina.

Policy Summary

PayerAnthem

PolicyTorisel (temsirolimus) — Medical Drug Clinical Criteria

Policy CodePolicy CC-0101

Change TypeReviewed — no material changes

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization and submit clinical documentation demonstrating diagnosis, line of therapy, histology, and required prognostic factors or disease status.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3primary covered indications

>=3poor-prognosis risk factors required

Bili>1.5xexclusion lab threshold

KPS 60-70performance status cited

Coverage Criteria for Temsirolimus (Torisel)

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Covered indications and criteria

Requests for Torisel (temsirolimus) may be approved if ALL of the following matched criteria are met for the relevant indication.

Indication Group

I. Advanced Renal Cell Carcinoma - non-clear cell histology
- RCC usage: 1. Relapsed metastatic disease OR 2. Surgically unresectable stage IV disease with poor prognosis
  Poor prognosis requires >=3 of specified factors
- Poor prognosis criteria (counted): At least 3 of the following: LDH >1.5x ULN; hemoglobin below LLN; corrected calcium >10 mg/dL; interval <1 year from diagnosis to systemic therapy start; KPS 60-70 or ECOG 2-4; >=2 metastatic sites>=3 required
  Based on Hudes 2007 and NCCN
II. Soft Tissue Sarcoma: Temsirolimus as single agent for sarcomas including PEComa, recurrent angiomyolipoma, lymphangioleiomyomatosis OR temsirolimus in combination with cyclophosphamide and vinorelbine for non-pleomorphic rhabdomyosarcoma
Per NCCN 2A
III. Endometrial / Uterine PEComa: Temsirolimus as single-agent monotherapy for unresectable, recurrent, or metastatic endometrial adenocarcinoma or uterine PEComa
Per NCCN 2A

ref": "b0_0", "title": "Covered indications and criteria"}

ERROR

Regimen	Indication	Coverage
Temsirolimus plus cyclophosphamide and vinorelbine	Non-pleomorphic rhabdomyosarcoma	Covered

Regimen	Indication(s)	Coverage
Temsirolimus (single-agent monotherapy)	PEComa (including uterine PEComa); angiomyolipoma; lymphangioleiomyomatosis; select sarcomas; endometrial adenocarcinoma with unresectable, recurrent, or metastatic disease	Covered

Coding and Laboratory Thresholds

HCPCS / ICD-10 codes includedmixed

J84.81	Lymphangioleiomyomatosis
C48.0-C48.8	Malignant neoplasm of retroperitoneum and peritoneum
C49.0-C49.9	Malignant neoplasm of other connective and soft tissue
C54.0-C54.9	Malignant neoplasm of corpus uteri
C55	Malignant neoplasm of uterus, part unspecified
C64.1-C64.9	Malignant neoplasm of kidney, except renal pelvis
C65.1-C65.9	Malignant neoplasm of renal pelvis
Z85.528	Personal history of other malignant neoplasm of kidney

inv-05: Bilirubin — lab exclusion threshold value.

Bilirubin exclusion thresholdGreater than 1.5 times the upper limit of normal (ULN)

ContextRequests for Torisel may not be approved if bilirubin > 1.5 x ULN

Policy locationExcluded under 'Torisel (temsirolimus) may not be approved' section

inv-06: Lactate dehydrogenase (LDH) — lab threshold.

LDH threshold for poor-prognosis RCCLactate dehydrogenase (LDH) > 1.5 times the upper limit of normal (ULN)

UseOne of the counted poor-prognosis criteria required (>=3) for surgically unresectable stage IV RCC cohort

Source trial/guidanceHudes 2007 and NCCN Kidney Cancer Guidelines referenced in policy

inv-07: Corrected calcium — lab threshold.

Corrected calcium thresholdCorrected calcium > 10 mg/dL (2.5 mmol/L)

Role in criteriaCounted as one of the poor-prognosis factors (>=3 required) for unresectable stage IV RCC

Units notedProvided in mg/dL with mmol/L equivalent (2.5 mmol/L)

inv-08: Karnofsky Performance Status / ECOG — performance status thresholds cited for poor-prognosis RCC cohort.

Performance status threshold for poor-prognosis RCCKarnofsky performance status 60 to 70 OR ECOG performance score of 2, 3, or 4

RoleCounts as one of the poor-prognosis factors; >=3 of listed factors required to qualify poor-prognosis cohort

Equivalent mappingPolicy states KPS 60-70 is equivalent presentation to ECOG 2-4 for eligibility assessment

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval is granted only when the clinical criteria for the specific diagnosis and intended use are met.

Policy CC-0101 effective 2025-07-01
Applies to Torisel (temsirolimus) medical benefit requests

Documentation Required

Required Documentation

Clinical documentation must demonstrate the diagnosis, line of therapy, and prior treatments as applicable. Include relevant lab values and performance status when required by the clinical criteria (e.g., LDH, hemoglobin, corrected calcium, interval from diagnosis to systemic therapy, Karnofsky or ECOG score, sites of metastasis).

Document diagnosis using appropriate ICD-10 code(s) (e.g., C64.*, C49.*, C54.*, C48.*, J84.81 as applicable)
Provide indication-specific details: metastatic vs unresectable disease, histology (non-clear cell RCC, sarcoma subtypes, endometrial/PEComa), and prior lines of systemic therapy
Include labs when relevant (LDH, bilirubin, hemoglobin, corrected calcium) and performance status (Karnofsky or ECOG)

Denial Risk

Denial Triggers

Requests may be denied when coverage criteria are not met or when exclusion thresholds are present.

Denial trigger: Total bilirubin > 1.5 x ULN
Denial trigger: Missing or insufficient documentation to support diagnosis, line of therapy, prior treatments, or required lab/performance data
Denial trigger: Indication not listed in the clinical criteria (e.g., uses other than RCC, specified sarcoma indications, endometrial/PEComa) or criteria elements not satisfied

Line of Therapy Criteria

first-line | second-line

Line of therapy: Temsirolimus may be used as first-line in select poor-risk RCC (per label/NCCN) and as subsequent (second-line) therapy for relapsed metastatic or unresectable stage IV disease as specified

Policy references first-line and subsequent therapy in NCCN; use must match the indication branch

Background

Temsirolimus (Torisel) is an mTOR inhibitor with an approved role in advanced renal cell carcinoma and recognized by NCCN for select non-clear cell RCC and certain soft tissue sarcomas. The policy supports temsirolimus as single-agent therapy for indications such as PEComa, angiomyolipoma, lymphangioleiomyomatosis, and as part of a combination regimen with cyclophosphamide and vinorelbine for non-pleomorphic rhabdomyosarcoma. Approval decisions reference pivotal trial data and NCCN recommendations for poor-prognosis RCC and the listed sarcoma and uterine/endometrial indications.

Definitions

inv-13: KPS — Karnofsky Performance Status definition/value.

KPS definitionKarnofsky Performance Status (KPS): standard measure of ability to perform ordinary tasks; scores range 0 to 100 with higher scores indicating better function (NCI, 2015)

UseUsed to determine prognosis and eligibility for clinical trials or treatments in policy

Score interpretationHigher score = better ability to carry out daily activities; policy references 60–70 as a poor-prognosis range

inv-14: PEComa — definition and examples (angiomyolipoma, lymphangioleiomyomatosis).

PEComa definitionPerivascular epithelioid cell tumor (PEComa): a soft tissue mesenchymal tumor with perivascular epithelioid cell differentiation

Representative examplesAngiomyolipoma and lymphangioleiomyomatosis (also includes clear cell-sugar-tumor of the lung)

Clinical notesAngiomyolipoma often associated with tuberous sclerosis and commonly involves the kidney; lymphangioleiomyomatosis affects predominantly females of child-bearing age