CurrentEmblemHealthPolicy N/A

Torisel_Usage_Policy

Defines accepted indications, contraindications, exclusion criteria, coding, applicable lines of business, and continuation/authorization expectations for Torisel (temsirolimus) utilization and reimbursement under Evolent/EmblemHealth-managed plans.

Policy Summary

PayerEmblemHealth

PolicyTorisel_Usage_Policy

Policy CodePolicy N/A

Change Typerevised

Effective Date

Next Review Date

Key ActionMedication requests must be processed/authorized by Evolent and supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature; continuation requests must meet continuation criteria (no progression, prior use within 1 year without >30 day lapse, no added medications).

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1200 Torisel policy; indication section and references updated.

1Primary Covered Indication

1Absolute Contraindication (bilirubin >1.5xULN)

25Single Dose Maximum (mg)

Coverage Summary

Coverage stance: covered_with_criteria. Scope: defines accepted indications, contraindications, exclusions, coding (HCPCS J9330), continuation and authorization expectations for Torisel (temsirolimus) under Evolent/EmblemHealth-managed plans. High-level coverage rule: Torisel (temsirolimus) is authorized as monotherapy for relapsed/refractory metastatic renal cell carcinoma (RCC) when documentation and evidence meet policy criteria; it is not authorized for first-line (initial) treatment of RCC. Use must be supported by FDA labeling, CMS‑approved compendia, NCCN/ASCO guidelines, or adequate peer‑reviewed evidence per policy; continuation requests must meet the continuation criteria (no progression, prior use within 1 year without >30 day lapse, no added medications).

General Coverage Requirements / Continuation

Covered when ALL of the following are met:

Acceptable evidence for use: Use is supported by one of: FDA approved product labeling, CMS‑approved compendia, NCCN, ASCO clinical guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.
Continuation request exemption criteria
- No disease progression: The member has not experienced disease progression on the requested medication.
- Recent prior use: The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
- No added medications: Additional medication(s) are not being added to the continuation request.

Indication: Renal Cell Carcinoma (RCC)

Torisel may be used when the following are satisfied:

Indication - relapsed/refractory metastatic RCC: Indication: relapsed/refractory metastatic renal cell carcinoma (RCC) as monotherapy.
Not for first-line use: Not authorized for initial (first-line) treatment of RCC. Policy notes lack of Level 1 evidence showing superior outcomes versus single‑agent oral TKIs or immune checkpoint inhibitor regimens; alternative agents/regimens recommended by Evolent should be considered.

Contraindications & Exclusions (Not Covered)

Contraindications / Exclusions (Not Covered)

Not covered when ANY of the following are present:

Bilirubin contraindication: Bilirubin > 1.5 times the upper limit of normal (ULN).> 1.5 x ULN
Contraindication.
Progression on Torisel: Disease progression while taking Torisel (temsirolimus).
Exclusion criterion — therapy not covered if disease progression occurred on Torisel.
Concurrent combination use: Concurrent use with other chemotherapy, immunotherapy, or targeted therapy.
Exclusion — concurrent combination use is not allowed.
Single dose limit: Dosing exceeds single dose limit of Torisel (temsirolimus) 25 mg.25 mg
Investigational / off-label insufficient evidence
- Patient representation: Insufficient evidence defined by lack of representation of patient/ cancer clinical characteristics in published evidence.
- Regimen representation: Administered regimen not adequately represented in published evidence.
- Clinically meaningful outcomes: Reported study outcomes do not represent clinically meaningful outcomes (ASCO definitions: e.g., hazard ratio < 0.80 and recommended survival benefit for OS/PFS at least 3 months).HR < 0.80; OS/PFS benefit >= 3 months
- Study design and quality: Inappropriate experimental design or reliance on low‑quality evidence (case reports, abstracts without full article).

Key Thresholds

Single dose limit25 mg

Bilirubin contraindication threshold> 1.5 x ULN

Provider Actions & Authorization

Prior Authorization

Authorization required and documentation standards

All requests for Torisel (temsirolimus) must be authorized by Evolent prior to administration. Requests should be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature that meets the standards outlined in CMS Medicare Benefit Policy Manual Chapter 15. Continuation requests should refer to the policy's continuation criteria (no disease progression on the agent, prior use within the last year without >30-day lapse, and no addition of other medications).

Affected code: J9330

Denial Risk

Denial if exclusion criteria met

Requests will be denied when any exclusion criteria are met, including liver dysfunction with bilirubin > 1.5 × ULN, documented disease progression while receiving Torisel, concurrent administration with other chemotherapy, immunotherapy, or targeted therapy, single-dose administration exceeding 25 mg, or investigational/off‑label uses lacking sufficient evidence or general acceptance in the medical community. Off‑label or investigational indications without support from CMS compendia or acceptable peer‑reviewed literature are not approvable.

Affected code: J9330
Exclusion highlights: bilirubin >1.5×ULN; progression on Torisel; concurrent systemic oncologic therapies; single dose >25 mg; investigational/off-label uses without sufficient evidence

Documentation Required

Evidence requirements for off-label/less supported uses

For non‑FDA, non‑compendia, or otherwise less-supported uses, submit peer‑reviewed literature that directly represents the patient population and regimen under consideration, reports clinically meaningful outcomes as defined by ASCO (for example hazard ratio < 0.80 and recommended survival benefit thresholds such as ≥3 months for OS or PFS where applicable), and is derived from an appropriate study design. Well‑conducted nonrandomized trials with substantial subject numbers may be considered supportive when randomized trials are not feasible. Abstracts, meeting summaries without full peer‑reviewed publications, and case reports are generally insufficient to establish medical necessity.

Acceptable evidence must: represent the clinical characteristics of the patient and cancer; represent the administered regimen; report clinically meaningful outcomes per ASCO; use an appropriate experimental design
Unacceptable or generally insufficient: abstracts without full peer‑reviewed publication; case reports
Affected code: J9330

Clinical Evidence & References

Evidence summary: Key references include the Torisel prescribing information (Wyeth Pharmaceuticals LLC. 2023) and the cited 2025 compendia/guidelines (NCCN/ASCO/Clinical Pharmacology/Micromedex) referenced in the policy. The policy emphasizes that Level 1 evidence is lacking for first-line superiority of temsirolimus versus single‑agent oral tyrosine kinase inhibitors or immune checkpoint inhibitor regimens, and therefore alternatives recommended by Evolent (including regimens in Evolent Pathways) should be considered. Per policy, non‑FDA/compendia uses require peer‑reviewed literature that adequately represents the patient/regimen, reports clinically meaningful outcomes (ASCO thresholds), and uses appropriate study design; abstracts and case reports are generally insufficient.

Background

Background: Evolent (for EmblemHealth) defines utilization management expectations for temsirolimus based on FDA labeling, CMS‑approved compendia, NCCN/ASCO guidance, or adequate peer‑reviewed evidence per the CMS Medicare Benefit Policy Manual Chapter 15. The policy emphasizes authorized use as monotherapy in relapsed/refractory metastatic RCC and explicitly disallows first‑line use due to lack of Level 1 evidence showing superiority versus recommended alternatives. Continuation and exclusion rules (e.g., no progression, prior use within one year without >30 day lapse, no concurrent systemic anticancer agents, bilirubin > 1.5 x ULN contraindicates use, single dose limit 25 mg) are specified and govern authorization decisions.

Policy Metadata

Scope summaryDefines accepted indications, contraindications, exclusion criteria, coding, applicable lines of business, and continuation/authorization expectations for Torisel (temsirolimus) utilization and reimbursement under Evolent/EmblemHealth-managed plans.

SubjectTorisel (temsirolimus) usage

StatusCURRENT

Confidence0.84