CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Torisel (temsirolimus) — Coverage Criteria

Defines accepted indications, continuation, exclusion criteria, and approval authority for temsirolimus (Torisel) for members whose medication requests are processed by Evolent on behalf of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTorisel (temsirolimus) — Coverage Criteria

Policy CodePolicy N/A

Change TypeRoutine review — no material changes

Effective DateMay 31, 2024

Next Review DateMay 8, 2024

Key ActionObtain prior authorization via Evolent; support use with FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

25 mgsingle dose maximum

May 31, 2024effective date

RR mRCCcovered indication

not first-linetreatment line

Coverage Criteria for Temsirolimus (Torisel)

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Indication: Torisel (temsirolimus) is requested as monotherapy for relapsed/refractory metastatic renal cell carcinoma (RCC).

Line of therapy: Not requested for initial (first-line) treatment of RCC; use in the first-line setting is not supported by policy.

Supportive evidence: Use is supported by FDA product labeling, a CMS-recognized compendium, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

Continuation criteria: For continuation (renewal) requests: the medication was used within the last year; the member has not experienced disease progression and/or intolerance to the medication; and no additional medications are being added to the continuation request.

The policy excludes coverage in several specific clinical scenarios. Coverage is not provided for disease progression while taking Torisel (temsirolimus). Concurrent administration of Torisel with other systemic anticancer agents is prohibited; specifically, concurrent use with other chemotherapy, immunotherapy, or targeted therapy is an exclusion. Requests that exceed the established dosing limit are not approvable — the policy sets a single dose limit of 25 mg for Torisel and dosing above this threshold constitutes an exclusion. Finally, investigational or off‑label indications lacking sufficient evidence or not generally accepted by the medical community are excluded, with sufficiency defined by criteria including representativeness of patient/cancer characteristics, regimen representation, clinically meaningful outcomes (ASCO definitions), appropriate study design, and preference for randomized trials where feasible.

Torisel (temsirolimus) is not supported for initial (first‑line) treatment of renal cell carcinoma under this policy. This position is based on the lack of Level 1 evidence (randomized clinical trials and/or meta‑analyses) demonstrating superior outcomes versus single‑agent oral tyrosine kinase inhibitors or immune checkpoint inhibitors; therefore Torisel is reserved as monotherapy for relapsed/refractory metastatic RCC rather than a first‑line option.

Regimen	Indication	Dosing / Limits	Coverage
Temsirolimus (Torisel) — single-agent
Relapsed/refractory metastatic renal cell carcinoma (not first-line)
Single-agent dosing must not exceed 25 mg per single dose
Covered with criteria (monotherapy for relapsed/refractory metastatic RCC; not supported for initial/first-line RCC)

Coding and Dose Limits

Single dose limit — Torisel (temsirolimus)

Maximum single dose25 mg per single administration of Torisel (temsirolimus)

Related exclusionRequests exceeding this single-dose limit are listed as an exclusion and risk denial

ApplicabilityLimit applies to all dosing requests processed by Evolent per this policy

Policy locationDocumented under Exclusion Criteria (dosing exceeds single dose limit)

Provider Actions, Prior Authorization, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization via Utilization Management — all medication requests are processed by Evolent. Final approval authority resides with the Utilization Management Committee; UM review and decision criteria apply.

Requests must be submitted to Evolent for prior authorization and will be reviewed by the UM Department.
Final approval decisions are made by the Utilization Management Committee.

Note

Permitted and Not Permitted RCC Use

Torisel may be used as monotherapy for relapsed/refractory metastatic renal cell carcinoma (RCC), but NOT for initial (first-line) treatment of RCC. Initial RCC treatment with Torisel is not supported due to lack of Level 1 evidence showing superior outcomes versus recommended alternatives.

Allowed: Monotherapy for relapsed/refractory metastatic RCC (post‑first line).
Not supported: Initial (first‑line) treatment of RCC.

Documentation Required

Evidence Requirements

Use of Torisel must be supported by one of the following sources: FDA‑approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature that meets CMS Medicare standards.

Acceptable evidence: FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Denial Risk

Denial Risk — Exclusions and Dose Limits

Denial risk exists if any exclusion criteria are met, including dosing that exceeds a single dose limit of 25 mg, investigational or off‑label indications lacking sufficient evidence, concurrent use with other chemotherapy/immunotherapy/targeted therapy, or disease progression while on Torisel.

Dosing limit: Single dose must not exceed 25 mg.
Exclusions: Disease progression while taking Torisel; concurrent use with other anticancer therapies; investigational/off‑label uses without sufficient supporting evidence per policy.

Drug	Allowed Use	Single-dose Maximum	Coverage Status
Temsirolimus (Torisel) — single-agent
Monotherapy for relapsed/refractory metastatic renal cell carcinoma; not supported for initial (first-line) RCC
25 mg per single dose maximum
Covered with criteria

Definitions and Evidence Standards

Definition — Sufficient evidence

Accepted sources of evidenceFDA-approved product labeling; CMS-recognized compendia; NCCN or ASCO clinical guidelines; or acceptable peer‑reviewed literature

Criteria for sufficiency — representativenessPublished evidence should adequately represent the clinical characteristics of the patient and the cancer

Criteria for sufficiency — regimen representationPublished evidence should adequately represent the administered therapy regimen (chemotherapy/biologic/targeted/immune therapy)

Criteria for sufficiency — clinically meaningful outcomesReported outcomes should be clinically meaningful (ASCO definitions preferred; e.g., HR <0.80 and OS/PFS benefit ≥3 months)

Criteria for sufficiency — study design and evidence typeAppropriate experimental design is required; well‑conducted non‑randomized trials may be supportive, while case reports and meeting abstracts without full peer‑reviewed articles are insufficient

Background

Temsirolimus (Torisel) is an mTOR inhibitor with an established oncology label and supporting compendia references. Within this policy, use of Torisel is principally restricted to monotherapy for relapsed/refractory metastatic renal cell carcinoma. The policy explicitly disallows its use as initial therapy for RCC due to insufficient Level 1 evidence comparing it to preferred first‑line agents (oral TKIs or immune checkpoint inhibitors).