CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Thalomid (thalidomide) — Drug Policy (coverage criteria)

Defines accepted indications, authorization and continuation rules for Thalomid (thalidomide) for cancer treatment and describes evidentiary sources required for coverage; applies to medication requests processed by Evolent on behalf of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyThalomid (thalidomide) — Drug Policy (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateNov 29, 2024

Next Review DateNov 13, 2024

Key ActionSubmit prior authorization with documentation of indication and supporting evidence from FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

200 mgsingle dose max

28/56/28/28monthly limits

11/13/24committee review

11/29/24effective

Coverage Criteria

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inv-01: Continuation Therapy Exemption

Continuation requests exemption

Continuation exemption: Continuation requests are exempt from this policy when ALL of the following are met: (1) the requested medication was used within the last year; (2) the member has not experienced disease progression or intolerance to the requested medication; (3) no additional medication(s) are being added to the continuation request.

inv-02: Multiple Myeloma — Initial and Subsequent Regimens

Covered uses for Multiple Myeloma when any ONE of the following clinical situations applies

MM regimen uses: Member has multiple myeloma and Thalomid (thalidomide) is being used in any ONE of the following: (a) in combination with Velcade (bortezomib) + dexamethasone +/- Darzalex/Darzalex Faspro (daratumumab) as primary/initial therapy for transplant-eligible newly diagnosed multiple myeloma; (b) as part of VTD-PACE (bortezomib, dexamethasone, thalidomide, cisplatin, doxorubicin, cyclophosphamide, and etoposide) for relapsed/refractory multiple myeloma or as a subsequent line of therapy; (c) in DT-PACE (dexamethasone, thalidomide, cisplatin, doxorubicin, cyclophosphamide, and etoposide) for relapsed/refractory multiple myeloma.

Exclusions and limits: Coverage excludes dosing that exceeds the single dose limit of 200 mg; excludes dosing exceeding monthly capsule limits (28 x 50 mg; 56 x 100 mg; 28 x 150 mg; 28 x 200 mg); excludes use when the member has disease progression on or after taking Thalomid (thalidomide); and excludes investigational or off‑label uses not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. Sufficient evidence criteria for off‑label use include representation of patient and therapy characteristics, appropriate experimental design, and reliance on adequate clinical outcomes (see policy for details).

Investigational or off‑label uses of Thalomid (thalidomide) that lack sufficient supporting evidence or are not generally accepted by the medical community are not covered. The policy excludes requests when the proposed off‑label indication does not meet standards for adequate evidence — for example, when the patient or therapy characteristics are not adequately represented in the published evidence, the regimen under study is not representative of the requested use, study design is inadequate to answer the clinical question, or reliance is on uncontrolled case reports or abstracts without full peer‑reviewed publication. Such investigational/off‑label uses are specifically listed as exclusions under the Multiple Myeloma coverage criteria.

Requests for Thalomid (thalidomide) that are not supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO clinical guidelines, or acceptable peer‑reviewed literature meeting CMS standards will be considered not approvable / not medically necessary. The policy applies CMS standards when evaluating evidence — including whether study outcomes are clinically meaningful (e.g., ASCO‑recommended thresholds such as hazard ratios and survival benefit), whether study design is appropriate, and downgrading evidence based on uncontrolled case reports or meeting abstracts without full articles.

Initial Therapy (Multiple Myeloma)

inv-14: Initial Therapy (Multiple Myeloma)

Initial/primary therapy for transplant-eligible newly diagnosed multiple myeloma when used in specified combination regimen

Initial therapy: Thalidomide (Thalomid) in combination with bortezomib + dexamethasone with or without daratumumab is an accepted initial/primary line of therapy for transplant‑eligible newly diagnosed multiple myeloma.

Continuation Therapy

inv-15: Continuation Therapy

Continuation requests may be exempt from policy requirements if criteria are met.

Continuation exemption: Continuation requests are exempt when the medication was used within the last year; the member has not experienced disease progression or intolerance to the medication; and no additional medications are being added to the continuation request.

Quantity Limits

inv-17: Thalomid (thalidomide) — 28 (50 mg), 56 (100 mg), 28 (150 mg), 28 (200 mg) capsules/month; single dose limit 200 mg

Monthly capsule limits by strength28 capsules (50 mg); 56 capsules (100 mg); 28 capsules (150 mg); 28 capsules (200 mg)

Single-dose limit200 mg per dose

ApplicabilityLimits apply to Thalomid (thalidomide) when used for multiple myeloma regimens listed in the policy

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required. Evolent processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Prior authorization required with documentation of indication and evidence basis
Evolent is the authorizing entity for medication requests

Note

Regimen-Based Use Defined

Regimen-based uses are defined by this policy — specific combination regimens (e.g., VTD-PACE, DT-PACE, and combinations with bortezomib + dexamethasone ± daratumumab) are recognized indications rather than a step-wise monotherapy sequence.

Regimen examples: VTD-PACE, DT-PACE, Velcade (bortezomib) + Dexamethasone ± Darzalex/Darzalex Faspro (daratumumab)

Documentation Required

Evidence Support Required

Evidence support required — Use must be supported by FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or peer-reviewed literature that meets CMS standards per the Medicare Benefit Policy Manual Chapter 15.

Acceptable evidence sources: FDA labeling, CMS-recognized compendia, NCCN, ASCO, peer-reviewed literature meeting CMS requirements

Denial Risk

Investigational / Off-Label Use Denial Risk

Investigational or off-label uses without sufficient supporting evidence may be denied. Off-label indications not generally accepted by the medical community or not supported by CMS compendia/acceptable peer-reviewed literature are at risk for denial.

Use for investigational/off-label indications lacking sufficient evidence may be denied
Sufficient evidence must represent the patient and regimen in published literature

Denial Risk

Dose & Quantity Exceedance Denial Risk

Dose and quantity exceedance denial risk — Requests that exceed single dose limits or monthly capsule quantity limits may be denied.

Single dose limit: Thalomid (thalidomide) 200 mg
Monthly capsule limits noted: 28 (50 mg), 56 (100 mg), 28 (150 mg), 28 (200 mg) — requests exceeding these may be denied

Step Therapy / Regimen Sequencing

Step therapy policy	Details
Regimen-based acceptance (no step edits)	Policy defines accepted uses by specific combination regimens (e.g., thalidomide in combination with bortezomib + dexamethasone ± daratumumab for transplant‑eligible newly diagnosed multiple myeloma; VTD‑PACE or DT‑PACE for relapsed/refractory disease) rather than a step-wise monotherapy sequence. No explicit step therapy sequence or required prior trial of alternative monotherapies is specified.

Step therapy policy

Details

Regimen-based acceptance (no step edits)

Policy defines accepted uses by specific combination regimens (e.g., thalidomide in combination with bortezomib + dexamethasone ± daratumumab for transplant‑eligible newly diagnosed multiple myeloma; VTD‑PACE or DT‑PACE for relapsed/refractory disease) rather than a step-wise monotherapy sequence. No explicit step therapy sequence or required prior trial of alternative monotherapies is specified.

Definitions & Acceptable Evidence

inv-13: Acceptable evidence — FDA labeling, CMS-approved compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature meeting CMS standards

Acceptable evidence sourcesFDA-approved product labeling

Acceptable evidence sourcesCMS-recognized compendia

Acceptable evidence sourcesNCCN or ASCO clinical guidelines

Acceptable evidence standardPeer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements

Background

Thalidomide (Thalomid) is an antineoplastic / immunomodulatory agent used in oncology, notably for multiple myeloma where its role is as part of specific combination regimens. This policy covers Thalomid when used in defined multiple myeloma regimens — for example, in combination with bortezomib + dexamethasone ± daratumumab as initial therapy for transplant‑eligible newly diagnosed disease, and as part of VTD‑PACE or DT‑PACE regimens for relapsed/refractory disease. Continuation therapy requests are exempt from new‑start criteria when the medication was used within the last year, the member has not experienced disease progression or intolerance, and no additional medications are being added to the continuation request. Quantity and dosing limits apply (including a single dose limit of 200 mg and monthly capsule limits by strength).