CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Non‑Oncology Policy: Thalomid (thalidomide) — Non‑oncology indications

This policy governs coverage and prior authorization requirements for non-oncology indications of thalidomide (Thalomid) for Medicaid members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNon‑Oncology Thalomid (thalidomide) coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization; approvals may be granted for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

112/28dqty limit (100 mg)

28/28dqty limit (50 mg)

9compendial uses listed

Coverage and Medical Necessity Criteria

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Indication is listed: The request is for an indication listed in Section II: either the FDA-approved indication (Erythema Nodosum Leprosum) or one of the specified compendial uses (multicentric Castleman's disease; recurrent aphthous stomatitis; recurrent HIV-associated aphthous ulcers; cachexia in patients with cancer or HIV-associated wasting syndrome; diarrhea in patients with HIV infection; AIDS-related Kaposi's sarcoma; Behcet's syndrome; chronic graft-versus-host disease; Crohn's disease).

See Section I and II for full lists of covered indications.

Member eligibility and exclusions: Member has no exclusions to the prescribed therapy and the requested use is not an unlisted indication. All other indications not listed in Section II are considered experimental/investigational and not medically necessary.

See policy statement that unlisted indications are not medically necessary.

Limitation of use for ENL: For Erythema Nodosum Leprosum (ENL), thalidomide is indicated for acute treatment of cutaneous manifestations of moderate to severe ENL and for maintenance to prevent recurrence; it is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.

Refer to FDA-approved indication limitations.

Continuation of Therapy

Continuation therapy covered when ALL of the following are met

On-treatment response and tolerability: Member has not experienced unacceptable toxicity or disease progression while on the current regimen.

Authorization of up to 12 months may be granted for continued treatment when these conditions are met.

Authorization Durations

Authorization durations by indication (when covered)

Standard authorization length: Authorization of 12 months may be granted for treatment of the listed non-oncology indications; specific indications with 12-month authorization include erythema nodosum leprosum, recurrent HIV-associated aphthous ulcers, Behcet's syndrome, Crohn's disease, AIDS-related Kaposi's sarcoma (in combination with antiretroviral therapy), chronic graft-versus-host disease, multicentric Castleman's disease (relapsed/refractory/progressive), recurrent aphthous stomatitis, cachexia caused by HIV infection, and HIV-associated diarrhea.12 months

Policy indicates 12-month authorizations may be granted for each listed indication.

Required Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required and may be granted for up to 12 months for covered non-oncology indications when approval criteria are met.

Prior authorization required
Approval may be granted for up to 12 months for continuation

Step Therapy

No step therapy sequence is specified in this policy for initiation of thalidomide for covered indications.

Documentation Required

Indication Documentation

Documentation must support that the requested use is one of the FDA-approved indications or one of the compendial uses listed in Section II. Requests for indications not listed in Section II (FDA-approved indications and the listed compendial uses) are considered experimental/investigational and not covered.

Documentation must confirm FDA-approved indication or listed compendial use
Unlisted indications are considered experimental/investigational and not covered

Background

Thalidomide (Thalomid) has a set of recognized compendial uses which include: multicentric Castleman's disease; recurrent aphthous stomatitis; recurrent HIV‑associated aphthous ulcers; cachexia in patients with cancer or HIV‑associated wasting syndrome; diarrhea in patients with HIV infection; AIDS‑related Kaposi's sarcoma; Behcet's syndrome; chronic graft‑versus‑host disease; and Crohn's disease. Per the policy, indications outside of these listed uses are treated as experimental/investigational and not medically necessary.

Limitations and Definitions

Limitation of Use — ENL

Limitation of use (ENL)Thalidomide is not indicated as monotherapy for ENL treatment in the presence of moderate to severe neuritis.

ENL indications coveredAcute treatment of cutaneous manifestations of moderate to severe ENL and maintenance therapy for prevention/suppression of recurrence.

ApplicabilityThis limitation applies specifically to the FDA-approved ENL indication listed in the policy.