Prior authorization required — include diagnosis, specialist, platelet counts, prior therapies

Prior authorization is required for agents covered under this policy. Requests must document the diagnosis of ITP, that the medication is prescribed by or in consultation with a hematologist (or other specified specialist as applicable), platelet counts within the previous 30 days meeting the policy thresholds, and prior therapy and response (insufficient response to corticosteroids or IVIG when required). For romiplostim (Nplate) administered medically, billing uses HCPCS J2802 and prior authorization requirements apply.

• Diagnosis of ITP must be documented.
• Prescribed by or in consultation with a hematologist (or specified specialist for non‑ITP indications).
• Platelet counts within previous 30 days meeting policy thresholds (<30 x10^9/L or <50 x10^9/L with significant bleeding, or other drug‑specific thresholds).
• Documentation of prior therapy and insufficient response to corticosteroids or IVIG when required.
• Romiplostim (Nplate) billed HCPCS J2802 — subject to prior authorization.

Prior authorization required — show criteria are met (diagnosis, specialist, platelet thresholds)

Prior authorization requests must show that the applicable coverage criteria are met: documented diagnosis, required specialist prescriber or consultation, and platelet thresholds within the previous 30 days as specified in the policy for the requested indication.

• Document which coverage criteria node the request is seeking (e.g., ITP, peri‑procedural CLD, SAA).
• Include required specialist (hematologist, hepatologist/gastroenterologist, infectious disease as applicable).
• Provide platelet count within 30 days that meets the threshold for the indication.

Prior authorization for listed ITP agents — includes Nplate (HCPCS J2802)

Prior authorization applies to the ITP therapies listed in the policy, including medical administration of romiplostim (Nplate) which is billed under HCPCS J2802; providers must follow Univera Healthcare pharmacy management prior authorization procedures.

• For Nplate (romiplostim) medical administration, use HCPCS J2802 on claims.
• Follow Univera Healthcare prior authorization processes for therapies listed in this policy.

Step therapy expectations — agents indicated after insufficient response to steroids or IVIG

Step therapy expectations: TPO receptor agonists and other agents in this policy are indicated after insufficient response to first‑line corticosteroids or IVIG; requests should document prior therapies and inadequate response before initiating these agents.

• Document prior use of corticosteroids and/or IVIG and evidence of insufficient response (policy defines insufficient response).
• Indicate why first‑line therapies were ineffective or not tolerated.

Step therapy considerations — trials may be required; exceptions allowed

Step therapy or a trial of preferred agents may be required per contract; exceptions to step therapy are allowed when contraindicated, expected to be ineffective, previously tried under the current or prior plan, or the member is stable on the requested drug.

• If a preferred agent trial is waived, supportive documentation of prior drug use is required.
• Provide clinical rationale if claiming contraindication or expected inefficacy of preferred agents.

Policy revision note — consult revision history for updated step‑therapy/sequencing

The policy has undergone multiple revisions and P&T committee reviews; providers should consult the policy revision history for details that may affect step therapy or sequencing requirements.

• Revision and P&T Committee review dates are listed in the policy updates.
• Check the full policy for any changes to sequencing or step therapy resulting from recent revisions.

Required documentation — diagnosis, prescriber specialty/hematologist consult, platelet counts, prior therapies

Required documentation for prior authorization and recertification includes diagnosis, prescriber specialty or documentation of consultation with a hematologist (or other specified specialist), platelet counts within the previous 30 days meeting policy thresholds, and prior treatment history including insufficient response to corticosteroids or IVIG.

• Confirm diagnosis (ITP, chronic liver disease with thrombocytopenia, SAA, etc.).
• Provide specialist prescriber or consultation note (hematology; hepatology/gastroenterology or infectious disease for specific indications).
• Include platelet count within 30 days that meets the indication threshold.
• Document prior therapies and evidence of insufficient response when required.

Clinical documentation requirements — progress notes, labs, treatment history, genetic/biomarker results, imaging

Clinical documentation must be submitted for each initial and recertification request and should include progress notes, laboratory test results, treatment history, and when relevant genetic/biomarker results or imaging to support medical necessity and continued benefit.

• Progress notes documenting prior treatments and response.
• Recent lab results (platelet counts within 30 days).
• Treatment history and evidence of benefit or stability for recertification.
• Genetic/biomarker results or imaging if relevant to the indication.

Use prescribing information documents to support requests for referenced agents

When submitting clinical details, include prescribing information documents for the referenced agents (for example Nplate, Promacta, Alvaiz, Doptelet, Tavalisse, Wayrilz, Mulpleta) to support dosing, indications, and other agent‑specific information.

• Attach or reference manufacturer prescribing information for the requested agent where relevant.

ITP initial therapy denial triggers — missing diagnosis, hematologist involvement, platelet counts, prior insufficient response

Denial triggers for initial ITP therapy requests include failure to document the diagnosis of ITP, lack of hematologist involvement, missing platelet counts within 30 days that meet policy thresholds, or missing documentation of prior insufficient response to corticosteroids or IVIG.

• Missing or out‑of‑range platelet counts within 30 days.
• No documentation of insufficient response to required prior therapies.
• No hematologist prescriber or consultation noted.

Peri‑procedural agent denial triggers — missing procedure date, platelet count, or prescriber specialty

Peri‑procedural agent requests (e.g., avatrombopag, lusutrombopag) may be denied if the request lacks the procedure date, a platelet count within 30 days that meets the policy threshold (<50 x10^9/L), or appropriate prescriber specialty/consultation documentation.

• Include scheduled procedure date and timing relative to dosing.
• Provide platelet count within 30 days prior to procedure.
• Document prescriber specialty (hepatology, gastroenterology, or hematology).

General denial risk — missing clinical documentation or unmet plan/contract criteria; Nplate claim risks

General denial risk: requests lacking adequate clinical documentation of diagnosis, prior treatment trials, laboratory results, or that do not meet plan/contract criteria may be denied; claims for Nplate billed under HCPCS J2802 are subject to the policy's pharmacy management rules and may be denied if criteria are not met.

• Insufficient supporting clinical documentation for initial or recertification requests.
• Failure to meet contract‑specific utilization management rules or formularies.
• Claims for Nplate (J2802) without meeting medical necessity criteria may be denied.

Billing rule — Nplate (romiplostim) claims billed under HCPCS J2802 subject to prior authorization and denial if criteria unmet

Claims for Nplate (romiplostim) billed under HCPCS J2802 are listed in the policy and subject to the plan's pharmacy management prior authorization and medical necessity rules; claims may be denied if documentation and criteria are not met.

• Use HCPCS code J2802 for Nplate (romiplostim).
• Ensure prior authorization and clinical criteria are met before billing.