Immune Checkpoint Inhibitor Clinical Review Prior Authorization (CRPA)
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Defines prior-authorization (Clinical Review Prior Authorization, CRPA) criteria for oncologic immune checkpoint inhibitor drugs across Univera Healthcare lines of business (excluding Medicare Part D). Applies to provider requests for coverage of listed PD-1, PD-L1, CTLA-4, and LAG-3 inhibitors.
No material clinical or coverage changes in this revision.
Coverage Criteria
Universal Criteria
Universal criteria — coverage requires ALL of the following:
See drug‑specific criteria in Table 4 and Table 5 for details.
Approval Timeframes and Recertification
Recertification and duration rules:
Table 1 lists LOB‑specific timeframes; recertification reviews may require trial of more cost‑effective alternatives as available.
Drug-specific Maximum Durations
Duration limits for specific drugs/indications (per Table 3):
Refer to Table 3 for the complete mapping of drug, diagnosis, and maximum duration.
Step Therapy Criteria
Step therapy requirements for new starts:
Adequate medical justification includes contraindication, intolerance, or documented failure on preferred therapy.
See Table 5 for agent‑ and indication‑specific step requirements.
Drug-specific coverage with agent-preference condition
Covered when drug-specific indication is met AND any required agent-preference conditions are satisfied
See each drug entry in the drug specific criteria (Table 4) for exact indications and regimen details.
Document rationale in the prior authorization request (e.g., contraindication, intolerance, or prior treatment failure).
Accelerated approval considerations
Coverage conditional on FDA accelerated approval status
Links to FDA pages for ongoing, verified, and withdrawn accelerated approvals are provided in the policy.
This policy does not apply to Medicare Part D and D‑SNP pharmacy benefits; it applies to other lines of business including commercial and Medicare Advantage. For members covered under Medicare Advantage, any medication subject to a National Coverage Determination (NCD) or Local Coverage Determination (LCD) will be adjudicated according to the NCD/LCD criteria listed on the CMS website. Where an NCD/LCD does not address the indication, coverage is determined per the Health Plan's criteria (which may reference the Off‑Label Use policy). Step therapy may be imposed in addition to NCD/LCD requirements.
Treatments whose FDA accelerated approval indication has been withdrawn are not eligible for new starts under this policy. Coverage of a withdrawn accelerated approval indication will only be considered for patients who were established on therapy prior to the withdrawal date listed on the FDA webpage; providers should consult the FDA accelerated approvals pages for current withdrawn/verified/ongoing status.
Use of an immune checkpoint inhibitor following documented disease progression on a prior immune checkpoint inhibitor is generally considered experimental and investigational and will be subject to off‑label review unless otherwise supported by NCCN compendia or explicit drug‑specific criteria. Requests must therefore include clinical justification and relevant evidence when seeking coverage in this context.
Codes referenced in this policy follow the policy's code key. Individual HCPCS codes for drug‑specific requests are listed within the drug sections; reimbursement eligibility depends on the member's contract. Per the code key, a code may be designated Not Medically Necessary (NMN) or Experimental/Investigational (E/I), and such designations affect coverage determinations.
Coding
| J9023 | Bavencio (avelumab) |
| J9173 | Imfinzi (durvalumab) |
| J9347 | Imjudo (tremelimumab-actl) |
| J9272 | Jemperli (dostarlimab-gxly) |
| J9271 | Keytruda (pembrolizumab) |
| J9277 | Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) |
| J9119 | Libtayo (cemiplimab-rwlc) |
| J3263 | Loqtorzi (toripalimab-tpzi) |
| J9299 | Opdivo (nivolumab) |
| J9289 | Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) |
| J9298 | Opdualag (nivolumab/relatlimab-rmbw) |
| HCPCS | See drug specific criteria for the associated HCPCS code |
Provider Actions & Requirements
CRPA prior authorization required
Prior authorization via the Immune Checkpoint Inhibitors Clinical Review Prior Authorization (CRPA) is required. A Letter of Medical Necessity (LOMN), Exception Form, or Prior Authorization Form must be completed for consideration of drug coverage under this policy.
- Completion of LOMN, Exception Form, or Prior Authorization Form is required for consideration.
Drug‑specific CRPA prior authorization
Prior authorization is required per the drug‑specific CRPA criteria; providers must reference the drug‑specific HCPCS codes in the policy for billing and claims alignment when submitting requests.
Step therapy required for new starts (Table 5)
Step therapy applies to new starts only for the agents and indications listed in Table 5; requests must document trial and failure of preferred agents or provide adequate medical justification why preferred agents cannot be used.
- Applies to new starts only (Table 5).
- Adequate medical justification includes contraindication or intolerable side effects or prior trial failure.
Agent‑preference / step requirement
Many agents require demonstration that preferred agents cannot be used before approving alternate agents; for example, requests often must explain why pembrolizumab (Keytruda) or Keytruda Qlex (and in some cases atezolizumab) are unsuitable.
- Document why Keytruda or Keytruda Qlex cannot be used.
- Some agents additionally require justification relative to Tecentriq (atezolizumab) or other named preferred agents.
Submit required clinical documentation
Clinical documentation must be submitted for each request (initial and recertification), including progress notes, laboratory results, genetic/biomarker testing, imaging, and documentation of prior drug use when step or trial requirements exist.
- Supportive documentation of previous drug use must be submitted when a trial of a preferred agent is required and not found in claims history.
- Dose and frequency should be consistent with FDA labeling, NCCN, or peer‑reviewed literature.
Provide medical justification for alternative agents
When requesting an alternative immune checkpoint inhibitor, provide adequate medical justification explaining why the preferred agent(s) (e.g., pembrolizumab/Keytruda or Keytruda Qlex) cannot be used; supportive documentation should substantiate contraindication, intolerance, or prior failure.
- Justification may include contraindication, likely harm, expected ineffectiveness, intolerance, or prior discontinuation for lack of efficacy.
- Support with prior treatment records or claims history when possible.
Risk of denial for nonconforming indications
Requests that do not meet the policy criteria may be subject to off‑label review and may be denied if not supported by FDA labeling or NCCN level 1 or 2A evidence.
Withdrawn accelerated approvals — continuation only if established prior
Coverage for indications with withdrawn FDA accelerated approvals will only be considered for patients who were established on therapy prior to the FDA withdrawal date; providers should verify accelerated approval status on the FDA accelerated approvals pages.
- Providers should consult the FDA pages for ongoing, verified, and withdrawn accelerated approvals.
- Coverage will only be considered for members established on therapy before the withdrawal date.
Initial Therapy Criteria
Initial Therapy and Step Requirements
New start requirements
Applies only to drug‑indication pairs listed in Table 5.
See agent‑specific entries for examples and required justification.
Initial therapy indications (agent-specific)
Agent-specific first-line or single-agent uses
See the drug‑specific criteria lines for agent and indication details.
Continuation / Recertification Criteria
Continuation Therapy
Recertification requirements
Approval timeframes for recertification are listed in Table 1 (commonly 6 months).
Continuation for withdrawn accelerated approvals
Continuation for indications with regulatory changes
Providers should consult the FDA accelerated approvals webpages linked in the policy to confirm withdrawal dates and status.
Step Therapy
| Applies to | Scope / Note |
|---|---|
| New starts only | |
| Step therapy requirements apply to specified drug–indication pairs listed in Table 5; criteria apply to shared FDA‑labeled or compendia‑supported indications (NCCN level 1 or 2A). Adequate medical justification includes contraindication to preferred product or intolerable side‑effects; use without progression after a preferred product trial may still be appropriate. |
| Requirement | What to document |
|---|---|
| Prior authorization frequently requires medical justification that preferred agent(s) are unsuitable before approving alternate agents. | |
| Documentation should describe why pembrolizumab (Keytruda) or Keytruda Qlex (and where specified, atezolizumab or other named preferred agents) cannot be used — examples include contraindication, intolerance, or prior trial failure; include clinical notes, labs, and prior therapy details. |
Site of Care
Site‑of‑care may impact approval timeframe
Requested site of care (e.g., infusion center) may affect the approval timeframe and is subject to review during prior authorization.
Background
Immune checkpoint inhibitors — including agents that block PD‑1, PD‑L1, CTLA‑4, and LAG‑3 — enhance antitumor immune activity by blocking inhibitory receptors or their ligands. Use of these agents is guided by FDA‑approved indications or, where appropriate, by NCCN recommendations (level 1 or 2A) and the clinical criteria in this policy.
Definitions
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