Oncology Medication Clinical Coverage (for Pennsylvania Only)
Parameters for coverage of injectable oncology medications (including therapeutic radiopharmaceuticals and specified biologics/biosimilars) under the UnitedHealthcare Medical Benefit for Pennsylvania members.
Revised list of UnitedHealthcare preferred and non-preferred oncology products and added specific agents with HCPCS codes.
Replaced language about how unnamed FDA-approved products are treated for preferred status with clarified language including products approved via FDA 505(b)(2).
Added HCPCS codes J9045, J9174, J9184, J9196, J9201, J9275, J9277, J9278, and Q5160 to applicable codes.
Noted that coverage determinations shall be based upon U.S. FDA labeling when there is no NCCN Compendium entry.
Coverage Criteria for Injectable Oncology Medications
Diagnosis-Specific Coverage
Covered when NCCN Compendium recommendations or FDA labeling support the indication as follows:
Pediatric patients (<19 years) — all chemotherapy agents are covered for oncology indications.
Preferred vs Non-Preferred Product Criteria
Coverage preference and override conditions:
See Oncology Products table for preferred/non‑preferred designations.
Physician attestation and clinical history required per Preferred Product Criteria.
Coverage Rationale / Oncology Products
Covered when meeting plan, compendia, and FDA labeling considerations
Policy history clarifies FDA labeling is the fallback when NCCN is absent.
See Policy History and Oncology Products table for updated preferred/non‑preferred listings and HCPCS mappings.
CAR‑T and TIL products are addressed under Transplantation Services guidance rather than in this injectable oncology medications policy.
This policy does not provide coverage criteria for Chimeric Antigen Receptor (CAR)-T Cell or Tumor-Infiltrating Lymphocyte (TIL) cell products. Coverage for CAR‑T and TIL therapies is addressed under separate benefit guidance and is evaluated per the member's Transplantation Services benefit and OptumHealth Transplant Solutions criteria for CAR‑T/TIL therapies.
Any U.S. Food and Drug Administration–approved oncology product that is not listed by name in this policy — including products approved via the FDA 505(b)(2) pathway — will be treated as non-preferred until reviewed by the UnitedHealthcare Pharmacy & Therapeutics (P&T) committee. Preferred status for unnamed or newly approved agents must be established through UnitedHealthcare review before the product is considered preferred for coverage purposes.
Indications listed in the NCCN Drugs & Biologics Compendium with a Category of Evidence and Consensus of 3 are considered unproven and not medically necessary under this policy. Requests for coverage of therapies that are supported only by NCCN Category 3 recommendations may be denied.
Specific Regimens and Product Preferences
| Regimen | Indication | Coverage Status |
|---|---|---|
| Tecentriq (atezolizumab) + Mvasi (bevacizumab-awwb) | ||
| Hepatocellular carcinoma — combination systemic therapy | ||
| Covered when criteria met (per Oncology Products table) |
| Agent(s) | Indication(s) | Coverage Status |
|---|---|---|
| Keytruda (pembrolizumab) / Keytruda Qlex (pembrolizumab + berahyaluronidase alfa-pmph) / Libtayo (cemiplimab-rwlc) / Tecentriq (atezolizumab) and listed biosimilars/alternatives | ||
| Head and Neck Cancers: Cancer of the Nasopharynx — recurrent, unresectable, oligometastatic, or metastatic disease (nasopharyngeal) | ||
| Covered when NCCN/FDA-supported; specific preferred vs non-preferred designations apply per Oncology Products table |
| Agent | Indication | Preference Status |
|---|---|---|
| Keytruda (pembrolizumab) | ||
| Squamous Cell Skin Cancer | ||
| Non-Preferred (Policy designates Keytruda non-preferred for Squamous Cell Skin Cancer) |
Applicable Billing and HCPCS/J-Codes
| A9513 | Lutetium lu 177, dotatate, therapeutic, 1 millicurie. |
| A9590 | Iodine i-131, iobenguane, 1 millicurie. |
| A9607 | Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie. |
| A9606 | Radium Ra-223 dichloride, therapeutic, per microcurie. |
| A9699 | Radiopharmaceutical, therapeutic, not otherwise classified. |
| J0640 | Injection, leucovorin calcium, 50 mg. |
| J0641 | Injection, levoleucovorin, not otherwise specified, 0.5 mg. |
| J0642 | Injection, levoleucovorin (khapzory), 0.5 mg. |
| J1323 | Injection, elranatamab-bcmm, 1 mg. |
| J3263 | Injection, toripalimab-tpzi, 1 mg. |
| J9119 | Injection, cemiplimab-rwlc, 1 mg. |
| J9171 | Injection, docetaxel, 1 mg. |
| J9172 | Injection, docetaxel (Docivyx), 1 mg. |
| J9174 | Injection, docetaxel (Beizray), 1mg. |
| J9184 | Injection, gemcitabine hydrochloride (avyxa), 200 mg. |
| J9196 | Injection, gemcitabine hydrochloride (accord), 200 mg. |
| J9201 | Injection, gemcitabine hydrochloride, 200 mg. |
| J9205 | Injection, irinotecan liposome, 1 mg. |
| J9206 | Injection, irinotecan, 20 mg. |
| J9228 | Injection, ipilimumab, 1 mg. |
| J9304 | Injection, pemetrexed, 10 mg. |
| J9305 | Injection, pemetrexed nos 10mg. |
| J9310 | Injection, rituximab, 100 mg. |
| J9311 | Injection, rituximab 10 mg and hyaluronidase. |
| J9312 | Injection, rituximab, 10 mg. |
| J9314 | Injection, pemetrexed (Teva), not therapeutically equivalent to J9305, 10 mg. |
| J9324 | Injection, pemetrexed (Pemrydi RTU), 10 mg. |
| J9329 | Injection, tislelizumab-jsgr, 1mg. |
| J9355 | Injection, trastuzumab, 10 mg. |
| J9356 | Injection, trastuzumab, 10 mg and Hyaluronidase-oysk. |
| Q5107 | Injection, bevacizumab-awwb, biosimilar, (mvasi), 10 mg. |
| Q5112 | Injection, trastuzumab-dttb, biosimilar, (ontruzant), 10 mg. |
| Q5113 | Injection, trastuzumab-pkrb, biosimilar, (herzuma), 10 mg. |
| Q5114 | Injection, trastuzumab-dkst, biosimilar, (ogivri), 10 mg. |
| Q5115 | Injection, rituximab-abbs, biosimilar, (truxima) 10 mg. |
| Q5116 | Injection, trastuzumab-qyyp, biosimilar, (trazimera), 10 mg. |
| Q5117 | Injection, trastuzumab-anns, biosimilar, (kanjinti), 10 mg. |
| Q5118 | Injection, bevacizumab-bvzr, biosimilar, (zirabev), 10 mg. |
| Q5119 | Injection, rituximab-pvvr, biosimilar, (ruxience), 10 mg. |
| Q5123 | Injection, rituximab-arrx, biosimilar, (Riabni), 10 mg. |
| J9999 | Place-holder — additional specific product codes (e.g., for Jobevne, Kyxata) referenced by name in changes but not all mapped to codes in this chunk |
Provider Requirements and Operational Notes
Prior Authorization Required
Prior authorization is required for injectable oncology medications, including therapeutic radiopharmaceuticals, per this policy and UnitedHealthcare oncology prior authorization rules. Submit prior authorization requests before initiating treatment to avoid claim denials or delays.
- Applies to chemotherapy agents, biologics, and therapeutic radiopharmaceuticals
- Includes pediatric oncology agents (coverage for individuals under age 19)
HCPCS-Coded Oncology Drugs May Require PA
Some HCPCS‑coded oncology drugs listed in the Oncology Products table may require prior authorization. Check benefits and the member’s plan for HCPCS-specific PA requirements and submit supporting clinical documentation with the request.
Preferred Product First — Non‑Preferred Use May Affect Coverage
UnitedHealthcare’s preferred oncology products are expected to be used first when clinically appropriate. Use of a non-preferred product when a preferred alternative is indicated may affect coverage and could result in denial if Preferred Product Criteria are not met.
- Non-preferred products require meeting the Preferred Product Criteria (history of intolerance/contraindication and physician attestation)
- Formulary sequencing and step therapy may be implemented operationally per this policy
Documentation Required for Preferred Product Override
If prescribing a non-preferred oncology product, document intolerance or contraindication to the UnitedHealthcare preferred product. The physician must attest that the same intolerance, contraindication, or adverse event would not be expected with the non-preferred product.
- Include clinical history, prior medication trials, and specific adverse events or contraindications
- Attach relevant medical records, test results, and prior authorization forms as supporting documentation
Plan Terms and Use of External Tools
Coverage decisions are subject to the member’s federal, state, and contractual benefit terms. In the event of conflict, those terms govern. UnitedHealthcare may use external clinical tools (for example, InterQual®) to assist in administering benefits.
- Verify plan-specific benefit terms and any state or federal mandates before submitting PA requests
- External tools may be referenced during medical necessity review
Definitions and Terminology
Line-of-Therapy Informational Note
informational
See Policy History/Revision Information for enumerated agent changes (e.g., Avgemsi, Beizray, Carboplatin, Gemcitabine, Jobevne, Kyxata, Keytruda Qlex, Libtayo, etc.).
Background and Scope
This policy aligns coverage of injectable oncology medications — including therapeutic radiopharmaceuticals and listed biologics/biosimilars — with the NCCN Drugs & Biologics Compendium. UnitedHealthcare considers NCCN recommendations with Categories of Evidence and Consensus 1, 2A, and 2B as supported for coverage. When no NCCN Compendium entry exists for an indication, U.S. FDA labeling will be used to determine coverage. The policy scope therefore covers injectable oncology medications and related therapeutic radiopharmaceuticals under the medical benefit.
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