Colorado Rocky Mountain Health Plans Oncology Coverage Update

Coverage Criteria for Injectable Oncology Medications

inv-01: Preferred vs Non-Preferred Product Coverage and Diagnosis-Specific Criteria

Coverage for injectable oncology medications is determined by product preferred status and diagnosis-specific evidence:

Preferred product coverage: Coverage will be provided for UnitedHealthcare preferred oncology products contingent on meeting the Diagnosis-Specific Criteria linked to NCCN or FDA labeling.

See Oncology Products table for preferred products (examples listed).

Non-preferred product coverage: Coverage for non-preferred products is medically necessary when BOTH: 1) history of intolerance or contraindication to a UnitedHealthcare preferred oncology product; and 2) physician attests that the same intolerance/contraindication/adverse event would not be expected with the non-preferred product (Preferred Product Criteria).

See Oncology Products table for non-preferred equivalents.

Evidence requirement: UnitedHealthcare recognizes NCCN Compendium Categories 1, 2A, and 2B as proven/covered; Category 3 is unproven and not medically necessary. When NCCN guidance is not available, FDA labeling governs coverage determinations.

Pediatric patients under 19 years: all chemotherapy agents covered for oncology indications.

inv-02: Evidence sources and coverage basis

Coverage decisions are based on the NCCN Drugs & Biologics Compendium and NCCN Guidelines; when NCCN compendium categories are not available, FDA labeling is used. CAR T-cell therapy coverage may be considered under transplantation services per OptumHealth Transplant Solutions criteria.

Evidence sources and hierarchy: Use NCCN Drugs and Biologics Compendium and NCCN Clinical Practice Guidelines as primary sources; if no NCCN compendium entry exists, use U.S. FDA labeling for coverage determinations.

Supported by policy background and revision language.

This policy does not provide coverage criteria for CAR T-cell or TIL (tumor‑infiltrating lymphocyte) cell products. Coverage determinations for these therapies are made according to the member's benefit plan and the OptumHealth Transplant Solutions criteria referenced in the Clinical Guideline for CAR T‑cell or TIL cell therapy.

Policy revision on 04/01/2026 removed prior state‑specific content: language pertaining to the state of Louisiana was excised from the policy.

Uses and recommendations listed as NCCN Category 3 are considered unproven and not medically necessary for purposes of coverage under this policy.

inv-25: first-line — line-of-therapy criterion node (1 top-level node)

NSCLC PD-L1 monotherapy: Coverage for pembrolizumab and other listed PD-1/PD-L1 agents as monotherapy for advanced or metastatic non-small cell lung cancer when PD-L1 expression is ≥ 50%.PD-L1 >= 50%

See Oncology Products - Keytruda and equivalents.

inv-26: salvage — line-of-therapy criterion node (1 top-level node)

CAR T-cell coverage pathway: CAR T-cell therapy may be eligible for coverage as an autologous stem cell therapy under a member's transplantation services benefit per OptumHealth Transplant Solutions criteria.

Refer to OptumHealth Transplant Solutions guideline and member benefit terms.

Covered Regimens and Example Combinations

Regimen	Indication	Coverage Status
Tecentriq (atezolizumab) + Mvasi (bevacizumab-awwb)	Hepatocellular carcinoma — combination systemic therapy	Covered
Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) + Mvasi (bevacizumab-awwb)	Hepatocellular carcinoma — combination systemic therapy	Covered
Imjudo (tremelimumab-actl) + Imfinzi (durvalumab)	Hepatocellular carcinoma — combination systemic therapy	Covered
Imjudo + Imfinzi (listed as non-preferred equivalent combinations)	Hepatocellular carcinoma — combination systemic therapy	Not covered when substituted with listed non-preferred bevacizumab products without meeting Preferred Product Criteria

Example Preferred Product	Example Non-Preferred Equivalent	Notes / Impact
Carboplatin (J9045)	Beizray (docetaxel, J9174) listed as non-preferred for all oncology indications in revision history	Revision history (04/01/2026) updates preferred/non-preferred designations and adds quarterly edit flags for certain codes.
Mvasi (bevacizumab-awwb, Q5107)	Avastin (bevacizumab) or other listed bevacizumab products (Avastin, Zirabev, Alymsys, Vegzelma) — non-preferred when used as substitutes per Oncology Products table	For certain regimens (e.g., atezolizumab combinations) Mvasi is the preferred bevacizumab product; non-preferred bevacizumab products require Preferred Product Criteria documentation.
Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph)	Keytruda (pembrolizumab) and other pembrolizumab formulations — designation varies by cancer type (see revision history)	Revision history lists Keytruda Qlex as preferred for NSCLC but non-preferred for certain head & neck and skin cancer indications.
Libtayo (cemiplimab-rwlc)	Opdivo (nivolumab) and Opdivo Qvantig (nivolumab + hyaluronidase) — non-preferred for squamous cell skin cancer per revision history	Preferred/non-preferred selections differ by indication; physician attestation required to use a non-preferred product when clinically necessary.

Applicable HCPCS/J/Q Codes and Coding Details

Applicable HCPCS/Codesmixed

A9513	Lutetium lu 177, dotatate, therapeutic, 1 millicurie.
A9590	Iodine i-131, iobenguane, 1 millicurie.
A9606	Radium Ra-223 dichloride, therapeutic, per microcurie.
A9607	Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie.
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.
J1950	Injection, leuprolide acetate (for depot suspension), 3.75 mg.

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Applicable HCPCS/J codes (partial list - chunk 18)HCPCSCovered

A9513	Lutetium lu 177, dotatate, therapeutic, 1 millicurie
A9590	Iodine i-131, iobenguane, 1 millicurie
A9606	Radium Ra-223 dichloride, therapeutic, per microcurie
A9607	Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie
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
J1950	Injection, leuprolide acetate (for depot suspension), 3.75 mg

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Applicable HCPCS/J codes (partial list - chunk 19)HCPCSCovered

J9073	Injection, cyclophosphamide, dr reddys, 5 mg
J9074	Inj, cyclophosphamide, sandoz, 5 mg
J9075	Inj, cyclophosphamide, nos, 5 mg
J9076	Inj, cyclophosphamide, baxter, 5 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

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Applicable HCPCS/J codes (partial list - chunk 20)HCPCSCovered

J9206	Injection, irinotecan, 20 mg
J9217	Leuprolide acetate (for depot suspension), 7.5 mg
J9228	Injection, ipilimumab, 1 mg
J9271	Injection, pembrolizumab, 1 mg
J9275	Injection, cosibelimab-ipdl, 2mg
J9277	Injection, pembrolizumab, 1 mg and berahyaluronidase alfa-pmph
J9278	Injection, carboplatin (avyxa), 1 mg
J9289	Injection, nivolumab, 2 mg and hyaluronidase-nvhy
J9292	Injection, pemetrexed dipotassium, 10 mg
J9294	Injection, pemetrexed (Hospira), not therapeutically equivalent to J9305, 10 mg

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Applicable HCPCS/Q codes and biosimilars (chunk 21)HCPCSCovered

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, pemrydi RTU, 10 mg
J9329	Injection, tislelizumab-jsgr, 1mg
J9355	Injection, trastuzumab, 10 mg
J9356	Injection, trastuzumab, 10 mg and Hyaluronidase-oysk
J9380	Injection, teclistamab cqyv, 0.5 mg
Q5107	Injection, bevacizumab-awwb, biosimilar, (mvasi), 10 mg

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PD-L1 expression — >= 50% (biomarker threshold)

PD-L1 threshold>= 50%

Indication contextAdvanced or metastatic non-small cell lung cancer, monotherapy

Relevant agentsPembrolizumab and other PD-1/PD-L1 agents listed in Oncology Products section

Dose units — per-document unit descriptions

Millicurie dosing examplesLutetium Lu 177 dotatate (A9513) — 1 millicurie; Iodine i-131 iobenguane (A9590) — 1 millicurie; Lutetium Lu 177 vipivotide tetraxetan (A9607) — 1 millicurie

Per-microcurie unit

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for the listed injectable oncology drugs. Coverage for UnitedHealthcare preferred oncology products will be provided contingent on meeting the Diagnosis-Specific Criteria. Coverage for any respective non-preferred oncology product will be provided only when both the Preferred Product Criteria and the Diagnosis-Specific Criteria are met.

Prior authorization required for listed oncology injectables and therapeutic radiopharmaceuticals.
Coverage for preferred oncology products contingent on meeting Diagnosis-Specific Criteria.
Coverage for non-preferred oncology products contingent on meeting Preferred Product Criteria and Diagnosis-Specific Criteria.

Step Therapy

Preferred Product Selection Required

Treatment with a non-preferred oncology product is considered medically necessary only when both of the following are documented: (1) the member has a history of intolerance or contraindication to a UnitedHealthcare preferred oncology product; and (2) the prescribing physician attests that, in their clinical judgment, the same intolerance, contraindication, or adverse event would not be expected to occur with the requested non-preferred product.

Definitions and NCCN Evidence Categories

NCCN Categories of Evidence and Consensus — coverage implications

Covered CategoriesNCCN Categories 1, 2A, and 2B are considered proven and covered for coverage determinations

Not medically necessaryNCCN Category 3 uses are considered unproven and not medically necessary

Evidence interpretationCategory 1 = high-level evidence with uniform consensus; Category 2A = lower-level evidence with uniform consensus; Category 2B = lower-level evidence with nonuniform consensus

Radiopharmaceuticals — therapeutic radiopharmaceuticals in policy scope

Scope inclusionTherapeutic radiopharmaceuticals are included in the policy scope for coverage under the medical benefit

ExamplesA9513 (lutetium Lu 177 dotatate), A9590 (iobenguane I-131), A9606 (radium Ra-223), A9607 (lutetium Lu 177 vipivotide tetraxetan)

Background and Scope

This medical benefit drug policy governs coverage of injectable oncology medications (including therapeutic radiopharmaceuticals) administered under the medical benefit. Coverage is tied to the NCCN Drugs & Biologics Compendium and NCCN Clinical Practice Guidelines: indications with NCCN Categories of Evidence and Consensus 1, 2A, and 2B are considered proven/covered. When no NCCN compendium entry exists for an indication, coverage determinations shall be based upon U.S. FDA labeling. The policy also identifies UnitedHealthcare preferred and non‑preferred oncology injectable products and applies diagnosis‑specific criteria; prior authorization and documentation requirements apply per the policy and payer procedures.

Policy Revision History

04/01/2026policy_revisionLatest

Revised UnitedHealthcare preferred and non-preferred oncology product designations (added/updated product listings across multiple indications), added specific HCPCS codes including J9045, J9174, J9275, J9277*, J9278*, and Q5160* with quarterly edit flags, and added language that when no NCCN compendium entry exists coverage determinations shall be based on U.S. FDA labeling; archived previous version CS2026D0030AP.

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