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Coverage criteria policies

Oncology drug coverage

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Oncology medications listed in this policy require prior authorization from Pharmacy Administration.

If a drug that is FDA-approved for an oncology indication is not listed on this policy, not posted under a separate policy specific to each drug or included on the Recent FDA Approved Medications Coverage policy, it does not require prior authorization from HealthPartners Pharmacy Administration.

In certain circumstances, HealthPartners reserves the right to develop criteria more restrictive than FDA-labeling or NCCN Compendium® guidance. In such circumstances, HealthPartners will publish a medical policy specific to the drug specifying the associated criteria.

Coverage

Covered indications

Oncology drugs listed in this policy are generally covered when meeting all of the following criteria:

  1. The requested drug, indication and regimen is consistent with the FDA-labeling for the product. The FDA labeling describes both the indication and the associated dosing regimen. Requests must meet these and all other components of the product labeling pertinent to the requested reason for use.
    or
  2. For off-label requests, the requested drug, indication and regimen is consistent with an NCCN recommendation with a level of evidence of Category 1 or 2A.
    and
  3. When consulting oncologists indicate that the requested drug and regimen is the most appropriate and most cost-effective therapy option. Consulting oncologists will ensure that acceptable, peer-reviewed literature supports a particular use of an oncology drug. The consulting oncologists are independent, external board-certified medical oncologists and hematologists who work with the health plan and providers to ensure that patients receive the most effective, affordable, and least toxic cancer care possible.

Authorizations will be provided for six months or for the maximum FDA approved duration, whichever is less.

Reauthorizations will be approved annually thereafter while there is no progression of disease.

Approval will not be authorized beyond FDA approved maximum treatment duration or number of treatments.

The FDA approved companion diagnostic test is not required unless required in the FDA label. Any commercially available test covered by HealthPartners may be used. Please see separate medical coverage policies for more information on coverage of genetic testing.

Indications that are not covered

All requests failing to meet the criteria above will not be covered.

Providers may request approval for off-label indications not supported by NCCN Category 1 or 2A recommendations. Requests must be in writing and include supporting medical documentation, a statement of clinical rationale, and clinical literature. Requests will be reviewed on a case-by-case basis for medical necessity and include an evaluation of the quality of literature.

Definitions

The NCCN Compendium® is a consensus-based guideline that lists the appropriate drugs and biologics for specific cancers using US Food and Drug Administration (FDA)-approved disease indications and specific NCCN panel recommendations. Each recommendation is supported by a level of evidence category. The NCCN Compendium® is recognized by the Centers for Medicare and Medicaid Services (CMS) as an authoritative reference for oncology coverage policy.

The NCCN Drugs & Biologics Compendium® Levels of Evidence:

Category 1: Based on high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

Category 2A: Based on lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

Category 2B: Based on lower-level evidence, there is NCCN consensus that the intervention is appropriate.

Category 3: Based any level of evidence, there is major NCCN disagreement that the intervention is appropriate.

Off-label medication use is not consistent with the FDA-labeling for the product. The FDA labeling describes both the indication and the associated dosing regimen and contraindications to medication use.

If available, codes for a procedure, device or diagnosis are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

New drugs without assigned HCPC may not be listed here. Please refer to the “Recent Food and Drug Administration (FDA) approved medications coverage policy” for those medications.

Please also refer to the policy list on https://www.healthpartners.com/public/coverage-criteria to determine whether coverage for a particular drug not listed here is cited elsewhere.

HCPCS codes / NDC codes

Preparation

NDC

HCPCS

Ado-trastuzumab (Kadcyla)

50242008801

J9354 - Injection, ado-trastuzumab emtansine, 1 mg

50242008701

Atezolizumab (Tecentriq)

50242091701

J9022 – Injection, atezolizumab, 10 mg

Avelumab (Bavencio)

44087353501

J9023 – Injection, avelumab, 10 mg

Belinostat (Beleodaq)

68152010809

J9032 - Injection, Belinostat, 10mg

Blinatumomab (Blincyto)

55513016001

J9039 - Injection, blinatumomab, 1 microgram

Brentuximab vedotin (Adcetris)

51144005001

J9042 - Injection, brentuximab vedotin, 1 mg

Cabazitaxel (Jevtana)

00024582411

J9043 - Injection, cabazitaxel, 1 mg

Carfilzomib (Kyprolis)

76075010101

J9047 - Injection, carfilzomib, 1 mg

76075010201

Copanlisib (Aliqopa)

50419038501

C9399 - Unclassified drugs or biologicals

J9999 - Not otherwise classified, antineoplastic drugs

C9030 - (Injection, copanlisib, 1mg

Cytarabine/ daunorubicin (Vyxeos)

68727074501

68727074502

68727074505

C9024 - Injection, liposomal, 1 mg daunorubicin and 2.27 mg cytarabine

J9999 - Not otherwise classified, antineoplastic drugs

Daratumumab (Darzalex)

57894050205

J9145 - Injection, daratumumab, 10mg

57894050220

Dinutuximab (Unituxin)

66302001401

C9399 - Unclassified drugs or biologicals

J9999 - Not otherwise classified, antineoplastic drugs

Durvalumab (Imfinzi)

00310450012

00310461150

C9492 - Injection, durvalumab, 10 mg

J9999 - Not otherwise classified, antineoplastic drugs

Elotuzumab (Empliciti)

00003229111

00003452211

J9176 - Injection, elotuzumab, 1mg

Eribulin (Halaven)

62856038901

J9179 - Injection, eribulin mesylate, 0.1 mg

Gemtuzumab (Mylotarg)

00008451001

J9203 - Injection, gemtuzumab ozogamicin, 0.1 mg

Inotuzumab (Besponsa)

00008010001

C9028 - Injection, inotuzumab ozogamicin, 0.1 mg J9999 - Not otherwise classified, antineoplastic drugs

Irinotecan liposomal (Onivyde)

69171039801

15054004301

J9205 - Injection, irinotecan liposome, 1 mg

Lutetium Lu 177 dotatate (Lutathera)

69488000301

C9399 - Unclassified drugs or biologicals

C9031 - Injection, voretigene neparvovec-rzyl, 1 billion vector genome

Midostaurin (Rydapt)

00078069899

00078069851

00078069802

00078069819

C9399 - Unclassified drugs or biologicals

J8999 - Prescription drug, oral, chemotherapeutic, Not Otherwise Specified

Nivolumab (Opdivo)

00003377211

J9299 - Injection, nivolumab, 1 mg

00003377412

00003377412

Obinutuzumab (Gazyva)

50242007001

J9301 - Injection, obinutuzumab, 10mg

Ofatumumab (Arzerra)

00078066913

J9302 - Injection, ofatumumab, 10 mg

00078069061

00078066961

00173082101

00173082102

00173082133

Olaratumab (Lartruvo)

00002892601

00002719001

J9285 - Injection, olaratumab, 10 mg

Omacetaxine mepesuccinate (Synribo)

63459017714

J9262 - Injection, omacetaxine mepesuccinate, 0.01mg

Paclitaxel protein-bound

particles for injectable suspension (Abraxane)

6881713450

J9264 – Injection, paclitaxel protein-bound particles, 1 mg

Pembrolizumab (Keytruda)

00006302901

J9271 - Injection, pembrolizumab, 1 mg

00006302902

00006302601

00006302602

Pertuzumab (Perjeta)

50242014501

J9306 - Injection, pertuzumab, 1 mg

Pralatrexate (Folotyn)

48818000101

J9307 - Injection, pralatrexate, 1 mg

48818000102

Radium 223 (Xofigo)

50419020801

A9606 - Radium Ra-223 dichloride, therapeutic, per microcurie

Ramucirumab (Cyramza)

00002766901

J9308 - Injection, ramucirumab, 5 mg

00002767801

Siltuximab (Sylvant)

57894042001

J2860 - Injection, siltuximab, 10 mg

57894042101

Sipuleucel-T (Provenge)

30237890006

Q2043 - Sipuleucel-t, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion

Talimogene (Imlygic)

55513007801

J9325 - Injection, talimogene laherparepvec, per 1million plaque forming units

55513007901

Trabectedin (Yondelis)

59676061001

J9352 - Injection, trabectedin, 0.1mg

Vincristine liposomal (Marqibo)

20536032201

J9371 - Injection, vincristine sulfate liposome, 1 mg

Ziv-aflibercept (Zaltrap)

00024584001

J9400 - Injection, ziv-aflibercept, 1 mg

00024584101

CPT Copyright American Medical Association. All rights reserved.  CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References

  1. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. (an account may be required)
  2. The NCCN Drugs and Biologics Compendium (NCCN Compendium®). http://www.nccn.org/professionals/drug_compendium/content/contents.asp. (a subscription may be required)

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Policy activity

  • 02/06/2017 - Date of origin
  • 05/07/2018 - Effective date
Review date
  • 02/2018
Revision date
  • 05/07/2018

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