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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 through Pharmacy Administration.

When use of a drug is consistent with the coverage outlined below, approvals will be given for six months of therapy. Reauthorizations will be approved annually thereafter while there is no progression of disease. Any maximum duration of use or number of treatments found in the FDA-labeling will be applied. Unless stated or HealthPartners genetic test coverage requires, the FDA approved companion diagnostic test is not required. Any commercially available test covered by HealthPartners, may be used.

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

Coverage

Drugs approved by the U.S. Food and Drug Administration for oncology indications are generally covered subject to the indications listed below.

Indications that are covered

Generally, HealthPartners oncology medication coverage will be based on 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.

When a requested indication is not included in the FDA-labeling information (off-label), HealthPartners will use the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium (NCCN Compendium®) to determine coverage. The NCCN Compendium® 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.

Coverage will be provided for Commercial and Minnesota Health Care Plan members when NCCN lists the indication with a level of evidence of Category 1 or 2A.

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.

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.

Providers may request approval for additional off-label indications by submitting the request in writing with supporting medical documentation and clinical literature.

Indications that are not covered

Indications without sufficient evidence based on the criteria above will not be covered.

Definitions

Based directly on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®, the NCCN Drugs & Biologics Compendium (NCCN Compendium®) contains authoritative, scientifically derived information designed to support decision-making about the appropriate use of drugs and biologics in patients with cancer.

The NCCN Compendium® is recognized by the Centers for Medicare and Medicaid Services (CMS) as an authoritative reference for oncology coverage policy.

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 Recently FDA-approved Drugs 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

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 (This code should only be used for drugs and biologicals that are approved by the FDA on or after January 1, 2004) (Hospital Outpatient Use ONLY)

J9999 - Not otherwise classified, antineoplastic drugs

Cytarabine/ daunorubicin (Vyxeos)

68727074501

68727074502

68727074505

C9024 - Injection, liposomal, 1 mg daunorubicin and 2.27 mg cytarabine (For Hospital OPPS billing prior to 1/1/18 use C9399)

J9999 - Not otherwise classified, antineoplastic drugs

Daratumumab (Darzalex)

57894050205

J9145 - Injection, daratumumab, 10mg

57894050220

Dinutuximab (Unituxin)

66302001401

C9399 - Unclassified drugs or biologicals (This code should only be used for drugs and biologicals that are approved by the FDA on or after January 1, 2004) (Hospital Outpatient Use ONLY)

J9999 - Not otherwise classified, antineoplastic drugs

Durvalumab (Imfinzi)

00310450012

00310461150

C9492 - Injection, durvalumab, 10 mg (For Hospital OPPS billing prior to 10/1/17 use C9399)

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 (For billing prior to 1/1/18 use J9999 or C9399 for OPPS billing)

Inotuzumab (Besponsa)

00008010001

C9028 - Injection, inotuzumab ozogamicin, 0.1 mg (For Hospital OPPS billing prior to 1/1/18 use C9399)

J9999 - Not otherwise classified, antineoplastic drugs

Irinotecan liposomal (Onivyde)

69171039801

15054004301

J9205 - Injection, irinotecan liposome, 1 mg

Midostaurin (Rydapt)

00078069899

00078069851

00078069802

00078069819

C9399 - Unclassified drugs or biologicals (This code should only be used for drugs and biologicals that are approved by the FDA on or after January 1, 2004) (Hospital Outpatient Use ONLY)

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 (For billing prior to 1/1/15 use C9399 or A9699)

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
  • 01/01/2018 - Effective date
Review date
  • 02/2018
Revision date
  • 01/01/2018

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