Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Coverage of Prescription Oral Anticancer Drugs and/or Biologics as Provided Under the Company's Medical Benefit

Policy #:08.01.08c

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. State mandates do not automatically apply to self-funded groups; therefore, individual group benefits must be verified.
  • For members who have prescription drug coverage. Members who have a pharmacy benefit and prescription drug coverage through the Company will receive coverage for prescription oral anticancer drugs and biologics in accordance with the applicable pharmacy policies administered through the member’s pharmacy benefit.
  • For members who do not have prescription drug coverage. If a member does not have prescription drug coverage through the Company, coverage of prescription oral anticancer drugs and biologics will be facilitated through the Company's Direct Ship Injectables Program under the member’s medical benefits. Prescription oral anticancer drugs and biologics are covered under the member’s medical benefits only when the member does not have prescription drug coverage through the Company.

A prescription oral anticancer drug or biologic is considered medically necessary and, therefore, covered as provided under the Company's medical benefit when the member has no pharmacy benefit through the Company and the prescription oral anticancer drug or biologic meets one of the following criteria:
  • The drug is prescribed for an FDA-approved indication that is based on reliable evidence demonstrating a positive effect on health outcomes.
  • The drug is prescribed off-label when either of the following criteria are met:
    • The drug and its indication are recommended in the section below, titled Compendia for Oncologic Indications.
    • The drug and its indication are recommended in the section below titled, Published Clinical Research.

COMPENDIA FOR ONCOLOGIC INDICATIONS (ANTICANCER CHEMOTHERAPY)

For coverage of an anti-cancer chemotherapy regimen, the off-label use is considered medically necessary and, therefore, covered when one of the following criteria are met:
  • The narrative text in American Hospital Formulary Service--Drug Information (AHFS-DI®) is supportive of the use; or
  • The indication is classified as Category 1 or 2A by National Comprehensive Cancer Network (NCCN®) Drugs and Biologics Compendium™; or
  • The indication is classified as Class I or Class IIa in Micromedex® DrugDex® Compendium.

An anti-cancer chemotherapy regimen is considered experimental/investigational even when above criteria have been met, and when one of the following exists:
  • The indication is classified as Category 3 by NCCN® or Class III in Micromedex® DrugDex®.
  • The narrative text in AHFS-DI® is not supportive of the use.
  • Any of the compendia listed above state that the prescription drug and/or biologic is not indicated, is unsupported, is not recommended, or equivalent terms are used regarding the prescription drug and/or biologic.

When a compendia is considered neither supportive nor non-supportive (i.e., Category 2B in NCCN®, Class IIb in Micromedex® DrugDex®, or an absence of narrative text or evidence classification from any Company-recognized compendia), please refer to the section in this policy entitled Published Clinical Research.

PUBLISHED CLINICAL RESEARCH

In order for an off-label use to be supported by published clinical research, all of the following criteria must be met:
  • The prescription oral anticancer drug or biologic must have been studied in at least two clinical trials conducted at different centers, and the results must have been published in national or international peer-reviewed journals with an editorial committee composed of physicians. Peer-reviewed medical literature includes scientific, medical, and pharmaceutical publications. It does not include in-house publications of pharmaceutical manufacturing companies or abstracts (including meeting abstracts).
    • A use is considered supported by clinical research when it appears in at least two Phase III clinical trials that have definitively demonstrated its safety and effectiveness as an appropriate medical treatment for the condition. If no Phase III trial evidence is available, at least two Phase II clinical trials with reasonably large patient samples showing consistent results of safety and efficacy may be considered in certain instances (e.g., in rare diseases in which a Phase III study might be difficult to complete in a reasonable period of time after completion of the Phase II studies, or when overwhelmingly good evidence of safety and effectiveness is noted in the Phase II studies).
  • Reliable evidence must demonstrate that the proposed off-label use for the specified medical condition is safe and effective and that the beneficial effects of the treatment outweigh its risks.
  • In determining whether there is supportive clinical evidence for a particular use of a prescription drug or biologic, the Company considers the quality of the evidence in published, peer-reviewed medical literature. Among other things, such consideration involves the assessment of the following:
    • The prevalence and life history of the disease when evaluating the adequacy of the number of subjects and the response rate.
    • The effect on the individual's well-being and other responses to therapy that indicate effectiveness (e.g., reduction in mortality, morbidity, and signs and symptoms).
    • Whether the clinical characteristics of the beneficiary and the indication are adequately represented in the published evidence.
    • Whether the study is appropriate to address the clinical question, such as:
      • If the study design is appropriate to address investigative questions (e.g., in some clinical studies, it may be unnecessary or not feasible to use randomization, double-blind trials, placebos, or crossover).
      • If non-randomized clinical trials with a significant number of subjects may be a basis for supportive clinical evidence for determining accepted uses of drugs.
      • Generally, case reports are considered uncontrolled, are based on anecdotal information, and do not provide adequate supportive clinical evidence for determining accepted uses of drugs.
  • The off-label use is supported by published clinical research, and the results have been published in major peer-reviewed medical journals such as, but not limited to:
    American Journal of Medicine
    Annals of Internal Medicine
    Annals of Oncology
    Annals of Surgical Oncology
    Biology of Blood and Marrow Transplantation
    Blood
    Bone Marrow Transplantation
    British Journal of Cancer
    British Journal of Hematology
    British Medical Journal
    Cancer
    Clinical Cancer Research
    Drugs
    European Journal of Cancer
Gynecologic Oncology
International Journal of Radiation, Oncology, Biology, and Physics
Journal of Clinical Oncology
Journal of the National Cancer Institute
Journal of the National Comprehensive Cancer Network (NCCN®)
Journal of Urology
Lancet
Lancet Oncology
Leukemia
Radiation Oncology
Journal of the American Medical Association
New England Journal of Medicine

EXPERIMENTAL/INVESTIGATIONAL

Prescription oral anticancer drugs and/or biologics that are considered experimental/investigational are not covered because the safety and/or effectiveness of the prescription oral anticancer drug and biologic cannot be established by a review of the available published peer-reviewed literature. Prescription oral anticancer drugs and/or biologics are considered experimental/investigational for any of the following:
  • The prescription oral anticancer drug and/or biologic has not received US Food and Drug Administration (FDA) approval for any indication.
  • The off-label use of the prescription oral anticancer drug and/or biologic does not meet the medical necessity criteria listed in this policy or in any other specific Company Medical Policy addressing a drug and/or biologic (i.e., the off-label use is not recognized by the appropriate compendia or published clinical research).
  • The FDA determines a prescription oral anticancer drug and/or biologic to be contraindicated for specific condition(s) or specific off-label use(s).
  • The off-label use is not medically accepted or not indicated by a compendium for specific conditions (i.e., the indication is a Category 3 in NCCN®, Class III in Micromedex® DrugDex®, or when the narrative text in AHFS-DI® is not supportive).
    • The absence of narrative text for an off-label use is considered neither supportive nor non-supportive.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug or biologic.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, a prescription oral anticancer drug and/or biologic is covered under the medical benefits when the medical necessity criteria listed in this medical policy are met and the member does not have any pharmacy benefit through the Company.

MANDATES

This policy is consistent with applicable state mandates.

New Jersey and Pennsylvania mandate that orally administered anticancer prescription medications used to kill or slow the growth of cancerous cells shall be covered by the health plan with no difference in cost and other provisions, compared to intravenously or injectable anticancer prescription medications. The laws of the state where the group benefit contract is issued determine the mandated coverage.

Description

Orally administered anticancer drugs and/or biologics are prescription medications taken by mouth that are used to kill or slow the growth of cancerous cells. There are many types of oral anticancer medications that can be swallowed as a liquid, tablet, or capsule.
References


American Hospital Formulary Service--Drug Information (AHFS-DI®) 2017. Available at: http://online.lexi.com/lco/action/home [via subscription only]). Accessed July 17, 2017.

Benefit Contracts.

Centers for Medicare & Medicaid Services (CMS). Agency for Healthcare Research and Quality (AHRQ) Technology Assessment Program. Technology assessment: Compendia for coverage of off-label uses of drugs and biologics in an anticancer chemotherapeutic regimen. Final report. [CMS Web site]. 05/07/07. Available at: http://www.cms.gov/medicare-coverage-database/details/technology-assessments-details.aspx?TAId=46&CoverageSelection=Both&ArticleType=All&PolicyType=Final&s=Pennsylvania&KeyWord=compendia&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAABAAAAAAAA%3d%3d&. Accessed July 17, 2017.

Centers for Medicare & Medicaid Services (CMS). Medicare Benefit Policy Manual. Chapter 15: Covered medical and other health services. §50.4.5: Off-Label Use of Drugs and Biologicals in an Anti-Cancer Chemotherapeutic Regimen. Rev 212, Issued: 11/06/15. Effective: 08/12/15. Implementation: 02/10/16. [CMS Web site]. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-Ioms-Items/Cms012673.html and
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R212BP.pdf. Accessed July 17, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. [NCCN Web site]. Available at: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp [via subscription only]. Accessed July 17, 2017.

National Comprehensive Cancer Network (NCCN®). NCCN Drugs & Compendium™.[NCCN® Web site]. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed July 17, 2017.

New Jersey P.L.2011,c.188 (s1834 1R). 01/17/2012. Available at: http://www.njleg.state.nj.us/bills/BillView.asp or http://www.njleg.state.nj.us/2010/Bills/PL11/188_.HTM. Accessed July 17, 2017.

Noridian Medicare Local Coverage Determination (LCD): Oral Anticancer Drugs (L33826 & A52479). Original 10/01/15; Revised 01/01/17. Available at: https://med.noridianmedicare.com/web/jadme/policies/lcd/active. Accessed July 17, 2017.

Novitas Solutions, Inc. Local Coverage Article A53049. Approved Drugs and Biologicals. Includes Cancer Chemotherapeutic Agents. [Novitas Solutions, Inc. Medicare Services Web site]. Original 10/01/2015; Revised: 01/01/2017. Available at:
https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53049&ver=34&Cntrctr=319&ContrVer=1&CntrctrSelected=319*1&bc=AgABAAEAAAAAAA%3d%3d&. Accessed July 17, 2017.

PA House Bill – HB 60; signed July 8, 2016. Available at:
http://www.legis.state.pa.us/cfdocs/billInfo/billInfo.cfm?sYear=2015&sInd=0&body=H&type=B&bn=0060. Accessed July 17, 2017.

Truven Health Analytics. Micromedex® DrugDex® Compendium. [Internet database]. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed July 17, 2017.

US Food and Drug Administration (FDA). Regulatory Information. Federal Food, Drug, and Cosmetic Act. [FDA Web site]. 10/05/15. Available at: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterVDrugsandDevices/default.htm. Accessed July 17, 2017.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions from 08.01.08c
09/12/2018This policy has been reissued in accordance with the Company's annual review process.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2018
Version Issued Date: 12/29/2017
Version Reissued Date: 09/12/2018

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.