Commercial

• ​The drug or biolo​gic is approved by the US Food and Drug Administration (FDA) for the indication

​AND

• ​The prescription of the drug or biologic​ is consistent with the best clinical practices for the treatment of stage four, advanced metastatic cancer or a severe adverse health condition experienced as a result of stage four, advanced metastatic cancer, and is supported by peer-reviewed medical literature.

• 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.

• The drug or biologic is prescribed for an FDA-approved use that is based on reliable evidence demonstrating a positive effect on health outcomes.
• The drug or biologic is prescribed for an off-label use when either of the following criteria are met:
  • The drug or biologic and its indication, dosage, frequency, or route of administration, etc., are recommended in the section below, titled Compendia for Oncologic Uses.
  • The drug or biologic and its indication, dosage, frequency, or route of administration, etc., are recommended in the section below titled, Published Clinical Research.

• The narrative text in American Hospital Formulary Service–​Drug Information (AHFS-DI®) is supportive of the use.
• The use is classified as Category 1 or 2A by National Comprehensive Cancer Network (NCCN®) Drugs and Biologics Compendium™.
• The use is classified as Class I or Class IIa in Micromedex® DrugDex® Compendium.

• The use 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.

• 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 use 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 nonrandomized 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:

• The prescription oral anticancer drug and/or biologic has not received US Food and Drug Administration (FDA) approval for any use.

• 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 use 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 nonsupportive.