UnitedHealthcare® Oxford Clinical Policy INJECTABLE CHEMOTHERAPY DRUGS: APPLICATION OF NCCN CLINICAL PRACTICE GUIDELINES Policy Number: CANCER 009.18 T2 Effective Date: June 1, 2018 Table of Contents Page Related Policies INSTRUCTIONS FOR USE .......................................... 1 Acquired Rare Disease Drug Therapy Exception CONDITIONS OF COVERAGE ...................................... 1 Process BENEFIT CONSIDERATIONS ...................................... 2 Clinical Trials COVERAGE RATIONALE ............................................. 2 Drug Coverage Guidelines APPLICABLE CODES ................................................. 4 Experimental/Investigational Treatment DESCRIPTION OF SERVICES ...................................... 7 REFERENCES ........................................................... 7 Experimental/Investigational Treatment for NJ Plans POLICY HISTORY/REVISION INFORMATION ................. 7 Gonadotropin Releasing Hormone Analogs Lemtrada (Alemtuzumab) Rituxan® (Rituximab) Related Clinical Guideline Transplant Review Guidelines: Hematopoietic Stem Cell Transplantation INSTRUCTIONS FOR USE This Clinical Policy provides assistance in interpreting Oxford benefit plans. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage members. Oxford reserves the right, in its sole discretion, to modify its policies as necessary. This Clinical Policy is provided for informational purposes. It does not constitute medical advice. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies. When deciding coverage, the member specific benefit plan document must be referenced. The terms of the member specific benefit plan document [e.g., Certificate of Coverage (COC), Schedule of Benefits (SOB), and/or Summary Plan Description (SPD)] may differ greatly from the standard benefit plan upon which this Clinical Policy is based. In the event of a conflict, the member specific benefit plan document supersedes this Clinical Policy. All reviewers must first identify member eligibility, any federal or state regulatory requirements, and the member specific benefit plan coverage prior to use of this Clinical Policy. Other Policies may apply. UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. CONDITIONS OF COVERAGE Applicable Lines of Business/ Products This policy applies to Oxford Commercial plan membership. Benefit Type General benefits package Referral Required No (Does not apply to non-gatekeeper products) Authorization Required Yes1,2 (Precertification always required for inpatient admission) Note: All requests are handled by eviCore healthcare. Precertification with Medical Director Review Required No Applicable Site(s) of Service Office, Outpatient, Home (If site of service is not listed, Medical Director review is required) Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines Page 1 of 7 UnitedHealthcare Oxford Clinical Policy Effective 06/01/2018 ©1996-2018, Oxford Health Plans, LLC Special Considerations 1Precertification is required for services covered under the Member's General Benefits package when performed in the office of a participating provider. For Commercial plans, precertification is not required, but is encouraged for out-of-network services performed in the office that are covered under the Member's General Benefits package. If precertification is not obtained, Oxford may review for medical necessity after the service is rendered. 2Precertification is required for injectable chemotherapy drugs administrated by a participating provider in an office, outpatient or home setting. Precertification is not required for injectable chemotherapy drugs administrated by a non-participating provider in an office and outpatient setting however precertification will be provided upon request. BENEFIT CONSIDERATIONS Before using this policy, please check the member specific benefit plan document and any federal or state mandates, if applicable. If the coverage review using the NCCN Compendium determines that the drug is unproven, then further review is indicated. Some Certificates of Coverage allow for coverage of experimental/investigational/unproven treatments for life-threatening illnesses when certain conditions are met. The member-specific benefit document must be consulted to make coverage decisions for this service. Some states mandate benefit coverage for off-label use of medications for some diagnoses or under some circumstances. Some states also mandate usage of other Compendium references. Where such mandates apply, they supersede language in the benefit document or in the Clinical Policy. Chimeric Antigen Receptor (CAR)-T Cell Therapy may be eligible for coverage as an autologous stem cell therapy under a member’s Transplantation Services benefit. Coverage determinations are based on the OptumHealth Transplant Solutions criteria for covered transplants; refer to the Clinical Guideline titled Transplant Review Guidelines: Hematopoietic Stem Cell Transplantation. Benefit coverage for an otherwise not medically necessary service for the treatment of serious rare diseases may occur when certain conditions are met. Essential Health Benefits for Individual and Small Group For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”). Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to provide coverage for benefits which are deemed EHBs, the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is made on a state by state basis. As such, when using this policy, it is important to refer to the member specific benefit plan document to determine benefit coverage. COVERAGE RATIONALE Oxford has engaged eviCore healthcare to perform precertification* reviews for injectable chemotherapy drugs administrated by participating providers in an office, outpatient or home setting to treat a cancer diagnosis. Oxford continues to be responsible for claims payment decisions and for appeals. *Note: Precertification is not required for injectable chemotherapy drugs administrated by a non-participating provider in an office or outpatient setting however precertification will be provided upon request. All precertification requests for injectable chemotherapy drugs are handled by eviCore healthcare. To obtain precertification for injectable chemotherapy medications providers must contact CCN. Providers are encouraged to obtain precertification on line by logging in to OxfordHealth.com and selecting the link to the eviCore healthcare authorization web site. Providers may also obtain precertification by calling 1-877-773-2884. eviCore healthcare uses the National Comprehensive Cancer Network’s (NCCN) guidelines in their decision making process. These guidelines provide independent recommendations for evidence-based cancer treatment. The guidelines Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines Page 2 of 7 UnitedHealthcare Oxford Clinical Policy Effective 06/01/2018 ©1996-2018, Oxford Health Plans, LLC are continually updated to be consistent with the current treatment options. Providers and patients may access and view the NCCN guidelines at NCCN.org. Description This policy provides parameters for coverage of injectable oncology medications (J9000-J9999) and select ancillary and supportive care medications used for oncology conditions [including, but not limited to octreotide acetate (J2353 and J2354), leuprolide acetate (J1950), leucovorin (J0640) and levoleucovorin (J0641)] covered under the medical benefit based upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium® (NCCN Compendium®). In addition, J0640 and J0641 are included and Q codes as listed below, covered under the medical benefit based upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium® (NCCN Compendium®). The 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. This policy does not provide coverage criteria for Chimeric Antigen Receptor (CAR)-T Cell products. Coverage determinations are based on the member’s benefits and the OptumHealth Transplant Solutions criteria for covered transplants in the Clinical Guideline titled Transplant Review Guidelines: Hematopoietic Stem Cell Transplantation. Coverage Rationale Injectable Oncology, Ancillary, and Supportive Care Medications Oxford recognizes indications and uses of oncology medications listed in the NCCN Drugs and Biologics Compendium with Categories of Evidence and Consensus of 1, 2A, and 2B as proven and medically necessary and Categories of Evidence and Consensus of 3 as unproven