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Global Oncology Global Oncology Line(s) of Business: Original Effective Date: HMO; PPO; QUEST Integration; 03/01/2019 Medicare Advantage Current Effective Date: 04/01/2019 A. DESCRIPTION Precertification is required for one or more agents within a prescribed oncology regimen. The entire regimen will be covered when all drugs within the regimen are being prescribed in accordance with the guidelines set forth in this policy provided the member has no exclusions to the prescribed therapy. This policy applies to drugs covered under the medical benefit listed in the Appendix. Oral drugs will also be reviewed when prescribed as part of the oncology regimen. B. REQUIRED DOCUMENTATION Initial therapy o Chart notes or clinical information supporting the diagnosis Continuation therapy o Documentation that supports a response to treatment (e.g, clinical notes, laboratory tests, and any pertinent pathology reports and/or imaging studies) C. CRITERIA/GUIDELINES Authorization of 3 months may be granted for members who are prescribed a single agent or regimen as supported by one of the following: 1. FDA-approved indication 2. National Comprehensive Cancer Network (NCCN) I or IIA recommendation 3. HMSA Off-Label Drug Use policy D. CONTINUATION OF THERAPY 1. No previous authorization/precertification: All members (including new members and members currently receiving treatment without prior authorization) must meet criteria for initial approval in section C. 2. Reauthorization: Members who were previously approved for the drug or regimen by HMSA/CVS may request reauthorizations after their initial approval. Approval for an additional 12 months may be granted when the following documentation shows benefit from treatment: A current oncology note documenting the patient’s response to treatment showing no progression of disease Current imaging studies and other objective measures showing no progression of disease when compared with previous results Global Oncology 2 E. DOSAGE AND ADMINISTRATION Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. F. ADMINISTRATIVE GUIDELINES Precertification is required. Please refer to the HMSA medical policy web site for the fax form. G. IMPORTANT REMINDER The purpose of this Medical Policy is to provide a guide to coverage. This Medical Policy is not intended to dictate to providers how to practice medicine. Nothing in this Medical Policy is intended to discourage or prohibit providing other medical advice or treatment deemed appropriate by the treating physician. Benefit determinations are subject to applicable member contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. This Medical Policy has been developed through consideration of the medical necessity criteria under Hawaii’s Patients’ Bill of Rights and Responsibilities Act (Hawaii Revised Statutes §432E-1.4), generally accepted standards of medical practice and review of medical literature and government approval status. HMSA has determined that services not covered under this Medical Policy will not be medically necessary under Hawaii law in most cases. If a treating physician disagrees with HMSA/CVS’s determination as to medical necessity in a given case, the physician may request that HMSA reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation. H. APPENDIX Drugs requiring precertification from CVS Caremark in accordance with criteria stated in this policy. Medical benefit drugs (mostly injectable/infused dosage forms) prior to 03/01/2019 Brand/Generic Name Route of Administration Alimta (pemetrexed) IV infusion Aliqopa (copanlisib dihydrochloride) IV infusion Avastin (bevacizumab) IV infusion Bavencio (avelumab) IV infusion Besponsa (inotuzumab ozogamicin) IV infusion Cyramza (ramucirumab) IV infusion Darzalex (daratumumab) IV infusion Eligard (leuprolide acetate) Subcutaneous Elzonris (tagraxofusp-erzs) IV infusion Empliciti (elotuzumab) IV infusion Erbitux (cetuximab) IV infusion Folotyn (pralatrexate) IV infusion Gazyva (obinutuzumab) IV infusion Global Oncology 3 Herceptin (trastuzumab) IV infusion Imfinzi (durvalumab) IV infusion Imlygic (talimogene laherparepvec) Injection Kadcyla (ado-trastuzumab emtansine) IV infusion Keytruda (pembrolizumab) IV infusion Khapzory (levoleucovorin) IV infusion Kyprolis (carfilzomib) IV infusion Lartruvo (olaratumab) IV infusion Libtayo (cemiplimab-rwlc) IV infusion Lumoxiti (moxetumomab pasudotox-TDFK) IV infusion Mylotarg (gemtuumab) IV infusion Onivyde (irinotecan hydrochloride) IV infusion Opdivo (nivolumab) IV infusion Perjeta (pertuzumab) IV infusion Portrazza (necitumumab) IV infusion Poteligeo (mogamulizumab-kpkc) IV infusion Provenge (sipuleucel-T) IV infusion Rituxan Hycela (rituximab and hyaluronidase human) Subcutaneous Sylvant (siltuximab) IV infusion Synribo (omacetaxine mepesuccinate) Subcutaneous Tecentriq (atezolizumab) IV infusion Torisel (temsirolimus) IV infusion Trisenox (arsenic trioxide) IV infusion Unituxin (dinutuximab) IV infusion Vectibix (panitumumab) IV infusion Velcade (bortezomib) Subcutaneous IV infusion Yervoy (ipilimumab) IV infusion Yondelis (trabectedin) IV infusion Zaltrap (ziv-aflibercept) IV infusion Medical benefit drugs (mostly injectable/infused dosage forms) as of 03/01/2019 Brand/Generic Name Route of FDA Approved Date Drug Launch Date Administration Herceptin Hylecta (trastuzumab Subcutaneous February 28, 2019 April 4, 2019 and hyaluronidase-oysk Infugem (gemcitabine) IV infusion July 16, 2018 March 12, 2019 Document History 03/01/2019 Original effective date 03/2019 Added Infugem 04/2019 Added Herceptin Hylecta .
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