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Medical Policy Update: November 2018

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Medical Policy Update: November 2018 November 2018 In This Issue Coverage Criteria Revised for Histone Deacetylase (HDAC) Inhibitors ..................................................... 2 Coverage Criteria Established for Mogamulizumab-kpkc (Poteligeo) ........................................................ 4 Polymerized Sucralfate Malate Paste (ProThelial) Considered Experimental/Investigational .................... 5 REMINDER: Molecular and Genomic Testing .......................................................................................... 6 Contents .......................................................................................................................................................... 11 Policy Coverage Criteria Revised for Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies Highmark Blue Shield has revised coverage criteria for Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies per approved Food and Drug Administration (FDA) indications and National Comprehensive Cancer Network (NCCN) guidelines. The updated criteria will include cemiplimab (Libtayo®) for advanced or metastatic urothelial carcinoma or metastatic non-small cell lung cancer. The updated criteria will also include FDA approved indications for Atezolizumab (Tecentriq®), Nivolumab (Opdivo®) and Pembrolizumab (Keytruda®). The Medical Policy will apply to both professional provider and facility claims. The effective date is November 12, 2018. Please refer to Medical Policy I-120, Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies, for additional information. Place of Service: Outpatient Highmark Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. Note: This publication may contain certain administrative requirements, policies, procedures, or other similar requirements of Highmark Inc. (or changes thereto) which are binding upon Highmark Inc. and its contracted providers. Pursuant to their contract, Highmark Inc. and such providers must comply with any requirements included herein unless and until such item(s) are subsequently modified in whole or in part. Medical Policy Update November 2018 Coverage Criteria Revised for Immune Globulin Therapy Highmark Blue Shield has revised coverage criteria for immune globulin therapy to include subcutaneous immune globulin (Hizentra®) for the Food and Drug Administration (FDA) approved indication of chronic inflammatory demyelinating polyneuropathy (CIDP). The Medical Policy will apply to both professional provider and facility claims. The effective date is November 12, 2018. Please refer to Medical Policy I-14, Immune Globulin Therapy, for additional information. Place of Service: Outpatient Coverage Criteria Revised for Histone Deacetylase (HDAC) Inhibitors Highmark Blue Shield has revised the coverage criteria for HDAC Inhibitors, including belinostat (Beleodaq®) and romidepsin (Istodax®). Coverage criteria revised to expand coverage of belinostat (Beleodaq) to include use as systemic therapy for treatment of mycosis fungoides (MF) and peripheral T-Cell Lymphoma for: Stage IIB MF with: o Limited tumor lesions refractory to multiple previous therapies or progression, with or without skin-directed therapy; or o Generalized tumor lesions that is relapsed with T3 disease or has persistent T3 disease, with or without skin-directed therapies; or Stage IV non-Sezary or visceral disease that is relapsed or persistent, with or without radiation therapy for local control; or Second-line or subsequent therapy as a single agent for relapsed or refractory nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype; or Second-line or subsequent therapy as a single agent for relapsed or refractory anaplastic large cell lymphoma. Coverage criteria revised to expand coverage of romidepsin (Istodax) to include use as primary systemic treatment for: Stage IA MF with blood B1 involvement, with or without skin-directed therapy; or Stage IB-IIA MF with blood B1 involvement, with or without skin-directed therapy; or Stage IB-IIA MF with histologic evidence of folliculotropic or large-cell transformed MF, with or without: o Local radiation therapy for limited tumor lesions; or o Skin-directed therapy for generalized tumor lesions; or Stage IIB MF with: o Limited tumor lesions, with or without local radiation therapy; or o Generalized tumor lesions, with or without skin-directed therapy; or o Stage III MF with blood B1 involvement, with or without skin-directed therapy; or o Stage IV non-Sezary or visceral disease, with or without radiation therapy for local control; or o Stage IV Sezary syndrome. 2 Medical Policy Update November 2018 Coverage criteria revised to expand coverage of romidepsin (Istodax) to include use as systemic therapy for: Stage IA MF with blood B1 involvement refractory to multiple previous therapies or progression to greater than stage IA on skin-directed therapies, with or without skin- directed therapies; or Stage IA MF refractory to multiple previous therapies or progression to greater than stage IA on skin-directed therapies, with histologic evidence of folliculotropic or large-cell transformed MF, with or without: o Local radiation for limited tumor lesions; or o Skin-directed therapy for generalized tumor lesions; or Stage IB-IIA MF refractory to multiple previous therapies or progressions to greater than Stage IB-IIA; or Stage IIB MF with limited tumor lesions that is: o Relapsed with T3 limited extent disease or has persistent T3 limited extent disease, with or without local radiation therapy; or o Refractory to multiple previous therapies or progression, with or without skin- directed therapy; or Stage IB MF with generalized tumor lesions that is relapsed with T3 disease or has persistent T3 disease, with or without skin-directed therapy; or Stage III MF with blood B1 involvement that is relapsed or persistent, with or without skin-directed therapy; or Stage IV Sezary syndrome that is relapsed or persistent; or Stage IV non Sezary or visceral disease that is relapsed or persistent, with or without radiation therapy for local control. Coverage criteria revised to expand coverage of romidepsin (Istodax) to include use as second line or subsequent therapy as a single agent for relapsed or refractory: Second-line or subsequent therapy as a single agent for relapsed or refractory nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype; or Second-line or subsequent therapy as a single agent for relapsed or refractory anaplastic large cell lymphoma. This Medical Policy will apply to both professional provider and facility claims. The effective date is November 12, 2018. Please refer to Medical Policy I-159, Oncologic Indications for Histone deacetylase (HDAC) Inhibitors, for additional information. Place of Service: Outpatient 3 Medical Policy Update November 2018 Coverage Criteria Established for Mogamulizumab-kpkc (Poteligeo) Highmark Blue Shield has established coverage criteria for mogamulizumab-kpkc (Poteligeo®). Mogamulizumab-kpkc (Poteligeo) may be medically necessary for the following: Food and Drug Administration (FDA) Indications: For treatment of relapsed or refractory mycosis fungoides (MF) or Sezary syndrome (SS) after at least one prior systemic therapy when: Individual is 18 years of age or older; and Documentation by clinician of at least one prior systemic therapy. National Comprehensive Cancer Network (NCCN) Recommendations: Systemic therapy as primary treatment for: Stage IA MF with blood B1 involvement, with or without skin-directed therapy; or Stage IB-IIA MF with blood B1 involvement, with or without skin-directed therapy; or Stage IB-IIA MF with histologic evidence of folliculotropic or large-cell transformed MF, with or without local radiation therapy for: o Limited tumor lesions; or o Generalized tumor lesions; or Stage IIB MF with: o Limited tumor lesions, with or without local radiation therapy; or o Generalized tumor lesions, with or without skin-directed therapy; or Stage III MF with blood B1 involvement, with or without skin-directed therapy; or Stage IV SS; or Systemic therapy as treatment for: Stage IA MF with blood B1 involvement refractory to multiple previous therapies or progression to > stage IA on skin-directed therapies, with or without skin-directed therapy; or Stage IA MF refractory to multiple previous therapies or progression to > Stage IA on skin-directed therapies, with histologic evidence of folliculotropic or large-cell transformed MF, with or without local radiation for limited tumor lesions; or Stage IA MF refractory to multiple previous therapies or progression to > stage IA on skin-directed therapies; with histologic evidence of folliculotropic or large-cell transformed MF, with or without skin-directed therapy for generalized tumor lesions; or Stage IB-IIA MF refractory to multiple previous therapies or progression > stage IB- IIA; or Stage IIB MF with limited tumor lesions that is relapsed with T3 limited extent disease or has persistent T3 limited extent disease, with or without local radiation therapy; or Stage IIB MF with limited tumor lesions refractory to multiple previous therapies or progression, with or without skin-directed therapies; or Stage IIB MF with generalized tumor lesions that is relapsed with T3 disease or has persistent T3 disease, with or without skin-directed therapy; or Stage III MF with blood B1 involvement that is relapsed or persistent, with or without
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