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.

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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

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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 skin-directed therapy; or  Stage IV SS that is relapsed or persistent; or

4 Medical Policy Update November 2018

Preferred second-line therapy with intention to proceed to high-dose therapy/allogeneic stem cell rescue (HDC/ASCR) or subsequent therapy to HDT/ASCR as a single agent for nonresponders to first-line therapy for acute or lymphoma subtypes.

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-202, Mogamulizumab-kpkc (Poteligeo) for additional information.

Polymerized Sucralfate Malate Paste (ProThelial) Considered Experimental/Investigational.

Effective January 28, 2019 Highmark Blue Shield will consider Polymerized Sucralfate Malate Paste (ProThelial) experimental/investigational for all indications as the literature does not show conclusive evidence of clinical efficacy.

For additional information see Medical Policy I-203, Polymerized Sucralfate Malate Paste (ProThelial).

Coverage Guidelines Established for Moxetumomab Pasudotox (Lumoxiti)

Highmark Blue Shield has established coverage guidelines for moxetumomab pasudotox (LumoxitiTM) for relapsed or refractory hairy cell leukemia (HCL) previously treated with at least two prior systemic therapies (including at least one purine nucleoside analog) per approved Food and Drug Administration (FDA) indications and National Comprehensive Cancer Network (NCCN) guidelines. 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-204, Moxetumomab Pasudotox (Lumoxiti), for additional information.

Place of Service: Outpatient

5 Medical Policy Update November 2018

REMINDER: Molecular and Genomic Testing

Highmark Blue Shield is providing a reminder to all providers. As previously announced, the molecular and genomic testing medical policies and requirements will be updated and take effect January 1, 2019. This will apply to both professional provider and facility claims.

At that time, policies can be accessed from the medical policy homepage.

Coverage Criteria Revised for Hematopoietic Stem-Cell Transplantation for Multiple Myeloma and POEMS Highmark Blue Shield has revised the coverage criteria for Hematopoietic Stem-Cell Transplantation for Multiple Myeloma and Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin abnormalities (POEMS). This revised Medical Policy will apply to both professional provider and facility claims. The effective date is January 28, 2019.

A single or second (salvage) autologous HSCT may be considered medically necessary to treat multiple myeloma.

Tandem autologous HSCT may be considered medically necessary to treat multiple myeloma in patients who fail to achieve at least a near-complete or very good partial response after the first transplant in the tandem sequence. A near complete response, as defined by the European Group for Blood and Marrow Transplant (EBMT), is the disappearance of M protein at routine electrophoresis, but positive immunofixation. A very good partial response has been defined as a 90% decrease in the serum paraprotein level.

Tandem transplantation with an initial round of autologous HSCT followed by a non-marrow- ablative conditioning regimen and allogeneic HSCT (i.e., reduced-intensity conditioning transplant) may be considered medically necessary to treat newly diagnosed multiple myeloma patients.

Autologous HSCT for the treatment of multiple myeloma that does not meet the above criteria is considered not medically necessary.

Allogeneic hematopoietic stem-cell transplantation, myeloablative or nonmyeloablative, as upfront therapy of newly diagnosed multiple myeloma or as salvage therapy, is considered experimental/investigational and therefore non-covered as the safety and efficacy of this service cannot be established by the available published peer review literature.

Please refer to Medical Policy S-207, Hematopoietic Stem-Cell Transplantation for Multiple Myeloma and POEMS, for more information.

Medicare Advantage Policy 6 Medical Policy Update November 2018

Coverage Criteria Revised for Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies Highmark’s Medicare Advantage products have 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

Coverage Guidelines Established for Moxetumomab Pasudotox (Lumoxiti) Highmark’s Medicare Advantage products have established coverage guidelines for moxetumomab pasudotox (LumoxitiTM) for relapsed or refractory hairy cell leukemia (HCL) previously treated with at least two prior systemic therapies (including at least one purine nucleoside analog) per approved Food and Drug Administration (FDA) indications and National Comprehensive Cancer Network (NCCN) guidelines. 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-204, Moxetumomab Pasudotox (Lumoxiti), for additional information.

Place of Service: Outpatient

Coverage Criteria Revised for Histone Deacetylase (HDAC) Inhibitors

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Highmark’s Medicare Advantage products have 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:

8 Medical Policy Update November 2018

 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.

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

Coverage Criteria Established for Mogamulizumab-kpkc (Poteligeo) Highmark’s Medicare Advantage products have established coverage criteria for mogamulizumab-kpkc (Poteligeo®). Mogamulizumab-kpkc (Poteligeo) may be medically necessary for the following:

Food and Drug Administration (FDA) Indications:

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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

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-202, Mogamulizumab-kpkc (Poteligeo) for additional information.

Comments on these new medical policies?

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We want to know what you think about our new medical policy changes. Send us an email with any questions or comments that you may have on the new medical policies in this edition of Medical Policy Update.

Write to us at [email protected]. Contents Coverage Criteria Revised for Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies ...... 1 Coverage Criteria Revised for Immune Globulin Therapy ...... 2 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 Coverage Guidelines Established for Moxetumomab Pasudotox (Lumoxiti) ...... 5 REMINDER: Molecular and Genomic Testing ...... 6 Coverage Criteria Revised for Hematopoietic Stem-Cell Transplantation for Multiple Myeloma and POEMS ...... 6 Coverage Criteria Revised for Programmed Death Receptor (PD-1)/ Programmed Death-Ligand (PD-L1) Blocking Antibodies ...... 7 Coverage Guidelines Established for Moxetumomab Pasudotox (Lumoxiti) ...... 7 Coverage Criteria Revised for Histone Deacetylase (HDAC) Inhibitors ...... 7 Coverage Criteria Established for Mogamulizumab-kpkc (Poteligeo)...... 9 Comments on these new medical policies? ...... 10 Contents ...... 11

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About this newsletter

Medical Policy Update is the monthly newsletter for most health care professionals (and office staff) and facilities who participate in our networks and submit claims to Highmark using the 837P HIPAA transaction or the CMS 1500 form, or the 837I HIPAA transaction. Medical Policy Update focuses only on medical policy and claims administration updates, including coding guidelines and procedure code revisions, and is the sole source for this information. For all other news, information and updates, be sure to read Provider News, available on the Provider Resource Center at www.highmarkblueshield.com.

Inquiries about Eligibility, Benefits, Claims Status or Authorizations For inquiries about eligibility, benefits, claim status or authorizations, Highmark Blue Shield encourages providers to use the electronic resources available to them - NaviNet® and the applicable HIPAA transactions – prior to placing a telephone call to the Provider Service Center at 1-866-803-3708.

Acknowledgement The five-digit numeric codes that appear in Medical Policy Update were obtained from the Current Procedural Terminology (CPT), as contained in CPT- 2018, Copyright 2017, by the American Medical Association. Medical Policy Update includes CPT descriptive terms and numeric procedure codes and modifiers that are copyrighted by the American Medical Association. These procedure codes and modifiers are used for reporting medical services and procedures.