Contents Please refer to Medical Policy I-31, Tocilizumab (Actemra) for additional information.

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1 In This Issue January 2018 Coverage Criteria Revised for Alpha1-Proteinase Inhibitor Infusions... 2 Coverage Criteria Revised for Eculizumab (Soliris)... 3 Coverage Criteria Revised for Chimeric Antigen Receptor T-Cell Therapy... 6 Contents Policy Coverage Criteria Revised for Tocilizumab (Actemra) Highmark Blue Cross Blue Shield has revised the coverage criteria for tocilizumab (Actemra ). This Medical Policy will apply to both professional provider and facility claims. The effective date was January 1, Tocilizumab (Actemra) IV may be considered medically necessary for the treatment of cytokine release syndrome (CRS) for adults and pediatric patients two (2) years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or lifethreatening cytokine release syndrome. Please refer to Medical Policy I-31, Tocilizumab (Actemra) for additional information. Highmark Blue Cross 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.

2 Coverage Criteria Revised for Ustekinumab (Stelara) Highmark Blue Cross Blue Shield has revised the coverage criteria for ustekinumab (Stelara ). This Medical Policy will apply to both professional provider and facility claims. The effective date is April 2, For the treatment of moderately to severely active Crohn s disease for individuals 18 years of age or older. For the treatment of moderate to severe plaque psoriasis for individuals 12 years of age or older. Please refer to Medical Policy I-37, Ustekinumab (Stelara) for additional information. Coverage Criteria Revised for Alpha1-Proteinase Inhibitor Infusions Highmark Blue Cross Blue Shield has revised the coverage criteria for Alpha-1 antitrypsin (A1AT) inhibitor augmentation therapy and established coverage criteria for Prolastin-C Liquid. This Medical Policy will apply to both professional provider and facility claims. The effective date is April 2, Prolastin-C Liquid may be considered medically necessary for the treatment of emphysema due to Alpha-1 antitrypsin deficiency when coverage criteria are met. A1AT inhibitor augmentation therapy may be considered medically necessary when EITHER of the following is present: o Moderate airflow obstruction is evidenced by forced expiratory volume (FEV1) of 30-65% of predicted value, prior to initiation of therapy; or o Individual has a rapid decline in lung function as measured by a change in FEV1 greater than 120 ml/year. Coverage criteria removed: Progressive panacinar emphysema is present with a documented rate of decline in FEV1. Please refer to Medical Policy I-126, Alpha1-Proteinase Inhibitor Infusions for additional information. 2

3 Coverage Criteria Revised for Belimumab (Benlysta) Highmark Blue Cross Blue Shield has revised the coverage criteria for belimumab (Benlysta ). This Medical Policy will apply to both professional provider and facility claims. The effective date is April 2, Positive anti-nuclear antibody (ANA) titer (greater than or equal to 1:80) or antidouble-stranded DNA antibody (anti-dsdna) greater than or equal to 30 IU/ml. Insufficient response to two standard of care drug classes: o Corticosteroids (e.g. prednisone); or o Antimalarials (i.e. hydroxychloroquine); or o Immunosuppressives (e.g. azathioprine, mycophenolate mofetil, or methotrexate). Coverage criteria removed: Non-steroidal anti-inflammatory drugs from the concomitant standard of care for treatment of systemic lupus. Please refer to Medical Policy I-33, Belimumab (Benlysta) for additional information. Coverage Criteria Revised for Eculizumab (Soliris) Highmark Blue Cross Blue Shield has revised the coverage criteria for eculizumab (Soliris ). This Medical Policy will apply to both professional provider and facility claims. The effective date is April 2, For the treatment of an individual 18 years of age or older with documented paroxysmal nocturnal hemoglobinuria. Please refer to Medical Policy I-130, Eculizumab (Soliris) for additional information. 3

4 Criteria Revised for Vedolizumab (Entyvio) Highmark Blue Cross Blue Shield has revised the coverage criteria for vedolizumab (Entyvio ). This Medical Policy will apply to both professional provider and facility claims. The effective date is April 2, Primary Non-responders to adalimumab (Humira) or infliximab (Remicade) or its biosimilars, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis) Treatment with infliximab (Remicade) or its biosimilars, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis) for at least fourteen weeks was ineffective, not tolerated, or is contraindicated in patients with moderate to severe disease activity of ulcerative colitis (UC) or Crohn s disease (CD). Primary Responders to adalimumab (Humira) now relapsing: Treatment with infliximab (Remicade) or its biosimilars, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis) for at least fourteen weeks was ineffective, not tolerated, or is contraindicated. Primary Responders to infliximab (Remicade) now relapsing: Vedolizumab (Entyvio) may be considered medically necessary for moderate to severe disease activity of UC or CD in patients who initially achieved remission in their disease with infliximab (Remicade) or its biosimilars, inflixmab-dyyb (Inflectra) or infliximab-abda (Renflexis) and have lost response as evidenced by a relapse in their symptoms during treatment. Coverage criteria removed: For new or current members established on vedolizumab (Entyvio) therapy, for the treatment of moderate to severe disease activity of UC or CD, continued treatment may be considered medically necessary. Please refer to Medical Policy I-129, Vedolizumab (Entyvio) for additional information. 4

5 Coverage Criteria Revised for Chimeric Antigen Receptor T-Cell Therapy Highmark Blue Cross Blue Shield has revised coverage criteria for tisagenlecleucel (Kymriah ) from patients 3 to 26 years of age to patients 25 years of age or younger. This Medical Policy will apply to both professional provider and facility claims. The effective date was January 29, Highmark Blue Cross Blue Shield has established coverage criteria for axicabtagene ciloleucel (Yescarta ). This Medical Policy will apply to both professional provider and facility claims. The effective date is April 2, Axicabtagene ciloleucel (Yescarta) may be considered medically necessary for individuals 18 years of age or older when all the following criteria are met: Individual has a diagnosis of any one of the following aggressive forms of NHL: o Diffuse large B-cell lymphoma (DLBCL), not otherwise specified; or o High-grade B-cell lymphoma; or o Double hit lymphoma; or o Primary mediastinal large B-cell lymphoma (PMBCL); or o Transformed follicular lymphoma (TFL); and For the treatment of DLCBL, High-grade B-cell lymphoma, double hit lymphoma, or PMBCL individual meets either of the following criteria: o Axicabtagene ciloleucel (Yescarta) is additional therapy for individuals with intention to proceed to high-dose therapy who have partial response, no response, or progressive disease following second-line therapy for relapsed or refractory disease; or o Treatment of disease in second relapse or greater (if not previously given); or For the treatment of TFL individual meets either of the following criteria: o For individuals who have received minimal or no prior chemotherapy prior to histologic transformation to DLBCL and have partial response, no response, relapsed, or progressive disease (only after treatment with greater than or equal to two (2) chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated); or o For individuals who have received multiple therapies (not including axicabtagene ciloleucel) prior to histologic transformation to DLBCL (only after treatment with greater than or equal to two (2) chemoimmunotherapy regimens which included at least one anthracycline or anthracenedionebased regimen, unless contraindicated); and No active or latent hepatitis B or active hepatitis C, human immunodeficiency virus (HIV) positive or any uncontrolled infection; and No active central nervous system involvement by malignancy; and No prior anti-cd19/anti-cd3 therapy, or any other anti-cd19 therapy, or gene therapy; and An Eastern Cooperative Oncology Group (ECOG) scale of performance status less than or equal to one (1); and No live vaccination within two weeks prior to initiation of lymphodepleting chemotherapy; and Apheresis product received and accepted by manufacturing site. Please refer to Medical Policy I-180, Chimeric Antigen Receptor T-Cell Therapy for additional information. 5

6 REMINDER: Radiation Therapy Highmark Blue Cross Blue Shield is providing a reminder to all providers. As previously announced in the January 12, 2018 Special Bulletin, the radiation therapy medical policies and requirements will be updated and take effect April 2, This applies to both professional provider and facility claims. At that time, policies can be accessed from the medical policy homepage. 6

7 Medicare Advantage Policy Coverage Criteria Revised for Denosumab (Prolia, Xgeva) Highmark s Medicare Advantage products have revised the coverage criteria for denosumab (Prolia, Xgeva ) based on the National Comprehensive Cancer Network and Food and Drug Administration approved indications. This Medical Policy will apply to both professional provider and facility claims. The effective date was December 18, Please refer to Medical Policy I-20, Denosumab (Prolia, Xgeva) for additional information. Coverage Criteria Revised for Ustekinumab (Stelara) Highmark s Medicare Advantage products have revised the coverage criteria for ustekinumab (Stelara ). This Medical Policy will apply to both professional provider and facility claims. The effective date is April 2, For the treatment of moderately to severely active Crohn s disease for individuals 18 years of age or older. For the treatment of moderate to severe plaque psoriasis for individuals 12 years of age or older. Please refer to Medical Policy I-139, Ustekinumab (Stelara) for additional information. 7

8 Coverage Criteria Revised for Chimeric Antigen Receptor T-Cell Therapy Highmark s Medicare Advantage products have established coverage criteria for axicabtagene ciloleucel (Yescarta ) based on the National Comprehensive Cancer Network and Food and Drug Administration approved indications. This Medical Policy will apply to both professional provider and facility claims. The effective date is April 2, Please refer to Medical Policy I-180, Chimeric Antigen Receptor T-Cell Therapy for additional information. Coverage Criteria Revised for Alpha1-Proteinase Inhibitor Infusions Highmark s Medicare Advantage products have revised the coverage criteria for Alpha-1 antitrypsin (A1AT) inhibitor augmentation therapy. This Medicare Advantage Medical Policy will apply to both professional provider and facility claims. The effective date is January 8, Prolastin-C Liquid may be considered medically necessary for the treatment of emphysema due to Alpha-1 antitrypsin deficiency. Coverage criteria removed: The individual is 18 years of age or older; and There is a documented high risk phenotype** resulting in a low serum concentration of AAT as evidenced by less than 80 mg per deciliter (mg/dl) (0.8 g/l) by radial immunodiffusion (or less than 50 mg/dl (0.5 g/l) if measured by nephelometry) or less than 11 um/l (35% of normal); and Progressive panacinar emphysema is present with a documented rate of decline in forced expiratory volume in one second (FEV1); and The individual is a non-smoker or is a smoker undergoing active smoking cessation therapy; and Must be on standard therapy for chronic obstructive pulmonary disease (COPD) (i.e. inhaled bronchodilators, inhaled steroids) as defined by current clinical guidelines (i.e. the Global Initiative COPD- GOLD guidelines); and The individual is likely to be compliant with the prescribed protocol. ** PiZZ, PiZ, or Pi phenotype (homozygous) or other phenotypes,(pisz or PiMS) associated with serum AAT concentrations of less than 80 mg/dl. Please refer to Medical Policy I-126, Alpha1-Proteinase Inhibitor Infusions for additional information. 8

9 Coverage Criteria Revised for Eculizumab (Soliris) Highmark s Medicare Advantage products have revised the coverage criteria for eculizumab (Soliris ). This Medical Policy will apply to both professional provider and facility claims. The effective date is April 2, For the treatment of an individual 18 years of age and older with documented paroxysmal nocturnal hemoglobinuria. Coverage criteria removed: For the treatment of paroxysmal nocturnal hemoglobinuria: Flow cytometry demonstrates: o Greater than or equal to 10% PNH type III red blood cells; or o Greater than or equal to 50% of glycosylphosphatidylinositol-anchored proteins (GPI-AP)-deficient polymorphonuclear cells (PMNs); and Individual has been immunized with a meningococcal vaccine at least 2 weeks prior to administration of the first dose of eculizumab (Soliris) (unless the clinical record documents that the risks of delaying eculizumab (Soliris) outweigh the risk of meningococcal infection); and There is no evidence of an active meningococcal infection; and The member meets EITHER of the following criteria: o Hemoglobin that is less than or equal to 7 g/dl, or the individual has symptoms of anemia and the hemoglobin is less than or equal to 9 g/dl; or o Evidence of clinically elevated hemolysis lactate dehydrogenase (LDH) greater than or equal to 1.5 times the upper limit of normal (ULN); or Documented history of a major adverse vascular event (MAVE) from thromboembolism that may include: Venous thrombosis Deep vein thrombosis Pulmonary embolism Hepatic or portal vein thrombosis Mesenteric or splenic thrombosis Renal vein thrombosis Thrombophlebitis Arterial thrombosis Embolic stroke Myocardial infarction Transient ischemic attack Unstable angina For the treatment of atypical hemolytic uremic syndrome: The diagnosis of ahus is supported by the absence of Shiga toxin-producing E. coli infection; and Thrombotic thrombocytopenic purpura (TTP) has been ruled out (for example, normal ADAMTS 13 activity and no evidence of an ADAMTS 13 inhibitor), or if TTP cannot be ruled out by laboratory and clinical evaluation, a trial of plasma exchange did not result in clinical improvement; and 9

10 Individual has been immunized with a meningococcal vaccine at least 2 weeks prior to administration of the first dose of eculizumab (Soliris) (unless the clinical record documents that the risks of delaying eculizumab (Soliris) outweigh the risk of meningococcal infection); and There is no evidence of an active meningococcal infection. Continuation of eculizumab (Soliris) following an initial 6-week trial for the treatment of ahus may be considered medically necessary when there is clinical improvement after the initial trial (for example, increased platelet count or laboratory evidence of reduced hemolysis). Please refer to Medical Policy I-130, Eculizumab (Soliris) for additional information. 10

11 Comments on these new medical policies? We want to know what you think about our new medical policy changes. Send us an 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 Contents Coverage Criteria Revised for Tocilizumab (Actemra)... 1 Coverage Criteria Revised for Ustekinumab (Stelara)... 2 Coverage Criteria Revised for Alpha1-Proteinase Inhibitor Infusions... 2 Coverage Criteria Revised for Belimumab (Benlysta)... 3 Coverage Criteria Revised for Eculizumab (Soliris)... 3 Criteria Revised for Vedolizumab (Entyvio)... 4 Coverage Criteria Revised for Chimeric Antigen Receptor T-Cell Therapy... 5 REMINDER:RadiationTherapy.6 Coverage Criteria Revised for Denosumab (Prolia, Xgeva) 7 Coverage Criteria Revised for Ustekinumab (Stelara)..7 Coverage Criteria Revised for Chimeric Antigen Receptor T-Cell Therapy 8 Coverage Criteria Revised for Alpha1-Proteinase Inhibitor Infusions.8 Coverage Criteria Revised for Eculizumab (Soliris)..9 Comments on these new medical policies Contents...11 Save yourself valuable time with e-subscribe! Sign up today and you ll begin receiving notifications with a direct link to the latest issue of Medical Policy Update. 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 Inquiries about Eligibility, Benefits, Claims Status or Authorizations For inquiries about eligibility, benefits, claim status or authorizations, Highmark Blue Cross 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 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 2016, 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. 11