Medical Policy Update Bulletin

October 2019 medical policy update bulletin

Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates

Updated Oct. 4, 2019: Implementation of the changes described in this bulletin for the following Medical Benefit Drug Policies has been delayed until further notice:  Page 21: Cimzia® (Certolizumab Pegol) (New)  Page 26: Actemra® (Tocilizumab) Injection for Intravenous Infusion (Revised)  Page 41: Orencia® (Abatacept) Injection for Intravenous Infusion (Revised)  Page 43: Simponi Aria® (Golimumab) Injection for Intravenous Infusion (Revised) Updated Oct. 8, 2019: Implementation of the changes described in this bulletin for the following Clinical Policy has been delayed until further notice:  Page 27: Benlysta® (Belimumab) (Revised)

UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to support you and your patients in making the most informed decisions regarding the choice of quality and cost-effective care, and to support practice staff with a simple and predictable administrative experience. The Medical Policy Update Bulletin was developed to share important information regarding UnitedHealthcare Medical Policy, Medical Benefit Drug Policy, Coverage Determination Guideline, Utilization Review Guideline, and Quality of Care Guideline updates.* *Where information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare follows such applicable federal and/or state law.

Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates Overview

This bulletin provides complete details on UnitedHealthcare Medical Policy Update Classifications Policy, Medical Benefit Drug Policy, Coverage Determination New Guideline (CDG), Utilization Review Guideline (URG), and/or New clinical coverage criteria and/or documentation review Quality of Care Guideline (QOCG) updates. The inclusion of a requirements have been adopted for a health service (e.g., test, drug, health service (e.g., test, drug, device or procedure) in this bulletin device or procedure) indicates only that UnitedHealthcare has recently adopted a new Updated policy and/or updated, revised, replaced or retired an existing An existing policy has been reviewed and changes have not been made policy; it does not imply that UnitedHealthcare provides coverage to the clinical coverage criteria or documentation review requirements; for the health service. In the event of an inconsistency or conflict however, items such as the clinical evidence, FDA information, and/or between the information provided in this bulletin and the posted list(s) of applicable codes may have been updated policy, the provisions of the posted policy will prevail. Note that most benefit plan documents exclude from benefit coverage health Revised services identified as investigational or unproven/not medically An existing policy has been reviewed and revisions have been made to necessary. Physicians and other health care professionals may not the clinical coverage criteria and/or documentation review requirements seek or collect payment from a member for services not covered by Replaced the applicable benefit plan unless first obtaining the member’s written consent, acknowledging that the service is not covered by An existing policy has been replaced with a new or different policy the benefit plan and that they will be billed directly for the service. Retired The health service(s) addressed in the policy are no longer being The complete library of UnitedHealthcare Medical managed or are considered to be proven/medically necessary and are Policies, Medical Benefit Drug Policies, CDGs, URGs, and therefore not excluded as unproven/not medically necessary services, QOCGs is available at UHCprovider.com > Policies and unless coverage guidelines or criteria are otherwise documented in Protocols > Commercial Policies > Medical & Drug another policy Policies and Coverage Determination Guidelines. Note: The absence of a policy does not automatically indicate or imply coverage. As always, coverage for a health service must be determined Tips for using the Medical Policy Update Bulletin: in accordance with the member’s benefit plan and any applicable  From the table of contents, click the policy title to be federal or state regulatory requirements. Additionally, UnitedHealthcare directed to the corresponding policy update summary. reserves the right to review the clinical evidence supporting the safety  From the policy updates table, click the policy title to view a and effectiveness of a medical technology prior to rendering a coverage complete copy of a new, updated, or revised policy. determination.

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Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates In This Issue

Take Note

QUARTERLY CPT® AND HCPCS CODE UPDATES

Effective Oct. 1, 2019, all applicable Medical Policies and Medical Benefit Drug Policies have been modified to reflect the quarterly Current Procedural Terminology (CPT®) and Healthcare Common Procedure Coding System (HCPCS) code additions, revisions, and deletions.

Medical Policy Updates Page UPDATED  Electric Tumor Treatment Field Therapy – Effective Nov. 1, 2019 ...... 5  Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions – Effective Oct. 1, 2019 ...... 5  Skin and Soft Tissue Substitutes – Effective Oct. 1, 2019 ...... 5 REVISED  Apheresis – Effective Nov. 1, 2019 ...... 5  Bariatric Surgery – Effective Dec. 1, 2019 ...... 10  Epidural Steroid and Facet Injections for Spinal Pain – Effective Dec. 1, 2019 ...... 12  Genetic Testing for Hereditary Cancer – Effective Oct. 1, 2019 ...... 14  Omnibus Codes – Effective Dec. 1, 2019 ...... 17  Vagus and External Trigeminal Nerve Stimulation – Effective Dec. 1, 2019 ...... 18 Medical Benefit Drug Policy Updates NEW  Cimzia® (Certolizumab Pegol) – Effective Oct. 1, 2019 TBD ...... 21  Krystexxa® (Pegloticase) – Effective Oct. 1, 2019 ...... 24 UPDATED  Complement Inhibitors (Soliris® & Ultomiris™) – Effective Oct. 1, 2019 ...... 25  Evenity™ (Romosozumab-Aqqg) – Effective Oct. 1, 2019 ...... 26  Gamifant™ (Emapalumab-Lzsg) – Effective Oct. 1, 2019 ...... 26  Onpattro™ (Patisiran) – Effective Oct. 1, 2019 ...... 26 REVISED  Actemra® (Tocilizumab) Injection for Intravenous Infusion – Effective Oct. 1, 2019 TBD ...... 26  Benlysta® (Belimumab) – Effective Oct. 1, 2019 TBD ...... 27  Clotting Factors, Coagulant Blood Products & Other Hemostatics – Effective Oct. 1, 2019 ...... 28

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Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates In This Issue

 Infliximab (Remicade®, Inflectra™, Renflexis™) – Effective Oct. 1, 2019 ...... 28  Ketalar® (Ketamine) and Spravato™ (Esketamine) – Effective Oct. 1, 2019 ...... 33  Maximum Dosage – Effective Oct. 1, 2019 ...... 36  Oncology Medication Clinical Coverage – Effective Oct. 1, 2019 ...... 38  Orencia® (Abatacept) Injection for Intravenous Infusion – Effective Oct. 1, 2019 TBD ...... 41  Review at Launch Medication List – Effective Oct. 1, 2019 ...... 42  Self-Administered Medications List – Effective Oct. 1, 2019 ...... 43  Simponi Aria® (Golimumab) Injection for Intravenous Infusion – Effective Oct. 1, 2019 TBD ...... 43  Sodium Hyaluronate – Effective Oct. 1, 2019 ...... 44  Stelara® (Ustekinumab) – Effective Oct. 1, 2019 ...... 47 Coverage Determination Guideline (CDG) Updates REVISED  Preventive Care Services – Effective Dec. 1, 2019 ...... 51

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Medical Policy Updates

Policy Title Effective Date Summary of Changes UPDATED Electric Tumor Nov. 1, 2019 Template Update Treatment Field  Added Documentation Requirements section Therapy Coverage Rationale  Replaced language indicating “the use of devices to generate electric tumor treatment fields (TTF) is considered investigational, unproven, and not medically necessary when the criteria [in the policy] are not met and for all other indications [not listed in the policy]” with “the use of devices to generate electric tumor treatment fields (TTF) is unproven and not medically necessary when the criteria [in the policy] are not met and for all other indications [not listed in the policy]” Definitions  Updated definition of “Supratentorial” Applicable Codes  Added HCPCS code A4555 Supporting Information  Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect the most current information

Molecular Oncology Oct. 1, 2019 Applicable Codes Testing for Cancer  Updated list of applicable CPT codes to reflect quarterly code edits; added 0113U and 0118U Diagnosis, Prognosis, and Treatment Decisions

Skin and Soft Oct. 1, 2019 Applicable Codes Tissue Substitutes  Updated list of applicable HCPCS codes to reflect quarterly code edits; revised description for Q4122, Q4165, and Q4184

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Apheresis Nov. 1, 2019 Coverage Rationale Therapeutic apheresis is proven and medically necessary for treating  Revised list of or managing the following conditions/diagnoses: conditions/diagnoses for which  Acute inflammatory demyelinating polyneuropathy (Guillain-Barré therapeutic apheresis is proven syndrome), primary treatment and medically necessary:  Acute liver failure (requiring High Volume Plasma Exchange) o Added:  ANCA-associated rapidly progressive glomerulonephritis (Granulomatosis . Cryoglobulinemia with polyangiitis; and Microscopic Polyangiitis) (second line therapy) o Dialysis dependent . Hypertriglyceridemic o Diffuse alveolar hemorrhage (DAH)

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Apheresis Nov. 1, 2019 pancreatitis, severe  Anti-glomerular basement membrane disease (Goodpasture’s syndrome) (continued) . Major hematopoietic o Dialysis independent stem cell transplant, o DAH ABO incompatible,  Cardiac transplantation, second line therapy second line therapy o Recurrent rejection - HPC(M) o Desensitization - HPC(A)  Chronic inflammatory demyelinating polyneuropathy . Myeloma cast  Cryoglobulinemia, second line therapy nephropathy (second line  Cutaneous T-cell lymphoma; mycosis fungoides; Sezary syndrome, therapy) erythrodermic . Neuromyelitis optica  Familial hypercholesterolemia spectrum disorders o Homozygous (Devic’s syndrome), o Heterozygous, second line therapy relapse (second line  Focal segmental glomerulosclerosis, recurrent in transplanted kidney, therapy) second line therapy . Renal transplantation,  Graft-versus-host disease ABO incompatible o Acute (second line therapy) o Chronic, second line therapy - Antibody mediated  Heart transplantation in children less than 40 months of age, ABO rejection incompatible, second line therapy . Voltage gated potassium  Hereditary hemochromatosis channel antibodies-  Hyperlipoproteinemia related conditions  Hypertriglyceridemic pancreatitis, severe o Removed:  Hyperviscosity in hypergammaglobulinemia . ABO incompatible major  Idiopathic dilated cardiomyopathy, NYHA class II-IV, via IA hematopoietic stem  Inflammatory bowel disease, via adsorptive cytapheresis cell/bone marrow  Liver transplantation, ABO incompatible transplant (only as o Desensitized ABOi second line therapy) o Living donor . ABO incompatible kidney  Lung transplantation, bronchiolitis obliterans syndrome transplantation (only as  Major hematopoietic stem cell transplant, ABO incompatible, second line second line therapy) therapy - Antibody mediated o HPC(M) rejection, living o HPC(A) donor (LD)  Multiple sclerosis, second line therapy desensitization o Acute CNS inflammatory, demyelinating - A²/A²B into B, o Relapsing form with steroid resistant exacerbations deceased donor  Myasthenia gravis, acute . Age-related macular  Myeloma cast nephropathy, second line therapy

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Apheresis Nov. 1, 2019 degeneration, dry  Neuromyelitis optica spectrum disorders (Devic’s syndrome), acute or (continued) . Coagulation factor relapse, second line therapy inhibitors, autoantibody  N-methyl D-aspartate receptor antibody encephalitis via immunoadsorption  Paraproteinemic polyneuropathies via Therapeutic Plasma Exchange (IA) (TPE) . Hyperleukocytosis, o Anti-MAG symptomatic o Multifocal motor . Systemic lupus o IgG/IgA erythematosus nephritis o IgM o Replaced:  Pediatric autoimmune neuropsychiatric disorders associated with . “ABO incompatible liver streptococcal infections (PANDAS exacerbation) transplantation,  Peripheral vascular diseases desensitized ABOi,  Polycythemia vera; erythrocytosis deceased donor” with  Progressive multifocal leukoencephalopathy associated with natalizumab “liver transplantation,  Pruritus due to hepatobiliary diseases ABO incompatible:  Renal transplantation, ABO compatible desensitized ABOi, living o Antibody mediated rejection donor” o Desensitization, living donor . “Graft-versus-host  Renal transplantation, ABO incompatible, second line therapy disease: acute or o Antibody mediated rejection chronic, skin and non-  Rheumatoid arthritis, refractory, second line therapy skin” with “graft-versus-  Sickle cell disease host disease: acute or o Acute stroke or multiorgan failure chronic” o Acute chest syndrome, severe, second line therapy . “Hyperviscosity in o Stroke prevention monoclonal o Prevention of transfusional iron overload gammopathies” with  Thrombotic microangiopathy, complement mediated “hyperviscosity in o MCP mutations hypergammaglobulinemi  Thrombotic microangiopathy, Shiga toxin mediated a” o Absence of severe neurological symptoms . “Myasthenia gravis” with  Thrombotic thrombocytopenic purpura “myasthenia gravis,  Vasculitis acute” o Behcet’s disease (adsorptive cytapheresis) . “Sickle cell disease: o Idiopathic PAN (TPE) primary or secondary  Voltage gated potassium channel antibodies-related conditions stroke prevention” with  Wilson’s disease, fulminant “sickle cell disease: stroke prevention” Due to insufficient evidence of efficacy, therapeutic apheresis . “Vasculitis: Behçet’s including plasma exchange, plasmapheresis, or photopheresis is

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Apheresis Nov. 1, 2019 disease (adsorption unproven and not medically necessary for treating or managing the (continued) granulocytapheresis), following conditions/diagnoses, including but not limited to: EGPA (TPE)” with  Acute disseminated encephalomyelitis “Vasculitis: Behçet’s  Acute inflammatory demyelinating polyneuropathy (Guillain-Barré disease (adsorptive syndrome), after IVIG cytapheresis)”  Age related macular degeneration o Added language to indicate  Amyloidosis, systemic therapeutic apheresis is  Amyotrophic lateral sclerosis proven and medically  ANCA-associated rapidly progressive glomerulonephritis, dialysis necessary for the following independent (Granulomatosis with polyangiitis; and Microscopic only as second line therapy: Polyangiitis) . Cardiac transplantation  Anti-glomerular basement membrane disease, dialysis dependent, . Multiple sclerosis: acute without DAH (Goodpasture’s syndrome) CNS inflammatory,  Aplastic anemia; pure red cell aplasia demyelinating  Atopic (neuro-) dermatitis (atopic eczema), recalcitrant  Revised list of  Autoimmune hemolytic anemia; warm autoimmune hemolytic anemia conditions/diagnoses for which (WAIHA); cold agglutinin disease therapeutic apheresis is  Babesiosis unproven and not medically  Burn shock resuscitation necessary:  Cardiac neonatal lupus o Added:  Cardiac transplantation . Age related macular o Antibody mediated rejection degeneration o Rejection prophylaxis . Liver transplantation  Catastrophic antiphospholipid syndrome - ABO incompatible  Chronic focal encephalitis (Rasmussen’s encephalitis) - Antibody mediated  Coagulation factor inhibitors rejection  Complex regional pain syndrome o Removed:  Cutaneous T-cell lymphoma; mycosis fungoides; Sézary syndrome, non- . ABO incompatible liver erythrodermic transplantation, antibody  Dermatomyositis/polymyositis mediated rejection  Erythropoietic porphyria, liver disease . Cryoglobulinemia  Focal segmental glomerulosclerosis, native kidney, steroid resistant . Myeloma cast  Hashimoto’s encephalopathy nephropathy  HELLP syndrome . Prevention of RhD  Hematopoietic stem cell transplantation alloimmunization after o HLA desensitized RBC exposure o Major/minor ABO incompatibility with pure RBD aplasia . Voltage gated potassium o Minor HPC(A) channel antibodies  Hemolytic uremic syndrome

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Apheresis Nov. 1, 2019 o Replaced:  Hemophagocytic lymphohistiocytosis (continued) . “Coagulation factor  Henoch-Schonlein purpura inhibitors, alloantibody  Heparin induced thrombocytopenia and thrombosis (via IA), autoantibody  Hyperleukocytosis (via TPE or IA)” with  Hypertriglyceridemic pancreatitis, prevention “coagulation factor  Immune thrombocytopenia inhibitors”  IgA nephropathy (Berger’s Disease) . “Hematopoietic stem cell  Inflammatory bowel disease, via Extracorporeal Photopheresis transplantation,  Lambert-Eaton myasthenic syndrome major/minor HPC(A)”  Liver transplantation with “hematopoietic o ABO incompatible stem cell o Antibody mediated rejection transplantation,  Lung transplantation major/minor ABO o Antibody mediated rejection incompatibility with pure o Desensitization RBD aplasia, minor  Malaria HPC(A)”  Multiple sclerosis, chronic (unless noted above as proven) . “Hyperleukocytosis,  Nephrogenic systemic fibrosis prophylaxis” with  Neuromyelitis optica spectrum disorders, maintenance “hyperleukocytosis”  Overdose, venoms, and poisoning . “Hypertriglyceridemic  Paraneoplastic neurologic syndromes pancreatitis” with  Paraproteinemic polyneuropathy (unless noted above as proven) “hypertriglyceridemic  Pediatric autoimmune neuropsychiatric disorders associated with pancreatitis, prevention” streptococcal infections (Sydenham’s chorea, severe) . “Immunoglobulin  Pemphigus vulgaris nephropathy” with “IgA  Phytanic acid storage disease (Refsum’s disease) nephropathy (Berger’s  Post transfusion purpura Disease)”  Psoriasis . “Multiple sclerosis  Red cell alloimmunization, prevention and treatment (unless noted [in the  Renal transplantation, ABO compatible, desensitized, deceased donor policy] as proven)” with  Scleroderma (systemic sclerosis) “multiple sclerosis,  Sepsis with multiorgan failure chronic (unless noted [in  Sickle cell disease (unless noted above as proven) the policy] as proven)”  Stiff-person syndrome . “Red cell  Sudden sensorineural hearing loss alloimmunization, in  Systemic lupus erythematosus, severe pregnancy” with “red cell  Thrombocytosis alloimmunization,  Thrombotic microangiopathy (unless noted above as proven) prevention and  Thyroid storm

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Apheresis Nov. 1, 2019 treatment”  Toxic epidermal necrolysis (continued) . “Sickle cell disease, non-  Vasculitis (unless noted above as proven) acute (unless noted [in the policy] as proven)” Note: Refer to the Description of Services section for information regarding with “sickle cell disease all apheresis-based procedures. (unless noted [in the policy] as proven)” Supporting Information  Updated Clinical Evidence and References sections to reflect the most current information

Bariatric Surgery Dec. 1, 2019 Coverage Rationale The following bariatric surgical procedures are proven and medically  Added language to indicate the necessary for treating obesity: TransPyloric Shuttle (TPS)  Gastric bypass (includes robotic-assisted gastric bypass) Device is unproven and not o Laparoscopic adjustable gastric banding for individuals > 18 years of medically necessary for treating age. Refer to the U.S. Food and Drug Administration (FDA) section obesity for additional information Supporting Information  Gastric sleeve procedure  Updated Description of Services,  Vertical banded gastroplasty Clinical Evidence, FDA, and  Biliopancreatic bypass References sections to reflect the  Biliopancreatic diversion with duodenal switch most current information In adults, bariatric surgery using one of the procedures identified above for treating obesity is proven and medically necessary when ALL of the following criteria are met: . Class III obesity; or . Class II obesity in the presence of one or more of the following co- morbidities: o Type 2 diabetes; or o Cardiovascular disease [e.g., stroke, myocardial infarction, poorly controlled hypertension (systolic blood pressure greater than 140 mm Hg or diastolic blood pressure 90 mm Hg or greater, despite pharmacotherapy)]; or o History of coronary artery disease with a surgical intervention such as coronary artery bypass or percutaneous transluminal coronary angioplasty; or o History of cardiomyopathy; or o Obstructive Sleep Apnea (OSA) confirmed on polysomnography with

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Bariatric Surgery Dec. 1, 2019 an AHI or RDI of >30 (continued) and  The individual must also meet the following criteria: o Both of the following: . Completion of a preoperative evaluation that includes a detailed weight history along with dietary and physical activity patterns; and . Psychosocial-behavioral evaluation to provide screening and identification of risk factors or potential postoperative challenges that may contribute to a poor postoperative outcome or o Participation in a multi-disciplinary surgical preparatory regimen

In Adolescents, the bariatric surgical procedures identified above are proven and medically necessary for treating obesity when ALL of the following criteria are met:  Class III obesity; or  Class II obesity in the presence of one or more of the following co- morbidities: o Type 2 diabetes; or o Cardiovascular disease [e.g., stroke, myocardial infarction, poorly controlled hypertension (systolic blood pressure greater than 140 mm Hg or diastolic blood pressure 90 mm Hg or greater, despite pharmacotherapy)]; or o History of coronary artery disease with a surgical intervention such as coronary artery bypass or percutaneous transluminal coronary angioplasty; or o History of cardiomyopathy; or o Obstructive Sleep Apnea confirmed on polysomnography with an AHI or RDI of >30 and  The individual must also receive an evaluation at, or in consultation with, a multidisciplinary center focused on the surgical treatment of severe childhood obesity. This may include adolescent centers that have received accreditation by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) or can demonstrate similar programmatic components.

Revisional Bariatric Surgery using one of the procedures identified

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Bariatric Surgery Dec. 1, 2019 above is proven and medically necessary when due to a Technical (continued) Failure or Major Complication from the initial bariatric procedure.

The following procedures are unproven and not medically necessary for treating obesity due to insufficient evidence of efficacy:  Revisional Bariatric Surgery for any other indication than those listed above  Bariatric surgery as the primary treatment for any condition other than obesity  Bariatric surgical interventions for the treatment of obesity including but not limited to: o Transoral endoscopic surgery o Mini-gastric bypass (MGB) or laparoscopic mini-gastric bypass (LMGBP) o Gastric electrical stimulation with an implantable gastric stimulator (IGS) o VBLOC® vagal blocking therapy o Intragastric balloon o Laparoscopic greater curvature plication, also known as total gastric vertical plication o Stomach aspiration therapy (AspireAssist®) o Bariatric artery embolization (BAE) o Single-Anastomosis Duodenal Switch (also known as duodenal switch with single anastomosis, or stomach intestinal pylorus sparing surgery [SIPS]) o TransPyloric Shuttle (TPS) Device

Gastrointestinal liners (EndoBarrier®) are investigational, unproven and not medically necessary for treating obesity due to lack of U.S. Food and Drug Administration (FDA) approval, and insufficient evidence of efficacy.

Epidural Steroid Dec. 1, 2019 Coverage Rationale Note: This policy addresses Epidural Steroid Injections (ESI) of the lumbar and Facet  Added coverage criteria for spine only. The policy does not address Epidural Steroid Injections of the Injections for Epidural Steroid Injections (ESI) cervical or thoracic spine, nor does it address injections for obstetrical or Spinal Pain for treating lumbar radicular pain surgical anesthetic. The policy addresses Facet Joint Injections of multiple caused by spinal stenosis, disc sites and is not limited to Facet Joint Injections of the lumbar spine. herniation or degenerative changes in the vertebrae The following are proven and medically necessary:

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Epidural Steroid Dec. 1, 2019 requiring:  Epidural Steroid Injections (ESI) for treating lumbar radicular pain and Facet o The pain is associated with caused by spinal stenosis, disc herniation, degenerative changes in the Injections for symptoms of nerve root vertebrae or for the short-term management of low back pain when the Spinal Pain irritation and/or low back following criteria are met: (continued) pain due to disc extrusions o The pain is associated with symptoms of nerve root irritation and/or and/or contained low back pain due to disc extrusions and/or contained herniations; herniations; and and o The pain is unresponsive to o The pain is unresponsive to Conservative Treatment, including but Conservative Treatment, not limited to pharmacotherapy, exercise or physical therapy including but not limited to  Diagnostic Facet Joint Injection (FJI) and/or facet nerve block (i.e., pharmacotherapy, exercise medial branch block) to localize the source of pain to the facet joint in or physical therapy persons with spinal pain  Replaced language indicating “therapeutic Facet Joint Injection The following are unproven and not medically necessary due to (FJI) is unproven and not insufficient evidence of efficacy: medically necessary for treating  The use of ultrasound guidance for ESIs and FJIs chronic spinal pain” with  ESI for all other indications of the lumbar spine not included above “therapeutic Facet Joint Injection  Therapeutic Facet Joint Injection (FJI) and/or facet nerve block (i.e., (FJI) and/or facet nerve block medial branch block) for treating chronic spinal pain (i.e., medial branch block) are unproven and not medically Epidural Steroid Injection Limitations necessary for treating chronic  A maximum of three (3) ESI (regardless of level, location, or side) in a spinal pain” year will be considered medically necessary when criteria (indications for Definitions coverage) are met for each injection  Added definition of:  A session is defined as one date of service in which ESI injection(s) are o Facet Joint Injections (FJIs) performed o Facet Nerve Block  A year is defined as the 12-month period starting from the date of o Medial Branch Block service of the first approved injection Supporting Information  Updated Clinical Evidence and References sections to reflect the most current information

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2019 Notice of Revision: The following Genetic counseling is strongly recommended prior to these tests in order to Hereditary Cancer summary of changes has been inform persons being tested about the advantages and limitations of the test modified. Revisions to the previous as applied to a unique person. policy update announcement are outlined in red below. Please take Hereditary Breast and Ovarian Cancer (BRCA1/BRCA2) note of the additional updates Genetic testing for BRCA1 and BRCA2 for individuals with a personal implemented on Oct. 1, 2019. history of a related cancer is proven and medically necessary in the following situations: Coverage Rationale  Individuals with a BRCA 1/2 pathogenic mutation detected in tumor  Simplified content tissue; or Hereditary Breast and Ovarian  Individuals with a personal history of pancreatic cancer; or Cancer (BRCA1/BRCA2)  Men with a personal history of Breast Cancer; or  Revised list of proven and  Men with a personal history of prostate cancer in any of the following medically necessary indications situations: for: o At least one Close Blood Relative who has a BRCA1 or BRCA2 o Men with a personal history mutation; or of prostate cancer o Metastatic prostate cancer; or o Women with a personal o High risk prostate cancer (Gleason Score at least 7) with at least one history of Breast Cancer Close Blood Relative with a BRCA-Related Cancer; or o Individuals without a o At least two Close Blood Relatives with BRCA-Related Cancer; or personal history of a related o Ashkenazi Jewish ancestry; or cancer o An unknown or Limited Family History Multi-Gene Hereditary Cancer  Women with a personal history of Ovarian Cancer; or Panel Testing Criteria  Women with a personal history of Breast Cancer in any of the following  Revised coverage situations: guidelines/criteria for o Metastatic Breast Cancer; or individuals: o Breast Cancer diagnosed at age 45 or younger; or o With an indication for testing o An additional Breast Cancer primary (prior diagnosis or bilateral for hereditary Breast and cancer); or Ovarian Cancer o Triple-Negative Breast Cancer diagnosed at age 60 or younger; or o With an indication for testing o At least one Close Blood Relative who has a BRCA1 or BRCA2 for hereditary colorectal mutation; or cancer o Ashkenazi Jewish ancestry; or o Without an indication for o At least one Close Blood Relative with a BRCA-Related Cancer; or testing for hereditary Breast o An unknown or Limited Family History and Ovarian cancer or colorectal cancer Genetic testing for BRCA1 and BRCA2 for individuals without a Documentation Requirements personal history of a related cancer is proven and medically

 Removed 0104U from the list of necessary in the following situations:

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Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2019 CPT codes with associated  A known BRCA1/BRCA2 mutation in a Close Blood Relative; or Hereditary Cancer documentation requirements  At least two Close Blood Relatives with a BRCA-Related Cancer; or (continued) (quarterly code edit)  Ashkenazi Jewish ancestry and at least one Close Blood Relative with a Applicable Codes BRCA-Related Cancer  Updated list of applicable CPT codes for multi-gene panel to Genetic testing for BRCA1 and/or BRCA2 is unproven and not reflect quarterly code edits: medically necessary for all other indications including: o Added 0129U, 0130U,  Screening for cancer risk for individuals not listed in the proven 0131U, 0132U, 0133U, indications above; or 0134U, 0135U, and 0138U  Risk assessment of other cancers; or o Removed 0104U  Confirmation of direct to consumer genetic testing without meeting any Definitions of the proven indications above  Added definition of: o BRCA-Related Cancers Multi-Gene Hereditary Cancer Panel Testing Criteria o Multi-Gene Panel Genetic testing with a Multi-Gene hereditary cancer Panel in o Panel individuals with an indication for testing for hereditary Breast and  Modified definition of: Ovarian cancer is proven and medically necessary if all of the o Lynch Syndrome-Associated following criteria are met: Cancer  The suspected hereditary cancer syndromes can be diagnosed by testing Supporting Information of two or more genes included in the specific hereditary cancer Panel;

 Updated Description of Services, and Clinical Evidence, CMS, and  The individual meets at least one of the criteria for Hereditary Breast and References sections to reflect the Ovarian Cancer (BRCA1/BRCA2) (see above section); and most current information  The individual has a family history or personal history that is strongly suggestive of more than one hereditary cancer syndrome including at least one of the following: o A personal history of at least two different cancers (e.g., Breast and Ovarian); or o A personal history of cancer diagnosed at age 40 or younger; or o A personal history of cancer and at least one Close Blood Relative with a cancer associated with Lynch Syndrome; or o At least one Close Blood Relative diagnosed with a BRCA-Related Cancer at age 40 or younger; or o At least three Close Blood Relatives diagnosed with any cancer

Genetic testing with a Multi-Gene hereditary cancer Panel in individuals with an indication for testing for hereditary colorectal cancer is proven and medically necessary in the following situations:  The suspected hereditary cancer syndromes can be diagnosed by testing

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Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2019 of two or more genes included in the specific hereditary cancer Panel; Hereditary Cancer and (continued)  The individual has a personal or family history with at least one of the following criteria for Hereditary Colorectal Cancer/Lynch Syndrome- Associated Cancer or colorectal polyposis syndrome: o A personal history of cancer associated with Lynch Syndrome; or o A personal history of cancer where tumor testing results demonstrate that the cancer was MSI-high or had immunohistochemical staining showing the absence of one or more mismatch repair proteins (MLH1, MSH2, MSH6 or PMS2); or o A personal history of colorectal polyposis with at least 10 adenomatous polyps, at least 2 hamartomatous polyps or at least 5 serrated polyps proximal to the sigmoid colon; or o At least one 1st degree Blood Relative with a cancer associated with Lynch Syndrome; or o At least one Close Blood Relative with a cancer associated with Lynch Syndrome diagnosed at age 50 or younger; or o At least one Close Blood Relative with at least two cancers associated with Lynch Syndrome; or o Two or more Close Blood Relatives with a cancer associated with Lynch Syndrome; or o At least one Close Blood Relative with a clinical diagnosis of Familial Adenomatous Polyposis, Attenuated Familial Adenomatous Polyposis, Juvenile Polyposis Syndrome or Peutz-Jeghers Syndrome; or o A PREMM5, MMRpro or MMRpredict Score of 2.5% or greater for having a Lynch syndrome gene mutation

Genetic testing with a Multi-Gene hereditary cancer Panel in individuals without an indication for testing for hereditary Breast and Ovarian cancer or colorectal cancer is proven and medically necessary in the following situations:  The suspected hereditary cancer syndromes can be diagnosed by testing of two or more genes included in the specific hereditary cancer Panel; and  The results of testing will directly impact this individual’s medical management; and  The individual has a family history or personal history that is strongly suggestive of more than one hereditary cancer syndrome as outlined below:

16 Medical Policy Update Bulletin: October 2019

Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Genetic Testing for Oct. 1, 2019 o A personal history of at least two different cancers (e.g., Breast and Hereditary Cancer colon); or (continued) o A personal history of cancer diagnosed at age 40 or younger; or o A personal history of cancer and at least one Close Blood Relative with a cancer associated with Lynch Syndrome; or o At least one Close Blood Relative diagnosed with a BRCA-Related Cancer at age 40 or younger; or o At least three Close Blood Relatives diagnosed with any cancer

Genetic testing with a Multi-Gene hereditary cancer Panel in individuals diagnosed with cancer at age 18 or younger is proven and medically necessary.

Multi-Gene hereditary cancer Panels are unproven and not medically necessary for all other indications.

Omnibus Codes Dec. 1, 2019 Coverage Rationale Refer to the policy for complete details on the coverage guidelines for  Revised coverage guidelines for: Omnibus Codes. Sinus tarsi implant (CPT code 0335T and HCPCS code S2117) o Updated list of applicable codes; added S2117 Electroretinogram (CPT codes 0509T and 92274) o Added language to indicate multifocal electroretinogram (mfERG) is proven and medically necessary for chloroquine (CQ) and hydroxychloroquine (HCQ) retinopathy screening o Replaced language indicating “multifocal electroretinogram (mfERG) is unproven and not medically necessary due to insufficient evidence of safety and/or efficacy” with “multifocal electroretinogram

17 Medical Policy Update Bulletin: October 2019

Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Omnibus Codes Dec. 1, 2019 (mfERG) is unproven and not (continued) medically necessary for all other indications [not listed as proven and medically necessary] due to insufficient evidence of safety and/or efficacy” Instrument-based ocular photoscreening (CPT codes 99174 and 99177) o Updated language pertaining to age requirements to indicate instrument-based ocular photoscreening is proven and medically necessary for one of the following: . As a mass screening instrument for children 1-5 years of age (ends on 6th birthday) . In individuals 6 years of age and older who are developmentally delayed and are unable or unwilling to cooperate with routine visual acuity screening Supporting Information  Updated Clinical Evidence and References sections to reflect the most current information

Vagus and External Dec. 1, 2019 Title Change Implantable vagus nerve stimulators are proven and medically Trigeminal Nerve  Previously titled Vagus Nerve necessary for treating epilepsy in individuals with ALL of the Stimulation Stimulation following (see below for implants that allow detection and stimulation of Coverage Rationale increased heart rate):  Revised coverage criteria for  Medically refractory epileptic seizures with failure of two or more trials of proven and medically necessary single or combination antiepileptic drug therapy or intolerable side effects

18 Medical Policy Update Bulletin: October 2019

Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Vagus and External Dec. 1, 2019 use of implantable vagus nerve of antiepileptic drug therapy; and Trigeminal Nerve stimulators for treating epilepsy;  The individual is not a candidate for epilepsy surgery or has failed Stimulation replaced criterion requiring “the epilepsy surgery; and (continued) individual is not a surgical  No history of left or bilateral cervical vagotomy. The U.S. Food and Drug candidate or has failed a surgical Administration (FDA) identifies a history of left or bilateral cervical intervention” with “the individual vagotomy as a contraindication to vagus nerve stimulation is not a candidate for epilepsy Implantable vagus nerve stimulators are unproven and not medically surgery or has failed epilepsy necessary for treating ALL other conditions due to insufficient

surgery” evidence of efficacy.  Revised list of unproven and not These conditions include but are not limited to: medically necessary indications:  Alzheimer's disease o Added external or  Anxiety disorder transcutaneous  Autism spectrum disorder (nonimplantable) trigeminal  Back and neck pain nerve stimulation devices  Bipolar disorder (e.g., Monarch® eTNS  Bulimia

System, Cefaly®) for  Cerebral palsy preventing or treating all  Chronic pain syndrome conditions, including but not  Cluster headaches limited to:  Depression . Attention deficit  Fibromyalgia hyperactivity disorder  Heart failure (ADHD)  Migraines . Depression  Morbid obesity

. Epilepsy  Narcolepsy . Headache  Obsessive-compulsive disorder o Updated list of examples of  Paralysis agitans vagus nerve stimulation  Sleep disorders implants that allow detection  Tourette's syndrome and stimulation of increased heart rate; added “SenTiva™ The following are unproven and not medically necessary due to Model 1000” insufficient evidence of efficacy:

Supporting Information  Vagus nerve stimulation implants that allow detection and stimulation of

 Updated Description of Services, increased heart rate (e.g., AspireSR™ Model 106, SenTiva™ Model 1000)

Clinical Evidence, FDA, CMS, and for treating epilepsy References sections to reflect the  Transcutaneous (nonimplantable) vagus nerve stimulation (e.g., ® most current information gammaCore for headaches) for preventing or treating all indications  External or transcutaneous (nonimplantable) trigeminal nerve stimulation ® ® devices (e.g., Monarch eTNS System, Cefaly ) for preventing or

19 Medical Policy Update Bulletin: October 2019

Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Vagus and External Dec. 1, 2019 treating all conditions including but not limited to: Trigeminal Nerve o Attention deficit hyperactivity disorder (ADHD) Stimulation o Depression (continued) o Epilepsy o Headache

Note: For vagus nerve blocking for the treatment of obesity, refer to the Medical Policy titled Bariatric Surgery.

20 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Coverage Rationale NEW Cimzia® Oct. 1, 2019 Notice of Implementation Delay: This policy will not be effective on Oct. 1, 2019, as previously announced. (Certolizumab TBD Implementation of the new Medical Benefit Drug Policy has been postponed until further notice; complete details Pegol) will be provided in a future edition of the Medical Policy Update Bulletin.

This policy refers to Cimzia (certolizumab pegol) injection. Cimzia (certolizumab pegol) for self-administered subcutaneous injection is obtained under the pharmacy benefit.

Cimzia is proven and/or medically necessary for the treatment of:

Crohn’s Disease (CD) when all of the following criteria are met:  For initial therapy, all of the following: o Diagnosis of moderately to severely active Crohn’s disease; and o Patient has had an inadequate response to conventional therapies (examples include anti-inflammatory drugs, corticosteroids, or oral immunosuppressive agents); and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for self-administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for CD; and o Patient is not receiving Cimzia in combination with either of the following: . Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] and o Initial authorization will be issued for 12 months.  For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for self-administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for CD; and o Patient is not receiving Cimzia in combination with either of the following: . Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] and o Authorization will be issued for 12 months.

Rheumatoid Arthritis (RA) when all of the following criteria are met:  For initial therapy, all of the following: o Diagnosis of moderately to severely active rheumatoid arthritis; and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for

21 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Coverage Rationale NEW Cimzia® Oct. 1, 2019 self-administration; physician must submit explanation; and (Certolizumab TBD o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for RA; and Pegol) o Patient is not receiving Cimzia in combination with either of the following: (continued) . Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] and o Initial authorization will be issued for 12 months.  For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for self-administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for RA; and o Patient is not receiving Cimzia in combination with either of the following: . Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] and o Authorization will be issued for 12 months.

Psoriatic Arthritis (PsA) when all of the following criteria are met:  For initial therapy, all of the following: o Diagnosis of active psoriatic arthritis; and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for self- administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for PsA; and o Patient is not receiving Cimzia in combination with either of the following: . Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and o Initial authorization will be issued for 12 months.  For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for self- administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for PsA; and o Patient is not receiving Cimzia in combination with either of the following:

22 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Coverage Rationale NEW Cimzia® Oct. 1, 2019 . Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (Certolizumab TBD (abatacept)] Pegol) . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] (continued) . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and o Authorization will be issued for 12 months.

Ankylosing Spondylitis (AS) and non-radiographic Axial Spondyloarthritis (nr-axSpA) when all of the following criteria are met:  For initial therapy, all of the following: o Diagnosis of active ankylosing spondylitis or non-radiographic axial spondyloarthritis; and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for self- administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for AS or nr- axSpA; and o Patient is not receiving Cimzia in combination with either of the following: . Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and o Initial authorization will be issued for 12 months.  For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for self- administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for AS or nr- axSpA; and o Patient is not receiving Cimzia in combination with either of the following: . Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and o Authorization will be issued for 12 months.

Plaque Psoriasis (PS) when all of the following criteria are met:  For initial therapy, all of the following: o Diagnosis of moderate to severe plaque psoriasis; and

23 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Coverage Rationale NEW Cimzia® Oct. 1, 2019 o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for (Certolizumab TBD self- administration; physician must submit explanation; and Pegol) o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for PS; and (continued) o Patient is not receiving Cimzia in combination with either of the following: . Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and o Initial authorization will be issued for 12 months.  For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for self- administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for PS; and o Patient is not receiving Cimzia in combination with either of the following: . Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and o Authorization will be issued for 12 months.

Krystexxa® Oct. 1, 2019 Krystexxa (pegloticase) is proven for the treatment of chronic gout refractory to conventional therapy. (Pegloticase) Krystexxa (pegloticase) is medically necessary for the treatment of chronic gout when all of the following criteria are met:

 For initial therapy, all of the following: o One of the following: . History of at least 2 gout flares in the previous 12 months . At least 1 gouty tophus . Chronic gouty arthropathy and o History of contraindication, intolerance, or treatment failure after 3 months of therapy (at the maximally medically appropriate dose) with both of the following: . Zyloprim (allopurinol) . Uloric (febuxostat) and

24 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Coverage Rationale NEW Krystexxa® Oct. 1, 2019 o One of the following: (Pegloticase) . Patient has a confirmed baseline serum uric acid of 6 mg/dL or greater prior to initiating Krystexxa (continued) despite conventional therapy; or . Both of the following: - Patient has a baseline serum uric acid less than 6 mg/dL - Patient has at least 1 gouty tophus and o Member has undertaken appropriate life style modifications (e.g., limiting of alcohol consumption and diet modifications, discontinuing or changing medications known to cause gout attacks); and o Patient does not have glucose‐6‐phosphate dehydrogenase (G6PD) deficiency; and o Prescribed by a rheumatologist; and o Dosing is in accordance with the United States Food and Drug Administration approved labeling; and o Initial authorization will be for no more than 12 months.

 For continuation therapy, all of the following: o Patient has previously received treatment with Krystexxa; and o Patient has experienced a positive clinical response to Krystexxa (e.g., serum uric acid levels < 6mg/dL, tophus reduction, etc); and o Patient has not experienced one of the following: . Pre-infusion serum uric acid concentration of > 6 mg/dL accompanied by an infusion reaction . Pre-infusion serum uric acid concentration of > 6 mg/dL on two consecutive occasions and o Member has undertaken appropriate life style modifications (e.g., limiting of alcohol consumption and diet modifications, discontinuing or changing medications known to cause gout attacks); and o Prescribed by a rheumatologist; and o Dosing is in accordance with the United States Food and Drug Administration approved labeling; and o Reauthorization will be for no more than 12 months.

Krystexxa (pegloticase) is unproven and not medically necessary for the treatment of asymptomatic hyperuricemia.

Policy Title Effective Date Summary of Changes UPDATED Complement Oct. 1, 2019 Applicable Codes Inhibitors (Soliris®  Updated list of applicable HCPCS codes to reflect quarterly code edits: & Ultomiris™) o Replaced J3590 with J1303 o Removed C9052

25 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes UPDATED Evenity™ Oct. 1, 2019 Template Update (Romosozumab-  Reorganized policy template; relocated Background and FDA sections Aqqg) Coverage Rationale  Removed reference link to the Medical Benefit Drug Policy titled Review at Launch for New to Market Medications (prior authorization requirements effective Oct. 1, 2019) Applicable Codes  Updated list of applicable HCPCS codes to reflect quarterly code edits; replaced C9399 and J3590 with J3111

Gamifant™ Oct. 1, 2019 Applicable Codes (Emapalumab-  Updated list of applicable HCPCS codes to reflect quarterly code edits: Lzsg) o Replaced J3490 and J3590 with J9210 o Removed C9050

Onpattro™ Oct. 1, 2019 Applicable Codes (Patisiran)  Updated list of applicable HCPCS codes to reflect quarterly code edits: o Replaced J3490 with J0222 o Removed C9036

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Actemra® Oct. 1, 2019 Notice of Implementation Delay: The changes described below will not be effective on Oct. 1, 2019, as (Tocilizumab) TBD previously announced. Implementation of the revised Medical Benefit Drug Policy has been postponed until further Injection for notice; complete details will be provided in a future edition of the Medical Policy Update Bulletin. Intravenous Infusion Template Update  Reorganized policy template; relocated Background and FDA sections Coverage Rationale  Revised coverage criteria:

All Indications

o Added criterion for initial therapy and continuation of therapy requiring: . One of the following:

- Both of the following:

 History of failure, contraindication, or intolerance to Actemra labeled for self-administration

 Physician attests that, in their clinical opinion, the clinical response would be expected to be superior with Actemra for intravenous infusion - Physician attestation that the patient or caregiver are not competent to administer Actemra FDA labeled for self-administration; physician must submit explanation . Authorization is for no more than 12 months

26 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Actemra® Oct. 1, 2019 . For continuation of therapy: Patient has previously received Actemra injection for intravenous infusion (Tocilizumab) TBD Rheumatoid Arthritis Injection for o Added criterion for initial therapy requiring history of failure, contraindication, or intolerance to two of the Intravenous following preferred products (document drug, date, and duration of trial): Infusion . Cimzia (certolizumab) (continued) . Humira (adalimumab) . Simponi (golimumab) . Olumiant (baricitinib) . Rinvoq (upadacitinib) . Xeljanz/Xeljanz XR (tofacitinib)

Supporting Information  Updated References section to reflect the most current information

Benlysta® Oct. 1, 2019 Notice of Implementation Delay: The changes described below will not be effective on Oct. 1, 2019, as (Belimumab) TBD previously announced. Implementation of the revised Medical Benefit Drug Policy has been postponed until further notice; complete details will be provided in a future edition of the Medical Policy Update Bulletin.

Template Update  Reorganized policy template; relocated Background and FDA sections Coverage Rationale  Replaced language indicating “Benlysta (belimumab) is proven and medically necessary for the treatment of systemic lupus erythematosus when all of the [listed] criteria are met” with “Benlysta (belimumab) is proven and medically necessary for the treatment of active systemic lupus erythematosus when all of the [listed] criteria are met”  Revised criteria for initial therapy: o Added criterion requiring: . One of the following: - Both of the following:  History of failure, contraindication, or intolerance to Benlysta labeled for self-administration  Physician attests that, in their clinical opinion, the clinical response would be expected to be superior with Benlysta for intravenous infusion - Physician attestation that the patient or caregiver is not competent to administer Benlysta FDA labeled for self-administration; physician must submit explanation . Initial authorization is for no more than 12 months o Replaced criterion requiring: . “Diagnosis of active systemic lupus erythematosus” with “diagnosis of active systemic lupus erythematosus without severe active lupus nephritis or severe active central nervous system lupus” . “Currently receiving at least one standard of care treatment for active systemic lupus erythematosus”

27 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Benlysta® Oct. 1, 2019 with “currently receiving at least one standard of care treatment for active systemic lupus (Belimumab) TBD erythematosus that is not a biologic or intravenous cyclophosphamide” (continued)  Added criteria for continuation of therapy

Clotting Factors, Oct. 1, 2019 Coverage Rationale Refer to the policy for complete details on the coverage guidelines for Coagulant Blood  Revised list of applicable long- Clotting Factors, Coagulant Blood Products & Other Hemostatics. Products & Other acting Factor VIII (recombinant) Hemostatics products; added Esperoct® [antihemophilic factor (recombinant), glycopegylated- exei]  Added language to indicate Esperoct [antihemophilic factor (recombinant), glycopegylated- exei] is not medically necessary for treatment of hemophilia A for the following: o Routine prophylactic treatment o Perioperative management of surgical bleeding o Treatment of bleeding episodes Supporting Information  Updated Clinical Evidence, FDA, CMS, and References sections to reflect the most current information

Infliximab Oct. 1, 2019 Template Update This policy refers to the following infliximab products: (Remicade®,  Reorganized policy template;  Remicade® (infliximab) Inflectra™, relocated Background and FDA  Inflectra™ (infliximab-dyyb) Renflexis™) sections  Renflexis™ (infliximab-abda) Coverage Rationale  Added language to indicate Preferred Product Inflectra™ (infliximab-dyyb) is a Medical Necessity Plans preferred infliximab product; Remicade® (infliximab) and Inflectra™ (infliximab-dyyb) are the preferred coverage will be provided for infliximab products. Coverage will be provided for Remicade® or Inflectra™ Inflectra™ (infliximab-dyyb) (infliximab-dyyb) contingent on the coverage criteria in the Diagnosis-

28 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Infliximab Oct. 1, 2019 contingent on the coverage Specific Criteria section. (Remicade®, criteria in the Diagnosis-Specific Inflectra™, Criteria section of the policy Coverage for Renflexis™ (infliximab-abda) will be provided contingent on the Renflexis™)  Revised preferred product criteria in this section and the coverage criteria in the Diagnosis-Specific (continued) criteria to indicate treatment Criteria section. In order to continue coverage, members already on with Renflexis™ (infliximab- Renflexis™ (infliximab-abda) will be required to change therapy to abda) or another infliximab Remicade® or Inflectra™ unless they meet the criteria in this section. biosimilar is medically necessary for the indications specified in Preferred Product Criteria the policy when treatment with Treatment with Renflexis™ (infliximab-abda), or other infliximab Remicade and Inflectra is biosimilar is medically necessary for the indications specified in this contraindicated or has failed policy when BOTH the following criteria are met: Applicable Codes  One of the following:  Added ICD-10 diagnosis codes o Both of the following: H20.10, H20.11, H20.12, . History of a trial of at least 14 weeks of Remicade and Inflectra H20.13, H20.821, H20.822, resulting in minimal clinical response to therapy and residual H20.823, H20.829, H30.001, disease activity. H30.002, H30.003, H30.009, . Physician attests that in their clinical opinion, the clinical H30.011, H30.012, H30.013, response would be expected to be superior with Renflexis or H30.019, H30.021, H30.022, other infliximab biosimilar product, than experienced with H30.023, H30.029, H30.031, Remicade or Inflectra. H30.032, H30.033, H30.039, or H30.041, H30.042, H30.043, o Both of the following: H30.049, H30.101, H30.102, . History of intolerance, contraindication, or adverse event to H30.103, H30.109, H30.111, Remicade and Inflectra. H30.112, H30.113, H30.119, . Physician attests that in their clinical opinion, the same H30.121, H30.122, H30.123, intolerance, contraindication, or adverse event would not be H30.129, H30.131, H30.132, expected to occur with Renflexis or other infliximab biosimilar H30.133, H30.139, H30.20, product. H30.21, H30.22, H30.23, and H30.811, H30.812, H30.813,  Both of the following H30.819, H30.891, H30.892, o Patient has not had a loss of a favorable response after established H30.893, H30.899, H30.90, maintenance therapy with Remicade or other infliximab biosimilar H30.91, H30.92, H30.93, product. H35.021, H35.022, H35.023, o Patient has not developed neutralizing antibodies to any infliximab H35.029, H35.061, H35.062, biosimilar product that has led to an attenuation of efficacy of H35.063, H35.069, H44.111, therapy. H44.112, H44.113, and H44.119 Non-Medical Necessity Plans

29 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Infliximab Oct. 1, 2019 Any infliximab product is to be approved contingent on the coverage criteria (Remicade®, in the Diagnosis-Specific Criteria section. Inflectra™, Renflexis™) Diagnosis-Specific Criteria (continued) “Infliximab” will be used to refer to all infliximab products.

Infliximab is proven and medically necessary for the treatment of:

 Ankylosing spondylitis when the following criterion is met: o Diagnosis of ankylosing spondylitis (AS).

 Crohn’s disease when ONE of the following criteria is met: o Diagnosis of fistulizing Crohn’s disease (Crohn’s Disease Activity Index (CDAI) ≥ 220 and ≤ 400); or o Both of the following: . Diagnosis of moderately to severely active Crohn’s disease; and . History of failure, contraindication, or intolerance to at least one conventional therapy (e.g., corticosteroids, 6-mercaptopurine, azathioprine, methotrexate, etc.).

 Noninfectious uveitis when BOTH of the following criteria are met: o Diagnosis of refractory noninfectious uveitis that is causing or threatening vision loss (e.g., noninfectious uveitis associated with Behçet’s or Reiter’s syndromes); and o History of failure, contraindication, or intolerance to all of the following: . Topical corticosteroids; and . Systemic corticosteroids; and . Immunosuppressive drugs (e.g., azathioprine, cyclosporine, or methotrexate).

 Plaque psoriasis when BOTH of the following criteria are met: o Diagnosis of chronic severe plaque psoriasis (i.e., extensive and/or disabling); and o Patient is a candidate for systemic therapy.

 Psoriatic arthritis when the following criterion is met: o Diagnosis of psoriatic arthritis (PsA).

 Rheumatoid arthritis when BOTH of the following criteria are met:

30 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Infliximab Oct. 1, 2019 o Diagnosis of moderately to severely active rheumatoid arthritis (RA); (Remicade®, and Inflectra™, o One of the following: Renflexis™) . Patient is receiving concurrent therapy with methotrexate. (continued) . History of contraindication or intolerance to methotrexate.

 Sarcoidosis when ALL of the following criteria are met: o Diagnosis of sarcoidosis; and o History of failure, contraindication, or intolerance to corticosteroids (e.g., prednisone, methylprednisolone); and o History of failure, contraindication, or intolerance to one immunosuppressant (e.g., methotrexate, cyclophosphamide, azathioprine).

 Ulcerative colitis when BOTH of the following criteria are met: o Diagnosis of moderately to severely active ulcerative colitis (UC); and o History of failure, contraindication, or intolerance to at least one conventional therapy (e.g., 6-mercaptopurine, aminosalicylate, azathioprine, corticosteroids).

 Immune checkpoint inhibitor-related toxicities when BOTH of the following criteria are met: o Patient has recently received checkpoint inhibitor therapy [e.g., Keytruda (Pembrolizumab), Opdivo (Nivolumab)];and o One of the following: . Both of the following: - Diagnosis of moderate (G2) or severe (G3-4) immunotherapy-related diarrhea or colitis; and - History of failure, contraindication, or intolerance to corticosteroids (e.g. methylprednisolone). or . Both of the following: - Diagnosis of severe (G3-4) immunotherapy-related pneumonitis; and - History of failure, contraindication, or intolerance to corticosteroids (e.g. methylprednisolone). or . Both of the following:

31 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Infliximab Oct. 1, 2019 - Diagnosis of severe (G3) or life-threatening (G4) (Remicade®, immunotherapy-related acute renal failure/elevated serum Inflectra™, creatinine; and Renflexis™) - Toxicity remains >G2 after 1 week of corticosteroids. (continued) or . Both of the following: - Diagnosis of severe (G3-4) immunotherapy-related uveitis; and - Toxicity remains after 1 week of high dose systemic corticosteroids. or . Both of the following: - Diagnosis of life threatening (G4) immunotherapy-related myocarditis, pericarditis, arrhythmias, or impaired ventricular function; and - No improvement of toxicity within 24 hours of starting pulse- dose methylprednisolone. or . Both of the following: - Diagnosis of severe immunotherapy-related inflammatory arthritis; and - No symptom improvement within 2 weeks of starting high- dose corticosteroids.

There may be other conditions that qualify as serious, rare diseases for which the use of infliximab may be appropriate. Refer to the Benefit Considerations section of the policy for additional information.

Infliximab is unproven and not medically necessary for the treatment of:  Still’s disease  Sjögren’s syndrome  Graft-vs-host disease  Myelodysplastic syndromes  Undifferentiated spondyloarthropathy  Reiter’s syndrome  Hidradenitis suppurativa  Wegener’s granulomatosis  Juvenile idiopathic arthritis (juvenile rheumatoid arthritis)

32 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Infliximab Oct. 1, 2019 Infliximab is unproven for the treatment of the above conditions because (Remicade®, statistically robust randomized controlled trials are needed to address the Inflectra™, issue of whether infliximab has sufficient superiority in clinical efficacy Renflexis™) compared to other available treatments to justify the inherent clinical risk in (continued) the use of a monoclonal antibody anti-tumor necrosis factor agent.

® Ketalar Oct. 1, 2019 Coverage Rationale This policy refers to the following ketamine products: (Ketamine) and  Revised medical necessity  Ketalar (ketamine) Spravato™ criteria for the treatment of  Spravato (esketamine) (Esketamine) treatment-resistant depression (TRD) with Spravato; replaced Spravato (Esketamine) Nasal Spray initial therapy criterion requiring Spravato is proven for the treatment of treatment-resistant “Spravato will be used in depression (TRD) when ALL of the following criteria are met: combination with a newly initiated daily oral Initial Therapy antidepressant that has not  Diagnosis for major depressive disorder (treatment-resistant) according

previously been tried” with to the current DSM (i.e., DSM-5), by a mental health professional; and “Spravato will be initiated at the  Patient has not experienced a clinically meaningful improvement after

same time the member starts a treatment with at least two different antidepressants of adequate dose,

new daily oral antidepressant duration (at least 6 weeks), and adherence in the current depressive

(one that has not previously episode (must document medications, doses, and durations); and been tried)”  Patient is to receive Spravato therapy in conjunction with another oral

antidepressant; and

 Provider and/or the provider’s healthcare setting is certified in the

Spravato REMS program; and

 Spravato dosing is in accordance with the United States Food and Drug

Administration approved labeling; and

 Initial authorization will be for no longer than 12 weeks.

Continuation of Therapy  Patient has previously been treated with Spravato; and  Documentation demonstrating a positive clinical response from baseline (e.g., improved Montgomery-Asberg Depression Rating Scale [MADRS], clinical remission, response, etc.), as defined by the provider; and  Patient is to receive Spravato therapy in conjunction with another oral antidepressant; and  Provider and/or the provider’s healthcare setting is certified in the Spravato REMS program; and  Spravato dosing is in accordance with the United States Food and Drug

33 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Ketalar® Oct. 1, 2019 Administration approved labeling; and (Ketamine) and  Authorization will be for no longer than 6 months. Spravato™ (Esketamine) Spravato is medically necessary for the treatment of treatment- (continued) resistant depression (TRD) when ALL of the following criteria are met:

Initial Therapy  Diagnosis of major depressive disorder (treatment-resistant), according to the current DSM (i.e., DSM-5), by a mental health professional; and  Prescribed by or in consultation with a psychiatrist; and  Attestation of baseline scoring (prior to starting Spravato) on at least one of the following clinical assessments has been completed: o Baseline score on the 17-item Hamilton Rating Scale for Depression (HAMD17) o Baseline score on the 16-item Quick Inventory of Depressive Symptomatology (QIDS-C16) o Baseline score on the 10-item Montgomery-Asberg Depression Rating Scale (MADRS) and  Patient has not experienced a clinically meaningful improvement after treatment with at least three different antidepressants or treatment regimens of adequate dose (maximally tolerated), duration (at least 8 weeks), and adherence in the current depressive episode o An antidepressant or treatment regimen would include any of the following classes or combinations (document medication, dose, and duration): . Selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline) . Serotonin norepinephrine reuptake inhibitors (e.g., duloxetine, venlafaxine, etc.) . Bupropion . Tricyclic antidepressants (e.g., amitriptyline, clomipramine, nortriptyline, etc.) . Mirtazapine . Monoamine oxidase inhibitors (e.g., selegiline, tranylcypromine, etc.) . Serotonin modulators (e.g., nefazodone, trazodone, etc.) . Augmentation with lithium, Cytomel (liothyronine), antipsychotics, or anticonvulsants

34 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Ketalar® Oct. 1, 2019 and (Ketamine) and  Spravato will be initiated at the same time the member starts a new Spravato™ daily oral antidepressant (one that has not previously been tried); and (Esketamine)  Provider and/or the provider’s healthcare setting is certified in the (continued) Spravato REMS program; and  Spravato dosing is in accordance with the United States Food and Drug Administration (FDA) approved labeling; and  Initial authorization will be for no longer than 12 weeks.

Continuation of Therapy  Patient has previously been treated with Spravato; and  Documentation of remission or a positive clinical response to Spravato; and  Submission of baseline and recent (within the last month) scoring on at least one of the following assessments demonstrating remission or clinical response (e.g., score reduction from baseline) as defined by the: o Hamilton Rating Scale for Depression (HAMD17; remission defined as a score of ≤7) o Quick Inventory of Depressive Symptomatology (QIDS-C16; remission defined as a score of ≤5) o Montgomery-Asberg Depression Rating Scale (MADRS; remission defined as a score of ≤12) and  Patient is to receive Spravato therapy in conjunction with an oral antidepressant; and  Provider and/or the provider’s healthcare setting is certified in the Spravato REMS program; and  Prescribed by or in consultation with a psychiatrist; and  Spravato dosing is in accordance with the United States FDA approved labeling; and  Authorization will be for no longer than 6 months.

Spravato is unproven and not medically necessary for the following:  Anesthetic agent  Chronic pain (including but not limited to nonmalignant pain, Fibromyalgia, neuropathic pain, Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy)  Migraine headaches

35 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Ketalar® Oct. 1, 2019 Ketalar (Ketamine) Injection (Ketamine) and Ketamine injection is considered medically necessary and may be Spravato™ covered for the following: (Esketamine)  Anesthesia for diagnostic and surgical procedures that do not require (continued) skeletal muscle relaxation  The induction of anesthesia prior to administration of other anesthesia agents  As supplemental anesthesia for low-potency agents, such as nitrous oxide

Ketamine injection is investigational, and therefore not proven or medically necessary for the following:  Psychiatric disorders (including, but not limited to depression, bipolar disorder, & posttraumatic stress disorder)  Chronic pain (including but not limited to nonmalignant pain, Fibromyalgia, neuropathic pain, Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy)  Migraine headaches

Maximum Dosage Oct. 1, 2019 Related Policies This policy provides information about the maximum dosage per  Added reference link to the administration for certain medications administered by a medical Medical Benefit Drug Policy professional. Most medications have a maximum dosage based upon body titled: surface area or patient weight or a set maximal dosage independent of o Cimzia® (Certolizumab Pegol) patient body size. o Onpattro™ (Patisiran) Coverage Rationale Drug Products:  Added language to clarify the  bevacizumab (Avastin®) use of medications included in  bevacizumab-awwb (Mvasi™) this policy, when given within  bevacizumab-bvzr (Zirabev™) the maximum dosage based  certolizumab pegol (Cimzia®) upon body surface area or  denosumab (Prolia® & Xgeva®) patient weight or a set of  eculizumab (Soliris®) maximal dosage independent of  infliximab (Remicade®) patient body size, are proven  infliximab-dyyb (Inflectra™) when used according to labeled  infliximab-abda (Renflexis™) indications or when otherwise  nivolumab (Opdivo®) supported by published clinical  omalizumab (Xolair®) evidence  patisiran (Onpattro™)  Revised list of applicable drug  pegfilgrastim (Neulasta®)

36 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Maximum Dosage Oct. 1, 2019 products; added:  pegfilgrastim-cbqv (Udenyca™) (continued) o bevacizumab-awwb  pegfilgrastim-jmdb (Fulphila™) (Mvasi™)  ravulizumab-cwvz (Ultomiris™) o bevacizumab-bvzr  rituximab (Rituxan®) (Zirabev™)  rituximab-abbs (Truxima®) o certolizumab pegol (Cimzia®)  trastuzumab (Herceptin®) o patisiran (Onpattro™)  trastuzumab-anns (Kanjinti™) o ravulizumab-cwvz  trastuzumab-dkst (Ogivri™) (Ultomiris™)  trastuzumab-dttb (Ontruzant™) o rituximab-abbs (Truxima®)  trastuzumab-pkrb (Herzuma®) o trastuzumab-anns  trastuzumab-qyyp (Trazimera™) (Kanjinti™)  ustekinumab (Stelara®) o trastuzumab-dkst (Ogivri™)  vedolizumab (Entyvio®) o trastuzumab-dttb  zoledronic acid (zoledronic acid, Reclast® and Zometa®) (Ontruzant™) o trastuzumab-pkrb The use of medications included in this policy when given within the (Herzuma®) maximum dosage based upon body surface area or patient weight or o trastuzumab-qyyp a set of maximal dosage independent of patient body size are proven (Trazimera™) when used according to labeled indications or when otherwise  Revised Maximum Allowed supported by published clinical evidence. Quantities by HCPCS Units and Maximum Allowed Quantities for The medications included in this policy when given beyond maximum National Drug Code (NDC) Billing dosages based upon body surface area or patient weight or a set Applicable Codes maximal dosage independent of patient body size are not supported  Added HCPCS codes J0222, by package labeling or published clinical evidence and are unproven. J0717, J1303, Q5107, Q5112, Q5113, Q5114, Q5115, Q5116, This policy creates an upper dose limit based on the clinical evidence and the th Q5117, and Q5118 95 percentile for adult body weight (128 kg) and body surface area (2.59 2  Updated National Drug Codes meters ) in the U.S. (adult male, 30 to 39 years, Fryar, 2016). In some (NDCs): cases, the maximum allowed units and/or vials may exceed the upper level o Added 00006-5033-02, limit as defined within this policy due to an individual patient body weight > 2 00069-0305-01, 00069- 128 kg or body surface area > 2.59 meters . 0315-01, 00069-0342-01, 25682-0022-01, 50242- Maximum Allowed Quantities by HCPCS Units 0214-01, 50242-0215-01, Refer to the policy for complete details on the Maximum Allowed 50474-0700-62, 50474- Quantities by HCPCS Units for the drug products listed above. 0710-79, 50474-0710-81, 55513-0132-01, 55513- Maximum Allowed Quantities for National Drug Code (NDC) Billing

0206-01, 55513-0207-01, Refer to the policy for complete details on the Maximum Allowed

37 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Maximum Dosage Oct. 1, 2019 63459-0103-10, 63459- Quantities for NDC Billing for the drug products listed above. (continued) 0104-50, 63459-0303-43, 63459-0305-47, 67457- 0847-44, 67457-0991-15, and 71336-1000-01 o Removed 50242-0056-56 and 50242-0134-68 Supporting Information  Updated CMS and References sections to reflect the most current information

Oncology Oct. 1, 2019 Related Policies Description Medication Clinical  Added reference link to the This policy provides parameters for coverage of injectable oncology Coverage Medical Policy titled Therapeutic medications (J9000-J9999) [including, but not limited to octreotide acetate Radiopharmaceuticals (J2353 and J2354), leuprolide acetate (J1950), leucovorin (J0640) and Coverage Rationale levoleucovorin (J0641)] covered under the medical benefit based upon the  Removed language pertaining to National Comprehensive Cancer Network (NCCN) Drugs & Biologics “select ancillary and supportive Compendium® (NCCN Compendium®). The Compendium lists the appropriate care medications for oncology drugs and biologics for specific cancers using US Food and Drug conditions” Administration (FDA)-approved disease indications and specific NCCN panel  Added language to indicate: recommendations. Each recommendation is supported by a level of evidence o Coverage of White Blood Cell category. Coverage of White Blood Cell Colony Stimulating Factors is Colony Stimulating Factors is addressed in a separate policy. This policy does not provide coverage criteria addressed in a separate for Chimeric Antigen Receptor (CAR)-T Cell products. Coverage policy determinations are based on the member’s benefits and the OptumHealth Medical Necessity Plans Transplant Solutions criteria for covered transplants; refer to the Clinical o The Oncology Products table Guideline titled Transplant Review Guidelines: Hematopoietic Stem Cell lists the UnitedHealthcare Transplantation. preferred oncology products and respective non-preferred Coverage Rationale products; coverage will be Medical Necessity Plans

provided for the The Oncology Products table below lists the UnitedHealthcare preferred

UnitedHealthcare preferred oncology products and respective non-preferred products. Coverage will be

oncology product contingent provided for the UnitedHealthcare preferred oncology product contingent on

on the coverage criteria in the coverage criteria in the Diagnosis-Specific Criteria section.

the Diagnosis-Specific

Criteria section of the policy Coverage for any respective non-preferred oncology product will be provided o Coverage for any respective

38 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Oncology Oct. 1, 2019 non-preferred oncology contingent on the criteria in the Medical Necessity Criteria and the Diagnosis- Medication Clinical product will be provided Specific Criteria sections. Members new to therapy will be required to utilize Coverage contingent on the criteria in the UnitedHealthcare preferred oncology product unless they meet the (continued) the Medical Necessity criteria in this section. Criteria and the Diagnosis- Specific Criteria sections of Medical Necessity Criteria the policy; members new to Treatment with the respective non-preferred product specified in the therapy will be required to Oncology Products table is medically necessary for oncology utilize the UnitedHealthcare indications when BOTH of the following are met: preferred oncology product  History of intolerance or contraindication to the UnitedHealthcare unless they meet the preferred oncology product; and [following] criteria:  Physician attests that, in their clinical opinion, the same intolerance, . Treatment with the contraindication, or adverse event would not be expected to occur with respective non-preferred the respective non-preferred product. product specified in the Oncology Products table Oncology Products is medically necessary Below are UnitedHealthcare preferred oncology products with therapeutically for oncology indications equivalent and/or biosimilar* non-preferred products as determined by the when both of the United Helathcare P&T Committee: following are met: UnitedHealthcare Preferred - History of intolerance Non-Preferred Product or contraindication to Oncology Product the UnitedHealthcare Avastin (bevacizumab) Mvasi (bevacizumab-awwb) preferred oncology Zirabev (bevacizumab-bvzr) product; and Herceptin (trastuzumab) - Physician attests that, in their clinical Herceptin Hylecta (trastuzumab and opinion, the same hyaluronidase-oysk) intolerance, contra- Kanjinti (trastuzumab-anns) Herzuma (trastuzumab-pkrb) indication, or adverse Ogivri (trastuzumab-dkst) event would not be Ontruzant (trastuzumab-dttb) expected to occur Trazimera (trastuzumab-qyyp) with the respective Leucovorin Levoleucovorin non-preferred product o The Oncology Products table *Biosimilar means that the biological product is FDA-approved based on data lists the UnitedHealthcare demonstrating that it is highly similar to an already FDA-approved biological preferred oncology products product, known as a reference product, and that there are no clinically with therapeutically meaningful differences between the biosimilar product and the reference equivalent and/or biosimilar product.

39 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Oncology Oct. 1, 2019 non-preferred products as Diagnosis-Specific Criteria Medication Clinical determined by the Injectable Oncology Medications Coverage UnitedHealthcare Pharmacy UnitedHealthcare recognizes indications and uses of injectable oncology (continued) and Therapeutics (P&T) medications listed in the NCCN Drugs and Biologics Compendium with Committee; biosimilar Categories of Evidence and Consensus of 1, 2A, and 2B as proven and means that the biological medically necessary, and Categories of Evidence and Consensus of 3 as product is FDA-approved unproven and not medically necessary. based on data demonstrating that it is highly similar to an UnitedHealthcare will cover all chemotherapy agents for individuals under the already FDA-approved age of 19 years for oncology indications. The majority of pediatric patients biological product, known as receive treatments on national pediatric protocols that are quite similar in a reference product, and concept to the NCCN patient care guidelines. that there are no clinically meaningful differences Refer to the Medical Necessity Criteria for the UnitedHealthcare preferred between the biosimilar oncology products that have therapeutically equivalent and/or biosimilar product and the reference products available. product Diagnosis-Specific Criteria Additional Information o Refer to the Medical Necessity The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) are

Criteria section of the policy comprehensive guidelines documenting management decisions and

for the UnitedHealthcare interventions and interventions that apply to malignancies which apply to

preferred oncology products more than 97% of cancers affecting U.S. patients.

that have therapeutically

equivalent and/or biosimilar NCCN Categories of Evidence and Consensus products available  Category 1: The recommendation is based on high-level evidence (i.e., Additional Information high-powered randomized clinical trials or meta-analyses), and the panel o Modified language to indicate has reached uniform consensus that the recommendation is indicated. In the NCCN Clinical Practice this context, uniform means near unanimous positive support with some Guidelines in Oncology possible neutral positions. (NCCN Guidelines®) are  Category 2A: The recommendation is based on lower level evidence, comprehensive guidelines but despite the absence of higher level studies, there is uniform documenting management consensus that the recommendation is appropriate. Lower level evidence decisions and interventions is interpreted broadly, and runs the gamut from phase II to large cohort and interventions that apply studies to case series to individual practitioner experience. Importantly, to malignancies which apply in many instances, the retrospective studies are derived from clinical to more than 97% of cancers experience of treating large numbers of patients at a member institution, affecting U.S. patients so panel members have first-hand knowledge of the data. Inevitably, Supporting Information some recommendations must address clinical situations for which limited  Updated References section to

40 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Oncology Oct. 1, 2019 reflect the most current or no data exist. In these instances the congruence of experience-based Medication Clinical information opinions provides an informed if not confirmed direction for optimizing Coverage patient care. These recommendations carry the implicit recognition that (continued) they may be superseded as higher level evidence becomes available or as outcomes-based information becomes more prevalent.  Category 2B: The recommendation is based on lower level evidence, and there is nonuniform consensus that the recommendation should be made. In these instances, because the evidence is not conclusive, institutions take different approaches to the management of a particular clinical scenario. This nonuniform consensus does not represent a major disagreement, rather it recognizes that given imperfect information, institutions may adopt different approaches. A Category 2B designation should signal to the user that more than one approach can be inferred from the existing data.  Category 3: The recommendation has engendered a major disagreement among the panel members. Several circumstances can cause major disagreements. For example, if substantial data exists about two interventions but they have never been directly compared in a randomized trial, adherents to one set of data may not accept the interpretation of the other side's results. Another situation resulting in a Category 3 designation is when experts disagree about how trial data can be generalized. A Category 3 designation alerts users to a major interpretation issue in the data and directs them to the manuscript for an explanation of the controversy.

Orencia® Oct. 1, 2019 Notice of Implementation Delay: The changes described below will not be effective on Oct. 1, 2019, as (Abatacept) TBD previously announced. Implementation of the revised Medical Benefit Drug Policy has been postponed until further Injection for notice; complete details will be provided in a future edition of the Medical Policy Update Bulletin. Intravenous Infusion Template Update  Reorganized policy template; relocated Background and FDA sections Coverage Rationale  Added language to indicate Orencia (abatacept) for self-administered subcutaneous injection is obtained under the pharmacy benefit  Replaced language indicating “Orencia is proven and medically necessary for the treatment of [the listed indications]” with “Orencia is proven and/or medically necessary for the treatment of [the listed indications]  Revised coverage criteria: All Indications o Added criterion for initial therapy and continuation of therapy requiring:

41 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Orencia® Oct. 1, 2019 . One of the following: (Abatacept) TBD - Both of the following: Injection for  History of failure, contraindication, or intolerance to Orencia labeled for self-administration Intravenous  Physician attests that, in their clinical opinion, the clinical response would be expected to be Infusion superior with Orencia for intravenous infusion (continued) - Physician attestation that the patient or caregiver is not competent to administer Orencia FDA labeled for self-administration; physician must submit explanation . Authorization is for no more than 12 months . For continuation of therapy: Patient has previously received Orencia injection for intravenous infusion Rheumatoid Arthritis o Added criterion for initial therapy requiring history of failure, contraindication, or intolerance to two of the following preferred products (document drug, date, and duration of trial): . Cimzia (certolizumab) . Humira (adalimumab) . Simponi (golimumab) . Olumiant (baricitinib) . Rinvoq (upadacitinib) . Xeljanz/Xeljanz XR (tofacitinib) Psoriatic Arthritis o Added criterion for initial therapy requiring history of failure, contraindication, or intolerance to two of the following preferred products (document drug, date, and duration of trial): . Cimzia (certolizumab) . Humira (adalimumab) . Simponi (golimumab) . Stelara (ustekinumab)

Review at Launch Oct. 1, 2019  Removed Cutaquig® [Immune Refer to the Review at Launch Medication List for complete details. Medication List Globulin Subcutaneous (Human) – hipp], Evenity™ (romosozumab- Refer to the Medical Benefit Drug Policy titled Review at Launch for New to aqqg), and Zolgensma® (ona- Market Medications for additional information. semnogene abeparvovec-xioi); prior authorization requirements effective Oct. 1, 2019

42 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Self-Administered Oct. 1, 2019 Applicable Codes Refer to the Self-Administered Medications List for complete details. Medications List  Added Fasenra (benralizumab) autoinjector, prefilled syringe Refer to the Medical Benefit Drug Policy titled Self-Administered Medications labeled for self-administration for additional information. (HCPCS code J0517)  Removed Hemlibra (emicizumab)  Updated list of applicable HCPCS codes for: Ajovy (fremanezumab-vfrm) o Replaced J3590 with J3031* o Removed C9040* Cimzia (certolizumab pegol)  Revised description for J0717 Takhzyro (lanadelumab-flyo) o Replaced J3590 with J0593* (*quarterly code edit)

Simponi Aria® Oct. 1, 2019 Notice of Implementation Delay: The changes described below will not be effective on Oct. 1, 2019, as (Golimumab) TBD previously announced. Implementation of the revised Medical Benefit Drug Policy has been postponed until further Injection for notice; complete details will be provided in a future edition of the Medical Policy Update Bulletin. Intravenous Infusion Template Update  Reorganized policy template; relocated Background and FDA sections Coverage Rationale  Revised coverage criteria for initial therapy and continuation of therapy for all indications; added criterion requiring: o One of the following: . Both of the following: - History of failure, contraindication, or intolerance to Simponi labeled for self-administration - Physician attests that, in their clinical opinion, the clinical response would be expected to be superior with Simponi Aria for intravenous infusion . Physician attestation that the patient or caregiver are not competent to administer Simponi FDA labeled for self-administration; physician must submit explanation o Authorization is for no more than 12 months o For continuation of therapy: Patient has previously received Simponi Aria injection for intravenous infusion

43 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Sodium Oct. 1, 2019 Notice of Revision: The following Medical Necessity Plans Hyaluronate summary of changes has been Coverage for Durolane, Euflexxa, and Gelsyn-3 is contingent on modified. Revisions to the previous criteria in the Diagnosis-Specific Criteria section. Prior authorization is policy update announcement are not required. outlined in red below. Please take note of the additional updates Coverage for GenVisc 850, Hyalgan, Supartz, Visco-3, Hymovis,

implemented on Oct. 1, 2019. Orthovisc, Synvisc or Synvisc-One, Gel-One, Monovisc, Triluron,

TriVisc, or Synojoynt is contingent on the Medical Necessity Criteria Template Update and Diagnosis-Specific Criteria. In order to continue coverage, members  Changed policy type already on these products will be required to change therapy to Durolane, classification from “Medical Euflexxa, or Gelsyn-3 unless they meet the criteria below. Policy” to “Medical Benefit Drug

Policy” Medical Necessity Criteria  Added Documentation Treatment with GenVisc 850, Hyalgan, Supartz, Visco-3, Hymovis, Orthovisc, Requirements section Synvisc or Synvisc-One, Gel-One, Monovisc, Triluron, TriVisc, or Synojoynt is Coverage Rationale medically necessary for the indications specified in this policy when one the  Added language to indicate: criteria below are met: Medical Necessity Plans  Both of the following: o Coverage for Durolane, o History of a trial of adequate dose and duration of Durolane, Euflexxa, and Gelsyn-3 is Euflexxa, and Gelsyn-3, resulting in minimal clinical response; and contingent on criteria in the o Physician attests that, in their clinical opinion, the clinical response Diagnosis-Specific Criteria would be expected to be superior than experienced with Durolane, section of the policy; prior Euflexxa, and Gelsyn-3. authorization is not required or o Coverage for GenVisc 850,  Both of the following: Hyalgan, Supartz, Visco-3, o History of failure, contraindication, or intolerance to Durolane, Hymovis, Orthovisc, Synvisc Euflexxa, and Gelsyn-3; and or Synvisc-One, Gel-One, o Physician attests that, in their clinical opinion, the same failure, Monovisc, Triluron, TriVisc, contraindication, or intolerance would not be expected to occur with or Synojoynt is contingent GenVisc 850, Hyalgan, Supartz, Visco-3, Hymovis, Orthovisc, Synvisc on the Medical Necessity or Synvisc-One, Gel-One, Monovisc, Triluron, TriVisc, or Synojoynt. Criteria and Diagnosis-

Specific Criteria sections of Non-Medical Necessity Plans the policy . In order to continue Any sodium hyaluronate product is to be approved contingent on the coverage, members coverage criteria in the Diagnosis-Specific Criteria section. already on these products will be required Diagnosis-Specific Criteria to change therapy to Initial Authorization (sodium hyaluronate naïve patients)

44 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Sodium Oct. 1, 2019 Durolane, Euflexxa, or Intra-articular injections of sodium hyaluronate are proven and Hyaluronate Gelsyn-3 unless they medically necessary when all of the following are met: (continued) meet the Medical  Diagnosis of one of the following: Necessity Criteria listed o Hip osteoarthritis in the policy o Knee osteoarthritis o Treatment with GenVisc 850, o Temporomandibular joint osteoarthritis Hyalgan, Supartz, Visco-3, o Temporomandibular joint disc displacement Hymovis, Orthovisc, Synvisc and or Synvisc-One, Gel-One,  The member has not responded adequately to conservative therapy Monovisc, Triluron, TriVisc, which may include physical therapy or pharmacotherapy (e.g., non-

or Synojoynt is medically steroidal anti-inflammatory drugs [NSAIDs], acetaminophen and/or

necessary for the indications topical capsaicin cream) or injection of intra-articular steroids and such

specified in this policy when therapy has not resulted in functional improvement after at least 3 one of the criteria below are months, or the member is unable to tolerate conservative therapy met: because of adverse side effects; and . Both of the following:  The member reports pain which interferes with functional activities (e.g., - History of a trial of ambulation, prolonged standing); and adequate dose and  The pain cannot be attributed to other forms of osteoarthritis; and duration of Durolane,  There are no contraindications to the injections (e.g., active joint Euflexxa, and infection, bleeding disorder); and Gelsyn-3, resulting  Dosing is in accordance with the US FDA approved labeling as shown in in minimal clinical the table below; and response  Initial authorization is for a single injection course once per joint for 6 - Physician attests months. that, in their clinical

opinion, the clinical Reauthorization/Continuation

response would be Repeated courses of intra-articular hyaluronan injections may be expected to be considered when ALL of the following are met: superior than  Documentation of positive clinical response to therapy (e.g., significant experienced with pain relief was achieved with the prior course of injections); and Durolane, Euflexxa,  Pain has recurred; and and Gelsyn-3  At least 6 months have passed since the prior course of treatment for the or respective joint; and . Both of the following:  Dosing is in accordance with the US FDA approved labeling as shown in - History of failure, the table below; and contraindication, or  Continuing authorization is for a single injection course once per joint for intolerance to 6 months. Durolane, Euflexxa,

and Gelsyn-3 The table below shows the FDA approved sodium hyaluronate products and

45 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Sodium Oct. 1, 2019 - Physician attests their respective FDA labeled dosage per treatment course per joint: Hyaluronate that, in their clinical Sodium Hyaluronate Product Course of Treatment per Joint (continued) opinion, the same Durolane 1 injection failure, contraindication, or Euflexxa 3 injections intolerance would Gel One 1 injection not be expected to occur with GenVisc Sodium Hyaluronate Product Course of Treatment per Joint 850, Hyalgan, Gelsyn-3 3 injections

Supartz, Visco-3, GenVisc 850 3 to 5 injections

Hymovis, Orthovisc, Hyalgan 5 injections Synvisc or Synvisc- Hymovis 2 injections One, Gel-One, Monovisc, Triluron, Monovisc 1 injection TriVisc, or Synojoynt Orthovisc 3 to 4 injections Non-Medical Necessity Plans Supartz 3 to 5 injections o Any sodium hyaluronate product is to be approved Synvisc 3 injections contingent on the coverage Synvisc One 1 injection criteria in the Diagnosis- TriVisc 3 injections Specific Criteria section of the policy Visco-3 3 injections  Revised Diagnosis-Specific Synojoynt 3 injections Criteria Applicable Codes Intra-articular injections of sodium hyaluronate are unproven and  Updated list of applicable HCPCS not medically necessary for treating any other indication due to codes to reflect quarterly code insufficient evidence of efficacy. edits; added J7331 and J7332  Added ICD-10 diagnosis codes Hyaluronic acid gel preparations to improve the skin's appearance, M16.0, M16.10, M16.11, contour and/or reduce depressions due to acne, scars, injury or M16.12, M16.2, M16.30, wrinkles are considered cosmetic and are not covered. M16.31, M16.32, M16.4, M16.50, M16.51, M16.52, M16.6, M16.7, and M16.9 Supporting Information  Updated FDA and References sections to reflect the most current information

46 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Stelara® Oct. 1, 2019 Template Update This policy refers to Stelara (ustekinumab) injection. Stelara (Ustekinumab)  Reorganized policy template; (ustekinumab) for self-administered subcutaneous injection is obtained relocated Background and FDA under the pharmacy benefit. sections Coverage Rationale Stelara is proven and/or medically necessary for the treatment of:  Added language to indicate

Stelara (ustekinumab) for self- Crohn’s disease when ALL of the following criteria are met:

administered subcutaneous  Diagnosis of moderately to severely active Crohn’s disease; and

injection is obtained under the  One of the following:

o History of inadequate response or failure, contraindication, or pharmacy benefit intolerance to at least one tumor necrosis factor (TNF) blocker [e.g.,  Replaced language indicating “Stelara is proven and medically infliximab, Humira (adalimumab), Cimzia (certolizumab)]; or necessary for the treatment of o Both of the following: [the listed indications]” with . History of inadequate response or failure, contraindication, or “Stelara is proven and/or intolerance to at least one immunomodulator or corticosteroid medically necessary for the (e.g., corticosteroids, 6-mercaptopurine, azathioprine, treatment of [the listed methotrexate, etc.); and indications] . Patient has never failed a TNF blocker [e.g., infliximab, Humira  Revised coverage criteria for: (adalimumab), Cimzia (certolizumab)] Crohn’s Disease and o Replaced criterion for initial o One of the following:

therapy requiring: . Initial Therapy

. “History of failure, - Stelara is to be administered as an intravenous induction

contraindication, or dose; and - Stelara induction dosing is in accordance with the United intolerance to at least one tumor necrosis States Food and Drug Administration approved labeled dosing for Crohn’s disease: factor (TNF) blocker”  260mg for patients weighing ≤55kg with “history of  390mg for patients weighing >55kg to ≤85kg inadequate response or failure, contraindication,  520mg for patients weighing >85kg or intolerance to at least and one tumor necrosis - Patient is not receiving Stelara in combination with any of factor (TNF) blocker” the following: . “History of failure,  Biologic DMARD [e.g., infliximab, Humira (adalimumab), contraindication, or Cimzia (certolizumab), Simponi (golimumab)] intolerance to at least  Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] one immunomodulator  Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla or corticosteroid” with (apremilast)] “history of inadequate and

47 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Stelara® Oct. 1, 2019 response or failure, - Authorization will be for one induction dose. (Ustekinumab) contraindication, or . Continuation of Therapy (continued) intolerance to at least - Physician attestation that the patient or caregiver is not one immunomodulator competent to administer Stelara FDA labeled for self- or corticosteroid” administration; physician must submit explanation; and o Updated criteria for - Stelara is to be subcutaneously administered 8 weeks after continuation of therapy: the initial intravenous dose; and . Added criterion - Stelara continuation dosing is in accordance with the United requiring: States Food and Drug Administration approved labeled - Physician attestation dosing for Crohn’s disease: 90mg every 8 weeks

that the patient or subcutaneously; and

caregiver are not - Patient is not receiving Stelara in combination with any of

competent to the following: administer Stelara  Biologic DMARD [e.g., infliximab, Humira (adalimumab), FDA labeled for self- Cimzia (certolizumab), Simponi (golimumab)] administration;  Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] physician must  Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla submit explanation (apremilast)] - Authorization is for - Authorization is for no more than 12 months. no more than 12 months Plaque psoriasis when ALL of the following criteria are met: . Removed criterion  For initial therapy, all of the following: requiring patient is o Diagnosis of moderate to severe plaque psoriasis; and unable to self-administer o Patient is a candidate for systemic therapy; and subcutaneous doses o Physician attestation that the patient or caregiver is not competent to

Plaque Psoriasis administer Stelara FDA labeled for self-administration; physician

o Updated criteria for initial must submit explanation; and o Stelara is initiated and titrated according to US Food and Drug therapy: Administration labeled dosing for plaque psoriasis up to a maximum . Added criterion of (or equivalent dose and interval schedule): requiring: - Physician attestation . 45mg every 12 weeks for patients weighing ≤100kg that the patient or subcutaneously caregiver are not . 90mg every 12 weeks for patients weighing >100kg competent to subcutaneously administer Stelara and FDA labeled for self- o Patient is not receiving Stelara in combination with any of the administration; following: physician must . Biologic DMARD [e.g., Enbrel (etanercept), Humira submit explanation (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]

48 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Stelara® Oct. 1, 2019 - Initial authorization . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] (Ustekinumab) is for no more than . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] (continued) 12 months o Initial authorization is for no more than 12 months. . Removed criterion  For continuation of therapy, all of the following: requiring patient is o Documentation of positive clinical response; and unable to self-administer o Physician attestation that the patient or caregiver is not competent to subcutaneous doses administer Stelara FDA labeled for self-administration; physician o Added criteria for must submit explanation; and continuation of therapy o Stelara is initiated and titrated according to US Food and Drug

Psoriatic Arthritis Administration labeled dosing for plaque psoriasis up to a maximum

of (or equivalent dose and interval schedule): o Updated criteria for initial . 45mg every 12 weeks for patients weighing ≤100kg therapy: . Added criterion subcutaneously requiring: . 90mg every 12 weeks for patients weighing >100kg - Physician attestation subcutaneously that the patient or and caregiver are not o Patient is not receiving Stelara in combination with any of the competent to following: administer Stelara . Biologic DMARD [e.g., infliximab, Humira (adalimumab), Cimzia FDA labeled for self- (certolizumab), Simponi (golimumab)] administration; . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] physician must . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] submit explanation o Authorization is for no more than 12 months. - Initial authorization is for no more than Psoriatic arthritis when ALL of the following criteria are met:

12 months  For initial therapy, all of the following:

. Removed criterion o Diagnosis of psoriatic arthritis; and o Stelara is initiated and titrated according to US Food and Drug requiring patient is Administration labeled dosing for psoriatic arthritis up to a maximum unable to self-administer of 90mg every 12 weeks subcutaneously (or equivalent dose and subcutaneous doses o Added criteria for interval schedule); and continuation of therapy o Physician attestation that the patient or caregiver is not competent to administer Stelara FDA labeled for self-administration; physician must submit explanation; and o Patient is not receiving Stelara in combination with any of the following: . Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

49 Medical Policy Update Bulletin: October 2019

Medical Benefit Drug Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Stelara® Oct. 1, 2019 . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] (Ustekinumab) o Initial authorization is for no more than 12 months. (continued)  For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Physician attestation that the patient or caregiver is not competent to administer Stelara FDA labeled for self-administration; physician must submit explanation; and o Stelara is initiated and titrated according to US Food and Drug Administration labeled dosing for psoriatic arthritis up to a maximum of 90mg every 12 weeks subcutaneously (or equivalent dose and

interval schedule); and

o Patient is not receiving Stelara in combination with any of the following: . Biologic DMARD [e.g., infliximab, Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] . Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] . Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] o Authorization is for no more than 12 months.

Stelara is unproven and not medically necessary for the treatment of multiple sclerosis. In available studies, Stelara does not demonstrate efficacy in the treatment of multiple sclerosis.

50 Medical Policy Update Bulletin: October 2019

Coverage Determination Guideline (CDG) Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Preventive Care Dec. 1, 2019 Applicable Codes: Preventive Indications for Coverage Services Care Services Introduction Hepatitis B Virus Infection UnitedHealthcare covers certain medical services under the preventive care Screening services benefit. The federal Patient Protection and Affordable Care Act  Updated service description for (PPACA) requires non-grandfathered health plans to cover certain Pregnant Women: “recommended preventive services” as identified by PPACA under the o Removed June 2009 USPSTF preventive care services benefit, without cost sharing to members when “A” rating provided by network physicians. This includes: o Added July 2019 USPSTF “A”  Evidence-based items or services that have in effect a rating of “A” or rating to indicate the USPSTF “B” in the current recommendations of the United States Preventive recommends screening for Services Task Force. hepatitis B virus (HBV)  Immunizations for routine use in children, adolescents and adults that infection in pregnant women have in effect a recommendation from the Advisory Committee on at their first prenatal visit Immunization Practices of the Centers for Disease Control and Newborn Screenings Prevention.  Updated service description;  With respect to infants, children and adolescents, evidence-informed removed July 2008 USPSTF “B” preventive care and screenings provided for in the comprehensive rating guidelines supported by the Health Resources and Services  Removed list of applicable Administration. CPT/HCPCS codes for Hearing  With respect to women, such additional preventive care and screenings Screening: 92551, 92558, as provided for in comprehensive guidelines supported by the Health 92585, 92586, 92587, 92588, Resources and Services Administration. and V5008

Osteoporosis Screening Member Cost-Sharing

 Updated list of applicable CPT  Non-Grandfathered Plans: codes; removed 77078 o Non-grandfathered plans provide coverage for preventive care Screening for Visual Impairment services with no member cost sharing (i.e., covered at 100% of in Children Allowed Amounts without deductible, coinsurance or copayment)  Updated service when services are obtained from a Network provider. description/Bright Futures o Under PPACA, services obtained from an out-of-network provider are recommendation to indicate: not required to be covered under a plan’s preventive benefit, and o Visual acuity screening is may be subject to member cost sharing. Refer to the member recommended for age 4 and specific benefit plan document for out-of-network benefit 5 years, as well as in information, if any. cooperative 3 year olds  Grandfathered Plans: o Instrument-based screening o Plans that maintain grandfathered status under PPACA are not is recommended for age 12 required by law to provide coverage for these preventive services and 24 months, in addition without member cost sharing; although a grandfathered plan may to the well visits at age 3

51 Medical Policy Update Bulletin: October 2019

Coverage Determination Guideline (CDG) Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Preventive Care Dec. 1, 2019 through 5 years choose to voluntarily amend its plan document to include these Services  Revised preventive benefit preventive benefits. (continued) instructions/age limit guidelines o Except where there are state mandates, a grandfathered plan might to indicate: include member cost sharing, or exclude some of the preventive care o Visual acuity screening services identified under PPACA. (CPT code 99173): Up to o Refer to the member specific benefit plan document for details on age 21 years (ends on 22nd how benefits are covered under a grandfathered plan. birthday); does not have diagnosis code requirements Preventive vs. Diagnostic Services for preventive benefits to Certain services can be done for preventive or diagnostic reasons. When a apply service is performed for the purpose of preventive screening and is o Instrument-based appropriately reported, it will be considered under the preventive care screening (CPT codes services benefit. This includes services directly related to the performance of 99174 and 99177): th a covered preventive care service (see the Frequently Asked Questions . Age 1 to 5 (ends on 6 section of the policy for additional information.) birthday); does not have diagnosis code Preventive services are those performed on a person who: requirements for  has not had the preventive screening done before and does not have preventive benefits to symptoms or other abnormal studies suggesting abnormalities; or apply  has had screening done within the recommended interval with the . Age 6 to 21 years (ends nd findings considered normal; or on 22 birthday); refer  has had diagnostic services results that were normal after which the to the Medical Policy physician recommendation would be for future preventive screening titled Omnibus Codes for studies using the preventive services intervals. allowable diagnoses Hearing Tests (Bright Futures) When a service is done for diagnostic purposes it will be considered under the  Updated list of applicable codes: applicable non-preventive medical benefit. Diagnostic services are done on a o Added CPT/HCPCS codes person who: 92558, 92585, 92586,  had abnormalities found on previous preventive or diagnostic studies that 92587, 92588, and V5008 require further diagnostic studies; or o Added ICD-10 diagnosis  had abnormalities found on previous preventive or diagnostic studies that codes Z00.00 and Z00.01 would recommend a repeat of the same studies within shortened time intervals from the recommended preventive screening time intervals; or  had a symptom(s) that required further diagnosis; or  does not fall within the applicable population for a recommendation or guideline

Covered Breastfeeding Equipment

Personal-use electric breast pump:

52 Medical Policy Update Bulletin: October 2019

Coverage Determination Guideline (CDG) Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Preventive Care Dec. 1, 2019  The purchase of a personal-use electric breast pump (HCPCS code Services E0603). (continued) o This benefit is limited to one pump per birth. In the case of a birth resulting in multiple infants, only one breast pump is covered. o A breast pump purchase includes the necessary supplies for the pump to operate.  Replacement breast pump supplies necessary for the personal-use electric breast pump to operate. This includes: standard power adaptor, tubing adaptors, tubing, locking rings, bottles specific to breast pump operation, caps for bottles that are specific to the breast pump, valves, filters, and breast shield and/or splash protector for use with the breast pump.

Coverage Limitations and Exclusions  Services not covered under the preventive care benefit may be covered under another portion of the medical benefit plan.  The coverage outlined in this guideline does not address certain outpatient prescription medications, tobacco cessation drugs and/or over the counter items, as required by PPACA. These preventive benefits are administered by the member’s pharmacy plan administrator. For details on coverage, refer to the member-specific pharmacy plan administrator.  A vaccine (immunization) is not covered if it does not meet company vaccine policy requirements for FDA labeling and if it does not have explicit ACIP recommendations for routine use published in the Morbidity and Mortality Weekly Report (MMWR) of the Centers for Disease Control and Prevention (CDC).  Examinations, screenings, testing, or vaccines (immunizations) are not covered when: o required solely for the purposes of career or employment, school or education, sports or camp, travel (including travel vaccines (immunizations)), insurance, marriage or adoption; or o related to judicial or administrative proceedings or orders; or o conducted for purposes of medical research; or o required to obtain or maintain a license of any type.  Services that are investigational, experimental, unproven or not medically necessary are not covered.  Breastfeeding equipment and supplies not listed above. This includes, but is not limited to: o Manual breast pumps and all related equipment and supplies.

53 Medical Policy Update Bulletin: October 2019

Coverage Determination Guideline (CDG) Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Preventive Care Dec. 1, 2019 o Hospital-grade breast pumps and all related equipment and supplies. Services o Equipment and supplies not listed in the Covered Breastfeeding (continued) Equipment section above, including but not limited to: . Batteries, battery-powered adaptors, and battery packs. . Electrical power adapters for travel. . Bottles which are not specific to breast pump operation. This includes the associated bottle nipples, caps and lids. . Travel bags, and other similar travel or carrying accessories. . Breast pump cleaning supplies including soap, sprays, wipes, steam cleaning bags and other similar products. . Baby weight scales. . Garments or other products that allow hands-free pump operation. . Breast milk storage bags, ice-packs, labels, labeling lids, and other similar products. . Nursing bras, bra pads, breast shells, nipple shields, and other similar products. . Creams, ointments, and other products that relieve breastfeeding related symptoms or conditions of the breasts or nipples.

54 Medical Policy Update Bulletin: October 2019