MP/CG Update/Notice - October 2019 Form

Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insurance Company are independent licensees of the Blue Cross Association. Anthem is a registered trademark of Anthem Insurance Companies, Inc. October 1, 2019

[Provider Name] [Contact Title] [Address] [City], [State] [Zip Code]

Dear Provider:

Anthem Blue Cross (Anthem) is pleased to provide you with our new and updated Medical Policies and Clinical UM Guidelines. Please refer to the specific policy for coding, language, and rationale updates and changes that are not summarized below.

Updates to AIM Specialty Health® (AIM) programs, a separate company, apply to local fully-insured Anthem members and select members who are covered under self-insured (ASO) benefit plans with services medically managed by AIM.
They do not apply to HMO, BlueCard®, Medicare Advantage, Medicaid, Medicare Supplement, Federal Employee Program® (FEP®). For more information, please contact the phone number of the back of the member ID card

NEW Medical Policy effective January 1, 2020

• MED.00130 Surface Electromyography Devices for Seizure Monitoring: This document addresses devices that use surface electromyography (sEMG) to monitor seizures. These devices are proposed as an adjunct in recording and storing data for characterization of seizure events.

UPDATED Medical Policies and Clinical Guidelines effective January 1, 2020

• CG-DME-46 Pneumatic Compression Devices for Prevention of Deep Vein Thrombosis of the Extremities:
This document addresses the use of pneumatic compression devices (PCDs) for the prevention of deep vein thrombosis (DVT) of the lower limbs.
o Previous title: Pneumatic Compression Devices for Prevention of Deep Vein Thrombosis of the Lower Limbs o Revised Medically Necessary statement to include upper extremities o As communicated in the September 1, 2019 provider letter, prior authorization for treatment of the lower limbs will be required effective December 1, 2019

• GENE.00023 Gene Expression Profiling of Melanomas: This document addresses gene expression profiling to assist in the risk stratification and clinical management of cutaneous and uveal (ocular) melanoma.
o Expanded Scope to include diagnosis of melanoma, and Investigational and Not Medically Necessary statement to include suspicion of melanoma

• GENE.00046 Prothombin (Factor II) Genetic Testing: This document addresses prothrombin G20210A (factor II) mutation testing for the screening, diagnosis and management of prothrombin-related thrombophilia.
o Revised title (Previous title: Prothrombin G20210A (Factor II) Mutation Testing o Expanded scope to include all prothrombin (factor II) variations

• MED.00110 Growth Factors, Silver-based Products and Autologous Tissues for Wound Treatment, Soft Tissue Grafting, and Regenerative Therapy: This document addresses the use of recombinant human platelet- derived growth factor, antimicrobial silver wound dressings, autologous blood-derived wound products, platelet rich plasma (PRP), bone marrow aspirate concentrate, and bioengineered autologous skin-derived products.
o Revised title (Previous title: Growth Factors, Silver-based Products and Autologous Tissues for Wound Treatment and Soft Tissue Grafting o Added new Investigational and Not Medically Necessary statements addressing Autologous adipose- derived regenerative cell therapy and Use of autologous protein solution

• SURG.00052 Percutaneous Vertebral Disc and Vertebral Endplate Procedures: This document addresses several minimally invasive surgical procedures designed to alter the biomechanics of the disc annulus.
o Revised title (Previous title: Intradiscal Annuloplasty Procedures (Percutaneous Intradiscal Electrothermal Therapy [IDET], Percutaneous Intradiscal Radiofrequency Thermocoagulation [PIRFT] and Intradiscal Biacuplasty [IDB]) o The three Investigational and Not Medically Necessary statements were combined into a single statement o Added Intraosseous basivertebral nerve ablation to the Investigational and Not Medically Necessary statement

• TRANS.00035 Non-Hematopoietic Adult Stem Cell Therapy: This document addresses the use of mesenchymal stem cell (MSC) therapy for the treatment of joint and ligament disorders due to injury or degeneration, as well as autoimmune, inflammatory and degenerative diseases.
o Revised title (Previous title: Mesenchymal Stem Cell Therapy for the Treatment of Joint and Ligament Disorders, Autoimmune, Inflammatory and Degenerative Diseases) o Expanded Position Statement to include non-hematopoietic adult stem cell therapy

Medical Policy converted to Clinical Guideline effective November 20, 2019 (Changes noted in Attachment A)

MP Number Title CG Number GENE.00044 PIK3CA Mutation Testing (previous title: Analysis of PIK3CA Status in Tumor Cells) CG-GENE-12

Medical Policy and Clinical Guidelines to be archived and added to other existing Clinical Guidelines effective November 20, 2019 (Changes noted in Attachment A)

MP/CG Number Title Moved into CG Number CG-SURG-80 Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Embolization (TAE) for Treating Primary or Metastatic Liver Tumors CG-SURG-78 CG-THER-RAD-04 Selective Internal Radiation Therapy (SIRT) of Primary or Metastatic Liver Tumors CG-SURG-78 RAD.00004 Peripheral Bone Mineral Density Measurement CG-MED-39

Medical Policies archived September 25, 2019

• MED.00041 Microvolt T-Wave Alternans • RAD.00040 PET Scanning Using Gamma Cameras

Clinical UM Guidelines De-adopted effective November 1, 2019

• CG-DME-06 Pneumatic Compression Devices for Lymphedema • CG-DME-42 Non-implantable Insulin Infusion and Blood Glucose Monitoring Devices • CG-MED-66 Cryopreservation of Oocytes or Ovarian Tissue • CG-MED-68 Therapeutic Apheresis • CG-MED-70 Wireless Capsule Endoscopy for Gastrointestinal Imaging and the Patency Capsule • CG-MED-72 Hyperthermia for Cancer Therapy • CG-MED-77 SPECT/CT Fusion Imaging • CG-SURG-09 Temporomandibular Disorders • CG-SURG-72 Endothelial Keratoplasty • CG-SURG-73 Balloon Sinus Ostial Dilation • CG-SURG-74 Total Ankle Replacement • CG-SURG-87 Nasal Surgery for the Treatment of Obstructive Sleep Apnea • CG-THER-RAD-04 Selective Internal Radiation Therapy (SIRT)

Clarification for CG-GENE-11

The August 1, 2019 provider letter identified CG-GENE-11 Genotype Testing for Individual Genetic Polymorphisms to Determine Drug-Metabolizer Status as a new Clinical Guidelines instead of a conversion of some codes from GENE.00010 (Genotype Panel Testing for Genetic Polymorphisms to Determine Drug-Metabolizer Status). The prior authorization requirement has not changed for either GENE.00010 or CG-GENE-11. These updates apply only to plans with services medically managed by AIM Specialty Health.

Specialty pharmacy medical step therapy drug review clarification

The February 1 and May 1 provider letters shared that medical step therapy review will be effective May 1, 2019 for the non-oncology uses of Colony Stimulating Factor Agents (ING-CC-0002). We will now begin the medical step therapy review process for oncology uses of these drugs starting October 1, 2019. Zarxio® will be the preferred short-acting colony stimulating factor (CSF) agent over Neupogen®, Granix®, and Nivestym™®. Prior authorization review of these specialty pharmacy drugs is managed by AIM Specialty Health® (AIM).

Additional information regarding biosimilar drugs can be found by viewing the reference document, “Biosimilar Drugs – What are they?” at the end of this letter.

To access the clinical criteria information please go to www11.anthem.com/ca/pharmacyinformation/clinicalcriteria.html

Clinical Criteria Status Drug HCPCS or CPT Code NDC Code ING-CC-0002 Preferred Agent Zarxio® Q5101 61314-0304-01 61314-0304-10 61314-0312-01 61314-0312-10 61314-0318-01 61314-0318-10 61314-0326-01 61314-0326-10 ING-CC-0002 Non-Preferred Agent Neupogen® J1442 55513-0530-01 55513-0530-10 55513-0546-01 55513-0546-10 55513-0924-01 55513-0924-10 55513-0924-91 55513-0209-01 55513-0209-10 55513-0209-91 ING-CC-0002 Non-Preferred Agent Granix® J1447 63459-0910-11 63459-0910-12 63459-0910-15 63459-0910-17 63459-0910-36 63459-0912-11 63459-0912-12 63459-0912-15 63459-0912-17 63459-0912-36 ING-CC-0002 Non-Preferred Agent Nivestym™ Q5110 00069-0291-10 00069-0291-01 00069-0292-01 00069-0292-10

Update to AIM Clinical Appropriateness Guidelines

Effective for dates of service on and after February 9, 2020, the following updates by section will apply to the AIM Clinical Appropriateness Guidelines.

Updates to AIM Advanced Imaging of the Abdomen and Pelvis Clinical Appropriateness Guideline • Foreign body (Pediatric only), Gastrointestinal bleeding, Henoch-Schonlein purpura,
Hematoma or hemorrhage – intracranial or extracranial, Perianal fistula/abscess (fistula in ano), Ascites, Biliary tract dilatation or obstruction , Cholecystitis, Choledocholithiasis, Focal liver lesion, Hepatomegaly, Jaundice, Azotemia, Adrenal mass, indeterminate, Hematuria, Renal mass, Urinary tract calculi, Adrenal hemorrhage, Adrenal mass, Lymphadenopathy, Splenic hematoma, Undescended testicle (cryptorchidism) • Abdominal and/or pelvic pain o Combined pelvic pain with abdominal pain criteria in new “abdominal and/or pelvic pain” indication o Required ultrasound or colonoscopy for select adult patients based on clinical scenario

o Ultrasound-first approach for pediatric abdominal and pelvic pain • Lower extremity edema o Added requirement to exclude DVT prior to abdominopelvic imaging • Splenic mass, benign, Splenic mass, indeterminate, Splenomegaly o Added new indications for diagnosis, management, and surveillance of splenic incidentalomas following the ACR White Paper (previously reviewed against “tumor, not otherwise specified”)

• Pancreatic mass o Separated criteria for solid and cystic pancreatic masses o Defined follow up intervals for cystic pancreatic masses • Diffuse liver disease
o Added criteria for MR elastography • Inflammatory bowel disease o Limited requirement for upper endoscopy to patients with relevant symptoms o New requirement for fecal calprotectin or CRP to differentiate IBS from IBD • Enteritis or colitis, not otherwise specified o Incorporated Intussusception (pediatric only), and Ischemic bowel • Prostate cancer o Moved this indication to Oncologic Imaging Guideline • CPT codes o Added MR elastography CPT code 76391

Updates to AIM Radiation Therapy Clinical Appropriateness Guideline
• Special Treatment Procedure and Special Physics Consult
o Removed oral cone endocavitary indication • Intensity Modulated Radiation Therapy (IMRT), Stereotactic Radiosurgery (SRS) or Stereotactic Body Radiotherapy (SBRT) for bone metastases o Broadened description of adjacent normal tissues which may be of concern.
• Single fraction treatment o Removed poor performance status criteria • Central Nervous System cancers o Added evidence review • Spine Lesions; Primary or Metastatic Lesions of the Spine, Metastatic Lesions in the Lung
o Added note calling out separate criteria for curative intent treatment of extracranial oligometastatic disease. • SBRT in the treatment of extracranial oligometastatic disease o Added new section with discussion and indications • Prostate cancer – hypofractionation o Added fractionation guideline with EBRT/IMRT. • Prostate cancer – postoperative radiotherapy and SBRT o Added indication based on ASTRO/ASCO/AUA recommendation • Prostate cancer – use of hydrogel spacer o Added discussion and medical necessity statement about hydrogel spacers for prostate irradiation • CPT code changes o Added 77316, 77295 and 55874 o Removed 77427

Updates to AIM Spine Surgery Clinical Appropriateness Guideline
• Conservative management – all sections o Addition of physical therapy or home therapy requirement and one complementary modality for all spine procedures based on preponderance of benefit over harm to conservative care
• Lumbar Disc Arthroplasty o Changed the duration of conservative management from 1 year to 6 months based on the FDA prospective study that was done to approve the lumbar disc arthroplasty procedure
o Added age, level requirements, and symptom/sign requirement and clarified contraindications in reflect these changes o Added exclusions criteria of Prior spine surgery of any form at the target level • Lumbar Fusion and Treatment of Spinal Deformity (including Scoliosis and Kyphosis) o Inclusion for implant failure similar to cervical spine

o Consolidated juvenile and congenital in adolescent idiopathic o Decreased duration of conservative management required based on lower evidence for efficacy in spinal stenosis and specialty panel feedback o Excluded anterior lumbar interbody fusion for foraminal stenosis without evidence of instability exclusion due to very low quality evidence for efficacy

• Lumbar Laminectomy
o Decreased duration of conservative care required for known spinal stenosis based on guidance from NASS and less evidence for efficacy of conservative management in this population
o Aligned conservative care duration with discectomy criteria o Added new indication for synovial cyst • Noninvasive Electrical Bone Growth Stimulation o Clarification of guideline intent o Allow active nicotine use as a risk factor in lumbar uses of bone growth stimulation
o Allow thoracic fusion similar to lumbar
• Bone Graft Substitutes and Bone Morphogenetic Proteins o Allow active nicotine use as a risk factor for pseudoarthrosis in graft failure

Updates to AIM Sleep Disorder Management Clinical Appropriateness Guideline
• Polysomnography and Home Sleep Testing: Established sleep disorder (OSA or other) – follow-up laboratory studies o Expanded contraindications including the addition of chronic narcotic use.
• Management of OSA using APAP and CPAP Devices
o Expanded treatment of mild OSA with APAP and CPAP to patients with any hypertension
o Expanded contraindications including the addition of chronic narcotic use

As a reminder, ordering and servicing providers may submit prior authorization requests to AIM in one of several ways:
• Access AIM’s ProviderPortallSM directly at providerportal.com. Online access is available 24/7 to process orders in real-time, and is the fastest and most convenient way to request authorization. • Access AIM via the Availity Web Portal at availity.com • Call the AIM Contact Center toll-free number: 1-877-291-0360, Monday–Friday, 7:00 a.m.–5:00 p.m. PT.

For questions related to guidelines, please contact AIM via email at aim.guidelines@aimspecialtyhealth.com. Additionally, you may access and download a copy of the current and upcoming guidelines at specialtyhealth.com/marketing/guidelines/185/index.html.

The complete list of our Medical Policies and Clinical UM Guidelines may be accessed on the Anthem’s Web site at http://www.anthem.com/ca and then hovering over “Providers”, then selecting “Policies and Guidelines” under the Provider Resources column, scrolling down to select “View Medical Policies & UM Guidelines”, then selecting “Medical Policies and Clinical UM Guidelines (for Local Plan members)”, then selecting “Continue” at the bottom of the page.

We thank you for your continued efforts on behalf of our members and your partnership toward improved access to quality health care for Californians.

Sincerely,

John Yao, MD, MPH, MBA, MPP, FACP Senior Clinical Officer

Attachment A – Updates as of October 1, 2019 Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-GENE-02 Analysis of RAS Status • Previous title: Analysis of KRAS Status • Revised Medically Necessary criteria to include NRAS • Revised Not Medically Necessary criteria to include all other indications for NRAS CG-GENE-12 PIK3CA Mutation Testing • Content moved from GENE.00044 • Revised title (previous title: Analysis of PIK3CA Status in Tumor Cells) • Revised Medically Necessary indications to include the use of a circulating tumor DNA (ctDNA) test to detect mutations of the PIK3CA gene • Investigational and Not Medically Necessary changed to Medically Necessary
CG-MED-39 Bone Mineral Density Testing Measurement • Revised title (previous title: Central [Hip or Spine[ Bone Density Measurement and Screening for Vertebral Fractures Using Dual Energy X-Ray Absorptiometry)
• Expanded document to address central and peripheral BMD testing as well as screening for vertebral fractures using DEXA • Content of RAD.00004 Peripheral Bone Mineral Density Measurement moved to this document CG-MED-68 Therapeutic Apheresis • Added Medically Necessary indications for acute inflammatory demyelinating polyradiculoneuropathy/Guillain-Barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, myasthenia gravis, N-methyl D- aspartate receptor antibody encephalitis and renal transplant recipients • Revised the Medically Necessary indication for anti-neutrophil cytoplasmic antibodies vasculitis • Clarified several Medically Necessary indications based on 2019 ASFA indications • Added Not Medically Necessary indications for red blood cell exchange and adsorptive cytapheresis when criteria are not met • Clarified Not Medically Necessary statements • Removed clarifying Not Medically Necessary statement regarding immunoadsorption • Clarified term Low-density lipid (LDL) apheresis as also lipoprotein apheresis CG-REHAB-08 Private Duty Nursing in the Home Setting • Clarified Not Medically Necessary statement CG-SURG-09 Temporomandibular Disorders • Corrected diagnosis range to S03.00XA-S03.03XS CG-SURG-63 Cardiac Resynchronization Therapy with or without an Implantable Cardioverter Defibrillator for the Treatment of Heart Failure • Removed references to “FDA approved” from Clinical Indications
• Updated Description, Discussion/General Information, References, and Websites for Additional Information sections

CG-SURG-78 Locoregional and Surgical Techniques for Treating Primary and Metastatic Liver Malignancies • Revised title: Locally Ablative Techniques for Treating Primary and Metastatic Liver Malignancies • Incorporation of CG-SURG-80 Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Embolization (TAE) for Treating Primary or Metastatic Liver Tumors and CG-THER-RAD-04 Selective Internal Radiation Therapy (SIRT) of Primary or Metastatic Liver Tumors clinical criteria into existing clinical UM guideline CG-SURG-78 • Added radiofrequency ablation (RFA) and percutaneous ethanol injection (PEI) treatment as Medically Necessary for downsizing of hepatic lesions for individuals who may become eligible for transplant CG-SURG-79 Implantable Infusion Pumps • Clarified Medically Necessary clinical indications criteria for implantable infusion pumps for pulmonary arterial hypertension by adding generic name of medication • Updated Discussion, References and Websites for Additional Information sections CG-SURG-86 Endovascular/Endoluminal Repair of Aortic Aneurysms, Aortoiliac Disease, Aortic Dissection and Aortic Transection • Removed ICD-10-PCS codes 04V03D6, 04V03E6, 04V03F6 deleted September 30, 2019 GENE.00001 Genetic Testing for Cancer Susceptibility • Removed CPT PLA code 0104U deleted September 30, 2019 GENE.00009 Gene-Based Tests for Screening, Detection and Management of Prostate Cancer • Added CPT PLA code 0113U effective October 1, 2019 for
Mi-Prostate Score GENE.00011 Gene Expression Profiling for Managing Breast Cancer Treatment • Clarified Investigational and Not Medically Necessary position statement GENE.00012 Preconception or Prenatal Genetic Testing of a Parent or Prospective Parent • Added CPT PLA code 0136U effective October 1, 2019 for ATM GENE.00028 Genetic Testing for Colorectal Cancer Susceptibility • Added CPT PLA codes 0130U and 0134U for panels as
Investigational and Not Medically Necessary GENE.00029 Genetic Testing for Breast and/or Ovarian Cancer Syndrome • Added Medically Necessary indication for “Individual with a first-, second- or third-degree relative with metastatic prostate cancer” • Clarified Medically Necessary indications regarding “at least” GENE.00033 Genetic Testing for Inherited Peripheral Neuropathies • Updated References • Removed CPT code 81440 (addressed in GENE.00043) GENE.00041 Genetic Testing to Confirm the Identity of Laboratory Specimens • Added 81265 and 81266 when billed as provenance testing by diagnosis as Not Medically Necessary GENE.00043 Genetic Testing of an Individual’s Genome for Inherited Diseases • Added CPT PLA code 0136U effective October 1, 2019 for ATM as Investigational and Not Medically Necessary for diagnoses not on GENE.00012 (Preconception or Prenatal Genetic Testing of a Parent or Prospective Parent) LAB.00011 Analysis of Proteomic Patterns • Revised descriptor for 0080U effective October 1, 2019 MED.00129 Gene Therapy for Spinal Muscular Atrophy • Modified bullet F in first Medically Necessary statement
• Added second Medically Necessary statement OR-PR.00003 Microprocessor Controlled Lower Limb Prosthesis • Clarified Medically Necessary position statement criteria 3 and 4

RAD.00023 Single Photon Emission Computed Tomography Scans for Noncardiovascular Indications • Added dopamine transporter (DaT) scan to Medically Necessary Position Statement • Revised dopamine transporter (DaT) scan criterion in Investigational and Not Medically Necessary Position Statement SURG.00011 Allogeneic, Xenographic, Synthetic and Composite Products for Wound Healing and Soft Tissue Grafting • Added HCPCS codes Q4205, Q4206, Q4208, Q4211, Q4212, Q4213, Q4214, Q4215, Q4216, Q4217, Q4218, Q4219, Q4220, Q4221, Q4222 effective October 1, 2019 for new products as Investigational and Not Medically Necessary SURG.00129 Oral, Pharyngeal and Maxillofacial Surgical Treatment for Obstructive Sleep Apnea or Snoring • Removed Not Medically Necessary indication for nasal surgery SURG.00132 Drug-Eluting Devices for Maintaining Sinus Ostial Patency • Added HCPCS code J7401 for Sinuva, Propel replacing C2625, J3490, L8699 and S1090 effective October 1, 2019 TRANS.00016 Umbilical Cord Blood Progenitor Cell Collection, Storage and Transplantation • Removed ICD-10-PCS codes deleted September 30, 2019 for artery administration TRANS.00023 Hematopoietic Stem Cell Transplantation for Multiple Myeloma and Other Plasma Cell Dyscrasias • Removed ICD-10-PCS codes deleted September 30, 2019 for artery administration; added ICD-10-PCS codes effective October 1, 2019 for T-cell depleted stem cells TRANS.00024 Hematopoietic Stem Cell Transplantation for Select Leukemias and Myelodysplastic Syndrome • Removed ICD-10-PCS codes deleted September 30, 2019 for artery administration; added ICD-10-PCS codes effective October 1, 2019 for T-cell depleted stem cells TRANS.00027 Hematopoietic Stem Cell Transplantation for Pediatric Solid Tumors • Removed ICD-10-PCS codes deleted September 30, 2019 for artery administration; added ICD-10-PCS codes effective October 1, 2019 for T-cell depleted stem cells TRANS.00028 Hematopoietic Stem Cell Transplantation for Hodgkin Disease and non-Hodgkin Lymphoma • Removed ICD-10-PCS codes deleted September 30, 2019 for artery administration; added ICD-10-PCS codes effective October 1, 2019 for T-cell depleted stem cells TRANS.00029 Hematopoietic Stem Cell Transplantation for Genetic Diseases and Aplastic Anemias • Added ICD-10-CM diagnosis codes D81.30-D81.39 replacing D81.3 effective October 1, 2019; removed ICD-10-PCS codes deleted September 30, 2019 for artery administration; added ICD-10-PCS codes effective October 1, 2019 for T-cell depleted stem cells TRANS.00030 Hematopoietic Stem Cell Transplantation for Germ Cell Tumors • Removed ICD-10-PCS codes deleted September 30, 2019 for artery administration; added ICD-10-PCS codes effective October 1, 2019 for T-cell depleted stem cells TRANS.00031 Hematopoietic Stem Cell Transplantation for Autoimmune Disease and Miscellaneous Solid Tumors • Removed ICD-10-PCS codes deleted September 30, 2019 for artery administration; added ICD-10-PCS codes effective October 1, 2019 for T-cell depleted stem cells TRANS.00034 Hematopoietic Stem Cell Transplantation for Diabetes Mellitus • Removed ICD-10-PCS codes deleted September 30, 2019 for artery administration; added ICD-10-PCS codes effective October 1, 2019 for T-cell depleted stem cells

Biosimilars – What are they? What are biologics and biosimilars? Biologics are medicines made from living cells, manufactured in living systems. The manufacturing process is complex with extensive quality controls, because the living systems used to produce biologics can change ever so slightly over time. A biosimilar of a biologic is similar to a generic version of a conventional drug, but there is a key difference. By law, a generic must be an exact copy of the original medication, or reference product. Because of the complexity of the biological medication, it is not possible to exactly replicate biologic reference products. Therefore, biosimilars must be highly similar in terms of structure and function and lack clinically meaningful difference in terms of safety and efficacy to their reference product. What are some examples of biosimilars? Only six biosimilars are commercially available in the U.S. as of October 2018. These include Zarxio®, Nivestym™, and Fulphila™, which treat neutropenia; Inflectra® and Renflexis®, which treat inflammatory diseases; and Retacrit™, which treats anemia. Six additional products — treatments for various cancers, as well as additional treatments for inflammatory diseases — have been approved by the FDA but are not yet commercially available.
Are biosimilars approved for all the same indications as the reference product? Biosimilars may be approved for all or some of the indications as the reference product. Some biosimilars may have a subset of indications as the reference product due to patent exclusivity of certain indications. There is no clinical reason why the biosimilar cannot be used for all indications of the reference product, even though the biosimilar might not share the same indications. What are the potential benefits of biosimilars? As patents start to expire on the biologic drugs, the rise of biosimilars brings increased competition to the market resulting in potentially lower treatment cost. We also expect to see innovation evolve with product competition. Examples of differentiating product attributes already seen include individualized anti-drug antibody monitoring and subcutaneous formulations for greater convenience. Will the pharmacist substitute a reference product with the biosimilar if the prescription indicates may substitute? Although the biosimilar lacks clinically meaningful difference compared to its reference product, it is not automatically substitutable by the pharmacist, unless it is rated as interchangeable. To date, no biosimilars are considered interchangeable. The prescription needs to be written for the biosimilar by name.