policy update bulletin

Transcription

1 June 2018 plicy update bulletin Medical & Administrative Plicy Updates UnitedHealthcare respects the expertise f the physicians, health care prfessinals, and their staff wh participate in ur netwrk. Our gal is t supprt yu and yur patients in making the mst infrmed decisins regarding the chice f quality and cst-effective care, and t supprt practice staff with a simple and predictable administrative experience. The Plicy Update Bulletin was develped t share imprtant infrmatin regarding Oxfrd Medical and Administrative Plicy.* *Where infrmatin in this bulletin cnflicts with applicable state and/r federal law, UnitedHealthcare fllws such applicable federal and/r state law

2 Oxfrd Medical and Administrative Plicy Updates Overview This bulletin prvides cmplete details n Oxfrd Clinical, Administrative and Reimbursement Plicy updates. The inclusin f a health service (e.g., test, drug, device r prcedure) in this bulletin indicates nly that UnitedHealthcare has recently adpted a new plicy and/r updated, revised, replaced r retired an existing plicy; it des nt imply that Oxfrd prvides cverage fr the health service. In the event f an incnsistency r cnflict between the infrmatin prvided in this bulletin and the psted plicy, the prvisins f the psted plicy will prevail. Nte that mst benefit plan dcuments exclude frm benefit cverage health services identified as investigatinal r unprven/nt medically necessary. Physicians and ther health care prfessinals may nt seek r cllect payment frm a member fr services nt cvered by the applicable benefit plan unless first btaining the member s written cnsent, acknwledging that the service is nt cvered by the benefit plan and that they will be billed directly fr the service. Tips fr using the Plicy Update Bulletin: A cmplete library f Oxfrd Medical and Administrative Plicies is available at OxfrdHealth.cm > Prviders > Tls & Resurces > Medical Infrmatin > Medical and Administrative Plicies. Frm the table f cntents, click the plicy title t be directed t the crrespnding plicy update summary. Frm the plicy updates table, click the plicy title t view a cmplete cpy f a new, updated, r revised plicy. Plicy Update Classificatins New New clinical cverage criteria and/r dcumentatin review requirements have been adpted fr a health service (e.g., test, drug, device r prcedure) Updated An existing plicy has been reviewed and changes have nt been made t the clinical cverage criteria r dcumentatin review requirements; hwever, items such as the clinical evidence, FDA infrmatin, and/r list(s) f applicable cdes may have been updated Revised An existing plicy has been reviewed and revisins have been made t the clinical cverage criteria and/r dcumentatin review requirements Replaced An existing plicy has been replaced with a new r different plicy Retired The health service(s) addressed in the plicy are n lnger being managed r are cnsidered t be prven/medically necessary and are therefre nt excluded as unprven/nt medically necessary services, unless cverage guidelines r criteria are therwise dcumented in anther plicy Nte: The absence f a plicy des nt autmatically indicate r imply cverage. As always, cverage fr a health service must be determined in accrdance with the member s benefit plan and any applicable federal r state regulatry requirements. Additinally, UnitedHealthcare reserves the right t review the clinical evidence supprting the safety and effectiveness f a medical technlgy prir t rendering a cverage determinatin. 2 Oxfrd Plicy Update Bulletin: June 2018

3 Oxfrd Medical and Administrative Plicy Updates In This Issue Clinical Plicy Updates Page UPDATED Assisted Administratin f Cltting Factrs and Cagulant Bld Prducts - Effective... 6 Carrier Testing fr Genetic Diseases - Effective... 6 Csmetic and Recnstructive Prcedures - Effective... 6 Gastrintestinal Mtility Disrders, Diagnsis and Treatment - Effective... 6 Gynecmastia Treatment - Effective Jun. 1, Intrauterine Fetal Surgery - Effective Jun. 1, Macular Degeneratin Treatment Prcedures - Effective... 7 Mifeprex (Mifepristne) - Effective Jun. 1, Mlecular Onclgy Testing fr Cancer Diagnsis, Prgnsis, and Treatment Decisins - Effective... 7 Occipital Neuralgia and Headache Treatment - Effective... 7 Prltherapy fr Musculskeletal Indicatins - Effective Jun. 1, Repsitry Crtictrpin Injectin (H.P. Acthar Gel ) - Effective Jun. 1, Rutine Ft Care - Effective... 8 Transpupillary Thermtherapy - Effective Jun. 1, Alpha 1 -Prteinase Inhibitrs - Effective... 8 Cltting Factrs and Cagulant Bld Prducts - Effective Densumab (Prlia & Xgeva ) - Effective Jun. 1, Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins - Effective Drug Cverage Guidelines - Effective Jun. 1, Prlia, Xgeva (Densumab) Drug Cverage Guidelines - Effective Aralast NP [Alpha 1 -Prteinase Inhibitr (Human)] Balctra (Ethinyl Estradil/Levnrgestrel/Ferrus Bisglycinate) Bevyxxa (Betrixaban) Buphenyl (Sdium Phenylbutyrate) Cerezyme (Imiglucerase) Chemtherapy (Injectable) Drugs) Climara (Brand Only) (Estradil) Cdeine/Phenylephrine/Prmethazine Cdeine/Prmethazine Crinne (Prgesterne Gel) Effient (Prasugrel) (Brand Only) Oxfrd Plicy Update Bulletin: June 2018

4 Oxfrd Medical and Administrative Plicy Updates In This Issue Elelys (Taliglucerase Alfa) Flwtuss (Hydrcdne/Guaifenesin) Fsrenl Chewable Tablets (Lanthanum Carbnate) (Brand Only) Glassia [Alpha 1 -Prteinase Inhibitr (Human)] Hemlibra (Emicizumab-Kxwh) Hemphilia Drugs Humira (Adalimumab) 10 mg/0.1 ml, 20 mg/0.2ml, 40 mg/0.4 ml, 80 mg/0.8 ml Strengths Only Hycfenix (Hydrcdne/Pseudephedrine/Guaifenesin) Hydrcdne/Hmatrpine Mrphabnd ER (Mrphine Sulfate) Nrvir Tablets Obredn Slutin (Hydrcdne/Guaifenesin) Orfadin (Nitisinne) Osmlex ER (Amantadine) Otrexup (Methtrexate Injectin) Prevymis (Letermvir) Prlastin-C [Alpha 1 -Prteinase Inhibitr [Human)] Relpax (Eletriptan) (Brand Only) Reyataz (Atazanavir) (Brand Only) Sublcade (Buprenrphine Extended-Release) Tamiflu Suspensin (Oseltamivir Phsphate) (Brand Only) Taperdex Pak 6-Day & 12-Day (Dexamethasne) Tazrac (Tazartene) Tazartene 0.1% Cream (Generic Tazrac) Trgarz (Ibalizumab) Tussinex Tuzistra XR (Cdeine/Chlrpheniramine) Utibrn Nehaler (Indacaterl/Glycpyrrlate) Viagra (Sildenafil Citrate) (Brand Only) VPRIV (Velaglucerase) Xenazine (Tetrabenazine) Zemaira [Alpha 1 -Prteinase Inhibitr (Human)] Zutrip Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines - Effective Intravenus Enzyme Replacement Therapy (ERT) fr Gaucher Disease - Effective Manipulative Therapy - Effective Preventive Care Services - Effective Radiatin Therapy Prcedures Requiring Precertificatin fr evicre healthcare Arrangement - Effective Radipharmaceuticals and Cntrast Media - Effective Oxfrd Plicy Update Bulletin: June 2018

5 Oxfrd Medical and Administrative Plicy Updates In This Issue Specialty Medicatin Administratin - Site f Care Review Guidelines - Effective Trgarz (Ibalizumab-Uiyk) - Effective White Bld Cell Clny Stimulating Factrs - Effective RETIRED/REPLACED Gait Analysis - Effective Jun. 1, Administrative Plicy Updates Assignment f Benefits & Balance Billing - Effective Durable Medical Equipment, Orthtics, Ostmy Supplies, Medical Supplies and Repairs/ Replacements - Effective Precertificatin Exemptins fr Outpatient Services - Effective Reimbursement Plicy Updates UPDATED Injectin and Infusin Services - Effective Jun. 1, Physical Medicine & Rehabilitatin: Multiple Therapy Prcedure Reductin - Effective Preventive Medicine and Screening - Effective Prcedure and Place f Service - Effective Jun. 1, Discntinued Prcedure (CES) - Effective Preventive Medicine and Screening (CES) - Effective Reduced Services (CES) - Effective Split Surgical Package (CES) - Effective Supply Plicy - Effective Oxfrd Plicy Update Bulletin: June 2018

6 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes UPDATED Assisted Administratin f Cltting Factrs and Cagulant Bld Prducts Carrier Testing fr Genetic Diseases Csmetic and Recnstructive Prcedures Updated list f applicable HCPCS cdes; added J3590 Updated cverage ratinale; replaced language indicating: [The listed service] is prven and medically necessary with [the listed service] is prven and/r medically necessary [The listed services] are unprven and nt medically necessary with [the listed services] are unprven and/r nt medically necessary Updated list f applicable CPT cdes; remved and Updated definitins: Added definitin f Adjacent Tissue Transfer Replaced references t Functinal/Physical Impairment with Functinal r Physical Impairment Updated list f applicable CPT cdes that may be csmetic (review is required t determine if cnsidered csmetic r recnstructive); added 14000, 14001, 14020, 14021, 14040, 14041, 14060, 14061, 14301, and Gastrintestinal Mtility Disrders, Diagnsis and Treatment Gynecmastia Treatment Intrauterine Fetal Surgery Updated cverage ratinale: Replaced language indicating: [The listed services] are prven and medically necessary with [the listed services] are prven and/r medically necessary [The listed services] are unprven and nt medically necessary with [the listed services] are unprven and/r nt medically necessary Replaced references t patient with member Updated supprting infrmatin t reflect the mst current descriptin f services, clinical evidence, FDA infrmatin, and references Jun. 1, 2018 Replaced references t Functinal/Physical Impairment with Functinal r Physical Impairment Updated supprting infrmatin t reflect the mst current references Jun. 1, 2018 Updated cverage ratinale: Replaced language indicating: [The listed service] is prven and medically necessary with [the listed service] is prven and/r medically necessary [The listed service] is unprven and nt medically necessary with [the listed service] is unprven and/r nt medically necessary Replaced references t in uter fetal surgery with intrauterine fetal surgery Updated supprting infrmatin t reflect the mst current descriptin f services, clinical evidence, and 6 Oxfrd Plicy Update Bulletin: June 2018

7 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes UPDATED Intrauterine Fetal Surgery (cntinued) Macular Degeneratin Treatment Prcedures Jun. 1, 2018 references Replaced references t patient with individual Updated cverage ratinale; replaced language indicating: [The listed service] is prven and medically necessary with [the listed service] is prven and/r medically necessary [The listed services] are unprven and nt medically necessary with [the listed services] are unprven and/r nt medically necessary Updated list f applicable CPT cdes; added Updated supprting infrmatin t reflect the mst current descriptin f services, clinical evidence, FDA infrmatin, and references Mifeprex (Mifepristne) Mlecular Onclgy Testing fr Cancer Diagnsis, Prgnsis, and Treatment Decisins Occipital Neuralgia and Headache Treatment Prltherapy fr Musculskeletal Indicatins Repsitry Crtictrpin Injectin (H.P. Acthar Gel ) Jun. 1, 2018 Rutine review; n cntent changes Updated list f applicable CPT cdes: Added 0022U Remved and Crrected typgraphical errr in descriptin fr 0012M; replaced reference t XCR2 with CXCR2 Updated cverage ratinale; replaced language indicating: [The listed service] is prven and medically necessary with [the listed service] is prven and/r medically necessary [The listed services] are unprven and nt medically necessary with [the listed services] are unprven and/r nt medically necessary Updated list f applicable HCPCS cdes; remved E0720 and L8683 Updated supprting infrmatin t reflect the mst current clinical evidence and references Jun. 1, 2018 Updated nn-cverage ratinale; replaced language indicating [the listed service] is unprven and nt medically necessary with [the listed service] is unprven and/r nt medically necessary Updated supprting infrmatin t reflect the mst current clinical evidence and references Jun. 1, 2018 Updated supprting infrmatin t reflect the mst current clinical evidence, FDA infrmatin, and references; n change t cverage ratinale r lists f applicable cdes 7 Oxfrd Plicy Update Bulletin: June 2018

8 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes UPDATED Rutine Ft Care Updated and refrmatted list f applicable CPT/HCPCS cdes; mdified ntatins pertaining t Rutine Ft Care and Nail Trimming, Cutting, r Debriding t clarify the cdes listed in the plicy are: Cvered fr all diagnses that are listed n the Cvered Diagnsis Cdes tab f the Ft Care ICD-10 Diagnsis Cdes list (attachment file) Excluded fr all diagnses that are nt listed n the Cvered Diagnsis Cdes tab f the Ft Care ICD-10 Diagnsis Cdes list (attachment file) Updated and refrmatted list f applicable/cvered ICD-10 diagnsis cdes (attachment file): Cmbined cntent frm multiple tabs int a single list f Cvered Diagnsis Cdes Added O24.011, O24.012, O24.013, O24.019, O24.02, O24.03, O24.111, O24.112, O24.113, O24.119, O24.12, O24.13, O24.311, O24.312, O24.313, O24.319, O24.32, O24.33, O24.811, O24.812, O24.813, O24.819, O24.82, and O24.83 Remved B35.3, L60.1, L60.2, L60.3, L60.4, L60.5, L60.8, L62, L84, M21.6X1, M21.6X2, and M21.6X9 Transpupillary Thermtherapy Jun. 1, 2018 Updated cverage ratinale: Replaced language indicating: [The listed service] is prven and medically necessary with [the listed service] is prven and/r medically necessary [The listed service] is unprven and nt medically necessary with [the listed service] is unprven and/r nt medically necessary Replaced reference t patients with individuals Updated supprting infrmatin t reflect the mst current clinical evidence and references Plicy Title Effective Date Summary f Changes Cverage Ratinale Alpha 1 -Prteinase Inhibitrs Updated list f related plicies; added reference link t the plicy titled Specialty Medicatin Administratin - Site f Care Review Guidelines Revised cnditins f cverage/precertificatin requirements; added language t indicate: Additinal precertificatin requirements apply t requests fr hspital utpatient facility infusin f alpha 1 -prteinase inhibitrs (Aralast N, Glassia, Alpha 1 -prteinase inhibitrs (Aralast NP, Glassia, Prlastin -C and Zemaira ) are prven and medically necessary fr chrnic augmentatin and maintenance therapy f patients with emphysema due t cngenital deficiency f alpha 1 -prteinase inhibitr (A 1 -PI), als knwn as alpha 1 -antitrypsin (AAT) deficiency. The treatment f emphysema due t cngenital deficiency f alpha1- prteinase inhibitr (A 1 -PI) in patients wh meet all f the fllwing criteria: Fr initial therapy, all f the fllwing: Diagnsis f cngenital alpha 1 -antitrypsin deficiency cnfirmed by ne f the fllwing: Pi*ZZ, Pi*Z(null) r Pi*(null)(null) prtein phentypes (hmzygus); r 8 Oxfrd Plicy Update Bulletin: June 2018

9 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes Cverage Ratinale Alpha 1 -Prteinase Inhibitrs (cntinued) Prlastin-C and Zemaira); refer t the plicy titled Specialty Medicatin Administratin - Site f Care Review Guidelines Other rare AAT deficiency disease-causing alleles assciated with serum alpha 1 -antitrypsin (AAT) level < 11 µml/l [e.g., Pi(Maltn, Maltn)] and Circulating serum cncentratin f AAT level < 11 µml/l (which crrespnds t < 80 mg/dl if measured by radial immundiffusin r < 57 mg/dl if measured by nephelmetry); and Cntinued ptimal cnventinal treatment fr emphysema (e.g., brnchdilatrs, supplemental xygen if necessary); and Current nnsmker; and Diagnsis f emphysema cnfirmed with pulmnary functin testing; and Dsing is in accrdance with the United States Fd and Drug Administratin apprved labeling: dsage is 60 mg/kg bdy weight administered nce weekly; and Initial authrizatin will be fr n mre than 12 mnths. Fr cntinuatin therapy, all f the fllwing: Diagnsis f cngenital alpha 1 -antitrypsin deficiency cnfirmed by ne f the fllwing: Pi*ZZ, Pi*Z(null) r Pi*(null)(null) prtein phentypes (hmzygus); r Other rare AAT deficiency disease-causing alleles assciated with serum alpha 1 -antitrypsin (AAT) level < 11 µml/l [e.g., Pi(Maltn, Maltn)] and Submissin f medical recrds (e.g., chart ntes, labratry values) dcumenting a psitive clinical respnse frm pretreatment baseline t alpha1-prteinase inhibitr treatment; and Current nnsmker; and Diagnsis f emphysema cnfirmed with pulmnary functin testing; and Dsing is in accrdance with the United States Fd and Drug Administratin apprved labeling: dsage is 60 mg/kg bdy weight administered nce weekly; and Reauthrizatin will be fr n mre than 12 mnths. Alpha 1 -prteinase inhibitr is unprven and nt medically necessary fr: 9 Oxfrd Plicy Update Bulletin: June 2018

10 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes Cverage Ratinale Alpha 1 -Prteinase Inhibitrs (cntinued) Cnditins ther than emphysema assciated with alpha1-antitrypsin deficiency Cystic fibrsis Cltting Factrs and Cagulant Bld Prducts Revised cverage ratinale: Updated list f applicable prducts; added bispecific factr IXa- and factr X- directed antibdy [Hemlibra (emicizumab-kxwh)] Updated cverage criteria fr: Vn Willebrand Disease (VWD) Added language t indicate factr VIII (plasma-derived)/vn Willebrand Factr Cmplex (plasmaderived) [Wilate] is prven and medically necessary when bth f the fllwing criteria are met: - Diagnsis f vn Willebrand disease; and - One f the fllwing: Treatment f spntaneus r trauma induced bleeding episdes; r Peri-perative management f surgical bleeding Remved language indicating factr VIII (plasma-derived)/vn Willebrand Factr Refer t the plicy fr cmplete details n the cverage guidelines fr Cltting Factrs and Cagulant Bld Prducts. 10 Oxfrd Plicy Update Bulletin: June 2018

11 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes Cverage Ratinale Cltting Factrs and Cagulant Bld Prducts (cntinued) Cmplex (plasmaderived) [Wilate] is prven and medically necessary when ne f the fllwing criteria is met: - Bth f the fllwing: Diagnsis f severe vn Willebrand disease; and Treatment f spntaneus r trauma-induced bleeding episdes; r - Bth f the fllwing: Diagnsis f mild r mderate vn Willebrand disease; and Histry f failure, cntraindicatin r intlerance t treatment with Desmpressin Hemphilia A Added language t indicate emicizumabkxwh [Hemlibra] is prven and medically necessary when all f the fllwing criteria are met (please nte that emicizumab-kxwh [Hemlibra] is a self- 11 Oxfrd Plicy Update Bulletin: June 2018

12 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes Cverage Ratinale Cltting Factrs and Cagulant Bld Prducts (cntinued) injectable medicatin that shuld be btained under the member s pharmacy benefit unless the fllwing criteria is met): - Diagnsis f hemphilia A; and - Patient has develped high-titer factr VIII inhibitrs (> 5 Bethesda units [BU]); and - Prescribed fr the preventin f bleeding episdes (i.e., rutine prphylaxis); and - One f the fllwing: Patient is less than 7 years f age; r Patient is 7 years f age r lder and cannt selfinject and des nt have a caretaker wh can be trained t administer emicizumabkxwh Updated list f applicable HCPCS cdes; added J3590 Updated supprting infrmatin t reflect the mst current backgrund infrmatin, FDA infrmatin, and references 12 Oxfrd Plicy Update Bulletin: June 2018

13 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes Cverage Ratinale Densumab (Prlia & Xgeva ) Jun. 1, 2018 Ntice f Revisin: The fllwing summary f changes has been mdified. Revisins t the riginal plicy update annuncement are utlined in red belw. Please take nte f the additinal updates t be implemented n Jun. 1, Updated list f related plicies; added reference link t the plicy titled Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines Revised cnditins f cverage/precertificatin requirements t indicate: Precertificatin with review by a Medical Directr r their designee is required fr nn-nclgy indicatins All precertificatin requests fr nclgy indicatins are handled by evicre healthcare Revised cverage ratinale: Added instructin t refer t the plicy titled Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines fr updated infrmatin based upn the Natinal Cmprehensive Cancer Netwrk (NCCN) Drugs & Bilgics Cmpendium (NCCN Cmpendium ) fr nclgy indicatins Added language t indicate Please refer t the plicy titled Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines fr updated infrmatin based upn the Natinal Cmprehensive Cancer Netwrk (NCCN) Drugs & Bilgics Cmpendium (NCCN Cmpendium ) fr nclgy indicatins. This plicy refers t the fllwing densumab prducts: Prlia Xgeva Prven Prlia (densumab) is prven and medically necessary fr: The treatment f pstmenpausal patients with steprsis, r t increase bne mass in patients with steprsis at high risk fr fracture wh meet ALL f the fllwing criteria: Diagnsis f steprsis; and One f the fllwing: BMD T-scre -2.5 based n BMD measurements frm lumbar spine (at least tw vertebral bdies), hip (femral neck, ttal hip), r radius (ne-third radius site); r Histry f ne f the fllwing resulting frm minimal trauma: - Vertebral cmpressin fracture - Fracture f the hip - Fracture f the distal radius - Fracture f the pelvis - Fracture f the prximal humerus r Bth f the fllwing: - BMD T-scre between -1 and -2.5 (BMD T-scre greater than-2.5 and less than r equal t -1) based n BMD measurements frm lumber spine (at least tw vertebral bdies), hip (femral neck, ttal hip), r radius (ne-third radius site); and - One f the fllwing: and FRAX 10-year fracture prbabilities: majr steprtic fracture at 20% r mre FRAX 10-year fracture prbabilities: hip fracture at 3% r mre; and 13 Oxfrd Plicy Update Bulletin: June 2018

14 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes Cverage Ratinale Densumab (Prlia & Xgeva ) (cntinued) Jun. 1, 2018 precertificatin requests fr nclgy indicatins are handled by evicre healthcare; fr precertificatin infrmatin, refer t the plicy titled Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines Histry f failure, cntraindicatin, r intlerance t ral r intravenus bisphsphnate therapy; and Prlia dsing is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 60 mg every 6 mnths; and Authrizatin is fr n mre than 12 mnths. T increase bne mass in patients at high risk fr fracture receiving andrgen deprivatin therapy fr nn-metastatic prstate cancer in patients wh meet ALL f the fllwing criteria: Nte: All precertificatin requests fr nclgy indicatins are handled by evicre healthcare. Fr precertificatin infrmatin, refer t the plicy titled Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines. Diagnsis f nn-metastatic prstate cancer; and Patient is receiving andrgen deprivatin therapy; and Histry f failure, cntraindicatin, r intlerance t ral r intravenus bisphsphnate therapy; and Prlia dsing is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 60 mg every 6 mnths; and Authrizatin is fr n mre than 12 mnths. T treat patients at high risk fr fracture receiving adjuvant armatase inhibitr therapy fr breast cancer in patients wh meet ALL f the fllwing criteria: Nte: All precertificatin requests fr nclgy indicatins are handled by evicre healthcare. Fr precertificatin infrmatin, refer t the plicy titled Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines. Diagnsis f breast cancer; and Patient is receiving armatase inhibitr therapy; and Histry f failure, cntraindicatin, r intlerance t ral r intravenus bisphsphnate therapy; and Prlia dsing is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 60 mg every 6 mnths; and Authrizatin is fr n mre than 12 mnths. 14 Oxfrd Plicy Update Bulletin: June 2018

15 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes Cverage Ratinale Densumab (Prlia & Xgeva ) (cntinued) Jun. 1, 2018 Xgeva (densumab) is prven and medically necessary fr: The preventin f skeletal-related events in patients with multiple myelma and with bne metastases frm slid tumrs when ALL f the fllwing criteria are met: Nte: All precertificatin requests fr nclgy indicatins are handled by evicre healthcare. Fr precertificatin infrmatin, refer t the plicy titled Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines. Patient is ne f the fllwing: Patient is 18 years f age; r Patient is a skeletally mature adlescent as defined by having at least 1 mature lng bne (e.g., clsed epiphyseal grwth plate f the humerus) and One f the fllwing: Diagnsis f multiple myelma; r Presence f metastatic disease secndary t a slid tumr (e.g., bladder, kidney, lung, varian, thyrid, etc.) and Individual has an expected survival f 3 mnths r greater; and Refractry (within the past 30 days), cntraindicatin (including renal insufficiency), r intlerance t treatment with intravenus bisphsphnate therapy (e.g., pamidrnate, zledrnic acid) ; and Xgeva dsing is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 120 mg every 4 weeks; and Authrizatin is fr n mre than 12 mnths. The treatment f giant cell tumr f the bne when ALL f the fllwing criteria are met: Nte: All precertificatin requests fr nclgy indicatins are handled by evicre healthcare. Fr precertificatin infrmatin, refer t the plicy titled Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines. Patient is ne f the fllwing: Patient is 18 years f age; r Patient is a skeletally mature adlescent as defined by having at least 1 mature lng bne (e.g., clsed epiphyseal grwth plate f 15 Oxfrd Plicy Update Bulletin: June 2018

16 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes Cverage Ratinale Densumab (Prlia & Xgeva ) (cntinued) Jun. 1, 2018 the humerus) and Diagnsis f lcalized r metastatic giant cell tumr f the bne; and Disease is ne f the fllwing: Unresectable; r Surgical resectin is likely t result in severe mrbidity and Xgeva dsing is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 120 mg every 4 weeks (additinal 120 mg dses allwed n Day 8 and 15 in the first mnth f therapy); and Authrizatin is fr n mre than 12 mnths. The treatment f hypercalcemia f malignancy when ALL f the fllwing criteria are met: Nte: All precertificatin requests fr nclgy indicatins are handled by evicre healthcare. Fr precertificatin infrmatin, refer t the plicy titled Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines. Patient is ne f the fllwing: Patient is 18 years f age; r Patient is a skeletally mature adlescent as defined by having at least 1 mature lng bne (e.g., clsed epiphyseal grwth plate f the humerus) and Diagnsis f hypercalcemia f malignancy as defined as: albumincrrected serum calcium level greater than 12.5 mg/dl (3.1 mml/l); and N pre-existing hypcalcemia (i.e., serum calcium r crrected calcium within nrmal limits per labratry reference); and Refractry (within the past 30 days), cntraindicatin (including renal insufficiency), r intlerance t treatment with intravenus bisphsphnate therapy (e.g., pamidrnate, zledrnic acid); and Xgeva dsing is in accrdance with the United States Fd and Drug Administratin apprved labeling: maximum dsing f 120 mg every 4 weeks (additinal 120 mg dses allwed n Day 8 and 15 in the first mnth f therapy); and Authrizatin is fr n mre than 12 mnths. 16 Oxfrd Plicy Update Bulletin: June 2018

17 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes Cverage Ratinale Densumab (Prlia & Xgeva ) (cntinued) Jun. 1, 2018 Unprven Xgeva is unprven and nt medically necessary fr the fllwing indicatins: Cmbinatin therapy f densumab and intravenus bisphsphnates Bne lss assciated with hrmne-ablatin therapy (ther than armatase inhibitrs) in breast/prstate cancer Cancer pain Central giant cell granulma Hyper-parathyridism Immbilizatin hypercalcemia Ostegenesis imperfecta Ostepenia Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins Revised list f medicatins requiring precertificatin thrugh the pharmacy benefit manager (PBM): Added Balctra, Climara (brand nly), Effient (brand nly), Fsrenl Chewable Tablets (brand nly), Humira Prefilled Syringe, Nrvir Tablets, Orfadin, Osmlex ER, Relpax (brand nly), Reyataz Capsules (brand nly), Tamiflu Suspensin (brand nly), Tazartene 0.1% Cream (generic Tazrac), Utibrn Nehaler, and Viagra (brand nly) Remved Bevyxxa, MrphaBnd ER, Otrexup, Prevymis, and Taperdex Pak Updated frmulary alternatives fr Clarinex/Deslratidine, Clarinex-D, Exfrge, Exfrge HCT, Fabir, Genadur Kit, Gentrpin and Gentrpin Refer t the plicy fr cmplete details n Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins. 17 Oxfrd Plicy Update Bulletin: June 2018

18 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes Cverage Ratinale Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins (cntinued) Miniquick, Gcvri, Humatrpe, L Minastrin FE, Metzlv ODT, Nrditrpin, Nrditrpin Nrdiflex, Nrditrpin Flexpr, Omnitrpe, Ozempic, Retin-A Micr (brand and generic), Retin-A Micr Pump (brand and generic), Saizen, Stilt Respimat, Twynsta, and Zmactn Plicy Title Effective Date Drug/Medicatin Status Summary f Changes Drug Cverage Guidelines Drug Cverage Guidelines Jun. 1, 2018 Prlia, Xgeva (Densumab) Revised Revised cverage guidelines t indicate precertificatin is required thrugh: Oxfrd s Medical Management fr all requests fr nn-nclgy indicatins evicre healthcare fr all requests fr nclgy indicatins Added evicre guidelines; refer t evicre Guidelines: Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines fr cmplete details Revised utilizatin review guidelines; refer t Utilizatin Review Guideline: Opiid Overutilizatin Cumulative Drug Utilizatin Review Criteria fr cmplete details Aralast NP [Alpha 1 - Revised Revised cverage criteria/precertificatin guidelines; added language t Prteinase Inhibitr indicate: (Human)] Administratin in a hspital utpatient facility (including any ambulatry infusin suite assciated with the hspital) requires precertificatin with review by a Medical Directr r their designee; refer t Precertificatin Guidelines: Specialty Medicatin Administratin Site f Care Review Guidelines fr cmplete details Balctra (Ethinyl New Added language t indicate precertificatin is required thrugh the Estradil/Levnrgestrel/ Pharmacy Benefit Manager (PBM) Ferrus Bisglycinate) Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details 18 Oxfrd Plicy Update Bulletin: June 2018

19 Clinical Plicy Updates Plicy Title Effective Date Drug/Medicatin Status Summary f Changes Drug Cverage Guidelines (cntinued) Bevyxxa (Betrixaban) Revised Revised cverage criteria/precertificatin requirements t indicate precertificatin is n lnger required Remved therapeutic equivalent guidelines and crrespnding reference link t plicy titled Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins Buphenyl (Sdium Phenylbutyrate) New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added prir authrizatin/ntificatin guidelines; refer t Prir Authrizatin/Ntificatin Guidelines: Sdium Phenylbutyrate fr cmplete details Cerezyme (Imiglucerase) Revised Revised cverage criteria/precertificatin guidelines; added language t indicate: Administratin in a hspital utpatient facility (including any ambulatry infusin suite assciated with the hspital) requires precertificatin with review by a Medical Directr r their designee; refer t Precertificatin Guidelines: Specialty Medicatin Administratin Site f Care Review Guidelines fr cmplete details Chemtherapy Updated Updated list f applicable HCPCS cdes; added J0897 (Injectable) Drugs Climara (Brand Only) (Estradil) New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details Cdeine/Phenylephrine/ Prmethazine New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added prir authrizatin/medical necessity guidelines; refer t Prir Authrizatin/Medical Necessity Guidelines: Opiid Cntaining Cugh Medicines fr cmplete details Cdeine/Prmethazine New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added prir authrizatin/medical necessity guidelines; refer t Prir Authrizatin/Medical Necessity Guidelines: Opiid Cntaining Cugh Medicines fr cmplete details Crinne (Prgesterne Gel) Revised Revised cverage criteria/precertificatin requirements t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added step therapy guidelines; refer t Step Therapy Guidelines: Crinne fr cmplete details Updated ntatin pertaining t infertility use t indicate: 19 Oxfrd Plicy Update Bulletin: June 2018

20 Clinical Plicy Updates Plicy Title Effective Date Drug/Medicatin Status Summary f Changes Drug Cverage Guidelines (cntinued) Crinne (Prgesterne Gel) (cntinued) Effient (Prasugrel) (Brand Only) Elelys (Taliglucerase Alfa) Flwtuss (Hydrcdne/ Guaifenesin) Fsrenl Chewable Tablets (Lanthanum Carbnate) (Brand Only) Glassia [Alpha 1 - Prteinase Inhibitr (Human)] Hemlibra (Emicizumab- Kxwh) Revised Cverage is limited t Members with cverage fr fertility drugs thrugh their prescriptin drug plan; Members that d nt have fertility drug cverage thrugh their prescriptin drug plan shuld refer t their Certificate f Cverage fr cverage guidelines New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details Revised Revised cverage criteria/precertificatin guidelines; added language t indicate: Administratin in a hspital utpatient facility (including any ambulatry infusin suite assciated with the hspital) requires precertificatin with review by a Medical Directr r their designee; refer t Precertificatin Guidelines: Specialty Medicatin Administratin Site f Care Review Guidelines fr cmplete details Revised Added prir authrizatin/medical necessity guidelines; refer t Prir Authrizatin/Medical Necessity Guidelines: Opiid Cntaining Cugh Medicines fr cmplete details New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details Revised Revised cverage criteria/precertificatin guidelines; added language t indicate: Administratin in a hspital utpatient facility (including any ambulatry infusin suite assciated with the hspital) requires precertificatin with review by a Medical Directr r their designee; refer t Precertificatin Guidelines: Specialty Medicatin Administratin Site f Care Review Guidelines fr cmplete details Revised Revised cverage criteria/precertificatin requirements t indicate precertificatin is required thrugh Oxfrd s Medical Management Added precertificatin guidelines; refer t the fllwing plicies fr cmplete details: Precertificatin Guidelines: Assisted Administratin f Cltting Factrs and Cagulant Bld Prducts Precertificatin Guidelines: Cltting Factrs and Cagulant Bld Prducts 20 Oxfrd Plicy Update Bulletin: June 2018

21 Clinical Plicy Updates Plicy Title Effective Date Drug/Medicatin Status Summary f Changes Drug Cverage Guidelines (cntinued) Hemphilia Drugs Revised Revised list f applicable brand name drugs; added Hemlibra Humira (Adalimumab) 10 mg/0.1 ml, 20 New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) mg/0.2ml, 40 mg/0.4 ml, 80 mg/0.8 ml Strengths Only Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details Hycfenix (Hydrcdne/ Pseudephedrine/ Guaifenesin) Hydrcdne/ Hmatrpine Revised Added prir authrizatin/medical necessity guidelines; refer t Prir Authrizatin/Medical Necessity Guidelines: Opiid Cntaining Cugh Medicines fr cmplete details New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added prir authrizatin/medical necessity guidelines; refer t Prir Authrizatin/Medical Necessity Guidelines: Opiid Cntaining Cugh Medicines fr cmplete details Mrphabnd ER (Mrphine Sulfate) Revised Remved therapeutic equivalent guidelines and crrespnding reference link t plicy titled Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins Nrvir Tablets New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details Obredn Slutin (Hydrcdne/ Guaifenesin) Revised Added prir authrizatin/medical necessity guidelines; refer t Prir Authrizatin/Medical Necessity Guidelines: Opiid Cntaining Cugh Medicines fr cmplete details Updated step therapy guidelines; refer t Step Therapy Guidelines: Obredn fr cmplete details Orfadin (Nitisinne) Revised Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details Osmlex ER (Amantadine) Otrexup (Methtrexate Injectin) New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details Revised Remved therapeutic equivalent guidelines and crrespnding reference link t plicy titled Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins 21 Oxfrd Plicy Update Bulletin: June 2018

22 Clinical Plicy Updates Plicy Title Effective Date Drug/Medicatin Status Summary f Changes Drug Cverage Guidelines (cntinued) Prevymis (Letermvir) Revised Revised cverage criteria/precertificatin requirements t indicate precertificatin is n lnger required Remved therapeutic equivalent guidelines and crrespnding reference link t plicy titled Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins Prlastin-C [Alpha 1 - Prteinase Inhibitr Revised Revised cverage criteria/precertificatin guidelines; added language t indicate: [Human)] Administratin in a hspital utpatient facility (including any ambulatry infusin suite assciated with the hspital) requires precertificatin with review by a Medical Directr r their designee; refer t Precertificatin Guidelines: Specialty Medicatin Administratin Site f Care Review Guidelines fr cmplete details Relpax (Eletriptan) (Brand Only) Revised Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details Updated medicatin/drug name t include brand nly Reyataz (Atazanavir) (Brand Only) Sublcade (Buprenrphine Extended-Release) Tamiflu Suspensin (Oseltamivir Phsphate) (Brand Only) New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details Revised Revised cverage criteria/precertificatin requirements t indicate precertificatin is required thrugh Oxfrd s Medical Management New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details Taperdex Pak 6-Day & 12-Day Revised Revised cverage criteria/precertificatin requirements t indicate precertificatin is n lnger required (Dexamethasne) Remved therapeutic equivalent guidelines and crrespnding reference link t plicy titled Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins Tazrac (Tazartene) Updated Updated medicatin/drug name; crrected spelling fr tazartene Tazartene 0.1% Cream (Generic Tazrac) New Added language t indicate precertificatin is required fr Members ver 30 years f age thrugh the Pharmacy Benefit Manager (PBM) Added prir authrizatin/ntificatin guidelines; refer t Prir Authrizatin/Ntificatin Guidelines: Tazrac (Tazartene) fr cmplete 22 Oxfrd Plicy Update Bulletin: June 2018

23 Clinical Plicy Updates Plicy Title Effective Date Drug/Medicatin Status Summary f Changes Drug Cverage Guidelines (cntinued) Tazartene 0.1% Cream New details (Generic Tazrac) (cntinued) Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details Trgarz (Ibalizumab) Revised Revised cverage criteria/precertificatin guidelines; added language t indicate: Precertificatin is required thrugh Oxfrd s Medical Management Administratin in a hspital utpatient facility (including any ambulatry infusin suite assciated with the hspital) requires precertificatin with review by a Medical Directr r their designee; refer t Precertificatin Guidelines: Specialty Medicatin Administratin Site f Care Review Guidelines fr cmplete details Tussinex New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added prir authrizatin/medical necessity guidelines; refer t Prir Authrizatin/Medical Necessity Guidelines: Opiid Cntaining Cugh Medicines fr cmplete details Tuzistra XR (Cdeine/ Chlrpheniramine) Revised Added prir authrizatin/medical necessity guidelines; refer t Prir Authrizatin/Medical Necessity Guidelines: Opiid Cntaining Cugh Medicines fr cmplete details Utibrn Nehaler (Indacaterl/ Revised Revised cverage criteria/precertificatin requirements t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Glycpyrrlate) Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details Viagra (Sildenafil Citrate) (Brand Only) New Added language t indicate precertificatin is required fr Members ver 30 years f age thrugh the Pharmacy Benefit Manager (PBM) Added prir authrizatin/ntificatin guidelines; refer t Prir Authrizatin/Ntificatin Guidelines: Erectile Dysfunctin Agents fr cmplete details Added therapeutic equivalent guidelines; refer t Therapeutic Equivalent Guidelines: Drug Cverage Criteria - New and Therapeutic Equivalent Medicatins fr cmplete details VPRIV (Velaglucerase) Revised Revised cverage criteria/precertificatin guidelines; added language t indicate: Precertificatin thrugh Oxfrd s Medical Management is required fr services prvided in a hspital utpatient facility setting nly Administratin in a hspital utpatient facility (including any ambulatry infusin suite assciated with the hspital) requires 23 Oxfrd Plicy Update Bulletin: June 2018

24 Clinical Plicy Updates Plicy Title Effective Date Drug/Medicatin Status Summary f Changes Drug Cverage Guidelines (cntinued) VPRIV (Velaglucerase) (cntinued) Xenazine (Tetrabenazine) Zemaira [Alpha 1 - Prteinase Inhibitr (Human)] Revised precertificatin with review by a Medical Directr r their designee; refer t Precertificatin Guidelines: Specialty Medicatin Administratin Site f Care Review Guidelines fr cmplete details New Added language t indicate precertificatin is required thrugh the Pharmacy Benefit Manager (PBM) Added prir authrizatin/ntificatin guidelines; refer t Prir Authrizatin/Ntificatin Guidelines: Tetrabenazine fr cmplete details Revised Revised cverage criteria/precertificatin guidelines; added language t indicate: Administratin in a hspital utpatient facility (including any ambulatry infusin suite assciated with the hspital) requires precertificatin with review by a Medical Directr r their designee; refer t Precertificatin Guidelines: Specialty Medicatin Administratin Site f Care Review Guidelines fr cmplete details Zutrip New Added language t indicate precertificatin is required thrugh the Plicy Title Effective Date Summary f Changes Cverage Ratinale Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines Updated list f related plicies: Added reference link t the plicy titled Densumab (Prlia and Xgeva ) Remved reference link t the plicy titled Lemtrada (Alemtuzumab) Revised list f injectable chemtherapy drugs requiring precertificatin fr nclgy indicatins: Added densumab (J0897), belinstat (J9032), blinatummab (J9039), pembrlizumab (J9271), nivlumab (J9299), and ramucirumab (J9308) Pharmacy Benefit Manager (PBM) Added prir authrizatin/medical necessity guidelines; refer t Prir Authrizatin/Medical Necessity Guidelines: Opiid Cntaining Cugh Medicines fr cmplete details Oxfrd has engaged evicre healthcare t perfrm precertificatin* reviews fr injectable chemtherapy drugs administrated by participating prviders in an ffice, utpatient r hme setting t treat a cancer diagnsis. Oxfrd cntinues t be respnsible fr claims payment decisins and fr appeals. *Nte: Precertificatin is nt required fr injectable chemtherapy drugs administrated by a nn-participating prvider in an ffice r utpatient setting hwever precertificatin will be prvided upn request. All precertificatin requests fr injectable chemtherapy drugs are handled by evicre healthcare. T btain precertificatin fr injectable chemtherapy medicatins prviders must cntact evicre healthcare. Prviders are encuraged t btain precertificatin n line by lgging in t OxfrdHealth.cm and selecting the link t the evicre healthcare authrizatin web site. Prviders may als btain precertificatin by calling Oxfrd Plicy Update Bulletin: June 2018

25 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes Cverage Ratinale Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines (cntinued) Remved alemtuzumab (J0202) Added instructin t refer t the plicy titled Densumab (Prlia and Xgeva) fr nnnclgy indicatins fr J0897 evicre healthcare uses the Natinal Cmprehensive Cancer Netwrk s (NCCN) guidelines in their decisin making prcess. These guidelines prvide independent recmmendatins fr evidence-based cancer treatment. The guidelines are cntinually updated t be cnsistent with the current treatment ptins. Prviders and patients may access and view the NCCN guidelines at NCCN.rg. Descriptin This plicy prvides parameters fr cverage f injectable nclgy medicatins (J9000-J9999) and select ancillary and supprtive care medicatins used fr nclgy cnditins [including, but nt limited t ctretide acetate (J2353 and J2354), leuprlide acetate (J1950), leucvrin (J0640) and levleucvrin (J0641)] cvered under the medical benefit based upn the Natinal Cmprehensive Cancer Netwrk (NCCN) Drugs & Bilgics Cmpendium (NCCN Cmpendium ). In additin, J0640 and J0641 are included and Q cdes as listed belw, cvered under the medical benefit based upn the Natinal Cmprehensive Cancer Netwrk (NCCN) Drugs & Bilgics Cmpendium (NCCN Cmpendium ). The Cmpendium lists the apprpriate drugs and bilgics fr specific cancers using US Fd and Drug Administratin (FDA)-apprved disease indicatins and specific NCCN panel recmmendatins. Each recmmendatin is supprted by a level f evidence categry. This plicy des nt prvide cverage criteria fr Chimeric Antigen Receptr (CAR)-T Cell prducts. Cverage determinatins are based n the member s benefits and the OptumHealth Transplant Slutins criteria fr cvered transplants in the Clinical Guideline titled Transplant Review Guidelines: Hematpietic Stem Cell Transplantatin. Cverage Ratinale Injectable Onclgy, Ancillary, and Supprtive Care Medicatins Oxfrd recgnizes indicatins and uses f nclgy medicatins listed in the NCCN Drugs and Bilgics Cmpendium with Categries f Evidence and Cnsensus f 1, 2A, and 2B as prven and medically necessary and Categries f Evidence and Cnsensus f 3 as unprven and nt medically necessary. Oxfrd will cver all chemtherapy agents fr individuals under the age f 19 years fr nclgy indicatins. The majrity f pediatric patients receive treatments n natinal pediatric prtcls that are quite similar in cncept t the NCCN patient care guidelines. 25 Oxfrd Plicy Update Bulletin: June 2018

26 Clinical Plicy Updates Plicy Title Effective Date Summary f Changes Cverage Ratinale Injectable Chemtherapy Drugs: Applicatin f NCCN Clinical Practice Guidelines (cntinued) Select ancillary and supprtive care medicatins fr nclgy cnditins have therapeutically equivalent prducts available. When a therapeutically equivalent alternative is available, as determined by the United Healthcare Pharmacy and Therapeutics (P&T) Cmmittee, certain medicatins may be excluded and/r nt medically necessary. Fr purpses f the United Healthcare P&T Cmmittee review, therapeutic equivalence refers t medicatins that can be expected t prduce essentially the same therapeutic utcme and adverse events. Belw are ancillary and supprtive care medicatins fr nclgy cnditins with therapeutically equivalent alternatives as determined by the United Healthcare P&T Cmmittee: Preferred Leucvrin Nn-Preferred Levleucvrin Additinal Infrmatin The NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) are a cmprehensive set f 67 guidelines dcumenting sequential management decisins and interventins that apply t malignancies which apply t mre than 97% f cancers affecting U.S. patients. They als address supprtive care issues. The guidelines are develped and updated by 52 vlunteer panels, cmpsed f mre than 1,200 clinicians and nclgy researchers representing the 27 NCCN member institutins and their affiliates. NCCN Categries f Evidence and Cnsensus Categry 1: The recmmendatin is based n high-level evidence (i.e., high-pwered randmized clinical trials r meta-analyses), and the panel has reached unifrm cnsensus that the recmmendatin is indicated. In this cntext, unifrm means near unanimus psitive supprt with sme pssible neutral psitins. Categry 2A: The recmmendatin is based n lwer level evidence, but despite the absence f higher level studies, there is unifrm cnsensus that the recmmendatin is apprpriate. Lwer level evidence is interpreted bradly, and runs the gamut frm phase II t large chrt studies t case series t individual practitiner experience. Imprtantly, in many instances, the retrspective studies are derived frm clinical experience f treating large numbers f patients at a member institutin, 26 Oxfrd Plicy Update Bulletin: June 2018