MBP 40.0 Orencia IV (abatacept)- Updated policy

Transcription

1 What s New Medical Pharmaceutical Plicy Nvember 2018 Updates MBP 5.0 Remicade (infliximab), Inflectra (infliximab-dyyb), Renflexis (infliximab-abda)- Updated plicy Fr Treatment f Rheumatid Arthritis: Must be 18 years f age r greater Requesting prvider must be a rheumatlgist Diagnsis f mderate t severe rheumatid arthritis accrding the American Cllege f Rheumatlgy Criteria fr the Classificatin and Diagnsis f Rheumatid Arthritis Medical recrd dcumentatin that the infliximab prduct is nt being used cncurrently with a TNF blcker r ther bilgic agent Medical recrd dcumentatin f an intlerance t, cntraindicatin t, r therapeutic failure n a minimum 3 mnth trial f Humira* Enbrel* Cntinuatin f effective dse f methtrexate during infliximab therapy Fr new start Remicade r Renflexis requests, medical recrd dcumentatin f an intlerance t, cntraindicatin t, r therapeutic failure n a minimum 3 mnth trial f Inflectra* MBP 40.0 Orencia IV (abatacept)- Updated plicy Orencia IV (abatacept) will be cnsidered medically necessary when all f the fllwing criteria are met: 1. Rheumatid arthritis that is refractry t DMARD therapy, including TNF (Tumr necrsis factr) antagnists: Dcumentatin f a diagnsis f mderate t severe RA in accrdance with the American Cllege f Rheumatlgy Criteria fr the Classificatin and Diagnsis f Rheumatid Arthritis; Member must be at least 18 years ld; Must be prescribed by a rheumatlgist; Medical recrd dcumentatin that Orencia is nt being used cncurrently with a TNF blcker r ther bilgic agent Dcumentatin f inadequate respnse t minimum 3 mnth trial f Humira* ne preferred TNF alpha inhibitr Enbrel Humira) 2. Plyarticular Juvenile Idipathic Arthritis (PJIA) Insured individual is 6 years f age r lder ; Medical recrd dcumentatin f a diagnsis f mderate t severe plyarticular juvenile idipathic arthritis r juvenile rheumatid Must be prescribed by a rheumatlgist; Medical recrd dcumentatin that Orencia is nt being used cncurrently with a TNF blcker r ther bilgic agent Medical recrd dcumentatin f therapeutic failure n, intlerance t, r cntraindicatin t a minimum 4 mnth trial f Humira* ne preferred TNF alpha inhibitr (Enbrel Humira) 3. Psriatic Arthritis (PsA): Prescriptin written by a rheumatlgist Medical recrd dcumentatin f a diagnsis f mderate t severe active psriatic arthritis which must include the fllwing: Dcumentatin f either active psriatic lesins a dcumented histry f psriasis. Medical recrd dcumentatin f age 18 years f age 1

2 Medical recrd dcumentatin that Orencia is nt being used cncurrently with a TNF blcker r ther bilgic agent Medical recrd dcumentatin f an inadequate respnse t a minimum 3 mnth trial f ne preferred bilgic (Humira* Csentyx*) MBP 48.0 Rituxan (rituximab)- Updated plicy Rituxan (rituximab) will be cnsidered medically necessary when all f the fllwing criteria are met: 1. Fr Rheumatid Arthritis: All f the fllwing criteria must be met: Physician dcumentatin f a diagnsis f mderate t severe rheumatid arthritis in accrdance with the American Cllege f Rheumatlgy Criteria fr the Classificatin and Diagnsis f Rheumatid Arthritis; At least 18 years f age r lder; Prescriptin written by a rheumatlgist; Medical recrd dcumentatin that an effective dse f methtrexate will be cntinued during rituximab therapy; Medical recrd dcumentatin that Rituxan is nt being used cncurrently with a TNF blcker Physician dcumentatin f an inadequate respnse t 12 weeks f therapy with etanercept (Enbrel) adalimumab (Humira); LIMITATIONS: If criteria are met, apprval will be limited t ne curse f therapy defined as tw infusins, ne given n day 1 and anther n day 15. Additinal curses may be cnsidered medically necessary if the fllwing criteria are met: At least 6 mnths has elapsed since the previus treatment curse; Physician dcumentatin f imprvement r lack r prgressin in the signs and symptms f rheumatid arthritis; Physician dcumentatin shwing previus treatment curse did nt result in active infectin. 2. Fr Chrnic Immunthrmbcytpenia (ITP): All f the fllwing criteria must be met: Diagnsis f primary chrnic ITP Platelet cunt f < 30,000/mm 3 with active bleeding r < 20,000/mm 3 with increased risk f bleeding Medical recrd dcumentatin f therapeutic failure n, intlerance t, r cntraindicatin t crticsterids IVIg* splenectmy (*prir authrizatin required) Authrizatin Duratin*: If patient meets criteria fr cverage, authrizatin will be given fr ne mnth f treatment with rituximab. 3. Fr Chrnic Lymphid Leukemia: Nte: Prir authrizatin is nt required fr diagnsis cdes C91.10, C91.11 and C In the event a requestr wuld like a medical necessity review cmpleted the fllwing criteria wuld apply: Medical recrd dcumentatin f a diagnsis f Chrnic Lymphcytic Leukemia (CLL) Medical recrd dcumentatin f a diagnsis f chrnic lymphid leukemia used in cmbinatin with fludarabine and cyclphsphamide 2

3 4. Fr Micrscpic Plyarteritis Ndsa Medical recrd dcumentatin f a diagnsis f micrscpic plyarteritis ndsa used in cmbinatin with gluccrticids 5. Fr Wegner s Granulmatsis Medical recrd dcumentatin f a diagnsis f Wegner s granulmatsis used in cmbinatin with gluccrticids 6. Fr Nn-Hdgkin Lymphma Nte: Prir authrizatin is nt required fr diagnsis cdes C82.00 thrugh C85.99 and C86.0 thrugh C88.9. In the event a requestr wuld like a medical necessity review cmpleted the fllwing criteria wuld apply: Medical recrd dcumentatin f a diagnsis f Nn-Hdgkin Lymphma 7. Fr Multiple Sclersis (MS) Nte: Prir authrizatin is nt required fr diagnsis cde G35. In the event a requestr wuld like a medical necessity review cmpleted the fllwing criteria wuld apply: Medical recrd dcumentatin f a diagnsis f Multiple Sclersis Fr Primary Prgressive MS (PPMS): All f the fllwing criteria must be met: Medical recrd dcumentatin f prescriptin written by a neurlgist Medical recrd dcumentatin f a diagnsis f PPMS Fr Secndary Prgressive MS (SPMS)/Relapsing Prgressive MS (RPMS): All f the fllwing criteria must be met: Medical recrd dcumentatin f prescriptin written by a neurlgist Medical recrd dcumentatin f a diagnsis f SPMS r relapsing prgressive MS Medical recrd dcumentatin f rapidly prgressing disease (ex. EDSS scre increase f >1 in 1 year) Medical recrd dcumentatin f slwly prgressing disease (ex. EDSS scre change f < 1 in 1 year) and therapeutic failure n, cntraindicatin t, r intlerance t Aubagi ^ Fr Relapsing/Remitting MS (RRMS): All f the fllwing criteria must be met: Medical recrd dcumentatin f prescriptin written by a neurlgist Medical recrd dcumentatin f a diagnsis f Relapsing/Remitting MS (RRMS) Medical recrd dcumentatin f therapeutic failure n, cntraindicatin t, r intlerance t three alternatives ne f which must be Tysabri* Medical recrd dcumentatin f pr prgnsis and therapeutic failure n, cntraindicatin t, r intlerance t Tysabri* NOTE: Accrding t the American Academy f Neurlgy recmmendatin, Tysabri may be cnsidered as a first line therapy in individuals with relapsing remitting multiple sclersis wh exhibit particularly aggressive initial curse f disease and in whm the ptential benefit is felt t utweigh the risk. Patients with a pr prgnsis/aggressive disease include thse with a heavy T2 lesin lad, lesins in brain stem, cerebellum, and spinal crd. Patients wh are anti- JCV antibdy psitive shuld avid Tysabri use. (* requires prir authrizatin, ^QL apply) 3

4 (**NOTE t reviewer: Studied dse fr MS is 1gm given n day 1 and 15, repeated every 6 mnths**) 8. Fr Refractry Chrnic Debilitating Myasthenia Gravis Medical recrd dcumentatin f refractry Chrnic Debilitating Myasthenia Gravis Prescribed by r in cnsultatin with a neurmuscular specialist Medical recrd dcumentatin f therapeutic failure n, intlerance t, r cntraindicatin t at least ne crticsterid Medical recrd dcumentatin f therapeutic failure n, intlerance t, r cntraindicatin t at least ne chlinesterase inhibitr Medical recrd dcumentatin f therapeutic failure n, intlerance t, r cntraindicatin t at least ne nn-steridal immunsuppressive therapy Nte: Crticsterids: betamethasne, dexamethasne, methylprednislne, prednisne Chlinesterase inhibitrs: pyridstigmine, nestigmine Immunsuppressants: azathiprine, mycphenlate, cyclsprine, Rituxan 9. Fr Pemphigus Vulgaris (PV) Prescriptin written by a dermatlgist Member is 18 years f age r lder Medical recrd dcumentatin f a diagnsis f mderate t severe pemphigus vulgaris Medical recrd dcumentatin f a cntraindicatin t, intlerance t, r therapeutic failure n crticsterids a 12-week trial f at least ne (1) nnsteridal immunmdulatry medicatin (e.g. azathiprine, cyclphsphamide, r mycphenlate). MBP 59.0 White Bld Cell Stimulating Factrs - Updated plicy Leukine: May als be cnsidered medically necessary fr the fllwing: 10. Delayed Neutrphil Recvery r Graft Failure Medical recrd dcumentatin that the member has had an allgeneic r autlgus bne marrw transplant and neutrphil recvery* has nt ccurred. *Nte t reviewer: Neutrphil engraftment is defined as the first day f three cnsecutive days where the neutrphil cunt (ANC) is 500 cells/mm 3 r greater. MBP 74.0 Cimzia (certlizumab pegl)- Updated plicy 2. Rheumatid Arthritis Physician dcumentatin fr a diagnsis f mderate t severe rheumatid arthritis (made in accrdance with the American Cllege f Rheumatlgy Criteria fr the Classificatin f Diagnsis f Rheumatid Arthritis); Prescriptin written by a rheumatlgist Insured individual is 18 years f age r lder Medical recrd dcumentatin that Cimzia is nt being used cncurrently with a TNF blcker r ther bilgic agent Medical recrd dcumentatin f an intlerance t, cntraindicatin t, r therapeutic failure n a minimum 3 mnth trial f Humira* Enbrel* (*requires prir authrizatin) MBP 76.0 Actemra IV (tcilizumab)- Updated plicy Actemra IV (tcilizumab) will be cnsidered medically necessary when all f the fllwing criteria are met: 1. Adults with mderate t severe rheumatid arthritis: Medical recrd dcumentatin that member is 18 years f age r greater 4

5 Prescriptin written by a rheumatlgist Physician prvided dcumentatin f a diagnsis f mderate t severe rheumatid arthritis (made in accrdance with the American Cllege f Rheumatlgy Criteria fr the Classificatin f Diagnsis f Rheumatid Arthritis); Medical recrd dcumentatin that Actemra is nt being used cncurrently with a TNF blcker r ther bilgic agent Medical recrd dcumentatin f a therapeutic failure n, cntraindicatin t r intlerance t 12 weeks f Humira* Enbrel* *Requires prir authrizatin 2. Active systemic juvenile idipathic arthritis (SJIA). Prescriptin written by a rheumatlgist Patient is 2 years f age r lder Medical recrd dcumentatin f a diagnsis f systemic juvenile idipathic arthritis Medical recrd dcumentatin that Actemra is nt being used cncurrently with a TNF blcker r ther bilgic agent 3. Active plyarticular juvenile idipathic arthritis (PJIA) Medical recrd dcumentatin that member is 2 years f age r greater Prescriptin is written by a rheumatlgist; Medical recrd dcumentatin f a diagnsis active plyarticular juvenile idipathic arthritis r juvenile rheumatid arthritis Medical recrd dcumentatin that Actemra is nt being used cncurrently with a TNF blcker r ther bilgic agent Physician prvided dcumentatin f a therapeutic failure n, cntraindicatin t r intlerance t a minimum 4 mnth trial f Humira* Enbrel* *Requires prir authrizatin MBP 81.0 Prlia (densumab)- Updated plicy Prlia (densumab) will be cnsidered medically necessary when all f the fllwing criteria are met: 1. Fr pst-menpausal wmen at high risk fr fractures: Physician prvided dcumentatin f a diagnsis f pst-menpausal steprsis; and Physician prvided dcumentatin f previus steprtic fracture r high risk f fracture (defined as a spine r hip DXA T-scre f less than r equal t -2.5, supprting clinical factrs, and/r FRAX calculatin shwing a >3% prbability f hip fracture >20% prbability f majr steprsis-related fracture); and Physician prvided dcumentatin f a failed attempt f therapy with r cntraindicatin t ne ral bisphsphnate 2. Fr increasing bne mass in wmen at high risk fr fracture receiving adjuvant armatase inhibitr therapy fr breast cancer: Physician prvided dcumentatin f a failed attempt f therapy with r cntraindicatin t ne ral bisphsphnate 3. Fr increasing bne mass in men at high risk fr fracture receiving andrgen deprivatin therapy fr nn-metastatic prstate cancer: 5

6 Physician prvided dcumentatin f a failed attempt f therapy with r cntraindicatin t ne ral bisphsphnate 4. Fr the treatment f men at high risk fr fractures: Physician prvided dcumentatin f a diagnsis f steprsis; and Physician prvided dcumentatin f previus steprtic fracture r high risk f fracture (defined as spine r hip DXA T-scre f less than r equal t -2.0, supprting clinical factrs, and/r FRAX calculatin shwing a >3% prbability f hip fracture >20% prbability f majr steprsis-related fracture); and Physician prvided dcumentatin f a failed attempt f therapy with r cntraindicatin t ne ral bisphsphnate 5. Fr the treatment f gluccrticid-induced steprsis: Medical recrd dcumentatin f a diagnsis f gluccrticid-induced steprsis Medical recrd dcumentatin that the patient is initiating r cntinuing systemic gluccrticids in a daily dsage equivalent t 7.5 mg r greater f prednisne Medical recrd dcumentatin that the patient is ging t remain n systemic gluccrticid therapy fr at least 6 mnths Medical recrd dcumentatin f previus steprtic fracture r high risk f fracture defined as DXA T-scre f less than r equal t -2.0 at the lumbar spine, ttal hip, r femral neck, supprting clinical factrs and/r FRAX calculatin shwing a >3% prbability f hip fracture >20% prbability f majr steprsis-related fracture Medical recrd dcumentatin f a failure n, intlerance t, r cntraindicatin t ne ral bisphsphnate MBP 91.0 Yervy (Ipilimumab)- Updated plicy 3. Clrectal Cancer Prescriptin written by a hematlgist/nclgist Medical recrd dcumentatin that patient is 12 years f age Medical recrd dcumentatin f a diagnsis f metastatic clrectal cancer Medical recrd dcumentatin f micrsatellite instability-high (MSI-H) r mismatch repair deficient (dmmr) disease Medical recrd dcumentatin f prgressin fllwing treatment with a flurpyrimidine, xaliplatin, r irintecan-based therapy Medical recrd dcumentatin that Yervy is being given in cmbinatin with nivlumab (Opdiv). AUTHIZATION DURATION: Fr Unresectable r metastatic melanma, clrectal cancer and Advanced Renal Cell Carcinma: Apprval will be fr ne (1) 6-mnth authrizatin fr the FDA-apprved maximum f up t fur (4) dses f Yervy. Requests fr authrizatin exceeding these limits will require the fllwing: Medical recrd dcumentatin f cntinued disease imprvement r lack f disease prgressin Medical recrd dcumentatin f peer-reviewed literature citing well-designed clinical trials t indicate that the member s healthcare utcme will be imprved by dsing beynd the FDAapprved treatment duratin MBP Simpni Aria (glimumab)- Updated plicy Rheumatid Arthritis Requesting prvider must be a rheumatlgist Medical recrd dcumentatin f age 18 years 6

7 Medical recrd dcumentatin f a diagnsis f mderate t severe rheumatid arthritis accrding the American Cllege f Rheumatlgy Criteria fr the Classificatin and Diagnsis f Rheumatid Arthritis Medical recrd dcumentatin that Simpni Aria will be given in cmbinatin with methtrexate Medical recrd dcumentatin that Simpni Aria is nt being used cncurrently with a TNF blcker r ther bilgic agent Medical recrd dcumentatin f an inadequate respnse t, cntraindicatin t, r failure n 12 weeks f etanercept (Enbrel*) adalimumab (Humira*) therapy. MBP Keytruda (pembrlizumab)- Updated plicy 2. Metastatic Nn-Small Cell Lung Cancer Prescriptin written by a hematlgist/nclgist Medical recrd dcumentatin that patient is 18 years f age Medical recrd dcumentatin f a diagnsis f metastatic NSCLC meeting ne f the fllwing situatins: Medical recrd dcumentatin that Keytruda is being given as mntherapy Medical recrd dcumentatin that tumrs have high PD-L1 expressin (Tumr Prprtin Scre (TPS) 50% as determined by an FDA-apprved test Medical recrd dcumentatin that tumrs d nt have EGFR r ALK genmic tumr aberratins Medical recrd dcumentatin that Keytruda is being given as mntherapy Medical recrd dcumentatin that tumrs express PD-L1 (TPS) 1% as determined by an FDA-apprved test Medical recrd dcumentatin f disease prgressin n r after platinum-cntaining chemtherapy Fr patients with EGFR r ALK genmic tumr aberratins: medical recrd dcumentatin f disease prgressin n FDA-apprved therapy fr these aberratins prir t receiving Keytruda. Medical recrd dcumentatin f metastatic nnsquamus NSCLC Medical recrd dcumentatin that Keytruda will be given in cmbinatin with pemetrexed carbplatin either carbplatin r cisplatin Medical recrd dcumentatin that tumrs d nt have EGFR r ALK genmic tumr aberratins 6. Urthelial Carcinma Prescriptin written by a hematlgist/nclgist Medical recrd dcumentatin that patient is 18 years f age Medical recrd dcumentatin f lcally advanced r metastatic urthelial carcinma Medical recrd dcumentatin f ne f the fllwing: Disease prgressin during r fllwing platinum-cntaining chemtherapy Disease prgressin within 12 mnths f neadjuvant r adjuvant treatment with platinum-cntaining chemtherapy Patient is nt eligible cisplatin-cntaining chemtherapy* Tumrs express PD-L1 (cmbined psitive scre [CPS] greater than r equal t 10) as determined by an FDA-apprved test 7

8 Patient is nt eligible fr any platinum-cntaining chemtherapy (regardless f PD-L1 status) *Nte: In clinical trials, patients wh were nt cnsidered cisplatin-eligible had the fllwing characteristics: baseline creatinine clearance f <60 ml/min, ECOG perfrmance status f 2, ECOG 2 and baseline creatinine clearance f <60 ml/min, ther reasns (Class III heart failure, Grade 2 r greater peripheral neurpathy, and Grade 2 r greater hearing lss). 9. Primary Mediastinal Large B-cell Lymphma (PMBCL) Prescriptin written by a hematlgist/nclgist Medical recrd dcumentatin f refractry primary mediastinal large B-cell lymphma (PMBCL) Medical recrd dcumentatin f relapse fllwing tw (2) prir lines f therapy MBP Opdiv (nivlumab)- Updated plicy 7.Clrectal Cancer Prescriptin written by a hematlgist/nclgist Medical recrd dcumentatin that patient is 12 years f age Medical recrd dcumentatin f a diagnsis f metastatic clrectal cancer Medical recrd dcumentatin f micrsatellite instability-high (MSI-H) r mismatch repair deficient (dmmr) disease Medical recrd dcumentatin f prgressin fllwing treatment with a flurpyrimidine, xaliplatin, r irintecan Medical recrd dcumentatin that Opdiv is being used as a single agent r in cmbinatin with ipilimumab (Yervy). 9.Small Cell Lung Cancer (SCLC) Prescriptin written by a hematlgist/nclgist Medical recrd dcumentatin that patient is 18 years f age Medical recrd dcumentatin f a diagnsis f metastatic small cell lung cancer (SCLC) Medical recrd dcumentatin f disease prgressin after tw different lines f therapy, ne f which must be a platinum-based chemtherapy. MBP Tecentriq (atezlizumab)- Updated plicy 1. Lcally Advanced r Metastatic Urthelial Carcinma: Prescriptin written by an nclgist Medical recrd dcumentatin f a diagnsis f lcally advanced r metastatic urthelial carcinma Medical recrd dcumentatin f ne f the fllwing: Disease prgressin during r fllwing platinum-cntaining chemtherapy Patient is nt eligible fr cisplatin-cntaining therapy Tumrs express PD-L1 (greater than r equal t 5%) as determined by an FDAapprved test Patient is nt eligible fr any platinum-cntaining chemtherapy (regardless f PD-L1 status) 8

9 Medical recrd dcumentatin f a cntraindicatin t, intlerance t, r therapeutic failure n platinum-cntaining chemtherapy MBP Crysvita (bursumab-twza)- New plicy Crysvita (bursumab-twza) is an anti-fgf23 mnclnal antibdy that binds t and inhibits the activity f fibrblast grwth factr 23 (FGF23), thereby restring renal phsphate reabsrptin and increasing the serum cncentratin f 1,25 dihydrxy vitamin D. CRITERIA F USE: Requires Prir Authrizatin by Medical Directr r Designee Crysvita (bursumab-twza) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Medical recrd dcumentatin that the patient is at least 1 year f age r lder Medical recrd dcumentatin that Crysvita is being prescribed by, r in cnsultatin with, an endcrinlgist, geneticist, r nephrlgist Medical recrd dcumentatin f a diagnsis f X-linked hypphsphatemia as evidenced by ne f the fllwing: Reduced TmP/GFR rati Reduced r nrmal plasma cncentratin f 1,25- dihydrxychlecalciferl (1,25-DHCC) r 25-hydrxyvitamin D [25(OH)D] Genetic testing cnfirming a mutatin in the PHEX (Phsphate regulating Endpeptidase n the X chrmsme) gene Medical recrd dcumentatin that the patient is nt cncurrently using vitamin D analgs r phsphate supplements. AUTHIZATION DURATION: Initial apprval will be fr 6 mnths r less if the reviewing prvider feels it is medically apprpriate. Subsequent apprvals will be fr an additinal 12 mnths r less if the reviewing prvider feels it is medically apprpriate and the fllwing criteria are met: Medical recrd dcumentatin that patient is being fllwed regularly by and receiving medicatin frm an endcrinlgist r nephrlgist Medical recrd dcumentatin that Crysvita is imprving patient s disease as evidenced by nrmalized r imprved serum phsphrus levels Medical recrd dcumentatin that the patient is nt cncurrently using Vitamin D analgs r phsphate supplements. MBP Andexxa (andexanet alfa)- New plicy Andexxa (andexanet alfa) is an antidte that binds and sequesters the FXa inhibitrs Xarelt (rivarxaban) and Eliquis (apixaban). In additin, andexanet alfa inhibits the activity f Tissue Factr Pathway Inhibitr (TFPI), increasing tissue factr-initiated thrmbin generatin. CRITERIA F USE: Requires Prir Authrizatin by Medical Directr r Designee Andexxa (andexanet alfa) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Medical recrd dcumentatin that Andexxa is being used fr the reversal f anticagulatin due t life-threatening r uncntrlled bleeding in patients treated with rivarxaban and apixaban. AUTHIZATION DURATION: Authrizatin will be limited t ne curse f treatment 9

10 The fllwing plicies were reviewed with n changes: MBP 11.0 Btulinum Txin MBP 42.0 Bniva IV (ibandrnate) MBP 43.0 Alpha 1-Antitrypsin Inhibitr Therapy MBP 44.0 Elaprase (idursulfase) MBP 46.0 Dacgen (decitabine) MBP 49.0 Erythrpeitin and Darbepetin Therapy MBP 58.0 Prialt (zicntide intrathecal infusin) MBP 73.0 Arzerra (fatumumab) MBP Lartruv (laratumab) MBP Exndys 51 (eteplirsen) MBP Sustl (granisetrn ER) MBP Kymriah (tisagenlecleucel) MBP Bespnsa (intuzumab zgamicin) MBP Aliqpa (cpanlisib) 10