Select Oral Oncology Drugs

Transcription

1 Select Oral Onclgy Drugs Plicy # Applies t all prducts administered r underwritten by Blue Crss and Blue Shield f Luisiana and its subsidiary, HMO Luisiana, Inc.(cllectively referred t as the Cmpany ), unless therwise prvided in the applicable cntract. Medical technlgy is cnstantly evlving, and we reserve the right t review and update Medical Plicy peridically. When Services May Be Eligible fr Cverage Cverage fr eligible medical treatments r prcedures, drugs, devices r bilgical prducts may be prvided nly if: Benefits are available in the member s cntract/certificate, and Medical necessity criteria and guidelines are met. Based n review f available data, the Cmpany may cnsider cabzantinib (Cabmetyx ), brand and generic imatinib (Gleevec ), palbciclib (Ibrance ), lenalidmide (Revlimid ), dasatinib (Sprycel ), sunitinib (Sutent ), and enzalutamide (Xtandi ) fr the treatment f cancer t be eligible fr cverage. Patient Selectin Criteria Cverage eligibility fr cabzantinib (Cabmetyx), brand and generic imatinib (Gleevec), palbciclib (Ibrance), lenalidmide (Revlimid), dasatinib (Sprycel), sunitinib (Sutent), and enzalutamide (Xtandi) will be cnsidered when the fllwing criteria are met fr the requested drug: Fr Cabmetyx requests Patient has a diagnsis f advanced renal cell carcinma (RCC); OR Patient has a diagnsis f nn-small cell lung cancer (NSCLC) with rearranged during transfectin (RET) gene rearrangements Fr Gleevec and generic imatinib requests Patient has a diagnsis f acute lymphblastic leukemia (ALL) that is Philadelphia chrmsme psitive (Ph+); OR Patient has a diagnsis f chrnic myelid leukemia (CML) that is Philadelphia chrmsme psitive (Ph+); OR Patient has a diagnsis f dermatfibrsarcma prtuberans (DFSP); OR Patient has a diagnsis f gastrintestinal strmal tumr (GIST); OR Patient has a diagnsis f hyperesinphilic syndrme (HES) and/r chrnic esinphilic leukemia (CEL); OR Patient has a diagnsis f aggressive systemic mastcytsis (ASM); OR Patient has a diagnsis f myeldysplastic/myelprliferative disease (MDS/MPD) [e.g. plycythemia vera, myelfibrsis]; AND The cnditin is assciated with platelet-derived grwth factr receptr (PDGFR) gene rearrangements; OR Patient has a diagnsis f chrdma; OR Patient has a diagnsis f unresectable r advanced fibrmatsis (Desmid tumrs); OR Patient has a diagnsis f chrnic graft versus hst disease (GVHD) AND Patient has tried at least ne cnventinal systemic treatment fr GVHD (e.g. crticsterids, cyclsprine, tacrlimus, mycphenlate); OR Patient has a diagnsis f metastatic melanma; AND Blue Crss and Blue Shield f Luisiana is an independent licensee f the Blue Crss and Blue Shield Assciatin and incrprated as Luisiana Health Service & Indemnity Cmpany. N part f this publicatin may be reprduced, stred in a retrieval system, r transmitted, in any frm r by any means, electrnic, mechanical, phtcpying, r therwise, withut permissin frm Blue Crss and Blue Shield f Luisiana. Page 1 f 8

2 Select Oral Onclgy Drugs Plicy # Patient has c-kit-psitive advanced/recurrent r metastatic melanma; OR Patient has a diagnsis f pigmented villndular synvitis/tensynvial giant cell tumr (PVNS/TGCT) If the request is fr brand Gleevec: the patient has tried and failed (e.g. intlerance r inadequate respnse) GENERIC imatinib unless there is clinical evidence r patient histry that suggests the use f GENERIC imatinib will be ineffective r cause an adverse reactin t the patient (e.g. difference in dyes, fillers, r preservatives). (Nte: this specific patient selectin criterin is an additinal Cmpany requirement fr cverage eligibility and will be denied as nt medically necessary** if nt met). Fr Ibrance requests Patient is a pstmenpausal female with a diagnsis f breast cancer and meets all f the fllwing criteria Patient has advanced r metastatic hrmne receptr psitive (HR+) [i.e., estrgen receptr psitive (ER+) and/r prgesterne receptr psitive (PR+)] disease; AND Patient has human epidermal grwth factr receptr 2 (HER2)-negative breast cancer; AND Patient meets ONE f the fllwing criteria Ibrance will be used as first-line (initial) endcrine based therapy in cmbinatin with anastrzle, exemestane, r letrzle; OR Patient meets bth f the fllwing cnditins: Patient has relapsed r prgressed during prir endcrine therapy with at least ne f the fllwing: anastrzle, exemestane, letrzle, tamxifen, tremifene (Farestn ), exemestane plus everlimus (Afinitr ), fulvestrant (Fasldex ), Afinitr plus Fasldex r tamxifen, megestrl, fluxymesterne, ethinyl estradil; AND Ibrance will be used in cmbinatin with Fasldex; AND Patient has nt had disease prgressin while n Ibrance, ribciclib (Kisqali ), r abemaciclib (Verzeni ) ; OR Patient is a pre/perimenpausal female with a diagnsis f breast cancer and meets all f the fllwing criteria: Patient has advanced r metastatic hrmne receptr psitive (HR+) [i.e., estrgen receptr psitive (ER+) and/r prgesterne receptr psitive (PR+)] disease; AND Patient has human epidermal grwth factr receptr 2 (HER2)-negative breast cancer; AND Patient is receiving varian suppressin/ablatin with a gnadtrpin-releasing hrmne (GnRH) agnist (e.g., leuprlide [Leuprn ], triptrelin [Trelstar ], gserelin [Zladex ] ), r has had surgical bilateral phrectmy r varian irradiatin; AND Patient meets ONE f the fllwing cnditins: Blue Crss and Blue Shield f Luisiana is an independent licensee f the Blue Crss and Blue Shield Assciatin and incrprated as Luisiana Health Service & Indemnity Cmpany. N part f this publicatin may be reprduced, stred in a retrieval system, r transmitted, in any frm r by any means, electrnic, mechanical, phtcpying, r therwise, withut permissin frm Blue Crss and Blue Shield f Luisiana. Page 2 f 8

3 Select Oral Onclgy Drugs Plicy # Ibrance will be used as first-line (initial) endcrine based therapy in cmbinatin with anastrzle, exemestane, r letrzle; OR Patient meets BOTH f the fllwing criteria: Patient has relapsed r prgressed during prir endcrine therapy with at least ne f the fllwing: anastrzle, exemestane, letrzle, tamxifen, Farestn, exemestane plus Afinitr, Fasldex, Afinitr plus Fasldex r tamxifen, megestrl acetate, fluxymesterne, ethinyl estradil; AND Ibrance will be used in cmbinatin with Fasldex; AND Patient has nt had disease prgressin while n Ibrance, Kisqali, r Verzeni; OR Patient is a male with a diagnsis f breast cancer and meets all f the fllwing criteria Patient has advanced r metastatic hrmne receptr psitive (HR+) (i.e. estrgen receptr psitive [ER+] and/r prgesterne receptr psitive [PR+]) disease; AND Patient has human epidermal grwth factr receptr 2 (HER2)-negative breast cancer; AND Patient meets ONE f the fllwing criteria: Patient meets BOTH f the fllwing criteria: Patient is receiving a GnRH agnist (e.g. Luprn, Trelstar, Zladex); AND Ibrance will be used as first-line (initial) endcrine based therapy in cmbinatin with anastrzle, exemestane, r letrzle; OR Patient meets BOTH f the fllwing criteria: Patient has relapsed r prgressed during prir endcrine therapy with at least ne f the fllwing: anastrzle, exemestane, letrzle, tamxifen, Farestn, exemestane plus Afinitr, Fasldex, Afinitr plus Fasldex r tamxifen, megestrl acetate, fluxymesterne, ethinyl estradil; AND Ibrance will be used in cmbinatin with Fasldex; AND Patient has nt had disease prgressin while n Ibrance, Kisqali, r Verzeni; OR Patient has a diagnsis f well-differentiated/dedifferentiated lipsarcma. Fr Revlimid requests Patient has a diagnsis f mantle cell lymphma (MCL) and ONE f the fllwing: Patient has tried TWO prir therapies r therapeutic regimens (e.g., HyperCVAD [cyclphsphamide, vincristine, dxrubicin, and dexamethasne alternating with high-dse methtrexate and cytarabine]+rituximab; the NORDIC regimen [dseintensified inductin immunchemtherapy with rituximab + cyclphsphamide, vincristine, dxrubicin, prednisne alternating with rituximab and high-dse cytarabine]; RDHAP [rituximab, dexamethasne, cytarabine, cisplatin]; RCHOP [rituximab, cyclphsphamide, dxrubicin, vincristine, prednisne]; bendamustine [Treanda ] plus rituximab; brtezmib (Velcade ) ± rituximab; Velcade; ibrutinib [Imbruvica ] ; r acalabrutinib [Calquence ] ); OR Blue Crss and Blue Shield f Luisiana is an independent licensee f the Blue Crss and Blue Shield Assciatin and incrprated as Luisiana Health Service & Indemnity Cmpany. N part f this publicatin may be reprduced, stred in a retrieval system, r transmitted, in any frm r by any means, electrnic, mechanical, phtcpying, r therwise, withut permissin frm Blue Crss and Blue Shield f Luisiana. Page 3 f 8

4 Select Oral Onclgy Drugs Plicy # Patient has tried ne prir therapy r therapeutic regimen (examples listed abve) and cannt take Velcade accrding t the prescribing physician; OR Patient has a diagnsis f multiple myelma (MM); OR Patient has a diagnsis f myeldysplastic syndrme (MDS) and meets ONE f the fllwing Patient has symptmatic anemia; OR Patient has transfusin-dependent anemia; OR Patient has anemia that is nt cntrlled with an erythrid stimulating agent (e.g. epetin [Epgen /Prcrit ] r darbepetin [Aranesp ] ); OR Patient has a diagnsis f refractry r prgressive Castleman s Disease; OR Patient has a diagnsis f diffuse large B cell lymphma (DLBCL); AND Patient has tried at least ne ther medicatin treatment regimen (e.g., RCHOP, dse-adjusted EPOCH [etpside, prednisne, vincristine, cyclphsphamide, dxrubicin] + rituximab, RCEPP [rituximab, cyclphsphamide, etpside, prednisne, prcarbazine], DHAP [dexamethasne, cisplatin, cytarabine] ± rituximab, and Treanda ± rituximab); OR Patient has a diagnsis f fllicular lymphma; OR Patient has a diagnsis f relapsed r refractry classical Hdgkin lymphma (i.e. ndular sclersis, mixed cellularity, lymphcyte depleted, and lymphcyte-rich subtypes f Hdgkin lymphma); OR Patient has a diagnsis f myelfibrsis; AND Patient has tried at least ne ther therapy (e.g., ruxlitinib [Jakafi ], andrgens [e.g. nandrlne, xymethlne], Epgen, Prcrit, Aranesp, prednisne, danazl, thalidmide, melphalan, Myleran [busulfan], alpha interferns, and hydrxyurea); OR Patient has a diagnsis f systemic light chain amylidsis. Fr Sprycel requests Patient has a diagnsis f acute lymphblastic leukemia (ALL) that is Philadelphia chrmsme psitive (Ph+); OR Patient has a diagnsis f chrnic myelid leukemia (CML) that is Philadelphia chrmsme psitive (Ph+); OR Patient has a diagnsis f gastrintestinal strmal tumr (GIST) and all f the fllwing: Patient has tried imatinib (Gleevec); AND Patient has tried sunitinib (Sutent); AND Patient has tried regrafenib (Stivarga ) Fr Sutent requests Patient has a diagnsis f gastrintestinal strmal tumr (GIST) AND ne f the fllwing Sutent will be used as a single agent AND the patient has tried imatinib (Gleevec); OR Sutent will be used in cmbinatin with everlimus (Afinitr ) ; AND the patient meets all f the fllwing criteria: Patient has tried imatinib (Gleevec); AND Blue Crss and Blue Shield f Luisiana is an independent licensee f the Blue Crss and Blue Shield Assciatin and incrprated as Luisiana Health Service & Indemnity Cmpany. N part f this publicatin may be reprduced, stred in a retrieval system, r transmitted, in any frm r by any means, electrnic, mechanical, phtcpying, r therwise, withut permissin frm Blue Crss and Blue Shield f Luisiana. Page 4 f 8

5 Select Oral Onclgy Drugs Plicy # Patient has tried Sutent mntherapy; AND Patient has tried Stivarga; OR Patient has a diagnsis f renal cell carcinma (RCC) AND ne f the fllwing: Patient is at high risk f recurrent RCC fllwing nephrectmy and Sutent is used fr adjuvant therapy; OR The patient has advanced RCC; OR Patient has a diagnsis f advanced, unresectable neurendcrine tumr; OR Patient has a diagnsis f alvelar sft part sarcma (ASPS); OR Patient has a diagnsis f angisarcma; OR Patient has a diagnsis f recurrent chrdma; OR Patient has a diagnsis f differentiated (i.e. papillary, fllicular, and Hürthle cell) thyrid carcinma that is refractry t radiactive idine therapy; OR Patient has a diagnsis f medullary thyrid carcinma that is refractry t vandetanib (Caprelsa ), r cabzantinib (Cmetriq ) treatment; OR Patient has a diagnsis f recurrent r prgressive meningima; OR Patient has a diagnsis f slitary fibrus tumr/hemangipericytma; OR Patient has a diagnsis f thymic carcinma that is refractry t chemtherapy (e.g., carbplatin/paclitaxel) r radiatin therapy Fr Xtandi requests Patient has a diagnsis f castratin-resistant prstate cancer (CRPC) When Services Are Cnsidered Nt Medically Necessary The use f brand Gleevec when the patient has nt tried and failed (e.g. intlerance r inadequate respnse) generic imatinib is cnsidered t be nt medically necessary.** When Services Are Cnsidered Investigatinal Cverage is nt available fr investigatinal medical treatments r prcedures, drugs, devices r bilgical prducts. Based n review f available data, the Cmpany cnsiders the use f cabzantinib (Cabmetyx), brand and generic imatinib (Gleevec), palbciclib (Ibrance), lenalidmide (Revlimid), dasatinib (Sprycel), sunitinib (Sutent), and enzalutamide (Xtandi) when patient selectin criteria are nt met fr the requested drug (except thse designated nt medically necessary**) t be investigatinal.* Backgrund/Overview Many cancers can be treated with ral therapies in additin t r instead f traditinal intravenus chemtherapy infusins. These ral treatments are typically administered daily until disease prgressin r unacceptable txicity and can be assciated with increased life expectancy and quality f life in patients with cancer. Dsing infrmatin as well as descriptins f pssible adverse drug reactins can be fund in the FDA-apprved package insert fr the respective drug. Many f these drugs are cmmnly used fr nclgy indicatins beynd thse apprved by the FDA. The Natinal Cmprehensive Cancer Netwrk Blue Crss and Blue Shield f Luisiana is an independent licensee f the Blue Crss and Blue Shield Assciatin and incrprated as Luisiana Health Service & Indemnity Cmpany. N part f this publicatin may be reprduced, stred in a retrieval system, r transmitted, in any frm r by any means, electrnic, mechanical, phtcpying, r therwise, withut permissin frm Blue Crss and Blue Shield f Luisiana. Page 5 f 8

6 Select Oral Onclgy Drugs Plicy # (NCCN) prvides evidence-based guidelines regarding the apprpriate treatment ptins fr each type f cancer. FDA r Other Gvernmental Regulatry Apprval U.S. Fd and Drug Administratin (FDA) Cabmetyx is FDA-apprved fr the treatment f patients with advanced renal cell carcinma. Gleevec is FDA-apprved fr the treatment f newly diagnsed Philadelphia chrmsme psitive (Ph+) chrnic myelid leukemia (CML); Ph+ CML in blast crisis, accelerated phase, r chrnic phase after interfern-alpha therapy; adult patients with relapsed r refractry Ph+ acute lymphblastic leukemia (ALL); pediatric patients with newly diagnsed Ph+ ALL; adult patients with myeldysplastic/myelprliferative diseases assciated with PDGFR gene re-arrangements; adult patients with aggressive systemic mastcytsis withut the D816V c-kit mutatin r with c-kit mutatinal status unknwn; adult patients with hyperesinphilic syndrme (HES) and/r chrnic esinphilic leukemia (CEL); adult patients with unresectable, recurrent, and/r metastatic dermatfibrsarcma prtuberans, patients with Kit psitive unresectable and/r metastatic gastrintestinal strmal tumr (GIST); and adjuvant treatment f adult patients fllwing cmplete grss resectin f Kit psitive GIST. Ibrance is FDA apprved fr the treatment f HR+, HER2 negative advanced r metastatic breast cancer in cmbinatin with an armatase inhibitr as initial endcrine based therapy in pstmenpausal wmen r in cmbinatin with fulvestrant in wmen with disease prgressin fllwing endcrine therapy. Revlimid is FDA apprved fr treatment f multiple myelma in cmbinatin with dexamethasne; as maintenance therapy in patients with multiple myelma fllwing autlgus hematpietic stem cell transplantatin; fr treatment f patients with transfusin-dependent anemia due t lw r intermediate-1- risk myeldysplastic syndrmes assciated with a deletin 5q cytgenetic abnrmality with r withut additinal cytgenetic abnrmalities; and fr the treatment f patients with mantle cell lymphma whse disease has relapsed r prgressed after tw prir therapies, ne f which included brtezmib. Sprycel is FDA apprved fr the treatment f adult patients with newly diagnsed Philadelphia chrmsme-psitive (Ph+) chrnic myelid leukemia (CML) in chrnic phase; fr the treatment f chrnic, accelerated, r myelid r lymphid blast phase Ph+ CML with resistance r intlerance t prir therapy including imatinib; fr treatment f Ph+ acute lymphblastic leukemia (ALL) with resistance r intlerance t prir therapy; and fr the treatment f pediatric patients with Ph+ CML in chrnic phase. Sutent is FDA apprved fr the treatment f gastrintestinal strmal tumrs (GIST) after disease prgressin n r intlerance t imatinib; fr the treatment f advanced renal cell carcinma; fr the adjuvant treatment f adult patients at high risk f recurrent renal cell carcinma fllwing nephrectmy; and fr the treatment f prgressive, well-differentiated pancreatic neurendcrine tumrs in patients with unresectable lcally advanced r metastatic disease. Xtandi is FDA apprved fr the treatment f patients with castratin-resistant prstate cancer. Blue Crss and Blue Shield f Luisiana is an independent licensee f the Blue Crss and Blue Shield Assciatin and incrprated as Luisiana Health Service & Indemnity Cmpany. N part f this publicatin may be reprduced, stred in a retrieval system, r transmitted, in any frm r by any means, electrnic, mechanical, phtcpying, r therwise, withut permissin frm Blue Crss and Blue Shield f Luisiana. Page 6 f 8

7 Select Oral Onclgy Drugs Plicy # Ratinale/Surce This medical plicy was develped thrugh cnsideratin f peer-reviewed medical literature generally recgnized by the relevant medical cmmunity, U.S. Fd and Drug Administratin apprval status, natinally accepted standards f medical practice and accepted standards f medical practice in this cmmunity, Blue Crss and Blue Shield Assciatin technlgy assessment prgram (TEC) and ther nnaffiliated technlgy evaluatin centers, reference t federal regulatins, ther plan medical plicies, and accredited natinal guidelines. The criteria in this plicy are based n FDA apprved indicatins fr each included drug as well as evidence based recmmendatins frm the NCCN and are designed t ensure the mst apprpriate therapy fr each patient. References 1. Cabmetyx [package insert]. Exelixis, Inc. Suth San Francisc, CA. December Gleevec [package insert]. Nvartis. East Hanver, NJ. July Ibrance [package insert]. Pfizer. New Yrk, NY. February Revlimid [package insert]. Celgene. Summit, NJ. December Sprycel [package insert]. Bristl Myers Squibb. Princetn, NJ. January Sutent [package insert]. Pfizer. New Yrk, NY. Nvember Xtandi [package insert]. Astellas Pharma US, Inc. Nrthbrk, IL. July Onclgy Cabmetyx Prir Authrizatin Plicy. Express Scripts. January Onclgy Gleevec Prir Authrizatin Plicy. Express Scripts. March Onclgy Ibrance Prir Authrizatin Plicy. Express Scripts. September Onclgy Revlimid Prir Authrizatin Plicy. Express Scripts. March Onclgy Sprycel Prir Authrizatin Plicy. Express Scripts. March Onclgy Sutent Prir Authrizatin Plicy. Express Scripts. April Onclgy Xtandi Prir Authrizatin Plicy. Express Scripts. July Plicy Histry 10/04/2018 Medical Plicy Cmmittee review 10/17/2018 Medical Plicy Implementatin Cmmittee apprval. New plicy. Next Scheduled Review Date: 10/2019 *Investigatinal A medical treatment, prcedure, drug, device, r bilgical prduct is Investigatinal if the effectiveness has nt been clearly tested and it has nt been incrprated int standard medical practice. Any determinatin we make that a medical treatment, prcedure, drug, device, r bilgical prduct is Investigatinal will be based n a cnsideratin f the fllwing: A. Whether the medical treatment, prcedure, drug, device, r bilgical prduct can be lawfully marketed withut apprval f the U.S. Fd and Drug Administratin (FDA) and whether such apprval has been granted at the time the medical treatment, prcedure, drug, device, r bilgical prduct is sught t be furnished; r B. Whether the medical treatment, prcedure, drug, device, r bilgical prduct requires further studies r clinical trials t determine its maximum tlerated dse, txicity, safety, effectiveness, r effectiveness as cmpared with the standard means f treatment r diagnsis, must imprve health utcmes, accrding t the cnsensus f pinin amng experts as shwn by reliable evidence, including: 1. Cnsultatin with the Blue Crss and Blue Shield Assciatin technlgy assessment prgram (TEC) r ther nnaffiliated technlgy evaluatin center(s); Blue Crss and Blue Shield f Luisiana is an independent licensee f the Blue Crss and Blue Shield Assciatin and incrprated as Luisiana Health Service & Indemnity Cmpany. N part f this publicatin may be reprduced, stred in a retrieval system, r transmitted, in any frm r by any means, electrnic, mechanical, phtcpying, r therwise, withut permissin frm Blue Crss and Blue Shield f Luisiana. Page 7 f 8

8 Select Oral Onclgy Drugs Plicy # Credible scientific evidence published in peer-reviewed medical literature generally recgnized by the relevant medical cmmunity; r 3. Reference t federal regulatins. **Medically Necessary (r Medical Necessity ) - Health care services, treatment, prcedures, equipment, drugs, devices, items r supplies that a Prvider, exercising prudent clinical judgment, wuld prvide t a patient fr the purpse f preventing, evaluating, diagnsing r treating an illness, injury, disease r its symptms, and that are: A. In accrdance with natinally accepted standards f medical practice; B. Clinically apprpriate, in terms f type, frequency, extent, level f care, site and duratin, and cnsidered effective fr the patient's illness, injury r disease; and C. Nt primarily fr the persnal cmfrt r cnvenience f the patient, physician r ther health care prvider, and nt mre cstly than an alternative service r sequence f services at least as likely t prduce equivalent therapeutic r diagnstic results as t the diagnsis r treatment f that patient's illness, injury r disease. Fr these purpses, natinally accepted standards f medical practice means standards that are based n credible scientific evidence published in peer-reviewed medical literature generally recgnized by the relevant medical cmmunity, Physician Specialty Sciety recmmendatins and the views f Physicians practicing in relevant clinical areas and any ther relevant factrs. Indicated trademarks are the registered trademarks f their respective wners. NOTICE: Medical Plicies are scientific based pinins, prvided slely fr cverage and infrmatinal purpses. Medical Plicies shuld nt be cnstrued t suggest that the Cmpany recmmends, advcates, requires, encurages, r discurages any particular treatment, prcedure, r service, r any particular curse f treatment, prcedure, r service. Blue Crss and Blue Shield f Luisiana is an independent licensee f the Blue Crss and Blue Shield Assciatin and incrprated as Luisiana Health Service & Indemnity Cmpany. N part f this publicatin may be reprduced, stred in a retrieval system, r transmitted, in any frm r by any means, electrnic, mechanical, phtcpying, r therwise, withut permissin frm Blue Crss and Blue Shield f Luisiana. Page 8 f 8