XX Abraxane 100 MG SUSR (CELGENE CORP)

Transcription

1 Plicy Medical Plicy Manual Apprved: D Nt Implement Until 1/31/19 Paclitaxel (Prtein-Bund) NDC CODE(S) XX Abraxane 100 MG SUSR (CELGENE CORP) DESCRIPTION Paclitaxel is a natural prduct with antitumr activity. Obtained frm Taxus media r Taxus baccata, a variety f the Western yew tree, it is highly lipphilic and insluble in water. Paclitaxel is an anti-micrtubule agent which induces abnrmal arrays r bundles f micrtubules during the cell cycle and inhibits vital interphase and mittic cellular functins. By refrmulating paclitaxel as albumin-bund nanparticles, the prtein-bund paclitaxel has imprved slubility ver cnventinal paclitaxel which requires the use f txic slvents such as plyxyethylated castr il and ethanl in its prductin. This allws infusin f the agent t be made in a shrter time, reduces the risk f hypersensitivity reactins and eliminates the need fr premedicatin with dexamethasne, diphenhydramine, and cimetidine. It is imprtant t nte that prtein-bund paclitaxel is nt a substitute fr cnventinal paclitaxel and shuld nt be used with ther paclitaxel frmulatins. It has been prven that prtein-bund paclitaxel des nt have the identical bichemical systemic reactin as paclitaxel. POLICY Paclitaxel (prtein-bund) fr the treatment f the fllwing is cnsidered medically necessary if the medical apprpriateness criteria are met. (See Medical Apprpriateness belw.) AIDS-related Kapsi Sarcma Bladder cancer/urthelial carcinma Breast cancer Melanma Nn-small cell lung cancer Ovarian cancer Pancreatic adencarcinma Uterine Cancer Paclitaxel (prtein-bund) fr the treatment f ther cnditins/diseases is cnsidered investigatinal. MEDICAL APPROPRIATENESS INITIAL APPROVAL Paclitaxel (prtein-bund) is cnsidered medically apprpriate if the individual is 18 years f age r lder with a diagnsis f ANY ONE f the fllwing: AIDS-related Kapsi Sarcma if ALL f the fllwing: Used as subsequent therapy in cmbinatin with antiretrviral therapy (ART) Individual has relapsed/refractry advanced, cutaneus, ral, visceral, r ndal disease Individual has disease prgressin after first-line and alternate first-line treatment Bladder cancer/urthelial carcinma if ALL f the fllwing: Used as a single agent Used subsequently fllwing prir treatment with a systemic therapy (i.e., platinum, checkpint inhibitr, r ther recmmended regimen) Further diagnsed as ANY ONE f the fllwing: Lcally advanced r metastatic disease This dcument has been classified as public infrmatin.

2 Plicy Medical Plicy Manual Apprved: D Nt Implement Until 1/31/19 Disease recurrence pst-cystectmy Metastatic Upper GU tract tumrs Metastatic Urthelial Carcinma f the Prstate Recurrent r metastatic Primary Carcinma f the Urethra and individual des nt have recurrent stage T3-4 disease r palpable inguinal lymph ndes. Breast cancer if ANY ONE f the fllwing: Individual has ALL f the fllwing: Failed n cmbinatin chemtherapy fr metastatic disease OR relapsed within 6 mnths f adjuvant therapy Previus chemtherapy included an anthracycline Disease is recurrent r metastatic and ANY ONE f the fllwing: HER-2 negative disease and using as single agent therapy and ANY ONE f the fllwing: Hrmne receptr negative r hrmne receptr psitive and refractry t endcrine therapy With symptmatic visceral disease r visceral crisis HER-2 psitive disease and using in cmbinatin with trastuzumab (in thse previusly treated with trastuzumab) and ANY ONE f the fllwing: Hrmne receptr negative r hrmne receptr psitive and refractry t endcrine therapy With symptmatic visceral disease r visceral crisis May be substituted fr paclitaxel r dcetaxel if the individual has experienced hypersensitivity reactins despite premedicatin r the individual has cntraindicatins t standard hypersensitivity premedicatins Melanma if ALL f the fllwing: Used as a single agent Disease is unresectable r metastatic and ANY ONE f the fllwing: Individual has uveal melanma Used as secnd-line r subsequent therapy individual has had ANY ONE f the fllwing: Disease prgressin after BRAF targeted therapies Maximum clinical benefit achieved frm BRAF targeted therapies Nn-small cell lung cancer (NSCLC) if ANY ONE f the fllwing: Disease is lcally advanced r metastatic used in cmbinatin with carbplatin used as first1st line therapy in individuals wh are nt candidates fr curative surgery r radiatin therapy. Disease is recurrent r metastatic and individual des nt have lcreginal recurrence withut evidence f disseminated disease as ANY ONE f the fllwing: Used as a single agent in patients with a perfrmance status scre f 2 Used in cmbinatin with carbplatin in patients with a perfrmance status scre f 0-2 fr ANY ONE f the fllwing: Used as first-line therapy fr genmic tumr aberratin (e.g., EGFR, ALK, ROS1, BRAF and PD-L1) negative r unknwn OR BRAF V600E-mutatin psitive Used as subsequent therapy fr genmic tumr aberratin (e.g., EGFR, BRAF V600E, ALK, ROS1, PD-L1) psitive and prir targeted therapy (See Genmic Aberratin Targeted Therapies chart belw) May be substituted fr paclitaxel r dcetaxel if individual has experienced hypersensitivity reactins despite premedicatin r the individual has cntraindicatins t standard hypersensitivity premedicatins Ovarian cancer if ALL f the fllwing: Disease further classified as ANY ONE f the fllwing: Epithelial Ovarian Cancer Fallpian Tube Cancer Primary Peritneal Cancer Disease is persistent and recurrent and individual is nt experiencing an immediate bichemical relapse used as ANY ONE f the fllwing: This dcument has been classified as public infrmatin.

3 Plicy Medical Plicy Manual Apprved: D Nt Implement Until 1/31/19 Single agent In cmbinatin with carbplatin if platinum-sensitive fr individuals with cnfirmed taxane hypersensitivity Pancreatic adencarcinma fr treatment in cmbinatin with gemcitabine fr ANY ONE f the fllwing: Lcally advanced unresectable r metastatic disease and individual has a gd perfrmance status (defined as an ECOG PS f 0-2) and ANY ONE f the fllwing: Used as first-line r inductin therapy Used as secnd-line therapy after prgressin with a flurpyrimidine-based therapy Individual s disease is recurrent used as secnd line therapy Individual s disease is resectable with high-risk features r brderline resectable used fr neadjuvant treatment Uterine Cancer if ALL f the fllwing: Used as single agent therapy Individual has endmetrial carcinma used as ANY ONE f the fllwing: Primary treatment fr metastatic r unresectable disease excluding individuals with cervical invlvement underging brachytherapy with r withut external beam radiatin therapy (EBRT) Adjuvant treatment excluding patients with Stage IA disease with adverse risk factrs present OR Stage IB disease withut adverse risk factrs present OR Stage II disease Used as treatment f lcal-reginal recurrent, prgressive r disseminated metastatic disease Individual has tried generic paclitaxel and treatment with paclitaxel was nt tlerated due t a dcumented hypersensitivity reactin, despite use f recmmended premedicatins r there is a dcumented medical cntraindicatin t recmmended premedicatins. Genmic Aberratin Targeted Therapies (nt all inclusive) Sensitizing EGFR mutatin-psitive tumrs Erltinib Afatinib Gefitinib Osimertinib ALK rearrangement-psitive tumrs Criztinib Ceritinib Brigatinib Alectinib ROS1 rearrangement-psitive tumrs Criztinib Ceritinib BRAF V600E-mutatin psitive tumrs Dabrafenib/Trametinib PD-L1 expressin-psitive tumrs (>50%) Pembrlizumab RENEWAL CRITERIA Paclitaxel (prtein-bund) is cnsidered medically apprpriate fr renewal if ALL f the fllwing criteria are met: Individual cntinues t meet initial apprval criteria Respnse t treatment is indicated by stabilizatin f disease r decrease in size f tumr r tumr spread This dcument has been classified as public infrmatin.

4 Plicy Medical Plicy Manual Apprved: D Nt Implement Until 1/31/19 Absence f unacceptable txicity frm the agent (Examples f unacceptable txicity include the fllwing: neutrphil cunts f < 1,500 cell/mm 3, sensry neurpathy, sepsis, pneumnitis, severe hypersensitivity reactins, myelsuppressin, etc.). INDICATION(S) Pancreatic Cancer All ther indicatins DOSAGE & ADMINISTRATION 125mg/m² days 1, 8, and 15 f a 28-day cycle 260mg/m² every 21 days OR 100mg/m² days 1, 8, and 15 f a 21-day cycle LENGTH OF AUTHORIZATION Cverage is prvided fr 6 mnths and may be renewed. Click here t view DOSAGE LIMITS APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS BlueCrss BlueShield f Tennessee s Medical Plicy cmplies with Tennessee Cde Anntated Sectin regarding cverage f ff-label indicatins f Fd and Drug Administratin (FDA) apprved drugs when the ff-label use is recgnized in ne f the statutrily recgnized standard reference cmpendia r in the published peer-reviewed medical literature. IMPORTANT REMINDER We develp Medical Plicies t prvide guidance t Members and Prviders. This Medical Plicy relates nly t the services r supplies described in it. The existence f a Medical Plicy is nt an authrizatin, certificatin, explanatin f benefits r a cntract fr the service (r supply) that is referenced in the Medical Plicy. Fr a determinatin f the benefits that a Member is entitled t receive under his r her health plan, the Member's health plan must be reviewed. If there is a cnflict between the Medical Plicy and a health plan, the express terms f the health plan will gvern. ADDITIONAL INFORMATION Fr apprpriate chemtherapy regimens, dsage infrmatin, cntraindicatins, precautins, warnings, and mnitring infrmatin, please refer t ne f the standard reference cmpendia (e.g., the NCCN Clinical Practice Guidelines in Onclgy (NCCN Guidelines ) published by the Natinal Cmprehensive Cancer Netwrk, Drugdex Evaluatins f Micrmedex Slutins at Truven Health, r The American Hspital Frmulary Service Drug Infrmatin). GRADE ECOG PERFORMANCE STATUS Fully active, able t carry n all pre-disease perfrmance withut 0 restrictin Restricted in physically strenuus activity but ambulatry and able 1 t carry ut wrk f a light r sedentary nature, e.g., light huse wrk, ffice wrk Ambulatry and capable f all selfcare but unable t carry ut any 2 wrk activities; up and abut mre than 50% f waking hurs This dcument has been classified as public infrmatin.

5 Plicy Medical Plicy Manual Apprved: D Nt Implement Until 1/31/19 Capable f nly limited selfcare; cnfined t bed r chair mre 3 than 50% f waking hurs Cmpletely disabled; cannt carry n any selfcare; ttally cnfined 4 t bed r chair 5 Dead SOURCES Lexicmp Online. (2018,February). AHFS DI. Paclitaxel. Retrieved September 24, 2018 frm Lexicmp Online with AHFS. MICROMEDEX Healthcare Series. Drugdex Drug Evaluatins. (2018, September). Paclitaxel prtein-bund. Retrieved September 24, 2018 frm MICROMEDEX Healthcare Series. Natinal Cmprehensive Cancer Netwrk. (2018). NCCN Drugs & Bilgics Cmpendium. Paclitaxel, albumin bund. Retrieved September 24, 2018 frm the Natinal Cmprehensive Cancer Netwrk. U. S. Fd and Drug Administratin. (2018 August). Center fr Drug Evaluatin and Research. Abraxane fr injectable suspensin (paclitaxel prtein-bund particles fr injectable suspensin) (albumin-bund). Retrieved September 24, 2018 frm EFFECTIVE DATE 1/31/2019 ID_MRx This dcument has been classified as public infrmatin.