Folotyn (pralatrexate)

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1 Fltyn (pralatrexate) Line(s) f Business: HMO; PPO; QUEST Integratin Akamai Advantage Original Effective Date: 10/01/2015 Current Effective Date: 01/01/2018TBD03/01/2017 POLICY A. INDICATIONS The indicatins belw including FDA-apprved indicatins and cmpendial uses are cnsidered a cvered benefit prvided that all the apprval criteria are met and the member has n exclusins t the prescribed therapy. FDA-Apprved Indicatin Fltyn is indicated fr the treatment f patients with relapsed r refractry peripheral T-cell lymphma (PTCL). This indicatin is based n verall respnse rate. Clinical benefit such as imprvement in prgressin-free survival r verall survival has nt been demnstrated. Cmpendial Uses Mycsis fungides/sézary syndrme (MF/SS) First-line therapy fr Stage IB-IIA MF with histlgic evidence f fllicultrpic r large cell transfrmatin Stage IIB with generalized tumr lesins Stage IV nn-sézary r visceral disease Stage III MF r SS which has prgressed r is refractry t multiple previus therapies Single-agent therapy fr tumrs with histlgic evidence f large cell transfrmatin and aggressive grwth rate fr Stage IB-IIA MF with histlgic evidence f fllicultrpic r large cell transfrmatin Stage IIB with generalized tumr lesins Stage IV nn-sézary r visceral disease Adult T-cell leukemia/lymphma (ATLL) Secnd-line therapy as a single agent fr nnrespnders t first-line therapy fr acute disease r lymphma Subsequent therapy after high dse therapy/autlgus stem cell rescue (HDT/ASCR) Primary cutaneus CD30+ T-cell lymphprliferative disrders (LPDs), single-agent therapy as primary treatment r therapy fr relapsed r refractry disease: Primary cutaneus anaplastic large cell lymphma (ALCL) with multifcal lesins Cutaneus ALCL with reginal ndes Peripheral T-cell lymphma (PTCL), secnd-line r subsequent therapy fr relapsed r refractry: Angiimmunblastic T-cell lymphma (AITL) PTCL, nt therwise specified

2 Fltyn 2 ALCL Enterpathy-assciated T-cell lymphma (EATL) Mnmrphic epithelitrpic intestinal T-cell lymphma B. REQUIRED DOCUMENTATION The fllwing dcumentatin frm the medical recrd is necessary t initiate the prir authrizatin review: Initial therapy: Current nclgy ntes Clinical ntes that include the histry f previus treatments Pertinent pathlgy reprts and/r imaging studies Cntinuatin f therapy: dcumentatin (including clinical ntes and bjective findings such as imaging studies) that demnstrate lack f disease prgressin n therapy C. INITIAL CRITERIA FOR APPROVAL INITIAL CRITERIA FOR APPROVAL 1. Adult T-cell leukemia/lymphma (ATLL) Authrizatin f 6 mnths may be granted t members wh are prescribed Fltyn when Fltyn is used fr secnd-line therapy as a single agent and eitherall f the fllwing criteria is are met: a. The member has ne f the fllwing subtypes f ATLL: i. Acute Lymphma a. The member is a nnrespnder t first-line therapy fr acute disease r lymphma, r b. Fltyn will be used as subsequent therapy after high-dse therapy/autlgus stem cell rescue 2. Peripheral T-cell lymphma (PTCL) Authrizatin f 6 mnths may be granted t members wh are prescribed Fltyn when ALL f the fllwing criteria are met: a. The member has ne f the fllwing subtypes f PTCL: i. Angiimmunblastic T-cell lymphma (AITL) PTCL, nt therwise specified i ALCL iv. Enterpathy-assciated T-cell lymphma (EATL) iv.v. Mnmrphic epithelitrpic intestinal T-cell lymphma b. Fltyn will be used as secnd-line r subsequent therapy fr relapsed r refractry disease 3. Primary cutaneus CD30+ T-cell lymphprliferative disrder (LDP) Authrizatin f 6 mnths may be granted t members wh are prescribed Fltyn when ALL f the fllwing criteria are met: a. Member has ne f the fllwing disease subtypes: i. Primary cutaneus anaplastic large cell lymphma (ALCL) with multifcal lesins Cutaneus ALCL with reginal ndes i CD30+ transfrmed mycsis fungides (Refer t criteria fr apprval in Sectin 4) b. Fltyn will be used as primary treatment OR as therapy fr relapsed r refractry disease c. Fltyn will be used as a single agent (as mntherapy)

3 Fltyn 3 4. Mycsis fungides (MF)/Sézary syndrme (SS) Authrizatin f 6 mnths may be granted t members wh are prescribed Fltyn fr when ALL f the criteria pertaining t the MF/SS disease stage are met (Sectins 4.1 t 4.34 belw) 4.1 Stage IB, and IIA MF/SS: Members with Stage IB r IIA disease must meet the criteria criterin a) and EITHER criterin b) r c) belw: a. Member has hhistlgic evidence f fllicultrpic r large cell transfrmatin is present a.b. Fltyn is used either in lw dses as first-line therapy r in standard dses as a single agent (mntherapy) fr tumrs with histlgic evidence f large cell transfrmatin and aggressive grwth rate b. Members with histlgic evidence f large cell transfrmatin must meet either i) r ii) belw: i. Members with evidence f an aggressive grwth rate must use Fltyn as a single agent (mntherapy) Members WITHOUT evidence f an aggressive grwth rate must meet ALL f the 1. Fltyn must be used as first line therapy 2. Lw-dse Fltyn must be prescribed (less than 30 mg/m 2 per week) c. Member withut histlgic evidence f large cell transfrmatin must meet all f the i. Fltyn must be used as first-line therapy Lw-dse Fltyn must be prescribed (less than 30 mg/m 2 per week) 4.2 Stage IIB MF/SS: Members with Stage IIB disease must meet the criteria criterin a) and EITHER criterin b) r c) belw: a. Member has generalized extent tumr lesins, transfrmed, and/r fllicultrpic disease b. Fltyn is used either in lw dses as first-line therapy r in standard dses as a single agent (mntherapy) fr tumrs with histlgic evidence f large cell transfrmatin and aggressive grwth rate a. b. Members with histlgic evidence f large cell transfrmatin must meet either i) r ii) belw: i. Members with evidence f an aggressive grwth rate must use Fltyn as a single agent (mntherapy) Members WITHOUT evidence f an aggressive grwth rate must meet ALL f the 1. Fltyn must be used as first line therapy 2. Lw-dse Fltyn must be prescribed (less than 30 mg/m 2 per week) c. Members WITHOUT histlgic evidence f large cell transfrmatin must meet ALL f the i. Fltyn must be used as first-line therapy Lw-dse Fltyn must be prescribed (less than 30 mg/m 2 per week) 4.3 Stage III and Stage IV (Sézary syndrme) MF:

4 Fltyn 4 Members with either Stage III disease r Stage IV Sézary syndrme must meet the ALL f the fllwing criteria belw: a. Member must have prgressive disease r disease refractry diseaset multiple previus therapies b. Fltyn is used in lw dses as first-line therapy b. Lw-dse Fltyn must be prescribed (less than 30 mg/m 2 per week) 4.4 Stage IV, nn-sézary r /visceral (slid rgan) disease Members with Stage IV nn-sézary r /visceral (slid rgan) disease must meet EITHER the fllwing criterin: Fltyn is used either in lw dses as first-line therapy r in standard dses as a single agent (mntherapy) fr tumrs with histlgic evidence f large cell transfrmatin and aggressive grwth rate a) r b) belw: a. Members with histlgic evidence f large cell transfrmatin must meet either i) r ii) belw: i. Members with evidence f an aggressive grwth rate must use Fltyn as a single agent (mntherapy) Members WITHOUT evidence f an aggressive grwth rate must meet ALL f the 1. Fltyn must be used as first line therapy 2. Lw-dse Fltyn must be prescribed (less than 30 mg/m 2 per week) b. Members WITHOUT histlgic evidence f large cell transfrmatin must meet ALL f the i. Fltyn must be used as first-line therapy Lw-dse Fltyn must be prescribed (less than 30 mg/m 2 per week) C.D. CONTINUATION OF THERAPY Authrizatin f an additinal 6 mnths may be granted t members wh are prescribed Fltyn fr cntinuatin f therapy that were previusly apprved by HMSA if there is evidence f a lack f disease prgressin n therapy. 1. N previus authrizatin/precertificatin: All members (including members currently receiving treatment withut prir authrizatin) must meet criteria fr initial apprval in sectin C. 2. Reauthrizatin: Authrizatin f 6 mnths may be granted t members requesting authrizatin fr cntinuatin f therapy if Fltyn was previusly authrized by HMSA/CVS and there is evidence f a lack f disease prgressin n therapy. E. DOSAGE AND ADMINISTRATION DOSAGE AND ADMINISTRATION Apprvals may be subject t dsing limits in accrdance with FDA-apprved labeling, accepted cmpendia, and/r evidence-based practice guidelines. D.F. ADMINISTRATIVE GUIDELINES Precertificatin is required. Please refer t the HMSA medical plicy web site fr the fax frm.

5 Fltyn 5 E.G. IMPORTANT REMINDER The purpse f this Medical Plicy is t prvide a guide t cverage. This Medical Plicy is nt intended t dictate t prviders hw t practice medicine. Nthing in this Medical Plicy is intended t discurage r prhibit prviding ther medical advice r treatment deemed apprpriate by the treating physician. Benefit determinatins are subject t applicable member cntract language. T the extent there are any cnflicts between these guidelines and the cntract language, the cntract language will cntrl. This Medical Plicy has been develped thrugh cnsideratin f the medical necessity criteria under Hawaii s Patients Bill f Rights and Respnsibilities Act (Hawaii Revised Statutes 432E-1.4), generally accepted standards f medical practice and review f medical literature and gvernment apprval status. HMSA has determined that services nt cvered under this Medical Plicy will nt be medically necessary under Hawaii law in mst cases. If a treating physician disagrees with HMSA s determinatin as t medical necessity in a given case, the physician may request that CVS/caremark recnsider the applicatin f the medical necessity criteria t the case at issue in light f any supprting dcumentatin. F.H. REFERENCES 1. Fltyn [package insert]. Westminster, CO: Alls Therapeutics, Inc.; May 2012Nvember The NCCN Drugs & Bilgics Cmpendium Natinal Cmprehensive Cancer Netwrk, Inc. Accessed May 5, , The NCCN Clinical Practice Guidelines in Onclgy T-cell Lymphmas (Versin ) Natinal Cmprehensive Cancer Netwrk, Inc. Accessed May 3, The NCCN Clinical Practice Guidelines in Onclgy Nn-Hdgkin s Lymphmas (Versin ) Natinal Cmprehensive Cancer Netwrk, Inc. Accessed May 3, Revised: May Dcument Histry 10/01/2015 Original effective date 05/2016 Annual review 03/01/2017 Revisin effective date 05/2017 Annual review TBD Revisin effective date

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