What s New Medical Pharmaceutical Policy September 2018 Updates MBP Site of Care- New policy

Transcription

1 What s New Medical Pharmaceutical Plicy September 2018 Updates MBP Site f Care- New plicy DESCRIPTION: Specific intravenus and injectable drugs must meet applicable medical necessity criteria fr cverage. If these criteria are met, this cverage plicy will be used t determine the medical necessity f administratin in the hspital based utpatient setting. If medical necessity criteria fr administratin in the hspital based utpatient setting are nt met, an alternative less intensive site f care facility shuld be utilized. CRITERIA FOR USE: Requires Prir Authrizatin by Medical Directr r Designee Administratin in the hspital based utpatient setting will be cnsidered medically necessary and LIMITED t a duratin f 60 days when ne f the fllwing criteria are met: This is the initial medicatin infusin OR Member is reinitiating treatment after nt receiving any treatments fr at least 6 mnths. AUTHORIZATION DURATION: Initial apprval will be fr a duratin f 60 days. Administratin in the hspital based utpatient setting fr lnger than 60 days will be required t meet the authrizatin criteria in the sectin belw. Administratin in the hspital based utpatient setting will be cnsidered medically necessary fr a duratin f greater than 60 days when ne f the fllwing criteria are met: The medicatin has a site f care restrictin fr administratin per the FDA apprved label OR Dcumented previus histry f severe r ptentially life-threatening adverse event during r fllwing administratin and the adverse event cannt be managed using pre-medicatin(s) r adjusting the rate f infusin OR Bth f the fllwing: All alternate nn-hspital utpatient settings are nt within a reasnable distance frm the member s hme (within 50 miles) AND Hme healthcare r infusin prvider has determined that the patient, hme caregiver, r hme envirnment is nt apprpriate fr hme infusin r hme infusin services are nt available due t limited netwrk access OR Fr IVIG any f the abve criteria OR Change f immune glbulin prducts (ne infusin will be permitted in the hspital utpatient setting) OR Labratry cnfirmed immunglbulin A (IgA) deficiency with anti-iga antibdies AUTHORIZATION DURATION: Initial apprval will be fr the same length f time as the authrizatin f the specific drug being administered. Subsequent apprvals will be required if the specific drug requires subsequent authrizatins. NOTE: T prevent a delay in care and allw adequate transitin time fr members t an alternate infusin site, members already established n therapy wh d nt meet any f the abve criteria will be given a 60-day transitin auth t allw them t cntinue receiving therapy at their current hspital based utpatient facility while they transitin t a different infusin site. LIMITATIONS: If nne f the abve criteria are met and the prpsed hspital based utpatient facility is cnsidered a least cstly site f care, the hspital utpatient infusin wuld be apprved. LINE OF BUSINESS: This plicy des nt apply t the Medicaid r Medicare line f business. Eligibility and 1

2 cntract specific benefit limitatins and/r exclusins will apply. Cverage statements fund in the line f business specific benefit dcument will supersede this plicy. MBP Hemlibra (emicizumab-kxwh)- New plicy DESCRIPTION: Hemlibra (emicizumab-kxwh) is a humanized mnclnal mdified immunglbulin G4 (IgG4) antibdy with a bispecific factr IXa- and factr X-directed antibdy, bridges activated factr IX and factr X t restre the functin f missing activated factr VIII that is needed fr effective hemstasis. Emicizumabkxwh has n structural relatinship r sequence hmlgy t FVIII and, therefre, des nt induce r enhance the develpment f direct inhibitrs t FVIII. Hemlibra is indicated fr rutine prphylaxis t prevent r reduce the frequency f bleeding episdes in patients with hemphilia A (cngenital factr VIII deficiency) with factr VIII inhibitrs. CRITERIA FOR USE: Requires Prir Authrizatin by Medical Directr r Designee Hemlibra (emicizumab-kxwh) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Medical recrd dcumentatin f a diagnsis f hemphilia A (a dcumented Factr VIII deficiency) AND Medical recrd dcumentatin that Hemlibra is being used fr rutine prphylaxis AND Medical recrd dcumentatin that the member has cltting factr inhibitrs (neutralizing antibdies), cnfirmed by labratry testing (i.e. Bethesda assay) LIMITATIONS: Hemlibra is nt indicated fr n-demand/periperative cntrl f bleeding episdes assciated with a diagnsis f hemphilia A. Hemlibra is frmulated t allw self-administratin. Requests fr rutine prphylaxis in which Hemlibra will be self-administered shuld be submitted under the members Pharmacy Benefit fr Prir Authrizatin. In the event a member is unable t self-administer, Hemlibra will be cvered under the Medical Benefit if abve Prir Authrizatin criteria are met, and it is dcumented that a health care prfessinal will be administering weekly dses fr rutine prphylaxis. Hemlibra will nt be cvered fr n-demand and periperative cntrl f bleeding episdes. MBP Kanuma (sebelipase alfa)- New plicy DESCRIPTION: Kanuma (sebelipase alfa) is a frm f enzyme replacement therapy that binds t cell surface receptrs via glycans expressed n the prtein and is subsequently internalized int lyssmes. Sebelipase alfa catalyzes the lyssmal hydrlysis f chlesteryl esters and triglycerides t free chlesterl, glycerl, and free fatty acids. In patients with lyssmal acid lipase (LAL) deficiency, replacement with sebelipase alfa, a recmbinant frm f LAL, results in imprvement in disease-related hepatic and lipid parameters. CRITERIA FOR USE: Requires Prir Authrizatin by Medical Directr r Designee Kanuma (sebelipase alfa) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Must be prescribed by a prvider specializing in genetics r metablism AND Medical recrd dcumentatin f Lyssmal Acid Lipase deficiency as either Wlman disease OR Chlesteryl ester strage disease (CESD) AND Medical recrd dcumentatin f cnfirmed diagnsis in ne f three ways: Dried Bld Spt (DBS) test, leuccyte testing, r genetic testing AND 2

3 Medical recrd dcumentatin that the member will receive a weight and diagnsis apprpriate dsing regimen QUANTITY LIMITS: Rapidly prgressing/ Wlman disease: Patients 0-6 mnths f age. Kanuma will initially be apprved fr quantity sufficient fr up t 3 mg/kg nce weekly. These requests shuld be apprved fr a ttal f 4 visits per mnth. Late nset/ CESD: Patients 4 years f age and lder will be apprved fr 1 mg/kg every ther week. These requests shuld be apprved fr a ttal f 2 visits per mnth. AUTHORIZATION DURATION: Initial apprval will be fr a perid f 3 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 medically apprpriate and will require medical recrd dcumentatin f cntinued disease imprvement r lack f disease prgressin. MBP 48.0 Rituxan (rituximab)- Updated plicy CRITERIA FOR USE: Requires Prir Authrizatin by Medical Directr r Designee 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; AND At least 18 years f age r lder; AND Prescriptin written by a rheumatlgist; AND Medical recrd dcumentatin that an effective dse f methtrexate will be cntinued during rituximab therapy; AND Physician dcumentatin f an inadequate respnse t 12 weeks f therapy with etanercept (Enbrel) AND adalimumab (Humira); AND 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; AND Physician dcumentatin f imprvement r lack r prgressin in the signs and symptms f rheumatid arthritis; AND 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 AND Platelet cunt f < 30,000/mm 3 with active bleeding r < 20,000/mm 3 with increased risk f bleeding AND Medical recrd dcumentatin f therapeutic failure n, intlerance t, r cntraindicatin t crticsterids AND IVIg* AND splenectmy (*prir authrizatin required) 3

4 Authrizatin Duratin*: If patient meets criteria fr cverage, authrizatin will be given fr ne mnth f treatment with rituximab. 3. Fr Chrnic Lymphid Leukemia: Medical recrd dcumentatin f a diagnsis f chrnic lymphid leukemia used in cmbinatin with fludarabine and cyclphsphamide 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) Fr Primary Prgressive MS (PPMS): All f the fllwing criteria must be met: Medical recrd dcumentatin f prescriptin written by a neurlgist AND 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 AND Medical recrd dcumentatin f a diagnsis f SPMS r relapsing prgressive MS AND Medical recrd dcumentatin f rapidly prgressing disease (ex. EDSS scre increase f >1 in 1 year) OR 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 AND Medical recrd dcumentatin f a diagnsis f Relapsing/Remitting MS (RRMS) AND Medical recrd dcumentatin f therapeutic failure n, cntraindicatin t, r intlerance t three alternatives ne f which must be Tysabri* OR 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 4

5 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) (**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 AND Prescribed by r in cnsultatin with a neurmuscular specialist AND Medical recrd dcumentatin f therapeutic failure n, intlerance t, r cntraindicatin t at least ne crticsterid AND Medical recrd dcumentatin f therapeutic failure n, intlerance t, r cntraindicatin t at least ne chlinesterase inhibitr AND 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 AND Member is 18 years f age r lder AND Medical recrd dcumentatin f a diagnsis f mderate t severe pemphigus vulgaris AND Medical recrd dcumentatin f a cntraindicatin t, intlerance t, r therapeutic failure n crticsterids AND a 12-week trial f at least ne (1) nnsteridal immunmdulatry medicatin (e.g. azathiprine, cyclphsphamide, r mycphenlate). AUTHORIZATION DURATION: Fr Multiple Sclersis: Initial apprval will be fr 12 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 will require medical recrd dcumentatin f cntinued disease imprvement r lack f disease prgressin. The medicatin will n lnger be cvered if patient experiences txicity r wrsening f disease. Fr all ther indicatins: Initial apprval will be fr 6 mnths r less if the reviewing prvider feels it is medically apprpriate (*except fr the diagnsis fr ITP). Subsequent apprvals will be fr an additinal 6 mnths r less if the reviewing prvider feels it is medically apprpriate and will require medical recrd dcumentatin f cntinued disease imprvement r lack f disease prgressin. The medicatin will n lnger be cvered if patient experiences txicity r wrsening f disease. 5

6 MBP Keytruda (pembrlizumab)- New Indicatin Keytruda (pembrlizumab) will be cnsidered medically necessary when all f the fllwing criteria are met: 1. Unresectable r Metastatic Melanma Prescriptin written by a hematlgist/nclgist AND Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f a diagnsis f unresectable r metastatic melanma AND Medical recrd dcumentatin that Keytruda is nt being used in cmbinatin with any ther agents fr the treatment f unresectable r metastatic melanma. 2. Metastatic Nn-Small Cell Lung Cancer Prescriptin written by a hematlgist/nclgist AND Medical recrd dcumentatin that patient is 18 years f age AND 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 AND Medical recrd dcumentatin that tumrs have high PD-L1 expressin (Tumr Prprtin Scre (TPS) 50% as determined by an FDA-apprved test AND Medical recrd dcumentatin that tumrs d nt have EGFR r ALK genmic tumr aberratins OR Medical recrd dcumentatin that Keytruda is being given as mntherapy AND Medical recrd dcumentatin that tumrs express PD-L1 (TPS) 1% as determined by an FDA-apprved test AND Medical recrd dcumentatin f disease prgressin n r after platinum-cntaining chemtherapy AND 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. OR Medical recrd dcumentatin f metastatic nnsquamus NSCLC AND Medical recrd dcumentatin that Keytruda will be given in cmbinatin with pemetrexed AND carbplatin 3. Head and Neck Squamus Cell Carcinma Prescriptin written by a hematlgist/nclgist AND Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f a diagnsis f Head and Neck Squamus Cell Carcinma that is recurrent r metastatic and had disease prgressin n r after platinum-cntaining chemtherapy 4. Classical Hdgkin Lymphma Prescriptin written by a hematlgist/nclgist AND Medical recrd dcumentatin f Classical Hdgkin Lymphma AND One f the fllwing: a. Medical recrd dcumentatin f a diagnsis f refractry Classical Hdgkin Lymphma OR b. Medical recrd dcumentatin f relapse fllwing three (3) r mre prir lines f therapy 5. Micrsatellite Instability-High Cancer 6

7 Prescriptin written by a hematlgist/nclgist AND Medical recrd dcumentatin f unresectable r metastatic micrsatellite instability-high (MSI-H) r mismatch repair deficient (dmmr) slid tumrs OR clrectal cancer AND Fr slid tumrs: Medical recrd dcumentatin f prgressin fllwing prir treatment(s) AND Medical recrd dcumentatin f n satisfactry alternative treatment ptins Fr clrectal cancer: Medical recrd dcumentatin f prgressin fllwing treatment with flurpyrimidine, xaliplatin, and irintecan 6. Urthelial Carcinma Prescriptin written by a hematlgist/nclgist AND Medical recrd dcumentatin that patient is 18 years f age AND Medical recrd dcumentatin f lcally advanced r metastatic urthelial carcinma AND Medical recrd dcumentatin f ne f the fllwing: Disease prgressin during r fllwing platinum-cntaining chemtherapy OR Disease prgressin within 12 mnths f neadjuvant r adjuvant treatment with platinum-cntaining chemtherapy OR Patient is nt eligible cisplatin-cntaining chemtherapy* *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). 7. Gastric Cancer Prescriptin written by a hematlgist/nclgist AND Medical recrd dcumentatin f a diagnsis f recurrent lcally advanced r metastatic gastric r gastresphageal junctin adencarcinma AND Medical recrd dcumentatin that tumrs express PD-L1 (cmbined psitive scre [CPS] greater than r equal t 1) as determined by an FDA-apprved test AND Medical recrd dcumentatin f disease prgressin n r after tw r mre prir lines f therapy (including flurpyrimidine- and platinum-cntaining chemtherapy)* AND If patient has HER2-psitive disease, medical recrd dcumentatin f disease prgressin n r after HER2/neu-targeted therapy (including but nt limited t trastuzumab (Herceptin))* *Nte t reviewer: Current recmmendatins intend Keytruda t be used as third-line treatment (i.e. patient is t have 2 prir lines f therapy, ne f which must include HER2/neu-targeted therapy if the patient has HER-2 psitive disease) 8. Cervical Cancer Prescriptin written by a hematlgist/nclgist AND Medical recrd dcumentatin f recurrent r metastatic cervical cancer AND Medical recrd dcumentatin that tumrs express PD-L1 (CPS 1) AND Medical recrd dcumentatin f disease prgressin after receiving at least ne prir line f therapy LIMITATIONS: The treatment f patients with multiple myelma with a PD-1 r PD-L1 blcking antibdy in cmbinatin with a thalidmide analgue plus dexamethasne is nt recmmended utside f cntrlled clinical trials. AUTHORIZATION 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 will require medical recrd dcumentatin f 7

8 cntinued disease imprvement r lack f disease prgressin. The medicatin will n lnger be cvered if patient experiences txicity r wrsening f disease. MBP Avycaz (cetfazidime/avibactam) Updated Plicy Avycaz (cetfazidime/avibactam) will be cnsidered medically necessary when all f the fllwing criteria are met: Prescribed by r in cnsultatin with an infectius disease specialist AND Medical recrd dcumentatin f ne f the fllwing: A diagnsis f cmplicated intra-abdminal infectin caused by caused by the fllwing susceptible micrrganisms: Escherichia cli, Klebsiella pneumniae, Prteus mirabilis, Enterbacter clacae, Klebsiella xytca, Citrbacter freundii cmplex and Pseudmnas aeruginsa OR A diagnsis f cmplicated urinary tract infectins (cuti) including pyelnephritis caused by the fllwing susceptible micrrganisms: Escherichia cli, Klebsiella pneumniae, Enterbacter clacae, Citrbacter freundii cmplex, Prteus mirabilis, and Pseudmnas aeruginsa OR A diagnsis f Hspital-acquired Bacterial Pneumnia and Ventilatr-assciated Bacterial Pneumnia (HABP/VABP) caused by the fllwing susceptible micrrganisms: Enterbacter clacae, Escherichia cli, Haemphilus influenzae, Klebsiella pneumniae, Prteus mirabilis, Pseudmnas aeruginsa and, Serratia marcescens AND Medical recrd dcumentatin f a creatinine clearance > 50 ml/min AND Dcumentatin f patient age > 18 years AND Medical recrd dcumentatin f culture and sensitivity shwing the patient s infectin is nt susceptible t alternative antibitic treatments OR a dcumented histry f previus intlerance t r cntraindicatin t ther antibitics shwn t be susceptible n the culture and sensitivity AUTHORIZATION DURATION: Apprval will be given fr a duratin f 14 days. LIMITATIONS: a quantity limit f 3 vials per day shuld apply, with ttal duratin f treatment nt exceeding 14 days. MBP Darzalex (daratumumab) Updated Plicy Darzalex (daratumumab) will be cnsidered medically necessary when all f the fllwing criteria are met: Prescriptin written by a hematlgist/nclgist AND Medical recrd dcumentatin a diagnsis f multiple myelma AND If newly diagnsed multiple myelma: Medical recrd dcumentatin that the member is nt eligible fr stem-cell transplantatin (e.g. cexisting cnditins, age greater than 65, etc.) AND Medical recrd dcumentatin that Darzalex will be given in cmbinatin with brtezmib (Velcade), melphalan, AND prednisne [VMP] OR If relapsed/refractry multiple myelma: One f the fllwing: Medical recrd dcumentatin f therapeutic failure n, intlerance t, r cntraindicatin t at least three prir lines f therapy including a prteasme inhibitr (including but nt limited t Velcade*, Kyprlis*, r Ninlar*) and an immunmdulatry agent (including but nt limited t Pmalyst*, Revlimid*, Thalmid*) OR 8

9 Medical recrd dcumentatin that the patient is duble-refractry t a prteasme inhibitr (including but nt limited t Velcade*, Kyprlis*, r Ninlar*) and an immunmdulatry agent (including but nt limited t Pmalyst*, Revlimid*, Thalmid*) OR Medical recrd dcumentatin f therapeutic failure n, intlerance t, r cntraindicatin t at least 1 prir therapy including a prteasme inhibitr (including but nt limited t Velcade*, Kyprlis*, r Ninlar*) r an immunmdulatry agent (including but nt limited t Pmalyst*, Revlimid*, Thalmid*) AND ne f the fllwing: Medical recrd dcumentatin that Darzalex will be prescribed in cmbinatin with lenalidmide and dexamethasne OR Medical recrd dcumentatin that Darzalex will be prescribed in cmbinatin with brtezmib and dexamethasne AUTHORIZATION DURATION: Initial apprval will be fr 12 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 will require medical recrd dcumentatin f cntinued disease imprvement r lack f disease prgressin. The medicatin will n lnger be cvered if patient experiences txicity r wrsening f disease. MBP Prbuphine (buprenrphine) Updated Plicy Prbuphine (buprenrphine) will be cnsidered medically necessary when ALL f the fllwing criteria are met: Prescriber must have a unique identificatin number issued by the Drug Enfrcement Agency (DEA) certifying prescribing authrity fr buprenrphine agents AND Prescriber must have enrlled, trained, and demnstrated cmpetency in Prbuphine prcedures as described by the Prbuphine REMS Prgram AND Prbuphine must be prescribed by a participating prvider r a prvider wh participates in the plan s designated behaviral health benefit prgram AND Medical recrd dcumentatin f a diagnsis f piid dependence AND Medical recrd dcumentatin that patient is clinically stable by verifying ALL f the fllwing: N reprts f significant withdrawal symptms Reprts f lw t n desire/need t use illicit piids N episdes f hspitalizatins (fr addictin r mental health issues), emergency rm visits, r crisis interventins in the past 90 days Cnsistent cmpliance with clinic visit requirements as evidenced by dcumentatin f attendence t all scheduled appintments at least 6 mnths prir t the rdering f Prbuphine AND Medical recrd dcumentatin that patient is stable fr at least the last 6 mnths n lw-tmderate dses f a transmucsal buprenrphine cntaining prduct (i.e., dses f n mre than 8 mg per day f Subutex r Subxne sublingual tablets r generic equivalent) AND Medical recrd dcumentatin that the member is cmpliant with ral buprenrphine therapy, dcumented by all urine drug screens within 90 days f the request, ne f which must be dated within 28 days f request date, fr piates and buprenrphine. The drug screen must be psitive fr buprenrphine and nrbuprenrphine and negative fr piates. The presence f ther nnpiate cntrlled substances must be cnsistent with prescribed cntrlled substances and dcumentatin that their use is medically necessary and the benefit utweighs any risks assciated with their use in the member must be prvided. AND Medical recrd dcumentatin f member abstinence frm alchl AND Medical recrd dcumentatin that the member will nt be receiving supplemental sublingual buprenrphine after implant insertin AND Member must be actively invlved in frmal cunseling with a licensed behaviral health prvider. Must prvide the name f cunselr and/r facility r ratinale fr nn-participatin 9

10 AND There is cnfirmatin that the prescriber r the prescriber s delegate has cnducted a review f Pennsylvania s Prescriptin Drug Mnitring Prgram (PDMP) prir t prescribing Prbuphine. Fr re-authrizatin: Member must be adherent t buprenrphine and must nt be using piates. Must be verified by all urine drug screens within the past 6 mnths, ne f which must be dated within 28 days f request date fr piates and buprenrphine. All drug screens must be psitive fr buprenrphine and nrbuprenrphine, and negative fr piates. The presence f ther nn-piate cntrlled substances must be cnsistent with prescribed cntrlled substances and dcumentatin that their use is medically necessary and the benefit utweighs any risks assciated with their use in the member must be prvided. AND Medical recrd dcumentatin that member cntinues t be actively invlved in frmal cunseling with a licensed behaviral health prvider. Must prvide the name f cunselr and/r facility r ratinale fr nn-participatin AND Medical recrd dcumentatin f cntinued member abstinence frm alchl AND Medical recrd dcumentatin that Prbuphine has NOT been used fr greater than ne year AND Medical recrd dcumentatin that the new implants will be inserted int the cntralateral arm AND Medical recrd dcumentatin that member will nt be receiving supplemental sublingual buprenrphine after implant insertin AND There is cnfirmatin that the prescriber r the prescriber s delegate has cnducted a review f Pennsylvania s Prescriptin Drug Mnitring Prgram (PDMP) prir t prescribing Prbuphine. QUANTITY LIMIT: Fur (4) implants (ne kit) every 180 days AUTHORIZATION DURATION: If apprved, initial authrizatin duratin will be six (6) mnths. After the initial 6 mnth implantatin, if re-authrizatin criteria are met, ne subsequent authrizatin duratin will be given fr six (6) mnths. Nte: studies f Prbuphine use past ne year have nt be assessed. The fllwing plicies were reviewed with n changes: MBP 2.0 Synagis (palivizumab) MBP 15.0 Zevalin (Ibritummab) MBP 36.0 Abraxane (paclitaxel prtein bund particles) MBP 57.0 Tysabri (natalizumab) MBP 62.0 Remdulin IV (treprstinil) MBP 68.0 Nplate (rmiplstim) MBP 82.0 Jevtana (cabazitaxel) MBP Lemtrada (alemtuzumab) MBP Cresemba IV (isavucnaznium sulfate) MBP Unituxin (dinutuximab) MBP Radicava (edaravne) 10