DEPARTMENT OF DEFENSE PHARMACY AND THERAPEUTICS COMMITTEE RECOMMENDATIONS INFORMATION FOR THE UNIFORM FORMULARY BENEFICIARY ADVISORY PANEL

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1 DEPARTMENT OF DEFENSE PHARMACY AND THERAPEUTICS COMMITTEE RECOMMENDATIONS INFORMATION FOR THE UNIFORM FORMULARY BENEFICIARY ADVISORY PANEL I. UNIFORM FORMULARY REVIEW PROCESS Under 10 United States Cde 1074g, as implemented by 32 Cde f Federal Regulatins , the Department f Defense (DD) Pharmacy and Therapeutics (P&T) Cmmittee is respnsible fr develping the Unifrm Frmulary (UF). Recmmendatins t the Directr, Defense Health Agency (DHA), n frmulary status, prir authrizatin (PA), pre-authrizatins, and the effective date fr a drug s change frm frmulary t nnfrmulary (NF) status are received frm the Beneficiary Advisry Panel (BAP), which must be reviewed by the Directr befre making a final decisin. II. UF CLASS REVIEWS WEIGHT LOSS AGENTS P&T Cmments A. Weight Lss Agents Relative Clinical Effectiveness Analysis and Cnclusin Backgrund Prir t the Natinal Defense Authrizatin Act (NDAA) 2017, weight lss agents were excluded frm the TRICARE pharmacy benefit. An Interim Final Rule published n September 29, 2017, (DOD-2017-HA-RIN 0720) authrizes cverage under TRICARE Prime and TRICARE Select fr medically necessary treatment f besity, even if it is the sle r majr cnditin treated. Therefre, the P&T Cmmittee evaluated the weight lss agents. The medicatins apprved fr weight lss include bth generic and branded prducts. The lder generic drugs are phentermine (Adipex-P, generics), phendimetrazine immediate release (IR) and sustained release (SR) (Bntril, Bntril Slw Release, generics), benzphetamine (Didrex, generics), and diethylprpin (Tenuate, Tandil, generics). A branded, lw-dse frmulatin f phentermine 8 mg (Lmaira) is nw available. These lder drugs are apprved fr up t 12 weeks f treatment. The clinical review fcused n the newer branded drugs apprved fr lng-term treatment f weight lss beynd 12 weeks. The P&T Cmmittee cncluded (16 fr, 1 ppsed, 0 abstained, 0 absent) the fllwing: Prfessinal treatment guidelines frm several rganizatins differ with respect t recmmendatins fr weight lss. Hwever, there is agreement amng all the guidelines that cmprehensive lifestyle interventin is the fundatin f weight lss treatment. Pharmactherapy may be ffered t patients with a bdy mass index (BMI) 30 and t thse with a BMI 27 wh have besity-assciated cmrbidities. The weight lss agents were primarily studied in placeb-cntrlled trials and vary significantly in their reprted efficacy and safety. The individual trials als varied in 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 1 f 43

2 the requirements fr cncurrent lifestyle interventins. All the trials included the percentage f patients wh achieved a 5% reductin in weight frm baseline ver a 12- t 16-week perid. Fr all the drugs, apprximately 33% t 75% f patients achieved this endpint, cmpared t 25% f patients receiving placeb. Phentermine/tpiramate extended release (ER) (Qsymia) is a fixed-dse cmbinatin prduct that suppresses appetite. The safety cncerns with Qsymia include the risk f cngenital malfrmatins, and cautins in patients with hypertensin, elevated heart rate, r renal dysfunctin. The fixed-dse cmbinatin f naltrexne SR/buprpin SR (Cntrave) reduces cravings. Prduct labeling includes a black bx warning advising against use in patients with majr depressin r psychiatric disrders. Cntrave is nt recmmended in patients with a histry f seizures, r uncntrlled hypertensin, and in thse taking piids. Lrcaserin is available in tw frmulatins, immediate release (Belviq) and sustained release (Belviq XR). The mechanism by which lrcaserin induces weight lss is unknwn. Patients with cardiac cnditins, including cngestive heart failure, bradycardia, heart valve prblems, and secnd r third degree heart blck, require clse mnitring. Orlistat (Xenical) is a lipase inhibitr administered with high-fat meals. It is the nly weight lss drug apprved fr pediatric patients as yung as 12 years f age. Xenical shuld be avided in patients with gallbladder disease r malabsrptin syndrmes. Liraglutide (Saxenda) is a glucagn-like peptide-1 receptr agnist (GLP1RA) that is administered subcutaneusly (SC) nce daily in a 3 mg dsage. It causes weight lss by increasing satiety. Liraglutide is als available in a 1.8 mg frmulatin (Victza) fr treating type 2 diabetes. In a tw-year dse cmparisn study, the tw dsages f liraglutide, 1.8 mg and 3 mg, were cmparable in efficacy fr weight lss. Other GLP1RAs, including exenatide nce weekly (Byduren), have shwn a decrease in weight frm baseline when evaluated in type 2 diabetic patients. In the 26-week DURATION-6 trial, Byduren reduced baseline weight by 2.7 kg, cmpared t 3.6 kg with Victza; these differences between the drugs are statistically significant but nt clinically relevant. Qsymia is the nly weight lss drug shwn t cause a significant reductin in bld pressure. Reductins in hemglbin A1c in type 2 diabetic patients have been reprted with Cntrave, Belviq, and Saxenda. In ne trial, Qsymia shwed a slwed rate f prgressin t type 2 diabetes cmpared t placeb. Due t the lack f head-t-head trials with the weight lss agents, systematic reviews were evaluated t determine cmparative clinical efficacy. The Institute fr Clinical & Ecnmic Review in 2015 evaluated 17 placeb-cntrlled trials. Qsymia and Saxenda had the highest prprtin f patients achieving a > 5% weight lss, fllwed by Cntrave, and then Belviq. Discntinuatins due t 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 2 f 43

3 adverse drug reactins ccurred mst cmmnly with Qsymia (1.3% 16%) and Cntrave (19% 29%). Xenical was nt included in the analysis. A 2016 Jurnal f the American Medical Assciatin (JAMA) systematic review included 28 studies with the newer weight lss drugs. Qsymia and Saxenda had the highest dds f achieving a 5% weight lss fllwed by Cntrave. Saxenda and Cntrave had the highest discntinuatin rate frm adverse events. A survey f Military Health System (MHS) prviders fund varied pinins regarding prescribing drugs fr weight lss. The respndents were divided n whether a weight lss drug was needed n the frmulary, with 43% respnding yes versus 40% saying n. Mre than half f prviders (59%) stated a willingness t prescribe tw agents separately in lieu f fixed-dse cmbinatins. Overall, these drugs have a mdest effect n weight lss, and evidence fr sustained weight lss beynd ne t tw years is minimal. Clinical cmparisns between the individual drugs are difficult due t the differing mechanisms f actin, lack f head-thead trials, lack f lng-term cardivascular utcmes studies, and widely varying adverse event prfiles. Discntinuatins due t adverse events can be f cncern. B. Weight Lss Agents Relative Cst-Effectiveness Analysis and Cnclusin Cst-minimizatin analysis (CMA), cst-effectiveness analysis (CEA), and budget impact analysis (BIA) were perfrmed t evaluate the weight lss agents. The P&T Cmmittee cncluded (17 fr, 0 ppsed, 0 abstained, 0 absent) the fllwing: CMA and CEA results fund that the generic agents including phentermine, phendimetrazine, benzphetamine, and diethylprpin were the mst cst effective, fllwed by phentermine 8 mg tablets (Lmaira), phentermine/tpiramate ER (Qsymia), lrcaserin (Belviq and Belviq XR), naltrexne SR/buprpin SR (Cntrave), rlistat (Xenical), and liraglutide 3 mg injectin (Saxenda). BIA was perfrmed t evaluate the ptential impact f designating selected agents as frmulary r NF n the UF. BIA results fund that designating the generic agents benzphetamine, diethylprpin, phendimetrazine, and phentermine as frmulary, with liraglutide 3 mg injectin (Saxenda), lrcaserin (Belviq and Belviq XR), naltrexne SR/buprpin SR (Cntrave), phentermine 8 mg tablets (Lmaira), phentermine/tpiramate ER (Qsymia), and rlistat (Xenical) as NF, demnstrated significant cst avidance fr the MHS. C. Weight Lss Agents UF Recmmendatin The P&T Cmmittee recmmended (15 fr, 2 ppsed, 0 abstained, 0 absent) the fllwing: UF benzphetamine (Didrex, generics) diethylprpin (Tenuate, Tandil, generics) phendimetrazine IR and SR (Bntril, Bntril SR, generics) 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 3 f 43

4 phentermine (Adipex-P, generics) NF liraglutide 3 mg injectin (Saxenda) lrcaserin (Belviq, Belviq XR) naltrexne SR/buprpin SR (Cntrave) rlistat (Xenical) phentermine 8 mg tablets (Lmaira) phentermine/tpiramate ER (Qsymia) D. Weight Lss Agents Manual Prir Authrizatin (PA) Criteria The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) manual PA criteria fr all the weight lss drugs, including the generic prducts, in all new and current users. In general, lifestyle interventin fr at least six mnths is required prir t use f a weight lss drug, and is required thrughut treatment. Additinally, a trial f phentermine is required prir t use f the branded agents, unless the patient has significant cardivascular disease r ther cntraindicatins t a stimulant. Renewal PA criteria are required after 12 weeks fr the generic prducts, and after fur mnths fr the prducts apprved fr lng-term use (Belviq, Belviq XR, Cntrave, Qsymia, Saxenda, and Xenical). PA Criteria: 1. benzphetamine, diethylprpin, phendimetrazine IR and SR, phentermine Manual PA criteria apply t all new and current users f phentermine, phendimetrazine, benzphetamine, and diethylprpin. Manual PA criteria Agent apprved if ALL f the fllwing criteria are met: Patient is 18 years ld Patient des nt have a histry f cardivascular disease (e.g., arrhythmias, crnary artery disease, heart failure, strke, uncntrlled hypertensin), hyperthyridism, r ther significant cntraindicatin t the abve agents Patient has a BMI 30 r a BMI 27 fr thse with risk factrs in additin t besity (diabetes, impaired glucse tlerance, dyslipidemia, hypertensin, sleep apnea) Patient has engaged in a trial f behaviral mdificatin and dietary restrictin fr at least 6 mnths and has failed t achieve the desired weight lss, and will remain engaged thrughut curse f therapy Fr Active Duty Service Members: The individual must be enrlled in a Service-specific Health/Wellness Prgram AND adhere t Service plicy, AND will remain engaged thrughut curse f therapy Patient is nt pregnant 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 4 f 43

5 If the patient has impaired glucse tlerance r diabetes, the patient must have tried metfrmin first, r is cncurrently taking metfrmin PA expires after 3 mnths Renewal PA Criteria: PA will be renewed fr an additinal 12 mnths if the fllwing are met: The patient is currently engaged in behaviral mdificatin and n a reduced calrie diet The patient has lst 5% f baseline bdy weight since starting medicatin The patient is nt pregnant Additinally, fr Active Duty Service Members: The individual cntinues t be enrlled in a Service-specific Health/Wellness Prgram AND adheres t Service plicy, AND will remain engaged thrughut curse f therapy 2. phentermine 8 mg tablets (Lmaira) Manual PA criteria apply t all new and current users f phentermine 8 mg tablets (Lmaira). Manual PA criteria Agent apprved if ALL f the fllwing criteria are met: Patient is 18 years ld The patient requires a dse f phentermine less than 15 mg due t elevated baseline heart rate Patient des nt have a histry f cardivascular disease (e.g., arrhythmias, crnary artery disease, heart failure, strke, uncntrlled hypertensin), hyperthyridism, r ther significant cntraindicatin t the abve agents Patient has a BMI 30, r a BMI 27 fr thse with risk factrs in additin t besity (diabetes, impaired glucse tlerance, dyslipidemia, hypertensin, sleep apnea) Patient has engaged in a trial f behaviral mdificatin and dietary restrictin fr at least 6 mnths and has failed t achieve the desired weight lss, and will remain engaged thrughut curse f therapy Fr Active Duty Service Members: The individual must be enrlled in a Service-specific Health/Wellness Prgram AND adhere t Service plicy, AND will remain engaged thrughut curse f therapy Patient is nt pregnant If patient has impaired glucse tlerance r diabetes, must have tried metfrmin first, r is cncurrently taking metfrmin PA expires after 3 mnths 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 5 f 43

6 Renewal PA Criteria: Lmaira will be apprved fr an additinal 12 mnths if the fllwing are met: The patient is currently engaged in behaviral mdificatin and n a reduced calrie diet The patient has lst 5% f baseline bdy weight since starting medicatin The patient is nt pregnant Additinally, fr Active Duty Service Members: The individual cntinues t be enrlled in a Service-specific Health/Wellness Prgram AND adheres t Service plicy, AND will remain engaged thrughut curse f therapy 3. phentermine/tpiramate ER (Qsymia) Manual PA criteria apply t all new and current users f Qsymia. Manual PA criteria Agent apprved if ALL f the fllwing criteria are met: Patient is 18 years ld Patient des nt have a histry f cardivascular disease (e.g., arrhythmias, crnary artery disease, heart failure, strke, uncntrlled hypertensin), hyperthyridism, r ther significant cntraindicatin t the abve agents Patient has a BMI 30, r a BMI 27 fr thse with risk factrs in additin t besity (diabetes, impaired glucse tlerance, dyslipidemia, hypertensin, sleep apnea) Patient has engaged in a trial f behaviral mdificatin and dietary restrictin fr at least 6 mnths and has failed t achieve the desired weight lss, and will remain engaged thrughut curse f therapy Fr Active Duty Service Members: The individual must be enrlled in a Service-specific Health/Wellness Prgram AND adhere t Service plicy, AND will remain engaged thrughut curse f therapy Patient is nt pregnant If patient has impaired glucse tlerance r diabetes, must have tried metfrmin first, r is cncurrently taking metfrmin Prir Authrizatin expires after 4 mnths Renewal PA Criteria: Qsymia will be apprved fr an additinal 12 mnths if the fllwing are met: The patient is currently engaged in behaviral mdificatin and n a reduced calrie diet The patient has lst 5% f baseline bdy weight since starting medicatin 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 6 f 43

7 Fr patients initially receiving Qsymia 7.5mg/46mg: discntinue Qsymia, r escalate t 15mg/92mg if 3% baseline bdy weight is nt achieved at after 12 weeks Fr patients receiving Qsymia 15mg/92mg: discntinue if 5% baseline bdy weight is nt achieved at 12 weeks The patient is nt pregnant Additinally, fr Active Duty Service Members: The individual cntinues t be enrlled in a Service-specific Health/Wellness Prgram AND adheres t Service plicy, AND will remain engaged thrughut curse f therapy 4. naltrexne SR/buprpin SR (Cntrave) Manual PA criteria apply t all new and current users f Cntrave. Manual PA criteria Agent apprved if ALL f the fllwing criteria are met: Patient is 18 years ld Patient has tried and failed t achieve a 5% reductin in baseline weight after a 12 week curse f phentermine unless there is a histry f cardivascular disease (e.g. arrhythmias, crnary artery disease, heart failure, strke, uncntrlled hypertensin), hyperthyridism, r significant cntraindicatin t phentermine) Patient is nt n cncurrent piid therapy and des nt have a seizure disrder r uncntrlled hypertensin Patient is nt currently n an mnamine xidase inhibitr (e.g., Emsam, Marplan, Nardil), r anther frmulatin f buprpin r naltrexne Patient has a BMI 30, r a BMI 27 fr thse with risk factrs in additin t besity (diabetes, impaired glucse tlerance, dyslipidemia, hypertensin, sleep apnea) Patient has engaged in a trial f behaviral mdificatin and dietary restrictin fr at least 6 mnths and has failed t achieve the desired weight lss, and will remain engaged thrughut curse f therapy Fr Active Duty Service Members: The individual must be enrlled in a Service-specific Health/Wellness Prgram AND adhere t Service plicy, AND will remain engaged thrughut curse f therapy Patient is nt pregnant If patient has impaired glucse tlerance r diabetes, must have tried metfrmin first, r is cncurrently taking metfrmin Prir Authrizatin expires after 4 mnths 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 7 f 43

8 Renewal PA Criteria: Cntrave will be apprved fr an additinal 12 mnths if the fllwing are met: The patient is currently engaged in behaviral mdificatin and n a reduced calrie diet The patient has lst 5% f baseline bdy weight since starting medicatin The patient is nt pregnant Additinally, fr Active Duty Service Members: The individual cntinues t be enrlled in a Service-specific Health/Wellness Prgram AND adheres t Service plicy, AND will remain engaged thrughut curse f therapy 5. lrcaserin (Belviq, Belviq XR) Manual PA criteria apply t all new and current users f Belviq r Belviq XR. Manual PA criteria Agent apprved if ALL f the fllwing criteria are met: Patient is 18 years ld Patient has tried and failed t achieve a 5% reductin in baseline weight after a 12 week curse f phentermine unless there is a histry f cardivascular disease (e.g. arrhythmias, crnary artery disease, heart failure, strke, uncntrlled hypertensin), hyperthyridism, r significant cntraindicatin t phentermine) Patient has a BMI 30, r a BMI 27 fr thse with risk factrs in additin t besity (diabetes, impaired glucse tlerance, dyslipidemia, hypertensin, sleep apnea) Patient has engaged in a trial f behaviral mdificatin and dietary restrictin fr at least 6 mnths and has failed t achieve the desired weight lss, and will remain engaged thrughut curse f therapy Fr Active Duty Service Members: The individual must be enrlled in a Service-specific Health/Wellness Prgram AND adhere t Service plicy, AND will remain engaged thrughut curse f therapy Patient is nt pregnant If patient has impaired glucse tlerance r diabetes, must have tried metfrmin first, r is cncurrently taking metfrmin Prir Authrizatin expires after 4 mnths Renewal PA Criteria: Belviq r Belviq XR will be apprved fr an additinal 12 mnths if the fllwing are met: The patient is currently engaged in behaviral mdificatin and n a reduced calrie diet 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 8 f 43

9 The patient has lst 5% f baseline bdy weight since starting medicatin The patient is nt pregnant Additinally, fr Active Duty Service Members: The individual cntinues t be enrlled in a Service-specific Health/Wellness Prgram AND adheres t Service plicy, AND will remain engaged thrughut curse f therapy 6. rlistat (Xenical) Adults 18 Years f Age Manual PA criteria apply t all new and current users f Xenical. Manual PA criteria Agent apprved if ALL f the fllwing criteria are met: Patient is 18 years ld The patient has tried and failed r has a cntraindicatin t ALL f the fllwing: Qsymia, Cntrave, and Belviq/Belviq XR The patient des nt have chrnic malabsrptin syndrme r chlestasis Patient has a BMI 30, r a BMI 27 fr thse with risk factrs in additin t besity (diabetes, impaired glucse tlerance, dyslipidemia, hypertensin, sleep apnea) Patient has engaged in a trial f behaviral mdificatin and dietary restrictin fr at least 6 mnths and has failed t achieve the desired weight lss, and will remain engaged thrughut curse f therapy Fr Active Duty Service Members: The individual must be enrlled in a Service-specific Health/Wellness Prgram AND adhere t Service plicy, AND will remain engaged thrughut curse f therapy Patient is nt pregnant If patient has impaired glucse tlerance r diabetes, must have tried metfrmin first, r is cncurrently taking metfrmin, including nnalchlic steathepatitis (NASH) Prir Authrizatin expires after 4 mnths Renewal PA Criteria: Xenical will be apprved fr an additinal 12 mnths if the fllwing are met: The patient is currently engaged in behaviral mdificatin and n a reduced calrie diet The patient has lst 5% f baseline bdy weight since starting medicatin The patient is nt pregnant 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 9 f 43

10 Additinally, fr Active Duty Service Members: The individual cntinues t be enrlled in a Service-specific Health/Wellness Prgram AND adheres t Service plicy, AND will remain engaged thrughut curse f therapy 7. rlistat (Xenical) Pediatric Patients 12 t 17 Years f Age Manual PA criteria apply t all new and current users f Xenical. Manual PA criteria Agent apprved if ALL f the fllwing criteria are met: Patient is between the ages f 12 and 17 years ld The patient currently has a BMI f 95th percentile fr age and sex, OR if in 85th percentile but < 95th percentile fr age and sex and has at least ne severe c-mrbidity (type 2 diabetes mellitus, premature cardivascular disease) r has a strng family histry f diabetes r premature cardivascular disease (CVD) Patient has engaged in a trial f behaviral mdificatin and dietary restrictin fr at least 3 mnths and has failed t achieve the desired weight lss, and will remain engaged thrughut curse f therapy Patient is nt pregnant Prir Authrizatin expires after 4 mnths Renewal PA Criteria: Xenical will be apprved fr an additinal 12 mnths if the fllwing are met: The patient is currently engaged in behaviral mdificatin and n a reduced calrie diet The patient s current BMI percentile has decreased fr age and weight (cnsidering the patient is increasing in height and will have a different nrmative BMI frm when Xenical was started) OR The patient currently has a BMI >85 th percentile The patient is nt pregnant 8. liraglutide 3 mg injectin (Saxenda) Manual PA criteria apply t all new and current users f Saxenda. Manual PA criteria Agent apprved if ALL f the fllwing criteria are met: Patient is 18 years ld Patient has tried and failed tried r has a cntraindicatin t all f the fllwing agents: Qsymia, Xenical, Cntrave, and Belviq r Belviq XR If the patient is diabetic, must have tried and failed metfrmin and the preferred GLP1-RA (Byduren) 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 10 f 43

11 Cncmitant use f Saxenda with anther GLP1RA is nt allwed (e.g., Byduren, Byetta, Adlyxin, Victza, Sliqua, Xultphy) The patient des nt have a histry f r family histry f medullary thyrid cancer, r multiple endcrine neplasia syndrme type 2 Patient has a BMI 30, r a BMI 27 fr thse with risk factrs in additin t besity (diabetes, impaired glucse tlerance, dyslipidemia, hypertensin, sleep apnea) Patient has engaged in a trial f behaviral mdificatin and dietary restrictin fr at least 6 mnths and has failed t achieve the desired weight lss, and will remain engaged thrughut curse f therapy Fr Active Duty Service Members: The individual must be enrlled in a Service-specific Health/Wellness Prgram AND adhere t Service plicy, AND will remain engaged thrughut curse f therapy Patient is nt pregnant, including Diabetes Mellitus Prir Authrizatin expires after 4 mnths Renewal PA Criteria: Belviq r Belviq XR will be apprved fr an additinal 12 mnths if the fllwing are met: The patient is currently engaged in behaviral mdificatin and n a reduced calrie diet Saxenda will be discntinued if a 4% decrease in baseline bdy weight is nt achieved at 16 weeks The patient is nt pregnant Additinally, fr Active Duty Service Members: The individual cntinues t be enrlled in a Service-specific Health/Wellness Prgram AND adheres t Service plicy, AND will remain engaged thrughut curse f therapy E. Weight Lss Agents UF and PA Implementatin Plan The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) an effective date f the first Wednesday after a 90-day implementatin in all pints f service. III. UF CLASS REVIEWS WEIGHT LOSS AGENTS BAP Cmments A. Weight Lss Agents UF Recmmendatin The P&T Cmmittee recmmended the fllwing: 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 11 f 43

12 UF Didrex, generics Tenuate, Tandil, generics Bntril, Bntril SR, generics Adipex-P, generics NF Saxenda Belviq, Belviq XR Cntrave Xenical Lmaira Qsymia BAP Cmment: Cncur Nn-cncur Additinal Cmments and Dissensin B. Weight Lss Agents Manual PA Criteria The P&T Cmmittee recmmended manual PA criteria fr all the weight lss drugs, including the generic prducts, in all new and current users. In general, lifestyle interventin fr at least six mnths is required prir t use f a weight lss drug, and is required thrughut treatment. Additinally, a trial f phentermine is required prir t use f the branded agents, unless the patient has significant cardivascular disease r ther cntraindicatins t a stimulant. Renewal PA criteria are required after 12 weeks fr the generic prducts, and after fur mnths fr the prducts apprved fr lng-term use (Belviq, Belviq XR, Cntrave, Qsymia, Saxenda, and Xenical). The renewal PA will expire after 12 mnths fr all the prducts. The full PA criteria were stated previusly. BAP Cmment: Cncur Nn-cncur Additinal Cmments and Dissensin C. Weight Lss Agents UF and PA Implementatin Plan 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 12 f 43

13 The P&T Cmmittee recmmended an effective date f the first Wednesday after a 90- day implementatin in all pints f service. BAP Cmment: Cncur Nn-cncur Additinal Cmments and Dissensin IV. UF CLASS REVIEWS ONCOLOGIC AGENTS: MULTIPLE MYELOMA SUBCLASS P&T Cmments A. Onclgic Agents: Multiple Myelma Subclass Relative Clinical Effectiveness Analysis and Cnclusin The P&T Cmmittee evaluated the ral therapies fr multiple myelma; the subclass has nt previusly been reviewed fr frmulary status. Multiple myelma is the 14th mst cmmn cancer, but represents nly 1.8% f all new cancers diagnsed in the United States. The median age f diagnsis is 69 years, and there is a 50% 5-year mrtality rate. The disease is characterized by a series f remissins and relapses, eventually prgressing t treatment-refractry disease, and ultimately, patient demise. The multiple myelma drug class cnsists f five prducts: three immunmdulatrs, thalidmide (Thalmid), lenalidmide (Revlimid), and pmalidmide (Pmalyst); ne prteasme inhibitr, ixazmib (Ninlar); and, the histne deacetylase inhibitr panbinstat (Farydak). N generic alternatives exist fr these branded agents, with the earliest patent r rphan drug expiratin expected in Despite the fact that multiple myelma impacts nly a small fractin f the MHS ppulatin, (<2,000 patients), the drugs accunt fr $136 millin in yearly expenditures. Expenditures are primarily driven by ne prduct, Revlimid, which has increased in price by 39% within the last 5 years, exceeding mre than $100 millin per year in expenditures. Cmplexities in determining the relative clinical effectiveness f the multiple myelma drugs include the use f cncmitant intravenus chemtherapies that are nt part f the TRICARE pharmacy benefit [e.g., brtezmib (Velcade), carfilzmib (Kyprlis)], the practice f cmbining therapies when patients relapse rather than replacing therapies, and the significant txicities f the drugs. Relative Clinical Effectiveness Cnclusin The P&T Cmmittee cncluded (16 fr, 0 ppsed, 0 abstained, 1 absent) the fllwing fr the Multiple Myelma drugs: Multiple Myelma is a cmplex and rapidly evlving field with management decisins based n several factrs, including staging and grading f disease, cytgenetic prfiles, 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 13 f 43

14 patient respnse t previus therapy, and adverse event prfiles. Treatment is nt curative. The Natinal Cmprehensive Care Netwrk (NCCN) guidelines supprt that the backbne f multiple myelma therapy includes regimens cmprised f triplet therapies (lenalidmide with Velcade and dexamethasne), prteasme inhibitin, and immunmdulatry agents. Lenalidmide (Revlimid) is the preferred immunmdulatry agent acrss the full spectrum f disease curse, frm frntline therapy t the multi-relapsed r refractry state. Lenalidmide is als FDA apprved fr treating mantle cell lymphma and myeldysplastic syndrme. Thalidmide (Thalmid) is reserved fr very specific circumstances, largely related t its increased txicity relative t lenalidmide. Thalidmide has a wide range f FDAapprved and ff-label indicatins. Pmalidmide (Pmalyst) is reserved as an alternative regimen in relapsed/refractry disease that has nt respnded t treatment with lenalidmide. Ixazmib (Ninlar) and panbinstat (Farydak) are indicated fr relapsed/refractry disease after at least ne previus therapy and demnstrate nly mdest efficacy. Panbinstat lacks an verall survival benefit and is prly tlerated. Each f the multiple myelma drugs is assciated with significant txicities that can be life threatening and frequently result in dsage reductins. The immunmdulatrs are well-knwn teratgens, with FDA requirements fr a Risk Evaluatin and Mitigatin Strategies (REMS) prgram; they als increase the risk fr venus thrmbemblism (VTE). Ninlar and Pmalyst bth cause thrmbcytpenia and diarrhea. Finally, Farydak increases the risk f death via hemrrhagic, arrhythmgenic, and ischemic cardiac events. B. Onclgic Agents: Multiple Myelma Subclass Relative Cst-Effectiveness Analysis and Cnclusin CMA was perfrmed. The P&T Cmmittee cncluded (16 fr, 0 ppsed, 0 abstained, 1 absent) the fllwing: CMA results shwed thalidmide (Thalmid) was the mst cst-effective multiple myelma drug, fllwed by ixazmib (Ninlar), panbinstat (Farydak), lenalidmide (Revlimid), and pmalidmide (Pmalyst). C. Onclgic Agents: Multiple Myelma Subclass UF Recmmendatin The P&T Cmmittee recmmended (15 fr, 0 ppsed, 0 abstained, 2 absent) the fllwing, based n clinical and cst effectiveness: UF: ixazmib (Ninlar) 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 14 f 43

15 lenalidmide (Revlimid) panbinstat (Farydak) pmalidmide (Pmalyst) thalidmide (Thalmid) NF: Nne D. Onclgic Agents: Multiple Myelma Subclass Manual PA Criteria The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) manual PA criteria fr new users f Ninlar, Revlimid, Farydak and Pmalyst. Full PA Criteria 1. ixazmib (Ninlar) Manual PA criteria apply t all new users f Ninlar. Manual PA criteria Ninlar is apprved if all f the fllwing apply: Patient is > 18 years ld Must be prescribed by r in cnsultatin with a hematlgist r nclgist Patient is diagnsed with multiple myelma Patient must nt have had disease prgressin with a brtezmib (Velcade) r carfilzmib (Kyprlis) cntaining regimen One r mre f the fllwing must apply: Patient must have failed r nt be candidate fr Velcade AND Kyrplis Patient has failed r is nt a candidate fr Kyprlis and has high risk cytgenetics Patient will be starting Ninlar as third (r higher) line f therapy Must be used in cmbinatin with lenalidmide (Revlimid), pmalildmide (Pmalyst), OR thalidmide (Thalmid) Must be used in cmbinatin with dexamethasne Must nt be used cncurrently with Velcade r Kyrplis Prir Authrizatin des nt expire 2. lenalidmide (Revlimid) Manual PA criteria apply t all new users f Revlimid. 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 15 f 43

16 Manual PA criteria Revlimid is apprved if all f the fllwing apply: Patient is > 18 years ld Must be prescribed by r in cnsultatin with a hematlgist r nclgist Patient has ne f the fllwing diagnses: Multiple myelma Mantle Cell Lymphma refractry t at least 2 prir treatment regimens, ne f which cntains brtezmib (Velcade) OR at least 1 prir treatment regimen and has failed r has a cntraindicatin t brtezmib Myeldysplastic syndrme w/5q deletin with ne r mre f the fllwing: symptmatic anemia, transfusin-dependent anemia, r anemia nt cntrlled with an erythrid stimulating agent Patient is nt n cncurrent pmalidmide (Pmalyst) r thalidmide (Thalmid) PA will be apprved fr the fllwing nn-fda apprved indicatins: Relapsed/refractry multi-centric Castleman Disease nt respnding t nn-lenalidmide management Diffuse large B-cell lymphma (Nn-Hdgkin Lymphma) as secnd-line (r subsequent) therapy relapsed/refractry t nnlenalidmide management Fllicular lymphma (Nn-Hdgkin Lymphma) Relapsed/refractry classical Hdgkin s lymphma Myelfibrsis refractry t r with cntraindicatins t alternative therapies Systemic light chain amylidsis with rgan invlvement Off-label uses ther than thse listed abve are nt apprved Prir Authrizatin des nt expire 3. panbinstat (Farydak) Manual PA criteria apply t all new users f Farydak. Manual PA criteria Farydak is apprved if all f the fllwing apply: Must be prescribed by r in cnsultatin with a hematlgist r nclgist Patient is > 18 years ld Patient is diagnsed with multiple myelma that is relapsed r refractry 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 16 f 43

17 Patient s disease is NOT refractry t all f the fllwing drugs: brtezmib (Velcade), carfilzmib (Kyprlis), ixazmib (Ninlar) Patient will be starting Farydak as the third (r higher) line f therapy Patient s previus regimens include at least ne regimen with brtezmib, carfilzmib OR ixazmib, AND at least ne regimen with lenalidmide, pmalidmide, OR thalidmide Must be used in cnjunctin with dexamethasne Must be used in cnjunctin with a brtezmib, carfilzmib, OR Ninlar-cntaining regimen Must meet the ALL f the fllwing requirements: Platelet cunt > 100x109/L QTc < 450 msec Patient has n evidence f acute r chrnic ischemic disease n EKG and n histry f MI r unstable angina within the last 6 mnths Patient must have access t anti-diarrheal therapy Prir Authrizatin expires after 12 mnths Renewal PA Criteria: PA will be re-apprved fr an additinal 6 mnths, if the patient has nt yet cmpleted 16 cycles f treatment 4. pmalidmide (Pmalyst) Manual PA criteria apply t all new users f Pmalyst. Manual PA criteria Pmalyst is apprved if all f the fllwing apply: Patient is > 18 years ld Must be prescribed by r in cnsultatin with a hematlgist r nclgist Patient is diagnsed with relapsed/refractry multiple myelma that is refractry t lenalidmide AND all f the fllwing must apply: Patient has previusly had a trial f a brtezmib, carfilzmib, OR Ninlar-cntaining regimen Patient will be starting Pmalyst as third (r higher) line f therapy Must be used in cmbinatin with dexamethasne Patient is nt using cncurrent lenalidmide r thalidmide PA will be apprved fr the fllwing nn-fda apprved indicatins: 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 17 f 43

18 Myelfibrsis refractry t r with cntraindicatins t alternative therapies (including lenalidmide) and erythrpietin levels > 500 mu/ml Systemic light chain amylidsis with rgan invlvement refractry t r with cntraindicatins t alternative therapies including lenalidmide Off-label uses ther than thse listed abve are nt apprved Prir Authrizatin des nt expire E. Onclgic Agents: Multiple Myelma Subclass UF and PA Implementatin Plan The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) 1) an effective date f the first Wednesday after a 60-day implementatin perid in all pints f service. V. UF CLASS REVIEWS ONCOLOGIC AGENTS: MULTIPLE MYELOMA SUBCLASS BAP Cmments A. Onclgic Agents: Multiple Myelma Subclass UF Recmmendatin The P&T Cmmittee recmmended the fllwing, based n clinical and cst effectiveness: UF: Ninlar Revlimid Farydak Pmalyst Thalmid NF: Nne BAP Cmment: Cncur Nn-cncur Additinal Cmments and Dissensin B. Onclgic Agents: Multiple Myelma Subclass Manual PA Criteria The P&T Cmmittee recmmended manual PA criteria fr new users f Ninlar, Revlimid, Farydak and Pmalyst. 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 18 f 43

19 PA des nt expire, with the exceptin f Farydak, where PA will be re-apprved fr an additinal 6 mnths, if the patient has nt yet cmpleted 16 cycles f treatment. The full manual PA criteria were stated previusly. The Full PA criteria were stated previusly BAP Cmment: Cncur Nn-cncur Additinal Cmments and Dissensin C. Onclgic Agents: Multiple Myelma Subclass UF and PA Implementatin Plan The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) 1) an effective date f the first Wednesday after a 60-day implementatin perid in all pints f service. BAP Cmment: Cncur Nn-cncur Additinal Cmments and Dissensin VI. UF CLASS REVIEWS VITAMINS: PRENATAL VITAMINS SUBCLASS P&T Cmments A. Vitamins: Prenatal Vitamins Subclass Relative Clinical Effectiveness Analysis and Cnclusin Backgrund At the August 2017 meeting, the P&T Cmmittee discussed the planned transitin f multiple Natinal Drug Cdes (NDCs), including all legend prenatal vitamins, frm prescriptin t nn-prescriptin status in the First DataBank drug database. Actins recmmended by the P&T Cmmittee in respnse t this change were apprved by the Directr, DHA, n Octber 20, 2017, but are n hld due t recent litigatin between utside parties cncerning the change in status fr these prducts. Therefre, prenatal vitamins currently listed as legend drugs remain a cvered TRICARE pharmacy benefit, and thus were cnsidered fr frmulary status. A ttal f 152 different prenatal vitamins (by brand name) were dispensed at any DD pint f service during Fiscal Year Relative Clinical Effectiveness Analysis and Cnclusin The P&T Cmmittee cncluded (17 fr, 0 ppsed, 0 abstained, 0 absent) the fllwing: 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 19 f 43

20 Prenatal vitamins are a lw-cst interventin knwn t imprve utcmes by preventing neural tube defects and prviding adequate irn stres t prevent anemia and decrease nausea and vmiting during pregnancy. U.S. Preventive Services Task Frce (USPSTF) guidelines recmmend that all wmen wh are planning r capable f pregnancy take a daily supplement cntaining 0.4 t 0.8 mg f flic acid (Grade A recmmendatin). Cntinued TRICARE cverage f prenatal vitamins is highly desirable in rder t ensure uninterrupted access t essential care. Prvisin f prenatal vitamins as part f the TRICARE pharmacy benefit is even mre imprtant fr the MHS than civilian health plans, given wrldwide assignment f female service members and beneficiaries t cuntries with variable availability f fd prducts frtified with flic acid. In additin t irn and flic acid, prenatal vitamins may als cntain additinal cmpnents, including fatty acids [e.g., dcsahexaenic acid (DHA), mega-3, and eicsapentaenic acid (EPA)] and calcium. Prenatal vitamins that prvide alternative dsage frms (gummies, chewable, smaller capsule r tablet size, etc.), are available due t patient preference r marketing issues. Prenatal vitamins exhibit a high degree f therapeutic interchangeability. B. Vitamins: Prenatal Vitamins Subclass Relative Cst-Effectiveness Analysis and Cnclusin The relative cst-effectiveness analysis included identifying the highest vlume, mst csteffective ptins that wuld prvide a variety f frmulatins t meet the clinical needs f beneficiaries, based n ingredient cst and usage at each pint f service (MTF, TRICARE Mail Order Pharmacy, Retail Netwrk pharmacies). The Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) the fllwing prducts (listed by brand name) cmprise the highest vlume, lwest cst ptins at all three pints f service: Prenatal Vitamins Plus Lw I, Prenatal Vitamin + Lw Irn, Prenatal Plus, Preplus, Prenatal (OTC), Prenatal Vitamins (OTC), Prenatal Multi + DHA (OTC) and Prenatal Frmula (OTC). C. Vitamins: Prenatal Vitamins Subclass UF Recmmendatin The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) placing the fllwing legend prducts n the UF, with all ther legend prenatal vitamins designated NF: UF: Prenatal Vitamins Plus Lw I Prenatal Vitamin + Lw Irn Prenatal Plus Preplus NF: All ther legend prenatal vitamins. 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 20 f 43

21 Nte that the prducts recmmended fr UF placement, listed abve, include apprximately 90% f the 30-day equivalent prescriptins dispensed fr prenatal vitamins. The prducts recmmended fr UF placement is different frm, and thus supersedes, the list f agents identified as highest value in the August 2017 DD P&T Cmmittee minutes (available at Pharmacy-and-Therapeutics-Cmmittee/Meeting-Minutes). Selecting these agents facilitates the standardizatin f available agents in the Prenatal Vitamin subclass acrss DD pints f service. D. Vitamins: Prenatal Vitamins Subclass Prir Authrizatin Age and Gender Edit Prenatal vitamins are nt currently cvered fr male patients, and female patients lder than 45 years f age, cnsistent with TRICARE cverage f legend prenatal vitamins fr pregnancy-related use nly. The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) maintaining the current age and gender requirements fr prenatal vitamins. The P&T Cmmittee nted expert pinin stating that pregnancy was very rare past the age f 45, but agreed that the requirement shuld be verridden in such cases. E. Vitamins: Prenatal Vitamins Subclass UF and PA Implementatin Plan The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) 1) an effective date f the first Wednesday after a 90-day implementatin perid in all pints f service and, 2) DHA send letters t beneficiaries wh are affected by the UF decisin. VII. UF CLASS REVIEWS VITAMINS: PRENATAL VITAMINS SUBCLASS BAP Cmments A. Vitamins: Prenatal Vitamins Class UF Recmmendatin The P&T Cmmittee recmmended placing the fllwing legend prducts n the UF, with all ther legend prenatal vitamins designated NF: UF: Prenatal Vitamins Plus Lw I Prenatal Vitamin + Lw Irn Prenatal Plus Preplus NF: All ther legend prenatal vitamins 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 21 f 43

22 BAP Cmment: Cncur Nn-cncur Additinal Cmments and Dissensin B. Vitamins: Prenatal Vitamins Subclass Prir Authrizatin Age and Gender Edit Prenatal vitamins are nt currently cvered fr male patients, and female patients lder than 45 years f age, cnsistent with TRICARE cverage f legend prenatal vitamins fr pregnancy-related use nly. The P&T Cmmittee recmmended maintaining the current age and gender requirements fr prenatal vitamins BAP Cmment: Cncur Nn-cncur Additinal Cmments and Dissensin C. Vitamins: Prenatal Vitamins Subclass UF and PA Implementatin Plan The P&T Cmmittee recmmended 1) an effective date f the first Wednesday after a 90- day implementatin perid in all pints f service and, 2) DHA send letters t beneficiaries wh are affected by the UF decisin. BAP Cmment: Cncur Nn-cncur Additinal Cmments and Dissensin VIII. NEWLY-APPROVED DRUGS PER CFR (g)(5) P&T Cmments A. Newly-Apprved Drugs per CFR (g)(5) Relative Clinical Effectiveness and Relative Cst-Effectiveness Cnclusins The P&T Cmmittee agreed (Day 1: 17 fr, 0 ppsed, 0 abstained, 0 absent; Day 2: 16 fr, 0 ppsed, 0 abstained, 1 absent) with the relative clinical and cst-effectiveness analyses presented fr the newly-apprved drugs reviewed accrding t 32 CFR (g)(5). 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 22 f 43

23 B. Newly-Apprved Drugs per CFR (g)(5) UF Recmmendatin The P&T Cmmittee recmmended (Day 1: 17 fr, 0 ppsed, 0 abstained, 0 absent; Day 2: 16 fr, 0 ppsed, 0 abstained, 1 absent) the fllwing: UF: NF: abemaciclib (Verzeni) Oral Onclgy Agents fr Breast Cancer belimumab (Benlysta) Immunsuppressive Agents Systemic Lupus Erythematsus plasma-derived human C1 esterase inhibitr SQ injectin (Haegarda) Hereditary Angiedema (HAE) enasidenib (Idhifa) Oral Onclgy Agents fr Acute Myelgenus Leukemia fluticasne furate/umeclidinium/vilanterl (Trelegy Ellipta) Pulmnary II Cmbinatin Agents Chrnic Obstructive Pulmnary Disease (COPD) glecaprevir/pibrentasvir (Mavyret) Hepatitis C Virus Direct Acting Antivirals (HCV DAAs) L-glutamine (Endari) Dietary Supplements naldemedine (Sympric) Gastrintestinal-2 Agents Opiid Induced Cnstipatin (OIC) Drugs neratinib (Nerlynx) Oral Onclgy Agents fr Breast Cancer nitisinne (Nityr) Metablic Replacement Agents perampanel (Fycmpa ral slutin) Anticnvulsants/Anti-Mania Agents sfsbuvir/velpatasvir/vxilaprevir (Vsevi) HCV DAAs amantadine ER (Gcvri) Parkinsn s Disease Drugs betrixaban (Bevyxxa) Oral Anticagulants delaflxacin (Baxdela) Antibitics Quinlnes fluticasne prpinate (ArmnAir RespiClick) Pulmnary I Agents Inhaled Crticsterids guselkumab (Tremfya) injectin Targeted Immunmdulatry Bilgics (TIBs) insulin aspart (Fiasp) Insulins Shrt-Acting Agents lesinurad/allpurinl (Duzall) Antigut Agents Chrnic methylphenidate ER rally disslving tablet (Ctempla XR ODT) Attentin Deficit Hyperactivity Disrder (ADHD) Drugs simvastatin ral suspensin (FlLipid) Antilipidemic-1s C. Newly-Apprved Drugs per CFR (g)(5) PA Criteria The P&T Cmmittee recmmended (Day 1: 17 fr, 0 ppsed, 0 abstained, 0 absent; Day 2: 16 fr, 0 ppsed, 0 abstained, 1 absent) the fllwing: Applying the same manual PA criteria fr Tremfya in new users, as is currently in place fr the ther nn step-preferred TIBs. Patients must first try adalimumab 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 23 f 43

24 (Humira). Additinally, fr Tremfya, a trial f bth secukinumab (Csentyx) and ustekinumab (Stelara) is required if the patient cannt be treated with Humira. Applying the same manual PA criteria t new users f Vsevi and Mavyret as is currently in place fr the ther nn step-preferred DAAs fr chrnic hepatitis C infectin. Harvni is the preferred agent. Revising the manual PA criteria fr Haegarda in new users t nt allw cncmitant use with anther C1 esterase inhibitr prduct. The full PA criteria will be presented in the Utilizatin Management sectin. Applying manual PA criteria t new users f Verzeni, Gcvri, Idhifa, Endari, Nerlynx, and Fycmpa. Applying PA criteria t new and current users f Benlysta, ArmnAir RespiClick, Fiasp, Duzall, Ctempla XR ODT, and FlLipid. Full PA Criteria fr the Newly-Apprved Drugs per CFR (g)(5) 1. TIBs: guselkumab (Tremfya) Changes made frm the Nvember 2017 meeting are in bld. Step therapy and Manual PA Criteria apply t all new users f guselkumab (Tremfya). Autmated PA criteria: The patient has filled a prescriptin fr adalimumab (Humira) at any MHS pharmacy pint f service (MTFs, retail netwrk pharmacies, r mail rder) during the previus 180 days. AND Manual PA criteria: If autmated criteria are nt met, cverage is apprved fr Tremfya if: AND Cntraindicatins exist t Humira and Csentyx, and Stelara Inadequate respnse t Humira and Csentyx, and Stelara (need fr different anti-tumr necrsis factr [TNF] r nn-tnf) There is n frmulary alternative: patient requires a nn-tnf TIB fr symptmatic cngestive heart failure (CHF) Adverse reactins t Humira and Csentyx, and Stelara nt expected with requested nn step-preferred TIB Cverage apprved fr patients 18 years with: 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 24 f 43

25 Mderate t severe plaque psriasis wh are candidates fr phttherapy r systemic therapy and have failed t respnd t r lst respnse t ther systemic therapies Prir Authrizatin des nt expire Cverage is NOT prvided fr cncmitant use with ther TIBs. 2. HCV DAAs: a) glecaprevir/pibrentasvir (Mavyret) Manual PA criteria apply t new users f Mavyret. Manual PA Criteria: cverage will be apprved if all criteria are met: The patient is 18 years f age and diagnsed with chrnic Hepatitis C Virus (HCV) infectin Mavyret is prescribed in cnsultatin with r by a gastrenterlgist, hepatlgist, infectius diseases physician r a liver transplant physician The patient cannt use Harvni (i.e. due t HCV GT2 r GT3) PA des nt expire. b) sfsbuvir/velpatasvir/vxilaprevir (Vsevi) Manual PA criteria apply t new users f Vsevi. Manual PA Criteria: cverage will be apprved if ALL f the fllwing criteria are met: The patient is 18 years f age and diagnsed with Chrnic Hepatitis C Virus (HCV) infectin Vsevi is prescribed in cnsultatin with r by a gastrenterlgist, hepatlgist, infectius diseases physician r a liver transplant physician The patient has HCV gentype 1, 2, 3, 4, 5, r 6 AND has tried and failed treatment with a NS5A Inhibitr (e.g., daclatasvir (Daklinza), ledipasvir, mbitasvir, velpatasvir, elbasvir) OR The patient has HCV gentype 1a r 3 AND has tried and failed treatment with Svaldi withut a NS5A Inhibitr AND the patient des nt have any f the fllwing: Decmpensated cirrhsis 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 25 f 43

26 Mderate r severe hepatic impairment (Child-Pugh Class B r C) Severe renal impairment (egfr <30 ml/min r End Stage Renal Disease) Prir Authrizatin des nt expire. 3. Oral Onclgic Agents: abemaciclib (Verzeni) Manual PA criteria apply t all new users f Verzeni Manual PA criteria Verzeni is apprved if all f the fllwing apply: The patient has a diagnsis f HR+, HER2 negative advanced r metastatic breast cancer Breast cancer has prgressed during r after endcrine therapy The patient is using Verzeni and meets ALL f the fllwing: Patient is pstmenpausal and will use Verzeni in cmbinatin with fulvestrant OR The patient is premenpausal r perimenpausal and is receiving varian suppressin with GnRH agnist AND Verzeni will be used in cmbinatin with fulvestrant OR Verzeni will be used as mntherapy and the patient has had prir chemtherapy fr treatment f metastatic breast cancer Prir Authrizatin des nt expire 4. Parkinsn s Disease Drugs: amantadine ER tabs (Gcvri) Manual PA criteria apply t all new users f Gcvri Manual PA Criteria Gcvri is apprved if: The patient is 18 years ld AND Has a diagnsis f Parkinsn s Disease AND Has had therapeutic failure f a trial f amantadine 200 mg immediate release tablets administered twice daily Off label uses are nt apprved Prir Authrizatin des nt expire 5. Oral Onclgic Agents: enasidenib (Idhifa) Manual PA criteria apply t all new users f Idhifa. Manual PA criteria Idhifa is apprved if all the fllwing criteria are met: 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 26 f 43

27 The patient is 18 years ld and has a diagnsis f relapsed refractry acute myelgenus leukemia (AML) Patient exhibits the IDH2 mutatin as determined by an FDA apprved test Must be prescribed by r in cnsultatin with hematlgist r nclgist Idhifa is used in cmbinatin with standard chemtherapy prtcls Prir Authrizatin expires at ne year. Renewal criteria: Idhifa will be apprved fr ne year if the patient has nt had disease prgressin. 6. Dietary Supplements: L-glutamine ral pwder (Endari) Manual PA criteria apply t new users f Endari. Manual PA Criteria: cverage will be apprved if ALL f the fllwing criteria are met: Patient has a diagnsis f sickle cell anemia r Sickle ß thalassemia Age 5 years ld Patient has had 2 sickle cell crises in the last 12 mnths Patient has had an inadequate treatment respnse t a 3 mnth trial f bth hydrxyurea and bld transfusin therapy Prir Authrizatin des nt expire. 7. Oral Onclgic Agents: neratinib (Nerlynx) Manual PA criteria apply t all new users f Nerlynx Manual PA criteria Nerlynx is apprved if meets all f the fllwing: The patient is an adult >18 years f age with early stage HER2- verexpressed/amplified breast cancer Nerlynx is used fllwing adjuvant trastuzumab-based therapy (preferably less than 1 year, but n mre than 2 years after cmpletin f trastuzumab (Herceptin)-based therapy. The patient has been cunseled n significant adverse event prfile Nerlynx is c-prescribed with an antidiarrheal t mitigate adverse events fr at a minimum 2 mnths 4 January 2018 Beneficiary Advisry Panel Backgrund Infrmatin Page 27 f 43