DEPARTMENT OF DEFENSE PHARMACY AND THERAPEUTICS COMMITTEE MINUTES AND RECOMMENDATIONS November 2017

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1 DEPARTMENT OF DEFENSE PHARMACY AND THERAPEUTICS COMMITTEE MINUTES AND RECOMMENDATIONS Nvember 2017 I. CONVENING The Department f Defense (DD) Pharmacy and Therapeutics (P&T) Cmmittee cnvened at 0800 hurs n Nvember 15 and 16, 2017, at the Defense Health Agency (DHA) Frmulary Management Branch, San Antni, Texas. II. ATTENDANCE The attendance rster is listed in Appendix A. A. Review Minutes f Last Meetings 1. Apprval f August 2017 Minutes Mr. Guy Kiykawa, Deputy Directr, DHA, apprved the minutes frm the August 2017 DD P&T Cmmittee meeting n Octber 20, 2017, and signed the first and secnd addenda t the minutes n September 27 and Octber 19, 2017, respectively. 2. Clarificatin t the August 2017 Minutes Implementatin Dates: The implementatin dates fr updated prir authrizatin criteria, quantity limits, line extensins, and the frmulary status and prir authrizatins fr the newly-apprved drugs per 32 CFR (g)(5) was changed t Nvember 1, III. REQUIREMENTS All clinical and cst evaluatins fr new drugs, including newly-apprved drugs reviewed accrding t 32 Cde f Federal Regulatins (CFR) (g)(5), and full drug class reviews included, but were nt limited t, the requirements stated in 32 CFR (e)(1) and (g)(5). All Unifrm Frmulary (UF) and Basic Cre Frmulary (BCF) recmmendatins cnsidered the cnclusins frm the relative clinical effectiveness and relative cst-effectiveness determinatins, and ther relevant factrs. Medical necessity (MN) criteria were based n the clinical and cst evaluatins, and the cnditins fr establishing MN fr a nnfrmulary (NF) medicatin. Nnfrmulary medicatins are generally restricted t the mail rder prgram accrding t amended sectin , revised paragraphs (h)(3)(i) and (ii), effective August 26, IV. UF DRUG CLASS REVIEWS A. Weight Lss Agents 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 Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 1 f 55

2 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. Relative Clinical Effectiveness Cnclusin 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 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. Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 2 f 55

3 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 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. Varied results were fund when Military Health System (MHS) prviders were asked their pinins n prescribing weight lss drugs. 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. 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, Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 3 f 55

4 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. 1. COMMITTEE ACTION: UF RECOMMENDATION The P&T Cmmittee recmmended (15 fr, 2 ppsed, 0 abstained, 0 absent) the fllwing: UF NF benzphetamine (Didrex, generics) diethylprpin (Tenuate, Tandil, generics) phendimetrazine IR and SR (Bntril, Bntril SR, generics) phentermine (Adipex-P, generics) 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) A weight lss drug was nt added t the BCF. 2. COMMITTEE ACTION: MANUAL PRIOR AUTHORIZATION (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 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). See Appendix C fr the full criteria. Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 4 f 55

5 3. COMMITTEE ACTION: MN CRITERIA The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) MN criteria fr Belviq, Belviq XR, Cntrave, Lmaira, Qsymia, Saxenda, and Xenical. See Appendix B fr the full criteria. 4. COMMITTEE ACTION: EXPANDED MILITARY TREATMENT FACILITY (MTF)/MAIL PHARMACY INITIATIVE (EMMPI) REQUIREMENTS The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) excluding the weight lss drugs frm the EMMPI list, as it is nt yet clear t what degree these prducts are maintenance medicatins. See Appendix G. 5. COMMITTEE ACTION: MAIL ORDER AUTO-REFILL REQUIREMENTS FOR WEIGHT LOSS AGENTS The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) excluding the weight lss agents frm the Aut-Refill prgram administered by Express Scripts, Inc. at the TRICARE Mail Order Pharmacy. 6. COMMITTEE ACTION: UF AND PA IMPLEMENTATION PERIOD 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. Based n the P&T Cmmittee s recmmendatin, the effective date is May 2, B. Onclgic Agents: Multiple Myelma Subclass Backgrund 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 Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 5 f 55

6 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, patient respnse t previus therapy, and adverse event prfiles. Treatment is nt curative. The Natinal Cmprehensive Cancer 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. 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). Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 6 f 55

7 1. COMMITTEE ACTION: UF RECOMMENDATION The P&T Cmmittee recmmended (15 fr, 0 ppsed, 0 abstained, 2 absent) the fllwing, based n clinical and cst effectiveness: UF: ixazmib (Ninlar) lenalidmide (Revlimid) panbinstat (Farydak) pmalidmide (Pmalyst) thalidmide (Thalmid) NF: Nne Nte that a BCF prduct was nt selected fr the Multiple Myelma drug subclass. 2. COMMITTEE ACTION: MANUAL PA CRITERIA The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) manual PA criteria fr new users f Revlimid, Pmalyst, Ninlar, and Farydak. See Appendix C fr the full criteria. 3. COMMITTEE ACTION: QUANTITY LIMITS (QLs) QLs fr the multiple myelma drugs have previusly been in place due t the likelihd f dsage reductins required due t txicity. The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) maintaining the current QLs fr Revlimid, Pmalyst, and Thalmid, and revising the QL fr Ninlar and Fardyak based n FDA dsing guidelines and treatment curses. See Appendix D fr the QLs. 4. COMMITTEE ACTION: UF AND PA IMPLEMENTATION PERIOD The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) an effective date f the first Wednesday after a 60-day implementatin perid in all pints f service. Based n the P&T Cmmittee s recmmendatin, the effective date is April 4, C. Vitamins: Prenatal Vitamins Subclass 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 2017 (see Appendix E). Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 7 f 55

8 Relative Clinical Effectiveness Analysis and Cnclusin The P&T Cmmittee cncluded (17 fr, 0 ppsed, 0 abstained, 0 absent) the fllwing: 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. Relative Cst-Effectiveness Analysis and Cnclusin The relative cst-effectiveness analysis included identifying the highest vlume, mst cst-effective 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) typically 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). 1. COMMITTEE ACTION: UF RECOMMENDATION 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 Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 8 f 55

9 NF: All ther legend prenatal vitamins listed in Appendix E ther than thse listed abve. 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 MHS-Organizatins/DD-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. 2. COMMITTEE ACTION: BCF RECOMMENDATION The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) t make n BCF selectin in the Prenatal Vitamin subclass, r in the verall Vitamin Class, given uncertainty regarding ptential future changes in legend status. The P&T Cmmittee als nted the pssibility f establishing a jint natinal cntract with the U.S. Department f Veterans Affairs (VA) fr prenatal vitamins. 3. COMMITTEE ACTION: MTF OTC TEST LIST RECOMMENDATION The P&T Cmmittee als agreed that prenatal vitamins currently listed as OTC prducts shuld be cnsidered fr additin t the MTF OTC Test List (see Aligning OTC Frmularies n page 52 f the May 2017 DD P&T Cmmittee meeting minutes). The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) placing the fllwing OTC prenatal vitamins n the MTF OTC Test List: Prenatal, Prenatal Vitamins, Prenatal Multi+DHA, Prenatal Frmula. Nte that items nt included n the MTF OTC Test List will reject at MTF sites under the new electrnic health recrd system (MHS Genesis). 4. COMMITTEE ACTION: MN CRITERIA The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) MN criteria fr the prenatal vitamins. See Appendix B fr the full criteria. 5. COMMITTEE ACTION: 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. Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 9 f 55

10 6. COMMITTEE ACTION: EMMPI REQUIREMENTS The P&T Cmmittee recmmended (17 fr, 0 ppsed, 0 abstained, 0 absent) t nt add the legend prenatal vitamins t the EMMPI prgram, and that the NF prenatal vitamins shuld be exempted frm the NF mail rder requirement due t feasibility issues related t the sheer number f prducts invlved. 7. COMMITTEE ACTION: UF IMPLEMENTATION PERIOD 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. Based n the P&T Cmmittee s recmmendatin, the effective date is May 2, V. NEWLY-APPROVED DRUGS PER 32 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). See Appendix F fr the cmplete list f newly-apprved drugs reviewed at the Nvember 2017 P&T Cmmittee meeting, a brief summary f their clinical attributes, and their frmulary recmmendatins, and see Appendix G fr their restrictin t r exemptin frm the Mail Order Pharmacy. A. COMMITTEE ACTION: UF RECOMMENDATION 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: 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 Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 10 f 55

11 sfsbuvir/velpatasvir/vxilaprevir (Vsevi) HCV DAAs NF: 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 B. COMMITTEE ACTION: MN 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) MN criteria fr Gcvri, Bevyxxa, Baxdela, ArmnAir RespiClick, Tremfya, Fiasp, Duzall, Ctempla XR ODT, and Fllipid. See Appendix B fr the full criteria. C. COMMITTEE ACTION: 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 (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. 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. Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 11 f 55

12 VI. D. COMMITTEE ACTION: UF, MN, AND PA IMPLEMENTATION PERIOD 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) an effective date upn the first Wednesday tw weeks after the signing f the minutes in all pints f service, n February 14, UTILIZATION MANAGEMENT A. PA Criteria, Step Therapy, and MN Criteria 1. New Manual PA Criteria: Antidepressants and Nn-Opiid Pain Syndrme Agents Buprpin Hydrbrmide (Aplenzin) Aplenzin is a branded frmulatin f buprpin ER apprved fr treating majr depressive disrder and seasnal affective disrder. It was designated NF at the Nvember 2009 meeting. Aplenzin cntains a hydrbrmide (HBr) salt, cmpared t the hydrchlride salt in Wellbutrin XL. The tw frmulatins are biequivalent. Cst-effective generic frmulatins f Wellbutrin are available and n the UF. a) COMMITTEE ACTION: BUPROPION HBr MANUAL PA CRITERIA The P&T Cmmittee recmmended (14 fr, 0 ppsed, 0 abstained, 3 absent) manual PA criteria fr Aplenzin, due t the significant cst differences and lack f clinically cmpelling benefits between Aplenzin and generic buprpin ER. New and current users f Aplenzin are required t try generic buprpin ER and a secnd antidepressant first. See Appendix C fr the full criteria. 2. Updated Manual PA Criteria, Step Therapy, and MN Criteria Updates t the step therapy and manual PA criteria fr several drugs were recmmended by the P&T Cmmittee due t a variety f reasns, including expanded FDA indicatins. The updated manual PA utlined belw will apply t new users. a) Oral Onclgical Agents: Dabrafenib (Tafinlar) and Trametinib (Mekinist) Tafinlar and Mekinist were reviewed in August 2014 with manual PA criteria recmmended. Criteria were updated t add the additinal indicatin fr nn-small cell lung cancer (NSCLC). b) Oral Onclgical Agents: Vemurafenib (Zelbraf) Zelbraf was reviewed in February 2012 with manual PA criteria recmmended. Criteria were updated t add the additinal indicatin fr Erdheim-Chester Disease with BRAF V600 mutatin. c) TIBs Ustekinumab (Stelara) Stelara was reviewed in August 2014 with manual PA criteria recmmended. Criteria were updated t add the additinal indicatin fr severe plaque psriasis in patients 12 t 18 years ld. d) Crticsterids Immune Mdulatrs Atpic Dermatitis Subclass: Crisabrle (Eucrisa) Eucrisa was reviewed in May 2017 with manual PA criteria recmmended. Several atpic dermatitis agents are nw available in Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 12 f 55

13 generic frmulatins. Due t the significant cst differences between Eucrisa and frmulary alternatives, the PA criteria were updated t include a tw-week trial f at least tw frmulary medium t high ptency tpical sterids r a tpical calcineurin inhibitr (e.g., tacrlimus, Elidel) prir t use f Eucrisa. e) Crticsterids Immune Mdulatrs Hereditary Angiedema (HAE) Subclass: Plasma-derived human C1 Esterase Inhibitr IV (Cinryze) The HAE drugs were reviewed fr frmulary status in August 2017, and Haegarda was reviewed as a new drug during the Nvember 2017 P&T Cmmittee meeting (see pages 10-11). Bth Haegarda and Cinryze are indicated fr prphylaxis f HAE episdes. The manual PA criteria were updated t prhibit cncmitant use f Cinryze and Haegarda. f) Gastrintestinal-2 (GI-2) Agents Miscellaneus Subclass: Rifaximin (Xifaxan) The GI-2 drugs were reviewed fr frmulary status in Nvember Manual PA criteria apply fr rifaximin fr diarrhea predminant irritable bwel syndrme (IBS-D), requiring a trial f antispasmdic and tricyclic antidepressant first. The evidence fr rifaximin fr treating IBS-D was reviewed thrughly fr any new guideline updates and fr new published clinical trials. PA criteria frm ther cmmercial health plans were als reviewed. N changes t the current rifaximin PA criteria were recmmended at this time. g) Nn-Insulin Diabetes Drugs: GLP1RAs Step Therapy, Manual PA Criteria, and MN Criteria The NF and nn step-preferred GLP1RAs [lixisenatide (Adlyxin), liraglutide (Victza), insulin degludec (Xultphy), insulin glargine/lixisenatide (Sliqua), exenatide micrspheres BID (Byetta), and dulaglutide (Trulicity)] all require a trial f exenatide weekly (Byduren) and albiglutide (Tanzeum). Tanzeum manufacturing will cease in June The step therapy, manual PA criteria, and MN criteria fr the GLP1RAs were updated t remve the requirement f a trial f Tanzeum. Additinally, the manual PA criteria fr the UF and step-preferred prducts (Byduren and Tanzeum) were updated t reflect the market discntinuatin f Tanzeum, and t advise prescribers f this issue. (1) COMMITTEE ACTION: UPDATED MANUAL PA CRITERIA, STEP THERAPY AND MN CRITERIA The P&T Cmmittee recmmended (14 fr, 0 ppsed, 0 abstained, 3 absent) updates t the manual PA criteria fr Tafinlar, Mekinist, Zelbraf, Stelara, Cinryze, and Eucrisa, and updates t the step therapy, manual PA criteria, and MN criteria fr the GLP1RAs. All updated criteria apply t new users f these agents. See Appendix C fr the full criteria. 3. Default Step Therapy Rules Step therapy requirements are in place fr several drugs classes, where clinically effective (frmulary alternatives) and cst-effective medicatins (the step-preferred Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 13 f 55

14 prducts) are required first, befre the use f the nn step-preferred prducts. The P&T Cmmittee meets n a quarterly interval; hwever, new prducts are apprved n a rutine basis by the FDA, leading t a ptential delay in respnding apprpriately when there are new entrants t a class with existing step therapy requirements. B. Quantity Limits (QLs) a) COMMITTEE ACTION: DEFAULT STEP THERAPY RULES The P&T Cmmittee recmmended (14 fr, 0 ppsed, 0 abstained, 3 absent) that in the drugs classes where there are existing step therapy requirements (listed belw), the DHA Pharmacy Operatins Divisin (POD) Frmulary Management Branch (FMB), thrugh administrative authrity, will direct Express Scripts, Inc. t practively identify and immediately implement step therapy requirements fr the newly-apprved drug. The new drug will fllw the respective step therapy and manual PA requirements as the ther nn step-preferred prducts in their respective drug class. Any actins taken f this type will be reviewed at the next P&T Cmmittee meeting. The specific drug classes are as fllws: TIBs, HCV DAAs, branded tetracycline antibitics, inhaled crticsterids (ICS), ICS/lng-acting beta agnists (LABAs), dipeptidyl peptidase 4 inhibitrs (DPP- 4s), GLP1RAs, sdium-glucse c-transprter 2 (SGLT2) inhibitrs, basal insulins, idipathic pulmnary fibrsis (IPF) drugs, prprtein cnvertase subtilisin/kexin type 9 (PCSK9) inhibitrs, and gut drugs. 1. General QLs QLs were reviewed fr 10 drugs frm drug classes where there are existing QLs, including the nclgic agents, HCV DAAs, ral inhalers, irn verlad, and fr 4 new drugs where QLs are nt currently in place. a) COMMITTEE ACTION: QLs The P&T Cmmittee recmmended (14 fr, 0 ppsed, 0 abstained, 3 absent) QLs fr Nerlynx, Idhifa, laparib tabs and caps (Lynparza), Verzeni, Mavyret, Vsevi, deferasirx sprinkles (Jadenu), titrpium/ldaterl (Stilt Respimat), ArmnAir RespiClick, Trelegy Ellipta, Benlysta, Bevyxxa, Endari, and tpical dxepin (Znaln, Prudxin) fr pruritus. See Appendix D fr the QLs. C. PA, Default Step Therapy, MN, and QLs Implementatin Perids 1. COMMITTEE ACTION: PA, DEFAULT STEP THERAPY, MN, AND QLs IMPLEMENTATION PERIODS The P&T Cmmittee recmmended (14 fr, 0 ppsed, 0 abstained, 3 absent) the fllwing implementatin perids: The new manual PA fr Aplenzin becme effective n the first Wednesday after a 90-day implementatin perid in all pints f service. Additinally, the P&T Cmmittee recmmended DHA send letters t the beneficiaries affected by this decisin. Based n the P&T Cmmittee s recmmendatin, the effective date is May 2, Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 14 f 55

15 Updates t the current PAs fr Tafinlar, Mekinist, Zelbraf, Stelara, Eucrisa, and Cinryze becme effective n the first Wednesday tw weeks after the signing f the minutes in all pints f service. The default step therapy rules fr the TIBs, HCV DAAs, branded tetracycline antibitics, ICS, ICS/LABA, DPP-4s, GLP1RAs, SGLT2s, basal insulins, IPF drugs, PCSK9 inhibitrs, and gut drugs becme effective n the first Wednesday tw weeks after the signing f the minutes in all pints f service. The QLs fr the 14 drugs listed in sectin VI, B, abve, and in Appendix D becme effective n the first Wednesday tw weeks after the signing f the minutes in all pints f service. VII. BRAND OVER GENERIC AUTHORIZATION FOR MESALAMINE DELAYED RELEASE (LIALDA) TRICARE Plicy requires dispensing f generic prducts at the Retail Netwrk and Mail Order Pharmacy. Hwever, pricing fr the branded Lialda prduct is mre cst effective than the AB-rated generic frmulatins fr mesalamine delayed release (DR), which were launched in June The manufacturer f Lialda has ffered a Blanket Purchase Agreement (BPA). Therefre, the branded Lialda prduct will cntinue t be dispensed, and the generic will nly be available with prir authrizatin (i.e., the reverse f the current brand t generic plicy). The Tier 1 (generic) cpayment will apply t Lialda. The brand ver generic requirement fr Lialda will be remved administratively when it is n lnger cst effective cmpared t the AB-rated generics. A. COMMITTEE ACTION: LIALDA BRAND OVER GENERIC REQUIREMENT AND PA CRITERIA The P&T Cmmittee recmmended (13 fr, 0 ppsed, 0 abstained, 4 absent) implementing the requirement t prefer the branded Lialda prduct ver generic frmulatins. Manual PA criteria are required fr generic mesalamine ER in the Retail Netwrk and Mail Order Pharmacy. The prescriber will prvide patientspecific justificatin as t why the branded Lialda prduct cannt be used. (See Appendix C). B. COMMITTEE ACTION: LIALDA BRAND COPAYMENT CHANGE The P&T Cmmittee recmmended (14 fr, 0 ppsed, 0 abstained, 3 absent) that the brand (Tier 2) frmulary cst share fr Lialda in the TRICARE Mail Order Pharmacy and the TRICARE Retail Netwrk Pharmacy be lwered t the generic (Tier 1) frmulary cst share. The authrity fr the last recmmendatin is cdified in 32 CFR (j)(3): [W]hen a blanket purchase agreement, incentive price agreement, Gvernment cntract, r ther circumstances results in a brand pharmaceutical agent being the mst cst effective agent fr purchase by the Gvernment, the P&T Cmmittee may als designate that the drug be cst-shared at the generic rate. Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 15 f 55

16 VIII. LINE EXTENSIONS The P&T Cmmittee clarified the frmulary status fr fur prduct line extensins ( fllw-n prducts ) by the riginal manufacturer. The line extensins have the same FDA indicatins and pricing as the parent drug and retain the same frmulary and cpayment status as the parent drug. A. COMMITTEE ACTION: LINE EXTENSIONS, FORMULARY STATUS CLARIFICATION, AND IMPLEMENTATION The P&T Cmmittee recmmended (14 fr, 0 ppsed, 0 abstained, 3 absent) clarifying the frmulary status f the fllwing fur prducts t reflect the current frmulary status, and applicable step therapy, PA criteria, MN criteria, and QLs fr the parent cmpund. Implementatin will ccur n the first Wednesday tw weeks after signing f the minutes. GI-2 Miscellaneus Agents: linacltide (Linzess) 72 mcg tablet is designated frmulary n the UF, which is the same as Linzess 145 mcg. Oral Onclgic Agents: laparib (Lynparza) 100 mg and 150 mg tablets are designated frmulary n the UF, which is the same as Lynparza capsules. Additinally, QLs will als apply. See Sectin VI, B, abve, n page 14, and Appendix D fr the QLs. Neurlgical Agents/Miscellaneus Mvement Disrders: valbenazine (Ingrezza) 80 mg is designated NF with the same PA criteria as Ingrezza 40 mg. (See the August 2017 DD P&T Cmmittee minutes fr the Ingrezza PA criteria.) TIBs: etanercept (Enbrel Mini single-dse prefilled cartridge) is designated NF and nn step-preferred, with the same PA criteria and QLs as Enbrel SQ injectin. (See the August 2014 and Nvember 2014 DD P&T Cmmittee minutes fr the PA criteria and QLs fr Enbrel SQ.) IX. FORMULARY STATUS UPDATE FOR TAPENTADOL IR (NUCYNTA) The Cmmittee received an MTF request t cnsider changing the frmulary status f the narctic analgesic tapentadl IR (Nucynta). Tapentadl IR was riginally designated NF at the Nvember 2009 meeting, while tapentadl ER (Nucynta ER) was mst recently reviewed in August 2015 and designated with UF status. The frmulary status change was requested in rder t assist with lcal MTF recapture effrts. The was n new pertinent clinical infrmatin t change the clinical cnclusin frm Nvember 2009 that there is insufficient evidence t suggest a clinically meaningful therapeutic advantage in patient utcmes, in terms f efficacy and safety, with tapentadl IR cmpared t the ther narctic analgesics already n the UF. A cst analysis, including an assessment f the verall csts t the MHS and MTF recapture rates, and a CMA cmparing selected narctic analgesics that are cmpetitrs t Nucynta IR, fund that csts t the MHS will increase with a frmulary change frm NF t frmulary n the UF. Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 16 f 55

17 A. COMMITTEE ACTION: NUCYNTA IR FORMULARY CHANGE REQUEST The P&T Cmmittee recmmended (14 fr, 0 ppsed, 0 abstained, 3 absent) maintaining tapentadl IR (Nucynta) as NF n the UF. X. REFILLS OF PRESCRIPTION MAINTENANCE MEDICATIONS THROUGH MTF PHARMACIES OR THE NATIONAL MAIL ORDER PHARMACY PROGRAM (EMMPI) See Appendix G fr the mail rder status f medicatins designated NF during the Nvember 2017 P&T Cmmittee Meeting. Nte that the Add/D Nt Add recmmendatins listed belw pertain t the cmbined list f drugs (the Select Maintenance List) under the EMMPI prgram and the nnfrmulary t mail requirement. The implementatin date fr all EMMPI recmmendatins frm the Nvember 2017 meeting, including the newly-apprved drugs affected by the EMMPI, will be effective n the first Wednesday tw weeks after the signing f the minutes, n February 14, A. Newly-Apprved Drugs per 32 CFR (g)(5) 1. COMMITTEE ACTION: NEWLY-APPROVED DRUGS PER 32 CFR (g)(5) RECOMMENDED FOR UF STATUS 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): a) Add: Trelegy Ellipta b) D Nt Add: Nt available at Mail Order: Nerlynx, Idhifa, Verzeni, Haegarda, Benlysta, and Nityr Nt currently required t g t Mail Order (e.g., nt n the EMMPI list): Vsevi and Mavyret (HCV DAAs), and Fycmpa ral slutin (anticnvulsant) Requires additinal infrmatin regarding relative prices at Retail versus the Mail Order Pharmacy: Endari Pending class review: Sympric 2. COMMITTEE ACTION: NEWLY-APPROVED DRUGS PER 32 CFR (g)(5) RECOMMENDED FOR NF STATUS 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):: a) Add: The P&T Cmmittee fund n reasn t exempt the fllwing drugs frm the mail rder requirement: Tremfya, ArmnAir RespiClick, Fiasp, Duzall, and FlLipid. b) D Nt Add: The previusly established exceptin frm the mail rder requirement fr acute use agents applies t Baxdela (antibitic) and Bevyxxa (anticagulant). The previusly Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 17 f 55

18 established exceptin frm the mail rder requirement fr C-II cntrlled substances applies t methylphenidate extended release rally disslving tablets (Ctempla XR ODT). The fllwing agent may nt be feasible t prvide thrugh mail rder and shuld be exempted pending further infrmatin: amantadine extended release (Gcvri). XI. RE-EVALUATION OF NF GENERICS Backgrund The DHA POD FMB mnitrs changes in clinical infrmatin, current csts, and utilizatin trends t determine whether the frmulary status f NF drugs needs t be readdressed. The P&T Cmmittee s prcess fr the reevaluatin f NF agents was established at the May 2007 meeting and apprved by the Directr, TMA, n July 24, A summary f the criteria is available in Appendix E f the Nvember 2012 P&T Cmmittee minutes. The P&T Cmmittee reviewed the current utilizatin, frmulary status, generic availability, cmparative clinical effectiveness and relative cst effectiveness, including the weighted average cst per unit, fr generically available NF agents in fur previusly reviewed drug classes: the ADHD/wakefulness prmting agents, benign prstatic hyperplasia (BPH) drugs, tpical antifungals, and renin-angitensin antihypertensive agents (RAAs). Existing step therapy and manual PA requirements, and BCF designatin were als discussed when pertinent. Relative Clinical Effectiveness and Relative Cst-Effectiveness Cnclusins Fr the tpical antifungals, BPH agents, and RAAs, the P&T Cmmittee cncluded (16 fr, 0 ppsed, 0 abstained, 1 absent) that there was n new pertinent efficacy r safety infrmatin t change the clinical effectiveness cnclusins frm when the classes were riginally reviewed fr UF placement. The P&T Cmmittee tk int accunt new infrmatin fr wakefulnessprmting agents. Specific cmments, including the results f cmparative cst reviews, are belw: A. ADHD/Wakefulness: Wakefulness Prmting Subclass armdafinil (Nuvigil, generics); mdafinil (Prvigil, generics) Currently, armdafinil is NF (Tier 3) and mdafinil is UF. The tw drugs are nw generically available frm multiple manufacturers, with the same unit cst based n weighted average cst acrss all pints f service. The unit cst fr bth prducts has drpped significantly frm the previus brand cst. Clinically, there was n new data t change the cnclusin that there are n cmpelling differences in efficacy r safety between the prducts. Bth prducts are classified as C-IV cntrlled substances, which prvides a ptential barrier t inapprpriate use. Current PA requirements are based primarily n the likelihd f their use fr nn-fda apprved indicatins that cannt be supprted based n available evidence. Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 18 f 55

19 The P&T Cmmittee reviewed an updated analysis f Internatinal Classificatin f Disease (ICD) 9/10 diagnsis cdes fr patients starting treatment with mdafinil r armdafinil. A ttal f 67% f all patients have an ICD 9/10 cde fr an FDA-apprved indicatin, which is a much lwer rate f ff-label use than in a 2012 MHS analysis. sdium xybate (Xyrem) There are n generic equivalents fr sdium xybate (Xyrem). Due t the significant abuse ptential, Xyrem is nly available under stringent restricted distributin requirements frm a single pharmacy. The current manual PA restricts use t its tw FDA-apprved indicatins: excessive sleepiness assciated with narclepsy withut cataplexy (which requires a trial f mdafinil first) r treatment f excessive daytime sleepiness and cataplexy in patients with narclepsy. An analysis f MHS utilizatin by diagnstic cdes suggests cntinued ff-label use f sdium xybate. B. Tpical Antifungals The nnfrmulary generic tpical antifungals are still nt cst effective relative t the generic frmulary prducts. Hwever, utilizatin f BCF cltrimazle cream and slutin was much lwer than ketcnazle cream and ketcnazle slutin, respectively, while unit csts were similar r lwer fr the UF ketcnazle prducts. C. BPH Agents: 5-Alpha Reductase Inhibitrs (5-ARI) Subclass Dutasteride (Avdart, generics) and dutasteride/tamsulsin (Jalyn, generics) are NF and nn step-preferred, requiring a trial f finasteride (Prscar, generics) first. The P&T Cmmittee nted that finasteride and dutasteride are highly therapeutically interchangeable fr the treatment f BPH, and the cmbinatin prduct Jalyn ffers n additinal benefit cmpared t either f the individual cmpnents, r finasteride plus tamsulsin. The weighted average cst per unit fr Jalyn was substantially higher than that fr finasteride, finasteride plus tamsulsin, r dutasteride plus tamsulsin as individual cmpnents. The weighted average cst per unit fr generic dutasteride was slightly higher than that fr finasteride. D. RAAs The NF generic antihypertensive agents are still nt cst effective relative t the generic frmulary prducts. Hwever, several prducts currently designated as UF and nn step-preferred were cnsidered fr UF and step-preferred status, given several factrs, including the cst difference by pints f service. 1. COMMITTEE ACTION: NF GENERIC PRODUCT, UF, BCF, PA RECOMMENDATIONS AND IMPLEMENTATION The P&T Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 19 f 55

20 Cmmittee recmmended the fllwing, effective the first Wednesday tw weeks after the signing f the minutes: a) Returning the fllwing prduct t UF status (16 fr, 0 ppsed, 0 abstained, 1 absent): ADHD/Wakefulness armdafinil (Nuvigil, generics) b) Remving the PA requirements fr the fllwing prducts, with reassessment in ne year (12 fr, 3 ppsed, 0 abstained, 2 absent): ADHD/Wakefulness armdafinil (Nuvigil, generics), mdafinil (Prvigil, generics) c) Revising the PA criteria fr the fllwing prduct in new users (16 fr, 0 ppsed, 0 abstained, 1 absent): ADHD/Wakefulness sdium xybate (Xyrem). See Appendix C fr the full criteria. d) Making the fllwing changes t the BCF (16 fr, 0 ppsed, 0 abstained, 1 absent): Add t the BCF: Tpical Antifungals ketcnazle cream and shamp Remve frm the BCF: Tpical Antifungals cltrimazle slutin e) Returning the fllwing prduct t the UF, with step therapy requirements and PA criteria remaining unchanged (16 fr, 0 ppsed, 0 abstained, 1 absent): BPH Agents dutasteride (Avdart, generics) f) Designating the fllwing prducts as UF and step-preferred, with pertinent updates made t the PA criteria fr the nn step-preferred RAAs (16 fr, 0 ppsed, 0 abstained, 1 absent): RAAs irbesartan (Avapr, generics), irbesartan/hctz (Avalide, generics) XII. ITEMS FOR INFORMATION A. MHS PRESCRIBING AND COST TRENDS The Cmmittee was briefed n varius aspects f MHS prescribing and cst trends, including verall trends and spends, specialty spend, tp 25 drug classes, and piid dispensing patterns. B. SELF-MONITORING BLOOD GLUCOSE TEST STRIPS: PRECISION XTRA GLUCOMETERS Manufacturing f the Precisin Xtra glucmeters will cease in mid-2018; manufacturing f the Precisin Xtra test strips will cntinue indefinitely. A passive cnversin t the FreeStyle Lite glucmeters is recmmended; MTFs shuld dispense FreeStyle Lite glucmeters t patients newly diagnsed with diabetes, r thse with a malfunctining Precisin Xtra glucmeter. Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 20 f 55

21 C. UF DRUG CLASS OVERVIEW An verview f the Ophthalmic Immunmdulatry Agents subclass was presented t the Cmmittee. Clinical infrmatin was prvided t assist with determining the mst apprpriate scenari fr slicitatin purpses. The clinical and ecnmic analyses f this drug class will be cmpleted at an upcming DD P&T Cmmittee meeting. D. QUANTITY LIMITS AT THE MTFs: The February 2005 DD P&T Cmmittee meeting was the first meeting under the new Unifrm Frmulary Rule. 10 U.S.C. 1074g requires the establishment f an effective, efficient, integrated pharmacy benefit prgram under chapter 55 f title 10, United States Cde, which applies t MTFs as well as t the purchased care system. The DD P&T Cmmittee makes recmmendatins t the Directr, TMA (nw DHA), nt nly n frmulary/nnfrmulary status fr pharmaceutical agents in a class, but als n prir authrizatins, quantity limits, and medical necessity criteria. Therefre, prir authrizatins, quantity limits, and medical necessity criteria established by the DD P&T Cmmittee will apply t all three pints f service. As shwn in Appendix D, quantity limits are listed fr the MTFs, alng with the Mail Order and Retail pints f service. In general up t a 90-day supply f medicatin is allwed at the MTFs, similar t the Mail Order. Unless specifically directed therwise by the DD P&T Cmmittee, QLs at the MTFs are t be prcessed in the same manner as in the Mail Order. XIII. ADJOURNMENT The meeting adjurned at 1545 hurs n Nvember 16, The next meeting will be in February Appendix A Attendance: Nvember 2017 DD P&T Cmmittee Meeting Appendix B Table f Medical Necessity Criteria Appendix C Table f Prir Authrizatin Criteria Appendix D Table f Quantity Limits Appendix E Table f Legend Prenatal Vitamins in the Class Appendix F Table f Frmulary Recmmendatins fr Newly-Apprved Drugs per 32 CFR (g)(5) Appendix G Mail Order Status f Medicatins Designated Nnfrmulary during the Nvember 2017 DD P&T Cmmittee Meeting Appendix H Table f Implementatin Status f Unifrm Frmulary Recmmendatins/Decisins Summary Appendix I Table f Abbreviatins Minutes & Recmmendatins f the DD P&T Cmmittee Meeting Nvember 15-16, 2017 Page 21 f 55