TennCare Drug Utilization Review (DUR) Board Minutes

Transcription

1 State f Tennessee Department f Finance and Administratin Bureau f TennCare 310 Great Circle Rad Nashville, TN TennCare Drug Utilizatin Review (DUR) Bard Minutes June 6, 2017 In attendance - DUR Bard: Denise Barker, PharmD Randall Ellis, MD Jshua Farrell, PharmD Rland Gray, MD Sheltn Harrell, MSN, ACNP-BC Rebecca Hpper, PharmD Richard Randlph, PharmD David Shepard, PharmD Bureau f TennCare: David Cllier, MD Victr Wu, MD Lrraine Buerhaus, RPh, JD Magellan (Pharmacy Benefit Manager): Justin Jhnsn, PharmD Tina Hawkins, PharmD Rbert Jnes, PharmD Rusty Hailey, PharmD, DPh, MBA, FAMCP Ray McIntire, DPh Renee Williams, PharmD Leslie Pittman, PharmD Leigh Ann Mre, CPhT Intrductin: The meeting was called t rder by Dr. Jhnsn, wh welcmed everyne t the TennCare Drug Utilizatin Review (DUR) Bard meeting. DUR Bard Appintees, Bureau f TennCare representatives, and Magellan representatives intrduced themselves. A new member, Jshua Farrell, PharmD was welcmed t the Bard and it was annunced that Dr. Swarr had resigned frm the DUR Bard. Review f minutes: The Bard was asked t review minutes frm the March 14, 2017 meeting. A mtin was made and secnded t apprve the minutes as written. Minutes were unanimusly apprved. Dr. Cllier gave a TennCare Update: Legislative Sessin: The 1st regular sessin f the 110th General Assembly adjurned n Wednesday, May 10, A $37 billin apprpriatins bill was passed which allwed the state t cntinue perating. The 2 nd legislatin sessin will resume n January 9 th, Fr TennCare, an $11.8 billin budget fr FY 2018 was passed. This budget included a 1% 1

2 recurring rate restratin fr TennCare prviders. Last year, the rate restratin was funded with nnrecurring dllars, but this year it was passed as recurring which will nt have t be included year after year. As part f the budget, SB 398/HB 628 was included which requires the implementatin f an MTM prgram. The hspital and nursing hme assessments were cntinued which allw TennCare t cntinue t perate withut excessive cuts t reimbursement r impsing limitatins. Nenatal Abstinence Syndrme: As f May 20, 2017, there were 341 cases f NAS reprted with 51% f the cases reprted frm East and Nrtheast Tennessee (including Knx and Sullivan cunties), cmpared t 348 cases reprted this time last year (2016) with 57% f the cases reprted frm East and Nrtheast Tennessee (including Knx and Sullivan cunties). In 2016, there were a ttal f 1002 cases reprted. In thse cases, apprximately 80% f the mthers were taking prescribed piids that caused the NAS with apprximately half n medicatin assisted therapy. TennCare cntinues t wrk t educate their prviders n NAS and part f the strategy t decrease the incidence f NAS is t make immediate pstpartum vluntary reversible lng-acting cntraceptives (IUDs & implants) available t TennCare enrllees. TennCare has wrked t make these prducts mre available and the prgram has expanded frm 30 practices, up t apprximately 50 practices currently. Dr. Wu added that decreasing NAS is an area f fcus fr the state as a whle. TennCare prvides a yearly NAS reprt which has recently been psted t the TennCare site and fr the first time in a number f years, TennCare has seen a flattening f the trend in NAS which had been rising yearly. TennCare cntinues t partner with multiple surces t address the tpic f NAS and is pen t partnerships. Tennessee Healthcare Innvatin Mdel/Episdes f Care: This is an initiative t pay fr value which was started by the gvernr in 2013 and has instituted an episdes f care mdel where reimbursement and billing has nt changed, but the prviders are given data t shw cst effectiveness and utilizatin rates that allws them t affect their utilizatin. The first rund f episdes included ttal hip replacement, nenatal/perinatal care, and asthma. After 1 year f being accuntable, there was an estimated savings f $11.1 millin which was annunced last fall. Last mnth, TennCare finished wave 7 which included lw back pain, spinal decmpressin, spinal fusin, femur/pelvic fractures, knee arthrscpy, and sprains/strains/nn-perative fractures f the shulder, wrist, knee, and ankle. The wave 8 technical advisry grups (TAGs) will begin in September with general surgery, gyneclgy, and internal medicine episdes being planned. Currently, there are 19 episdes f care are in the financial accuntability perid. The first year is used as a baseline, then in the secnd year, the prviders becme accuntable which means the prvider can either receive n change in their funding if they are able t maintain quality care, r if they are abve a certain threshld, they can actually receive additinal funding. There are 5 episdes which currently cannt be reprted and are being delayed because f data issues including the 3 nenatal episdes, breast cancer mastectmy, and breast cancer chemtherapy. On May 17 th, there was a telecnference held with prviders acrss the state t discuss the episdes f care and it was well received. The feedback frm the prviders included a request fr mre data related t their practice. Part f this payment refrm includes the Patient Centered Medical Hmes (PCMH) fr TennCare members wh have severe mental health issues. Wave 1 f the PCMH began n January 1 st with 29 primary care practices. Health Link began n December 1, 2016 with 19 behaviral health practices. Wave 2 f PCMH rganizatin applicatins are being accepted frm May 1, 2017 thrugh June 30, 2017 with selectins being annunced n August 1 st, and the rganizatins can being n January 1, The Care Crdinatin Tl is nw functining t prvide additinal infrmatin fr the PCMH practices including whether their assigned patients have had hspital admissins r ER visits r has been transferred between institutins. 2

3 American Health Care Act: TennCare is crdinating clsely with the Tennessee delegatin in Washingtn regarding the AHCA legislatin. TennCare was nt significantly affected by the Affrdable Care Act since Tennessee elected nt t expand Medicaid enrllment. If the ACA is repealed and sme frm f AHCA is passed, TennCare culd be significantly affected. There has been discussin abut granting increasing flexibility t the states t manage the medicaid prgram with new funding mdels. The AHCA purpses t change Medicaid funding frm a federal match mdel t a per capita alltment fr each persn enrlled beginning in FY The per capita alltment wuld be based n TennCare spending during FY States wuld receive different per capita amunts fr certain categries including the elderly, blind, disabled, children, and adults. Any expenditures that exceed the alltment amunt during a given fiscal year wuld be deducted frm the federal Medicaid funding received the fllwing fiscal year. Dr. Hailey gave a TennCare Pharmacy Update: Cvered Outpatient Drugs Because f the rule published by CMS regarding Cverage f Outpatient Drugs which required states t mve t a new pricing strategy, TennCare sent ut Requests fr Prpsal (RFPs) t survey the Actual Acquisitin Cst pricing methdlgy (awarded t Myers & Stffer) and the Cst f Dispensing survey (awarded t Mercer). TennCare was mandated t implement the new pricing strategies as f April 1, 2017 and TennCare is pleased t annunce that it has been implemented as f that time. Als, part f the Cvered Outpatient rule was t submit an updated State Plan Amendment (SPA) detailing the new pricing algrithm as f June 30, 2017 and TennCare was able t submit their revised SPA already and is awaiting feedback frm CMS. Medicatin Therapy Management: TennCare has started discussing the implementatin f an MTM prgram and started TAG meetings. As f this time, TennCare has had 2 TAG meetings with a 3 rd ne scheduled sn. TennCare was able t secure funding fr the MTM prgram in the gvernr s budget and the prgram will begin as f January 1, Dr. Williams added, the pilt MTM prgram will be pharmacist led and they will be layered int the PCMH and the care team. Pharmacist will have access t the Care Crdinatin Tl and be able t interact with patients and prviders t hpefully impact the verall cst f care. Mre details regarding the rle ut f this prgram will be available after the next TAG meeting. Nenatal Abstinence Syndrme: The TennCare pharmacy department cntinues t make effrts t reduce the incidence f NAS births. Last August, the TennCare pharmacy department partnered with Bayer and a specialty pharmacy in Tennessee t implement a lngacting reversible cntraceptive (LARC) pilt where tp OBs were identified and partnered with t increase access t the prducts. Prviders stated that it was difficult t get TennCare patients t return fr a fllw-up visit even if they had already agreed t receive the LARC. Therefre, this prgram will place prduct in the clinic t increase access t the enrllee and make the prducts available fr insertin upn agreement withut the need t schedule an additinal visit. This prgram started with 25 clinics and has nw been expanded t 37 clinics with additinal meetings set up t discuss the further expansin f the prgram. 3

4 Pharmacy Benefits Manager (PBM): TennCare has accepted the fifth year ptin t maintain Magellan as their PBM, hwever, this cntract will expire May 31, There will be a PBM RFP being released rughly arund June 15. Old Business: Clinical Criteria DUR Bard recmmendatins will be cnsidered fr the fllwing clinical criteria when the prducts are scheduled fr PAC review: Diabetic Test Strips (t cnsider insulin utilizatin) Recmmendatin t implement criteria t restrict the use f cdeine prducts in children was cnsidered at May 18th PAC (t cnsider the FDA BBW & AAP recmmendatins t avid use in peds) and PAC mved t implement criteria Outlier Prescriber Algrithm Update Next Steps: Cmmittee discussed a physician questinnaire r ptential fr One-n- One/Peer-t-Peer discussin RetrDUR Webpage n TennCare site The cnstructin f a RetrDUR webpage is cmplete and page is active Dr. McIntire presented a Retrspective Review f Nalxne Utilizatin: Nalxne Prducts fr Outpatient Use Nalxne hydrchlride (Injectin) Evzi Aut-injectr Available in 0.4mg / 0.4ml and 2mg / 0.4ml strengths Nalxne hydrchlride (Intranasal) Narcan Nasal Liquid Available in 4mg / 0.1ml and 2mg / 0.1ml strengths Narcan Nasal Liquid is listed n TennCare s PDL as preferred due t it s lw cst cmpared with Evzi TN AAAC fr Narcan Nasal is $ per 2-unit package NADAC fr Evzi is $ per unit (TN AAAC N/A). Due t the high cst, Evzi has nt been added t TennCare s Cvered Injectables List. Nalxne Indicatins: Nalxne Fr the cmplete r partial reversal f piid depressin (including respiratry depressin) induced by natural and synthetic piids. Nalxne is als indicated fr the diagnsis f suspected r knwn acute piid verdsage. Evzi and Narcan Nasal Fr the emergency treatment f knwn r suspected piid verdse as manifested by respiratry and/r CNS depressin. Intended fr immediate administratin as emergency therapy in settings where piids may be present. Nt a substitute fr emergency medical care. Dsing: Opiid verdse Fr the initial treatment f an piid-assciated life-threatening emergency, the American Heart Assciatin recmmends, after initiatin f CPR, the use f intranasal r IM nalxne with a repeat dse as needed. If there is an initial patient respnse (i.e., purpseful mvement, regular breathing, man r ther respnse) but the patient then stps respnding, begin CPR and 4

5 repeat nalxne dse. If n initial respnse, cntinue CPR and use AED as apprpriate. Usual dsage- Narcan Nasal 2 r 4 mg (cntents f 1 nasal spray) intranasally in ne nstril as a single dse; dse may be repeated every 2 t 3 minutes in alternating nstrils until emergency medical assistance becmes available. Usual dsage- Evzi 0.4 mg r 2 mg (cntents f 1 aut-injectr) IM r subcutaneusly as a single dse; dse may be repeated every 2 t 3 minutes until emergency medical assistance becmes available. Adverse Effects Cardivascular- Hypertensin, hyptensin, tachycardia, ventricular fibrillatin, ventricular tachycardia. CNS- Agitatin, bdy pain, brain disease, cma, irritability, nervusness, restlessness, shivering, withdrawal syndrme, yawning Nenates- Hyperreflexia, seizure, excessive crying Nasal- Headache Dermatlgic- Diaphresis, pilerectin. Nasal- Xerderma Gastrintestinal- Abdminal cramps, diarrhea, nausea, vmiting. Nasal- Cnstipatin, tthache Neurmuscular & skeletal- tremr, weakness. Nasal- Muscle spasm, musculskeletal pain Respiratry- dyspnea, pulmnary edema, rhinrrhea, sneezing Nasal- Dry nse, nasal cngestin, nasal discmfrt, nasal mucsa swelling, rhinitis Miscellaneus- fever Guidelines fr Use Wrld Health Organizatin, 2014 Cmmunity Management f Opiid Overdse Fund at the fllwing URL: pdf?ua=1&ua=1 WHO Guidelines Overview: An estimated peple die each year frm piid verdse. Opiid verdse is easily reversed with the piid antidte nalxne and with basic life supprt. Such care is generally nly available in medical settings, hwever. These guidelines recmmend that peple wh are likely t witness an piid verdse, including peple wh use piids, and their family and friends shuld be given access t nalxne and training in its use s that they can respnd t piid verdse in an emergency if a medical respnse is nt available. Nalxne can be injected r administered intra-nasally and has minimal effects in peple wh have nt used piids. While nalxne administered by bystanders is a ptentially life-saving emergency interim respnse t piid verdse, it shuld nt be seen as a replacement fr cmprehensive medical care. Objectives f the guidelines 5

6 These guidelines aim t reduce the number f deaths frm piid verdse by prviding evidence-based recmmendatins n the availability f nalxne fr peple likely t witness an piid verdse alng with advice n the resuscitatin and pst-resuscitatin care f piid verdse in the cmmunity. Specifically, these guidelines seek t: increase the availability f nalxne t peple likely t witness an piid verdse in the pre-hspital setting; increase the preparedness f peple likely t witness an piid verdse t respnd safely and effectively by carrying nalxne and being trained in the management f piid verdse; increase the rate f effective resuscitatin and pst-resuscitatin care by persns witnessing an piid verdse. Nalxne Clinical Criteria and Cverage Narcan Nasal is listed n TennCare s PDL as Preferred, and requires prir authrizatin. Althugh the State f Tennessee has passed legislatin t allw pharmacists t dispense nalxne under a cllabrative pharmacy practice agreement, prir authrizatin is still required. Under TennCare s State Plan with CMS, TennCare prvides Cvered Outpatient Drugs that are medically necessary fr TennCare enrllees. PA is necessary t ensure that nalxne is prvided t TennCare enrllees nly if requested by the enrllee. Nalxne Claims Retrspective Review Review Design We reviewed paid prescriptin claims alng with diagnsis infrmatin fr enrllees wh filled a claim fr nalxne paid by TennCare during the 1 st quarter f 2017 (1Q2017) (1/1/2017 3/31/2017). Ttal claims 174 paid claims in 1Q17 One claim was paid fr Evzi, and 173 claims were paid fr Narcan Nasal 174 Unique Users Identified n refills fr any enrllee during the 1Q17 review perid (hwever 2 enrllees have refilled since that time) Enrllee demgraphics Ages Fund in Unique Users <21 2 patients ( 1.1%) patients (17.2%) patients (75.3%) >60 12 patients ( 6.9%) 170 f 174 enrllees with paid claims fr nalxne in 1Q17 remained eligible fr TennCare benefits as f the date f the review: 3 f 4 enrllees eligibility has been terminated 1 enrllee has died Retrspective review f claims was made using paid claims and diagnses infrmatin fr the 170 enrllees currently eligible fr TennCare. Retrspective Review Findings 3 enrllees ut f 170 filled claims fr nalxne, but did nt have a paid claim fr an piid One is paying cash fr methadne, written by an APN in a pain management clinic and 6

7 One is paying cash fr fentanyl patches written by an MD in a pain management clinic ne is paying cash fr Hydrcdne/APAP written by an APN in family practice. 2 enrllees ut f 170 have filled anther claim paid by TennCare fr nalxne after 1Q17 One enrllee s nalxne is written by an APN in a pain management clinic The ther enrllee s nalxne is written by an APN in a family practice clinic A majrity f the nalxne user s claims, nalxne and cntrlled substance claims are written by pain management prviders: 558 f 640 (87.2%) ttal cntrlled substance claims in 1Q17 fr the 170 enrllees filling nalxne claims were written by pain management prviders 540 f 599 (90.2%) ttal piid claims in 1Q17 fr the 170 enrllees filling nalxne claims were written by pain management prviders 156 f 170 (91.8%) ttal nalxne claims in 1Q17 fr the 170 enrllees were written by pain management prviders 44 f 170 enrllees in the review had a diagnsis f piid dependency 42 f 44 are being treated by pain management prviders Only 1 enrllee in the study is being treated with a buprenrphinecntaining piid addictin drug prduct (nt by pain management). 4 f 170 enrllees in the review had a diagnsis f pisning by piids r adverse effect f ther synthetic narctics. All 4 are being treated by pain management prviders 1 f 4 als has a diagnsis f inhalant abuse and was prescribed an piid by a pain management prvider the next day. We had heard that drug dealers were prviding r selling nalxne and fund this article: It may seem cntradictry, but Mayr Ted Gatsas believes drug dealers are selling herin, fentanyl and the drug that reverses that high. "It is nw a selling tl," Gatsas said. As he was walking ut f his Manchester (N.H.) ffice Thursday, Gatsas said a "tugh" yung man apprached him. "And he said t me, 'Mayr, there's ging t be a lt less deaths in Manchester in the next few mnths.'" Prmpted, Gatsas asked hw that was ging t happen. "And he said, 'That's because the dealers have started t buy Narcan and carry it with them,'" Gatsas said. "'And they'll give yu yur herin r whatever they're selling yu, and they'll tell yu that, if yu have a prblem, yu'll have Narcan t bring yu back.'" Gatsas thinks this practice culd be dangerus, because many verdses require mre than ne dse f nalxne, r Narcan, t reverse the effects f drugs. The great majrity f enrllees wh are filling prescriptins fr nalxne are in the lder ranges f age fr TennCare enrllees ver 75% are ver age 40. The great majrity f enrllees wh are filling prescriptins fr nalxne are being treated by prviders in pain management clinics ver 90% 7

8 Only abut 25% f enrllees wh are filling prescriptins fr nalxne have been diagnsed with piid dependency, and very few have had a diagnsis f abuse r pisning due t piids in the past year. Shuld we fllw up with pain management clinics when we d nt see prescriptins fr nalxne? Shuld we investigate enrllees with multiple fills f nalxne? Are there any instances where TennCare shuld mandate the prescribing f nalxne when cnsidering piid prir authrizatins? Standing Business - Dr. Jhnsn Presented TennCare Drug Utilizatin Data: 1 st Quarter 2017 Ppulatin Highlights - Overall stable ppulatin statistics 0.4% YOY Average Ttal TennCare Ppulatin 0.6% Ttal Amunt Paid per Mnth 1 st Quarter 2017 Utilizatin Highlights - Ntable Changes Atypical Antipsychtics Payment Amunt 35.1% YOY payment amunt (generic aripiprazle apprved in April 2015) Antiviral Payment Amunt 128.5% YOY ( in seltamivir (Tamiflu ) payment amunt % YOY) Tumr Necrsis Factr Inhibitrs Payment 41.6% YOY ( in Humira payment amunt - 51% YOY) Insulin Lispr Payment Amunt 20.7% YOY ( cst/claim) Lurasidne (Latuda ) Payment Amunt 34.5% YOY ( cst/claim) Prspective Drug Utilizatin Review (PrDUR) 1 st Quarter 2017 Definitins Edits/Rejectins PrDUR Edit A cmputer system review f the member s medicatin histry Identifies ptential drug therapy prblems prir t dispensing the medicatin. Examples wuld include but nt limited t: Therapeutic Duplicatin (TD), Early Refill (ER), Max Dse, Drug t Gender, Drug t Drug, Drug t Inferred Disease, Geriatric and Pediatric Warnings Types f Rejectins: Hard Reject These edits will cause the claim t deny at the pint f sale (POS) Sft Reject- These edits will cause the claim t deny at the pint f sale. Hwever, with apprpriate dcumentatin the pharmacy will be able t re-submit the rejected claim using Prfessinal Pharmacy Service (PPS) cdes Message These edits will cause an alert r warning message t be returned t the dispensing pharmacist t infrm them f a ptential prblem. 8

9 The fllwing Prspective DUR metrics were presented (Refer t slides fr data presented) Tp 10 Therapeutic Duplicatin Tp 10 Early Refill Tp 10 Max Dse Tp 10 Drug t Inferred Diagnsis (Pregnancy) Tp 10 Drug t Gender Tp 10 Geriatric Precautin Tp 10 Pediatric Precautin Review f RetrDUR Activities: Lithium Therapy with N Level # f letters: r mre SABA in 90 days withut a cntrller medicatin # f letters: 159 Therapeutic Duplicatin f Inhaled Antichlinergic Agents # f letters: 241 Therapeutic Duplicatin f Inhaled Crticsterids # f letters: 177 Therapeutic Duplicatin f Lng Acting Beta-Agnists # f letters: 14 Prvider Practice Initiatives: Cncmitant Opiid & Benzdiazepine Cncerns 1650 Letters Sent FDA DSC - Canagliflzin and Amputatins 303 Letters Sent Dr. McIntire presented Pharmacy Lck-In Prgram: One thusand three (1003) enrllees that are currently lcked in were re-reviewed fr ptential escalatin r remval frm the Lck-In prgram. Results frm 1Q17 Re-Review results: Remain: 385 Remved: 579 Escalate: 10 Remain PA: 3 Refer t MCO: 1 Refer t Mbr Svc: 2 Refer Other: 1 Enrllee Died: 15 Remve PA: 11 New Business: 1 st Quarter 2017 FDA New Drug Apprvals: mrphine sulfate (Arym ER) FDA Apprved 01/09/2017 The extended-release (ER) mrphine sulfate Arym ER was FDA-apprved fr the management f pain severe enugh t require arund-the-clck, lng-term piid management fr which alternative treatments are inadequate. 9

10 The prduct utilizes Egalet s prprietary Guardian abuse-deterrent technlgy which cnsists f bth a physical and chemical barrier withut the need fr an piid antagnist cmpnent. Arym ER is a Schedule II cntrlled substance and carries the same bxed warnings regarding addictin, abuse, and misuse and is subject t the same REMS requirements as ther piid prducts and is dsed every 8 r 12 hurs depending n pain levels and piid tlerability. hydrcdne bitartrate ER (Vantrela ER) FDA Apprved 01/17/2017 Hydrcdne bitartrate ER (Vantrela ER) was granted apprval fr the management f pain severe enugh t require daily, arund-the-clck, lngterm piid treatment and fr which alternative treatment ptins are inadequate. The prducts is a Schedule II cntrlled substance frmulated with physicchemical abuse-deterrent prperties and is administered every 12 hurs and is subject t the same REMS and carries the same bxed warnings regarding addictin, abuse, and misuse as ther piids. xymetazline hydrchlride (Rhfade ) FDA Apprved 01/18/2017 Oxymetazline HCl 1% cream (Rhfade) has been apprved by the FDA fr tpical treatment f persistent facial erythema assciated with rsacea in adults. The alpha 1A adrenceptr agnist cream is apprved as a tube r pump and is t be applied nce daily in a thin layer cvering the entire face aviding eyes and lips. Cmmn adverse reactins include wrsening inflammatry lesins f rsacea, applicatin site dermatitis, pruritus, erythema, and pain. plecanatide (Trulance ) FDA Apprved 01/19/2017 Plecanatide (Trulance), a guanylate cyclase-c (GC-C) agnist, has been FDA-apprved fr the treatment f chrnic idipathic cnstipatin (CIC) in adults. Plecanatide was apprved as 3 mg tablets t be taken as 1 tablet rally nce daily, with r withut fd. Cntraindicatins include use in patients less than 6 years f age due t risk f serius dehydratin and in patients with knwn r suspected mechanical gastrintestinal bstructin and the mst cmmn adverse effects experienced in clinical trials was diarrhea. fluticasne prpinate (ArmnAir TM Respiclick ) FDA Apprved 01/27/2017 The FDA granted apprval fr the crticsterid fluticasne (ArmnAir Respiclick) fr the maintenance treatment f asthma in patients aged 12 years and cntains the same active ingredient as Flvent (GlaxSmithKline) which is apprved fr maintenance treatment f asthma in patients as yung as 4 years. It is nt indicated fr the relief f acute brnchspasms and shuld nt be used t treat status asthmaticus r acute asthma episdes requiring intensive measures. Use with a spacer r vlume hlding chamber is nt recmmended. Cntraindicatins include hypersensitivity t milk prteins. 10

11 Dsages fr Flvent are slightly less than ArmnAir; bth are administered twice-daily. fluticasne prpinate; salmeterl xinafate (AirDu TM Respiclick ) - FDA Apprved 01/27/2017 AirDu Respiclick is a fixed-dse cmbinatin f fluticasne prpinate and salmeterl, a crticsterid and lng-acting beta-agnist (LABA), t treat asthma in patients aged 12 years and cntains the same active ingredients as Advair HFA and Advair Diskus (GlaxSmithKline), with similar indicatins and warnings; hwever, dsages vary between the prducts. It is nt indicated fr the relief f acute brnchspasms and shuld nt be used t treat status asthmaticus r acute asthma episdes requiring intensive measures. The drug is administered as 1 inhalatin twice daily and is nt recmmended fr use with a spacer r vlume hlding chamber. deflazacrt (Emflaza TM ) - FDA Apprved 02/09/2017 The ral crticsterid, deflazacrt (Emflaza), was FDA apprved fr the treatment f Duchenne muscular dystrphy (DMD) in patients 5 years f age. It is the first agent apprved t treat all genetic frms f DMD and was granted rphan drug and rare pediatric disease prduct designatins. brdalumab (Siliq TM ) - FDA Apprved 02/15/2017 The FDA has apprved the human interleukin-17 receptr A (IL-17RA) antagnist brdalumab (Siliq) fr the treatment f mderate t severe plaque psriasis in adults wh are candidates fr systemic therapy r phttherapy and have failed t respnd t r have lst respnse t ther systemic therapies. It is apprved as a single-dse prefilled syringe, cntaining 210 mg f brdalumab, t be self-injected. A bxed warning exists fr suicidal ideatin and behavir, including cmpleted suicides. It is cntraindicated in patients with Crhn s disease. Siliq is available nly thrugh a restricted Risk Evaluatin and Mitigatin Strategy (REMS) prgram. huse dust mite allergen extract (Odactra ) - FDA Apprved 03/01/2017 Huse dust mite (HDM) allergen extract (Odactra) has been apprved t treat HDM-induced allergic rhinitis, with r withut cnjunctivitis, in patients 18 t 65 years ld. Diagnsis shuld be cnfirmed by in vitr testing fr IgE antibdies t Dermatphagides farinae r Dermatphagides pternyssinus HDMs, r skin testing t licensed HDM allergen extracts. Odactra is a sublingual tablet cntaining 12 SQ-HDM that is taken nce daily, year rund. The first dse is administered by an HCP, after which the patient is bserved fr 30 minutes fr ptential severe allergic reactins (bxed warning); subsequent dses may be self-administered, if tlerated. Nticeable benefit may take 8 t 14 weeks t appear. desmpressin acetate (Nctiva ) - FDA Apprved 03/03/2017 The FDA apprved desmpressin acetate nasal spray (Nctiva), a vaspressin analg, fr the treatment f ncturia due t ncturnal plyuria in adults wh awaken 2 times per night t vid. 11

12 Nctiva is self-administered as 1 spray in either nstril nightly apprximately 30 minutes befre bedtime. Nctiva has a bxed warning regarding hypnatremia and carries several cntraindicatins. safinamide (Xadag ) - FDA Apprved 03/21/2017 The FDA apprved the mnamine xidase type B (MAO-B) inhibitr safinamide (Xadag) as adjunct t levdpa/carbidpa in patients with Parkinsn s disease (PD) experiencing ff episdes. It has nt been shwn t be effective as mntherapy fr PD. naldemidine (Sympric ) - FDA Apprved 03/23/2017 Naldemidine (Sympric) is an piid antagnist FDA apprved t treat piid-induced cnstipatin (OIC) in adults with chrnic nn-cancer pain. It is a Schedule II cntrlled substance. The recmmended dse is ne 0.2 mg tablet taken nce daily with r withut fd and patients wh have been treated with piids fr < 4 weeks may be less respnsive t naldemidine. Dr. Jhnsn adjurned the meeting at 11:46 am. Next DUR Bard Meeting September 12,