specil feture Projecting future drug expenditures in U.S. nonfederl hospitls nd clinics 2013 Jmes M. Hoffmn, Edwrd Li, Fred Doloresco, Lind Mtusik, Roert J. Hunkler, Nily D. Shh, Lee C. Vermeulen, nd Glen T. Schumock Helth cre spending ws mjor topic of the 2012 presidentil rce nd promises to remin in the spotlight s the United Sttes ddresses the need to cut spending in the fce of the federl deficits in 2013 nd eyond. In 2013, helth cre expenditures re expected to grow 3.82%, reching $2915.5 illion, or 17.8% of the gross domestic product. 1 While this rte of growth ws slightly lower thn tht in 2012, y 2014, mjor coverge expnsions mndted in the Ptient Protection nd Affordle Cre Act re expected to drive growth y 7.4% (to $3130.2 illion). This will result in greter proportion of ntionl helth cre expenditures eing pid y the federl government (30% in 2014). This growth in federl spending on helth cre comined with the current focus on federl det nd deficit reduction my result in meningful chnges to Medicre nd other key helth cre progrms. Purpose. Fctors likely to influence drug expenditures, drug expenditure trends in 2012, nd projected drug expenditures for U.S. nonfederl hospitls nd clinics in 2013 re discussed. Methods. Prescription drug expenditure dt for 2011 through Septemer 2012 were otined from the IMS Helth Ntionl Sles Perspectives dtse. Expenditure projections were sed on comintion of quntittive nd qulittive nlyses, comined with expert opinion. Results. Totl prescription sles in the United Sttes for the 12-month period ending Septemer 2012 were $326.0 illion, 0.8% increse from the previous 12 months. This rte of growth ws the lowest in recent history nd cn e ttriuted to modest increses in expenditures for new products (3.3%) nd the prices of existing products (5.9%), coupled with mrked decline in overll volume nd Prescription drug expenditures remin n importnt component of overll helth cre expenditures. mix ( 8.4%). For the 9 months ending in Septemer 2012, totl prescription expenditures grew 2.7% when compred with the sme period in 2011. Oncology products remined importnt expenditures for hospitls nd clinics. Antineoplstic gents were the top mediction clss for expenditures in nonfederl hospitls, nd oncology products ccounted for 32.2% of drug expenditures in the clinic setting in the first 9 months of 2012. Conclusion. For 2013, we project 1 3% increse in totl drug expenditures cross ll settings, 2 4% increse in expenditures for clinic-dministered drugs, nd 0.5% decline to 1.5% increse in hospitl drug expenditures. Helth-system phrmcy leders should crefully exmine their own locl drug-utiliztion ptterns to determine their own orgniztion s drug expenditure forecst. Am J Helth-Syst Phrm. 2013; 70:In Press While growth in prescription expenditures hs slowed in recent yers, mny fctors influence future drug Jmes M. Hoffmn, Phrm.D., M.S., BCPS, is Associte Memer, Phrmceuticl Sciences, Mediction Outcomes nd Sfety Officer, Phrmceuticl Services, St. Jude Children s Reserch Hospitl, Memphis, TN, nd Associte Professor of Clinicl Phrmcy, College of Phrmcy, University of Tennessee Helth Science Center, Memphis. Edwrd Li, Phrm.D., BCOP, is Associte Professor, Deprtment of Phrmcy Prctice, College of Phrmcy, University of New Englnd, Portlnd, ME. Fred Doloresco, Phrm.D., M.S., is Clinicl Assistnt Professor, Deprtment of Phrmcy Prctice, School of Phrmcy nd Phrmceuticl Sciences, nd Reserch Assistnt Professor HS, Deprtment of Socil nd Preventive Medicine, School of Pulic Helth nd Helth Professions, University t Bufflo, Bufflo, NY. Lind Mtusik, B.A., is Senior Mnger, Reserch Support; nd Roert J. Hunkler, M.B.A., is Director, Professionl Reltions, IMS Helth, Plymouth Meeting, PA. Nily D. Shh, B.S.Phrm., Ph.D., is Assistnt Professor of Helth Services Reserch, Division of Helth Cre Policy nd Reserch, Myo Clinic College of Medicine, Rochester, MN, nd Senior Associte Consultnt, Myo Clinic, Rochester. Lee C. Vermeulen, B.S.Phrm., M.S., FCCP, is Director, Center for Clinicl Knowledge Mngement, UW Helth, Mdison, WI, nd Clinicl Professor, School of Phrmcy, University of Wisconsin, Mdison. Glen T. Schumock, Phrm.D., M.B.A., Ph.D., is Professor, Deprtment of Phrmcy Prctice, nd Director, Center for Phrmcoepidemiology nd Phrmcoeconomic Reserch, College of Phrmcy, University of Illinois Chicgo, Chicgo. Am J Helth-Syst Phrm Vol 70, 2013 e1
spending. Incresed utiliztion nd ccess to drugs ttriutle to the incresed ging popultion nd expnded insurnce coverge, long with the lunch of new nd expensive medictions, re the primry fctors rising drug expenditures, while ptent expirtions nd the vilility of less-expensive generic products re the primry fctors reducing drug expenditures. 2 This rticle discusses fctors likely to influence drug expenditures, descries drug expenditure trends in 2012, nd projects drug expenditures for 2013. Our intent is to provide informtion nd nlysis tht will id helth-system phrmcy executives nd other helth-system leders who re responsile for developing hospitl nd clinic drug udgets in determining how future chnges in mediction use will ffect drug expenditures in their own institutions. We exmined trends in phrmceuticl expenditures, oth generlly nd y setting (with n emphsis on nonfederl hospitls nd clinics), tht my help predict expenditures in 2013. We lso exmined other fctors tht my influence future phrmceuticl expenditures, including new drugs nd newly ville generics. Finlly, drug expenditures y sector (totl, hospitl, nd clinic settings) for 2013 were projected. Methods Our forecst of phrmceuticl expenditures in 2013 ws sed on exmintion of oth historicl trends in drug expenditures nd expected chnges in the drug mrketplce tht my influence drug expenditures in hospitls nd clinics, including recent drug pprovls nd expected ptent expirtions. First, we nlyzed prescription drug expenditures in 2011 through Septemer 2012. Dt for this nlysis were otined from the IMS Helth Ntionl Sles Perspectives (NSP) dtse. 3 NSP is sttisticlly vlid projected udit tht descries 100% of the sles in every mjor clss of trde nd distriution chnnel for prescription phrmceuticls, nonprescription products, nd select self-dministered dignostic products in the United Sttes, mesuring oth unit volume nd invoice dollrs. The NSP smple is derived from over 1.5 illion nnul trnsctions from over 100 phrmceuticl mnufcturers nd more thn 700 distriution centers. As of Septemer 2012, NSP trcked sles into 5,789 nonfederl hospitls, 145,812 clinics, 59,674 retil phrmcies, 323 mil-service phrmcies, 5,050 home helth fcilities, nd 3,307 long-term-cre outlets, in ddition to thousnds of other entities. All dt from NSP were used in the nlysis (e.g. nonsystemic formultions were used), nd drug clss groupings were sed on IMS Helth s proprietry Uniform System of Clssifiction. 4 When exmining drug expenditures, we reported totl dollrs spent s well s growth, the ltter eing the percentge chnge (increse or decrese) in expenditures from one period to the next. We ctegorized the fctors tht drive chnges in phrmceuticl expenditures s (1) new products, (2) price infltion, nd (3) volume nd mix. The new products ctegory represents growth in expenditures ttriutle to products tht were not on the mrket in the comprison time period (i.e., previous yer). Growth in prescription drug expenditures ttriutle to price infltion refers to chnges in the unit cost of drugs tht were previously on the mrket in the comprison time period (i.e., the chnge in price from one yer to the next). Lst, the volume nd mix ctegory comines chnges in volume of utiliztion of existing products (i.e., chnges in the numer of users, numer of dys of therpy, or numer of doses of therpy per dy) nd chnges in usge ptterns (i.e., from one product to nother). An exmple of mix is when prescriing moves from rnd to generic products, resulting in reduced expenditures. Additionl nlyses were conducted focused on oncology therpies ecuse of the importnce of these therpies to overll drug expenditures. The proportions of expenditures incurred in retil settings, mil-order phrmcies, long-term-cre fcilities, helth mintennce orgniztions, nonfederl fcilities, federl fcilities, nd clinics etween 2007 nd 2012 were estimted seprtely for orl nd injectle oncology gents to exmine shifts in distriution chnnel for these products. Recent drug pprovls nd drugs in development were reviewed, since these often increse drug expenditures. Drugs nd iologicl gents nticipted to e pproved y the Food nd Drug Administr- Address correspondence to Dr. Hoffmn t St. Jude Children s Reserch Hospitl, 262 Dnny Thoms Plce, MS 150, Memphis, TN 38105 (jmes.hoffmn@stjude.org). The contriutions of Dvid Chen, B.S.Phrm., M.B.A., re cknowledged. The ASHP Section of Phrmcy Prctice Mngers provided support for the development of this rticle. Dr. Hoffmn s contriutions to this rticle were supported in prt y ALSAC nd y Cncer Center Core Grnt NIH CA 21765. Dr. Schumock hs consulted for or received reserch funding from Aott Lortories, AMAG Phrmceuticls, Amgen, Genentech, nd Tked Phrmceuticl Compny in the pst three yers. Dr. Hoffmn, Dr. Schumock, Dr. Shh, nd Mr. Vermeulen re uncompensted memers of the steering committee of the Helth Services Reserch Network of IMS Helth from which much of the dt for this pper were otined. Dr. Li, Dr. Doloresco, Ms. Mtusik, nd Mr. Hunkler hve declred no potentil conflicts of interest. This rticle will pper in the Mrch 15, 2013, issue of AJHP. Copyright 2013, Americn Society of Helth-System Phrmcists, Inc. All rights reserved. 1079-2082/13/0000-0000$06.00. DOI 10.2146/jhp120759 e2 Am J Helth-Syst Phrm Vol 70, 2013
tion (FDA) in 2013 were identified y serching phrmceuticl nd iotechnology usiness news for rticles of interest to investors in the industry. Once products were identified, their Prescription Drug User Fee Act (PDUFA) dtes were determined y exmining informtion in officil press releses y the respective compnies sponsoring the drugs or iologicl gents. If no explicit PDUFA dte ws mentioned in the officil press relese, the dte ws extrpolted y dding 6-month (for priority reviews) or 10-month time frme (for stndrd reviews) to the new drug ppliction (NDA) or iologicl license ppliction (BLA) sumission dte. Drugs or iologicls tht hd negtive FDA committee reviews t the time this rticle ws prepred were not included. In ddition, gents with FDA-pproved leling for other indictions (without mjor differences in drug delivery) were lso excluded. Phrmceuticls nticipted to lose ptent protection were reviewed to estimte their impct on drug expenditures. Drugs nd iologicls whose ptent protection is expected to end in 2013 or the first qurter of 2014 were identified from severl sources. 2,5,6 nd confirmed y serching usiness news for rticles of interest to investors in the phrmceuticl nd iotechnology industry. The list of potentil future ptent expirtions provided in the 2012 forecst 2 ws exmined to determine if these gents were delyed or expected to lose ptent protection during 2013 or the first qurter of 2014. The list of potentil ptent expirtions ws further limited to phrmceuticls tht represent sustntil expenditures for the entire mrket or those tht re prticulrly importnt to the hospitl or clinic setting. Finlly, we projected drug expenditure growth in 2013 for nonfederl hospitls, clinics, nd ll sectors. These estimtes were generted through comintion of quntittive nd qulittive nlyses nd our opinions. An nlysis of pst expenditure ptterns using liner lestsqures regression ws performed to estimte 2013 expenditures in the sence of mjor chnges. We lso developed qulittively sed estimtes of growth, considering mjor fctors tht re elieved to influence future drug expenditures, s discussed in this rticle. Projections from other sources were lso exmined. Once we evluted these estimtes, consensus regrding nticipted drug expenditure growth rtes for 2013 ws reched. Results Historicl trends in prescription expenditures. Totl prescription sles in the United Sttes for the 12-month period ending Septemer 2012 were $326.0 illion, 0.8% increse from the previous 12 months. This rte of growth is the lowest in recent history nd cn e ttriuted to modest increses in expenditures for new products (3.3%) nd the prices of existing products (5.9%), coupled with mrked decline in overll volume nd mix ( 8.4%). The decrese in expenditures ttriutle to volume nd mix reflects the continued trend of greter use of generics over rndnme products. The $326.0 illion spent on prescription drugs from Octoer 1, 2011, to Septemer 30, 2012, occurred cross vrious sectors of helth cre (Tle 1). The retil phrmcy sector ccounted for the lrgest portion of prescription expenditures ($169.2 illion, or 51.9% of totl expenditures), followed y mil-order phrmcy ($65.1 illion, 20.0%) nd clinics ($39.3 illion, 12.1%). Other sectors, including nonfederl hospitls ($27.9 illion, 8.6%), ech ccounted for less thn 10% of totl expenditures. The gretest growth in prescription expenditures on percentge sis from the previous 12 months ending Septemer 30, 2012, occurred Tle 1. Prescription Drug Expenditures nd Growth y Sector 3 Sector Retil phrmcies Mil-order phrmcies Clinics Nonfederl hospitls Long-term cre Federl fcilities Stff-model HMO Home helth cre Other Totl Expenditures Percent of Totl ($ Millions) Expenditures 169,172 65,140 39,320 27,973 14,280 4,333 2,653 2,269 873 326,013 51.9 20.0 12.1 8.6 4.4 1.3 0.8 0.7 0.3 Growth (%) c 0.8 5.5 3.1 0.4 4.7 4.1 3.8 2.5 6.4 Retil phrmcies include licensed retil phrmcies including stndlone chin nd independent stores, s well s mss merchndisers nd food nd convenience stores with phrmcy. Mil-order phrmcies include licensed mil service phrmcies, including oth privte-sector nd federl fcilities. Clinics include physicin offices nd outptient clinics, including generl, fmily medicine, nd specilty clinics covering oncology, nephrology, dilysis, fmily plnning, orthopedics, nd urgent cre centers. Nonfederl hospitls include ll nonfederlly owned fcilities licensed s hospitls, including inptient tretment nd rehilittion fcilities, in ddition to generl nd specilty cute cre institutions. Long-term cre includes nursing homes nd residentil cre fcilities, including Deprtment of Veterns Affirs (VA) institutions. Federl fcilities include VA, Pulic Helth Service, nd other federl hospitls; VA clinics nd phrmcies; nd U.S. ships t se. Stff-model HMO (helth mintennce orgniztion) includes closed-pnel HMO phrmcies nd hospitls, union clinics nd phrmcies, nd workers compenstion clinics. Home helth cre includes licensed home helth orgniztions nd visiting nurse entities. Other covers vriety of otherwise unclssified government ccounts, s well s entities such s jils, prisons, nd veterinry hospitls nd clinics. Expenditures for Octoer 1, 2011, through Septemer 30, 2012. c Percent increse in expenditures compred with previous 12 months. Am J Helth-Syst Phrm Vol 70, 2013 e3
in mil-order phrmcies (5.5%), followed y federl fcilities (4.1%). Clinics experienced 3.1% growth. Sectors with decresed expenditures were long-term-cre fcilities ( 4.7%), retil phrmcies ( 0.8%), nd nonfederl hospitls ( 0.4%). While retil phrmcies experienced slight decrese in drug expenditures, this ws offset y increses in mil-order phrmcies nd reflects n ongoing shift etween these chnnels. A pttern of incresed expenditures due to greter use of new products nd incresed prices of existing products, comined with decresed expenditures from reduced overll volume nd mix, ws consistent cross ll sectors except clinics. While clinics experienced n overll 3.1% increse in expenditures, there were mjor shifts in the use of generics in this setting. Expenditures for generic injectles decresed 22.7%, primrily ecuse of decresed prices, nd expenditures for generic noninjectles incresed 28.8%, primrily ecuse of new products nd volume nd mix. Figure 1 shows trends in growth (increse or decrese) of prescription drug expenditures in the United Sttes from 1998 99 through 2011 12 in clinics, nonfederl hospitls, nd ll sectors. The vlues for 2011 12 represent the first nine months (yer to dte) of 2012 compred with the sme period in 2011. Growth in totl prescription drug expenditures generlly declined over the pst 15 yers, with high of 19.7% etween 1998 nd 1999 to low of 1.8% etween 2007 nd 2008, ut hs somewht leveled off since. Between 2010 nd 2011, totl prescription expenditures grew 4.0%; for the nine months ending Septemer 2012, totl prescription expenditures grew 2.7% (compred with the sme period in 2011). Note tht this growth is different thn tht shown in Tle 1 (nd discussed ove) ecuse it represents different (shorter) time period. In most yers, growth in expenditures for clinic-dministered drugs outpced growth in totl expenditures, ut clinic expenditures hve leveled off in the pst five yers. Between 2010 nd 2011, expenditures for clinic-dministered drugs grew y 5.7%; for the first nine months of 2012, they grew y 3.4% (compred with the sme period in 2011). Conversely, growth in prescription drug expenditures in nonfederl hospitls Figure 1. Annul growth in drug expenditures, 1998 2012. 3 YTD = yer to dte. % Annul Increse in Expenditures 30 25 20 15 10 5 0 26.3 19.7 14.8 24.6 15.3 4.9 26.8 22.5 21.4 23.0 18.1 12.4 12.6 9.7 6.2 13.5 9.3 6.4 20.9 12.8 8.7 5.9 5.9 3.8 9.9 4.0 2.1 1.8 1.6 1.0 5.2 5.1 2.8 6.0 5.7 4.0 2.7 1.5 0.8 3.4 2.7 0.2 5 1998 99 1999 2000 2000 01 2001 02 2002 03 2003 04 2004 05 2005 06 2006 07 2007 08 2008 09 2009 10 2010 11 YTD Sep 2011 12 Totl expenditures Nonfederl hospitls Clinics e4 Am J Helth-Syst Phrm Vol 70, 2013
decresed from 2.8% in 2008 09 to 0.8% in 2010 11. For the nine months ending Septemer 2012, prescription expenditures in nonfederl hospitls experienced negtive growth ( 0.2%), mening tht the solute spending ctully decresed in 2012 (compred with the sme period in 2011). Tle 2 shows the top 15 drugs sed on expenditures cross ll sectors in 2012. As expected, most of the drugs on the list re widely used in the retil sector nd re rnd-nme products. Esomeprzole rose to the top of the list in 2012 despite decrese in expenditures of 3.8%, compred with the sme nine months in 2011. Atorvsttin, clopidogrel, nd quetipine, which topped the list in 2011, ecme ville s generics in 2012 nd consequently sw lrge decreses in expenditures. Expenditures dropped y 40.6% for clopidogrel, 39.0% for quetipine, nd 34.9% for torvsttin compred with the sme nine months in 2011. The lrgest increse in expenditures for gents in the top 15 were for duloxetine (28.7%), insulin glrgine (24.9%), dlimum (21.9%), nd etnercept (21.7%). The top 15 drug products sed on expenditures in 2012 (nine months through Septemer 30, 2012) in the clinic setting re listed in Tle 3. Rnkings sed on expenditures were lrgely unchnged compred with 2011. Pegfilgrstim, epoetin lf, nd inflixim top the list. Among the top 15, the drugs with the iggest chnge in expenditures from 2011 to 2012 were denosum (119.0% increse), vricell vccine (28.9% increse), nd epoetin lf (21.2% decrese). Expenditures for cetuxim nd trstuzum incresed gretly (16.6% nd 11.1%, respectively), while those for zoledronic cid nd pneumococcl vccine decresed ( 11.0% nd 9.1% respectively). Oncology products ccounted for 32.2% of drug expenditures in the clinic setting in the first nine months of 2012. The top 20 clinicdministered ntineoplstic gents re highlighted in Tle 4. Oncology drug expenditures in clinics hve continued to moderte, growing just 1.4% in the first nine months of 2012 (compred with the sme time period in 2011) nd down from 4.4% in 2011. Rituxim, evcizum, nd trstuzum represent the top 3 oncology drugs sed on expenditures for clinic-dministered drugs in the first nine months of 2012, just s they did in 2011 nd 2010. Of the top 20 clinic-dministered oncology drugs on the list, the gent with the lrgest growth in 2012 ws ipilimum (80.0%), while czitxel sw the lrgest decrese ( 25.1%). Over the pst five yers, there hs een considerle shift in the distriution of spending for orl oncology gents y setting (Figure 2). 3 In the 12 months ending in Septemer 2007, 28% of spending on orl oncology gents ws through mil-order phrmcies, while 58% ws through Tle 2. Top 15 Drugs y Expenditures Overll in 2012 3 Drug Esomeprzole (Nexium) c Aripiprzole (Ailify) Atorvsttin (Lipitor) c Fluticsone slmetrol (Advir Diskus, Advir HFA) Rosuvsttin (Crestor) Duloxetine (Cymlt) Montelukst (Singulir) c Adlimum (Humir) Insulin glrgine (Lntus, Lntus Solostr) Etnercept (Enrel) Clopidogrel (Plvix) c Inflixim (Remicde) Gltirmer (Copxone) Pegfilgrstim (Neulst) Quetipine (Seroquel, Seroquel XR) c All others Totl 2011 Expenditures ($ Thousnds) 6,387,854 5,269,477 8,701,659 5,101,695 4,634,147 3,776,913 4,757,029 3,743,275 3,661,623 3,769,454 7,063,187 3,491,199 3,161,957 3,326,838 5,741,781 255,456,892 328,044,980 Bsed on dt collected etween Jnury 1 nd Septemer 30, 2012. Percent chnge compred with sme period in 2011 (dt not shown in tle). c Aville from one or more mnufcturers, distriutors, or repckgers y generic nme. Percent Chnge from 2010 0.4 15.7 20.0 2.6 23.2 19.7 16.7 21.7 20.3 14.5 15.1 5.7 31.8 10.2 10.9 4.7 6.7 2012 Expenditures ($ Thousnds) 4,504,844 4,329,396 3,915,301 3,903,586 3,765,940 3,443,695 3,376,185 3,355,731 3,269,934 3,170,952 3,054,467 2,904,964 2,635,364 2,627,821 2,589,222 194,014,245 244,861,647 Percent Chnge from 2011 3.8 12.0 34.9 5.5 15.0 28.7 1.1 21.9 24.9 21.7 40.6 10.5 11.1 6.2 39.0 4.4 2.7 Am J Helth-Syst Phrm Vol 70, 2013 e5
retil phrmcies. However, for the 12 months ending in Septemer 2012, 57% of the spending for orl oncology gents ws through milorder phrmcies, while only 27% ws through retil phrmcies. There ws no such shift in spending oserved for injectle oncology gents. In oth 2007 nd 2012, 72% of the spending for injectle oncology drugs ws incurred in the clinic setting, nd 23% of the spending ws incurred in the hospitl setting. The top 15 products sed on expenditures during the first nine months of 2012 in the nonfederl hospitl setting re listed in Tle 5. For the nine-month period ending Septemer 30, 2012, the top 3 hospitl drugs in terms of expenditures were immune gloulin, inflixim, nd rituxim. Immune gloulin mintined the top spot on the list despite 20.5% decrese in expenditures compred with the sme period in 2011. Of the gents included in this list, enoxprin experienced the lrgest decline in expenditures ( 36.6%), continuing downwrd trend tht egn in 2010. Of note, generic enoxprin ccounted for 36.7% of the enoxprin mrket in nonfederl hospitls in 2012, compred with 25.2% in 2011. Expenditures for pipercillin tzoctm lso hd doule-digit decrese ( 18.1%), s did those for epoetin lf ( 13.5%). Drugs included in the list tht hd the lrgest increses in expenditures in nonfederl hospitls were lteplse (20.8%), trstuzum (19.6%), rituxim (14.0%), inflixim (12.1%), nd oxlipltin (10.4%). Beyond the top 15 drugs listed in Tle 5, other gents used in nonfederl hospitls hd mjor decreses in expenditures in the nine-month period ending Septemer 30, 2012, compred with the sme period in 2011. These included olnzpine ( 67.5%, $137.8 million decrese), quetipine ( 41.3%, $63.1 million decrese), cogultion fctor VII ( 79.1%, $61.5 million decrese), levofloxcin ( 65.5%, $95.6 million decrese), nd cetuxim ( 31.0%, $46.9 million decrese). Four iodinted contrst medium gents, which comined represented $592.8 million in expenditures in the first nine months of 2011, experienced decrese ( 13.5%, $79.8 million decrese) in expenditures over the sme period in 2012. Iohexol, iodixnol, nd ioversol experienced significnt decreses in expenditures ( 10.4%, 22.1%, nd 26.5%, respectively) when compred with the first nine months of 2011 to those of 2012, lthough iopmidol expenditures experienced smller chnge ( 0.76%). Tle 6 presents the hospitl drug expenditures nd chnge in expenditures for the top 10 therpeutic clsses for the nine-month period ending Septemer 2012. These clsses ccounted for 69.2% of expenditures in the hospitl setting in 2012. Similr to wht ws oserved in 2011, ntineoplstic gents represented the highest totl expenditures in 2012, ccounting for 15.1% of ll nonfederl hospitl drug Tle 3. Top 15 Drugs y Expenditures in Clinics in 2012 3 Drug Pegfilgrstim (Neulst) Epoetin lf (Procrit, Epogen) Inflixim (Remicde) Rituxim (Rituxn) Bevcizum (Avstin) Rniizum (Lucentis) Trstuzum ( Herceptin) Oxlipltin (Eloxtin) c Vricell vccine (Vrivx, Zostvx) Pemetrexed (Alimt) Denosum (Xgev, Proli) Zoledronic cid (Zomet, Reclst) Pneumoccoccl vccine (Prevnr, Prevnr 13) Bortezomi (Velcde) Cetuxim (Eritux) All others Totl 2011 Expenditures ($ Thousnds) 2,411,397 3,119,524 2,255,393 2,119,656 2,092,741 1,592,326 1,328,336 840,706 771,031 804,033 382,903 758,485 637,880 526,431 455,628 18,715,804 38,812,274 Bsed on dt collected etween Jnury 1 nd Septemer 30, 2012. Percent chnge compred with sme period in 2011 (dt not shown in tle). c Aville from one or more mnufcturers, distriutors, or repckgers y generic nme. Percent Chnge from 2010 11.4 16.5 3.2 7.6 14.8 23.3 6.8 26.3 10.1 5.5 1873.0 9.3 2.6 17.6 4.0 9.0 5.7 2012 Expenditures ($ Thousnds) 1,919,238 1,870,309 1,865,160 1,633,746 1,533,918 1,101,816 1,082,530 862,309 652,645 639,058 525,098 512,328 443,686 400,255 390,627 14,187,464 29,620,187 Percent Chnge from 2011 7.2 21.2 8.5 5.2 2.1 6.1 11.1 6.9 28.9 7.5 119.0 11.0 9.1 3.9 16.6 4.5 3.4 e6 Am J Helth-Syst Phrm Vol 70, 2013
expenditures. Antineoplstics were followed y hemosttic modifiers (11.5% of totl) nd ntiinfectives (9.2% of totl). The clss with the lrgest chnge from 2011 to 2012 ws hospitl solutions, declining 13.4%, followed y hemosttic modifiers which decresed y 10.6%. Gstrointestinl gents grew the most (9.7% compred with 2011). Recent drug pprovls. Select novel gents tht my receive FDA pprovl in the United Sttes y the end of 2013 re listed in Tle 7, long with FDA review dedlines under the PDUFA. 7-27 The PDUFA dte is the dedline y which FDA must mke decision on drug s ppliction (this my e decision to pprove or not pprove drug) fter defined period of review. 28 Currently, the review period is 10 months for stndrd review or 6 months for priority review, fter the mnufcturer sumits n NDA. As shown in Tle 8, oncology drugs constitute mny newly pproved gents. For exmple, compred with 2011, there ws drmtic increse in the numer of new moleculr entities pproved y FDA to tret oncologicl disorders in 2012; 13 gents were pproved in 2012 versus 6 in 2011. The pproximte cost for 28 dys of therpy, sed on the verge wholesle price listed in Redook Online, is presented in Tle 8. 29 For drugs tht re dosed sed on ody weight or ody surfce re, stndrds of 70 kg nd 1.73 m 2, respectively, were used. In Novemer 2012, Snofi nnounced tht it would cut the price of the drug ziv-fliercept y hlf (not reflected in this tle) mid criticism tht the drug ws too expensive. 30 As in the pst, mny new oncology gents re orl dosge forms (e.g., xitini, osutini, cozntini, enzlutmide, pontini, regorfeni, vismodegi); thus, they re unlikely to significntly impct hospitl or clinic expenditures ecuse they re not usully initited during ptient s hospitl sty or dministered y prctitioner in the outptient clinic setting. Helth systems with modest-to-lrge oncology service line should pln for n increse in expenditures from the use of oth ziv-fliercept nd pertuzum. 31,32 These gents re considered ddons to existing therpeutic options for the tretment of high-incidence cncers. Institutions my see higher usge rtes of pertuzum, ecuse Tle 4. Top 20 Antineoplstic Drug Expenditures in Clinics in 2012 3 Drug Rituxim (Rituxn) Bevcizum (Avstin) Trstuzum (Herceptin) Oxlipltin (Eloxtin) Pemetrexed (Alimt) Bortezomi (Velcde) Cetuxim (Eritux) Bendmustine (Trend) Docetxel (Txotere) Ipilimum (Yervoy) Pclitxel lumin (Arxne) Leuprolide cette d Fulvestrnt (Fslodex) Azcitdine (Vidz) Decitine (Dcogen) Cyclophosphmide Czitxel (Jevtn) Eriulin (Hlven) Liposoml doxoruicin (Lipodox, Lipodox 50, Doxil) Pnitumum (Vectiix) All other ntineoplstic drugs Totl 2011 Expenditures ($ Thousnds) 2,119,656 2,092,741 1,328,336 1,127,515 804,033 526,431 455,628 372,628 695,997 225,066 307,197 299,245 216,934 225,460 143,991 74,064 146,763 87,769 106,894 99,543 1,200,418 12,656,309 Percent Chnge from 2010 7.6 14.8 6.8 69.3 5.5 17.6 4.0 29.8 23.0... c 1.5 1.4 76.4 11.9 15.7 94.7 87.2 5044.7 39.1 5.6 20.2 4.4 2012 Expenditures ($ Thousnds) 1,633,746 1,533,918 1,082,530 862,309 639,058 400,255 390,627 324,763 307,622 253,551 233,666 218,014 183,718 182,149 117,451 92,833 88,859 82,864 79,106 75,185 760,407 9,542,631 Percent Chnge from 2011 Bsed on dt collected etween Jnury 1 nd Septemer 30, 2012. Percent chnge compred with sme period in 2011 (dt not shown in tle). c Not ville in 2010. d Leuprolide cette includes the following formultions: Lupron, Lupron Depot, Lupron Depot-3 Month, Lupron Depot-4 Month, Lupron Depot-6 Month, Lupron Depot-Ped, nd Lupron Dep-Ped 3 Month. 5.2 2.1 11.1 6.9 7.5 3.9 16.6 18.2 45.9 80.0 4.6 2.6 16.6 8.6 11.7 74.8 25.1 35.8 19.6 2.0 18.0 1.4 Am J Helth-Syst Phrm Vol 70, 2013 e7
it is n dd-on to estlished firstline options for ptients with metsttic, humn epiderml receptor- 2-positive rest cncer. The impct of the other novel injectle ntineoplstic gents on n institution s expenditures will depend on the volume of ptients eing treted for multiple myelom (crfilzomi), chronic myeloid leukemi (omcetxine), nd cute lymphocytic leukemi (liposoml vincristine). Lrger tertiry institutions tht routinely use high-dose methotrexte should prepre for the use of glucrpidse to increse inptient drug expenditures, ut the use of this therpy is unpredictle. Ptent expirtions. The growing vilility nd susequent rpid use of generic drugs continue to hve sustntil moderting influence on prescription drug expenditures. Compred with 2012, fewer lockuster drugs (nnul sles of more thn $1 illion) re expected to lose ptent protection in 2013. Key products tht my fce generic competition in the coming yer sed on vrious sources re listed in Tle 9. 5 Severl gents tht were lockuster drugs or those tht occupy therpeutic niches hve recently lost ptent protection: torvsttin, clopidogrel, escitloprm, montelukst, pioglitzone, quetipine, nd orl vncomycin. These newly ville generic gents re expected to hve significnt impct on expenditures in the outptient setting, though some svings my e relized y hospitls s well. Expenditures on generic noninjectles (not including rnded generics) in the retil phrmcy setting incresed y 19.7% for the yer through Septemer 2012, with volume nd mix (3.0% increse) nd use of newly ville products (22.1% increse) contriuting to the increse, despite reduction in price of 5.4% during tht time. A similr increse (21.9%) in the sle of these gents occurred in nonfederl hospitls; however, noninjectle gents ccounted for only 28.6% of expenditures in this setting compred with 91.7% of expenditures in the retil setting. 3 While generic version of the sildenfil formultion used to tret pulmonry hypertension (Revtio, Pfizer) ecme ville in 2012, key ptent for the formultion used to tret erectile dysfunction ws upheld, nd generic vilility of this gent is not expected until 2020. Two lockuster drugs, fenofirte nd duloxetine, re projected to lose ptent exclusivity in 2013 (Tle 9). 5 Severl dditionl high-cost gents (e.g., extended-relese nicin, reprzole) re lso expected to lose ptent protection during tht time. While this is fewer thn the numer of lockuster gents tht lost exclusivity during 2012, significnt svings re expected to e relized through the reduced price of these gents. The relese of generic fenofirte is especilly interesting due to chnges mde y the mnufcturer of rnd-nme fenofirte, who hs reformulted the product multiple times nd gined dditionl ptent Figure 2. Distriution of expenditures for orl oncology gents y setting, 2007 12. 3 HMO = helth mintennce orgniztion. % Expenditures 100 90 80 70 60 50 40 30 20 10 Home helth cre Miscellneous Nonfederl hospitl HMO Federl fcilities Long-term - cre Clinics Retil Mil 0 2007 2008 2009 2010 2011 2012 e8 Am J Helth-Syst Phrm Vol 70, 2013
protection, mking generic sustitution not possile. 33 Despite previous pprovl of fenofirte products y FDA eginning in 2002, these reformultions hve limited diffusion of generic fenofirte products until now. Tev, Impx Ls, Myln, Rnxy, Vlent, nd Lupin hve received pprovl from FDA to mrket fenofirte. 6 Numerous mnufcturers hve received tenttive pprovl to mrket duloxetine, including Torrent Phrmceuticls, Impx Ls, Lupin, Dr. Reddy s Ls, Zydus Phrmceuticls (nd Zydus Helthcre), Sun Phrmceuticls, Wockhrdt, Sndoz, Auroindo Phrm, nd Tev. Tle 5. Top 15 Drugs y Expenditures in Nonfederl Hospitls in 2012 3 Drug Immune gloulin c Inflixim (Remicde) Rituxim (Rituxn) Pegfilgrstim (Neulst) Enoxprin (Lovenox) d Bevcizum (Avstin) Dptomycin (Cuicin) Alteplse (Activse, Cthflo Activse) Bivlirudin (Angiomx) Pipercillin tzoctm (Zosyn) d Filgrstim (Neupogen) Linezolid (Zyvox) Epoetin lf (Procrit, Epogen) Trstuzum (Herceptin) Oxlipltin (Eloxtin) d All others Totl 2011 Expenditures ($ Thousnds) 1,255,739 794,024 743,312 660,328 833,752 465,513 417,002 369,425 380,687 448,824 370,370 369,534 388,806 280,449 306,976 20,199,075 28,283,816 Percent Chnge from 2010 9.3 8.3 10.2 7.5 20.2 13.1 23.2 22.6 3.0 31.3 0.7 3.1 21.7 9.8 43.9 1.2 0.8 2012 Expenditures ($ Thousnds) 750,520 659,503 627,233 513,923 415,666 378,433 332,929 327,622 292,933 286,957 283,239 272,499 258,550 247,968 246,401 15,107,444 21,001,820 Percent Chnge from 2011 Bsed on dt collected etween Jnury 1 nd Septemer 30, 2012. Percent chnge compred with sme period in 2011 (dt not shown in tle). c Immune gloulin includes the following products: Bygm, Crimune NF, Fleogmm, Fleogmm DIF, Gmstn S/D, Gmimune N, Gmmgrd Liquid, Gmmgrd S.D., Gmunex, Gmunex-C, Privigen, Vivgloin. d Aville from one or more mnufcturers, distriutors, or repckgers y generic nme. 20.5 12.1 14.0 4.5 36.6 7.4 8.9 20.8 10.1 18.1 1.7 2.6 13.5 19.6 10.4 0.9 0.2 Tle 6. Top 10 Therpeutic Clsses in Nonfederl Hospitls in 2012 Therpeutic Clss 2011 Expenditures ($ Thousnds) Percent Chnge from 2010 2012 Expenditures Percent Chnge ($ Thousnds) from 2011 Antineoplstic gents 3,965,460 4.2 3,166,745 5.8 Hemosttic modifiers 3,527,441 10.3 2,415,081 10.6 Antiinfectives, systemic 2,821,727 8.4 1,942,031 9.8 Blood growth fctors 1,983,557 3.3 1,443,668 3.3 Hospitl solutions 1,782,160 5.3 1,160,435 13.4 Gstrointestinl gents 1,286,800 4.1 1,047,530 9.7 Respirtory therpy gents 1,189,049 8.1 919,811 4.2 Biologicls 1,112,541 6.3 916,949 6.6 Dignostic ids 1,234,994 5.8 854,497 8.7 Anesthetics 853,041 3.0 676,762 9.8 All others 8,527,088 6.7 6,458,311 5.8 Totl 28,283,858 0.8 21,001,820 0.2 Bsed on dt collected etween Jnury 1 nd Septemer 30, 2012. Percent chnge compred with sme period in 2011 (dt not shown in tle). Am J Helth-Syst Phrm Vol 70, 2013 e9
Although the mjority of expenditures for these four gents (fenofirte, duloxetine, extended-relese nicin, nd reprzole) occur in the community setting, these gents were responsile for $67.4 million in expenses for nonfederl hospitls in the first nine months of 2012. 3 The mjority of these expenditures were for duloxetine ($51.0 million). The vilility of numerous genericproducing competitors could result in significnt reductions in expenditures cross ll settings, though lim- ited impct is expected in 2013 due to the 180-dy exclusivity period provided to the first generic competitor. In ddition, generic vilility of two ngiotensin II receptor lockers cndesrtn nd vlsrtn s well s riztriptn for migrines, ws nticipted y the end of 2012; however, ll hve een delyed. 5 The ptent for rnd-nme vlsrtn expired in Septemer 2012; however, t the time of writing, Rnxy hs yet to relese its generic vlsrtn product. 34 Drug expenditure forecst for 2013. Severl groups provide nlysis nd projections of trends in drug expenditures, nd comprison of these projections is provided in Tle 10. 1,35 As with our forecst, these estimtes were generted through oth qulittive nlysis of current nd future drivers of phrmceuticl expenditures nd quntittive nlysis of pst nd current expenditure ptterns. It is importnt to note differences in the projections provided y vrious sources. The Centers for Tle 7. Selected Drugs nd Biologicl Agents Tht My Receive FDA-Approved Leling in 2013 7-27, Drug Mnufcturer Indiction Route PDUFA Dte Glycerol phenylutyrte Hyperion Therpeutics Ure cycle disorders Jnury 23, 2013 Alogliptin Furiex Phrmceuticls Type 2 dietes mellitus Jnury 27, 2013 Mipomersen Genzyme Sucutneous Jnury 29, 2013 Rinttolimod Trstuzum emtnsine Apixn Grnisetron, long cting Cystemine itrtrte Buprenorphine hydrochloride implnt Technetium Tc 99m tilmnocept Fluticsone furote vilnterol Gpentin extended relese Melphln chemosturtion system Levomilnciprn Tivozni Dihydroergotmine inhltion Hemispherx Biophrm Genentech Bristol-Myers Squi/ Pfizer A.P. Phrm Rptor Phrmceuticl Titn Phrmceuticls Nvide Biophrmceuticls GSK nd Thervnce Depomed Delcth Systems Forest Lortories AVEO Oncology nd Astells Phrm MAP Phrmceuticls Homozygous nd severe heterozygous fmilil hypercholesterolemi Chronic ftigue syndrome Brest cncer Prevention of stroke nd systemic emolism in ptients with nonvlvulr tril firilltion Chemotherpy-induced nuse nd vomiting Nephropthic cystinosis Opioid dependence Lymphtic mpping Chronic ostructive pulmonry disese Menopusl hot flshes Unresectle metsttic melnom in the liver Mjor depressive disorder Renl cell crcinom Migrine I.V. Suderml implnt Injection t tumor site Inhltion Percutneous heptic perfusion Inhltion Ferury 2, 2013 Ferury 26, 2013 Mrch 17, 2013 Mrch 27, 2013 April 13, 2013 April 29, 2013 April 30, 2013 My 12, 2013 My 31, 2013 June 15, 2013 July 27, 2013 July 28, 2013 August 16, 2013 FDA = Food nd Drug Administrtion, PDUFA = Prescription Drug User Fee Act, HIV = humn immunodeficiency virus, AIDS = cquired immune deficiency syndrome. PDUFA dte extrpolted sed on new drug ppliction sumission dte nd review sttus (i.e., 10 months for stndrd review nd 6 months for priority review) or specified dt provided when ville. e10 Am J Helth-Syst Phrm Vol 70, 2013
Medicre nd Medicid Services reports nd projects overll expenditures for ll settings. Medco Express Scripts reports trends nd projections in trditionl nd specilty medictions, not the sector in which those medictions re purchsed. We developed qulittive estimtes of growth in nonfederl hospitls, clinics, nd ll sectors comined for 2013, considering numer of fctors tht will influence future drug expenditures. First, s descried ove, recent expenditure trends hve shown significntly lower growth thn in previous decdes. In ll sectors comined nd in the hospitl sector, continued generic competition for widely used drugs should moderte expenditure increses. Although fewer lockuster gents will lose ptent protection in 2013 thn in 2011 nd 2012, 2013 will represent the first full yer of widespred generic competition (i.e., fter the expirtion of the 180-dy exclusivity period) for mny of the gents pproved in 2011 nd 2012. While significnt chnges resulting from the Ptient Protection nd Affordle Cre Act my e noted in the future, the only element expected to ffect phrmceuticl expenditures in the coming yer is the mndte to cover contrceptive prescription drugs, which is not expected to hve significnt effect on drug expenditures. In 2014, coverge of preexisting conditions will e expnded, nd the individul mndte to crry minimum level of helth insurnce will e required. This is likely to influence prescription drug expenditures in 2014 nd eyond. Bsed on the expenditure trends, new drug pprovls, nd ptent expirtions descried ove, we estimte n increse of 1 3% in expenditures overll (ll sectors comined). We expect tht expenditures for clinicdministered drugs will increse y 2 4%. For the hospitl setting, we project decrese of 0.5% to n increse of 1.5% for 2013. Discussion Emerging helth cre trends, including the continued implementtion of helth cre reform, expnsion of ccountle cre orgniztion development, efforts to reimurse providers on the sis of improving performnce, nd the growing consolidtion of helth cre into integrted helth systems, re rpidly chnging helth cre delivery in the United Sttes. These sustntil nd fundmentl chnges mke it essentil for helth-system phrmcy Tle 8. Oncology Agents Tht Received FDA-Approved Leling in 2012 Drug Mnufcturer Indiction Route Axitini (Inlyt) Bosutini (Bosulif) Cozntini (Cometriq) Crfilzomi (Kyprolis) Enzlutmide (Xtndi) Glucrpidse (Vorxze) Omcetxine mepesuccinte (Synrio) Pertuzum (Perjet) Pontini (Iclusig) Regorfeni (Stivrg) Vincristine sulfte liposome injection (Mrqio) Vismodegi (Erivedge) Ziv-fliercept (Zltrp) Pfizer Pfizer Exelixis Onyx Phrmceuticls Medivtion nd Astells Phrm US BTG Interntionl Tev Phrmceuticl Industries Genentech Arid Phrmceuticls Byer HelthCre Phrmceuticls Tlon Therpeutics Genentech Snofi U.S. Renl cell crcinom Chronic myeloid leukemi Thyroid cncer Multiple myelom Prostte cncer Toxic plsm methotrexte concentrtions Chronic myeloid leukemi Brest cncer Chronic myeloid leukemi nd cute lympholstic leukemi Colorectl cncer Acute lympholstic leukemi Bsl cell crcinom Colorectl cncer Injection Injection Injection Injection Injection Injection Approximte Price for 28 Dys of Therpy ($) 9,900 9,200... 9,300 c 8,300 94,500 d 8,700 e 4,900 e... 11,200... 9,000 10,800 Approximte cost clculted sed on verge wholesle price (AWP) listed in Redook Online. For drugs tht re dosed y weight or ody surfce re, stndrds of 70 kg nd 1.73 m 2, respectively, were used. FDA = Food nd Drug Administrtion. Price fter dosge djustment. c AWP not ville. d Price for one-time olus dose. e Price for mintennce therpy. Am J Helth-Syst Phrm Vol 70, 2013 e11
executives nd other leders to develop finncil plns nd udgets for prescription drug expenditures s ccurtely s possile. Over the pst severl yers, we hve cutioned reders to not use our finncil projections s multipliers to clculte future expenditure levels in their helth systems. 2,36-38 Insted, s descried previously nd in ASHP guidelines, locl dt must e crefully nd systemticlly incorported into n orgniztion s drug expenditure forecst, s well s the externl trends relevnt to drug expenditures descried in this rticle. 39,40 This dvice hs never een more importnt thn it is tody. As helth systems expnd nd ecome more highly integrted, helth-system phrmcy leders must emrce the phrmcy enterprise concept to improve ptient cre, lign with helth cre reform, nd effectively mnge prescription drug expenditures. 41 Leders who tke the phrmcy enterprise pproch will e positioned to mnge mediction use nd expenditures cross the continuum of cre. The dt presented in Figure 2 tht show the drmtic shift in spending on orl oncology gents over five yers from the retil phrmcies to the mil-order setting illustrte how essentil it is to monitor shifts in drug expenditures. Becuse IMS Helth does not hve seprtely defined nd mintined chnnel for drugs from specilty phrmcies, the milorder phrmcy ctegory lso reflects nticncer gents miled from specilty phrmcies. Therefore, the growth of specilty phrmcy my e the cuse of this chnnel shift, nd phrmcy leders must proctively monitor nd pln strtegy for specilty phrmceuticls for cncer nd ptients with other diseses. 42,43 Beyond drug use nd expenditures, phrmcy leders must tke proctive pproch to stying wre of developments in helth policy, helth finnce, technology, Tle 9. Selected Potentil Ptent Expirtions for 2012 or 2013 3, Drug Mnufcturer Indiction Duloxetine (Cymlt) Eli Lilly Esomeprzole (Nexium) Ethinyl estrdiol norethindrone (Loestrin 24 Fe) Fenofirte (Tricor) Meslmine extended-relese formultion (Ascol 400 mg) Moxifloxcin (Avelox) Nicin (Nispn) Nicin extended relese lovsttin (Advicor) Oxycodone extended-relese formultion (OxyContin) Reprzole (AcipHex) Rloxifene (Evist) Riluzole (Rilutek) Sirolimus (Rpmune) Telmisrtn (Micrdis) Temozolomide (Temodr) Vlgnciclovir (Vlcyte) Zoledronic cid (Zomet) Zolmitriptn (Zomig) Zolmitriptn (Zomig ZMT) Astr-Zenec Wrner Chilcott Aott Lortories Wrner Chilcott Byer AVie AVie Purdue Eisi Lilly Snofi-Aventis Wyeth Boehringer Ingelheim Merck Roche Novrtis IPR IPR Depression, nxiety, dietic neuropthy, pin Esophgel reflux, gstric/duodenl ulcer Contrception Dyslipidemi Ulcertive colitis Infection, community-cquired pneumoni, skin nd skin-structure infection Dyslipidemi, therosclerosis Dyslipidemi, therosclerosis Pin Esophgel reflux, duodenl ulcer Osteoporosis Amyotrophic lterl sclerosis Orgn trnsplnttion Hypertension Gliolstom multiforme, nplstic strocytom Cytomeglovirus Hyperclcemi of mlignncy Migrine Migrine 2011 Totl Sles ($ Thousnds) 3,776,913 6,387,854 572,438 1,406,197 595,939 385,699 1,239,026 60,847 2,899,932 976,392 772,617 56,987 212,402 294,998 407,553 334,039 676,235 168,167 34,164 Ptent expirtions listed were verified from multiple sources t the time of puliction. Drug ptent expirtions re suject to rpid chnge, nd ptent expirtion does not gurntee generic drug vilility. Represents sles for Tricor only; other fenofirte formultions re currently ville. e12 Am J Helth-Syst Phrm Vol 70, 2013
nd prctice in order to respond to new phenomen in confident nd thoughtful mnner. Even the most ssiduously developed, strtegic, tcticl, nd finncil plns must remin flexile to ccommodte unexpected events; chnges tht re known to e on the horizon must e considered in order to e responsive to unexpected events. Besides roder trends in helth cre nd phrmcy, this rticle includes key informtion to help guide plnning for phrmceuticls. Another resource tht hs recently een pulished nd tht provides dditionl guidnce must lso e red nd understood y helth-system phrmcy leders: Phrmcy Forecst 2013 2017: Strtegic Plnning Advice for Phrmcy Deprtments in Hospitls nd Helth Systems. 44 The report summrizes the results of survey exploring eight domins in which emerging trends re likely to chllenge phrmcy prctice leders. It lso includes recommendtions to guide plnning in phrmcy deprtments. We strongly urge reders to review nd use this report in finncil nd strtegic plnning. The complete report is freely ville t www.shpfoundtion.org/ phrmcyforecst. Our projections focus on fctors likely to influence prescription drug expenditures in 2013, ut phrmcy leders should crefully monitor other developments tht re expected to influence prescription drug expenditures eyond 2013, including the continuing implementtion of the pprovl pthwy for iosimilrs nd ctions to fcilitte the introduction of generic drugs. Biologicl gents re essentil ut often expensive therpies; they re well represented on the list of top clinic (oncology nd non-oncology) expenditures. An opportunity for decresing hospitl nd helth-system costs exists with iosimilrs, which re copies of iologicl gents (not mnufctured y the originl, in- novtor compny) nd re pproved through n revited pthwy. The legl frmework for pprovl of iosimilrs ws estlished through the Biologics Price Competition nd Innovtion (BPCI) Act of 2009, which ecme lw in Mrch 2010. 45 Although numer of unresolved issues remin, further detils of the regultory process to implement pprovl of iosimilrs through the BPCI Act ecme ville when FDA relesed series of drft guidnces on iosimilrs in erly 2012. 46 These guidnces provide informtion relted to scientific considertions when demonstrting iosimilrity nd on qulity considertions when developing iosimilrs. These documents lso stte tht iosimilr gent s lel will contin informtion explicitly stting whether the product is deemed to e interchngele with the reference product. Becuse iosimilrs re not new concept in Europe, the processes proposed y FDA cn e compred with regultions estlished y the Europen Medicines Agency. Legisltion first estlished Europen iosimilr pprovl pthwy in 2004, nd the first iosimilr product ws pproved in 2006. 47,48 Future development of the iosimilr pthwy in the United Sttes is expected to continue to drw on the Europen iosimilr experience. Tle 10. Projections of Chnges in Drug Expenditures Projection Source nd Type of Expenditure An lterntive pthwy for noninnovtor iologicl products to rech the mrket is through completing full development progrm nd sumitting new BLA. This pproch hs een tken for new grnulocyte colony-stimulting fctor product, to-filgrstim (Tev), which ws pproved y FDA in 2012. 49 Becuse the product ws pproved through full BLA, this product is not iosimilr to the innovtor filgrstim product (Neupogen, Amgen), nd when pprovl of the product ws nnounced, FDA mde it cler tht the product is not iosimilr. The mnufcturer of to-filgrstim nnounced tht the erliest the product will e ville is Novemer 2013; therefore, the product does not represent significnt opportunity for cost svings in 2013. 50 However, pprovl of this noninnovtor iologicl gent nd relese of the drft FDA guidnce for iosimilrs represent sustntive progress towrd competition nd susequent svings for expensive iologicl products. Phrmcy leders should continue to crefully monitor iosimilr developments over the next severl yers. The introduction of generic medictions cn e slowed when the innovtor compny pys generic mnufcturers to dely introduction of their generic product ( py to dely ). While legisltion rring such Projected Expenditure Increse (%) from 2012 to 2013 Centers for Medicre nd Medicid Services 1 Totl ntionl helth 3.8 Totl drug 2.4 Express Scripts Medco 35 Trditionl drug 1.6 Specilty drug 19.0 Authors Totl drug 1 to 3 Nonfederl hospitl drug 0.5 to 1.5 Clinic drug 2 to 4 Am J Helth-Syst Phrm Vol 70, 2013 e13
rrngements hs not progressed through Congress, significnt ction relted to py-for-dely greements hs occurred over the pst yer. The U.S. Court of Appels for the Third Circuit ruled in July 2012 tht py-for-dely greements etween phrmceuticl mnufcturers re nticompetitive. 51 The Federl Trde Commission hs requested tht the Supreme Court review different cse regrding py-for-dely rrngement etween Aott Lortories nd three generic mnufcturers. 52 Finl ction in these cses will influence the speed t which first-time generic products ecome ville. Our forecst hs severl limittions. The primry source of our drug expenditure trend dt ws IMS Helth NSP dt through the end of Septemer 2012, ut expenditure ptterns my chnge in the lst qurter of 2012. This my e especilly importnt for drugs tht hve sesonl fluctutions in utiliztion, like ntimicroils. IMS Helth hs roust process to review, verify, nd updte dt; therefore, dt my e revised in the future, which could influence trend dt nd our projections. Empiricl computtion of the expected chnge in expenditures is limited, nd the forecst projections were decided fter crefully nlyzing key trends. Further, we relied on reviews of key trends from vrious sources, ut some importnt trends my hve een missed. Due to these limittions, our forecsts re expressed in rnges, reflecting our uncertinty of the dt nlyzed. Conclusion For 2013, we project 1 3% increse in totl drug expenditures cross ll settings, 2 4% increse in expenditures for clinic-dministered drugs, nd 0.5% decline to 1.5% increse in hospitl drug expenditures. Helth-system phrmcy leders should crefully exmine their own locl drug-utiliztion ptterns to determine their own orgniztion s drug expenditure forecst. References 1. Keehn SP, Cuckler GA, Sisko AM et l. Ntionl helth expenditure projections: modest nnul growth until coverge expnds nd economic growth ccelertes. Helth Aff. 2012; 31:1600-12. 2. Hoffmn JM, Li E, Doloresco F et l. Projecting future drug expenditures 2012. Am J Helth-Syst Phrm. 2012; 69:405-21. 3. IMS Helth Ntionl Sles Perspectives. Anlysis conducted y the uthors. Anlysis conducted Novemer 2012. 4. IMS Helth. The Uniform System of Clssifiction (USC). www.imshelth.com/ deployedfiles/ims/glol/content/ Insights/Helth%20Services%20Reserch %20Network/USC_Clssifiction_Process_ 2011.pdf (ccessed 2013 Jn 14). 5. Medco Helth. Estimted dtes of possile first-time generics/rx-to-otc mrket entry. https://host1.medco helth.com/rt/.../nticiptedfirsttime_ generics.pdf (ccessed 2012 Nov 24). 6. Food nd Drug Administrtion. Drugs@ FDA. www.ccessdt.fd.gov/scripts/ cder/drugstfd/index.cfm (ccessed 2012 Nov 22). 7. Sntrus. Sntrus nnounces FDA extension of UCERIS new drug ppliction trget ction dte to Jnury 16, 2013. http://ir.sntrus.com/relesedetil. cfm?releseid=700255 (ccessed 2012 Nov 27). 8. NuPthe. FDA ccepts NuPthe s migrine ptch NDA resumission for filing. http://ir.nupthe.com/press-releses/ fd-ccepts-nupthe-s-migrine-ptchnd-resumiss-nsdq-pth-0914651 (ccessed 2012 Nov 27) 9. Impx Phrmceuticls. Impx Phrmceuticls nnounces extension of Rytry FDA review dte to Jnury 21, 2013. http://investors.impxls. com/medi-center/press-releses/ Press-Relese-Detils/2012/Impx- Phrmceuticls-Announces-Extension- of-rytrytm-fda-review-dte-to- Jnury-21-20131131423/defult.spx 10. Hyperion Therpeutics. Hyperion Therpeutics nnounces extension of ction dte for Rvicti NDA to Jnury 23, 2013. http://investors.hyperiontx.com/ relesedetil.cfm?releseid=704867 11. Sucmpo Phrmceuticls. U.S. Food nd Drug Administrtion grnts priority review sttus to AMITIZA (luiprostone) sumission seeking pprovl for tretment of opioid-induced constiption. http:// phx.corporte-ir.net/externl.file?item =UGFyZW50SUQ9MTU0NjIxfENo WxkSUQ9LTF8VHlwZT0z&t=1 12. Furiex Phrmceuticls. 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Nvide Biophrmceuticls nnounces PDUFA gol dte for Lymphoseek new drug ppliction resumission. http://ir.nvide.com/ phoenix.zhtml?c=68527&p=irolnewsarticle&id=1758296&highlight= 21. GSK nd Thervnce. GSK nd Thervnce nnounce FDA cceptnce of FF/VI new drug ppliction (NDA) sumission in the US for COPD. http:// investor.thervnce.com/relesedetil. cfm?releseid=709460 (ccessed 2012 Nov 27). 22. Depomed. Depomed nnounces Serd NDA cceptnce nd FDA dvisory committee meeting. http:// investor.depomedinc.com/ phoenix.zhtml?c=97276&p=irol-news e14 Am J Helth-Syst Phrm Vol 70, 2013
Article&ID=1745141&highlight= 23. Delcth Systems. Delcth nnounces FDA ccepts new drug ppliction for its proprietry chemosturtion system with melphln hydrochloride. www.delcth.com/news-events/news/ rticle/reuters/1745070/ (ccessed 2012 Nov 27). 24. Forest Lortories. Forest Lortories sumits new drug ppliction for levomilnciprn for the tretment of mjor depressive disorder. http://investor.frx. com/press-relese/usiness-development-news/forest-lortories-sumitsnew-drug-ppliction-levomilnci 25. MAP Phrmceuticls. MAP Phrmceuticls resumits new drug ppliction to FDA for LEVADEX orlly inhled migrine drug. http://ir.mpphrm.com/ relesedetil.cfm?releseid=713682 26. Slix Phrmceuticls. FDA ction on crofelemer NDA nticipted y end of 1Q2013. www.slix.com/news-medi/ news/index/fd-continues-review-ofcrofelemer-new-drug-pplictioneyond-pduf-gol-dte-of-septemer- 5-2012.spx 27. AVEO Oncology nd Astells Phrm. AVEO nd Astells nnounce sumission of new drug ppliction for tivozni for the tretment of dvnced renl cell crcinom. http://investor.veooncology. com/phoenix.zhtml?c=219651&p=irolnewsarticle&id=1739376&highlight 28. Crpenter D, Zucker EJ, Avorn J. Drugreview dedlines nd sfety prolems. N Engl J Med. 2008; 358:1354-61. 29. Greenwood Villge (CO): Truven Helth Anlytics Inc. http://www.redook.com/ redook/online/ (ccessed 2012 Nov 19). 30. Pollck A. Snofi hlves price of cncer drug Zltrp fter Slon-Kettering rejection. www.nytimes.com/2012/11/09/ usiness/snofi-hlves-price-of-drugfter-slon-kettering-lks-t-pying-it. html?_r=0 (ccessed 2013 Jn 14). 31. Vn Cutsem E, Ternero J, Lkomy R et l. Addition of fliercept to fluorourcil, leucovorin, nd irinotecn improves survivl in Phse III rndomized tril in ptients with metsttic colorectl cncer previously treted with n oxlipltinsed regimen. J Clin Oncol. 2012; 30:3499-506. 32. Bselg J, Cortés J, Kim SB et l. Pertuzum plus trstuzum plus docetxel for metsttic rest cncer. N Engl J Med. 2012; 366:109-19. 33. Downing NS, Ross JS, Jckevicius CA et l. Avoidnce of generic competition y Aott Lortories fenofirte frnchise. Arch Intern Med. 2012; 172:724-30. 34. Husten L. Another one ites the dust: Diovn ptent expires ut generic vlsrtn is MIA. www.fores.com/sites/lrryhusten/ 2012/09/25/nother-one-ites-the-dustdiovn-ptent-expires-ut-genericvlsrtn-is-mi/ (ccessed 2012 Nov 25). 35. Express Scripts. 2012 drug trend report. www.drugtrendreport.com/ (ccessed 2012 Dec 7). 36. Hoffmn JM, Shh ND, Vermeulen LC et l. Projecting future drug expenditures 2009. Am J Helth-Syst Phrm. 2009; 66:237-57. 37. Hoffmn JM, Doloresco F, Vermeulen LC et l. Projecting future drug expenditures 2010. Am J Helth-Syst Phrm. 2010; 67:919-28. 38. Doloresco F, Fominy C, Schumock GT et l. Projecting future drug expenditures 2011. Am J Helth-Syst Phrm. 2011; 68:921-32. 39. Hoffmn JM, Shh ND, Vermeulen LC et l. Projecting future drug expenditures 2005. Am J Helth-Syst Phrm. 2005; 62:149-67. 40. ASHP guidelines on mediction cost mngement strtegies for hospitls nd helth systems. Am J Helth-Syst Phrm. 2008; 65:1368-84. 41. Zellmer WA. Inventing our future. Am J Helth-Syst Phrm. 2007; 64:1262. Editoril. 42. Schwrtz RN, Eng KJ, Frieze DA et l. NCCN Tsk Force report: specilty phrmcy. J Ntl Compr Cnc Netw. 2010; 8(suppl 4):S-1-12. 43. Cselnov 3rd D, Donley K, Ehlers D et l. Report of the ASHP Tsk Force on Cring for Ptients Served y Specilty Suppliers. Am J Helth-Syst Phrm. 2010; 67:1650. 44. Zellmer WA, Wlling RS. Phrmcy forecst 2013 2017: strtegic plnning dvice for phrmcy deprtments in hospitls nd helth systems: executive summry of trends report from the Center for Helth-System Phrmcy Ledership, ASHP Reserch nd Eduction Foundtion. Am J Helth-Syst Phrm. 2012; 69: 2083-7. 45. Zelenetz AD, Ahmed I, Brud EL et l. NCCN iosimilrs white pper: regultory, scientific, nd ptient sfety perspectives. J Ntl Compr Cnc Netw. 2011; 9(suppl 4):S1-22. 46. Food nd Drug Administrtion. FDA issues drft guidnce on iosimilr product development. www.fd.gov/newsevents/ Newsroom/PressAnnouncements/ ucm291232.htm (ccessed 2013 Jn 17). 47. McCmish M, Woollett G. Worldwide experience with iosimilr development. MAs. 2011; 3:209-17. 48. Weise M, Bielsky MC, De Smet K et l. Biosimilrs: wht clinicins should know. Blood. 2012; 120:5111-7. 49. Food nd Drug Administrtion. FDA pproves new tretment for severe neutropeni in certin cncer ptients. www.fd.gov/newsevents/newsroom/ PressAnnouncements/ucm317392.htm (ccessed 2012 Dec 17). 50. Trynor K. FDA pproves Tev s Tofilgrstim. www.shp.org/menu/news/ PhrmcyNews/NewsArticle.spx?Source =News&Type=Rss&Id=3775 (ccessed 2012 Dec 17). 51. Hemphill Krus EJ. A shift on py for dely reopening doors for phrmceuticl competition? N Engl J Med. 2012; 367:1681-3. 52. FTC seeks U.S. Supreme Court review in AndroGel py-for-dely cse. www.ftc.gov/op/2012/10/ndrogel.shtm (ccessed 2012 Nov 24). Am J Helth-Syst Phrm Vol 70, 2013 e15