New Initiators to Asthma Biologics: Apre/Post Analysis of Utilization Patterns, Total Cost of Care, and H.V

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Asthma-related Events Commercially Insured Members Million 14 Among New Initiators to Asthma Biologics: APre/Post Analysis of Utilization Patterns, Total Cost of Care, and H.V. Shaw, PharmD All brand names are the property of their respective owners. respective their of property the are names brand All [email protected] 800.858.0723,PATRICK 5190 GLEASON, ext. USA AMCP, 2020, April TX, Houston, Crossing55121 MN Ames Road,2900 Eagan, LLC 04/20 Therapeutics 4085-A © Prime • • medical claims, describe the real world: members integrated pharmacy and insured commercially 14 million Using OBJECTIVE • • BACKGROUND • • • • • • • • cost of care (TCC), and asthma-related member total per average Persistence, spend among all members. Asthma biologic utilization trend and Cinqair biologic: asthma an recommended guidelines 2019 Global Initiative for Asthma asthma costs. accounts for almost 50% of all 5–10% of all asthma patients, but of asthma representing fewer than phenotype is an important subset $56 billion. an estimated societal cost of 25.2 million Americans and has approximately affects Asthma value-based contract negotiations. contract value-based insurers’ management strategies and understandingA better could assist care for asthma biologic utilizers. utilization and patterns total cost of is about known Little the real-world price. list from representing a73–80% discount per quality adjusted life year gained, for a$100,000the drug) investment $10,100and on (depending annually foundwas to $6,500 be between effectiveness.” accepted thresholds for cost- commonly “exceed biologics asthma final determined report that all five 2018 asthma Review Economic InstituteThe for Clinical and severe asthma phenotype. (omalizumab), for patients with a (mepolizumab), Xolair or Fasenra (reslizumab), Dupixent event rate among new initiators. ® (benralizumab), Nucala (benralizumab), 1, 2 Severe asthma 3 3 1 3

; C.I. Starner,; C.I. PharmD The fair price to value value to price fair The ® (dupilumab), ®

4 ®

1, 2 ; P.P. Gleason, PharmD • • • • • • • • Event Rate in Asthma BiologicNew Initiators Assessment 2:Persistence, Pre/Post Total Cost of Care, and Asthma ‑related • • • • Assessment 1: Asthma BiologicUtilization Trend andSpend 14 million commercially insured members. All analyses were conducted using integrated pharmacy and medical claims from METHODS • • • • • • • • • • • • related (J45% field) in primary hospitalizations and/or emergencyroom visits. (ER) Facility medical claims were queried in the and pre- post-periods to identify asthma- → → → and medical costs. Post-period TCC also was broken out by: member paid) in the and pre- post-periods. TCC Pre-period pharmacy as reported was TCC defined was theas sum of all pharmacy and medical claim(plan costs paid plus → → information: on index drug and definedas member receiving drug in accordancewith prescribing Persistence evaluated was at days and 90 182 after index date. Persistence was based pre-period. Members were required defined toas beasthmano new starts, biologic claims the in least 30 days apart. andpre- post-periods and required to have 2or more J45% ICD-10 codes in any field at To limit the intended use to asthma, member medical claims were queried during the 182 days after(post-period) their index date. Members were required to be continuously enrolled 182 days and prior (pre-period) index drug. Members’ earliest asthma biologic claim used to was definetheir index date and excludedwas because not it was approved FDA for asthma until October 2018. omalizumab. Dupilumab or mepolizumab, benralizumab, reslizumab, for claim biologic 2018 (18 months) using GPI and codes HCPCS to identify members with an asthma Pharmacy and medical claims data were queried July from 2017 through December (plan paid plus member paid) divided by average monthly membership count. Asthma biologic per member per month (PMPM) cost defined was as monthly total paid Asthma biologic utilization per 10,000 members calculated was and quarterly. reported ICD-10 code J45%, days 90 or more in any apart field. claims January 2017 from to June 2019 were queried and required to have 2or more code in any field theon claim.For pharmacy claims to be included, member medical and spend to asthma, medical claims were required to have aJ45% (asthma) ICD-10 Omalizumab and dupilumab have additional indications beyond asthma. To limit trend omalizumab. or dupilumab, mepolizumab, benralizumab, Coding System codes (HCPCS) to identify asthma biologic claims: reslizumab, (30 months) using Generic Product Identifier (GPI) and Healthcare CommonProcedure Pharmacy and medical claims data were queried January 2017 from through June 2019 → → → → → Asthma biologic cost pharmacy from and medical benefit. biologics. asthma without cost benefit Medical Pharmacy benefit costwithout asthma biologics. claims. omalizumab or mepolizumab, reslizumab, more or 6 or claims benralizumab Persistence index between date and 182 days post defined was as 4 or more claims. Persistence index between date and days 90 post defined was as 3 or more 1, 2 .

1 Prime Therapeutics United Eagan, MN, LLC, States; 2 University of Minnesota College of Pharmacy, Minneapolis, United MN, States. • • • Biologic New Initiators Average 6-month Pre/Post Total Cost of Care in Asthma • • • • Biologic New Initiators Persistence and Asthma-related Event Rate in Asthma • • (Figure 2) Asthma-related Event Rate in Asthma BiologicNew Initiators Assessment 2:Persistence, Pre/Post Total Cost of Care, and • • (Figure 1) Assessment 1: Asthma BiologicUtilization Trend andSpend RESULTS • • • • • • • • • • • than 2-fold for all asthma biologics, ranging 2.4 from to 3.1 3showsFigure the TCC break out by index drug. TCC increased more → → → 2.6 In the post-period, average per member TCC $28,233, was a cost accounted for $3,692 and medical cost $7,221. was In the pre-period, average per member TCC $10,913. was Pharmacy lowest in benralizumab users at 0%. period, event rate highest was in reslizumab users at 3.3% and users at 4.8% and lowest in omalizumab users at 2.5%. In the post- drug. In the pre-period, event rate highest was in benralizumab Table 1shows asthma-related event results broken out by index decrease the pre-period. from asthma-related event rate 1.6% was among a50% all new starts, experienced one or more asthma-related events. In the post-period, In the pre-period, 3.2% of all asthma biologic members new start 49.5%. at users omalizumab users with 70% meeting persistence definition, and lowest in 6monthsAt after index date, persistence was highest in reslizumab 59.5%. at users benralizumab users with 86.7% meeting persistence definition, and lowest in 3monthsAt after index date, persistence was highest in reslizumab omalizumab. 432benralizumab, (29.0%) (63.4%) 946 and mepolizumab, (2.0%)Thirty members reslizumab, newly started (5.6%) 84 identifiedasthmaas biologic starts. new JulyBetween 2017 and December 2018, 1,492 members were 85%, $0.45 from to $0.84. During the same period, asthma biologic PMPM cost increased members. insured commercially 5.8 utilizers per 10,000 members in 2Q2019 among 14 million 2.5 3.3 years, from utilizers per 10,000 members in 1Q2017 to a78% was There increase in asthma biologic utilization over → → → $16,460, accounting for 95% of the pre/post TCC increase. Average asthma biologic cost plus (pharmacy medical) was accounting for 1% of the pre/post TCC increase. Average medical cost without asthma biologic $7,436, was accounting for 4% of the pre/post TCC increase. Average pharmacy cost without asthma biologic $4,337, was ‑fold increase the pre-period from TCC. (Figure 3) (Table 1) ‑fold. required to have ICD-10 code J45%inany field. Dupilumab andomalizumab pharmacy claim utilizers were to required have two or more medical claims with ICD-10 code J45%(asthma) inany field, 90 days or more apart from 2017 to June January 2019. Omalizumab medical claims were Asthma biologic utilization per 10,000 members, January 2017 to June 2019, among 14 million commercially insured lives FIGURE 1 • • • • LIMITATIONS hospitalizations and/or emergency room visits. visits were bya identified facility medical claims in the 6-month query pre-period and6-month post-period asthma-related (J45% inprimaryfield) to identify asdefined 4or more benralizumab claims or 6or more reslizumab, mepolizumab, or omalizumab claims between index date and6months post. Hosp/ER with prescribing information. 3-month persistence was as defined 3or more claims between index date and3months post. 6-month persistence was new start if noasthma biologic claim was found within 6months before (pre-period) index date. Persistence was as dosing defined received inaccordance During the 18-month period,between July 2017andDecember 2018,member’s first asthma biologic claim was identified as theindex as claim anddefined Hosp/ER Persistence and asthma-related event rate in asthma biologic members new start 1 TABLE hosp/ER visits post-period 6-month hosp/ER visits pre-period 6-month Outcome 6-month persistence 6-month persistence3-month • • • • Unique Utilizers per 10,000 Members population and not generalizable to Medicare or Medicaid. or Medicare to generalizable not and population dataThe used in this analysis limited was to acommercial cost markups. professional, or pharmacy), which can contribute to differing Claim costs were not adjusted for site of care (e.g. facility, low utilization, potentially confounding the results. assessment. anas exploratory Some asthma biologic products had products shouldbetween not be made. This analysis intended was members’ Therefore, comparisons disease performed. was severity No statistical comparisons were made, and no assessment of diagnoses. and be miscoded and include assumptions of members’ actual drug use Administrative pharmacy and medical claims have the potential to

= hospitalizations or emergency room visits.

Q . . . . • Mar (atopicdermatitis), approval Dupilumab all utilizers all

Q 73.5% (1,096)73.5% N =1,492 . Overall 51.5% (769) 51.5% 3.2% (47) 3.2% 1.6% (24) 1.6% benralizumab, mepolizumab, and omalizumab and mepolizumab, benralizumab, dupilumab, reslizumab, utilizers: biologic asthma All

Q (reslizumab) Cinqair N =30 86.7% (26) 86.7% 70.0% (21) 70.0% reslizumab 3.3% (1) 3.3% (1) 3.3% • (asthma), Nov

Benralizumab approval Benralizumab ®

Q (benralizumab) Fasenra N =84 58.3% (49) 58.3% 59.5% (50) 4.8% (4) 4.8% ®

0% dupilumab

Q (mepolizumab) Nucala N 80.1% (346) 80.1% 53.5% (231)53.5% = 4.2% (18) 4.2% 2.5% (11) 2.5% 432 ®

(omalizumab) benralizumab 4. 3. 2. 1. REFERENCES • • • • CONCLUSIONS • • • • N Xolair 49.5% (468) 49.5% 71.2% (674) 71.2% Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2019.Available from: www.ginasthma.org/. Institute for Clinical and Economic Review. Biologic therapies for treatment of asthma associated with type 2inflammation: effectiveness, value, and value-based price benchmarks. Final Evidence December Report. 20,2018. Centers for Disease Control and Prevention. ASTHMA FACTS -CDC’s National Asthma Control Program Grantees. 2013;https://www.cdc.gov/asthma/pdfs/asthma_facts_program_grantees.pdf. Accessed October 2019. Centers for Disease Control and Prevention. National Center for Health Statistics Faststats. 2017;https://www.cdc.gov/nchs/fastats/asthma.htm. Accessed October 2019. implementing value-based agreements to ensure fair pricing to value, and clinical programs to improve persistence. persistence, and asmall decrease in hospitalization/ER visits aftertherapy initiation.The results evidence providefurther for insurers to consider This real-world asthma biologic therapy assessment found in alarge commercially insured population asubstantial increase in total cost of care, poor decline, dispelling the conventional wisdom that these agents decrease cost in the 6 first monthstreatment. of Afterasthma biologic initiation, total cost careof increased by 2.6-fold,with asthma biologics driving 95% theof cost increase. Medical costs did not address to barriers asthma biologic persistence and value-based contracting to obtain lack of persistence remuneration. 48.5% of asthma biologic members new did start not receive all recommended doses within the 6 first months, indicatingthe need exploreto and near doubling of asthma biologic utilization and drug expenditure over 2.5 years. Among 14 million commercially insured members, there were 8,447 members with an asthma biologic claim in 2Q2019 resulting in $0.84 PMPM cost, a =946 2.5% (24) 2.5% 1.3% (12) 1.3% ®

• Oct Oct (asthma), expansion indication Dupilumab Total cost of care (TCC) was 6months evaluated before andafter asthma biologic initiation andbroken out byindex drug. TCC was as defined the sum of all pharmacy andmedical claims costs (plan paidplus member paid). Average total cost of care for 1,492 asthma biologic members new start July between 2017 and December 2018 FIGURE 3 mepolizumab reslizumab

Q , , , N = = N -month pre-period total cost of care

Q benralizumab , , , N = = N omalizumab

Q pharmacy cost . . . . . . mepolizumab , N = = N , , Dupilumab was excluded from this analysis because it didnot receive label expansion for asthma until October 2018. identification member start biologic asthma New FIGURE 2 medical cost omalizumab , N = = N , , Members with ≥ New to asthma biologic therapy defined as no asthma biologic claims in the pre-period Members with ≥ N Continuous enrollment 182 days before (pre-period) and after (post-period)

= omalizumab. Dupilumab NOT was included 2017 (July through Dec 2018)

1,492 (30 reslizumab, 84 benralizumab, 432 mepolizumab, 946 omalizumab) omalizumab) 946 432 mepolizumab, benralizumab, 84 reslizumab, 1,492 (30 asthma biologic pharmacy plus medical cost 2 ICD-10 code J45% (asthma), ≥ Approximately 14,000,000 commercially insured members insured commercially 14,000,000 Approximately reslizumab , , , , N = = N 1 asthma biologic claim: reslizumab, benralizumab, mepolizumab, or -month post-period total cost of care first asthma biologic claim benralizumab No externalNo funding provided for this research N =5,320 N =3,142 N =7,343 , , , , N = = N 30 days apart during continuous enrollment mepolizumab , , N = = N , , omalizumab N = = N , , , ,

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