January 2019 2020 June through January Commercially a Insured Indication in by Population, Use Drug Autoimmune of Prevalence Specialty Cost and K. Bowen,K. MD, MBA [email protected] 800.858.0723,PATRICK 5190 GLEASON, ext. 13,April 2021, Conference National Virtual Annual Meeting, (AMCP) Academy of Managed Pharmacy Care Crossing55121 MN Ames Road,2900 Eagan, LLC 04/21 Therapeutics Prime 4085-C © • • • • • • • BACKGROUND • • OBJECTIVE All brand names are the property of their respective owners. respective their of property the are names brand All

by condition utilization trends, expenditure trends and and trends expenditure trends, utilization condition by drug expenditures, it is important to understand drugs AI represent drugs AI adisproportionateAs of all portion areof drugs the over-priced AI to the value they provide. psoriasisarthritis, and ulcerative colitis and has found many assessed the price to value for rheumatoid drugs of AI InstituteThe for Clinical and Economic Review (ICER) has claims. drug this information may only be available of AI for afraction such prior as authorization and step therapy. However, (UM), management utilization from information indication Pharmacy claims lack codes. Dx Health plans may have reimbursement. drug indication,specify if this is not required for diagnosis codes. (Dx) However, these may not always Classification of Diseases, Tenth Revision (ICD-10) International with submitted are claims drug Medical → → pricing. and formularies most cost-effectivetreatments through indication-based for managedan opportunity care plans to encourage the Many have drugs AI overlapping indications, presenting use an drug. AI benefits, lessthan 1% of commercially insured members in drug expenditures through the pharmacy and medical representAlthough drugs AI approximately $1 $5 in every benefit. pharmacy the via processed processed via the medical benefit andthe majority cost with approximately aquarter primarily of drugs the AI commercially insured pharmacy plus medical benefit drug currently accounts drugs (AI) for almost 20% of total A set of 29 specialty commonly drugs termed autoimmune drug for two sets of indications: sets drug for two Crohn’s disease and in tracking and treatment observed reporting cost by To illustrate the potential value of deduced indication information. UM available and data deduced integrated from pharmacy and medical claims quarter, January 2019 through June 2020, by indications cost in drugs of acommercially AI insured population by To determine the number of members using and the observed cost per treated member. treated per cost observed plaque .

average costs when used for different indications. maySome drugs have AI significantly different user. per costs average different significantly used for drugs theAI same indication may have 1 1 , C.I. Starner,, C.I. PharmD

1

1, 2 , P.P. Gleason, PharmD 2-4 • • • • METHODS • • • • RESULTS

therapy by indication by drug by quarter estimated was the as sum of payments divided by the perusers 100,000 members and payments per member per month (PMPM). mean The cost of or coupons calculated was by quarter, of claim, type indication and drug, and normalized to numberThe of and users sum of plan plus member payments without adjustment for rebates one claim diagnosis with the same frequency, were categorized not as deduced. UM information. Those with no UM diagnosis who had no medical claim diagnosis, or more than attempt to deduce off-label indicationsfor whereusers this was not specified by theprovider in indicating on plausible indication not FDA-approved were assigned off-label, as but we did not approved indications consistent with all the drugs the member AI used. Members with aUM Dx information, if available, or the member’s most frequently coded among Dx the set of FDA- Each member assigned drug use was with AI to asingle indication based on UM category for any of these and drugs all available UM information in which the provider had specifiedDx. a June 2020 for any goods that or services had code a Dx for any of the 12 FDA-approved indications (29 different drugs) We identified all pharmacy and medical claims January 2019 to June 2020 AI for drugs commercially month. per insured members Integrated pharmacy and medical claims and UM data were queried for an average of 15 million Figures 2a andFigures 2b → → indication. Table 2 (97.7%) and 46,064 (97.6%), respectively. the medical claims algorithm Dx assigned the same indication the as UM review for Dx 33,916 to assign indication for 34,731 (42.3%) and 47,210 (49.6%), respectively. For these members, theOf 82,030 unique drug in users AI 1Q2019 and 95,129 in 2Q2020, used UM review was Dx → → → $31.59 PMPM 524.5from to 613.9 per 100,000, and expenditures increased $7.70 (32.2%) $23.89 from to 1Q2019data, from to 2Q2020, members using an drug increased AI 89.4 per 100,000 (17.0%) Among ~15 million commercially insured members with integrated medical and pharmacy claims → → → → PsO and CD. number of users. of number

respectively, PMPM $2.24 and $1.57, and per users 100,000 were 28.9 and 14.1. largest PMPM drugThe expenditure increases were for treatment of PsO and CD: suppurativa. hidradenitis Crohn’s disease (CD), psoriatic ulcerative arthritis, colitis, ankylosing spondylitis and Seven indications accounted for over 95% of use: rheumatoid psoriasis arthritis, (PsO), 1Q2019 to $15,436 in 2Q2020. Mean drug payments per quarterly AI user increased $1,774 (13.0%) $13,662 from in 5.8 percentage 78.6% points from in 1Q2019 to 83.2% in 2Q2020. of proportion totalThe drug payments through AI the pharmacy benefit increased 0.9 percentage 77.3% points from in 1Q2019 to 78.2% in 2Q2020. of proportion totalThe with an users claim AI AI through the pharmacy benefit increased The adalimumabThe $19,779 per member per quarter mean CD drug treatment cost was 2.3 times higher than the SC mean $17,271 PsO treatment cost. ustekinumabThe SC $39,579 mean per member per quarter CD drug treatment cost was highest. the SC ustekinumab and . these, Of had the lowest mean cost and five mostThe commontherapies for CD were: , infliximab,ustekinumab SC, highest. the risankizumab and cost quarter per member ustekinumab SC and risankizumab. these, Of apremilast had the lowest mean per five mostThe commontherapies for Ps0 were: apremilast, adalimumab, , 1.3 times higher than the adalimumab $15,387 mean PsO treatment cost. 1, compares 1Q2019 and 2Q2020 drug payments PMPM AI and per users 100,000 by 2 .

1 Prime Therapeutics Eagan, United MN, LLC, States; (Figures 1a(Figures and 1b) describe 2Q2020 mean drug payments per AI user by drug for treatment of (Table 1)(Table and, for these members, all medical claims January 2018 to . 2 University of Minnesota College of Pharmacy, Minneapolis, United MN, States. Autoimmune Drug Payments Per Member Per Month and Users per 100,000 Members by Indication 2 TABLE Note: Rituximab, Rituximab-abbs and are other for also FDA-approved indications. Many of these also have agents off-labeluses. antigen), PDE IL-23 Targets: TNF =oral. PO =intravenous, IV administration, =subcutaneous,SC of Admin =methodspondylitis. idiopathic HS arthritis, =juvenileJIA spondylitis, Ank =ankylosing colitis, =ulcerativeUC =Crohn’sCD disease, arthritis, =psoriaticPsA =psoriasis,PsO arthritis, =rheumatoidRA Indications: Assigned Indications and Analysis the in Included Drugs Autoimmune 1 TABLE were categorized not as deduced. information. with no indication Those determined or UM claims from information, or whom for more than one indication scored equally as was probable claims by algorithm, amongcoded Dx the indications set of FDA-approved consistent with all the drugs of member the AI used. Off-label indication was onlyassigned if specifiedUM in memberEach assigned drug to was use a single with AI indication on based utilization category management (UM) information, if available, or the member’s most frequently Non-radiographic spondylitis axial drug utilization AI not shown due to < PMPM analysis. the in included drugs of 15 million member commercially insured population. PMPMs Generic Name Rituximab Vedolizumab IV Ustekinumab Ustekinumab Upadacitinib Tofacitinib Secukinumab Risankizumab-rzaa Infliximab-dyyb Infliximab-abda Infliximab IV Golimumab Etanercept pegol Certolizumab Baricitnib Apremilast Adalimumab Abatacept Natalizumab Rituximab-abbs Not deducedNot arteritis cell Giant Periodic fever syndromes Off-label uveitis Non-infectious Juvenile idiopathic arthritis Ankylosing spondylitis colitis Ulcerative arthritis Psoriatic Crohn’s disease Psoriasis arthritis Rheumatoid Any suppurativa Hidradenitis Indication = -23 antagonists, IL-6 = = Tumor necrosis factor-alpha antagonists, IL-12/24 phosphodiesterase inhibitors, JAK = hidradenitis suppurativa, Eye Rituxan Entyvio Stelara Stelara Rinvoq Xeljanz Actemra Ilumya Cosentyx Kevzara Skyrizi Taltz Inflectra Renflexis Remicade Tremfya Aria Simponi Simponi Enbrel Cimzia Ilaris Siliq Olumiant Otezla Kineret Humira Orencia Tysabri Truxima Trade Name Trade ® ® ® = ® ® interleukin-6 receptor inhibitors, costim ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® ® 1Q2019 ® ® ® ® $23.89 $4.69 $6.35 $0.76 $0.01 $0.04 $0.03 $0.10 $0.28 $0.45 $2.01 $3.00 $5.13 $1.04 ® = Janus kinase inhibitors. Integrin IL-12/24 IL-12/24 JAK JAK IL-6 IL-23 IL-17 IL-6 IL-23 IL-17 TNF TNF TNF IL-23 TNF TNF TNF TNF IL-1 IL-17 JAK PDE IL-1 TNF co-stim Integrin CD20 CD20 PMPM PMPM Target = non-infectious uveitis, PFS 2Q2020 = $31.59 per member per month plan plus member without payments adjustment any for rebates. See = $6.70 $6.93 $0.83 $0.02 $0.05 $0.06 $0.17 $0.37 $0.73 $2.63 $3.90 $1.37 $7.81 interleukin-12/24 antagonists, Integrin IV IV SC PO PO SC/IV SC SC SC SC SC IV IV IV SC IV SC SC SC SC SC PO PO SC SC SC/IV Admin IV IV IV 1Q2019 RA $0.01. X X X X X X X X X X X X X X X X X = 524.5 155.4 109.5 T-cell co-stimulation modulators, IL-1 90.3 24.8 42.0 69.8 17.6 = Users per Users 2.1 6.1 0.4 0.4 0.8 5.4 PsO 100,000 periodic syndromes, GCA fever X X X X X X X X X X X X X X PsA 2Q2020 X X X X X X X X X X X X X X 138.4 104.4 171.3 613.9

81.4 52.0 29.0 17.1 X = FDA approved for indication for approved FDA = X 1.5 0.5 0.4 3.0 7.2 7.7 CD X X X X X X X X X = Integrin receptor blockers, IL-27 UC X X X X X X X X X %of Total 2Q2020 PMPM PMPM 100.0% 12.3% 24.7% 21.2% 21.9% Ank 8.3% 2.6% 2.3% 4.3% 1.2% 0.1% 0.2% 0.2% 0.5% X X X X X X X X X = Giant cell arteritis, Spond = interluekin-1 antagonists, CD20 JIA X X X X X Users per per Users 100,000 HS 100.0% X 22.5% 13.3% 79% 27.9 70% 17.0 8.4% 2.8% 4.7% 1.2% 1.3% 0.1% 0.1% 0.2% 0.5% Eye X = interleukin-17 antagonists, PFS = 1Q2019 2Q2020 to PMPM PMPM X X non-radiographic axial $0.08 $0.01 $0.01 $0.03 $0.07 $0.10 $0.28 $0.33 $0.62 $0.90 $2.24 Change from $1.57 $1.46 $7.70 GCA = X anti-CD20 (B-cell Table 1 Users per per Users 100,000 Spond for list list for X X 28.9 14.1 15.9 10.0 89.4 11.6 (0.5) 2.3 4.3 1.0 1.1 0.2 0.0 0.7 Mean Autoimmune Drug Payments per User for Three Months for Treatment of Plaque Psoriasis and Crohn’s Disease 2 FIGURES among 15 Million Commercially Insured Members Autoimmune Drug Claims: Users per 100,000 Members and Drug Payments Per Member Per Month by Benefit 1 FIGURES See quarter. same the Note: Some members had drug claims AI through both pharmacy and medical benefits during Users per , Members by Benet Figure aAutoimmune DrugClaims: they had claims both ustekinumab for and IV ustekinumab SC. Excludes 286 members with aclaim more for than drug one incurred AI during 2Q2020 and 91 members whose drug only claim AI ustekinumab for was IV. 186 of the 286 members excluded because 15 million member commercially insured population. Mean payments the mean. Excludes 381 members with aclaim more for than drug one during AI 2Q2020. (n Infliximab-dyyb 15 million member commercially insured population. Mean payments Figure bCrohn’s Disease: Payment Mean Quarter for User by Drug,Q Figure aPlaque Psoriasis: MeanPayment Quarter for User by Drug,Q Risankizumab-rzaa (n Risankizumab-rzaa Certolizumab pegol (n Certolizumab pegol (n Ustekinumab SC (n Ustekinumab SC (n Table 1 Q  . . . Infliximab-dyyb(n Secukinumab (n Vedolizumab (n Vedolizumab Adalimumab (n Adalimumab Adalimumab (n Adalimumab Guselkumab (n Guselkumab Infliximab-abda (n Infliximab-abda Apremilast (n Apremilast Tildrakizumab (n for list for of autoimmune included. drugs Infliximab (n Infliximab Ixekizumab (n Brodalumab (n Brodalumab Etanercept (n Etanercept Natalizumab (n Natalizumab Infliximab (n Infliximab Either Q  . .  .

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ˆ , ˆ,  ˆ,  ˆ, ˆ,  See coupons. or PMPM Drug Payments PMPMby Benet Figure bAutoimmune DrugClaims: ˆ, ˆ, ˆ, Table 1 = Q  .  . = 5) and infliximab-abda (n . per member per month, plan plus member without payments adjustment any for rebates ˆ ,  „ , for list for of autoimmune included. drugs Q  .  . . = Pharmacy 2) not shown. Q  . . . Q  . . . Medical Q . . . Q .  . . 4. 3. 2. 1. REFERENCES • • • • • CONCLUSIONS • • • • LIMITATIONS

Report_101620.pdf. Accessed at:https://icer.org/wp-content/uploads/2020/08/ICER_UC_Final_Evidence_ Report and Meeting Summary). Targeted Immune Modulators for Ulcerative Colitis: Effectiveness and Value (Final Evidence ICER_Psoriasis_Update_Final_Evidence_Report_10042018.pdf. Economic Review. Effectiveness and Value (Condition Update, Final Evidence Report). Targeted Immunomodulators for the Treatment of Moderate-to-Severe Plaque Psoriasis: com/wp-content/uploads/2020/10/NE_CEPAC_RA_Evidence_Report_FINAL_040717.pdf. Institute for Clinical andEconomic Review. Targeted Immune Modulators for Rheumatoid Effectiveness Arthritis: & Value (Evidence Report). Prime internal data, Prime Therapeutics LLC. indication-based, cost-effectivemanagementformulary strategies and Assigning amember to drug indication AI can help in designing utilization. indication-based determining Integrated drug analysis AI including medical claims is essential for psoriasis. plaque for than treatment ustekinumab SC drug cost 2.3 was times higher for Crohn’s disease individual, within adrug and by the condition treated. For example, wereThere important real-world drug cost AI variances per treated 1Q2019from to 2Q2020, one of the growing drug categories. fastest autoimmuneThe PMPM increased drug category 32.2% over 15 months benefits. pharmacy approximately 20% of all drug expenditures through the medical and and these members’ drug utilization AI accounted for $31.59 PMPM, commercially insured members, 1in 158 (0.63%) utilized an drug AI In this integrated medical and pharmacy claims analysis of 15 million (approximately days) 90 is time ashort period and should alleviate new differencesrates andin start adherence, drug new althoughthe quarter meanThe per patient per quarter drug costs could be influenced by discounted costs if rebate information is available. an indication drug claim, to every which can be used to calculate fully actual cost However, drugs. of AI the methodology described attaches manufacturers’ rebates or coupons, which are important modifiers the of describedThe drug therapy AI costs represent payments unadjusted by supporting ahigh level of accuracy for this method. data, indication deduced claims from the was same for almost 98%, members. However, where provider attestation available was UM from algorithm rather than provider derived from attestation for individual drug therapy deduced was administrative from claims by an automated For slightly more than half of members described, the indication for AI intervals. time describe utilization within subpopulations or populations and in other practice variation. However, the described methodology can be used to geographicas variation in prevalence of the conditions and provider the of proportion members treated by indication due to such factors there considerable was variation among individual health plans in utilizationreflect in other populations. Within the described population, population comprised of many different health plans,which may not This study describes utilization in one large commercially insured value-based contracting. value-based impacts. adherence and start Aug. 3,2018.Accessed at:https://icer.org/wp-content/uploads/2020/10/ No externalNo funding provided for this research Institute for Clinical andEconomic Review. April 7,2017.Accessed at:http://icerorg.wpengine. Institute for Clinical and Oct. 16, 2020. 16,2020. Oct.