Market Access in Czech Republic 9 years of

Market Access in Czech Republic 9 years of experience with matured, transparent and predictable system of pricing and reimbursement which brings sustainability and stability Jaroslav Duba, OAKS Consulting s. r. o. | 2016 -12 -12

Agenda Czech pricing & reimbursement system in general Determination of Price & Reimbursement Sustainability of Price & Reimbursement System RWE in Czech Republic 2

Czech Republic Population: 10 553 843 (84 th) GDP/cap. : 32 622 USD (39 th) HDI: 0, 870 (28 th)

P&R (R)evolution Categorization committee 1. 1. 2008 P & R system 4

P&R system – How does it work? PHARMA COMPANY Submissions Evidence Appeals Decisions on appeals of participants Submission of dossiers Participants in proceedings Assessment reports Calls for cooperation Decisions Assessment of submissions Decision maker Submissions Evidence Appeals of participants Policy maker Appellate authority 5

Key steps in reimbursement process Submission of dossier by MAH or payer (D 0) • SUKL: external price references within 21 days Issuing of Decision with no suspensive effect (D 421562) Assessment of dossier and issuing of Assessment Report (AR) – can be more than 1 (D 267 -332) Reaction of MAH and payers to AR (D 267 -332) Appeal to Decision (D 280427) • SUKL send appeals to Mo. H • Mo. H assess appeals and issue Decision (positive – proc. returns back to SUKL; negative – SUKL Decision comes into legal force) 6

Time to Assessment Report and Decision 12 281 proceedings* Source: ACCESS TO INNOVATIVE MEDICINES IN THE CZECH REPUBLIC: LENGTH OF PRICE AND REIMBURSEMENT PROCEDURES; Jiří Klimeš, Leoš Fuksa, Milan Vocelka; ISPOR 2016 poster session * www. sukl. cz 2016 -12 -06 7

Administrative proceedings – reimbursement STANDARD SIMILAR PRODUCT HID • Determination or change of P and R • 165 days (P+R) • 75 days (P or R) • REA • CUA+BIA if not in group of interchangeable products • Determination of R or R+P • Decision within 30 days guaranteed • Used for generics, biosimilars, product extensions • Determination of temporary P+R (2+1 years) • 165 days (P+R) • Medicine must be for treat. of highly serious diss. + meet criteria of HID • Compulsory RSS contract and registry • REA • CUA+BIA 8

Determination of Price & Reimbursement

Two-level-regulation of reimbursed medicinal products MAXIMUM PRICE REIMBURSEMENT *; ** WPP (MP) * Except reimbursed products excluded from regulation based on Price Decision of Mo. H ** MP must be determined Medicinal products used only during hospitalization have to be regulated by MP

Maximum Price (MP) determination Average of 3 lowest ex-factory prices from reference basket countries (RB). RB are all countries except CZ, EST, CY, LUX, MT, DE, BG, RO, A Ex-factory price agreed between MAH and insurance company Based on the nearest therapeutically interchangeable product in CZ or RB countries Criteria are used step-by-step 11

Key steps in reimbursement process The therapeutic interchangeability • Similar clinical usage • Similar or close efficacy • Similar or close safety Product included/not included into the (pseudo)reference group Determination of identical level of reimbursement per ODTD (ordinary daily therapeutic dose) for all interchangeable products or individual reimbursement for not interchangeable products 12

Reimbursement determination Step-by-step 1. Based on reimbursement determined in latest revision (§ 39 c art. 7) 2. Based on decision in procedure which came into force till 30. 11. 2011 (transitional provision Art. II, sec. 2) If 1. resp. 2. is not applicable then: A. The lowest ex-factory price per ODTD (obvious daily therapeutic dose) in any EU country from all therapeutically interchangeable products B. Costs of alternative, cost-effective therapy with comparable efficacy C. Agreed ex-factory price with insurance company D. Agreed reimbursement with insurance company Lowest from A-D

General information about reimbursement Reimbursement of medicinal products determined only for out-patient usage In hospitals (in-patient usage) all medicinal products are reimbursed by law Basic reimbursement can have bonification up-to 30% (efficacy, safety, usage) Except basic reimbursement there can be determined 2 nd, 3 rd etc. reimb. for specific indication or group of patients Medicinal products without determined reimbursement can be reimbursed upon request of physician and approval by chief physician of insurance company in case of no other treatment option for particular patient (§ 16 Act 48/1997 Col. )

Sustainability of Price & Reimbursement System

System sustainability - Generics & Biosimilars 1 st generic/biosimilar in group of interchangeable products (irrespective of proc. type) • GENERICS: – 32% cut in price and reimbursement (till next revision) • BIOSIMILARS: – 15% cut in price and reimbursement (till next revision) • OTHERS: – 15% cut in price and reimbursement (till next revision) 2 nd + generic/biosimilar • No mandatory cut on P+R • Can choose type of procedure Fast access through “Similar product” procedure • Decision within 30 days Ex-offo fast reimbursement revision in group of interchangeable products after P+R determination at 1 st generic/biosimilar • Decision within 50 days 16

System sustainability - REVISIONS Periodical revision • Interval of 5 years • Open ex-offo • Separately for maximum prices and reimbursement • Procedures for the whole group of interchangeable products • Decision within 165+ days • Weakness: CUA+BIA is not the subject of revision Fast revisions • Can be open anytime ex-offo or initiated by payers in case of: • Expected savings of 30 mil. CZK in group of interchangeable products or 5 mil. CZK in HID • Price or reimbursement contract between MAH and payer(s) in case of expected savings of 20 mil. CZK • Entry of 1 st generic/biosimilar in group of interchangeable products • No fully reimbursed medicinal product in product group of Amendment 2 of Act 48/1997 Col. • Decision within 50 days 17

Public healthcare expenditures and public pharmaceutical expenditures 2010 -2014 (mil. EUR) 9, 010 8, 978 9, 132 9, 433 2, 500 2, 400 8, 500 2, 300 7, 500 2, 200 7% - 7, 3% GDP 6, 500 2, 000 5, 500 1, 928 4, 500 3, 500 2, 100 1, 836 1, 977 1, 900 1, 854 Pharmaceutical exp. Healtchare exp. 9, 500 9, 145 1, 700 2, 500 1, 600 1, 500 2011 Public healthcare expenditures 2012 2013 2014 out of which public pharmaceutical expenditures Source: ÚZIS Health Care Expenditures 2010 -2014; VZP 18

Expenditures on centralised drugs 2010 -2017 (mil. EUR) 600 500 427 400 511 352 258 300 200 459 562 285 204 Entry of new medicines 100 0 2011 2012 2013 2014 2015 2016 2017 Source: ÚZIS Health Care Expenditures 2010 -2014; VZP 19

RWE in Czech Republic 20

Sources of RWE in CZ Registry HC Providers Payers Public administration 21

REGISTRY Registry Most of them developed as „product“ registry Data entry is on voluntary base (except HID) but sponsored by industry Limited access to PLD RENIS, TULUNG, ATTRA, CLLEAR, NOR, BREAST, CAMELIA, DATOOL, RMG, EMPIRE and many others 22

HC providers HC Providers Owner = provider Gap between requested cohort and real cohort (voluntariness) = can influence results PLD mostly available Long time from idea to realisation 23

Payers Data providing based on “Freedom of information law 106/1999 Col. ” Example: • Rules for request submission www. vzp. cz/o-nas/informace/pristup-k-informacim • Outcomes and analysis (majority publicly available)) www. vzp. cz/o-nas/informace/odpovedi-na-zadosti-o-informace • 2015: 74 applications/ 7 rejected • Answer within 15 days (+ 10) • Fee 11, 4 EUR/hour 24

Public administration (www. uzis. cz) Public administration New since 1. 7. 2016 based on amendment to the Act 372/2011 Col. Administrator of 21 national registries • Oncology, Diabetology, Intensive Care, HC Providers, Registry of reimbursed healthcare services etc. (http: //www. uzis. cz/registry) Data provided upon request based on “Freedom of information law 106/1999 Col. ” • PLD + Aggregated analysis for scientific purposes, payers and for institutions of public administration (mostly free of charge) • Aggregated analysis for others (paid) Registry of reimbursed healthcare services • Launch 1. 1. 2017 • Processing of data from all payers • Payers have to send reports quarterly • Till 30. 6. 2017 payers have to complete data since 1. 1. 2010 25

Conclusion Strengths • Irrespective 7 Ministries within 9 years the system remains the same and only few “cosmetic” changes have been implemented • CZ system enables keeping HC expenditures under control what brings sustainability and stability • CZ system secures access to modern treatment for patients • 3 types of procedures help in entry of difference types of products (e. g. generics, innovative medicines etc. ) • For not reimbursed products with high unmet medical need exceptional reimbursement (§ 16) can be used even in EAP settings • RSS are applicable • Although medical associations are not participants in procedures, SUKL ask them for expert opinions which are taken into consideration • CZ is not country with lowest prices in EU Limitations • Duration of procedures of new medicines last more then 1 year • Most of new products have indication restrictions (no exception in EU) 26

Jaroslav Duba jaroslav. duba@oaks. cz +420 606 613 224 www. oaks. cz