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Launch of multiple IL inhibitors with impressive efficacy has significantly reduced unmet need in the disease, and also provided payers with leverage in price negotiations as they seek to control growing treatment cost.
Psoriasis Pricing, Reimbursement, and Access Highlights
Overview
Launch of multiple IL inhibitors with impressive efficacy has significantly reduced unmet need in the disease, and also provided payers with leverage in price negotiations as they seek to control growing treatment cost.
Key Questions Answered
CONTENTS
6 OVERVIEW
7 REGULATORY LABELS
7 Marketed psoriasis products in the US, Japan, and five major EU markets
12 Bibliography
14 GLOBAL ACCESS LEVERS
14 Spend on psoriasis biologics is a particular concern for payers
16 High prices of biologics are leading to access barriers and pressure to offer discounts
18 Payers use tenders, physician incentives, and formulary exclusions to drive biosimilar uptake
25 Payers prefer straight discounts to outcomes-based risk agreements
30 EVIDENCE AND VALUE
30 Payers and physicians regard PASI and DLQI as the most important endpoints
37 Limited scope for differentiation of new agents based on PASI or DLQI
38 Providing treatment holidays or drug-free remissions could differentiate future pipeline treatments
40 Head-to-head trials with active comparators are critical in establishing differentiation
42 Minimum efficacy data of six months needed for good formulary access
44 Six-monthly or annual maintenance dosing regimens may be advantageous for pipeline agents
46 Cardioprotective effect of interleukins remains speculative, but data are welcome
50 Real-world evidence could be used to bolster local or regional positioning in the treatment algorithm
52 ACCESS TO RECENTLY APPROVED AND PIPELINE DRUGS
53 IL-17 and IL-23 inhibitors are viewed as more efficacious drugs, but TNF-alpha inhibitors will remain first-line biologics
55 IL-23 agents exhibit impressive efficacy but struggle to achieve preferred access versus IL-17s
59 Payers plan to leverage growing competition in the interleukin space through local or regional discounts or contracts
61 Tremfya’s superiority results against Cosentyx will drive prescribing but not pricing or formulary access
62 Siliq’s prospects remain poor, despite no correlation to suicide
64 Dosing frequency is not an important point of differentiation
66 Weaker PASI scores dampen Ilumya’s access prospects
68 Risankizumab’s strong efficacy data boost access prospects, but there is limited scope for a price premium
72 Moderate appetite for an oral inhibitor competitor to Otezla in psoriasis
75 PRICING
78 US
78 Insights and strategic recommendations
79 CANADA
79 Insights and strategic recommendations
80 JAPAN
80 Insights and strategic recommendations
80 Japan’s pricing strategy is reliant on pricing premiums for innovative medicines
81 Bibliography
82 FRANCE
82 Insights and strategic recommendations
82 ASMR rating has an impact on pricing
84 Bibliography
85 GERMANY
85 Insights and strategic recommendations
85 Positive assessment from the G-BA will impact price negotiations
86 Bibliography
87 ITALY
87 Insights and strategic recommendations
87 Bibliography
88 SPAIN
88 Insights and strategic recommendations
88 National reimbursement decisions are not a major access barrier in Spain
88 Regional access to psoriasis medicines varies in Spain
89 Bibliography
91 UK
91 Insights and strategic recommendations
91 NICE approval is a key market access barrier
92 Bibliography
93 METHODOLOGY
93 Primary research
93 Price assumptions
94 Exchange rates
95 Bibliography
LIST OF FIGURES
94 Figure 1: Price sources and calculations for the US and EU, by country
LIST OF TABLES
8 Table 1: Marketed products and approved indications for psoriasis in the US, Japan, and five major EU markets
19 Table 2: Biosimilar access levers in the US and five major EU markets
27 Table 3: Levers impacting access to psoriasis drugs in the US and five major EU markets
32 Table 4: Summary of important key endpoints in psoriasis clinical trial design
56 Table 5: National reimbursement decisions for marketed and assessed ILs
61 Table 6: Contracting and financial agreements for interleukins
67 Table 7: Likely reimbursement for Ilumya in psoriasis
70 Table 8: Likely reimbursement for risankizumab in psoriasis
76 Table 9: Pricing of key psoriasis drugs in the US, Japan, and five major EU markets, by country, 2019
81 Table 10: Pricing premiums given to medicines in Japan that can demonstrate benefit over comparators
83 Table 11: Transparency Committee’s ASMR ratings and pricing implications
84 Table 12: Transparency Committee’s SMR ratings and pricing implications
89 Table 13: Spanish Society of Hospital Pharmacy ratings
95 Table 14: Exchange rates used for calculating drug prices
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