Psoriasis Pricing, Reimbursement, and Access
Psoriasis Pricing, Reimbursement, and Access
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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.
Publisher: Datamonitor Healthcare
- Highlights
- Description
- Contents
Psoriasis Pricing, Reimbursement, and Access Highlights
- Psoriasis spend is a moderate concern as most patients are treated with inexpensive medicines. However, expenditure for patients requiring biologics is more pressing as payers expect spend to increase with the launch of more interleukins in the market.
- TNF inhibitors will remain the standard first-line biologic, based on payers’ desire to leverage greater discounts from biosimilar competition and dermatologists’ conservative practices. IL inhibitors are unlikely to become first-line among biologics despite having head-to-head superiority to TNF inhibitors.
- Contracting among ILs is highly likely due to little perceived differentiation in the class. While safety and dosing are different, they are not perceived as critical attributes. Most payers plan to contract for preferred products by class, while more aggressive payers plan to have winners across all IL inhibitor classes.
- Treatment holidays and disease-free remission endpoints may help to differentiate pipeline therapies, especially as ILs are reaching the apex of efficacy scores. Manufacturers that invest in such trials could secure preferential positioning versus products without this treatment reduction target.
- Payers are positive about potential new oral compounds that would address an unmet need for patients who have failed conventional therapy but do not yet require biologics, provided they are priced appropriately.
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
- What access controls are payers imposing on biologics in psoriasis?
- How are biosimilar TNFs impacting the current and future market access for branded drugs?
- In which markets are payers most likely to leverage growing competition to reduce treatment costs?
- Which attributes will pipeline agents need to demonstrate to gain competitive advantage in a saturated biologics market?
- What are payer and physician views on the need for further oral therapies?
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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