Global Psoriatic Arthritis Pricing, Reimbursement, And Access Report 2016: Absence Of Head-To-Head Trials With Biosimilar Launches, Provide Payers With Leverage To Demand Favorable Pricing For Branded Products - Research And Markets

Dublin /PRNewswire/ -- Research and Markets has announced the addition of the "Psoriatic Arthritis Pricing, Reimbursement, and Access" report to their offering.

An absence of head-to-head trials, along with biosimilar launches, provide payers with leverage to demand favorable pricing for branded products in exchange for formulary access.

This report addresses the following questions:

• What access controls are payers imposing on interleukins in psoriatic arthritis?
• What discounts and market access levers will be required to drive uptake of interleukins and second-generation TNFalpha inhibitors?
• How do US and European payers view the launch of oral small molecules in psoriatic arthritis?
• What impact will biosimilar entry have on pricing and reimbursement of branded biologics?

Key Topics Covered:

EXECUTIVE SUMMARY

MARKET CONTEXT

• Market growth due to price increases and rising prevalence will be offset by biosimilar entry
• Marketed psoriatic arthritis products in the US, Japan, and five major EU markets 
• Pipeline psoriatic arthritis treatments in late-stage development 
• Bibliography 

GLOBAL PAYER INSIGHTS

• Insights and strategic recommendations 
• Spend on psoriasis and psoriatic arthritis drugs is moderate, but may vary depending on the patient population 
• Recently launched agents struggle to compete with TNF-alpha inhibitors 
• Dosing frequency and route of administration act as differentiating factors for TNF-alpha inhibitors 
• US and EU payers and physicians want head-to-head trials to assess efficacy directly and determine pricing, 
• Longer clinical trials with statistically and clinically significant results are favored by both US and EU payers 
• The psoriatic arthritis pipeline suffers from a dearth of promising candidates 
• Varying dosing and method of administration are important for patients, but oral formulation does not warrant a higher price 
• Bibliography 

US PRICING

US PAYER INSIGHTS

• Insights and strategic recommendations 
• Drugs with approvals in multiple inflammatory indications are favored in payer contracting 
• Psoriasis is usually approved first, but expanding to psoriatic arthritis is beneficial for pipeline and marketed drugs 
• Inflectra, the first TNF-alpha biosimilar, is approved by the FDA, but launch could take years due to legal battles 
• Bibliography 

US REIMBURSEMENT

• Insights and strategic recommendations 
• Trends in psoriatic arthritis drug expenditure 
• Bibliography 

JAPAN

• Price premiums are awarded for added benefit or innovation 
• Pricing of launched psoriatic arthritis treatments 
• Bibliography 

FIVE MAJOR EU MARKETS PRICING

FIVE MAJOR EU MARKETS PAYER INSIGHTS

• Insights and strategic recommendations 
• Access to biologics is mostly restricted in the five major EU markets, with a variety of tools used to curb access 

BIOSIMILAR TNF-ALPHA INHIBITORS IN THE FIVE MAJOR EU MARKETS

• Insights and strategic recommendations 
• Uptake of biosimilar TNF-alpha inhibitors varies across UK markets as the EMA does not determine interchangeability 
• Most physicians and payers consider biosimilars to be interchangeable, and an opportunity to reduce costs, but worries around indication extrapolation remain 
• Payers use biosimilars to pressure originators on pricing 
• Hospitals continue to procure both biosimilars and originators; dynamic pricing environment observed 
• Biosimilars will be used as price benchmarks for pipeline agents 
• Payers are unlikely to implement strong incentives to drive uptake of biosimilar infliximab due to limited use of the drug 
• Bibliography

FRANCE

• Insights and strategic recommendations 
• ASMR rating has an impact on pricing 
• Access restrictions for biologics are minimal, and are largely determined by national Transparency Committee guidelines 
• Both IL- 
• Cosentyx and Taltz are likely to get ASMR V from the TC 
• Bibliography

GERMANY

• Insights and strategic recommendations 
• Positive assessment from the G-BA will impact price negotiations 
• Certain sickness funds subject TNF-alpha inhibitors to indicative budget limits, but the relevance of this restriction may change under ongoing reforms 
• The G-BA follows IQWiG recommendation, and Otezla receives evaluation of no added benefit for psoriatic arthritis 
• IQWiG determines Cosentyx to offer no added benefit in psoriatic arthritis 
• Taltz is unlikely to get an added benefit assessment in psoriatic arthritis from the G-BA 
• Bibliography

ITALY

• Insights and strategic recommendations 
• Delays in AIFA decisions for newly launched biologics hamper regional and local access 
• Access to psoriatic arthritis medications is controlled for specialist use, but a more restrictive barrier is limited budget allocation 
• Emilia-Romagna outlines therapeutic strategy for biologics in psoriatic arthritis 
• Taltz will be placed in later lines of therapy in psoriatic arthritis 
• Bibliography

SPAIN

• Insights and strategic recommendations 
• National reimbursement decisions are not a barrier to access 
• Regional access to psoriatic arthritis drug treatments varies in Spain 
• Budget limitations and formulary restrictions are quoted as access barriers, with differences between hospitals 
• Risk-sharing agreements and local negotiations are used to control expenditure for biologics 
• Taltz's positioning in psoriatic arthritis remains speculative 
• Bibliography 

UK

• Insights and strategic recommendations 
• NICE approval is a key market access barrier 
• Patient population restrictions and brand preference in regional formularies are the main access levers in psoriatic arthritis 
• UK physicians reserve the use of biologics as a last resort for psoriatic arthritis patients 
• Use of Stelara in psoriatic arthritis is reserved for after failure with TNF-alpha inhibitors 
• Later biologic entrants require patient access schemes to have an acceptable ICER 
• NICE does not recommend Otezla for psoriatic arthritis due to lower effectiveness than TNFalpha Inhibitors 
• Biosimilars present the greatest threat to Cosentyx's chances of NICE recommendation for first-line biologic use 
• Taltz is likely to receive a similar NICE recommendation to Cosentyx 
• Regional formulary decisions 
• SMC approves Otezla for psoriatic arthritis contrary to NICE decision due to differences in treatment sequencing 
• SMC supports use of lower dose of Simponi, but higher dose is not deemed to be cost effective 
• Bibliography

For more information visit http://www.researchandmarkets.com/research/nw6wq2/psoriatic.