Dublin, Aug. 10, 2016 (GLOBE NEWSWIRE) -- 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
CONTACT: Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Sector: Immune Disorders Drugs
