Global Asthma Pricing, Reimbursement, and Access Report 2016 - Longer clinical trials with clinically significant results favored by both US and EU payers - Research and Markets
08 Aug, 2016, 12:10 BST
DUBLIN, August 8, 2016 /PRNewswire/ --
Research and Markets has announced the addition of the "Asthma Pricing, Reimbursement, and Access" report to their offering.
Growth in the asthma market will be fueled by the introduction of new and expensive biologics, but companies will have to navigate access restrictions imposed by payers concerned about budget impact.
This report addresses the following questions:
- What pricing benchmarks will European payers use in price negotiations for IL-5 inhibitors?
- What access levers will be used for IL-5 inhibitors in each of the five major EU markets and how will they impact their uptake?
- What attributes of future biologic entrants could secure a higher price and which ones are not valued by payers?
- What are the EU and US payers' and physicians' opinions on generic ICS/LABA inhalers?
- What discounts and market access levers will be required to drive uptake of generic ICS/LABA inhalers?
Key Topics Covered:
EXECUTIVE SUMMARY
MARKET CONTEXT
GLOBAL PAYER INSIGHTS
- Insights and strategic recommendations
- Nucala and other IL-5 inhibitors are viewed positively, but cost is a worry
- Unclear product differentiation among branded inhaled products is driving price competition
- Low adherence to inhaler therapy is a major treatment challenge for both payers and Physicians
- Longer clinical trials with clinically significant results favored by both US and EU payers
US PRICING
- ICS/LABA combination inhalers have annual treatment costs of around $3,0
- Expensive price tags for biologics like Nucala are a worry for payers
- Bibliography
US PAYER INSIGHTS
- Insights and strategic recommendations
- Strict prior authorization criteria used for IL-5 inhibitors but conditions may vary
- Payers will welcome generic ICS/LABA inhalers, but physicians are more sceptical
- Bibliography
US REIMBURSEMENT
- Insights and strategic recommendations
- Trends in asthma drug expenditure
- Asthma treatment guideline GINA is widely used across the US, Japan, and five major EU Markets
- Formulary placement
- Prior authorization is reserved for asthma biologics
- Generic Advair entry to the US market is a real threat for GlaxoSmithKline
- Bibliography
JAPAN
- Price premiums are awarded for added benefit or innovation
- Pricing of launched asthma treatments
- Bibliography
FIVE MAJOR EU MARKETS PRICING
FIVE MAJOR EU MARKETS PAYER INSIGHTS
- Insights and strategic recommendations
- Inhaler spend is one of the top budget items for European payers with high visibility
- Access to asthma inhalers relatively unrestricted in the five major EU markets
- Breo Ellipta not well received by EU payers
- Entry of biologic IL-5 inhibitors is a key event in 2016
GENERIC ICS/LABA INHALERS IN THE FIVE MAJOR EU MARKETS
- Insights and strategic recommendations
- Generic versions of Advair and Symbicort struggle to gain market share
- Generic versions of Advair have received limited approval and continue to see low market penetration in the EU
- Generic Symbicort DuoResp gains traction in the EU
- Bibliography
FRANCE
- Insights and strategic recommendations
- ASMR rating has an impact on pricing
- Branded generic versions of Advair and Symbicort have been reviewed by the TC
- Bibliography
GERMANY
- Insights and strategic recommendations
- Positive assessment from the G-BA will impact price negotiations
- Sickness funds tender for branded combination ICS/LABAs; uptake of generics remain low
- Asthma medications are subject to indicative budget limits but relevance of this restriction may change under ongoing reforms
- Nucala's prospect remains unclear as Germany undergoes new regulatory changes
- Bibliography
ITALY
- Insights and strategic recommendations
- AIFA is responsible for pricing and reimbursement decisions
- Delays in inclusion on regional formularies hamper access to recently launched inhalers
- Access to Xolair is tightly controlled, with a price-volume agreement in place
- IL-5 inhibitors are likely to have stringent access criteria in place, with price-volume agreements or risk-sharing possible
- In the absence of restrictions from AIFA and regional decision-makers, the choice between branded vs generic combination inhaler is left to the physician
- Bibliography
SPAIN
- Insights and strategic recommendations
- National reimbursement decision is not a major access barrier in Spain, 56.Breo Ellipta is the only asthma product assessed by IPTs so far
- Regional assessments and formulary decisions
- Spanish payers place more importance on GÉNESIS regional reports than IPTs
- Regional therapeutic reports cause further delays after national product launches
- Access conditions for IL-5 inhibitors will be based on detailed analyses of clinical trial results
- Bibliography
UK
- Insights and strategic recommendations
- NICE approval is a key access barrier in the UK
- Xolair, the only asthma drug appraised by NICE, received a positive recommendation
- Access to IL-5 inhibitors will be determined by NICE, with additional restrictions likely
- NICE recommends the most economical option for ICS or ICS/LABA combinations, with the ultimate choice made by regional commissioners.
- UK physicians prefer using BTS/SIGN guidelines for asthma
- Bibliography
For more information visit http://www.researchandmarkets.com/research/5k4jgf/asthma_pricing
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