Global COPD Pricing, Reimbursement, and Access Rep

Dublin, Aug. 11, 2016 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Copd Pricing, Reimbursement, and Access" report to their offering. In-class competition and generic entry provide payers with leverage to demand favorable pricing for inhalers in exchange for formulary access. This report addresses the following questions: - Which LABA/LAMAs have been most successful in securing national reimbursement and why? - How do US and European payers and physicians view the launch of once-daily Breo? - What discounts and market access levers will be required to drive uptake of generic ICS/LABA inhalers? - What impact will generic ICS/LABA inhalers have on pricing and reimbursement of triple combination ICS/LABA/LAMA therapies? - What role will biologics play in the treatment of COPD? Key Topics Covered: EXECUTIVE SUMMARY MARKET CONTEXT - While traditional first-line medications face generic competition, pipeline triple combinations and LABA/LAMAs will fuel modest growth in COPD - Marketed COPD products in the US, Japan, and five major EU markets - Pipeline COPD treatments in late-stage development GLOBAL PAYER AND KEY OPINION LEADER INSIGHTS - Physicians are looking forward to triple therapy combinations for severe COPD patients - Payers are less impressed with triple therapy combinations, with potential for overprescribing a concern - LABA/LAMAs set to overtake ICS/LABAs in non-exacerbating COPD patients - Key opinion leaders believe IL-5 biologics are unlikely to play a major role in COPD - Some payers welcome second-generation LAMAs, but they are unlikely to displace Spiriva as the market leader - Unclear product differentiation among branded ICS/LABA products is driving price competition - Reversal of disease progression is considered one of the main unmet needs in COPD - Once-daily dosing matters less to physicians than having access to both once-daily and twice daily inhalers - US and EU payers and physicians want more economically impactful, easily quantified outcomes, - Longer clinical trials with clinically significant results favored by both US and EU payers US PRICING - Pricing of LABA/LAMAs is comparable to ICS/LABAs - Spiriva Respimat is priced at a - discount over the HandiHaler device, US PAYER INSIGHTS - Co-pays continue to determine patients' therapeutic choices - Payers will welcome generic ICS/LABA inhalers, but physicians are more sceptical - Strong respiratory portfolio opens possibility for bundled contracting with some payers US REIMBURSEMENT - Trends in COPD drug expenditure - GOLD guidelines are widely used for COPD - Formulary tier positioning is the key utilization management tool used in COPD - Generic Advair entry to the US market is a real threat for GlaxoSmithKline JAPAN - Price premiums are awarded for added benefit or innovation - Pricing of launched COPD treatments - Pricing of LABA/LAMAs in Japan is considerably higher than ICS/LABAs FIVE MAJOR EU MARKETS PRICING - First-to-market Utibron enjoys high prices in most EU markets FIVE MAJOR EU MARKETS PAYER INSIGHTS - Inhaler spend is one of the top budget items for European payers with high visibility - Access to COPD inhalers relatively unrestricted in the five major EU markets - With the exception of the UK, GOLD remains the most frequently used guideline in EU Countries GENERIC ICS/LABA INHALERS IN THE FIVE MAJOR EU MARKETS - 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 product DuoResp gains traction in the EU - Generic tiotropium uptake highly dependent on determination of device substitutability for single inhaler LAMAs FRANCE - ASMR rating has an impact on pricing - Head-to-head trials of LABA/LAMAs vs ICS/LABAs likely to trigger a review by the TC and permit further education efforts - ICS/LABA/LAMA combinations unlikely to receive ASMR higher than V - Branded generic versions of Advair and Symbicort have been reviewed by the TC 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 - COPD medications are subject to indicative budget limits but relevance of this restriction may change under ongoing reform ITALY - AIFA is responsible for pricing and reimbursement decisions - Delays in inclusion on regional formularies hamper access for recently launched inhalers - Approvals of LABA/LAMAs Anoro and Utibron with treatment plan provision will further restrict market uptake - AIFA register is an access obstacle for Daliresp; prescription volumes remain low - In the absence of restrictions from AIFA and regional decision-makers, the choice between branded vs generic combination inhaler is left to the physician SPAIN

- National reimbursement decisions are not a barrier to access - Some general physicians are subjected to prescribing limitations for COPD drugs - None of the COPD drugs evaluated in IPTs offer additional therapeutic benefit - Regional assessments are an additional market access step UK - NICE approval is a key access barrier in the UK - Daliresp is restricted to patients with COPD currently undergoing clinical trials - NICE recommends most economical option for LABA/LAMA combinations; choice down to regional commissioners - NICE COPD treatment guidelines are used by NHS physicians - SMC decisions For more information visit http://www.researchandmarkets.com/research/9r...pd_pricing Sector: Respiratory Drugs , Bronchitis Drugs

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