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Global COPD Pricing, Reimbursement, and Access Report 2016 - Which LABA/LAMAs Have Been Most Successful in Securing National Reimbursement and why? - Research and Markets

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Research and Markets

11 Aug, 2016, 20:10 GMT

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DUBLIN, August 11, 2016 /PRNewswire/ --

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/9rtmqw/copd_pricing

Sector: Respiratory Drugs, Bronchitis Drugs

About Research and Markets
Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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