Table of Contents

7 EXECUTIVE SUMMARY
8 MARKET CONTEXT
8 Traditional branded drugs facing patent expiry are expected to decrease the asthma market
size, but pipeline biologics will fuel growth
8 Marketed asthma products in the US, Japan, and five major EU markets
16 Pipeline asthma products in late-stage development
18 Bibliography
22 GLOBAL PAYER INSIGHTS
22 Insights and strategic recommendations
22 Nucala and other IL-5 inhibitors are viewed positively, but cost is a worry
26 Unclear product differentiation among branded inhaled products is driving price competition
26 Low adherence to inhaler therapy is a major treatment challenge for both payers and
physicians
27 Longer clinical trials with clinically significant results favored by both US and EU payers
32 US PRICING
32 ICS/LABA combination inhalers have annual treatment costs of around $3,000
33 Expensive price tags for biologics like Nucala are a worry for payers
33 Bibliography
35 US PAYER INSIGHTS
35 Insights and strategic recommendations
35 Strict prior authorization criteria used for IL-5 inhibitors but conditions may vary
37 Payers will welcome generic ICS/LABA inhalers, but physicians are more skeptical
39 Bibliography
40 US REIMBURSEMENT
40 Insights and strategic recommendations
40 Trends in asthma drug expenditure
43 Asthma treatment guideline GINA is widely used across the US, Japan, and five major EU
markets
44 Formulary placement
58 Prior authorization is reserved for asthma biologics
64 Generic Advair entry to the US market is a real threat for GlaxoSmithKline
65 Bibliography
70 JAPAN
70 Price premiums are awarded for added benefit or innovation
71 Pricing of launched asthma treatments
74 Bibliography
76 FIVE MAJOR EU MARKETS PRICING
77 FIVE MAJOR EU MARKETS PAYER INSIGHTS
77 Insights and strategic recommendations
78 Inhaler spend is one of the top budget items for European payers with high visibility
79 Access to asthma inhalers relatively unrestricted in the five major EU markets
84 Breo Ellipta not well received by EU payers
85 Entry of biologic IL-5 inhibitors is a key event in 2016
92 GENERIC ICS/LABA INHALERS IN THE FIVE MAJOR EU MARKETS
92 Insights and strategic recommendations
92 Generic versions of Advair and Symbicort struggle to gain market share
104 Generic versions of Advair have received limited approval and continue to see low market
penetration in the EU
105 Generic Symbicort DuoResp gains traction in the EU
105 Bibliography
108 FRANCE
108 Insights and strategic recommendations
108 ASMR rating has an impact on pricing
119 Branded generic versions of Advair and Symbicort have been reviewed by the TC
119 Bibliography
122 GERMANY
122 Insights and strategic recommendations
122 Positive assessment from the G-BA will impact price negotiations
124 Sickness funds tender for branded combination ICS/LABAs; uptake of generics remain low
125 Asthma medications are subject to indicative budget limits but relevance of this restriction
may change under ongoing reforms
126 Nucala’s prospect remains unclear as Germany undergoes new regulatory changes
129 Bibliography
131 ITALY
131 Insights and strategic recommendations
131 AIFA is responsible for pricing and reimbursement decisions
139 Delays in inclusion on regional formularies hamper access to recently launched inhalers
139 Access to Xolair is tightly controlled, with a price-volume agreement in place
140 IL-5 inhibitors are likely to have stringent access criteria in place, with price-volume
agreements or risk-sharing possible
140 In the absence of restrictions from AIFA and regional decision-makers, the choice between
branded vs generic combination inhaler is left to the physician
141 Bibliography
143 SPAIN
143 Insights and strategic recommendations
143 National reimbursement decision is not a major access barrier in Spain
143 Breo Ellipta is the only asthma product assessed by IPTs so far
145 Regional assessments and formulary decisions
149 Spanish payers place more importance on GÉNESIS regional reports than IPTs
149 Regional therapeutic reports cause further delays after national product launches
150 Access conditions for IL-5 inhibitors will be based on detailed analyses of clinical trial results
150 Bibliography
153 UK
153 Insights and strategic recommendations
153 NICE approval is a key access barrier in the UK
154 Xolair, the only asthma drug appraised by NICE, received a positive recommendation
154 Access to IL-5 inhibitors will be determined by NICE, with additional restrictions likely
155 NICE recommends the most economical option for ICS or ICS/LABA combinations, with the
ultimate choice made by regional commissioners
168 UK physicians prefer using BTS/SIGN guidelines for asthma
168 Bibliography
172 METHODOLOGY
172 Primary research
172 Price assumptions
176 Exchange rates
176 Bibliography

LIST OF TABLES

9 Table 1: Marketed products and approved indications for asthma in the US, Japan, and five
major EU markets
16 Table 2: Pivotal safety and efficacy clinical trials for late-stage pipeline candidates in asthma
32 Table 3: US pricing of key marketed drugs
41 Table 4: Asthma and chronic obstructive pulmonary disease spend by payers, 2014
41 Table 5: Top 10 asthma and chronic obstructive pulmonary disease drug spend by Express
Scripts members
43 Table 6: Spend on the top three asthma and chronic obstructive pulmonary disease drugs by
Medicare Part D beneficiaries, 2013
44 Table 7: Global Initiative for Asthma treatment guidelines
45 Table 8: Formulary placement of asthma drugs in selected commercial formularies
49 Table 9: Formulary placement of asthma drugs in the top five 2016 Medicare Part D
formularies
54 Table 10: Formulary placement of asthma drugs in selected large Medicaid states’ preferred
drug lists
55 Table 11: CVS Caremark’s and Express Scripts’ formulary-excluded asthma drugs
56 Table 12: Express Scripts’ TRICARE formulary placement of asthma drugs
58 Table 13: Prior authorization criteria for asthma drugs by major health insurers and pharmacy
benefit managers
70 Table 14: Pricing premiums given to medicines that can demonstrate benefit over comparators
71 Table 15: Pricing of key marketed asthma drugs in Japan
72 Table 16: Price calculation methodologies for asthma drugs launched in Japan after 2008
76 Table 17: Annual treatment cost of asthma drugs in the five major EU markets
82 Table 18: Access controls for asthma medications in the five major EU markets
94 Table 19: Availability and substitutability of branded generic inhalers in the five major EU
markets
98 Table 20: List price differential between branded ICS/LABAs and branded generics in the five
major EU markets
102 Table 21: Market access levers impacting ICS/LABA generic inhaler uptake in the five major EU
markets
108 Table 22: Transparency Committee’s ASMR ratings and pricing implications
109 Table 23: Transparency Committee’s SMR ratings and pricing implications
110 Table 24: Transparency Committee’s assessment of asthma treatments
123 Table 25: G-BA assessment of key asthma therapy
132 Table 26: Reimbursement conditions for asthma treatments in Italy
137 Table 27: Local formulary decisions for asthma drugs
144 Table 28: Therapeutic positioning reports for asthma drugs in Spain
146 Table 29: Spain regional assessments of asthma drugs
154 Table 30: NICE assessments of key asthma therapies
156 Table 31: CCG formulary inclusions for key asthma drugs
163 Table 32: SMC decisions on key asthma therapies
168 Table 33: SIGN asthma treatment guidelines
172 Table 34: Price sources and calculations for the US
174 Table 35: Price sources and calculations for the EU
176 Table 36: Exchange rates used for calculating branded drug prices