Introduction:Amid Significant Unmet Need, What Magnitude of
Efficacy and Safety Do Pulmonologists and Payers Expect of an Emerging Therapy?
Although several effective anti-inflammatory agents and bronchodilators are currently available for controlling disease in mild to moderate asthmatics, great unmet needs exist in treating more-severe disease. Emerging once-daily inhaled regimens may potentially improve patient compliance by providing convenience over currently available inhalers with twice-daily dosing. Novel biological therapies in the pipeline hold a potential to address unmet need for severe, refractory patients, particularly those who experience severe exacerbations. According to our survey results, the most opportunity for differentiation exists for therapies offering enhanced efficacy in reducing the exacerbation rate in moderate to severe asthma, compared with leading marketed agents. Furthermore, novel agents’ strong efficacy in reducing the exacerbation rate will hold considerable influence on physicians’ prescribing and payers’ reimbursement decisions as competition among numerous pharmacological agents increases in the moderate to severe asthma market.
Questions Answered in This Report:
Salmeterol/fluticasone propionate (GlaxoSmithKline’s Advair/Seretide/Adoair) is the 2012 major-market sales leader for asthma. How will emerging therapies need to perform on key primary and secondary clinical trial end points to compete with salmeterol/fluticasone propionate? What weaknesses exist in its profile that would allow emerging therapies to gain a foothold in the market? How do U.S. and European pulmonologists weight specific efficacy end points and other drug attributes in their prescribing decisions for moderate to severe asthma?
Greater reduction in exacerbation rate and greater improvement in quality of life are key areas of unmet need for moderate to severe asthma, according to the insights of surveyed U.S. and European pulmonologists. Which therapies in development for moderate to severe asthma are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?
Effect on rate of severe exacerbations and oral corticosteroid use are key drivers of physicians’ prescribing decisions and/or the focus of drug development for new severe asthma therapies. What trade-offs across these and other clinical attributes are U.S. pulmonologists willing to make when considering the use of emerging therapies for the treatment of severe asthma? Based on the trade-offs in price and performance across key drug attributes that U.S. pulmonologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for severe asthma?
By 2017 mepolizumab will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is mepolizumab most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by mepolizumab?
Attributes included in conjoint analysis based assessment of target product profiles for severe asthma:
- Improvement in baseline FEV1 at 28 weeks (compared to background maintenance therapy alone).
- Rate of asthma exacerbations over 48 weeks (% less than background maintenance therapy alone).
- Reduction in oral corticosteroid use over 16 weeks (mean reduction from baseline in daily OCS dose in patients receiving maintenance OCS at baseline; not placebo-adjusted).
- Improvement in Asthma Quality of Life Questionnaire over 48 weeks (% of patients achieving improvement from baseline AQLQ score that exceeded the minimal clinically important difference; compared to background maintenance therapy alone).
- Rate of severe adverse events over 48 weeks (e.g., respiratory infections, severe cardiac event; compared to background maintenance therapy).
- Drug formulation and frequency.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for severe asthma:
- Effect on lung function (FEV1).
- Effect on rate of severe exacerbations.
- Effect on hospitalization rate.
- Effect on rate of life-threatening adverse events.
Physicians surveyed: 60 U.S. and 30 European pulmonologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Salmeterol/fluticasone propionate (GlaxoSmithKline’s Advair/Seretide/Adoair)
- Formoterol/budesonide (AstraZeneca/Astellas’s Symbicort)
- Fluticasone propionate (GlaxoSmithKline’s Flovent/Flixotide/Flutide)
- Omalizumab (Genentech/Novartis’s Xolair)
- Vilanterol/fluticasone furoate (GlaxoSmithKline/Theravance’s Breo/Relvar)
- Tiotropium (Boehringer Ingelheim/Pfizer’s Spiriva)
- Reslizumab (Cephalon/Teva’s Cinquil)
- Mepolizumab (GlaxoSmithKline’s Bosatria)
- Lebrikizumab (Roche/Genentech/Chugai)