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.
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)