How Can Novel Biologics Targeting Niche Populations Maximize Uptake in an Increasingly Competitive Marketplace?

Although several effective anti-inflammatory agents and bronchodilators are currently available for controlling disease in mild asthmatics, unmet needs exist in treating moderate to severe disease. 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:

  • Greater reduction in exacerbation rate and greater reduction in oral corticosteroid use 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?

  • 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 moderate to 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 among the different target product profiles for moderate to severe asthma?

  • By 2018 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. With six biological agents projected to enter the market over the next decade, on what clinical attributes is mepolizumab most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by mepolizumab?

Scope:

Attributes included in conjoint analysis based assessment of target product profiles for moderate to severe asthma:

- Improvement in baseline FEV1 at 28 weeks.

- Rate of asthma exacerbations per year.

- Reduction in oral corticosteroid use over 16 weeks.

- Rate of cardiovascular serious adverse events.

- Rate of severe adverse events over 48 weeks.

- Drug formulation and frequency.

- Price/day.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for moderate to severe asthma:

- Effect on lung function (FEV1).

- Effect on rate of severe exacerbations.

- Effect on oral corticosteroid use.

- Rate of severe adverse events.

Physicians surveyed: 60 U.S. and 30 European pulmonologists.

Payers surveyed: 21 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- LABA + ICS (e.g., salmeterol/fluticasone propionate [GlaxoSmithKline’s Advair/Seretide/Adoair], formoterol/budesonide [AstraZeneca/Astellas’s Symbicort])

- LABA + ICS + tiotropium (Boehringer Ingelheim’s Spiriva)

- Systemic (oral/parenteral) corticosteroids (e.g., prednisone [Merck’s Deltasone], methylprednisone [Pfizer’s Solu-Medrol])

- Omalizumab (Roche/Novartis’s Xolair)

Emerging Therapies

- Mepolizumab (GlaxoSmithKline)

- Reslizumab (Teva Pharmaceuticals’ Cinquil)

- Benralizumab (AstraZeneca/Kyowa Hakko Kirin)

- Lebrikizumab (Roche/Chugai)

- Dupilumab (Sanofi/Regeneron Pharmaceuticals)


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