DecisionBase

May 2013

Chronic Obstructive Pulmonary Disease

Introduction:

What Gains in Efficacy Will Be Necessary to Meet Pulmonologist and Payer Expectations for Emerging LABA/LAMAs, LABA/ICSs, and MABAs?

Chronic obstructive pulmonary disease (COPD) treatment is dominated by bronchodilators and polypharmacy is commonplace as patients’ COPD worsens. Substantial opportunity exists for a disease-modifying therapy but development of new COPD therapies has focused on therapies that combine two bronchodilators into one inhaler. Surveyed U.S. payers are receptive to favorable reimbursement for therapies offering improvements in lung function over current therapies while surveyed pulmonologists cite therapies providing a greater effect on quality of life as a key area of unmet need. Clinical data suggest at least some therapies in the late-stage pipeline will offer advantages in lung function and possibly advantages in other efficacy attributes. However, given the increasingly crowded marketplace, our data suggest emerging therapies will need to be clearly and substantially differentiated from current therapies and other emerging treatments to garner substantial uptake.

Questions Answered in This Report:

  *   Tiotropium (Boehringer Ingelheim/Pfizer’s Spiriva) is the 2011 major-market sales leader for COPD. How will new therapies need to fare on key primary and secondary clinical trial end points with which COPD therapies are evaluated to compete with tiotropium? How does the wealth of long-term clinical data for tiotropium and salmeterol/fluticasone propionate (GlaxoSmithKline’s Advair/Seretide/Aodair) impact how pulmonologists will evaluate new therapies? How do U.S. and European pulmonologists weight efficacy measures and other drug attributes in their prescribing decisions for COPD?

  *   Greater reduction of mortality and greater effect on quality of life are key areas of unmet need for COPD according to the insights of surveyed U.S. and European pulmonologists.  Which therapies in development for COPD 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?

  *   Improvement in lung function and reduction in the frequency of exacerbations are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new COPD 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 COPD? 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 COPD?

  *   By 2016, Novartis’s indacaterol/glycopyrronium 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 indacaterol/glycopyrronium most advantageously differentiated from its competitors? Which current therapies are at greatest risk of being replaced by indacaterol/glycopyrronium? Where are the weaknesses in its clinical profile that leave room for other emerging therapies?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for COPD:

- Improvement in lung function at 6 months (trough FEV1, placebo-adjusted)

- Reduction in frequency of exacerbations over 52 weeks (% reduction, placebo-adjusted)

- Improvement in quality of life at 52 weeks (SGRQ score improvement, placebo-adjusted)

- Reduction in mortality over 4 years (% reduction, placebo-adjusted)

- Frequency of most common minor side effect (% of patients, placebo-adjusted)

- Dosing burden (formulation and frequency)

- Price/day

Attributes included in assessment of U.S. payers’ receptivity to new therapies COPD:

- Effect on lung function

- Effect on frequency of exacerbations

- Effect on mortality

- Dosing burden (formulation and frequency)

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:

Current Therapies

- Tiotropium (Boehringer Ingelheim/Pfizer’s Spiriva)

- Salmeterol/fluticasone propionate (GlaxoSmithKline’s Advair/Seretide/Adoair)

- Formoterol/budesonide (AstraZeneca/Astellas Pharma’s Symbicort)

- Indacaterol (Novartis’s Arcapta/Onbrez)

- Roflumilast (Takeda/Nycomed/Forest Laboratories’ Daliresp/Daxas)

Emerging Therapies

- Vilanterol/fluticasone furoate (GlaxoSmithKline/Theravance’s Breo/Relvar)

- Indacaterol/glycopyrronium (Novartis)

- Vilanterol/umeclidinium (GlaxoSmithKline/Theravance’s Anoro)

- Olodaterol/tiotropium (Boehringer Ingelheim)

- GSK-961081 (GlaxoSmithKline/Theravance)


Search Reports

Mentioned in this report:

  • - Almirall
  • - Astellas Pharma
  • - AstraZeneca
  • - Boehringer Ingelheim
  • - Forest Laboratories
  • - GlaxoSmithKline
  • - Kyorin
  • - Merck
  • - Novartis
  • - Nycomed
  • - Pfizer
  • - Takeda
  • - Theravance
  • - UCB
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