While currently-available drugs aim to manage the frequency and severity of symptoms associated with COPD, none have been shown to modify long-term disease progression. In addition to the need for disease-modifying drugs, much of the unmet need associated with chronic obstructive pulmonary disease (COPD) has been linked to poor adherence to medication.
Senior Analyst Yasser Mushtaq: “Tedious drug delivery processes and the need for frequent daily doses ultimately lead to poor compliance and management of COPD symptoms. As a consequence, drug development programs are focusing on developing long-acting medication.
“There is also a need for alternative anti-inflammatory agents. Traditionally reliant on Inhaled Corticosteroids (ICS), analysis of the COPD product development pipeline has confirmed greater interest in novel anti-inflammatory agents.”
The analyst adds that beyond ICS therapy, the current market offers very limited anti-inflammatory treatment, which is a notable unmet need in COPD.
COPD’s Unmet Milestones Discussed at 2016 Respiratory Effectiveness Group (REG) Summit
May 26, 2016
Global COPD Pricing, Reimbursement, and Access Report 2016
GLOBAL PAYER AND KEY OPINION LEADER INSIGHTS
- Physicians are looking forward to triple therapy combinations for severe COPD patients
- Payers are less impressed with triple therapy combinations, with potential for overprescribing a concern
- LABA/LAMAs set to overtake ICS/LABAs in non-exacerbating COPD patients
- Key opinion leaders believe IL-5 biologics are unlikely to play a major role in COPD
- Some payers welcome second-generation LAMAs, but they are unlikely to displace Spiriva as the market leader
- Unclear product differentiation among branded ICS/LABA products is driving price competition
- Reversal of disease progression is considered one of the main unmet needs in COPD
- Once-daily dosing matters less to physicians than having access to both once-daily and twice daily inhalers
- US and EU payers and physicians want more economically impactful, easily quantified outcomes
- Longer clinical trials with clinically significant results favored by both US and EU payers
Conquering COPD: Value-Based Perspectives for Providers and Payers
- To discuss the challenges faced by the medical community in identifying and managing patients with COPD, and to brainstorm potential strategies to improve the diagnosis and treatment of COPD, an advisory group of respiratory specialists and payer stakeholders was convened on November 14, 2015, in Hoboken, NJ.
- The panel of experts included practicing pulmonologists with extensive research backgrounds, as well as medical and pharmacy directors from the payer side who represented the population-based value perspective.
- COPD remains an underdiagnosed and undertreated condition
- A low awareness of COPD and the initial symptoms of the disease among the general population, acceptance of these symptoms as a consequence of aging or smoking, clinical similarities to asthma, and failure of healthcare providers to use spirometry to guide COPD diagnosis all contribute to its suboptimal identification and treatment.
- In addition, challenges exist in managing patients diagnosed with the disease, and reducing the burden of COPD will require improved management of chronic symptoms. Acute exacerbations and hospitalizations are the primary driver of cost and morbidity in COPD; therefore, high priority should be given to interventions aimed at delaying the progression of disease, preventing exacerbations, and reducing the risk for comorbidities to alleviate the clinical and economic burden of COPD.
- Short- and long-acting bronchodilators remain the mainstays of pharmacologic treatment for COPD. Bronchodilators are most frequently given in an inhaled form using an MDI, DPI, or a nebulizer. Although current guidelines recommend inhalation therapy as the preferred route of drug administration for treating COPD, inhaler misuse remains a common problem in clinical practice, limiting its effectiveness and resulting in the suboptimal symptom relief for patients with COPD.
- Evidence suggests that nebulizer use for maintenance therapy in patients with moderate-to-severe COPD, including use during exacerbations, is comparable, and, in some respects superior, to the efficacy provided by MDIs and DPIs. In fact, nebulized therapy may be preferred in elderly patients, those with severe disease and frequent exacerbations, and those with physical and/or cognitive limitations.
- In an advisory meeting that included practicing pulmonologists and representatives from payer organizations, there was considerable agreement regarding the importance of specialty care in COPD; maintaining open access to pharmacologic therapy; and the need for redoubled focus on reducing acute exacerbations, hospital admissions, and hospital readmissions associated with COPD. Because payers do not want to hinder the effective management and control of COPD, they do not restrict access to specific short- and long-acting therapies.
- Participating pulmonologists recognized the value of nebulized therapy, but maintained that a good understanding of the patient clinical presentation and life circumstances were necessary to make informed treatment recommendations. In addition, they agreed that better clinical markers are needed to identify optimal candidates for nebulized therapy.
- In terms of unmet pharmacologic needs, participating pulmonologists noted that a nebulized LAMA option would likely increase the use of combination LABA/LAMA nebulized therapy. Both pulmonologists and payers voiced the need for clinical studies to include outcomes measures to help clinicians make better informed decisions about therapeutic selection.