Case Study in COPD

1. Drug Overview

Chronic Obstructive Pulmonary Disease (COPD) is a name given to a group of degenerative lung conditions, such as emphysema, chronic bronchitis or asthma that cause difficulty in breathing. COPD mainly affects middle-aged and older people who do/have smoked [1].

The treatment of COPD includes combination therapy of corticosteroids and bronchodilators, to reduce inflammation and increase airflow in the lungs [2].

Bud-form O Turbuhaler, containing budesonide and formoterol, has the following actions [3]:

  1. Budesonide: includes inhibitory activities against multiple cell types and mediators, involved in allergic and non-allergic inflammation;
  2. Formoterol: long-acting selective beta2-adrenertic agonist with a rapid onset of action, acting locally in the lung as a bronchodilator.

2. Market Overview

Bud-Form O competes in the R03F (b2-Stim+Cortico Inhalants) market. The market overview includes figures from 2003–2016. This market was dominated by two originator brands (Flu-Sal O and Bud-Form O) for over 9 years, before the first generics were launched.

Flu-Sal C (Flu-Sal O clone), was launched in 2010, with the generic product Flu-Sal G quickly following in 2012. Bud-Form C (clone), was launched in 2014 but has a different administration device (pressured aerosol inhaler), instead of a Turbuhaler (dry powder inhaler).

The launch of Bud-Form O had an immediate impact on the sales of Flu-Sal O, where in 2006 Bud-Form O took 26% of Flu-Sal O’s sales and by 2010 Bud-Form O had 35% of the RO3F market. Flu-Sal O still achieved 61% market share in 2010 and maintained market leadership.

3. Health Status

In 2000, COPD (excluding TB) ranked as the seventh most important cause of DALY s, being responsible for 2.3% of all deaths in South African [4]. The major cause of COPD is cigarette smoking, causing an estimated 80–90% of deaths in COPD patients. COPD is more often diagnosed after the age of 50, as the early stages of the disease are symptom-free, despite a moderate decrease in pulmonary function. Up to 50% of smokers at age 65 are affected by symptoms of the disease, presenting with chronic breathlessness, wheezing and/or cough [5]. Exacerbations are associated with diminished quality of life for COPD patients. The frequency of episodes, as well as the presence of comorbid conditions and the number of medications needed to manage the disease, all contribute to COPD severity [5].

4. Market Access Objectives

5. Market Players (Internal/External)

6. Results

7. References