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RWD Analysis

Case for GSK: RWD analysis of Chronic Obstructive Pulmonary Disease (COPD)

On behalf of GSK (NP-DK-CPU-BRF-190001_03.05.2019), DLI Market Intelligence has conducted a real-world data (RWD) analysis of Chronic Obstructive Pulmonary Disease (COPD) on different aspects of treatment and the patient journey in Denmark. An analysis of the COPD population's prescription redemption patterns in 2014-2016 was included in the RWD analysis. It appears that the most frequent treatment is triple therapy, consisting of a combination of long-acting beta-agonist, a long-acting muscarinic antagonist plus inhaled corticosteroid (LABA-LAMA-ICS), which was treatment for around 40,000 COPD individuals per year in 2014-2016, representing a declining share of the total COPD population.

The number of individuals on LAMA-LABA treatment increased between 2014 and 2016 (from 7,227 to 17,758, representing a shift from 7 to 16 percent of the COPD population), and a smaller increase in LABA-treated individuals occurred as well (from 6,497 in 2014 to 7,854 in 2016; however, this represented a more stable 7 percent of the COPD population). Other treatment types represent a decreasing share.

Looking at the most recent (2016) switches in treatment, the majority, 85 percent, were initiated by general practitioners (GPs). Hospital doctors performed 15 percent of the treatment switches, although this was higher at 21 percent in the Capital Region. The GPs two most frequent switches were from unknown treatment to LABA-ICS and from unknown treatment to LAMA-LABA. The most frequent switches performed by hospital doctors were from unknown treatment to LAMA-LABA treatment and from unknown treatment to triple therapy.

The prevalence of the COPD population has risen from 81,061 people in 2010 to 112,104 in 2016. The majority and a growing share of the COPD population are exclusively treated in primary care (in 2016: 77,535 COPD individuals). Fewer individuals are exclusively treated in hospitals (in 2016: 11,064). The share of COPD individuals that are treated for exacerbations has been stable around 40 percent throughout the analysis period.

Method in brief

The period of analysis was 2010-2016. Inclusion and exclusion criteria were evaluated from 1995-2016

The analysis was based on data from The Danish National Prescription Registry, which is a subset of the Register of Medicinal Product Statistics (RMPS), the Danish National Patient Registry (DNPR), the Danish Civil Registration System (CPR) and the Danish Register of Causes of Death.

COPD population

Citizens with COPD were identified and included in the population in the year(s) they complied with the inclusion/exclusion criteria with respect to the RMPS and DNPR.

Inclusion criteria

DNPR: Any individual that received a COPD diagnosis in hospitals was included the year of the diagnosis code (DJ44 including sub-codes, the code system in Danish Hospitals is the Danish version of International Statistical Classification of Diseases and Related Health Problems). However, the individual was excluded from the population if, within 2 years after their first COPD diagnosis, the individual was diagnosed with cystic fibrosis (code DE84 including sub-codes), lung/bronchi cancer (code DC34 including sub-codes) or asthma (code DJ45 including sub codes).

RMPS: A citizen was included in the population if either of the two following criteria were fulfilled during the year:

  1. At least two prescriptions within 12 months were redeemed where COPD was explicitly marked as indication by the physician (code 379 or 464)
  2. At least two prescriptions or 2 packages of "inclusion medicine" were redeemed within 12 months.

    Inclusion medicine was defined by the following medicine (ATC codes) within the COPD indication:
  • Long-acting beta-agonist (LABA): R03AC12-13, R03AC18-19, R03CC12
  • Long-acting beta-agonist plus inhaled corticosteroid (LABA ICS): R03AK
  • Short-acting muscarinic antagonist plus long-acting beta-agonist (SAMA LABA): R03AL01-02
  • Long-acting muscarinic antagonist plus long-acting beta-agonist (LAMA LABA): R03AL03-R03AL06
  • Long-acting muscarinic antagonist (LAMA): R03BB04-R03BB07
  • Phosphodiesterase type-4 inhibitors (PDE-4 inhibitors): R03DX07

    Exacerbation An individual was defined as having exacerbations if either of the two following criteria were fulfilled:

    a) At least 1 annual hospital diagnosis of DJ441 (COPD with acute exacerbation)
    b) At least 1 annual redemption of H02AB06 (prednisolone) or J01CR02 (amoxicillin and beta-lactamase inhibitor)

A treatment was defined as at least 2 annual prescriptions or packages of either ICS, LABA or LAMA or any combination of these (see the ATC codes in the below table). If an individual was treated with none of these, this was categorised as "unknown treatment".

Data processor: Statistics Denmark, Consulting@dst.dk
Data Controller: DLI MI, info@dli-mi.dk

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14-05-2019 09:01