Post-market Review of Chronic Obstructive Pulmonary Disease Medicines ToR 5 Final Report August 2017



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Pharmaceutical Benefits Scheme

Post-market Review of

Chronic Obstructive Pulmonary Disease Medicines

ToR 5

Final Report

August 2017


Contents


Contents 2

Section 5: ToR5


COPD Medicines Utilisation analysis 3

5.1 Key findings for ToR 5 3

Utilisation analysis of PBS/RPBS claims data 3

MedicineInsight data analysis 3

Stakeholder Views (Forum and public consultations) 4

5.2 Introduction 5

5.3 PBS/RPBS claims data sources and limitations 5

5.3.1 Department of Human Services (DHS) PBS claiming system 5

5.3.2 Department of Health (DoH) PBS claims database 5

5.4 PBS/RPBS utilisation analysis methodology 7

5.4.1 Department of Human Services (DHS) PBS claiming system 7

5.4.2 Department of Health (DoH) PBS claims database 7

5.5 Preliminary analysis of COPD PBS/RPBS utilisation 15

5.6 COPD utilisation analysis based on PBS individual unit record data 20

5.6.1 Data inclusions 20

5.6.2 Monthly prescriptions 20

5.6.3 Analysis of COPD prevalent patients 25

5.6.4 Utilisation outside COPD-X Guidelines – Initiations 25

5.6.5 Utilisation outside COPD-X Guidelines – Co-administration analysis 27

5.7 MedicineInsight data source and limitations 30

5.8 MedicineInsight COPD patient profile 32

5.9 MedicineInsight drug utilisation 32

5.9.1 Number of prescriptions 32

5.9.2 Co-prescribing in 2016 33

5.9.3 Initial therapy for COPD 34

5.9.4 Associated care for COPD patients 34

5.9.5 Adverse events 35

Section 5: ToR5
COPD Medicines Utilisation analysis


Analyse the current utilisation of PBS listed COPD medicines to identify the extent of co-prescribing and use that is inconsistent with clinical guidelines and/or PBS restrictions.

5.1 Key findings for ToR 5

Utilisation analysis of PBS/RPBS claims data


The number of PBS/RPBS prescriptions for COPD/Asthma medicines (LAMA, LABA and ICS) in the 2016 calendar year was approximately 5.2 million scripts based on claims processed. This number has increased by 70.5% compared to 2006 (Figure 5.3).

The total PBS/RPBS benefits paid for COPD/asthma medicines in the 2016 calendar year was $299 million based on claims processed. This number has grown from $215.2 million in 2006, which represents an increase in benefits paid of $84.1 million or 39.1% (Figure 5.2).

The number of prescriptions dispensed for tiotropium 18 μg and ICS/LABA has grown year on year to 2014; however, use of these items declined in 2015 and 2016 following the introduction new COPD medicines, mainly LABA/LAMA formulations.

There has been rapid uptake of tiotropium 2.5 μg since PBS listing in 2015.

A COPD only cohort was identified from PBS unit record data based on: patients aged 35 years and above who initiated on medicines restricted to COPD only, e.g. tiotropium, indacaterol or LAMA/LABA. Patients initiating ICS/LABA were excluded from the analysis to ensure all patients were treated for COPD and not asthma.

The final COPD cohort included unique patients that had been dispensed at least one COPD medication and at least one refill of the same medicine in the 8 years between 1 November 2008 and 31 October 2016. 2016 data was extrapolated to 12 months.

The percentage of patients in the COPD Cohort initiating to combinations outside COPD-X guidelines was 13.2% in 2010 and 25.7% in 2016.

The percentage of use outside COPD-X guidelines is dominated by initiation to combinations of LABA/LAMA (15.4%) and ICS/LABA plus LAMA (8.3%) in 2016.



MedicineInsight data analysis


The following information on prescribing of COPD medicines is based on GP clinical data collected from volunteer practices recruited to the MedicineInsight program. For this analysis, MedicineInsight data was drawn from 423 clinically relevant practice sites, 3,835 active GPs, and 2,230,658 active patients, to 31 December 2016 inclusive.
Of the 1.28 million current MedicineInsight patients aged 35 years and over included in the analysis, 3% were ever diagnosed with COPD only (n=38,650), and 1.6% with COPD plus asthma (n=20,546).

In MedicineInsight data in 2016, 51,903 prescriptions for the medicines of interest were ordered for current patients with COPD only, and 54,197 prescriptions for COPD plus asthma.

For all COPD and COPD plus asthma patients, 41.6% had no prescriptions written for any SAMA, SABA, LAMA, LABA or ICS (including combinations) inhalers in 2016.

With regard to medicine combinations of safety concern - for COPD only patients 3.6% were at risk of duplicated therapy, and 1.6% were on combinations of SAMA and LAMA. For patients with COPD plus asthma, 6.1% may be at risk of duplicated therapy, and 3.2% were on combinations of SAMA and LAMA.

Of the 38,650 COPD only patients, 3,043 people initiated therapy with a COPD medication (excluding SABA) between 1 July 2015 and 31 December 2016:


    1. 45.9% were prescribed only one medicine of interest as initial therapy, 49.0% were prescribed dual therapy, and 4.5% triple therapy.

    2. The most common choices of initial therapy by class were: dual therapy with ICS + LABA (41.6%), LAMA monotherapy (32.6%) and LAMA + LABA dual therapy (7.0%).

    3. A significant amount of combination use of COPD medications was therefore observed to be outside clinical guidelines and PBS restrictions (53.5%).

Among patients with COPD only and COPD plus asthma, 38.1% (n=22,524) ever had a record of one or more spirometry tests.

Common adverse events recorded for COPD medicines included: cough, rash, palpitations, muscle spasms, headache, nausea, laryngeal discomfort, and dyspnoea.



Stakeholder Views (Forum and public consultations)


  • In the PBS data analysis, the exclusion of patients initiating therapy with ICS/LABA may significantly underestimate the COPD only population.

  • The PBS data analysis did not consider samples, hospital initiations, or over-the-counter SABA use, which may lead to an overestimation of use outside guidelines and PBS restrictions.

  • Analysis of SAMA, SABA and ICS/LABA patient utilisation, including initiations, is required to better understand the overall use of all COPD medications.

  • The MedicineInsight analysis underestimates the utilisation of SABA medications (available over-the-counter) and should be interpreted with caution.

  • International evidence was presented regarding the uncertainty in COPD patient identification. Concerns were expressed by a number of stakeholders as to whether healthcare utilisation databases are adequate to inform PBAC decision making.

  • For further information, the Stakeholder Forum Summary is available at Appendix F.

  • Published references supplied by stakeholders are available in Appendix V.

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