Post-market Review of Chronic Obstructive Pulmonary Disease Medicines ToR 5 Final Report August 2017
Preliminary analysis of COPD PBS/RPBS utilisation
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- 5.6 COPD utilisation analysis based on PBS individual unit record data
- 5.6.2 Monthly prescriptions
- 5.6.3 Analysis of COPD prevalent patients
- 5.6.4 Utilisation outside COPD-X Guidelines – Initiations
- 5.6.5 Utilisation outside COPD-X Guidelines – Co-administration analysis
5.5 Preliminary analysis of COPD PBS/RPBS utilisationAnalysis of PBS/RPBS claims data for the whole market (includes all age groups and asthma and mixed airways disease patients) shows that the total benefits paid in 2016 calendar year for prescriptions for the ‘in-scope’ COPD medicines (LAMAs, LABAs, LAMA/LABAs and ICS/LABAs) was $299 Million (Refer to Figure 5.2). 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 5.3 shows PBS/RPBS prescription volumes in 2016 for all ‘in-scope’ COPD medicines (for the whole market including all age groups, and asthma and mixed airways disease patients) reached approximately 5.2 million. This number has increased from a total of 3.1 million scripts in 2006, which is an increase of 2.1 million scripts or 70.5%. Figure 5.4 shows PBS/RPBS prescription volumes by class. LAMAs, LABAs and LAMA/LABAs are indicated for use in COPD only patients and total prescription volumes for these COPD only medicines reached 2.5 million scripts in 2016 (noting this includes all patient age groups). This has increased from a total of 1.2 million scripts in 2006, which is an increase of 1.3 million scripts or 106.8%. Figure 5.4 also shows that total PBS/RPBS prescription volumes for COPD only medicines declined by 6.0% year on year between 2015 and 2016. Tiotropium 18 µg represents the medication with the highest PBS/RPBS utilisation and expenditure for COPD. ICS/LABA medications represent a significant proportion of prescriptions and may include patients with asthma. There is increasing use of all combination LABA/LAMAs and tiotropium 2.5 µg between 2015 and 2016. This is not unexpected given these medicines are new to market. Figure 5. COPD PBS/RPBS benefits paid, total market by COPD and asthma medicine, 2006 to 2016  Source: http://medicarestatistics.humanservices.gov.au/statistics/pbs_item.jsp (accessed 15 April 2017)
Includes PBS/RPBS claims data for the whole market including all age groups, and asthma and mixed airways disease patients. Abbreviations: COPD, chronic obstructive pulmonary disease; PBS, Pharmaceutical Benefits Scheme.
Source: http://medicarestatistics.humanservices.gov.au/statistics/pbs_item.jsp (accessed 15 April 2017) Includes PBS/RPBS claims data for the whole market including all age groups, and asthma and mixed airways disease patients. Abbreviations: COPD, chronic obstructive pulmonary disease; PBS, Pharmaceutical Benefits Scheme. Figure 5.4 COPD PBS/RPBS dispensed script volumes and year on year movement, total market by COPD and asthma medicine class, 2006 to 2016
Source: http://medicarestatistics.humanservices.gov.au/statistics/pbs_item.jsp (accessed 15 April 2017) Includes PBS/RPBS claims data for the whole market including all age groups, and asthma and mixed airways disease patients. Abbreviations: COPD, chronic obstructive pulmonary disease; PBS, Pharmaceutical Benefits Scheme. 5.6 COPD utilisation analysis based on PBS individual unit record data5.6.1 Data inclusionsOut of approximately 113 million prescribing records in the supplied file from the DoH claims database, 73.5 million records were excluded immediately as they were not for long-acting bronchodilators used to manage COPD. The remaining 39.5 million records relate to ‘in-scope’ COPD medicines (see Appendix Q for additional data). For the purposes of identifying the extent of co-prescribing and use that is inconsistent with clinical guidelines, the COPD cohort was further refined. A further 27.2 million records were excluded for patients that did not initiate to therapies within the period from 1 November 2008 to 31 October 2016 (allowing for a minimum two-year look-back). This allows a consistent commencement period of the analysis when trying to develop an understanding of regimen switches and additions, as well as therapy initiations that are typical for this patient population. Of the remaining 12.3 million records, 5.9 million related to patients that had initiated to ICS/LABA class drugs. As initiating to ICS/LABA is generally not recommended in clinical guidelines or PBS restrictions for COPD, these patients were also excluded leaving 6.4 million records in the final ‘likely COPD’ cohort. Acknowledging that the refinements discussed above will underestimate the number of COPD patients, the final COPD cohort represents 310,557 unique patients that have been prescribed at least one COPD medicine and at least one subsequent refill in the 8 years between 1 November 2008 and 31 October 2016. 5.6.2 Monthly prescriptionsFigure 5.6 (Figure 5.6 represents the analysis shown in Figure 5.5 with the exclusion of Tiotropium 18 μg to provide better visibility of the other COPD medicines) and Table 5.2 present the dispensed script volumes by month between November 2012 and October 2016 for the cohort of patients initiating to LABA, LAMA and LABA/LAMA between November 2008 and October 2012 based on PBS/RPBS claims data. This analysis was undertaken to better understand the utilisation of COPD medicines in the latter part of the study period that includes the most recent PBS listed medicines for a consistent patient cohort. The analysis is based on date of supply of prescriptions and excludes ICS/LABA initiations. Seasonal stockpiling towards the end of each calendar year can clearly be seen. Tiotropium 18 μg and fluticasone propionate/salmeterol 250/25 μg are responsible for the largest share of the script volumes throughout the study period. In November 2012, they accounted for 75.4% and 11.9% of scripts, respectively. By October 2016, Tiotropium 18 μg and fluticasone propionate/salmeterol 250/25 μg accounted for 48.7% and 12.4% of scripts, respectively. It is not possible to isolate and measure the factors responsible for the decline in the utilisation of Tiotropium 18 μg. Contributing factors will include patient deaths (which do not feature in the data set), switches to newer and alternative COPD medicines, and potentially discontinued use of Tiotropium 18 μg in cases where the patient is subsequently diagnosed with asthma. The results underline that ICS/LABA use remains a dominant feature of therapy in the management of COPD. Table 5.2 clearly demonstrates a downward trend in overall utilisation for COPD medicines. Year on year comparisons for each quarter show a reduction in every quarter with the exception of quarter 4, 2016 (noting that this quarter is extrapolated). As before, it is not possible to provide any detail on the proportion of patients that discontinue therapy, including due to patient death. Figure 5.5 and 5.6, and Table 5.2, also show the introduction of newer medicines. Indacaterol was introduced in December 2011. 2014 and 2015 saw the introduction of four new LAMA medicines (including an alternative dose of tiotropium), the introduction of the four LAMA/LABA FDCs, and two ICS/LABA FDCs with doses suitable for the management of COPD. Figure 5.5 COPD dispensed script volumes by year and month from 1 November 2012 to 31 October 2016 for patients initiating between 1 November 2008 and 31 October 2012 
Source: PBS Dispensing records between 1/11/2006 and 31/10/2016 file R2017068_PBS_COPD_DATA.CSV. Includes only patients who initiated COPD pharmacotherapy with a LABA, LAMA or LABA/LAMA between 1 November 2008 and 31 October 2012. Abbreviations: COPD, chronic obstructive pulmonary disease. Figure 5.6 COPD dispensed script volumes excluding Tiotropium 18 μg by year and month from 1 November 2012 to 31 October 2016 for patients initiating between 1 November 2008 and 31 October 2012 
Source: PBS Dispensing records between 1/11/2006 and 31/10/2016 file R2017068_PBS_COPD_DATA.CSV. Includes only patients who initiated COPD pharmacotherapy with a LABA, LAMA or LABA/LAMA between 1 November 2008 and 31 October 2012. Excludes Tiotropium 18 μg to prevent obfuscation of other COPD medicines due to the scale of the chart and magnitude of Tiotropium 18 μg dispensed script volumes. Abbreviations: COPD, chronic obstructive pulmonary disease. Table 5.2 COPD dispensed script volumes and year on year movement by quarter from Quarter 4 2012 to Quarter 4 2016 for patients initiating between 1 November 2008 and 31 October 2012
Source: PBS Dispensing records between 1/11/2006 and 31/10/2016 file R2017068_PBS_COPD_DATA.CSV. IMPORTANT NOTE: Includes only patients who initiated COPD pharmacotherapy with a LABA, LAMA or LABA/LAMA between 1 November 2008 and 31 October 2012. Quarter 4, 2012 was extrapolated from November and December 2012 using Quarter 4, 2013 ratios. Quarter 4, 2016 was extrapolated from October 2016 using Quarter 4, 2015 ratios. 5.6.3 Analysis of COPD prevalent patientsPrevalent patient numbers have increased substantially each year with 156,000 patients represented in 2015, and 165,000 patients represented in 2016 (note only 10 months of 2016 represented and therefore has been extrapolated by multiplying to 12 months). Patient deaths do not feature in the analysis, thus it is not possible to paint a complete picture of net COPD patient population. Dispensed prescriptions for Tiotropium 18 μg and fluticasone propionate/salmeterol 250/25 μg have consistently grown year on year to 2014, and declined from 2015 as patients switch, add and initiate to the newly introduced medicines. It is feasible that this may provide some evidence of adherence to the COPD-X guidelines on stepwise management of stable COPD. ICS/LABA is recommended for exacerbation prevention as the patient’s disease progresses. It is reasonable to expect that the selected cohort of patients may have a steadily growing proportion of patients that are moving from initiation to more advanced disease in the first few years, before settling into a more typical profile for COPD exacerbation prevention. 5.6.4 Utilisation outside COPD-X Guidelines – InitiationsPatient initiations are important in understanding typical patient regimens and how medicines are added and switched over time, and they provide a useful gauge for inappropriate prescribing for combination therapies outside clinical practice guidelines. An initiating patient is defined as a patient who has not received any in-scope COPD medicine prescription supply in the previous two-year period and the patient has initiated to a LABA, LAMA or LABA/LAMA medicine or combination therapy incorporating a LABA, LAMA or LABA/LAMA medicine and their the mono-therapy or combination therapy scripts have been filled again within two subsequent expected refill dates based upon SCD (see Appendix R for additional data). The requirement to have refilled provides increased confidence that the initiating patient has commenced therapy for COPD. Table 5.3 includes initiating patients by COPD class or combination of COPD class (note that 2016 is a part year and the data has been extrapolated to 12 months by applying 2015 month on month ratios by class to the corresponding 2016 months for September through December). It is immediately apparent from the figures that LAMA is the most common class of drug to initiate to, which as noted earlier, is consistent with, and may be indicative of, adherence to the COPD-X guidelines. It should be noted that patients initiating therapy with ICS/LABA, which would be inconsistent with guidelines, were removed from the dataset. Overall, initiations to combination therapy (which is inconsistent with the PBS restrictions and COPD-X guidelines) in 2016 was 26.2%, and has increased over the study period. Table 5. shows a growing number of patients initiating to LABA/LAMA medicines; 8.2% of initiating patients in 2015, and 15.2% in 2016 (note that 2016 is a part year and the data has been extrapolated to 12 months by applying 2015 month on month ratios by class to the corresponding 2016 months for September through December and may therefore be an underestimate). PBS restrictions specify the need for a stabilisation period on a LAMA and a LABA product separately, prior to switching to a FDC. Thus initiations to LABA/LAMA are inconsistent with PBS restrictions, and with stepwise management of COPD as recommended in the COPD-X guidelines. Table 5.3 Patients initiating by LABA, LAMA and LAMA/LABA classes by year
Source: PBS Dispensing records between 1/11/2006 and 31/10/2016 file R2017068_PBS_COPD_DATA.CSV IMPORTANT NOTE: 2016 is a part year and the data has been extrapolated to 12 months by applying 2015 month on month ratios by class to the corresponding 2016 months for September through December. Abbreviations: LABA, long-acting beta-2 agonist; LAMA, long-acting muscarinic antagonist. Table 5.shows patients by COPD class or combination of COPD class that do not refill the starting medicine or combination therapy and receive only a single script in the study period. These patients are predominantly those that receive an original supply of LAMA medicines. In 2015, there are 3,765 single script patients of which 2,957 or 78.5% receive a LAMA medicine (2016 is a part year, patients receiving their first COPD medicine in the final months of the study have not had the opportunity to refill and are overstated). This may be indicative of patients that are misdiagnosed and cease use of the COPD medicine. Table 5.4 Patients initiating to a medicine or combination therapy that is not refilled by LABA, LAMA and LAMA/LABA classes by year
Source: PBS Dispensing records between 1/11/2006 and 31/10/2016 file R2017068_PBS_COPD_DATA.CSV Abbreviations: LABA, long-acting beta-2 agonist; LAMA, long-acting muscarinic antagonist. Table 5.5 examines more closely the issue of patients initiating to combinations that are outside COPD-X guidelines. Table 5.5 reveals that the percentage of patients initiating to combinations outside COPD-X guidelines is dominated by LABA/LAMA combinations and ICS/LABA with LAMA combinations, which together represent 23.64% of initiators in 2016. It is interesting to note that ICS/LABA with LAMA initiations have been declining since 2012 where they represented 13.74% of initiations, to 8.29% of initiations in 2016 (again note extrapolation of data for 2016). Table 5.5 Patients initiating by group and year
Source: PBS Dispensing records between 1/11/2006 and 31/10/2016 file R2017068_PBS_COPD_DATA.CSV IMPORTANT NOTE: 2016 is a part year and the data has been extrapolated to 12 months by applying 2015 month on month ratios by class to the corresponding 2016 months for September through December. Abbreviations: ICS, inhaled corticosteroid; LABA, long-acting beta-2 agonist; LAMA, long-acting muscarinic antagonist. Table 5.5 reviews the most common initiation groups by prescriber type for the whole of 2015 and the 2016 part year. The prescriber type is captured at the time of the patient’s original supply to avoid double counting patients in multiple categories (i.e. in cases where the patient has changed prescriber). GPs are responsible for 86.5% of total prescribing for initiating patients in 2015, and 86.7% in 2016. Specialists are largely responsible for the remainder of prescribing for initiating patients, with the exception of 0.5%-0.6% which is attributable to Nurse Practitioners and un-coded supply in the data. Table 5.6 Patients initiating by prescriber type, 2015 and 2016 (Jan-Oct)
Source: PBS Dispensing records between 1/11/2006 and 31/10/2016 file R2017068_PBS_COPD_DATA.CSV Abbreviations: ICS, inhaled corticosteroid; LABA, long-acting beta-2 agonist; LAMA, long-acting muscarinic antagonist; NP, Nurse Practitioner 5.6.5 Utilisation outside COPD-X Guidelines – Co-administration analysisTable 5.7 broadens the analysis to co-administration of COPD inhaled medicines across all years from 2008 – 2016 and is not limited to drugs supplied upon initiation. The table shows that the proportion of patients with treatment regimens that are not consistent with the combinations recommended in COPD-X guidelines increased steadily from 3.16% in 2008 up to a peak of 8.61% in 2015, and receding slightly to 8.31% in 2016 (note that the 2016 result is for a part year and is extrapolated to full year). Figure 5. shows patients with treatment regimens in 2016 (note that the 2016 result is for a part year) that were outside recommendations in COPD-X guidelines as they include potentially unsafe combinations. The chart categorises the regimens into bands, depending on how much time the patient was undergoing treatment combinations outside COPD-X guidelines, to develop a sense of clinical significance. The chart shows that 68% of the regimens that were outside COPD-X guidelines were of three months’ duration or less. Only 14% of cases concerned regimens that lasted six months’ or more. Table 5.7 COPD medicines utilisation by COPD-X guideline indicator, drug class and year
Source: PBS Dispensing records between 1/11/2006 and 31/10/2016 file R2017068_PBS_COPD_DATA.CSV Abbreviations: COPD, chronic obstructive pulmonary disease; ICS, inhaled corticosteroid; LABA, long-acting beta-2 agonist; LAMA, long-acting muscarinic antagonist. Note: Refer to Appendix P for treatment combinations not recommended in COPD-X guidelines Figure 5.7 Patients COPD medicines utilisation duration by COPD-X guidelines indicator in 2016 
Source: PBS Dispensing records between 1/11/2006 and 31/10/2016 file R2017068_PBS_COPD_DATA.CSV Abbreviations: COPD, chronic obstructive pulmonary disease; Note: Refer to Appendix P for treatment combinations not recommended in COPD-X guidelines Yüklə 0,73 Mb. Dostları ilə paylaş:
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