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Changes to restrictions on medicines for COPD and asthma
Dr Kerry Hancock, Chair of the RACGP’s Respiratory Medicine Specific Interests network, examines the reasons behind recent changes to the PBS and what they mean for GPs and patients.
The PBAC has recommended raising prescriber awareness of current National Asthma Council Guidelines.
Changes to the Pharmaceutical Benefits Schedule (PBS) restrictions of some respiratory medicines came into effect on 1 August.
The changes arose from deliberations of the Pharmaceutical Benefits Advisory Committee (PBAC) involving the Post-market review of chronic obstructive pulmonary disease medicines and the evaluation report of the 2014 post-market review of PBS medicines used to treat asthma in children.
The PBAC makes recommendations to the Federal Minister of Health, which can be found in the PBAC minutes published on the PBS website.
The PBAC made a number of recommendations to match clinical criteria. These included changes to the authority level of PBS-listed inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) and long-acting muscarinic antagonist (LAMA)/LABA medicine combinations in chronic obstructive pulmonary disease (COPD), and ICS/LABA combinations in asthma, along with administrative advice (‘notes’).
The PBS changes in summary:
- ICS/LABA – Restriction level has been elevated from Restricted Benefit to Authority Required (Streamlined)
- LAMA/LABA – Addition of clinical criteria to the current restrictions, allowing their use in patients who have not been previously stabilised on a combination of LAMA and LABA medicines, but who have failed to have their symptoms controlled by either
- For all COPD and asthma ICS/LABA medicines – Administrative advice (or ‘Notes’ as they appear on the PBS website) updated as per recommendations made by the PBAC in August 2017
The PBAC noted there appears to be a high rate of initiation to ICS/LABA therapy in COPD, which is inconsistent with clinical guidelines.
In July 2014, the PBAC considered the initial 2013 report on the PBS medicines used to treat asthma in children. They were concerned about the high use of ICS/LABA therapies in children under 12 years of age, especially those under four years of age in whom ICS/LABA therapy is not PBS listed.
The PBAC did not recommend a change in the level of PBS restriction at that stage. However, they did recommend a number of other strategies, including:
- educational programs targeting quality use of medicines in children with asthma
- changes to software to include a signal to alert prescribers of the minimum age for which these medicines are registered and indicated (four years for Seretide and 12 years for Symbicort and Flutiform)
- inclusion of age and date of birth on paediatric prescriptions
- generally raising prescriber awareness of the current National Asthma Council Guidelines and PBS-restricted indications regarding use of fixed-dose combination LABA/ICS in children.
However, an evaluation report conducted three years later revealed that, despite those recommendations, there continued to be a high percentage of children initiating treatment with a fixed-dose combination of ICS/LABA that was outside of clinical guidelines.
A
commissioned systematic review of comparative clinical effectiveness showed there was no apparent clinical benefit associated with the use of ICS/LABA versus ICS alone in children. It was noted that 95% of ICS/LABA prescriptions for children were written by GPs.
The PBAC recommended in its advice to the Federal Health Minister to increase the PBS restriction level to Authority Required (Streamlined) for all ICS/LABAs inhalers that have dual listings on the PBS for the treatment of COPD and asthma.
The PBAC also recommended adding PBS restriction notes to encourage prescribers to implement best practice management. For example, to consider first-line treatment with ICS alone in asthma (in particular for children), to check inhaler device technique and to confirm a diagnosis of COPD with spirometry.
The PBAC encouraged healthcare professionals and consumers to access helpful educational resources available through the
Lung Foundation Australia and
NPS MedicineWise, as well as the
Australian Asthma Handbook and
Asthma Australia.
Improving use of inhaled medicines in accordance with current clinical guidelines would also improve the cost-effective use of therapies for COPD and asthma.
Full details of these changes can be found on the Schedule of Pharmaceutical Benefits (
summary of changes).
What do these changes mean for GPs?
For the ICS/LABA and LAMA/LABA combination therapies, which are now PBS authority streamlined, just a few more clicks on the computer when prescribing and reading the PBS notes as to whether the patient in front of us meets the criteria for prescribing that medicine.
Where clinically appropriate when stepping up therapy, patients no longer have to be stabilised on the individual medicines before prescribing a fixed-dose combination therapy.
What do these changes mean for patients?
Patients will receive the right medicine in accordance with current guidelines. Children will not be prescribed LABAs inappropriately and older children will have a trail of ICS before adding a LABA.
Those with COPD will reduce their risk of adverse effects from ICS by not being exposed to it unnecessarily.
A LAMA/LABA fixed dose combination is more convenient and less costly than having to be stabilised on the individual medicines before progressing to the fixed-dose combination.
What is the key aspect GPs should know about this development?
When initiating a new inhaled therapy, in particular, read the streamlined authority descriptors and ensure the patient’s clinical presentation, whether it be a child or adult with asthma or an adult with COPD, meets the criteria to prescribe that medicine.
For those already on inhaled respiratory medicines, it is a good opportunity to reassess whether they are on the most appropriate medicine for the severity of their condition.
For example, a patient with COPD who is already on an ICS/LABA will also need those medicines prescribed via the streamlined authority process. It is an opportunity to confirm their diagnosis by spirometry and assess their need for an ICS-containing medicine and consider withdrawing the ICS if their FEV1 > 50% predicted and they were not having frequent exacerbations (two or more per year) when they commenced on the ICS/LABA.
Of course, if the patient has co-existing asthma, either from the clinical history or previous investigations, then ICS should not be withdrawn.
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