PBAC review into Alzheimer’s medications
07 June, 2012
The Pharmaceutical Benefits Advisory Committee (PBAC) has announced a review of government subsidised anti-dementia drugs (cholinesterase inhibitors (CEIs) and memantine) to better understand usage patterns, efficacy and safety, cost-effectiveness and prescribing rules for these drugs.
Dowload the Alzheimer's Australia submission.
Doanload the report to the Pharmaceutical Benefits Advisory Committee (PBAC).
Doanload Alzheimer's Australia's comment on the Report to PBAC.
Overview
What are the current available medications for Alzheimer’s disease and what do we know about them?
The availability of these medications is already tightly controlled
Number of people receiving anti-dementia medications
What can you do?
Click here to see other people's views
Media
Overview
The review was prompted by an earlier review of government subsidised CEI medications that found the drugs were being prescribed to people for a longer period than anticipated when they were first approved for government subsidy through the Pharmaceutical Benefits Scheme (PBS) in 2001.
In other words, anti-dementia medications are costing the government more than expected, and the review is being undertaken to assess whether their public subsidy is cost-effective and appropriate, and what if anything needs to change.
The review is looking specifically at:
- Recent patterns of anti-dementia medication usage, and changes over time;
- The appropriateness of the rules for determining eligibility for continuation of subsidised prescription (primarily a 2 point improvement on the Mini Mental State Examination after 6 months);
- Any new evidence regarding the effectiveness and safety of these medications;
- The impact of the continuation rule on cost effective provision of these drugs through the PBS.
What are the current available medications for Alzheimer’s disease and what do we know about them?
There are currently four anti-dementia drugs available in Australia that are approved for the treatment of mild to moderately severe Alzheimer’s disease (but not other causes of dementia). All of these drugs are designed to help reduce symptoms (improving memory and other cognitive problems, improving daily functioning, and reducing the severity of behavioural and psychological symptoms), rather than to treat or cure the disease itself. In this way they can improve quality of life to some extent for people with Alzheimer’s disease, and assist family carers in their often stressful care task.
There is good evidence to show that the drugs are moderately effective. However, they don’t work for everyone and carry risks of side-effects including loss of consciousness and falls, among others.
The availability of these medications is already tightly controlled
All four drugs are ‘authority required’, meaning that to be eligible for a prescription, a diagnosis by a medical specialist of probable mild to moderate Alzheimer’s disease is required, along with baseline cognitive and/or functional test results. While the diagnosis must be made by a specialist, the medications can subsequently be prescribed by either specialists or GPs, or by a nurse practitioner for repeat prescriptions. Under this system, specialists act as gatekeepers to anti-dementia medications.
The initial approval for subsidised prescription lasts for 6 months. Continuation of subsidised prescription beyond 6 months requires a demonstrated improvement in cognitive function on the MMSE (minimum 2 point improvement), the ADAS-cog (minimum 4 point improvement), or an ‘improved’ rating on the Clinician’s Interview-Based Impressions of Severity (CIBIS) scale, depending on the assessment used at baseline. These benchmarks are based on what the PBAC deemed as cost-effective use of public funding at the time of their approval.
The requirement for improvement is already a tough regime for people with a progressive condition.
Number of People receiving anti-dementia medications
Based on the number of scripts issued (PBS data), and assuming an average course of 13 months, there were an estimated 30,940 people with Alzheimer’s disease receiving subsidised prescription of anti-dementia medications in 2010-11. This has increased from an estimated 27,554 people in 2007- 8 (a 12.3% increase; slightly less than the increase in dementia prevalence).
30,940 is only 16.6% of the estimated 186,200 people in Australia with Alzheimer’s disease (not other forms of dementia) in 2011 who could potentially be eligible to receive these drugs. This may be due to clinical judgements about the efficacy of the drugs by specialists, the tight controls over these medications, personal preference (because the medications are tried for a brief time and prove ineffective), or due to low rates of diagnosis of dementia and/or referral to specialists in primary care.
What can you do?
It is important that those with experience of these medications provide a consumer view – the best expert view. The questions you might consider are:
- Have these medications helped you in the relief of symptoms of dementia?
- How did the medications help you?
- Have these medications made it easier for the family carer to provide support and care?
- Were you able to access the medications without difficulty?
- Were the medications of no benefit to the person with dementia or their family carer?
- Was there any marked effect when the medications were discontinued?
You can make your views known by:
Submissions are due on 6 July, so if you would like to share your views, please make a submission, or let us know as soon as you are able.
Media
On 1 June 2012, CEO of Alzheimer's Australia, Glenn Rees, spoke to AAP about the announcement from PBAC and their review into mediations for people with dementia. Click here to view the article.