Review of Pharmaceutical Benefits Scheme Anti-dementia Drugs to Treat Alzheimers Disease
Review of Pharmaceutical Benefits Scheme Anti-dementia Drugs
to Treat Alzheimers Disease
An initial review of cholinesterase inhibitor (CEI) medicines to treat Alzheimer disease carried out by the Drug Utilisation Sub-Committee (DUSC) of the Pharmaceutical Benefits Advisory Committee (PBAC) in 2010–11, indicated that these medicines were being prescribed to a much larger population for longer periods of time than was originally agreed as cost-effective by the PBAC.
In March 2012, to ensure the ongoing appropriate and cost-effective use of these medicines, the PBAC recommended a Post-Market Review of all anti-dementia drugs listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of Alzheimer disease.
The PBAC is the independent, expert advisory body comprising doctors, other health professionals and a consumer representative, which makes recommendations to the Australian Government about PBS listings.
Publication of the findings of the DUSC review can be accessed on the Australasian Journal on Ageing.
Medicines included in this review
The PBS listed medicines included in this Review were: donepezil; rivastigmine; galantamine; and memantine.
Terms of Reference
The Terms of Reference for the Review are:
a. Review recent Australian utilisation data on patient initiation and continuation rates to cholinesterase inhibitors and memantine.
b. Review whether the two point improvement in Mini-Mental State Examination continues to be an adequate surrogate for measuring improvement in patients with dementia treated with these medicines; and are there other more reliable measures of patient relevant outcomes?
c. Investigate if there is more recent evidence on the safety and efficacy of these medicines that would inform the PBAC about their cost-effectiveness.
d. Review the current PBS restriction continuation rule and the likely effect it has on cost-effective utilisation of these medicines.
Outline of Process
The Australian Government, understanding the importance of effectively and safely treating people suffering from Alzheimer disease, supported the PBAC’s review of these medicines.
A small working group consisting of PBAC members guided the Department on the scope and methodology for the Review. An external evaluator was engaged to conduct a literature search and evaluation of recent clinical research on these medicines.
Submissions addressing the Review’s Terms of Reference were sought via an open public consultation process between 28 May
and 6 July 2012. Submissions made to the review are available at Submissions to the Review of Anti-dementia Drugs to Treat Alzheimer Disease. Submissions, or parts thereof, provided in-confidence are acknowledged, but have not been published.
The draft Report on the Review of anti-dementia medicines for Alzheimer disease was considered by the DUSC and the Economic Sub-Committee (ESC) of PBAC. Sponsor companies were also provided a copy of the draft Report and invited to comment prior to sub-committee consideration, in keeping with usual PBAC processes. The final Report was updated to include sub-committee and sponsor input.
A plain language summary was written, based on the Report for the PBAC. Stakeholder consultation on the plain language summary and final Report occurred on 2–22 November 2012. Due to its size and scientific nature, the Report was not published on the PBS website. However, those wanting to receive specific parts of the Report could do so by emailing the post-market inbox.
The Report, including PBAC Sub-Committee advice and stakeholder comments, was provided to the PBAC for consideration in December 2012. The full PBAC Minutes for this item are available from the web page or as a Word document (67 KB). The PBAC accepted the Report’s findings that these medicines are being used in a much broader population and for longer periods of time than originally agreed as cost-effective. Additionally, the research on the effectiveness of these medicines is consistent with that previously considered by PBAC, which indicates significant uncertainty in the benefits for patients, particularly beyond six months.
To account for the use of these medicines in a broader population the PBAC recommended a price reduction of 40 per cent and also agreed to simplify the continuing restriction to better align with current clinical use. The restriction changes are intended to make access to these medicines clinically appropriate for prescribers and patients who respond to treatment.
The Hon Tanya Plibersek, Minister for Health, accepted these recommendations and the new prices were implemented on 1 April 2013. The revised restriction will be published in the Pharmaceutical Benefit Schedule on 1 May 2013.
The Department appreciates the valuable contributions made by organisations and individuals who provided submissions or comments during this Review.
Please direct all queries to PBSpostmarket@health.gov.au