Your questions to the PBAC

Readers are invited to write in with their questions about decisions of the Pharmaceutical Benefits Advisory Committee (PBAC). Australian Prescriber publishes selected questions from readers, together with answers from the PBAC. Questions may address issues such as regulatory decisions, pharmaceutical benefits listings and withdrawals.

This exclusive arrangement helps Australian Prescriber readers understand how the contents of the Pharmaceutical Benefits Scheme (PBS) are determined.

Letters and responses are reviewed by the Editorial Executive Committee and may be edited before publication. It may not be possible to reply to all individual questions.

Your questions to the PBAC

I am writing to express my concern with respect to the February decision of the Pharmaceutical Benefits Advisory Committee (PBAC) to list bupropion. Even in my small town we have been inundated by requests for the drug, from smokers of all types. This has been spurred on by both word of mouth and continued media coverage. Making an assessment of the relevance of the drug to that particular person has been all but impossible, with people fearful that if they do not get in quick they will not get the bargain price. To be honest it has been almost like a fire sale at the local department store, with the hysteria to match.

It has been impossible to get through to the Health Insurance Commission for more relevant and urgent authority prescriptions because the staff are busy processing requests for bupropion. I am deeply concerned at the cost to taxpayers of this PBAC-induced mayhem, and what benefit there will be to Australian consumers.

Discussions I have had with patients reveal poor compliance with the drug. No associated rehabilitation program was offered in conjunction with the release of this drug, and there are no local resources to provide one on a mass scale.

All in all, this has got to be the poorest effort at listing of a drug by the PBAC that I have ever seen, and has put most general practitioners in an awkward position of having to decide how to respond to mass hysteria and pressure.

Dr Ewen McPhee
General Practitioner
Emerald, Qld.

PBAC response

At its September 2000 meeting the PBAC recommended that bupropion be listed as an authority required pharmaceutical benefit for use within a comprehensive treatment program, as short-term adjunctive therapy for nicotine dependence with the goal of maintaining abstinence. The recommended listing provided for only one application per patient per year and prohibited the authorisation of increased maximum quantities or repeats.

In making its recommendations, the PBAC considers the effectiveness, cost-effectiveness and clinical place of a product compared to other products. Where there is no alternative as was the case for bupropion, the PBAC compares the product with standard medical care and considers the benefits the new product will provide compared to the cost of achieving those benefits. The PBAC also took into account the comparative performance of bupropion and nicotine replacement therapy.

The PBAC considered treatment with bupropion to be clinically and cost-effective where compared to standard therapy and nicotine replacement therapy. The PBAC is of the view that the large number of Australians currently seeking this therapy is an encouraging indication that many smokers want to stop smoking, and that listing this treatment on the Pharmaceutical Benefits Scheme is entirely appropriate. Furthermore, the Commonwealth Government has a role in promoting the cessation of smoking as this is a public health issue.

In relation to the comprehensive treatment program requirement of the authority listing for bupropion, this need not necessarily be a formal rehabilitation program, and in fact may be limited to counselling by the prescribing practitioner. The manufacturer of bupropion advises that a comprehensive motivational support program in smoking cessation, developed by the company, was in place when the medication was first released, as a private prescription, in November 2000. Patient enrolment in the program may be initiated by the prescribing doctor, a pharmacist or the patient in response to a package insert outlining the program and relevant contact details. Encouragement for patients to access the well established national QUIT program is also appropriate as a source of motivational support.

The Health Insurance Commission (HIC) appreciates the frustration prescribers may have felt as they experienced difficulties in getting through to obtain telephone authorities when calls unexpectedly nearly doubled when bupropion was listed on 1 February 2001. The HIC responded by re-allocating staff from other areas and in some states, additional staff were recruited to assist during the period of high demand, which has since eased significantly.