The Pharmaceutical Benefits Advisory Committee has decided to recommend that ReVia (naltrexone) be listed on the subsidised Pharmaceutical Benefits Scheme (PBS) from 1 February next year for alcohol dependent patients.

Meeting in Canberra yesterday, the PBAC reconsidered an application from the drug's distributor Orphan Australia. PBAC decided to recommend that naltrexone be listed for alcohol dependence, but rejected an application for treatment of formerly opiate-dependent patients.

Managing Director of Orphan Australia, Mr Alastair Young, said that while he welcomed the decision to subsidise ReVia for alcohol dependence, he was disappointed that the PBAC had not accepted the evidence relating to its use for opioid addiction.

"The good news is that people in a treatment program for alcohol dependence will now be able to have ReVia prescribed on the PBS at a cost of around $20 compared to the $200 to $250 they are currently paying," Mr Young said.

"It's sad that it has been rejected for opioid addiction and I think a lot of people will be disappointed. We will explore our options when we receive the written reasons for the decision," he said.

Dr Stephen Jurd, director of the drug and alcohol services at Sydney's Royal North Shore hospital, said the PBS listing for alcohol would significantly improve access to naltrexone.

"There is very clear evidence that naltrexone is powerful in the treatment of patients with alcohol addiction," Dr Jurd said.

"Naltrexone may genuinely change the life of 20 percent of the people who take it. Around 5 percent of men are alcohol dependent. Conventional treatment works for about 20 percent of this group, which is one percent of the adult male population. Naltrexone will allow another 20 percent of this group to end their dependence on alcohol.

"Recently published research in the US confirmed that patients treated with naltrexone had a significantly higher percentage of time abstinent, they had a lower rate of relapse and, when they did drink, had significantly fewer drinks per drinking day than placebo-treated patients¹," Dr Jurd said.

PBS listing for alcohol was welcomed also by Professor John Saunders, Professor of Alcohol and Drug Studies at the University of Queensland, and Co-Scientific Director of the WHO Collaborating Centre for Mental Health and Substance Abuse.

"The availability of naltrexone on the PBS for alcohol dependent people is an important step forward in our efforts to reduce alcohol-related harm in Australia. I have been greatly concerned that so far it has been available only for those who could afford private medicine," Professor Saunders said.

"Individuals affected by alcohol can now be prescribed naltrexone by their general practitioner or specialist at a reasonable cost. When combined with support from a doctor or a program of counselling, naltrexone substantially reduces the likelihood of relapse into heavily drinking. It suppresses craving for alcohol and gives people a real boost in the efforts to get their life back in order.

"It won't be available on the PBS for opiate dependent people. However, there are many trials of naltrexone for opiate dependence being conducted in Australia at the present time. I hope that when the results of these trials are available, there will be sufficient evidence to support a reapplication for PBS listing. It is vital that we have options for opiate users who are aiming for a drug-free way of life," he said.

Dr Jon Currie, Director of Drug and Alcohol Services at Westmead Hospital, said the PBS rejection of naltrexone for maintenance therapy for detoxified opioid addicts meant the drug would remain prohibitively expensive.

"This is very good news for people with alcohol dependence, but it's a tragedy for people with a heroin addiction," Dr Currie said.

"It is very unfortunate that the only medication known to help keep people abstinent is being denied PBS listing. This means that one of the most vulnerable and disenfranchised groups in the community is being denied this drug at a price they can afford.

"It has been shown time after time that naltrexone helps some people break their heroin addiction - not everyone, but a significant number of addicts. Even if it only works for some people, I believe it should be subsidised for these people.

"The surveillance figures on heroin deaths found that the only state where deaths are not increasing is WA, where the population-based naltrexone program run by Dr George O'Neil appears to be making a difference.

"There is a heroin epidemic in Australia. The community wants effective action to help break this addiction. Any medication which can help some of these people must be made available," Dr Currie said.

1. Anton RF, Moak DH, Waid LR, Latham PK, Malcolm RJ, Dias JK, : Naltrexone and cognitive behavioural therapy for the treatment of outpatient alcoholics: results of a placebo-controlled trial. Am J Psychiatry 1999; 156:1758-1764

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