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, see www.pbs.gov.au) 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
Aust Prescr 2013;36:82 | 3 June 2013 | http://dx.doi.org/10.18773/austprescr.2013.040
I noted with interest in the latest edition of NPS RADAR that pregabalin has been approved for neuropathic pain. The stated justification is ‘non-inferior in efficacy and safety to amitriptyline and gabapentin (from indirect comparisons)’.1
Later it is stated that gabapentin is an effective treatment for neuropathic pain, but is not subsidised on the PBS for that indication. I would add that it has been available for many years and its dosage and adverse effects are well known to prescribers.
Many patients with neuropathic pain have been paying very high prices for their gabapentin for 10 years or more. The recent decision has created the illogical situation in which long-standing users of gabapentin, who are controlled on a well understood drug, will be paying more than patients being started on a much newer drug with less well established efficacy and safety.
Does the PBAC intend to rectify this scenario?
Gabapentin is currently available as a pharmaceutical benefit in Australia for the treatment of partial epileptic seizures which are not controlled satisfactorily by other antiepileptic drugs, however it is not listed for neuropathic pain. The PBAC has in the past rejected applications for the subsidy of gabapentin for the treatment of neuropathic pain.
The grounds for rejection were lack of evidence in the proposed population, as the clinical trial data did not reflect the population covered by the proposed PBS restriction, and uncertain cost-effectiveness in this patient group. Any re-submission must address those matters. It may provide new data or modify the previously requested indication.
In order to facilitate the listing of gabapentin for neuropathic pain, Professor Sansom, the former Chair of the PBAC, had held meetings with pain specialists. The Department of Health and Ageing is also in contact with sponsors of gabapentin to try to progress its listing for neuropathic pain. The PBAC would consider any submission proposing the listingof gabapentin as a pharmaceutical benefit for this condition on its merits.