Good news for chronic nerve pain sufferers…but it could have been better

The announcement on Friday last week that pregabalin (Lyrica) had made it onto the PBS is a huge relief for sufferers of chronic nerve pain.

It also means that the true cost of providing appropriate care to chronic pain sufferers can be better measured. Too many GPs and other doctors are forced to prescribe opioids for nerve pain when the evidence for their usefulness is known to be unconvincing. As previously mentioned in this column, long-term opioid therapy for non-cancer pain has limited benefits compared to the potential for reduced quality of life, even if the generally overstated risk of abuse and addiction is discounted. This is especially true for nerve pain, also known as neuropathic pain. The pain is simply generated in a way that opioid drugs don’t really influence.

In choosing to accept the PBAC recommendation to list pregabalin, we are finally seeing some movement on the issue of the scandalous undertreatment of chronic pain in Australia.

But Minister Plibersek and her bureaucrats have missed a big trick.

Gabapentin is an older drug with the same basic mechanism of action as pregabalin. It is out of patent and is manufactured by a number of generic manufacturers, including some Australian ones. Gabapentin will never be listed on the PBS despite its proven effectiveness because the company which originally held the patent is Pfizer. Pfizer also developed pregabalin, and will be the beneficiary of essentially all of the half a billion dollars that this listing will generate for it. There is no commercial imperative for them to reapply for gabapentin, which is what the current listing process demands.

However, if the Minister had insisted that gabapentin be listed alongside pregabalin, there would have been a cheaper alternative drug with the same mechanism of action, and which most experts agree is equally effective. Moreover, the financial rewards for treating neuropathic pain would not then all go to Pfizer, but would be split to include some home-grown generics.

It would have been a win all round. Doctors would have access to two first-line drugs instead of one to treat neuropathic pain. The PBAC could specify that gabapentin must be tried prior to pregabalin via the Authority system. Patients would have had the option of trying a different agent if they can’t tolerate the side effects of pregabalin (in our experience over the last four years of prescribing both drugs this happens a lot.) And finally the local generic drug manufacturers would get a share of the profit from treating locals more effectively. The total cost of treating neuropathic pain more effectively would arguably also be less, as for lower doses gabapentin is more cost-effective and better tolerated than pregabalin. The only losers from all this would be the Pfizer executives and shareholders.

So while I welcome with relief the news that pregablin will be available on the PBS, I can’t help thinking that we could have done better all around. We need both drugs to be available.

Join the conversation

14 Comments sorted by

  1. Edward John Fearn

    Edward John Fearn is a Friend of The Conversation.

    Hypnotherapist and Naturopath

    Thanks Michael
    So I assume this means that it’s too late to start sending letters to Minister Plibersek or starting an online petition? If however someone feels it’s worth starting one, then just let me know and I will “tweet” the details to my followers.
    Just one question, are opiates currently being prescribed by GP’s for those patients with neurogenic pain that are not responding to tricyclics, in combination with, or instead of?

    report
    1. Michael Vagg

      Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist at Barwon Health

      In reply to Edward John Fearn

      Thanks for your support Edward.

      I don't believe it's too late for common sense to prevail, but it would certainly be a rare move for a Health Minister to unilaterally decide on such a move. As far as I'm aware advocacy from consumer groups has not ever taken the form of online petitions, but old-fashioned paper ones have been tried before. The pressure would need to be as overwhelming and compelling as the arguments, and there would clearly have to be some votes in it for a Minister to act outside the usual framework of PBAC approvals. It has been done before, most famously after Janette Howard was said to have lobbied personally for Herceptin to be expedited through the registration process.

      report
    2. Michael Vagg

      Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist at Barwon Health

      In reply to Edward John Fearn

      Oh, and TCAs ought to be prescribed before opioids are tried but this presumes that a diagnosis of neuropathic pain has been thought of. Awareness of the potential diagnosis of neuropathic pain, and an appreciation that it requires different management to somatic pain is variable in primary care. In general the opioid drugs should be reserved for neuropathic pain where there is poor response to first-line agents such as gabapentinoids, TCAs and duloxetine.

      report
  2. Michael Macdonald

    Chemist

    For a government that wants to reduce the costs associated with healthcare, it seems an odd decision to list pregabalin and not gabapentin, on the PBS.

    report
  3. Cris Kerr

    Volunteer Community Health Researcher, Advocate for the value of Patient Testimony

    Dear Michael,

    I was heartened by your article and want to thank you sincerely for
    highlighting a health system failure that has not served the best interests of
    patients.

    The Consumers Health Forum have previously lobbied for PBS listings for
    new drugs.

    Maybe you could copy this article to them and ask for their support?

    Then again, if our new PCEHR system were purposefully designed for
    meaningful use (refer submission below*), then in the future, it would contain
    all the data needed for comparative treatment effectiveness, and all the data
    you'd need to justify this type of proposal.

    *296. Cris Kerr Case Health
    http://mckeonreview.org.au/sub/296_Cris_Kerr_Case_Health.pdf

    report
  4. Jac Hancox

    BSc. Agriculture - Biotech undergraduate

    Michael, can I please ask your opinion of the potential effectiveness of Lyrica for treatment of fibromyalgia? I know that it is prescribed for this condition in America but don't know much about its use in an Australian context.

    report
    1. Michael Vagg

      Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist at Barwon Health

      In reply to Jac Hancox

      Jac

      Pregabalin is a valuable drug for a minority of FMS patients. The data suggest it should be first line drug treatment for moderate to severe symptoms of FMS, with a NNT (number needed to treat) of around 6. This means that it can be expected to give good relief of pain and sleep symptoms in a little over 15% of FMS patients.

      My clinical experience with it is roughly in line with this. I have a number of FMS patients who basically have no symptoms at all as long as tbhey stay on it. I have…

      Read more
    2. Jac Hancox

      BSc. Agriculture - Biotech undergraduate

      In reply to Michael Vagg

      Thank you for your reply Michael, very interesting indeed. As a student I definitely would have to pass on anything that produced side effects affecting concentration and memory (it's hard enough with the fibro symptoms) but maybe when I don't have academic performance requirements on my plate I may discuss trying this medication with my GP. I find that life with fibro is a constant trade-off of how much pain I can tolerate before succumbing to taking something for pain relief. I have found a fairly low dose of amitriptyline has made a big difference in sleep symptoms and pain on waking, but it comes at the cost of screaming-the-house-down nightmares. My hubby and the kids aren't traumatised by my night wailings so I'm going to stick with the Endep as it really improves my symptoms. Thanks again for your response.

      report
  5. Pera Lozac

    Heat management assistant

    Almost a miracle cure I would say....

    "Adverse effects

    Adverse drug reactions associated with the use of pregabalin include:

    Very common (>10% of patients): dizziness, drowsiness.
    Common (1–10% of patients): blurred vision, diplopia, increased appetite, euphoria, confusion, vivid dreams, changes in libido (increase or decrease), irritability, ataxia, attention changes, abnormal coordination, memory impairment, tremors, dysarthria, parasthesia, vertigo, dry mouth and constipation…

    Read more
    1. Michael Vagg

      Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist at Barwon Health

      In reply to Pera Lozac

      Yes Pera, I would say that you have that ole cut'n'paste trick down pat.

      What Jac was asking about was 'context', ie how the drug (which has well documented risks and harms) is applied to people who have a medical condition in a particular setting (which is often based on other factors than just the science.)

      report
  6. Laurie Strachan

    Writer/photgrapher

    After reading your article and the minister's press release I asked my GP to prescribe Lyrica for me. He did but when I went to the pharmacist I was told it wasn't on the PBS unless I had an "authority". What does this mean?

    report
    1. Michael Vagg

      Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist at Barwon Health

      In reply to Laurie Strachan

      Hi Laurie

      At the moment, Lyrica is only available on private script, for which you would have to pay full whack. The PBS listing is due to commence on March 1st next year (I know, things move slowly in PBS-land)

      When the PBS have a concern about how a particular drug is used, and they wish to restrict it to only certain situation, or certain prescribers, this is called an 'Authority' listing. It means the that unless there is a pre-existing code to cover the situation (a 'streamlined Authority') the doctor has to ring up the PBS and get a code so the prescription is valid. I haven't yet seen the restriction for Lyrica, but I imagine it will be something like 'neuropathic pain not responding to other treatments' and it will likely be a phone Authority script.

      So to answer your question, an 'Authority' script is a bureaucratic annoyance that is placed there to try to ensure that the drugs are prescribed cost-effectively.

      report
    2. Michael Vagg

      Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist at Barwon Health

      In reply to Laurie Strachan

      Scrub that. I just found out that it is likely to be a streamlined Authority, which is great news. The wording for the listing will almost certainly be as described below

      report
  7. Sheryl Hawkins

    logged in via email @hawkinsfamily.com.au

    Hi Michael,

    Thank you for this article.
    I have FM plus I had a car accident almost two years ago, breaking my neck and back.
    Anyway, with having nerves crushed etc, four surgeries on I have major nerve damage down my left side.
    Both my neurologist, rheumatologist and orthopaedic surgeon decided to try me on Preglabin - Lyrica. I had a distressing side effect of having an orgasm continuously. At that stage all my friends wanted to try it. So, for me Preglabin is out of the question. Not a…

    Read more