Pharmac epilepsy drug process questions

Michael Woodhouse.
Michael Woodhouse.
There are many unanswered questions about Pharmac's decision to fund only one brand of the epilepsy drug lamotrigine from last October. The frustration of those concerned about the impact of the change is understandable.

It has been reported that five people who changed to the new drug have died.

At this point, it cannot be ascertained whether the change in the medication is linked to these deaths.

Sadly, every year there are around 40 deaths described as sudden unexplained death in epilepsy (SUDEP) in New Zealand.

A joint coronial investigation was instigated by chief coroner Judge Deborah Marshall last month to consider whether the brand switch may have changed the seizure control and whether that contributed to the deaths.

Health and disability commissioner Anthony Hill is also looking into questions about informed consent in the midst of claims some patients only found their medication had changed when they picked up their prescriptions or became unwell.

In November, Pharmac responded to concerns by making it easier for most people to get funding to stay on their preferred brand.

Medsafe's advice is that anyone who is taking anti epilepsy medicine should keep taking it and if they have any concerns consult their doctor.

Before October, three brands of the drug, which is also used for the treatment of bi-polar disorder, were funded.

Switching about 10,000 people to the generic brand Logem was estimated to save $30 million over five years, money which would be used to purchase other medicines.

Drug switches are not unusual for the country's drug-buying agency, with RNZ reporting it makes about 60 a year.

With a limited budget, Pharmac must get the best bang for its bucks and one way of freeing up money to buy new drugs is for it to reduce spending on some already funded medicines.

Moving to generic brands is not undertaken without considerable research and consultation with relevant clinicians. In this instance, Pharmac has been at pains to point out the thoroughness of its process.

In the case of this switch, however, there has been considerable consternation about Pharmac's attitude to concerns raised by Medsafe, the country's medicines and medical devices safety authority.

Medsafe advised against the switch, concerned it posed significant safety issues.

If it did proceed, it advised that patients should see a GP before the change and vulnerable patients should see a specialist.

Pharmac appeared worried about causing unnecessary anxiety by giving patients too much information.

There have been calls for a ministerial inquiry into the change by National's health spokesman Michael Woodhouse, backed up by Epilepsy New Zealand.

Naturally, Mr Woodhouse cannot resist suggesting Pharmac was better funded under a National-led government, but his concerns about the pressure on the drug-buying agency are worth considering.

In recent years it seems there has been a considerable increase in the public calls for Pharmac to fund more drugs, often, but not always, for cancer treatment.

Some of the commentary around this has often reflected little understanding of the New Zealand situation, and the hype around some drugs may not have matched the reality.

Has this clamour pushed Pharmac into what might be seen as more risky decisions about drug switches in order to free up money for newer drugs?

A ministerial inquiry is being resisted by the Government at this stage, with it pointing to the fact the deaths are being investigated by the coroner, and that changes have been made to allow people to stay on their preferred brand.

We can understand the Government not wanting to be seen to politicise this situation, but an independent look at the process followed by Pharmac in this instance seems pertinent.

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