Hurdles remain for Botox as a migraine treatment

Botox was approved in the UK this month for the treatment of migraines, however, the high costs of the cosmetic treatment as well as lingering safety concerns may restrict its ability to penetrate this new market.

Martin Adams, healthcare analyst at Datamonitor, said that a green light from the UK generally augers well for Botox’s approval as a migraine treatment throughout the rest of Europe and the US. It’s failure, however, to meet the primary efficacy endpoint in the first Phase III trial has led to concerns regarding potentially serious side-effects.

“Approval in the UK for Allergan’s Botox (onabotulinumtoxinA) for the prevention of chronic migraine bodes well for the US and other EU filings but even so there remain significant hurdles for the company to overcome,” he said.

“With the first clinical trial essentially failing, there remains a prospect that Botox will not be approved in the US and remaining EU countries”. And even if it is, Botox is very expensive with few insurance companies covering its use in treating migraine. Migraine patients typically require three to four sessions per year at around $US750 a pop, not including clinic and physician costs.

“If it is approved then the high associated costs will also see reimbursement restricted,” Adams said.

Recent studies have shown that patients with imploding and occular heachaches injected with Botox experienced a reduction in headache frequency, while patients with so-called exploding migraines did not respond.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) stipulates that Botox is be made available only to patients who suffer headaches for at least 15 days a month, with half of these attributable to migraine. The general consensus, though, is that Botox is unlikely to be effective in treating all chronic migraine sufferers, while predicting those likely to benefit is expected to be tricky.

Datamonitor reports that the migraine market has contracted by as much as $US1.5 billion over the last few years, largely as a result of patent expiries and increased competition from low-cost generics.

It predicts that approval in the seven key markets including the US, Japan, the UK and Germany could see sales of Botox for migraine treatment exceed $US390 million by 2019.