Botox HeadacheMonday, February 7. 2011
Datamonitor has reported that the use of Allergan’s Botox (onabotulinumtoxinA) for the prophylactic treatment of chronic migraine may soon be introduced in Australia following UK approval this month. However, independent market analyst Datamonitor suggests that approval is far from guaranteed and assuming a positive outcome, reimbursement challenges will provide Allergan with an ongoing headache.
Martin Adams, healthcare analyst at Datamonitor comments that “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.” The treatment will be governed by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and will only be available to those who have suffer headaches for at least 15 days a month. Although, the drug also failed to meet the primary efficacy endpoint in the first Phase III trial and, whilst generally perceived to be safe, has the potential to cause serious life-threatening side effects.
Martin adds: “With the first clinical trial essentially failing, there remains a prospect that Botox will not be approved in the US and remaining EU countries. However, a significant level of support exists amongst opinion leaders, particularly so in the US and it does address a high unmet need among the target patient population.”
The majority of health insurance policies currently do not cover the use of Botox for chronic migraine at $750 a session.
“However, even if formal approval is achieved, Datamonitor believes that reimbursement would pose a significant challenge for Allergan. Furthermore, while the UK’s MHRA approval is a significant milestone, Allergan may yet face difficulties in selling the product unless or until the National Institute for Health and Clinical Excellence (NICE) considers whether Botox offers value for money in this patient population.”
Martin adds: “If it is approved then the high associated costs will also see reimbursement restricted.”
If approved in the US, Japan and remainder of the 5EU, Datamonitor expects Botox to achieve peak seven major market migraine-specific annual sales of $392m by 2019.