NICE changes its mind on Botox
pharmafile | May 11, 2012 | News story | Sales and Marketing | Allergan, Botox, NHS, NICE
NICE is now recommending Allergan’s Botox for chronic migraines, reversing its previous decision.
The watchdog said in final draft guidance that Botox is recommended as an option to prevent headaches in some adults who experience chronic migraine.
The recommendation relates specifically to patients whose condition has not responded to taking at least three prior preventative medications.
It can also be used on those whose condition has been appropriately managed for medication overuse.
This goes against its previous round of draft guidance, where NICE said it was not minded to recommend the drug because of a lack of information about its effectiveness.
Since then however Allergan submitted new analyses to NICE, which swayed the watchdog to recommend the drug.
NICE also says that Botox injections should be stopped if the person’s headaches have not improved enough after two treatment cycles, or if the person’s ‘headache days’ have reduced to fewer than 15 days a month over three consecutive months.
It says this is because if a person’s headache days have reduced to fewer than 15 a month, they will have a different type of migraine (called episodic migraine), which is not covered in Allergan’s licence for Botox.
The drug’s total cost for treatment and administration for a 12-week cycle is expected to be just under £350 per patient.
Professor Carole Longson, director of the health technology evaluation centre at NICE, said: “Chronic migraines are extremely debilitating and can significantly affect a person’s quality of life.
“We are pleased that the committee has been able to recommend Botox as a preventative therapy for those adults whose headaches have not improved despite trying at least three other medications, and whose headaches are not caused by medication overuse.”
A final decision by NICE on the drug is expected by June.
This recommendation goes against the decision made by the Scottish Medicines Consortium last year, which said it wouldn’t recommend Botox for use on the NHS in Scotland due to “weaknesses in the clinical data that limit the ability to assess its likely clinical effectiveness in the target treatment population”.
New licences
The drug is best known for its use as an anti-wrinkle treatment, but in recent years Allergan has gained new licences for the treatment to broaden its use.
This includes approval from the Medicines and Healthcare Products Regulatory in 2010 for use as a headache prophylaxis, and last year’s FDA approval for use in patients with urinary incontinence.
Ben Adams
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