NICE to review Lucentis decision
pharmafile | August 17, 2011 | News story | Sales and Marketing | Lucentis, NICE, diabetic macular edema
NICE will allow an appeal against its decision not to recommend Novartis’s Lucentis for diabetic macular oedema.
The appeal came primarily from the Swiss manufacturer of Lucentis (ranibizumab), but also from the Royal College of Nursing, the RNIB charity, the Macular Disease Society, Juvenile Diabetes Research Foundation, Diabetes UK, and the Royal College of Ophthalmologists.
In an emailed statement Novartis UK told Pharmafocus it welcomed the opportunity to “voice [its] concerns regarding the process used and some of the conclusions reached” in NICE’s final draft guidance for Lucentis.
Earlier this year NICE said it could not recommended Lucentis for diabetic oedema (DMO) after ‘faulty analysis’ from Novartis was found not to prove the drug’s cost-effectiveness.
NICE’s chief executive Andrew Dillon said at the time that Novartis ‘substantially overestimated’ the life expectancy of people with diabetes, and underestimated the amount of Lucentis that people with DMO would have to take.
The appeal panel will convene on 4 October to hear from the appellants – members of the public, including consultees and commentators for this appraisal, can also request to attend the hearing.
NICE already recommends that patients with diabetic macular oedema receive laser photocoagulation, but Novartis maintains its drug is better than this treatment method.
The company said: “Individuals with visual impairment due to DMO could greatly benefit from [Lucentis], a treatment which can potentially restore vision rapidly, often within a week of receiving the first dose, prevent vision loss and sustain visual improvement.”
The company added that in recent trials Lucentis has been shown to double the likelihood of gaining vision, and reduce the chance of losing vision by up to three-fold compared to laser.
Novartis has submitted a patient access scheme to NICE and the Department of Health for its drug and added that it was continuing negotiations with both bodies to achieve a ‘mutually agreeable solution’.
Ben Adams
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