Limited lifting of NICE ‘ban’ on Tamiflu
pharmafile | October 29, 2003 | News story | Sales and Marketing |Â Â Â
Roche have won a limited recommendation for its flu drug Tamiflu following a second NICE approval.
An appraisal of flu drugs at the end of 2002 gave a highly restricted recommendation of Roche's Tamiflu and GlaxoSmithKline's Relenza, and ruled that Alliance Pharmaceutical Lysovir should not be routinely used either for the treatment or prevention of the condition.
GlaxoSmithKline chose not to challenge the guidance, but Roche and Alliance won subsequent appeals on a number of points, resulting in a new version of the guidance relating to flu prevention alone.
Roche and Alliance both claimed the original guidance amounted to a ban on their products, but the updated recommendation still does not recommend Tamiflu as a preventative in healthy people, only recommending it for 'at risk' patients who have been exposed to people with flu-like symptoms.
The drug has not been recommended as a seasonal prophylactic, a decision which eliminates its chances of challenging flu vaccines as a choice of treatments.
Meanwhile, NICE has once again not recommended Lysovir for either post-exposure prophylaxis or seasonal prophylaxis of the disease, which could be a serious blow to its sales.
The Institute advises that Tamiflu (oseltamivir) should be used as post-exposure prophylaxis of influenza in at-risk people aged 13 years or older who are not effectively protected by vaccination and who have been exposed to someone with influenza-like illness (ILI) and are able to begin prophylaxis within 48 hours of exposure.
The drug is also recommended if vaccination is contraindicated, or has yet to take effect, or if the vaccine is not well matched to the circulating strain of flu.
NICE's appraisal committee stressed that vaccination remained the most cost-effective defence against flu, and that preventative should not eplace or discourageuptake of vaccinations.
Launched in 1999, NICE stirred up controversy in the pharmaceutical industry with its first ever appraisal, ruling that GSK's Relenza was not cost or clinically effective. An updated review of the data subsequently recommended use of the drug for at risk groups in a second appraisal, but maintained its advice not to prescribe to the wider population.
