NICE rejects Merck’s COPD drug Daxas
pharmafile | December 9, 2011 | News story | Sales and Marketing | COPD, Daxas, Merck, Nycomed
NICE has not recommended Merck’s COPD drug Daxas and is asking for a new clinical trial to test its effectiveness.
In its final draft guidance NICE says it cannot recommend Merck’s Daxas (roflumilast) due to uncertainties over its cost effectiveness and efficacy.
The watchdog is now advising Merck to set up a clinical trial to establish how effective it is in adults with severe chronic obstructive pulmonary disease (COPD), associated with chronic bronchitis, as an add-on to bronchodilator treatment for people with a history of frequent exacerbations.
The trial should be designed to consider how well Daxas works – as well as testing its cost effectiveness – as an add-on to triple or dual therapy.
NICE added that there was ‘a real prospect’ that this research would inform future its future guidance on the drug, possibly tipping the balance for a recommendation.
The watchdog said that Daxas is most likely to be used in addition to triple therapy, but there was no direct clinical trial evidence related to Daxas used in this way.
Because of this, the Institute said it was not possible to know whether the drug is a cost-effective use of NHS resources.
“For that reason, NICE’s independent appraisal committee concluded that a clinical trial providing robust data about its clinical and cost effectiveness at this point in the treatment pathway would be beneficial for the NHS,” it said in a statement.
There are currently 1 million people with COPD in England and Wales, and it is estimated that almost 88,000 would be eligible for treatment with roflumilast by 2015.
NICE added that likely treatment duration would be many years, and therefore a long-term cost to the NHS.
Daxas is priced at £37.31 for a 30-tab pack and £113.14 for a 90-tab pack, according to the British National Formulary.
Treatments currently include inhaled bronchodilators, inhaled corticosteroids and inhaled combination therapy, but NICE does not recommend any targeted COPD drugs like Daxas.
The drug is the first in a new class of anti-inflammatory treatments for severe COPD, and is a once-daily pill, making it more patient-friendly.
It works as a selective long-acting inhibitor of the PDE-4 enzyme, and targets cells and mediators in the body believed to be important in COPD and other inflammatory diseases.
Ben Adams
Related Content
Dupixent approved as first biologic medicine in Japan for COPD patients
The Ministry of Health, Labour and Welfare in Japan has authorised marketing and manufacturing of …
Merck to acquire Curon Biopharmaceutical’s B-Cell Depletion Therapy
Merck have announced that they have entered into an agreement with private biotechnology company Curon …
Merck and Daiichi Sankyo expand development and commericalisation agreement to include MK-6070
Daiichi Sankyo and Merck (known as MSD outside of the US and Canada) have announced …
