Ian
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pm | | Re: NICE Guidance (23rd Jan 13 at 2:03pm UTC) | | The National Institute for Health and Clinical Excellence has suspended routine reviews of published clinical guidelines in 2013 and 2014.
Previously this routine review of the need to update a guideline was usually undertaken three years after its publication.
"At the moment the review process takes too long as it tends to overlap with a lot of the scoping process," says Professor Mark Baker, Director, Centre for Clinical Practice. "We want to redesign the review process so that it achieves what it is intended to do and no more."
"NICE will create a shortened and initially in-house process for the rapid updating of clinical guidelines which will be developed using staff within the Centre for Clinical Practice," continues Professor Baker. "The updates will take into consideration the latest drug information and pricing advice from the NICE Medicines and Prescribing Centre and will harmonise with the production of evidence updates.
"A criticism we have received in the past is that our guidance can become out of date as it is reviewed every three to four years. This can be the case in areas where there is a flood of new drugs on the market such as type two diabetes. In the future our guidance will be reviewed every two years with the expectation that an update of some extent will be more likely than not." | |
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Ian
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Ian
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pm | | Re: NICE Guidance (27th Jan 13 at 7:05pm UTC) | | http://www.pharmatimes.com/mobile/13-01-25/Forest_and_Novartis_gain_NICE_yes_for_lung_infections.aspx
Forest and Novartis gain NICE yes for lung infections - Ben Adams PharmaTimes
In final draft guidance NICE has recommended Forest Lab’s Colobreathe and Novartis’ Tobi Podhaler as options for treating certain lung infections in people with cystic fibrosis.
Following the consultation on the previous draft guidance and submission of a revised patient access scheme – which cuts the cost of the drug - Colobreathe is now recommended as an option for treating chronic pulmonary infection caused by Pseudomonas aeruginosa in people with cystic fibrosis, but only in certain circumstances.
These include being used for those patients who would clinically benefit from continued Colobreathe treatment, but do not tolerate it in its nebulised form and thus Novartis’ drug would otherwise be currently considered. It is also contingent upon Forest discounting the drug’s price, which before any deals costs £1,936 for 56 days of treatment.
The treatment was initially knocked back by NICE last year, but the price cut now means the Institute is minded to recommend the treatment.
Novartis’ Tobi Podhaler is also recommended as an option for treating chronic pulmonary infection caused by P. aeruginosa in people with cystic fibrosis, but again with provisos.
These include when nebulised Colobreathe is contraindicated, not tolerated or has not produced an adequate clinical response, and again if Novartis offers the drugs under the revised patient access scheme. The list price cost for 56 days of treatment is £1,790 for this therapy, before any price cuts.
Professor Carole Longson, health technology evaluation centre director at NICE, said: “The primary cause of death in people with cystic fibrosis is respiratory failure resulting from chronic pulmonary infection caused by Pseudomonas aeruginosa. We are therefore pleased to recommend both colistimethate sodium and tobramycin dry powders for inhalation as options for treating such infections in people with cystic fibrosis.”
Cystic fibrosis is one of the UK’s most common life-threatening inherited diseases, and currently affects around 8,000 people. Symptoms of cystic fibrosis can include a troublesome cough, repeated chest infections, prolonged diarrhoea and poor weight maintenance.
The aim of treatment in adults with cystic fibrosis is to clear the respiratory secretions in order to maintain lung function, as well as to reduce inflammation and bacterial growth in the respiratory tract. Treatment includes regular physiotherapy, antibiotics, and inhaled mucolyticsi through a nebuliser. The main goal is to improve or maintain lung function.
Tobi Podhaler is inhaled using a breath activated, hand-held device and works by decreasing the amount of bacteria (Pseudomonas aeruginosa) in the lungs.
Colobreathe is also inhaled with a breath activated, hand-held device. It works by disrupting the structure of bacterial cells, which kills the bacteria. | |
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Ian
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Ian
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Posts: 7,436
Status: Offline
Gender: Male
Joined:
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Ian
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Posts: 7,436
Status: Offline
Gender: Male
Joined:
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