NICE issues preliminary recommendations on earlier treatment with abiraterone for Ghd Hair Straightener Amazon
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The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high quality health and social care. We also Beats Studio Wireless
SMC published advice to NHS Scotland not recommending abiraterone for this indication as the manufacturer did not submit any evidence to be consideredAbiraterone is available through the cancer drugs fund.
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The Committee heard from clinical specialists that, when cytotoxic chemotherapy is indicated, most people would have docetaxel. But, when people have no or mild symptoms, and to defer chemotherapy and its adverse effects, clinicians may instead offer best supportive care including corticosteroids such as prednisolone or dexamethasone.
In draft guidance published today NICE has not recommended abiraterone for prostate cancer which has spread in people whose first treatment has failed, have no or mild symptoms and for whom chemotherapy is not yet clinically indicated1.
The clinical evidence submitted by the manufacturer came from one trial (COU AA 302). Although the results indicated that, when compared with placebo, abiraterone could extend time to progression, the Committee was concerned that as the trial was stopped early and that the results never reached the level needed to prove whether abiraterone improved survival.
issues with the way the manufacturer calculated estimated cost effectiveness. The health economic model was particularly complex and the committee felt that it was not transparent enough for the Evidence Review Group (ERG)2 to fully validate and critique. However, the manufacturer's current data showed that abiraterone cannot be considered value for money.
All the cost per QALYs (Quality Adjusted Life Year) estimated by both the manufacturer and the ERG fell substantially above the range normally considered cost effective that is, 20,000 to 30,000 per QALY gained. The manufacturer's base case cost per QALY was 46,700 gained and its sensitivity analysis resulted in ICERs from 45,000 to above 50,000 per QALY gained. The ERG presented an 'exploratory base case' of 57,300 per QALY gained. Additional sensitivity analyses resulted in ICERs of 57,200 to 74,800 per QALY gained.
Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the committee and following this meeting the next draft guidance will be issued.
Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).
Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said: "Although abiraterone is not a new drug, it is the first treatment to become available at this point in the treatment pathway. We know how Beats By Dre Rose Gold Headphones important it is for patients to have the option to delay chemotherapy and its associated side effects, so we are disappointed not to be able to recommend abiraterone for use in this way. However, the manufacturer's own economic model showed that the drug would not be cost effective at this stage because of this we cannot recommend the drug in this preliminary guidance. We hope that during this consultation, the manufacturer uses this opportunity to look again at its submission and provides the committee with additional information which may enable them to reconsider."
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The Committee considered that the mean life expectancy for people with metastatic hormone relapsed prostate cancer was unlikely to be less than 30 months; and abiraterone at this stage in the treatment pathway did not meet the first end of life criterion for short life expectancy. The Committee concluded that not all of the end of life criteria had been met and the end of life criteria did not apply to abiraterone taken before docetaxel in the treatment pathway.
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Negative National Institute for Clinical Excellence NICE Draft Guidance On Janssen Biotech Inc s Zytiga For Prostate Can
Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up to date evidence and provide value for money, in order to reduce inequalities and variation.
Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
The Evidence Review Group (ERG) assess the strength and quality of the research evidence submitted by manufacturers to NICE as part of the technology appraisals process. Embargoed copies of the draft guidance are available from the NICE press office on request.
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The Committee concluded that abiraterone compared with placebo increased the time to progression, but that whether it extended life was uncertain.
NICE already recommends abiraterone (also known as Zytiga and manufactured by Janssen) as a 'second line' treatment after a docetaxel containing chemotherapy regimen. This current appraisal looks at how well the drug works when people with the disease have few symptoms and chemotherapy would not yet be given.
For more information call the NICE press office on 0845 003 7782 or out of hours on 07775 583 813.
The cost of abiraterone is 2930 for 120 tablets (excluding VAT; British National Formulary [BNF] 67). Abiraterone is administered as a single dose of 1 g per day, taken as four 250 mg tablets. The manufacturer of abiraterone (Janssen) has agreed a patient access scheme with the Department of Health. This involves a single confidential discount applied to the list price of abiraterone across all indications.
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