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NICE has recommended Gileads Epclusa as a treatment option for all genotypes of hepatitis C in first draft guidance. Trial data has shown recently-approved Epclusa (sofosbuvir+velpatasvir) gives cure rates of 89% of above, and can be used without interferon, and in most cases without ribavirin reducing side effects. NICEs independent appraisal committee recognised the need for treatment without side effects for patients with genotype 3, who account for around 44% of the population with chronic disease. At the moment, patients with this genotype must rely on a drug combination involving interferon, with unpleasant side-effects for treatment. Epclusa costs nearly £39,000 for a 12-week course and £40,000 when taken in combination with ribavirin. NICE recommended Epclusa in all but one of its indicated uses saying it was not cost effective in people with untreated genotype 2 chronic hepatitis C who do not have cirrhosis and who can have interferon treatment. Gilead has agreed a confidential discount to the National Health Service. Professor Carole Longson, director of the NICE centre for health technology evaluation, said: The drug provides considerable health benefits to patients with hepatitis C, in particular, those with genotype 3 who can become very ill, very quickly. Our positive recommendation of sofosbuvir-velpatasvir means that more tolerable treatment options will become available to all patients with hepatitis C. NICE has previously recommended several other hepatitis C drugs, including Gileads Sovaldi (sofosbuvir), in combination with peginterferon alfa and/or ribavirin to treat all genotypes. However, it remains to be seen how many patients will benefit from Epclusa, as NHS England has kept a tight limit on the number of patients receiving the hepatitis C drugs, despite the positive recommendations from NICE. There are around 160,000 hepatitis C patients in England, but the NHS has decided to treat only 10,000 patients per year with the latest drugs, because of their high cost. The charity Addaction has called on the NHS to review the decision, saying rationing hepatitis C drugs is a potential death sentence for thousands. Just ahead of Epclusa in the NICE review process is a new rival - Merck, Sharp and Dohmes Zepatier (elbasvir+grazoprevir), which could help drive down prices further. Zepatiers list price is £36,500 per patient for a 12-week course, around the same price as its rivals but MSD is likely to be undercutting Gilead and AbbVie's hep C products on price, as it is in the US. NHS England has been using a competitive tendering system to help drive down prices in England, and this is likely to continue with the arrival of the new treatments. NICE will consult further on both drugs, publishing a second draft in the coming months, followed by final and binding guidance.
Original Article: Gilead's Epclusa cost-effective in hep C - NICENEXT ARTICLE
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...
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