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NICE /EU Issues Guidance Recommending Zepatier
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Download the PDF here
NICE: Europe -
Elbasvir-grazoprevir for treating chronic hepatitis C [ID842]
New draft guidance published today from NICE recommends elbasvir-grazoprevir - one of the newer hepatitis C antiviral drugs that can offer patients more effective treatment.
The Appraisal Committee has prepared a Final Appraisal Determination (FAD) on elbasvir-grazoprevir for treating chronic hepatitis C and submitted it to the Institute.
The FAD has been sent to consultees for this appraisal who have 15 working days to consider whether they wish to appeal against it and/or notify us of any factual errors. The FAD has been sent to commentators for information, who can consider notifying us of any factual errors only. Subject to any appeal by consultees, the FAD may be used as the basis for the Institute's guidance on the use of the appraised technology in the NHS in England.
Please note that the appeal period for this appraisal will close at 5pm on Friday 23 September 2016.
https://www.nice.org.uk/guidance/GID-TA10032/documents/html-content
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More options to be made available to treat hepatitis C
Another 'potential curative' drug for people with chronic hepatitis C will be made available on the NHS.
New draft guidance published today from NICE recommends elbasvir-grazoprevir - one of the newer hepatitis C antiviral drugs that can offer patients more effective treatment.
In clinical trials, elbasvir-grazoprevir showed cure rates above 90% for people with genotypes 1 and 4. The cure rate is dependent on the genotype, treatment history and presence of liver damage.
Professor Carole Longson, director of the NICE centre for health technology evaluation, said: "Treating chronic hepatitis C had previously been a major challenge with patients having to experience long and unpleasant courses of treatment.
"Elbasvir-grazoprevir, like other newer direct acting anti-viral treatments, is a drug that provides considerable health benefits to patients without some of the adverse side effects associated with earlier anti-viral treatments, such as peginterferon alpha with ribavirin."
A 12-week course of treatment with elbasvir-grazoprevir usually costs 36,500 per patient, but the NHS will pay less than this as the company has offered a confidential discount.
Taken once daily, the tablet could treat around 4,000 patients in the first year, alongside other options already available for hepatitis C.
Prof Longson continued: "Our positive recommendation for elbasvir-grazoprevir means that more treatment options will become available to patients with hepatitis C. And as these types of anti-viral drugs are more effective, the spread of the virus can be reduced."
Hepatitis C is a virus spread through blood which causes infection of the liver, and often leads to liver disease. The virus is spread through the blood, often from contaminated syringes and needles but also through the sharing of razors or toothbrushes, unprotected sex and from an infected mother to her child during pregnancy.
The draft guidance recommends that decisions to treat patients with elbasvir-grazoprevir are made by the multidisciplinary teams in the operational delivery networks put in place by NHS England, and to prioritise treatment for people with the highest unmet clinical need.
Final guidance is expected to publish in October, when the NHS will have a three month period to make the drug available to patients.
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NICE green light for Merck's hepatitis C drug Zepatier
9th September 2016
http://www.pharmatimes.com/news/nice_green_light_for_mercks_hepatitis_c_drug_zepatier_1126547
Cost regulators for the NHS in England and Wales are backing use of Merck, Sharp & Dohme's hepatitis C therapy Zepatier, potentially giving patients with certain types of the condition 'routine' access to another treatment option.
The National Institute for Health and Care Excellence has published draft guidelines endorsing Zepatier (elbasvir-grazoprevir) as an option to treat chronic hepatitis in adults with genotypes 1a, 1b or 4.
The appraisal committee concluded that all incremental cost effective ratios for the therapy were below 20,000 per QALY gained, regardless of genotype, treatment history or cirrhosis status, and could therefore be considered a cost-effective use of NHS resources.
Zepatier is a once-daily, fixed-dose combination tablet containing elbasvir (50mg) and protease inhibitor grazoprevir (100mg), administered for 12 weeks.
The drug belongs to the next-generation of hepatitis therapies called direct antivirals, which block the action of proteins essential for viral replication, in Zepatier's case NS3/4A and NS5A.
European approval, in August, was based on clinical trial data showing that sustained virologic response (SVR) 12 weeks after the completion of therapy was achieved in 96 percent (301/312) of chronic HCV GT1b-infected patients given MSD's therapy.
In chronic HCV GT1a-infected patients, 93 percent (483/519) and 95 percent (55/58) achieved cure following treatment with Zepatier for 12 weeks or Zepatier plus RBV for 16 weeks, respectively. Also, 94 percent (61/65) and 100 percent (8/8) of chronic HCV GT4-infected patients achieved cure in the treatment groups.
Chronic HCV infection, caused by a blood-borne virus, is a major public health concern affecting more than 170 million people globally, 15 million of whom are living in Europe. Of the six genotypes of chronic HCV infection, GT1 is the most common in Europe accounting for around 66 percent of cases.
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http://www.thepharmaletter.com/article/nice-says-yes-to-new-hepatitis-c-drug-from-merck-co
n draft guidance issued today, the National Institute for Health and Care Excellence (NICE) is recommending Zepatier (elbasvir-grazoprevir) as an option to treat certain types of hepatitis C.
Elbasvir-grazoprevir, developed by US pharma giant Merck & Co (NYSE: MRK) which trades in the UK as Merck Sharp & Dohme (MSD), is used to treat chronic hepatitis C in adults with genotypes 1a, 1b or 4. It works by blocking two proteins that cause the virus to multiply and infect new cells,noted the medicines cost-effectiveness watchdog for England and Wales.
In trials, elbasvir-grazoprevir had cure rates above 90% for people with hepatitis C genotypes 1 and 4. The cure rate of the drug depends on the genotype, treatment history and presence of liver damage. As elbasvir-grazoprevir was just as effective as similar treatments that are already available, the NICE appraisal committee concluded that it should be routinely available on the National Health Service.
"Treating chronic hepatitis C had previously been a major challenge with patients having to experience long and unpleasant courses of treatment," said Carole Longson, director of the NICE Centre for Health Technology Evaluation.
"Elbasvir-grazoprevir, like other newer direct acting anti-viral treatments, is a drug that provides considerable health benefits to patients without some of the adverse side effects associated with earlier anti-viral treatments, such as peginterferon alpha with ribavirin." Our positive recommendation for elbasvir-grazoprevir means that more treatment options will become available to patients with hepatitis C. And as these types of anti-viral drugs are more effective, the spread of the virus can be reduced," Prof Longson added.
Elbasvir-grazoprevir costs 36,500 ($49,021) per patient for a 12-week course of treatment. Around 4,000 patients will be eligible for elbasvir-grazoprevir alongside other options already available on the NHS.
Elbasvir-grazoprevir costs 12,166.67 per 28-day pack. The company has agreed a nationally available price reduction for elbasvir-grazoprevir with the Commercial Medicines Unit. The contract prices agreed through the framework are commercial in confidence.
The Scottish Medicines Consortium is due to look at elbasvir-grazoprevir in a forthcoming submission.
The guidance recommends that decision to treat and prescribing decisions for elbasvir-grazoprevir are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritize treatment for people with the highest unmet clinical need.
The draft guidance is now with consultees, who have the opportunity to appeal against it.
In draft guidance issued today, the National Institute for Health and Care Excellence (NICE) is recommending Zepatier (elbasvir-grazoprevir) as an option to treat certain types of hepatitis C.
Elbasvir-grazoprevir, developed by US pharma giant Merck & Co (NYSE: MRK) which trades in the UK as Merck Sharp & Dohme (MSD), is used to treat chronic hepatitis C in adults with genotypes 1a, 1b or 4. It works by blocking two proteins that cause the virus to multiply and infect new cells,noted the medicines cost-effectiveness watchdog for England and Wales.
In trials, elbasvir-grazoprevir had cure rates above 90% for people with hepatitis C genotypes 1 and 4. The cure rate of the drug depends on the genotype, treatment history and presence of liver damage. As elbasvir-grazoprevir was just as effective as similar treatments that are already available, the NICE appraisal committee concluded that it should be routinely available on the National Health Service.
"Treating chronic hepatitis C had previously been a major challenge with patients having to experience long and unpleasant courses of treatment," said Carole Longson, director of the NICE Centre for Health Technology Evaluation.
"Elbasvir-grazoprevir, like other newer direct acting anti-viral treatments, is a drug that provides considerable health benefits to patients without some of the adverse side effects associated with earlier anti-viral treatments, such as peginterferon alpha with ribavirin." Our positive recommendation for elbasvir-grazoprevir means that more treatment options will become available to patients with hepatitis C. And as these types of anti-viral drugs are more effective, the spread of the virus can be reduced," Prof Longson added.
Elbasvir-grazoprevir costs 36,500 ($49,021) per patient for a 12-week course of treatment. Around 4,000 patients will be eligible for elbasvir-grazoprevir alongside other options already available on the NHS.
Elbasvir-grazoprevir costs 12,166.67 per 28-day pack. The company has agreed a nationally available price reduction for elbasvir-grazoprevir with the Commercial Medicines Unit. The contract prices agreed through the framework are commercial in confidence.
The Scottish Medicines Consortium is due to look at elbasvir-grazoprevir in a forthcoming submission.
The guidance recommends that decision to treat and prescribing decisions for elbasvir-grazoprevir are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritize treatment for people with the highest unmet clinical need.
The draft guidance is now with consultees, who have the opportunity to appeal against it.
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