Scotland.....Hepatitis C drug is approved....
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June 10 http://www.thecourier.co.uk/news/scotland/hepatitis-c-drug-is-approved-1.413564
A drug treatment for chronic hepatitis C is to be made available to NHS patients in Scotland.
The Scottish Medicines Consortium (SMC) has approved sofosbuvir for restricted use within the NHS.
The SMC said its use addresses an unmet treatment need, while campaigners welcomed the move as a "step in the right direction."
Hepatitis C is a blood-borne virus thought to affect more than 200,000 people in the UK. It can cause cirrhosis and liver cancer but more than half of those living with the condition are believed to be undiagnosed.
There is no vaccine but treatment can clear the virus in most patients.
Sofosbuvir is the first medicine in a new class and stops the virus from multiplying, according to The Hepatitis C Trust.
It must be given in combination with other medication and is taken in tablet form once a day.
In the absence of other treatment options, the relatively high cost of the drug was deemed acceptable by the SMC, given the expected benefits of the treatment, the charity said.
Petra Wright, Scottish officer for The Hepatitis C Trust said: "The Trust welcomes the SMC's advice that sofosbuvir should be made available to NHS patients in Scotland, in what we hope to be the first of many emerging therapies for Hepatitis C.
"The advent of these 'patient friendly' medications will reduce treatment duration and the severity of side effects experienced by those affected.
"This is a step in the right direction which we hope will hasten the elimination of Hepatitis C from Scotland."
Stelios Karagiannoglou, UK general manager of drug manufacturer Gilead Sciences Ltd, said: "We are pleased that the SMC have recognised the significant efficacy and safety profile demonstrated by sofosbuvir in clinical studies and therefore agree it is a valuable use of NHS resources given the high unmet need in hepatitis C."
Hepatitis C drug Sofosbuvir approved for use on NHS - Sofosbuvir Scottish Medicines Consortium Advice/Assessment
People with the most common form of the virus will be prescribed the new drug on the NHS
Experts have approved the use of a new drug to treat hepatitis C on the NHS.
Sofosbuvir cures the majority of patients, but costs 36,000 per course. It is to be made available to people with the most common form of the virus.
It is estimated 50,000 people in Scotland have hepatitis C.
The Scottish Medicines Consortium (SMC) decided the high cost of offering the drug to such a large group of patients was outweighed by its effectiveness.
People with less common forms of the virus will be offered the new drug if conventional treatment fails.
Hepatitis C is contracted through contaminated needles, blood or sexual intercourse, and causes liver failure or liver cancer.
Current treatment involves regular injections for up to a year with a drug which has unpleasant side effects and works for only 60-70% of patients.
Sofosbuvir is one of a new generation of treatments which are much more effective but come with a high price tag.
A course of the drug takes just 12 weeks.
A statement by the SMC said: "The consortium accepted sofosbuvir for restricted use because it is effective and addresses an unmet treatment need."
Sofosbuvir Scottish Medicines Consortium Advice/Assessment
09 May 2014
The remit of the Scottish Medicines Consortium (SMC) is to provide advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the clinical and cost-effectiveness of all newly licensed medicines, all new formulations of existing medicines and new indications for established products (licensed from January 2002).
The SMC is a consortium of NHSScotland's 14 Health Boards. It was established in 2001 to benefit patients by providing NHSScotland with a single source of advice about the value of each new medicine and the patients for whom it would be of most benefit.
Its advice also helps to facilitate the early introduction of beneficial treatments across Scotland.
The Scottish Medicines Consortium (SMC) [http://www.scottishmedicines.org.uk/Home] has completed its assessment of the above product Sofosbuvir [http://www.scottishmedicines.org.uk/SMC_Advice/Advice/964_14_sofosbuvir_Sovaldi/sofosbuvir_Sovaldi] and advises NHS Boards and Area Drugs and Therapeutic Committees (ADTCs) on its use in Scotland. The advice is summarised as follows:
ADVICE: following a full submission
sofosbuvir (Sovaldi®) is accepted for restricted use within NHS Scotland.
Indication under review: in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
SMC restriction: Sofosbuvir is accepted for use in patients with genotypes 1 to 6. Use in treatment-naive patients with genotype 2 is restricted to those who are ineligible for, or are unable to tolerate, peginterferon alfa. Use of the 24-week interferon-free regimen of sofosbuvir in combination with ribavirin in patients with genotype 3 is restricted to those who are ineligible for, or are unable to tolerate, peginterferon alfa.
Sofosbuvir in combination with ribavirin, or peginterferon plus ribavirin, produced sustained virological suppression in patients with all genotypes of hepatitis C. It is the first medicine licensed for use in interferon-free regimens and may be associated with improved tolerability compared to standard interferon-based regimens.
No clinical or economic data were presented for treatment-experienced patients with genotype 1.
"There are no clinical data for sofosbuvir in treatment-experienced patients with genotypes 1, 4, 5 or 6. Both the European and US regulatory authorities note a similar point in relation to efficacy in this group. That is, about 50% of patients in a treatment-naïve population will become non-responders to peginterferon plus ribavirin, i.e. treatment-experienced. As peginterferon plus ribavirin is an immune therapy that does not select for viral resistance, these patients will have unchanged susceptibility to antivirals and can be considered to be functionally represented in the treatment-naïve population. Thus the high SVR12 rate in the NEUTRINO study in treatment-naïve patients supports effectiveness of the sofosbuvir regimen in treatment-experienced patients.2,5"