Janssen's Olysio 'pay if you clear' deal.....NHS in Scotland is to be reimbursed for the cost of a new hepatitis drug if sufferers fail to clear the virus
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......The novel approach was revealed after the drug Olysio was cleared for use by the Scottish Medicines Consortium (SMC)......The 'Pay If You Clear' scheme will come into impact if patients treated with the drug do not become free of the hepatitis C virus (HCV) after 12 weeks......SMC has ratified the drug, whose generic name is simeprevir, for use within NHS Scotland......It will treat patients with chronic HCV infection, including those for whom treatment has earlier failed......The manufacturer, Janssen, will pay for pre-treatment blood tests for patients to predict whether the drug is likely to be efficient before treatment is began
Unique 'pay if you clear' proposal for new hepatitis drug
More than 37,000 people in Scotland have chronic hepatitis C - but only half have been diagnosed
The NHS in Scotland could be reimbursed for the cost of a new hepatitis drug if sufferers fail to clear the virus.
The novel proposal was revealed after the drug Olysio was cleared for use by the Scottish Medicines Consortium (SMC).
The drug's manufacturer claims the move would help cut prescribing costs.
It is estimated Scotland wastes up to 44m each year on medicines for all conditions that are unused, ineffective or are taken incorrectly.
The 'Pay If You Clear' scheme would come into effect if patients treated with the drug do not become free of the hepatitis C virus (HCV) after 12 weeks.
SMC has approved the drug, whose generic name is simeprevir, for use within NHS Scotland. The 'Pay If You Clear' scheme is awaiting a formal decision by NHS Scotland.
The drug will be used to treat patients with chronic HCV infection, including those for whom treatment has previously failed.
The manufacturer, Janssen, will pay for pre-treatment blood tests for patients to predict whether the drug is likely to be effective before treatment is initiated.
"We must not forget the importance of prevention, earlier diagnosis and better testing strategies"
Charles Gore Hepatitis C Trust
Any patient who does not respond to treatment within four weeks will be offered alternative therapies.
Dr John Dillon, consultant hepatologist and gastroenterologist at Ninewells Hospital in Dundee, welcomed the decision by SMC.
"This decision provides us with another treatment option which is convenient for patients and more affordable to NHS Scotland than some other treatments," he said.
"To be able to predict a person's response to treatment, prior to them embarking on the medicine, is a particularly useful factor in managing hepatitis C care.
"It means we can select the most appropriate treatment option in a cost-efficient manner."
Charles Gore, chief executive of The Hepatitis C Trust, said: "Decisions such as this from the SMC provide us with a key milestone for our campaign to eliminate hepatitis C.
"However, we must not forget the importance of prevention, earlier diagnosis and better testing strategies."
Charities claim there are more than 37,000 Scots with chronic HCV, only 55% of whom have been diagnosed, because often it has no symptoms.
Of those who develop hepatitis C an estimated 30% will develop cirrhosis of the liver or cancer.
Hepatitis C is the most common reason for liver transplants in Europe.
Briefing note: sofosbuvir (+Rbv) (Sovaldi).......Accepted; Date Advice Published:
daclatasvir (Daklinza).....Advice Due: 10/11/2014.....Indication: In combination with other agents for the treatment of chronic hepatitis C virus (HCV) infection in adult patients with compensated liver disease (including cirrhosis)
Date Advice Published: 13 October 2014
The Scottish Medicines Consortium (SMC) has completed its assessment of the above product (Simeprevir, Olysio) and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHS Scotland
"In patients with HCV genotype 1 or 4, regardless of prior treatment history who are intolerant to or ineligible for interferon therapy, and are in urgent need of treatment, simeprevir may be administered with sofosbuvir (± ribavirin) for 12 weeks.......SVR12 has been accepted by European and US regulators as an appropriate primary endpoint in clinical studies of treatments for CHC.22"
This advice represents the view of the Scottish Medicines Consortium and was arrived at after careful consideration and evaluation of the available evidence. It is provided to inform the considerations of Area Drug & Therapeutics Committees and NHS Boards in Scotland in determining medicines for local use or local formulary inclusion
following a full submission
simeprevir (Olysio®) is accepted for use within NHS Scotland.
Indication under review: in combination with other medicinal products for the treatment of chronic hepatitis C in adult patients.
In four double-blind phase III studies, when given as part of triple regimen in combination with peginterferon-alfa and ribavirin, simeprevir was superior to placebo in treatment naive and prior relapsed patients and non-inferior to another direct acting antiviral drug in treatment experienced patients with genotype 1 hepatitis C virus.