UK:Hepatitis C patients in England denied lifesaving liver drug

Health experts concerned about decision not to extend Daklinza treatment to patients with genotype 3 strain of virus

Thousands of people in England with a chronic form of liver disease are being denied access to life-saving drugs that are available to patients in Wales, Scotland and Northern Ireland.

Despite being recommended by European regulators and available in countries such as France and Germany, draft guidance recently issued by the National Institute for Health and Care Excellence (Nice), the body that advises NHS England on whether to fund certain drugs, recommends restricting the use of Daklinza in England. The stance will affect the treatment of adult patients with a particular strain of hepatitis C.

The move has dismayed health experts and liver disease charities who say it will mean a large subset of the sickest and most at risk patients in England will not receive the treatment they need to prevent them from potentially fatal liver failure or cancer.

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UK: NHS accused of delaying access to 'highly tolerable' hepatitis C drugs over cost concerns

The NHS has been accused by leading health charities of attempting to “severely limit” the introduction of new drugs to treat hepatitis C because they are too expensive – despite the cost of them being cleared by officials.

The organisations have called on the Health Secretary to intervene, saying that NHS England has made a series of “unprecedented requests” for patients’ access to new drugs to be delayed because of the price.

Yet Nice has approved the drugs as “cost-effective”, leading to a plea from 14 organisations and senior doctors including the Hepatitis C Trust, the National Aids Trust and The Haemophilia Society to Jeremy Hunt.

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UK: NHS England sets up new £190m hep C fund

NHS England is stumping up £190m to pay for new hepatitis C treatments from AbbVie and Gilead that are yet to receive full funding from the country's health service.

 
The NHS's main commissioning body said that the existing budget for these drugs would be increased to £190m - up from the £40m budget that began last year.

This is the NHS's single largest investment in new treatments this year (except for the £280m Cancer Drugs Fund), but comes after a long delay for this extra funding stream.

The money will go to the roughly 3,500 hepatitis C patients in England and Wales with cirrhosis of the liver, and will gain access by the end of this year to AbbVie's Viekirax, a three-drug combination therapy for the disease, and Exviera (dasabuvir), as well as Gilead's hep C pills Sovaldi and Harvoni.

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UK: NHS England accused of interference over hepatitis C drug

Officials at NHS England have been accused of interfering in a process to decide whether a drug which can cure Hepatitis C should be made available to patients on the health service.

Harvoni, which is a combination of two new generation hepatitis C drugs, is currently being appraised by the National Institute for Health and Care Excellence.

But at a meeting at NICE on April 1, it is claimed that two senior NHS England officials reminded those attending that they had to take into account the cost to the health service when deciding whether to approve any treatment.

This is, in fact, not true. NICE does not focus on affordability but rather on cost-effectiveness.

- See more at: http://blogs.channel4.com/victoria-macdonald-on-health-and-social-care/nhs-england-accused-interfering-approval-hep-drug/3011#sthash.rkyi6yYa.dpuf

UK: NHS denies lifesaving drug to 5,000 patients it gave infected blood: Sofosbuvir has been approved by regulators but victims are STILL waiting for treatment

• Thousands of victims were infected by hepatitis C through imported blood 
• Breakthrough drug Sofosbuvir was approved by regulator NICE in January 
• But NHS England is delaying treatment for patients until at least August 

Thousands of patients who contracted a deadly disease through contaminated blood in the biggest scandal in NHS history are being denied a lifesaving drug.

About 7,500 victims are known to have been infected with hepatitis C in the 1970s and 1980s through imported blood products taken from high-risk donors such as prostitutes and prisoners.

A breakthrough drug called Sofosbuvir was approved in January by drugs regulator NICE and patients were told they would have to wait until April to get the ten-week course of tablets, which costs £45,000. 

But NHS England has decided on a further delay until August to ensure all patients have equal access to treatment.

Read more: http://www.dailymail.co.uk/health/article-3075151/NHS-denies-lifesaving-drug-5-000-patients-gave-infected-blood-Sofosbuvir-approved-regulators-victims-waiting-treatment.html#ixzz3ZhNPqkvn

U.K-Five Patients Test Positive for Hepatitis C in Mass Screening Following Hygiene Alert in Nottingham

Health bosses have confirmed that five patients have tested positively for hepatitis C in a mass screening programme set up after concerns were raised about the hygiene practises of a Nottinghamshire dentist.

Patients who had received treatment  at Daybrook Dental Practice from Mr Desmond D’Mello were contacted by the NHS to encourage them to go for blood tests after it was reported that the dentist did not clean his hands between patients and employ the relevant infection control procedures. Mr D’Mello had been working at the practice for many years and in total, more than 22,000 people were contacted.

In the largest ever NHS recall, 4,526 patients were tested and five were diagnosed with hepatitis C. There were no cases of HIV or hepatitis B.

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Nursing Times-NHS-NICE gives backing to hepatitis C drug in latest draft guidance

“The marketing authorisation for ledipasvir-sofosbuvir recommends treatment for hepatitis C genotypes 1, 3 – in combination with ribavirin – and 4”.

“Genotypes 1 and 3 hepatitis C account for the majority of chronic hepatitis C cases in England (46% and 43%, respectively). Genotype 4 hepatitis C accounts for around 4% of cases”.

“Ledipasvir-sofosbuvir, manufactured by Gilead, is administered orally as a single tablet – with or without ribavirin – and works by inhibiting the replication of the hepatitis C virus. It prevents hepatitis C virus replication by inhibiting the NS5A and NS5B proteins”.

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UK: Janssen will cover cost of unsuccessful hepatitis C treatment

NHS England will only have to pay for Olysio if patient clears virus 

The innovative 'pay if you clear' scheme marks a new way of dealing with the struggle for market access in the UK for pharma companies, with Janssen offsetting the cost of the drug if a patient remains infected after 12 weeks of treatment.

Olysio (simeprevir) is one of several new oral drugs that mark a major step forward in hepatitis C treatment, alongside Gilead Science's Sovaldi (sofosbuvir) and AbbVie's regimen combining Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir).

Both Olysio and Sovaldi were this week recommended for NHS reimbursement in draft guidance published by the National Institute for Health and Care Excellence (NICE).

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UK: Hepatitis C drug delayed by NHS due to high cost

The NHS is to delay the introduction of a highly expensive drug that can save the lives of people infected with the hepatitis C virus. The move by NHS England is unprecedented, because the NHS rationing body, Nice (the National Institute for Health and Care Excellence) has approved the drug. Nice says sofosbuvir is cost-effective, because it is a cure for people who would otherwise run up huge NHS bills.

One in three people infected with hepatitis C will develop liver cirrhosis and some will get cancer. A liver transplant costs more than £50,000.

But NHS England appears to be balking at the bill for the drug, which would hit £1bn for every 20,000 people treated. Approximately 160,000 people in England alone are infected with hepatitis C, although fewer than half are aware of it.

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UK: Diana Johnson MP: Final settlement of the contaminated blood scandal

Diana Johnson MP is Co-Chair of the All-Party Parliamentary Group on Haemophilia & Contaminated Blood. Today it publishes a report into the current support for individuals affected by the contaminated blood scandal.

From the 1970s through to the early-1990s, thousands of people underwent treatment with NHS-supplied blood products. Many of these products are now known to have been contaminated with HIV and/or Hepatitis C. Although this scandal only affected a small proportion of the population, it infected almost the entire community of people with haemophilia; and for everyone who was affected by these conditions, their lives were changed forever.

The tragic psychological and financial damage caused by these conditions is considerable, and stretches across generations. Primary earners’ careers were ruined by infection. Many affected found themselves completely unable to work, others were forced to cut down their hours and never enjoyed the career progression they would have had if the viruses never affected them. The scandal also spilled over to the carers, partners and dependants of those affected, who often had to sacrifice their own careers to support their loved ones. Should their partners die before they do, they find themselves unable to support themselves, having lost the skills necessary to get by in today’s labour market.

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