21 May 2015

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.

It is also claimed that the officials suggested that if NICE reached the wrong decision in appraising the drug, they would seek judicial review. Charles Gore, chief executive of the Hepatitis C Trust, told Channel 4 News: “I definitely felt they were suggesting that if NICE did not conform to what they would like to see happen, then they would potentially take judicial action.

“I definitely got the impression there was a threat there and that NICE should conform or face potential serious actions.”

In a statement, NICE told us: “Like other stakeholders, they (NHS England) have given us their views on how the evidence for using the drugs should be interpreted. NHS England are not acting in any way which would compromise the independence of our work.”

NHS England failed to answer our specific questions but in a statement they said: “NHS England is very supportive of expanded new treatment options for people with Hepatitis C, and has already begun funding their care. We also want to ensure that unresolved questions about the best treatment strategies are answered, and that phased investment in Hepatitis C services does not cause damaging cuts elsewhere.”

As many as 214,000 people in the UK are believed to be infected with hepatitis C. It can lead to cirrhosis of the liver and cancer. Some patients need to have transplants. And in the worst cases, sufferers die. Until recently the treatment lasted up to 48 weeks and had serious side-effects.

The new generation of drugs have been hailed as a breakthrough. There are far fewer side effects and a 92-98 per cent cure rate in some cases.

In January, NICE approved Gilead’s drug, Sofosbuvir.

Despite its cost – £35,000 for a 12-week course – they decided that it was of value because of its high cure rate, fewer side-effects and potential to prevent the need for costly liver transplants.

But there was outrage after they agreed to a request by NHS England for an unprecedented six month delay in implementation.

There is further concern that an early access scheme, so patients with cirrhosis did not have to wait the six months, has not yet started.

An employee checks a hepatitis B vaccine, at SciVac's laboratory in Rehovot

Harvoni – the drug currently being appraised – is a combination of Sofosbuvir and Ledipasvir.

Gilead is charging the same amount as they do for Sofosbuvir alone. Yet, we have been told that at the April 1 meeting the NHS England officials claimed it would cost £1.3bn if approval was given.

Mark Thursz, professor of hepatology at Imperial College London, said this was “a gross exaggeration”: “The likely cost is £300m to £400m because lots of patients who have cirrhosis have still not been diagnosed.”

He also said even if they were told they could treat 6,000 patients with cirrhosis it would take two years.

NHS England asked for a meeting this month to be delayed while they reassessed their figures. In the meantime, doctors are finding themselves unable to treat their patients.

Dave Gort, is a 37-year-old man with haemophilia. He was infected with Hepatitis C through contaminated blood 22 years ago. Last year he was told he now had cirrhosis of the liver but his consultant said that if he waited he would be given the new drugs.”We went to see him in January,” Mr Gort said. ” He told us it wasn’t yet available but it would be in April.

“We went back in April and he said he was sorry, it still hadn’t happened. So I decided to use my own money and pay for the treatment.”

In fact, the money Mr Gort used was from the ex-gratia Skipton Fund, set up for people who were infected by the tainted blood.

When his cirrhosis was diagnosed he received £50,000. He has now spent £45,000 on Harvoni (it is more expensive on a private prescription).

This is for a 12 week course, and he told us that within two days he began to feel better. And when we spoke to him earlier this week, his blood results showed what seemed to be an improvement.

However, if it does not clear the virus, Mr Gort faces paying for another course.

His final bill could be as much as £100,000.

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16 reader comments

  1. Jim says:

    I’m 25 and have Hep C with cirrhosis which is hanging by a thread into becoming final-stage and deadly. I’m literally months away from my liver going into a decompensated (failed) state. I needed Harvoni 5 months ago, because another 3 months would be too late.

    I’m highly educated, work in a STEM field, pay a lot of taxes. Non smoker, never had any alcohol in my life, good diet. I’ve done everything by the book and have led a good life. I would be the perfect patient for this drug, but because of what NHS is doing, I’m just one of the other thousands who will instead need a £100,000 live transplant and years of expensive medication afterwards – AND Harvoni afterwards probably.

    If I had started Harvoni in January, I would be cured and healthy by now. All for £35,000 and much faster, and more importantly, no transplants that have an expiration date.

    Thank you NHS, for your care… you murderers.

  2. Philip Edwards says:


    Here’s a thought:

    Make the drugs ourselves and sell them to the NHS at cost and without profit. Stuff the ripoff transnational pharma gangs and their paid-for legislation and hired politicians.

    That’d make a few economic hoodlum eyes water…………..

  3. H Statton says:

    The cost of Hepatitis C Virus (HCV) treatment has to be cheaper in developing countries else, to state the obvious, no-one would receive help. Indeed, it is not unreasonable to suggest that developing countries have a higher level of people infected with HCV due to e.g. HIV infection, so it has to be less expensive.


    However, living in the West, it appears that as with a lot of treatments, pharmaceutical companies seem able to charge a premium.

    As for the delay in providing drugs to treat HCV, I simply cannot fully appreciate it. Dave Gort paying £45,000 for a private prescription seems absolutely outrageous particularly as he became infected through no fault of his own. I sincerely hope for him that the drug Harvoni works and he recovers.

    But how many Dave Gorts are out there? And how many people even know that they have HCV? He has, dare I use the word fortunate, been able to pay for the drug, albeit privately. But there will be a huge number of people that can’t afford it. Any delay in treatment for some will prove fatal.

    A snapshot of some of the current opinions concerning treatment of HCV:

    Changing the face of hepatitis C management – the design and development of sofosbuvir.

    “The challenges in managing patients with CHC are in many ways different today in the era of highly effective DAA therapy. With the arrival of sofosbuvir ($1,000 per pill) and now Harvoni® ($1,125 per pill), concerns about cost have arisen.

    In developing countries, where access and affordability are paramount, generic pharmaceutical companies, through licensing agreements with Gilead Sciences Inc., expect to be able to provide the drug at a fraction of the US cost.

    While the cost of sofosbuvir or Harvoni® treatment today remains an issue, many provid¬ers feel that the real question is actually the relative cost of treating against the price paid by not treating – namely more patients at risk for complications from cirrhosis.”

    CROI 2015: Highlights of Viral Hepatitis Therapy

    “The high cost of HCV DAAs remains a central theme in discussions of new therapies and limits widespread use in those with HCV infection. Despite this high cost, new DAA regimens for HCV genotype 1 have generally been shown to be cost-effective when judged by the
    standard metric of an incremental cost-effectiveness ratio of approximately US $50,000 per quality-adjusted life-year.

    HCV/HIV coinfection has been asso-ciated with more-rapid progression of liver fibrosis and an elevated risk of complications such as renal insufficiency.

    It seems obvious that intervention in a disease process at an earlier time point would produce benefits relative to waiting for an advanced disease state to develop, whether it be cardiovascular disease, HIV infection, or malignancies.”

  4. Oliver S says:

    Victoria, all power to continue reporting this kind of thing but PLEASE include the Scottish and Welsh positions on the same topics to see how our so called NATIONAL Health Service is performing across the board.
    Further, I would like to see much more debate with politicians when faced with this kind of specific example as to how the NHS can possibly be funded going forward. The funding model is broken for new “super” drugs. People who are dying and can be saved need help. Unfortunately NICE have to play God simply because there is a limited budget and they have to put values on life. Its a thankless task because there in no good publicity in saving a few £.
    On your programme, the liver consultant said that this Hep C drug would cost “only” £350million for those that need it. That’s the salary of about 3,000- 4,000 GP’s who are also desperately needed and may indirectly save even more lives.
    My solution would be to hypothecate National Insurance Contributions which would also be to fund Home Carers and I would levy NI – at suitable income levels- on pensioners. I would also squeeze the Welsh and Scots to stop handing out free drugs and probably massively reduce the concessions for free drugs in England. People do not appreciate things that cost nothing and it is important that genuinely needy people get them when it really matters – such as Dave Gort

  5. Bill Wright says:

    Dear Victoria,
    Harvoni (sofosbuvir/lediposvir) was approved by the Scottish Medicines Consortium earlier this year for genotypes 1 & 4 but this development is extremely worrying as NICE is UK wide. It begs the question as to who from NHS England was involved and why. See this link http://haemophilia.scot/tag/interferon-free/ about the contrasting Scottish Health Ministers position.

    It follows on from the Prime Ministers failure to even acknowledge my letter of response to his statement on the day of publication of the Penrose Report. The UK DoH have recently clarified no steps have been taken to decide upon how the paltry sum of £25 million mentioned that day is to be allocated.

    Sadly yet again for those of us who received infected blood the political rhetoric on either treatment or financial support is not matched by action.

    Bill Wright, Chair, Haemophilia Scotland.

  6. Vicki says:

    I probably contrected Hepatitis at birth, I have done two trials to hep others and me,from 24 years ago I havehad now 4 treatments that don’t work and keep being promised new drugs.
    For years I have battled on being told i’m lazy and stigmatized,my two children have been bullied,we are just surviving, I’v lost friends,teeth anh hair,self respect,the drugs left me severely depressed and have given me early onset,I,B,S, hypothyroidism,panic attacks,depression,fybromyialgia,osteo arthiritis, I have done most of it alone . I did the trials to help people and myself,I,my family have been left broken. I hope because of me being a guniea pig that others would be cured and the N.H.S would look after me. I hae cirrhossis now,who will look after my children,they have already been traumatized enough for me having an illness that the government knew about. I have been traumatised as have my children,there is a cure but the government even after w said sorry we will help you have no intention of doing so. The sooner we are treated we can once again hopefully work instead of havving to beg for help all the time which is demoralizing .I worked for 35 years until no one would employ me,my body is broken to help others and I am left out in the cold,once again let down by the government, I’t’s there fault no matter who you are we should all be helped. I used to travel with my job teaching,telling everyone how wonderful Britain is,what a naive fool I have been, My children are clear but traumatized by my treatments and the ignorant cruelty of others,you have blood on your hands,David Cameron. Rivers of blood,we are kind caring individuals who are forgotten and cast aside. . This epidemic is worse than Ebola but we can find money to pump abroad ,how about helping our own people this is bigger and caused by the government,shame on them.

  7. Vicki says:

    I have done two drug trials for this country I now have cirrhossis and am a single mother to two lovely children whose lives have been blighted by the stigma,bullied excluded becanse of my openess about the illness so that others may avoid what’s happened to me. My last boyfriend kept telling me I was disgusting because of my illness which I may have contracted at birth. My mother died of Hepatitis C but there was no test in those days. Luckily I have now left the violent nasty partner and my children don’t have my illness. This government have blood on their hands alot of blood,they made every excuse not to treat us,they spent 12,000,000 on an inquiry when they should’ve treated us. A whitewash that wasn’t worth the paper it was written on. The state said if I worked which for 35 years I did until my husband left me due to my illness that they had a duty of care to us? Where is that duty of care. I can honestly say don’t ever believe anything anyone in power tells you. Liars and murderers,all politicians. This is worse than Ebola and it’s on our own doorstep. They gave it to us and now they should cure us,I am nearly dead who will look after my children?

  8. Julia says:

    Unfortunately for patients who contracted HCV through no fault of their own, the greater percentage of HCV Positive individuals are, or have been drug abusers. I suspect a degree of (understandable) discrimination on the part of those responsible for allocating funds, and suggest that the criteria applied to alcoholics in need of a transplant should be applied re: treatment for Hepatitis C. With regard to active drug abusers, an individual’s refusal to submit to a regime of pre-treatment testing to prove that they no longer inject would imply a lack of commitment to changing their lifestyle long term, and the likelihood of reinfection.

  9. Janis Paynter says:

    I contracted HCV after giving birth (emergency C-section) to my daughter in 1977 where I received 2 pints of contaminated blood while in Miami, Fl. my health is deteriorating as this virus attacks your liver constantly…I am borderline Cirrhotic…with all the awful symptoms…and I do not drink, smoke and I have never used drugs! Thank goodness I did not give this to my 2 children or husband…
    The NHS really should treat us asap for many reasons
    1. So we do not infect others making this an even bigger problem/cost/epidemic
    Example: I prepare food for my family…chopping vegetables, cut my finger…it bleeds all over knife, cutting board and food..continues to bleed ..if I know I have HCV I toss everything away disinfect board& knife(dishwasher is good) ..but what if did not know I had HCV…NHS makes us feel,safe that this is a disease that affect mostly drug addicts& alcoholics…guess what, HCV has been in the public domain for decades which means there are a lot of people like me (Anita Roddick) who have HCV and do not know it.
    2. No one really knows how fast the liver declines as a person with HCV ages..holding back treatment will only increase the number of patients with declining health in an ageing population, in my opinion
    3. Morally, it is wrong not to offer the cure for a patients disease if you have it and they need iit.
    4. If you had a disease like Ebola and you were suffering from that disease and knew eventually you would die from it, and I told you you had to wait until March…no April…oh, wait, no May..let’s see, well we will put you on the list for treatment but we can’t say when just now…what would you be doing while you waited?
    5. Unethical pricing of Harvoni
    6. I hope this wait means the NHS is organising and setting up how they will roll out treatment
    7.allow the NHS to develop a generic drug like Gilead (developer of Harvoni) is allowing the people in India to do
    A cure but at a cost!

  10. Roy Freeman says:

    I am 69 yrs old, have Hep C type 1a which I acquired in 1983 from a blood transfusion. For years I felt ok but now feel really ill. I just hope that Harvoni will be made available soon or it’s going to be too late for me. I heard on the radio that it was going to be made available in January 1916 – is this true? I do hope so, as I’d love to wake up one morning after treatment and not feel ill. Good luck to all of you who have this disease, and fingers crossed for a January treatment.

    1. patrick says:

      I truly feel sorry for all of you and understand your plight as I have suffered from hep c for 40 years but have been given a break Let me explain…..I am an expatriate New Zealander living in Nepal for many years and became unwell about six months ago and upon see a specialist in Kathmandu was offered generic sofosbuvir and Roche’s ribavirin . My viral load test before starting was 12000000 and after taking for 23 days was down to 9460.Iam taking for six months as I was a non responder to interferon. I don’t care what people say about generics it is working wonders for me… if you buy from an authentic source the results are the same for a fraction of the price.
      I have researched this for some months and individuals in the UK can obtain these medicines with a prescription from a doctor in the UK or otherwise come to NEPAL and take your medicines here and enjoy the wonders of the Himalayas for three months. and the cost would be fractional of the UK. This is only a short brief .If you wish to contact me to answer any questions you may have feel welcome to do so ps. act now don’t wait

  11. Paul Jensen says:

    It really does not matter about how one managed to get infected, you are or you are not. It is beyond belief that it would take two years to treat 6000. The staff and utility is already there so it is lame excuse. It is about allocating the funds to treat this silent killer that is the issue, more a lack of will I dare say. A five pence raise in diesel would raise one billion pounds is an example on how easy it is to fund treatment. 10000 of the new drug treatments per year (costs would come down due to competition of other drugs becoming available) would make realistic inroads into reversing the disease. The new treatment just involves taking tablets over three months and some blood tests, it has a 90%+ success rate for the difficult to treat. Currently with the data that is available on cure, the people who make decisions in this matter ought to fear GOD under the law. They ought to do the right thing and make a real effort to cure hepatitis here in the UK.

  12. Jan Paynter says:

    I am writing on this blog again to let you all know I still have HCV genotype 1b, with compensated cirrhosis, and I am still waiting for the NHS to treat and cure me of this disease. Symptoms are slowly worsening over time. So much for my retirement…do any of us have any rights, such as being told WHEN we will be treated by our liver specialist team at least?

    I recently finished a free course which the NHS offers to people, like me, to help cope with learning how to live with a long term illnesses or condition. Ironic?

    During my attendance, everyone was in disbelief when I told them my biggest issue was managing my anger and stress (which is unhealthy) because my disease is curable but the NHS is not treating me at this time even though I am on a list and have cirrhosis.

    It is maddening when my health means everything to me, I have taken excellent care of myself to reduce symptoms and slow this disease’s progression…but, by the very nature of HCV and the length of time I have had it (since 1977) I am losing the battle as it weakens my immune system and destroys my liver…thus, the cirrhosis now…Can I wait…I hardly know the answer to that question because I have no idea how long that wait is and at what point will this disease ruin any chance to return to normal health when I am treated.

    From where I stand, it seems the NHS are putting my life on hold, gambling with my health, in an impersonal manner. And the pharmaceutical companies such as Gilead are putting a price on my life…on all HCV sufferers.

  13. Julia says:

    I didn’t know whether to post this as so many people are being denied access to these ‘super’ drugs, and I am one of the lucky few who was prescribed them. However, I was prescribed them because, in addition to Hep C 3a, I have Primary Biliary Cirrhosis (an auto-immune disease that attacks the liver). As a result, I had developed cirrhosis of the liver. I was very ill, and my specialist did everything possible to access the drugs I needed. I will be grateful to him for the rest of my life.

    I am currently one week away from completing the treatment, but blood tests show that the virus has been eradicated. Having failed a previous treatment with Peginterferon, I am hopeful that I will remain clear of it.

    The journey isn’t over for me. I still have Primary Biliary Cirrhosis and Cirrhosis of the liver. Unless a cure for PBC is discovered, I will need a transplant. In the meantime, I hope to become well enough to work again if only part-time.

    I hope patients won’t continue to blame the NHS for being unable to fund these drugs for everyone who needs them. The fault lies with the government who is underfunding the NHS in preparation for privatisation. As for Gilead, the fact is, the cost of research and development has to turn a profit. If pharmaceutical companies don’t have the financial incentive to develop a drug, no progress is made. Target your anger at those who are responsible. In this case, its the government, who can find the money to pay 750 doddering old men £350 a day for simply turning up in the House of Lords, but cannot, will not, fund the NHS or pay the Junior Doctors appropriately. (Rant over!)

    1. Janis Paynter says:

      Hi Julia
      Great to hear you have cleared HCV I assume you were treated with Harvoni.
      I think no one condemns the had working NHS staff…Great to hear you have been looked after. However, I do wonder about the management side of NHS. There is terrible pressure on existing staff. Here we have thousands of HCV patients who are looking to clear their HCV with these new drugs thus increasing the uptake of patients looking for treatment…but no increase in staff to treat them. So they have to move slowly and treat the sickest first. In the meantime, thousands of HCV patients are still waiting to be treated…lives on hold while this liver disease professes, Harvoni has been available since October 2014.
      Meanwhile, Gilead have made $3.5 billion last time I looked at their financial reports FT and they are very much in profit since getting their drug Harvoni to market. NHS and Gilead should be negotiating reducing the price of this drug..perhaps Gilead might consider releasing the patent as they have in India..so, the U.K. can produce their own generic drug equivalent. One day.
      The Government said they gave the NHS £190million specifically for HCV patients..that’s enough to pay for over 4,500 patients’ drugs using .Harvoni.
      The most important factor here is that all those new drugs being developed now by different drug companies worldwide that will cure tomorrow’s diseases will not be available to all patients on NHS. Who decides who is treated and who is left to wait in the queue? Unless, of course, you can afford private healthcare, then that won’t be your worry…unless your are poor. In the meantime, the price of living keeps going up.
      Anyhow, I hope your treatment slows down the progression of your PBC and you feel well. I wish you good health…The liver is an amazing organ…let’s hope you never need a transplant. We are living in incredible times medically…Thanks for allowing me to rant!

  14. lee hawkins says:

    Hi there.
    I have had hep c since I was 25 and have gone through two treatments since then and both have not worked.I am sitting here waiting for the NHS to decide that my case is important enough to get treatment. I was told that I would have to wait for new drugs, I have recently seen that there is a new drug but its really expensive and so the liver cli if is doing sonograms to see who’s livers are in bad shape and only those who are in really bad shape are getting treated. Not to be funny but because I live a healthy lifestyle and don’t drink im being put on the back shelf and all the people who abuse there liver with drink etc are getting priority and usually these people continue drinking and don’t care.
    It’s really unfair that people like me who have lived with this virus for many years cannot get treatment due to affordability.

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