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Charity loses legal challenge to NHS England drug decision

The Hepatitis C Trust has lost its legal challenge to NHS England’s decision to cap access to new drugs for the disease.


Hepatitis C Trust loses legal challenge to NHS England’s decision to cap access to new drugs for the disease
Judge rules decision to roll out treatments via “monthly run rate” is “legitimate” and “rational”
Charity argued that capping therapy approved as cost effective went against NICE rules

Mr Justice Blake ruled that NHS England’s decision to roll out access to the treatments via a “monthly run rate” was “legitimate” and “rational”.

In 2015, new oral treatments for hepatitis C were approved by the National Institute for Health and Care Excellence.

The drugs are extremely clinically effective. However, NHS England has identified them as a significant financial risk because of their high cost and the prevalence of the disease. It capped courses of treatment at around 10,000 in 2016-17.

The drugs are being rolled out via 22 “operational delivery networks” with each network working to a monthly run rate dictating how many courses of treatment it is allowed to administer.

The Hepatitis C Trust said capping a therapy approved as cost effective went against NICE rules, and applied for a judicial review of NHS England’s decision.

In his judgment refusing the application, the judge said: “In my view, the claim form focuses on a single point that the defendant’s decision is unlawful as it amounts to an arbitrary cap of 10,011 treatments a year that was not part of the NICE guidance and is unlawful.”

He said he was “persuaded” by NHS England’s defence that this was a “mischaracterisation of the decision and that a monthly run rate is not an arbitrary cap but a legitimate way of giving effect to the guidance that the treatments must be available as an option for patients with qualifying conditions ‘to prioritise treatment for people with the highest unmet clinical need’”.

“If prioritising need is legitimate then a monthly run rate is a rational way of implementing the duty whether it was a means foreseen by NICE or not,” the judgment added.

The charity applied for its liability to pay NHS England’s legal costs to be capped at £49,000.

However, Mr Justice Blake said there were “uncertainties as to what the terms of the claimants lawyers’ retainer are, and the financial relationship between the claimant and the interested parties”.

The drug companies Gilead, Bristol-Myers Squibb and Abbvie are listed as interested parties in the application for judicial review.

The judge said he was “not persuaded that the cap proposed is appropriate”, though he capped costs for the “permission stage” of the judicial review to £20,000.

“I consider that sum is proportionate having regard to the central legal point in dispute and the means of the respective parties,” he added.

An NHS England spokeswoman said hepatitis C medicines were the health service’s “single biggest new treatment investment over the past year” and worth about an extra £200m annually.

“We welcome the High Court’s decision that NHS England’s approach to prioritising treatment ‘for people with the highest unmet clinical need’ is both ‘rational’ and ‘legitimate’,” she said.

She said NHS England would “focus on securing an improved deal for patients from pharmaceutical companies so as to expand access to hepatitis C treatments even further in future years”.

The Hepatitis C Trust declined to comment.




If the HepC Trust had only put more faith in the generic route... more people would be cured . Just my opinion.

I know they are campaigning in the right direction and there is a recommendation to Fix HepC on their website now, but what about the reality for the patients ??? I know so many who pin their hopes on this kind of thing.

If you register at : www.hsj.co.uk/ - You can comment on the article.

Hi LG,

thank you for sharing this information.
In another thread on this forum I was specifying that the pressure is being wrongly made towards the government or authorities to allocate more money in order to treat more people. So the outcome from the news you posted here was somehow predictable, even though personally I find it very sad.

But perhaps with such an outcome, people and the advocacy groups will realize that the solution stays in the generic HCV drugs. So what they should do is to put on the table the generics. Oh, and to get rid of the ghosts related to generic drugs.

GENERIC DRUGS EXIST, ARE REAL, MUCH CHEAPER AND EFFECTIVE!!!!
So instead of wasting time wondering if the HCV generic drugs really work, people should better focus their minds on how to provide the effective generic drugs to the patients.

The issue of treating patients in mass would be much faster solved if people would start sharing more fiercely the news about the generic drugs.

I end here repeating the message from my signature:

HCV GENERIC DRUGS WORK. SHARE THIS KNOWLEDGE TO SAVE SOMEONE'S LIFE!
Cheers,
RHF

Yes, it is sad, but at the same time unsurprising.

Yes, agreed.

Ok, I know no one will probably like this, but here is my cynical view:

Hepatitis C trust is possibly a scam charity in as much as it takes donations and tries to work within the system. They make a nice living doing nothing, and helping no one.

NEWSFLASH: Western countries have a patent system in place. Gilead has a patent: Which is effectively a monopoly for Sofosbuvir based treatments for the next 20 years.

THERE IS ONLY ONE MESSAGE TO PROMOTE. IF PEOPLE WANT TREATMENT, THEY CAN IMPORT 3 MONTHS OF MEDICATION: THEY WILL HAVE TO PAY FOR IT THEMSELVES.

I say these people are a money making scam (Hepatitis C trust) For this reason, Gilead and the other companies have patents. The governments are not going to overturn that system. So it's a big joke. Sure, generics are effective, people are dying.

But officials have been bribed to allow Gilead to control the marketplace. If you fall through the cracks, that is so sad, but we need to show a profit to investors (Gilead). It's a shame you died.

STOP WAITING FOR A HANDOUT AND CURE YOURSELF. CONTACT ME IF YOU NEED HELP. Don't be a victim of these lies and deceit.

Hi GF,

There are many kind souls that give a good listening ear at the HepC Trust and no doubt this charity was originally started with good intentions, by patients. The kind listening souls, who are volunteers and not paid. However, that was then and this is now.

However, how much are they doing to actually help patients access treatment working within the system? (If anyone reading this knows any different, I would love to hear about it).

The patients again, are asked to set up patient advocate patient groups in NHS hospitals, I can't speak for all, but I know two years ago, when I was feeling very ill, there was no way I could have mustered up the energy for this and I was only F2, you know? I also didn't want to revisit the hospital where I staggered with joint pain for my long waited first appointment and where the consultant didn't didn't show up, leaving a note saying he 'didn't want to see me'. Not forgetting the risk of loss of privacy, which is a concern for many due to stigma.

Likewise, patients were asked to fundrase to pay HepC Trust legal fees for this recent legal challenge.

I suggested to the HepC Trust that maybe they should ask the pharma companies to contribute, seeing as they are funded in part by Gilead eg. Their response was to say they wanted to keep it separate, but how can they do this in reality if big pharma sponsor them in part? There is clearly a conflict of interest, (didn't the lawyers see this?)

Pre Fix HepC, I was continuously frustrated by the amount of meetings, expensive conferences, charities and think tanks that were set up to tackle the diabolical state of lack of humane treatments for HepC patients. Did the enormous amount of money spent for these endless debates and recommendations for highly paid 'quangos' etc bring access to treatment further forward - At all? I suggest not. I'm sure there are a few genuine people in there, not to belittle their work, but patient care is surely the aim?

That money could have been treating the sickest of patients, including a dear friend of mine for whom access to treatment came too late (still untreated) mostly due to health authority 'error' - Criminal and devastating for that patient and all close to them.

You are so right with this statement :

STOP WAITING FOR A HANDOUT AND CURE YOURSELF. CONTACT ME IF YOU NEED HELP. Don't be a victim of these lies and deceit.

Look at what has been achieved here by Dr Freeman, MonkMed and Greg Jeffereys who started the ball rolling.
REAL results! Real lives changed for the better and real lives saved. When Dr Freeman went to Barcelona, no doubt at his own cost, it helped hundreds to get monitoring by getting EASL support from official trial results My latest hospital blood request forms had 'Redemption' written under the treatment section - What an achievement! This is the type of thing that is needed. Real positive action, not endless and costly words via unconnected bodies.

I believe there is still a place for the HepC Trust as a supportive, listening body who can offer advise. The advise should be 'If you're not getting treated by the health authority, insurance etc get generics via a trusted supply chain, ie FixHepC '. Not all can afford this, but the cost is not so high and it can be raised with some effort for most. For those who are very poor and whose exchange rate is prohibitative, then these charities should be raising money for these people to get treated, not fior endless meetings of talk, no action that raises the hopes of patients only to be dashed again. It seems an extremely expensive way to keep the cause vaguely in the public eye with little in the way of results.

Many, Cancer charities in the UK eg offer financial support to those in need for many cases, why not HepC charities too?

I'm sure my post won't be popular either, but hey.

Hi GF and LG,
What you are saying are aspects that have been noticed/observed or felt in the real world. Of course, there might be cases when what you said can perhaps be expressed with other words, but that's more a matter of talking.

Looking at the politicians, they seem to avoid assuming responsibility for sensitive issues (like the case of patent law vs right to health) by claiming that they represent the majority of the people and as long as people were not asking in large number for the access to generic drugs... they can easily claim their hands are tight and cannot do much about it.

The political view will change dramatically if only people would start to talk more and more about the HCV generic drugs.....

BR

RHF