Monday, 1 August 2016

PoliticalSpeak: should we let NHS England get away with ignoring NICE?

Should we trust NHS England to deliver on NICE promises? #PoliticalSpeak #MSBlog #MSResearch

"The following news feature in this week's BMJ highlights the dilemma NHS England has in paying for high-cost drugs when it has a limited annual budget. The cost of curing people with hepatitis C is causing a political maelstrom. This has implications for the treatment of MS and other diseases that involve the use of high-cost drugs. It looks as if NHS England are pushing to get the rules that govern NICE changed; they want NICE to turn into a recommendatory rather than mandatory body. The implications for this a worrying; already the UK lags behind other developed countries in our adoption of new healthcare innovations. If we leave it up to the bean-counters to decide on what to adopt, and what not to adopt, then we will be doing our the people who live in England and Wales 
a disservice. What's more post-Brexit we will have fewer legal avenues to explore to keep NHS England and the Department of Health in check. It was the threat of a legal challenge in the EU parliament to the original NICE guidance on interferon-beta and glatiramer acetate that led to the Department of Health's risk-sharing scheme."

"As a taxpayer you may think that the NHS England shenanigans over access to hepatitis C drugs is appropriate as they are looking after your money. But a much better thought experiment is imagine how you would feel if you had hepatitis C, with ongoing liver injury, and you were denied access to an effective treatment or cure? In regard to liver disease time is as important as it is in MS. Why wait for your liver to be irreversibly damaged from hepatitis C when you can be cured of the infection now (Time is Liver, Time is Brain)?"

"The other debate that needs to happen is why has Gilead priced their drugs so high? Is it to provide them with cash to support their next cycle of innovation? More on this topic, i.e. pharma price gouging, later in the week."


Gornall et al. A pill too hard to swallow: how the NHS is limiting access to high priced drugs. BMJ 2016;354:i4117.

Experts:

..... Highly priced medicines are challenging health systems around the world in unprecedented ways. And none more so than the new sofosbuvir based antiviral drugs introduced by Gilead Sciences in 2014. Offering greatly reduced treatment durations and high cure rates, these medicines hold out the real prospect of eliminating hepatitis C in countries where they are widely administered, with all that implies for long term savings in healthcare costs....

.....But launch of these drugs has ignited a global debate about high priced medicines. With launch prices ranging from around $90 000 (£69 000; €82 000) per patient in the US to almost £35 000 in England and €41 000 in France,they have sparked a US Senate investigation, been raised at both the G7 and G20 summits, and has been a major consideration for to a UN high level panel on access to medicines....

..... In a joint investigation, The BMJ and researchers from the University of Cambridge and the University of Bath, show how NHS England, unable to budget for broad access to these drugs, tried to alter the outcome of the NICE process and, when it failed, defied NICE’s authority by rationing access to the drugs......

...... The case shows how high prices for high prevalence diseases places huge stress on health systems and reveals the limitations of conventional cost effectiveness analysis. Although NICE may deem such medicines to be cost effective, the NHS is ill equipped to deal with the budgetary allocations required. This leads to conflict and damaging delays for patients. It also reveals an urgent need for reform to allow better deal making, transparent pricing, and new payment models, such as the one used to make the hepatitis C drugs available in Australia.......

..... NHS England is also accused of pursuing the broader agenda of trying to hamper NICE's ability to impose budget busting drugs on the health service, and of having cynically chosen this battleground because most people with hepatitis C infection are from marginalised groups without a voice, such as people who inject drugs.....

...... “The difficulty is that NICE looks at cost effectiveness over a long period and says a drug is cost effective because it’s saving people from dying or having problems years down the road,” says Ustianowski, “and cost effectiveness is very different from budget impact, which is what NHS England is facing.”.....

...... Is company pricing to blame? .....

...... Faced with the intensifying criticisms, the NHS England highlighted Gilead's pricing as the key reason why treatment was being delayed. A press release issued in March 2016 said that while the NHS had made “the tough prioritisation choices necessary to free up funds to invest significantly in new treatments [drug companies] also need to play their part; quite simply, making faster progress for patients in eliminating this disease will depend on pharmaceutical companies making them more affordable.”......

...... This echoed major criticisms of Gilead’s pricing strategy, perhaps best documented in an 18 month investigation by the US Senate Committee on Finance into the pricing and marketing of sofosbuvir and Harvoni in America. The US legislators concluded that the company had adopted a strategy “designed to maximise revenue with little concern for access or affordability.” This was made evident by the company's income jumping from about $10bn in 2013 to over $32bn in 2015, a year in which its revenue from Harvoni alone amounted to $10bn in the US and $2.2bn in Europe......

...... "Time, however, is not on the side of many patients and last month the Hepatitis C Trust launched legal action seeking a judicial review of the decision to limit access to the new drugs—a decision which, it says, could have repercussions for other patient groups as increasingly expensive drugs become available......

..... “It is truly ironic that NHS England should choose to start rationing drugs that are so effective they cure almost everyone who is treated,” said the charity in a statement. “It feels like people with hepatitis C are being picked on.".....

...... Legal action, said its chief executive, was “a very significant financial risk for us but we absolutely have to stand up for the people we are here to support. We do not want to fight the NHS but we will fight for a fair NHS.” ......

4 comments:

  1. Re "they want NICE to turn into a recommendatory rather than mandatory body."

    I thought they were already only recommendatory. I queried why a GP didn't follow NICE guidelines once with NHS England or the GMC can't remember which. NHS England or the GMC responded saying NICE guidelines are recommended but not mandatory.

    ReplyDelete
    Replies
    1. But there STAs and MTAs (single and multi-technology appraisals) in relation to high-cost drugs are mandatory. Once NICE gives a green-light then NHS England has 3 months to make the drug(s) available under the NHS. Clinical guidelines and quality standards are what you are referring to and in their case they are recommendations.

      Delete
    2. Thanks Prof G, that helps.
      Tecfidera was given the green light by NICE on 11th July 2014 (if that's correct). I got to start it Jan 2015, it was a long wait being on no DMT and having very active RRMS.
      The time it took from NICE giving the green light to taking first dose was six months (my first DMT).

      Delete
  2. They don't make them like Salk anymore, alas.

    ReplyDelete

Please note that all comments are moderated and any personal or marketing-related submissions will not be shown.