Diabetes developments – by Simon O’Neill

In a regular blog series, Simon O’Neill, Diabetes UK’s Director of Health Intelligence and Professional Liaison, rounds up the latest diabetes news.
This week Simon rounds up the latest technologies, medicines and treatments.

An appointment with Google glass

Simon-O'Neill-Director-of-HGoogle Glass first appeared in 2012 as a pet project of Google’s co-founder Sergey Brin. The technology allows the wearer to record what they are seeing and to interact verbally with a visual interface, to have information displayed in front of the wearer’s eyes. However sales failed to materialize, mainly because of lawsuits linked to privacy and safety issues, and sales to the public were discontinued last year.

However, a new use for the headsets may have been found in the doctor’s surgery. Doctors can record their examination on video but also, by talking through the headset to a medical scribe, can immediately write up the notes of their consultation. As the medical scribe, who may be based in another country altogether, can access the patient’s notes, they can also advise the doctor on previous test results or examinations. Doctors piloting the technology say that they can escape the burden of several hours a day spent typing information into the Electronic Health Record.

The people behind the technology claim that it’s the first step in providing clinicians with instant information that can transform how medical decisions are made. The long term future would see artificial intelligence software transcribe the clinic visit in real time, while immediately comparing the patient’s medical issues with those of millions of others, then making predictions about what treatments would work best. They also suggest that the technology allows the clinician to engage personally with the patient rather than worrying about inputting data into a computer.

However, critics raise potential problems. Medical scribing requires a great degree of accuracy and understanding of medical terminology – potentially errors could lead to the wrong medical treatment being provided. There are also concerns over cyberattacks, which are on the rise in the health industry and patient confidentiality, with their records having to be shared outside the clinic setting.

However, currently about 500 doctors in the US are using Google Glass. They wear them throughout the day, live-streaming their clinics to the virtual scribes, who look on and take detailed notes. And patients seem to like it, feeling the appointment is more patient focused, with less than 2% asking the clinician to remove the headset.

The AP has landed (almost!)

At the end of September the FDA approved Medtronic’s MiniMed 670G hybrid closed loop insulin pump and more accurate Guardian continuous glucose monitoring (CGM) sensor, Guardian Sensor 3. This is the first step to having an artificial pancreas commercially available.

This is not a totally closed-loop system, as the wearer still has to input bolus doses for meals (though if they forget, the system can compensate to some degree). However, it is the first major breakthrough in making this technology available and it has been interesting to see just how quickly the device went through the FDA processes, gaining approval in 104 days, about a third of the time typically allowed for new devices.

The system will be launched in spring 2017 in the US for people with T1D aged 14 and over, although a paediatric study (7-13 year olds) is currently underway to see whether this could be expanded to younger people. The device can’t be used in children under seven years old or for those on less than eight units of insulin per day.

For those of us not in the US, international approval of the device is expected in summer 2017. In the US it looks as though the 670G will be priced on a par with existing Medtronic pumps and CGM systems. Of course, even if we get approval in the UK, there will still be the issue of availability on the NHS. Although Type 1 NICE guidance allows for both pump and CGM use, we know that, in reality, very few people are getting both systems funded under the NHS and it is hard to see this changing any time soon.

This is just the first in quite a large pipeline of new AP type devices. Some state that they are fully automated, others, like the Medtronic system, may require some user intervention.

  •  Tandem are trialing their t:slim pump with a built in algorithm to minimize both hypo and hyperglycaemia. Trials are due to start next year with potential launch by the end of 2018.
  • Beta Bionics who have been developing the dual hormone iLet bionic pancreas, will be starting major trials in 2017 with the plan to submit the insulin only device to the FDA by the end of next year. The insulin/glucagon version will have to wait a little longer it would seem.
  •  Bigfoot Medical have announced that their Smartloop technology has come from a standing start 18 months ago to being ready for FDA submission at the end of 2017. If all goes to plan, they hope to launch by the end of 2018.
  • Animas are also piloting a pump with an integrated hypo/hyperglycaemia minimizer algorithm with a planned launch of 2017.
  • Insulet are developing a hybrid closed loop algorithm for use with the Omnipod and a smartphone app with a plan to market in 2018.When and whether all of these devices make it to the approval stage is one thing. Whether they then make it to the UK (and when) is another question and one that we need to continue to raise with policy makers and others to ensure that people with T1D in the UK don’t miss out on these life-changing technologies.

Not so NICE affordability test?

The National Institute for Health and Care Excellence and NHS England have launched a consultation on introducing an affordability test into the process for authorising new treatments.

Currently NICE reviews any new treatment on its cost effectiveness, reviewing the benefits and costs of the treatment against QALYs (Quality-Adjusted Life Years) which are a measure of the burden of disease. This gives a price per QALY and if that is between £20-30,000 the treatment is normally assessed as cost effective.

However, this doesn’t consider whether the NHS can afford that cost and this is often why NICE approved drugs are not included in local CCG formularies. The introduction of new hepatitis C treatments last year greatly highlighted this issue. The drugs are judged to be cost effective by NICE but were subject to unprecedented restrictions on their availability because of their high cost to NHS England.

This new consultation is investigating whether there should also be an affordability criteria, or budget impact threshold, on any new therapies, with a suggestion that any new drug that would cost the NHS more than £20m a year, in any of the first three years of its introduction, could be subject to a delayed roll out. The proposal is that, if this threshold is triggered, the manufacturer and NHS England would enter commercial negotiations to try and bring the cost to the NHS below £20M.

If no agreement can be reached, NHS England will be able to “make a case for NICE to allow a longer period of phased introduction” of the drug. This would mark a significant departure from existing NICE rules, where NHS England is obliged to commission a treatment 90 days after it has been authorised by NICE.

About 20 per cent of treatments that NICE approved between June 2015 and June 2016 would have triggered the budget impact threshold.

However, there is a concern that this could impact unfairly on conditions, such as Type 2 diabetes, where there are large numbers of people affected. Looking at the current NHS spend on T2D treatments, several therapies are costing the NHS more than £20M per year – for example Exenatide (£21M), Liraglutide (£41M) and Sitagliptin (£77M) – but this may be caused less by the expense of the drug per person per year but because so many people have T2D and are using these therapies.

In addition the consultation suggests introducing a cost effectiveness threshold for NICE’s “highly specialised technology” process for approving drugs for very rare diseases. This threshold already exists but has never been applied to treatments for very rare conditions, and could make it more difficult for these drugs to win NICE approval, unless companies lower their prices, with a QALY threshold set at £100,000.

The consultation also suggests a new “fast track” appraisal process for drugs that are predicted to be below £10,000 per QALY, with these drugs routed through a “lighter touch” process that could take 10 weeks off NICE’s normal appraisal timescale.

Diabetes UK is examining the consultation carefully and will respond accordingly.

The accelerated access review

The final report of the Accelerated Access Review has now been released. The review, which was commissioned by the government, aims to make the UK a world-leader in healthcare innovation, ensuring that the NHS embraces new drugs and technologies that patients need and supports work with local areas to develop solutions to their specific healthcare needs.

The report proposes streamlined processes which could bring forward patient access to new drugs by up to 4 years and enable people to benefit from earlier access to medical technologies. The plan is that the recommendations will help the NHS to provide the best care to people whilst using funds more effectively, and creating the best conditions to help the life sciences industry continue to thrive.

Recommendations include the creation of a new accelerated access partnership to speed up and simplify the process for getting the most promising new treatments and diagnostics safely from pre-clinical development to people living with the relevant conditions. Current evidence has shown that the UK sometimes lags behind other countries in doing this, which is incredibly distressing for people living with life threatening conditions. Current methods also deter innovators from developing solutions for the UK market, as they know they will have to go through multiple channels to get them approved.

The new partnership will enable innovators to access joined-up help for clinical development, regulation, and assessment of cost effectiveness. The report recommends that the partnership includes NHS England, NHS Improvement, the National Institute for Health and Care Excellence (NICE) and the Medicines and Healthcare Products Regulatory Agency (MHRA).

The Review suggests that access to drugs could be brought forward by up to 4 years if a scientific opinion from the early access to medicines scheme is used (which can save 12 to 18 months) and if there is also no delay during the technology appraisal (which can take up to 2 years) or during the process for NHS commissioning and adoption (which can take two years or more).

The Review also recommends a simpler process for digital technologies which are often developed by smaller companies, such as healthcare apps for managing long-term conditions. In addition the Review recommends that a new strategic commercial unit should be created within NHS England to enter into dialogue to create flexible arrangements with innovators who are working on transformative new products. The suggestion is that innovators would benefit from earlier access to the NHS market and increased sales whilst offering better value to the NHS and patients for that early access.

The Government will now consider the proposals and respond in due course, though overall affordability to the NHS will still be an issue.

Next week, Simon looks at work around pilots and statins.

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