NHS to Trial 800-Calorie Diet Aimed at Reversing Diabetes

Peter Russell

November 30, 2018

Clinical trials suggesting that very low calorie diets could help some people newly diagnosed with type 2 diabetes achieve remission have prompted NHS England to sanction pilot schemes from next year.

New guidance issued by the National Institute for Health and Care Excellence (NICE) this week included a positive announcement on a liver cancer drug, and a recommendation for a treatment for melanoma.

Low Calorie Diet for Diabetes Remission

Plans were announced to offer very low calorie diets to some people recently diagnosed with type 2 diabetes to help put the disease into remission.

NHS England said that thousands of people could be entitled to receive help to counter obesity from next year.

Patients would be prescribed a liquid diet of just over 800 calories a day for 3 months and then a period of follow up support to help achieve remission.

The radical approach followed the Diabetes UK funded DiRECT trial (Diabetes Remission Clinical Trial), where almost half of individuals who went on a very low calorie diet achieved remission of their type 2 diabetes after one year. A quarter of participants achieved weight loss of 15kg (33lbs) or more and of these, 86% put their type 2 diabetes into remission.

A more recent trial of very low calorie diets, DROPLET (Doctor Referral of Overweight People to Low Energy Treatment), demonstrated similar weight loss in obese individuals, NHS England said.

The approach would initially be piloted in up to 5000 people.

The 9 month programme aims to help people:

  • Achieve a healthy weight

  • Improve overall nutrition

  • Increase levels of physical activity

Online versions of the DPP (Diabetes Prevention Programme), which involve wearable technologies and apps to help those at risk of type 2 diabetes, would also be available for those who found it difficult to attend sessions because of work or family commitments.

With the health service spending around 10% of its budget on treating diabetes, the initiative could save money for frontline care, NHS England said.

Simon Stevens, chief executive of NHS England, said: "The NHS is now going to be ramping up practical action to support hundreds of thousands of people avoid obesity-induced heart attacks, strokes, cancers, and type 2 diabetes. The NHS Long Term Plan is going to give people the power and the support to take control of their own lifestyles – so that they can help themselves while also helping the NHS.

"Because what's good for our waistlines is also good for our wallets, given the huge costs to all of us as taxpayers from these largely preventable illnesses. However this isn’t a battle that the NHS can win on its own. The NHS pound will go further if the food industry also takes action to cut junk calories and added sugar and salt from processed food, TV suppers and fast food takeaways."

Chris Askew, chief executive of Diabetes UK, said: "The first year results of Diabetes UK DiRECT study showed that – for some people with type 2 diabetes – an intensive, low-calorie weight loss programme delivered with ongoing support through primary care could put their condition into remission. While this ground-breaking study continues to explore how long-lasting these benefits are, we are delighted that NHS England have been inspired by this work to pilot a type 2 remission programme through the NHS."

Professor Roy Taylor, co-chief investigator of the DiRECT study, commented: "This is a hugely important step forward for the NHS, allowing people with type 2 diabetes to return to full health. This approach has gradually been taken up by doctors, nurses and dietitians, but now practical support will be provided."

Liver Cancer Drug Go-ahead

NICE said its appraisal in March this year had concluded the oral multi-kinase inhibitor was too expensive for an end-of-life treatment, but that the manufacturer had since agreed an acceptable price discount.

It said clinical trial evidence suggested that people with liver cancer that had been treated with sorafenib, and who have good performance status and less severe liver impairment, live longer with regorafenib than those offered only supportive care.

The recommendation was dependent on patients having a Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Meindert Boysen, director for the NICE Centre for Health Technology Evaluation, said: "We are pleased that the company has responded by seeking a rapid review of our original guidance and offered a price that allows us to conclude that the drug is cost-effective for routine use on the NHS in England and Wales."

Judi Rhys, chief executive of the British Liver Trust, commented: "Hepatocellular carcinoma is the most common form of liver cancer. It is particularly aggressive, with the 5-year survival rate being on average only 12% and a diagnosis is therefore devastating for the patient and their families.

"There are also very few effective treatments, so the decision to approve regorafenib for routine use in England and Wales is a welcome step forward.

"Access to the drug will potentially provide patients with valuable extra time with their loved ones."

NICE said the decision was likely to benefit a few hundred patients each year.

Ulcerative Colitis Recommendation

Final guidance recommended tofacitinib (Xeljanz, Pfizer) as an option for treating moderately to severely active ulcerative colitis in adults.

It said treatment was appropriate when conventional therapy or a biological agent could not be tolerated, or the disease had responded inadequately, or lost response to treatment.

Clinical evidence suggested that tofacitinib was more effective than placebo.

The average cost per patient was estimated at £10,350.45 for the first year of treatment and £8,970.39 for the subsequent year.

However, the manufacturer had agreed a confidential price discount, NICE said.

Melanoma Treatment for CDF

An appraisal consultation document recommended nivolumab (Opdivo, Bristol-Myers Squibb) for use within the Cancer Drugs Fund (CDF) as an option for the adjuvant treatment of completely resected melanoma in adults with lymph node involvement or metastatic disease.

An appraisal committee concluded that there was potential for nivolumab to be cost-effective, subject to further data confirming current efficacy predictions for recurrence-free and overall survival. Inclusion on the CDF would allow longer-term data to be collected, it decided.

NICE said around 1480 people would be eligible for the treatment – quoting manufacturer estimates.

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