'Fast-track' Pledge for New Cancer Drugs

Peter Russell

June 21, 2019

In our weekly roundup of NHS announcements, a promise by NHS England to introduce a new generation of tumour-targeting cancer drugs, the hospital listeria outbreak, and the latest National Institute for Health and Care Excellence (NICE) guidance.

CAR-T Cancer Therapy

The fast-track introduction of new cancer drugs that target tumours according to their genetic make-up rather than where they originate in the body was announced this week by NHS England.

In a speech to health leaders at Confed19 - The NHS Confederation conference in Manchester, Simon Stevens, NHS England chief executive, said the health service should be prepared to accelerate the introduction of tumour-agnostic drugs in the same way that it had fast-tracked genetically modified CAR-T [chimeric antigen receptor T-cell] cancer therapy for some patients with leukaemia and lymphoma.

However, Mr Stevens warned that manufacturers must be prepared to reach price deals that would allow these 'game changing' drugs to be introduced into the NHS.

Two of the first candidate drugs could be licenced later this year and, dependent on price, approved by NICE soon afterwards, NHS England said.

The drugs target tumours with a genetic variation which accelerates growth, and children could be among the first to benefit.

Both drugs target tumours with the genetic variation known as neurotropic tyrosine receptor kinase (NTRK), which accelerates growth.

"Preparations are underway to make sure the NHS can adopt these next generation of treatments, but manufacturers need to set fair and affordable prices so treatments can be made available to those who need them," Mr Stevens said.

Dany Bell, specialist advisor for treatment and recovery at Macmillan Cancer Support, commented: "It’s exciting that new cancer drugs may be available on the NHS, if they are approved by the National Institute for Health and Care Excellence, to help people receive more effective and targeted treatment.

"Of course, no new treatment can be safely administered without enough doctors and nurses with the right skills and resources to both deliver it and support patients through their treatment.

"We urgently need investment to support hardworking NHS staff to deliver the personalised care that the increasing number of people living with cancer need. The new Prime Minister must make investing in the NHS workforce an absolute priority for their Government."

Listeria Outbreak

A retrospective analysis of listeria cases linked to sandwiches at hospitals in England identified an additional three cases, including two deaths linked to the outbreak.

To date, there have been nine confirmed cases, and five deaths.

Public Health England (PHE), the Food Standards Agency, and the NHS said that the individuals who died were diagnosed and treated at:

  • Manchester University NHS Foundation Trust (two cases)

  • Aintree University Hospital NHS Foundation Trust

  • University Hospitals of Derby and Burton NHS Foundation Trust

  • University Hospitals of Leicester NHS Trust

Dr Nick Phin from PHE said: "To date, there have been no patients linked to this incident outside healthcare organisations, but we continue to investigate. Swift action was taken to protect patients and any risk to the public is low.

"PHE is continuing to analyse all recent and ongoing samples of listeria from hospital patients to understand whether their illness is linked to this outbreak."

Last week, PHE said that affected sandwiches and salads linked to the patients had been withdrawn and the supplier, The Good Food Chain, had voluntarily ceased production while the investigation continues. North Country Cooked Meats, which had supplied the meat used in the sandwiches, had produced a positive test result for the outbreak strain of listeria, and had also voluntarily ceased production.

The Good Food Chain supplied affected product lines to 43 NHS Trusts, plus one independent provider, PHE confirmed.

Prof Jose Vazquez-Boland, chair of infectious diseases at the University of Edinburgh, said: "Pre-packed sandwiches are recurrently incriminated in the UK in listeriosis episodes.  In 2017 for example one such episode in Yorkshire and The Humber involved also sandwiches supplied to hospitals. 

"There is clearly a warning here that microbiological controls for listeria need to be stepped up with pre-packed sandwiches."

NICE Backs Treatment for Non-infectious Uveitis

People with recurrent non-infectious uveitis affecting the back of the eye could benefit from the fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences), the National Institute for Health and Care Excellence (NICE) said in draft guidance.

Clinical trials suggested that the treatment, which is injected into the eye, and lasts for 3 years, improved visual acuity after 12 months by 5.9 letters on a Snellen chart compared with 4.3 letters in the control group.

It also suggested that 97.6% of people in the control group had a recurrence recorded by 12 months, compared with only 37.9% of people receiving the fluocinolone acetonide implant. Although recurrence rates in the implant group were likely to be overestimated, fewer hospital visits were likely compared with those patients receiving the usual treatment of corticosteroid injections, immunosuppressants, and dexamethasone (Ozurdex, Allergan) and adalimumab (Humira, AbbVie) implants, an appraisal committee concluded.

Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE, said: "Existing treatments for controlling recurrent non-infectious uveitis can be burdensome and disruptive to daily life for both patients and their carers, needing frequent hospital visits for administration and monitoring.

"The fluocinolone acetonide implant offers patients a new treatment option that could lead to more consistent disease control with a reduced treatment burden. We are happy to be able to provide people with recurrent non-infectious uveitis affecting the posterior segment of the eye with an additional treatment option, particularly one with potentially long-lasting benefits."

Around 8500 people in England have non-infectious uveitis affecting the back of the eye. However, the number of people with recurrent disease who would be eligible for this treatment is far fewer, NICE said.

Treatment for Acute Lymphoblastic Leukaemia

In final draft guidance NICE recommended blinatumomab (Blincyto, Amgen) for treating acute lymphoblastic leukaemia (ALL) in patients in first complete remission with minimal residual disease (MRD) activity of at least 0.1%.

It said that use of blinatumomab, compared to usual first-step treatment chemotherapy could reduce MRD and help increase the time people have without their disease relapsing.

Also, patients with lower MRD levels had a higher chance of their disease being cured after stem cell transplantation, it said.

Treatment would be available on the NHS if the patient's disease was in first complete remission and providing the manufacturer supplied the drug at an agreed confidential price discount.

An estimated 102 people could be eligible for treatment with blinatumomab every year, it was estimated.

'No' to Lipodystrophy Treatment

NICE rejected metreleptin (Myalepta, Aegerion) as an option for treating lipodystrophy.

The draft recommendations covered patients who were either:

  • 2 years and over, and had congenital or acquired lipodystrophy, or

  • 12 years and over, had familial partial or acquired partial lipodystrophy, and did not have adequate metabolic control despite having standard treatments

An appraisal committee acknowledged that clinical study results suggested that metreleptin appeared to improve hyperphagia, and reduced HbA1c and triglyceride levels, in people with lipodystrophy. However, it said the studies did not include any objective measure of hyperphagia or any comparison of metreleptin with other treatments.

Final recommendations are expected on 31st July 2019.

Transmission Risk for Creutzfeldt-Jakob Disease

NICE issued a consultation document on reducing the risk of transmission of Creutzfeldt-Jakob disease (CJD) from surgical instruments used for interventional procedures on high-risk tissues.

Draft recommendations included:

  • Ensuring that all surgical instruments that have come into contact with high-risk tissues during an interventional procedure are kept moist until decontamination

  • Surgical instruments that come into contact with high-risk tissues must not be moved from one set to another and must remain within their individual sets

  • Supplementary instruments that have come into contact with high-risk tissues must remain within the individual set to which they have been introduced

  • Rigid neuroendoscopes (rather than flexible neuroendoscopes) should be used if possible

Evidence on cost effectiveness did not support introducing systems to maintain separate sets of neuroendoscopes and reusable surgical instruments for use on high-risk tissues for people born after 1996, an appraisal committee said.

The closing date for comments is 17th July, and the target date for final interventional procedures guidance is expected in October 2019.

Primary Liver Cancer

Draft guidance from NICE on irreversible electroporation for primary liver cancer said the procedure showed "serious but well-recognised complications" as well as inadequate evidence on efficacy.

It suggested that the procedure should only be used for research purposes and by experienced teams at specialist centres.

A consultation period ends on 17th July 2019, and final guidance is expected in the autumn.

Midcarpal Hemiarthroplasty for Wrist Arthritis

NICE said it was consulting on the safety and efficacy of midcarpal hemiarthroplasty for wrist arthritis.

It recommended that the procedure should only be used in the context of research because of a lack of reliable evidence.

Future research should concentrate on patient selection, type and severity of arthritis, patient-reported outcome measures, and the need for revision after 5 years or more, it said.

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