NICE Decision Could Increase Liver Transplants

Peter Russell

January 18, 2019

A transplant surgeon says approval by the National Institute for Health and Care Excellence (NICE) for routine NHS use of a technique to keep donor livers healthy for longer before transplantation is a 'game changer'.

Among other announcements this week, the Government gave the go-ahead for women in England to take a second abortion pill in their own homes.

Perfusion for Liver Transplants

The number of donor livers which could be used for transplantation in England and Wales could increase after NICE recommended an "exciting" technique to increase organ viability.

A perfusion machine reduces the rate of tissue deterioration that occurs after the liver has been removed from the donor and extends how long the liver can be stored before transplantation.

The liver is flushed with an oxygenated solution, sometimes blood, supplemented with metabolites and nutrients under normothermic or hypothermic conditions.

Issuing final guidance, NICE said it had not identified any major safety concerns but that the technique should be used under special arrangements while further data was gathered.

Surgeons must inform patients about the uncertainty of the procedure's efficacy, comply with the relevant regulatory and legal requirements of the Human Tissue Authority, and should enter details about all patients having this procedure into the NHS Blood & transplant UK transplant registry.

If machine perfusion increased the number of organs viable for transplant, waiting lists could shorten and lives could be saved, NICE said.

Liver transplantation is a highly successful treatment for end-stage liver disease, which kills 11,000 people each year in England. Deaths from liver disease have risen by 25% in a decade and continue to rise.

In the 12 months to 31st March 2018, there were 1043 liver transplants in the UK and 359 patients on the UK active transplant list, according to NHS Blood and Transplant. The number of patients on the active transplant list reached a 10 year high in 2015 when 611 patients were on the waiting list.

Professor Kevin Harris, programme director and clinical advisor for the Interventional Procedures Programme at NICE, said: "This procedure offers hope for patients needing a liver transplant.

"It offers another way of preserving the liver, and assessing whether livers which might have previously been considered unsuitable, can be used safely."

Darius Mirza, professor of hepatobiliary and transplant surgery at University Hospitals Birmingham NHS Foundation Trust, said: "In the 30 years I've been involved with transplantation there have been three or four events which have been game changers and I'm absolutely certain we are looking at a game changer that will change the way we practice organ storage and transplantation."

Vanessa Hebditch, director of policy at the British Liver Trust commented: "It is an exciting development that has the potential to shorten waiting list times and reduce mortality rates from advanced liver disease.

"After transplant, the vast majority of people go on to lead full and healthy lives and it is truly amazing to see the transformation."

Second-stage Pregnancy Terminations at Home

Women in England will be able to undergo the second stage of treatment for early medical abortion in their own home, the Government confirmed this week.

Previously, women have had to take two pills – mifepristone and misoprostol – at a clinic.

The Secretary of State for Health and Social Care approved a woman's permanent home address as a suitable place to take misoprostol where the gestation of the pregnancy has not exceeded 9 weeks and 6 days at the time the mifepristone was taken.

The decision brought England into line with Scotland and Wales where women had already been given the option of taking misoprostol at home.

Melanoma Treatment

NICE recommended encorafenib (Braftovi, Pierre Fabre) with binimetinib (Mektovi, Pierre Fabre) as a treatment option for some people with melanoma.

In a final appraisal document, it said the combination therapy would be available as an option for treating unresectable or metastatic BRAF V600 mutation-positive melanoma in adults.

An appraisal committee said that clinical trial results showed that encorafenib and binimetinib had longer rates of median overall survival compared to vemurafenib (Zelboraf, Roche), which was already recommended by NICE.

It also appeared to be as effective as the drug combination dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis), which were recommended in October 2018.

It is anticipated that around 858 people would be eligible for the treatment in the first year.

Chronic Lymphocytic Leukaemia

Venetoclax (Venclyxto, Abbvie) with rituximab (MabThera, Roche) as an option for treating chronic lymphocytic leukaemia in adults who have had at least one previous therapy was recommended in draft guidance.

Appraisers concluded that the drug combination would be welcomed as a new treatment option by some patients.         

Venetoclax would be offered at a discounted price, NICE said, making the treatment cost-effective for routine NHS use.

Cerebral Palsy

New guidelines to address variations in care for adults with cerebral palsy were issued this week.

They were aimed at improving health and wellbeing, promoting access to services, and supporting participation in activities and independent living, NICE said.

The guideline recommends, among other things, that:

  • Commissioners and service providers should ensure patients have access to a local care network

  • Physical barriers, such as access to buildings, should be addressed to ensure patients can access primary and secondary health care, and participate in activities

  • Regular reviews for adults with cerebral palsy, tailored to their needs and preferences should be considered

  • Adults with cerebral palsy who would like to live independently should be referred to a professional with expertise in independent living for advice

Abemaciclib for Breast Cancer

NICE issued draft guidance which recommended abemaciclib (Verzenios, Eli Lilly) with an aromatase inhibitor as an option for treating locally advanced or metastatic, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer as first endocrine-based therapy in adults.

An appraisal committee found that abemaciclib was as effective in treating the condition as both palbociclib (Ibrance, Pfizer) and ribociclib (Kisqali, Novartis), which NICE already recommends.

The decision was supported by clinical trial evidence which showed that abemaciclib with an aromatase inhibitor increased how long people lived without their disease getting worse, compared with an aromatase inhibitor alone.

Abemaciclib has been made available to the NHS at a discounted price under a patient access scheme

The manufacturer estimated that approximately 8000 women in England and Wales would be eligible for treatment with abemaciclib.

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