Improving the availability of drugs and devices

NICE technology appraisals provide recommendations on the use of new and existing medicines and treatments within the NHS. Based on reviews of clinical and economic evidence the guidance recommends whether a medicine or treatment represents value for money for the NHS.

NICE is asked to look at particular drugs and devices when the availability of the drug or device varies across the country. This may be due to different local prescribing or funding policies, or because there is confusion or uncertainty over its value. Our advice ends the uncertainty and helps to standardise access to healthcare across the country.

New process for developing TAs calls for greater transparency

In September 2014, we launched an updated version of the process guide we use for developing technology appraisal guidance. This followed a public consultation which received responses from over 50 external organisations including a number of pharmaceutical companies and the Association of the British Pharmaceutical Industry.

The update outlines a drive for greater access to clinical trial data when appraising new drugs. It strengthens the section on information handling to ensure that medical directors sign a declaration when their companies make submissions to NICE that all relevant clinical data have been made available to NICE.

Further changes help speed up the appraisal process by allowing for earlier decision problem meetings so that any potential issues with the methodology or presentation of clinical trial data can be discussed.

Professor Carole Longson, Director for the Health Technology Evaluation Centre at NICE, said: “We strongly believe that all clinical trial data should be made available so that those with responsibility for developing guidance and making treatment decisions have all the necessary information to hand to help them do so safely and efficiently.

“Our technology appraisals process guide has been strengthened to ensure that NICE gets all the relevant clinical trial data needed to develop our recommendations.”

Positive recommendations for treatments on blood clots

Over the course of the year we published 30 technology appraisals on treatments for conditions such as kidney cancer, heart arrhythmia and type 2 diabetes.

In December 2014, we published guidance which had positive recommendations on the use of dabigatran to treat and prevent recurrent and potentially fatal blood clots in the legs and lungs in adults.

Around 1 in every 1000 people in the UK is affected by deep vein thrombosis (DVT), a condition that increases in risk with age. Further risk factors include a previous DVT or pulmonary embolism, obesity and the presence of comorbidities such as heart disease.

In current practice, people with suspected DVT or a pulmonary embolism are generally treated immediately with anticoagulant drugs, most commonly with injections of low molecular weight heparin.

When the diagnosis has been confirmed, it is overlapped with an oral anticoagulant, such as warfarin. The usual length of treatment is for 3 months or more, though this can be life-long in certain patients to prevent further episodes.

However, some patients find warfarin inconvenient due to the need for careful monitoring, and regular blood tests which require frequent clinic visits to ensure the blood’s clotting properties remain within acceptable limits.

Following our guidance, patients can now be offered dabigatran etexilate to prevent recurring DVT and pulmonary embolism in adults.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “For many people, using warfarin can be difficult because of the need for frequent tests to see if the blood is clotting properly, and having to adjust the dose of the drug if it is not.

“The Appraisal Committee felt that dabigatran represents a potential benefit for many people who have had a DVT or a pulmonary embolism, particularly those who have risk factors for recurrence of a blood clot and who therefore need longer term treatment.

“We are pleased, therefore, to be able to recommend dabigatran as a cost-effective option for treating DVT and pulmonary embolism and preventing further episodes in adults.”

NICE recommends drug to help cut drink dependence

In November, we produced guidance that recommends the use of nalmefene as a treatment option to help people who are dependent on alcohol to cut down on the amount they drink.

There were around 1.2 million hospital admissions in England in 2012/13 due to an alcohol-related condition or injury. Estimates suggest alcohol-related harm costs the NHS in England £3.5bn a year.

Nalmefene, also called Selincro, is taken as a tablet once a day on an as-needed basis and reduces the urge to drink. The drug is licensed for use alongside psychosocial support to help people reduce their alcohol consumption and give them the encouragement they need to continue with their treatment.

It is recommended in line with its marketing authorisation for men who drink more than 7.5 units per day and for women who drink 5 units a day. According to the manufacturer’s submission, 35,000 people are expected to be given nalmefene whilst receiving a psychosocial intervention.

Compared with placebo plus psychosocial support, nalmefene plus psychosocial support can reduce heavy drinking days by 3.2 days/month and reduce total alcohol consumption by 1.8 units/day. Nalmefene costs £42.42 for a 14-tablet pack. Assuming it is used for approximately 60 per cent of the time, as used in studies, the cost of a 28-day supply is estimated to be £48.48.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “Many people have a difficult relationship with alcohol even though they have a very stable lifestyle, maintain jobs and a social life and would not automatically assume they have a problem. But regularly drinking over the recommended daily amount of alcohol can seriously damage your health.

“Those who could be prescribed nalmefene have already taken the first big steps by visiting their doctor, engaging with support services and taking part in therapy programmes. We are pleased to be able to recommend the use of nalmefene to support people further in their efforts to fight alcohol dependence.

“When used alongside psychosocial support nalmefene is clinically and cost effective for the NHS compared with psychosocial support alone.”