GPs warned about the risks of over-diagnosis after the National Institute for Health and Care Excellence (NICE) produced draft guidance recommending that more people at risk of cardiovascular disease should be offered blood-pressure-lowering medication.
Also this week, NICE approved funding for more people with severe to profound hearing loss to be fitted with cochlear implants.
Plus, NHS England clarified funding criteria for flash glucose monitoring devices for people with type 1 diabetes, effectively ending the controversial FreeStyle Libre postcode lottery.
Updated Hypertension Guideline
Thousands more people in England and Wales could be offered drugs to lower their blood pressure after NICE issued new treatment guidelines.
It said the draft clinical guideline would improve outcomes in cardiovascular disease (CVD) in line with the Government's long-term plan for the NHS.
The move was welcomed by some experts, although GPs' leaders warned about the risk of over-diagnosis.
The updated guidance recommended that blood pressure lowering drugs should be offered in addition to lifestyle advice to adults aged under 80 with persistent stage 1 hypertension who have one or more of the following:
Target organ damage
Established cardiovascular disease
An estimated 10-year risk of cardiovascular disease of 10% or more
An estimated 450,000 men and 270,000 women would fall into the category of having stage 1 hypertension and a CVD risk of between 10% and 20%. However, NICE acknowledged that it was difficult to be certain of numbers because there was variability in how the previous 2011 recommendation using a 20% cardiovascular threshold was being implemented in practice.
Anthony Wierzbicki, a consultant in metabolic medicine and chair of the guideline committee, said: "A rigorous evaluation of new evidence has resulted in updated recommendations around when to treat raised blood pressure that have the potential to make a real difference to the lives of many thousands of people with the condition.
"The guideline effectively shifts the focus to earlier intervention with lifestyle or drug treatment because this may slow the age-related deterioration of blood pressure. This would keep people well for longer and reduce the long-term need for multiple medications. It unifies and simplifies the advice given to GPs in implementing the NHS health check and it supports the NHS long-term plan's aim to improve chronic disease prevention.
"The guideline also places a greater emphasis on achieving and maintaining blood pressure targets as many people with high blood pressure are undertreated."
The Royal College of GPs (RCGP) said CVD prevention was vital but it had concerns about unintended harms of prescribing medication to groups of patients when the benefits might be limited.
Prof Helen Stokes-Lampard, RCGP chair, said: "Lowering the threshold for making a diagnosis of hypertension … a condition that already affects a very large number of patients in the UK – is likely to affect thousands, if not millions of patients, so this decision must not be taken lightly and must be evidence-based.
"Clinical guidelines are regularly updated to take into account the most current research and make recommendations of how to implement it in the best interests of patients. Now that this draft guideline is open for consultation, we would encourage experts in the area to respond to express their views."
Prof Liam Smeeth, head of the Department of Non-Communicable Disease at the London School of Hygiene & Tropical Medicine, said the guidance "remains reliant on somewhat arbitrary thresholds that divides people into those with 'hypertension' and those without.
"This guideline does recognise the importance of risk of vascular disease, but continues to suggest that treatment should largely be determined by blood pressure thresholds," he said. "I would suggest we should be moving towards a more unified approach to cardiovascular disease prevention, identifying people at high risk and targeting all their major risk factors rather than seeing blood pressure in isolation."
Consultation on the draft guidelines closes on the 23rd April 2019.
Hundreds more children in England and Wales with severe to profound hearing loss will be eligible for cochlear implants following new recommendations.
The final guidance came after a review of the definition of severe to profound hearing loss.
It is now recognised as only hearing sounds louder than 80dB HL at two or more frequencies without hearing aids. Previously it was defined as only hearing sounds louder than 90dB HL.
Meindert Boysen, director of the Centre for Technology Evaluation, said: "The new eligibility criteria for cochlear implants will ensure that they continue to be available on the NHS to those individuals who will benefit from them the most.
"As previously, cochlear implants should only be considered in those who do not receive adequate benefit from acoustic hearing aids. The hearing test that should be used to assess this in adults has also been updated."
Vicki Kirwin, a children's audiologist at the National Deaf Children's Society, said: "With this updated guidance, Britain will go from having some of the strictest criteria in the developed world for accessing cochlear implants to being at the forefront of giving this technology to deaf children."
It was estimated that the updated guidance could mean a total of 2150 people in England being eligible for cochlear implants each year by 2024-25 – an increase of 71% on the current figure of 1260 people.
The total cost of a cochlear implant for one ear including the surgery is £22,919, and for two ears is £37,904.
The annual cost associated with implementing the guidance was anticipated to be around £5.5m in the first year, rising to around £30 million after 6 years, NICE said.
Withdrawal of Surgical Mesh Products
One of the main manufacturers of surgical mesh in the UK announced it was voluntarily withdrawing all its products for vaginal implants.
CR Bard, owned by Becton, Dickinson and Company (BD), was withdrawing all surgical mesh used for stress urinary incontinence and pelvic organ prolapse from hospitals and distribution centres, the Medicines and Healthcare products Regulatory Agency (MHRA) said.
A spokesperson for the MHRA said: "It’s important to note, there are no specific safety concerns associated with this recall and there is no need for people to have the device removed or have any extra follow-up checks."
The deadline for withdrawal was set for 21st March 2019.
Flash Glucose Monitoring
National minimum criteria for flash glucose monitoring devices were published by NHS England as part of its commitment to ending the FreeStyle Libre postcode lottery.
The guidance set out the criteria for flash glucose monitoring and the maximum amounts clinical commissioning groups would be reimbursed for the ongoing costs of flash glucose sensors in accordance with pledges made in the NHS long-term plan.
The type 1 diabetes charity, JDRF, said that despite some access limitations, the postcode lottery for flash in England had been effectively ended.
Spokesperson Karen Addington, said: "We are delighted that these new guidelines will effectively end the inequity of access to flash glucose monitoring that people living with type 1 diabetes have experienced, based simply on where they live in England.
"JDRF has worked with NHS England and partners to secure this outcome and look forward to supporting the implementation in April."
The charity said that NHS commissioning bodies in Northern Ireland, Wales, and most of Scotland had already agreed to provide the technology, although criteria affecting who received it was variable.
Two Psoriasis Treatments
In a draft appraisal, NICE announced it would recommend tildrakizumab (Ilumetri, Almirall), for patients with moderate to severe plaque psoriasis.
It overturned previous draft guidance rejecting the treatment after the manufacturer offered a price discount.
Clinical trial results showed that tildrakizumab improved severe psoriasis more than placebo or etanercept, (Enbrel, Wyeth Pharmaceuticals) – a drug which is already recommended by NICE.
Final guidance was expected on 17th April 2019.
NICE also announced in draft guidance that it would recommend certolizumab pegol (Cimzia, UCB Pharma) as a treatment option for adults with severe plaque psoriasis, subject to certain conditions being met.
An appeal period for the appraisal will conclude on 22nd March 2019.
Benralizumab for Asthma Control
In final guidance, NICE recommended benralizumab (Fasenra, AstraZeneca), as an add-on therapy for treating severe eosinophilic asthma that is inadequately controlled in adults despite maintenance therapy with high-dose inhaled corticosteroids and long-acting beta-agonists.
Conditions for treatment were that:
The patient agreed to and followed the optimised standard treatment plan
The blood eosinophil count had been recorded as 300 cells per microlitre or more and the person had four or more exacerbations needing systemic corticosteroids in the previous 12 months, or had continuous oral corticosteroids of at least the equivalent of prednisolone 5 mg per day over the previous 6 months
The blood eosinophil count had been recorded as 400 cells per microlitre or more with three or more exacerbations needing systemic corticosteroids in the past 12 months
NICE said that clinical trial results showed that taking benralizumab plus standard treatment reduced exacerbations and the use of oral corticosteroids, compared with placebo.
The manufacture had agreed to provide the drug at a confidential discount to the list price, NICE said.
Blinatumomab for Leukaemia
NICE asked for further evidence on blinatumomab (Blincyto, Amgen) for the treatment of adults with minimal residual B-precursor acute lymphoblastic leukaemia in remission.
The committee concluded that blinatumomab had significant clinical benefits but that further evidence on cost-effectiveness was needed from the manufacturer before the case for routine NHS funding could be evaluated.
The average cost of blinatumomab for each treatment cycle at the list price is £56,476.
A second appraisal committee meeting was scheduled for 3rd April 2019.
Intrapartum Care for Some Women During Pregnancy
NICE updated its guideline that covered care during labour and birth for women who need extra support because they have a medical condition or complications in their current or previous pregnancy.
The guideline also covered women who have had no antenatal care.
Prof Liam Smeeth reports grants from Wellcome, MRC, NIHR, BHF, Diabetes UK, ESRC and the EU; grants and personal fees for advisory work from GSK, and personal fees for advisory work from AstraZeneca. He is a Trustee of the British Heart Foundation and a member of the steering committee for UK Biobank. He is the principal investigator of the NIHR funded StatinWise trial established to investigate whether statins cause muscle symptoms .
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Cite this: Peter Russell. NICE Updates Blood Pressure Guidelines - Medscape - Mar 08, 2019.