ITP and ITT

NHS England has established an Innovation and Technology Payment (ITP) and NHS Innovation Accelerator (NIA) Programme to fast track the introduction and adoption of innovations.

The ITP and NIA are intended to help reduce the difficulties experienced by innovators and clinicians in achieving uptake and spread of technologies and services across the NHS.


Innovation and Technology Payment and Innovation and Technology Tariff

The Innovation Technology Payment (ITP) and predecessor, the Innovation and Technology Tariff (ITT) removes financial or procurement barriers to the uptake of products and technologies. It achieves this by:

  • removing the need for multiple price negotiations between providers and suppliers;
  • guaranteeing automatic reimbursement by NHS England when an approved innovation is used; and
  • allowing NHS England and the Department of Health to negotiate national “bulk buy” discounts on behalf of hospitals, GPs and patients.
Implementation of ITT initiatives in the North East and North Cumbria
  • Locally, a clinical evaluation of Episcissors-60 (fixed angle scissors which take away human error in estimating episiotomy angles during childbirth and minimise the risk of obstetric and anal sphincter injury) has been commissioned from five maternity units in the region, coordinated by The Newcastle upon Tyne Hospitals NHS Trust, with a qualitative evaluation of the adoption process led by Newcastle University. A final report is due soon.
  • There is growing interest in myCOPD, a web-based application for the self-management of COPD, which has been taken up by two CCGs by June 2018, with more to follow in the near future.
  • The Non-Injectable Arterial Connector (NIC), which prevents accidental injection of IV medication into arterial lines, is being piloted in a number of areas (intensive care, theatre suite and two wards) for six months commencing May 2018 at The Newcastle upon Tyne Hospitals NHS Foundation Trust.
  • The Urolift day case procedure for treatment of lower urinary tract symptoms of benign prostatic hyperplasia is provided by three Trusts in the region (City Hospitals Sunderland NHS Foundation Trust, The Newcastle upon Tyne Hospitals NHS Foundation Trust and South Tees Hospitals NHS Foundation Trust). This procedure has a distinct tariff under the Payment by Results system.
  • The Pneux for prevention of ventilation associated pneumonia in critically ill patients has yet to be taken up by any Trusts in the region.
  • Frozen Faecal Microbiota Transplantation (FMT), the provision of a screened, specially prepared stool administered via a nasal tube into the intestine to restore the balance of bacteria within the gut to treat recurrent Clostridium Difficile Infection, is expected to be available in the summer 2018 under this initiative.

Case studies for the above ITT innovations can be found in the AHSN NENC Innovation Library

ITP initiatives (announced by NHS England in April 2018)

The AHSN will be seeking opportunities for adoption across the region for:

  • Heartflow – Rapid diagnosis of patients with suspected Coronary Heart Disease (CAD) using advanced image analysis software (only for Trusts with >700 CT angiographies per annum).
  • Plus Sutures – Reduction of Surgical Site Infections (SSI) through the use of antimicrobial suture packs (only for Trusts with a greater than 4% infection rate and therefore no local trusts are eligible).
  • Endocuff – Improved colorectal examination for patients undergoing bowel cancer screening (six Trusts in the region were involved in the clinical trial of Endocuff Vision).
  • SecurAcath – Improved stability and reduced infection risk for patients with a peripherally inserted catheter.
ITP initiatives (announced by NHS England in June 2019)

NHS England announced details of further innovations which will be fast-tracked into use in the NHS through the Innovation and Technology Payment 2019/20 programme, supported by the AHSN Network.read the full press release and the AHSN Network response to the announcement.

A series of webinars are running on the new ITP innvations – find out more.

The innovations are:

 

Challenge/problem identified

Around 14,000 men a year receive radiotherapy as a treatment option for prostate cancer.

As the rectum is very close to the prostate, it can inadvertently receive high dose radiation during radiotherapy, causing rectal toxicity. Side effects of rectal toxicity are common and include radiation proctitis, diarrhoea, rectal bleeding, painful defaecation and faecal urgency.  These debilitating side effects can linger for many years, and significantly diminish a patient’s quality of life.

Symptoms can range from mild to severe and may require hospital treatment – according to data from the National Prostate Cancer Audit 2018, one in ten men will suffer a severe gastrointestinal complication within two years of undergoing radiotherapy to treat their prostate cancer.

Solution

To address the issue of rectal toxicity, Augmenix Inc (acquired by Boston Scientific in October 2018) developed SpaceOARTM Hydrogel.

SpaceOAR is a soft, absorbable polyethylene glycol (PEG) gel spacer that is injected into the space between the prostate and the rectum prior to prostate radiotherapy. It pushes the rectum away from the prostate to decrease a patient’s exposure to rectal radiation during radiotherapy, which is proven to reduce to reduce short and long-term radiation exposure side-effects.

It remains in place for around three months, and then liquefies. It is naturally absorbed and cleared from the body via the kidneys within around six months.

The gel is inserted via one injection and because it is a minimally invasive procedure, it can be carried out under local or general anaesthesia. A team of dedicated international clinical specialists provide clinicians with training through a certification programme.

Impact

SpaceOAR™ Hydrogel is clinically proven to minimise urinary, sexual, and bowel side-effects of radiation therapy. There are over 60 clinical publications on SpaceOAR, including a 222-patient prospective multicentre randomised clinical study with three-year follow up data which demonstrated:

  • 73% relative reduction in rectal V70 (radiation to the rectum)
  • 75% reduction in rectal toxicity at three years
  • No grade 2+ rectal toxicity at three years in the SpaceOAR arm
  • 67% of men maintained potency at three years compared to 38% in the control group
  • Control patients were eight-times more likely to experience a decline in bowel, sexual or urinary quality of life compared to the SpaceOAR arm.

As a result, follow-up care costs including for physician visits, endoscopy procedures, hospital stays and medication can be reduced.

Over 35,000 patients worldwide have benefitted from the SpaceOAR hydrogel procedure and there are currently nine NHS hospitals using SpaceOAR.

Find out more

www.spaceoar.co.uk

Mark Buckley, International Marketing Manager

E: Mark.Buckley@bsci.com

T: +44 7920 834 458

Twitter: https://twitter.com/spaceoar

Facebook: https://www.facebook.com/SpaceOAR/

Challenge/problem identified

Cluster headaches are excruciating attacks of pain in one side of the head, often felt around the eye. Cluster headaches (CH) are rare.  Anyone can get them, but they’re more common in men and tend to start when a person is in their 30s or 40s. Around 66,000 people in the UK experience cluster headache.

Current treatments and therapies can be limited by side effects, and the off-label use of medications designed for the treatment of unrelated conditions is common.

Cluster headaches are estimated to cost the NHS in England in excess of £10,000 a year, on average per patient on average.

High-flow oxygen cylinders may be sent to a patient’s home to provide acute pain relief during an attack, but this can be impractical and requires regular re-fills and maintenance.

It is estimated that for 5% of people with cluster headache, standard care will not work or be unsuitable, or for whom standard treatment has been unsuccessful or in people who cannot have other prescribed treatments.

Many patients do not gain adequate control of their condition and as such remain ‘treatment refractory’. These patients may end up being referred for an expensive surgical procedure as their last chance of achieving treatment success.

Solution

electroCore™ have developed a device called gammaCore™ which administers vagus nerve stimulation non-invasively by delivering a proprietary signal through the skin to either the right or the left branches of the vagus nerve in the neck.

Stimulating the vagus nerve affects many important autonomic functions in the brain and in the body, including neurotransmitters and inflammation levels.

A large body of clinical evidence supports the use of non-invasive vagus nerve stimulation (nVNS) in the treatment of primary headache conditions including the acute and preventive treatment of cluster headache.

gammaCore™ is a simple-to-use, handheld medical device that enables patients to self-administer discrete doses of nVNS therapy both prophylactically and acutely in the management of their CH. gammaCore works by sending a mild electrical stimulation through the skin to activate the vagus nerve from outside the body.

gammaCore differs from other vagus nerve stimulators in being applied to the skin of the neck rather than implanted by a surgical procedure.

Note: gammaCore can only be prescribed by a specialist in primary or secondary care.

Impact

Real world evidence from headache experts shows that in clinical practice, gammaCore is effective in approximately 50% of patients with CH.

Patients who respond typically experience reductions in the frequency, duration and severity of CH attacks, and some may even find the condition is placed into remission.

electroCore currently provides 93 consecutive days of nVNS therapy, at no cost to the NHS. This introductory, patient-by-patient, evaluation identifies positive nVNS responders. Only those patients deemed to be responders will continue onto paid for therapy.

Cost-savings are realised as CH symptoms are reduced and the need for expensive acute rescue medication usage becomes less. There may also be a reduction in the use of general healthcare services, such as outpatient appointments, telephone consultations, GP visits and A&E attendances, as a consequence of an improvement in prophylactic control as the patient is able to better manage their CH symptoms with gammaCore.

Find out more

www.gammaCore.co.uk

www.electroCore.com

E: customerserviceuk@electroCore.com iain.strickland@electroCore.com

 

Twitter: @ElectroCoreVNS

LinkedIn: www.linkedin.com/company/electrocore/

Challenge/problem identified

Pre-eclampsia (PE) is a multisystem hypertensive disorder of pregnancy that affects approximately 3% of all pregnancies, however to date there has been no definitive test to diagnose PE. The exact cause of the condition is unknown, but it is thought to occur when the placenta becomes dysfunctional or “unwell”, and the only way to cure PE is to deliver the baby.

If the disease is allowed to progress, it can result in maternal organ failure and foetal growth restriction and in some cases foetal or maternal death. Clinical teams therefore have a high degree of suspicion for the disease and a low threshold to admit pregnant women with suspected PE, placing unnecessary burden on the healthcare system and causing unnecessary anxiety for the woman and her family.

PlGF-based testing can help with clinical risk stratification for women with suspected pre-eclampsia, meaning they can be treated appropriately according to their need, improving both patient experience and outcomes and improving the use of scarce system resources.

 

Solution

Preterm pre-eclampsia is caused by defective placentation. As the baby grows and places increased demand on a poorly functioning placenta, the consequential maternal (pre-eclampsia) and foetal (growth restriction) disorders place the pregnancy at increased risk for eclampsia and stillbirth, respectively.

The Quidel Triage PLGF test is a point-of-care or laboratory quantitative immunoassay for the measurement of placental growth factor (PLGF).

Circulating maternal PLGF levels are abnormally low in pregnancies with defective placentation. The test is used to help detect abnormal placentation in pregnancies where there is clinical suspicion of preterm pre eclampsia. PLGF helps clinicians and midwives to accurately diagnose pre-eclampsia and to assess the risk for complications associated with pre-eclampsia.

Clinical decision points and a clinical management algorithm, using three PLGF-based ‘risk groups’ integrated into the NICE Hypertension in Pregnancy Clinical Guideline (CG107), have been developed and validated in NHS England University maternity units (the PELICAN Study and the PARROT Study).

Impact

The PELICAN Study demonstrated that PLGF measured on the Triage platform is a better predictor of pregnancy outcome (pre-eclampsia requiring delivery within 14 days) than all standard of care tests (ie blood pressure, proteinuria, liver enzymes, and uric acid). The Triage PLGF test has high clinical sensitivity (96%) with a high NPV (98%) and high specificity (96%) with a high PPV (94%), respectively.

The PARROT Study validated the Triage PLGF test in 11 NHS England maternity hospitals in a stepped-implementation study where hospitals gradually phased-in PLGF-guided clinical management of suspected preterm pre-eclampsia. Triage PLGF helped clinicians and midwives make more appropriate clinical decisions (ie when to schedule the next out-patient clinic appointment, whether to order a specialist ultrasound scan and whether to consider hospital admission, etc).

Predicted cost-savings are £635 per woman with suspected pre-eclampsia over the rule-out interval (14 days) or £36,069 per 1,000 pregnant women, of whom 56 (managed by PLGF testing) will have suspected pre-eclampsia before 35 weeks of gestation. Therefore, a maternity unit with 10,000 deliveries each year could achieve savings of £360,690 per annum (Source 3).

PLGF testing on Triage removes clinical uncertainty, allows faster diagnoses and decision-making, and removes both the burden and uncertainty/anxiety placed by possible pre-eclampsia on pregnant women, their families, healthcare workers and maternity services.

Find out more

www.quidel.com/immunoassays/triage-test-kits/triage-plgf-test

Customer enquiries: emeacustomerservice@quidel.com

Technical support: emeatechnicalsupport@quidel.com

Roche Diagnostics Elecsys® sFlt-1:PlGF ratio test

Challenge/problem identified

Pre-eclampsia (PE) is a multisystem hypertensive disorder of pregnancy that affects approximately 3% of all pregnancies, however to date there has been no definitive test to diagnose PE. The exact cause of the condition is unknown, but it is thought to occur when the placenta becomes dysfunctional or “unwell”, and the only way to cure PE is to deliver the baby.

If the disease is allowed to progress, it can result in maternal organ failure and foetal growth restriction and in some cases foetal or maternal death. Clinical teams therefore have a high degree of suspicion for the disease and a low threshold to admit pregnant women with suspected PE, placing unnecessary burden on the healthcare system and causing unnecessary anxiety for the woman and her family.

PlGF-based testing can help with clinical risk stratification for women with suspected pre-eclampsia, meaning they can be treated appropriately according to their need, improving both patient experience and outcomes and improving the use of scarce system resources.

 

Solution

The test measure two proteins, both are known to be involved in the development of the placenta during pregnancy and reduce placental blood flow to the baby. In a pre-eclamptic placenta the sFlt-1 will be higher than expected and the PlGF will be lower than expected. Both can be measured weeks before the onset of symptoms.

Measuring both markers is important; sFlt-1 is the mechanism behind the development of PE, the increased sFlt-1 binds to the receptors of the free PlGF causing its reduction.

The ratio test can successfully rule out pregnant women who do not have PE and have a low chance of developing it (>99% accuracy over the next seven days and >97% accuracy over the next four weeks) up to 36+6 weeks of pregnancy. This prevents their initial admission for the suspicion of PE, also allowing an appropriate regimen of planned care to be delivered providing better care for individual women and more efficient use of NHS resources.

Impact

Positive impacts identified from the implementation of the ratio test pathway by existing users are listed below:

  • Improved patient safety through accurate diagnosis on the suspicion of PE
  • Reduced (unnecessary) admissions for suspected PE
  • Improved patient experience by reducing anxiety and the need to be in hospital
  • Improved maternity capacity due to needing to monitor fewer women
  • Improved community midwifery capacity due to reduction in follow-on appointments
  • Reduced direct costs to the system relating to inpatient monitoring tests for woman and foetus. This includes keeping more women on the most appropriate treatment pathway (standard, intermediate or intensive) avoiding PE-related escalation and related cost pressures.

Find out more

www.diagnostics.roche.com/global/en/products/params/elecsys-sflt-1-plgf-preeclampsia.html

E: burgesshill.accessinnovation@roche.com

Twitter: @RocheDiaUK

Facebook: /Roche-Diagnostics-Ltd

LinkedIn: /roche

Roche Elecsys® Troponin T-hs test

Challenge/problem identified

Chest pain, with the suspicion of myocardial infarction (MI or heart attack), is responsible for around 700,000 emergency department attendances per year and over 253,765 emergency admissions in England and Wales. This accounts for approximately 5% of all emergency admissions.

However, only approximately 20% of emergency admissions for chest pain will be diagnosed with MI. Therefore, it is important to diagnose true MI cases as early as possible to ensure access to effective treatment for patients who need it. In parallel, it is also crucial to discharge non-MI cases to avoid unnecessary hospital admissions.

With the current pressures on the emergency department (ED), there is a great need for tools that can support quicker discharge from the ED.

Solution

The Roche Elecsys® Troponin T-hs (TnT-hs) test supports a faster diagnosis of acute myocardial infarction (MI or heart attack). Two blood tests are performed one or three hours apart compared to standard testing (10-12 hours apart). This supports an earlier detection of acute MI within four hours of presentation at the ED, as long as test results are rapidly available and a final clinical decision is based on multiple factors.

This improvement in time-to diagnosis enables a more efficient allocation of resources, by reducing the fines paid by trusts for delayed discharge from the ED and potentially by reducing unnecessary hospital admission. It also improves patient experience by reducing time-to-discharge and by targeting the right care to the true MI cases.

Impact

Implementing the Roche Elecsys® high-sensitivity troponin test would:

  1. Improve the management of patients and patient experience. Studies demonstrated that rapid TnT-hs testing can reduce time-to-discharge (1): >75% of patients were rapidly ruled ‘out’ or ‘in’ in the ED and approximately 70% were safely sent home. (2)
  2. Improve clinical confidence as “it is likely that high-sensitivity troponin testing will detect additional people who would benefit from treatment in practice.” (3)
  3. Lead to the application of a validated rapid protocol and the NICE DG15 guidance. (3)
  4. Standardise care which would reduce length of stay in the ED and improve compliance with the four-hour discharge from the ED target. Currently, “16.5% of hospital A&E attendees spent longer than 4 hours in the department in 2017, compared with 5.6% in 2012” (4).
  5. Produce cost savings. An economic evaluation found that the implementation of the one-hour TnT-hs protocol resulted in a reduction of 46% in total costs per patient compared to standard practice (4).

 

Find out more

E: burgesshill.accessinnovation@roche.com

Social media (Twitter / Facebook / LinkedIn)

Twitter: @RocheDiaUK

Facebook: /Roche-Diagnostics-Ltd

LinkedIn: /roche