NICE UPDATE for COMMISSIONERS November 2020
South, Central and West NICE UPDATE FOR COMMISSIONERS November 2020
This NICE Update for Commissioners includes:
Coronavirus (COVID-19) guidance NICE published rapid guidelines and evidence reviews
At-a-glance summary Headline update: what’s been published?
Guidance and quality standards published by NICE in November 2020 What’s new for CCGs?
Horizon scanning What’s coming out from NICE in the next six months?
NICE guidance in consultation What NICE guidance is in consultation?
For your reference, a summary of the types of NICE guidance Reference – a guide to NICE products
The next (December 2020) NICE Update for Commissioners will be issued at the beginning of January 2021.
For further information about NICE guidance and its implementation contact:
Tiina Korhonen, Clinical Effectiveness Lead Kim Tie, Clinical Effectiveness Manager Kathryn Markey, Clinical Effectiveness Manager Katie Newens, Clinical Effectiveness Researcher Kate Forbes, Clinical Effectiveness Manager Rachel Finch, Clinical Effectiveness Administrator Rebecca Hodge, Clinical Effectiveness Manager Helen Hicks, Clinical Effectiveness Administrator Jenny Kovalaine-Kwan, Clinical Effectiveness Manager [email protected]
SCWCSU/Clinical effectiveness/v1.0 Page 1 of 20
NICE Coronavirus (COVID-19) Rapid guidelines and evidence reviews
NICE is currently developing and updating rapid guidelines and evidence reviews to support the NHS and social care to respond quickly to the challenges of the coronavirus pandemic.
Rapid guidelines are developed in collaboration with NHS England and NHS Improvement and a cross-speciality clinical group, supported by the specialist societies and royal colleges. These guidelines are developed using the NICE interim process and methods for developing rapid guidelines on COVID-19.
Rapid evidence reviews will look at whether certain medicines or treatments may affect the severity or length of COVID-19 illness.
NICE is also working with the Medicines and Healthcare products Regulatory Agency (MHRA) to facilitate rapid review of information and advice on the safety and efficacy of treatments for COVID-19.
The following COVID rapid guidelines have been published or updated:
Guidance type and Title Overview reference
COVID-19 rapid COVID-19 rapid guideline: In this update, NICE removed the option to defer treatments that prevent long-term guideline NG161 delivery of systemic anticancer complications, and amended guidance on treatments suitable for home delivery. Update treatments COVID-19 rapid COVID-19 rapid guideline: This guideline covers pharmacological VTE prophylaxis for patients being treated for guideline NG186 reducing the risk of venous COVID-19 pneumonia. It includes patients receiving treatment in hospital or in a thromboembolism (VTE) in community setting such as a ‘hospital at home’ service or COVID-19 ‘virtual ward’. over 16s with COVID-19 The guideline applies to all patients with COVID-19 pneumonia, including those who have other conditions. For guidance on VTE prophylaxis for hospital patients who do not have COVID-19 pneumonia, see the NICE guideline NG89 on venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism.
SCWCSU/Clinical effectiveness/v1.0 Page 2 of 20
At-a-glance summary
The table below shows all NICE guidance published in November 2020. New guidelines, or those likely to have a significant impact for CCG commissioners, are discussed further in the ‘What’s new for Clinical Commissioning Groups’ section (link to relevant section provided within guidance reference).
Guidance type and Title Commissioner(s) Main providers(s) Impact for CCG commissioners (financial reference /public interest/quality of care)
Technology appraisal Guidance on the use of NHS England and Secondary care Recommendation 1.1 was updated to be in guidance TA71 Update coronary artery stents CCGs line with the recently published NICE guideline on acute coronary syndromes. See NICE guideline NG185 below for more details. Technology appraisal Drug-eluting stents for the NHS England and Secondary care Recommendation 1.1 was updated to be in guidance TA152 treatment of coronary artery CCGs line with the recently published NICE Update disease guideline on acute coronary syndromes. See NICE guideline NG185 below for more details. Technology appraisal Siponimod for treating NHS England Secondary care guidance TA656 secondary progressive multiple sclerosis Technology appraisal Carfilzomib for previously NHS England Secondary care guidance TA657 treated multiple myeloma
Technology appraisal Isatuximab with NHS England Secondary care guidance TA658 pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma Technology appraisal Galcanezumab for CCGs Secondary care NICE estimates that potential savings can be guidance TA659 preventing migraine made in the form of: reduced GP appointments and burden on acute healthcare SCWCSU/Clinical effectiveness/v1.0 Page 3 of 20
Guidance type and Title Commissioner(s) Main providers(s) Impact for CCG commissioners (financial reference /public interest/quality of care)
providers, improved clinic capacity due to reduced uptake of botulinum toxin A; reduced use of triptans; and reduction in economic burden through reducing frequency of migraine days. Technology appraisal Darolutamide with androgen NHS England Secondary care guidance TA660 deprivation therapy for treating hormone-relapsed non-metastatic prostate cancer Technology appraisal Pembrolizumab for NHS England Secondary care guidance TA661 untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma Technology appraisal Durvalumab in combination Terminated appraisal guidance TA662 for untreated extensive- stage small-cell lung cancer NICE Guideline NG184 Human and animal bites: CCGs Primary care and This guideline aims to optimise antibiotic use antimicrobial prescribing Secondary care and reduce antibiotic resistance. Although NICE have not produced an impact report or statement for this guideline, it is possible that savings may arise from a reduction in antibiotic prescribing and complications associated with antibiotic resistance.
SCWCSU/Clinical effectiveness/v1.0 Page 4 of 20
Guidance type and Title Commissioner(s) Main providers(s) Impact for CCG commissioners (financial reference /public interest/quality of care)
NICE Guideline NG185 Acute coronary syndromes NHS England and Primary care and There are 4 recommendations which are CCGs Secondary care likely to lead to a significant resource impact when implemented: Offer prasugrel as part of dual antiplatelet therapy with aspirin to people with acute ST-elevation myocardial infarction (STEMI) intended for treatment with primary percutaneous coronary intervention (PCI); Offer complete revascularisation with PCI for people with acute STEMI and multivessel coronary artery disease; Offer prasugrel or ticagrelor, as part of dual antiplatelet therapy with aspirin, to people with unstable angina and non-ST elevated myocardial infarction (NSTEMI) who are having coronary angiography; Offer ticagrelor, as part of dual antiplatelet therapy with aspirin, to people with unstable angina and NSTEMI when PCI is not indicated, unless they have a high bleeding risk.
NICE Quality Standard Acute coronary syndromes NHS England and Primary care and Changes have been made to align this quality QS68 Update in adults CCGs Secondary care standard with the updated NICE guideline on acute coronary syndromes. Statement 3 was amended to reflect that not all people in this group will have early invasive intervention, in line with the updated recommendations. The source guidance and references were also updated.
SCWCSU/Clinical effectiveness/v1.0 Page 5 of 20
Interventional Procedures Guidelines
Type of Guidance and Title Recommendation reference Interventional Swallowable gastric balloon Evidence on the safety of the swallowable gastric balloon capsule for weight loss procedures guidance capsule for weight loss shows infrequent but potentially serious adverse events: IPG684 For people who need to lose weight in the short term for medical reasons, the evidence of efficacy is adequate to support the use of this procedure provided that special arrangements are in place for clinical governance, consent and audit. For people who are aiming for long-term weight loss, the evidence on efficacy is inadequate in quantity and quality, so the procedure should only be used in the context of research.
What’s new for Clinical Commissioning Groups?
Technology Appraisals
Galcanezumab for preventing migraine https://www.nice.org.uk/guidance/ta659 Elevated calcitonin gene-related peptide (CGRP) blood concentrations have been associated with migraine attacks. Galcanezumab is a humanised IgG4 monoclonal antibody that binds with CGRP, thus preventing its biological activity. Galcanezumab is recommended as an option for preventing migraine in adults, only if: they have 4 or more migraine days a month at least 3 preventive drug treatments have failed and the company provides it according to the commercial arrangement.
Treatment with galcanezumab should be stopped after 12 weeks if: in episodic migraine (less than 15 headache days a month) the frequency does not reduce by at least 50% in chronic migraine (15 headache days a month or more with at least 8 of those having features of migraine) the frequency does not reduce by at least 30%.
Galcanezumab is available as a once monthly injection which can be self-administered. Training may be required before a person can self- administer the treatment at home. The list price of galcanezumab is £450.00 per 120mg injection (excluding VAT). The company has a commercial arrangement; and makes galcanezumab available to the NHS with a discount. The size of the discount is commercial in confidence.
SCWCSU/Clinical effectiveness/v1.0 Page 6 of 20
Impact: Galcanezumab is commissioned by CCGs and provided by NHS hospital trusts. NICE has produced a resource impact report and resource impact template for local use. NICE estimates that 144,000 people with episodic migraine and 59,000 people with chronic migraine are eligible for treatment with galcanezumab each year. Based on trial data for migraine frequency reduction of at least 50%, NICE estimates 48.8% of people’s episodic migraine responds to treatment at 12 weeks. Based on trial data for migraine frequency reduction of at least 30%, NICE estimates 57.5% of people’s chronic migraine responds to treatment at 12 weeks. People whose episodic or chronic migraine does not reduce by the levels above would stop treatment at 12 weeks.
The estimated uptake of galcanezumab predicted in future practice is much lower than the number of people eligible for treatment, particularly in people who have episodic migraine. This is because most episodic migraines are adequately treated with acute medication. Galcanezumab is most likely to be prescribed to people whose episodic migraine is higher frequency and who are referred on to secondary care.
As galcanezumab is effective in preventing migraine attacks in both episodic and chronic migraine, it has the potential to generate savings through a reduction in GP appointments, acute care visits and acute medication such as triptans. Reducing the frequency of chronic migraine attacks is likely to reduce the burden on healthcare providers. There may be a reduced use of pain medication such as triptans which could have potential savings; however, this is not included in the resource impact template as individual use is difficult to quantify. There is potential to free up clinic capacity if people choose galcanezumab instead of botulinum toxin A, because people whose migraine is responding to botulinum toxin A (around 50% of people) have four treatments per year (as per TA260), whereas people whose migraine is responding to galcanezumab may need two clinic attendances per year. Lastly, reducing frequency of migraine days has benefits on reducing the need for NHS interventions, and improving people’s ability to do their usual activities including work thereby potentially reducing economic burden due to migraine attacks.
Clinical Guidelines
Human and animal bites: antimicrobial prescribing https://www.nice.org.uk/guidance/ng184 This guideline sets out an antimicrobial prescribing strategy for human and animal bites (excluding insect bites) in adults, young people and children aged 72 hours and over. It aims to optimise antibiotic use and reduce antibiotic resistance. Recommendations include:
Managing human and animal bites o Assessment o Antibiotic prophylaxis for uninfected bites o Treating infected bites o Advice o Reassessment o Referral and seeking specialist advice Choice of antibiotic
SCWCSU/Clinical effectiveness/v1.0 Page 7 of 20
Impact: Treatment services for insect bites and stings are commissioned by CCGs; services are provided in both primary and secondary care. NICE have not produced an impact report or statement for this guideline, however it is possible that savings may arise from a reduction in antibiotic prescribing and complications associated with antibiotic resistance.
Acute coronary syndromes https://www.nice.org.uk/guidance/ng185 This guideline covers the early and longer-term (rehabilitation) management of acute coronary syndromes. These include ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina. The guideline aims to improve survival and quality of life for people who have a heart attack or unstable angina.
This guideline includes new and updated recommendations on:
dual antiplatelet therapy and antithrombin therapy for primary percutaneous coronary intervention (PCI) for acute STEMI complete revascularisation versus culprit vessel-only PCI for STEMI drug-eluting stents for acute STEMI dual antiplatelet therapy for STEMI not treated with PCI initial drug therapy for unstable angina and NSTEMI coronary angiography with follow-on PCI for unstable angina and NSTEMI managing unstable angina and NSTEMI not treated with PCI combination antiplatelet and anticoagulant treatment as secondary prevention for people with a separate indication for anticoagulation duration of beta-blocker treatment for people with reduced left ventricular ejection fraction after myocardial infarction (MI)
These supplement the existing recommendations on:
the early management of STEMI the early management of unstable angina and NSTEMI MI: secondary prevention and rehabilitation
Impact: NICE has produced a resource impact report and resource impact template for local use. NICE is currently reviewing impact on NHS workforce and resources and will publish the results shortly. Acute coronary services are commissioned by NHS England and CCGs. NHS England commission adult specialist cardiac services including complex cardiac rhythm management, complex interventional cardiology services and primary PCI for STEMI. CCGs commission other cardiology services including PCI for patients with stable angina and patients with NSTEMI. Providers are NHS hospital trusts. CCGs commission anticoagulant and antiplatelet treatments.
The following 4 recommendations will have the greatest resource impact nationally (for England), and will need the most additional resources to implement or potentially generate the biggest savings: SCWCSU/Clinical effectiveness/v1.0 Page 8 of 20
Offer prasugrel as part of dual antiplatelet therapy with aspirin to people with acute STEMI intended for treatment with PCI (recommendation 1.1.11) Evidence showed that prasugrel was more clinically effective than the other 2 treatment options in people with acute STEMI. Prasugrel costs more than clopidogrel but considerably less than ticagrelor. Nationally the overall effect of this recommendation will be a saving to the NHS. However, this recommendation will need to be assessed locally as the resource impact may vary depending on what is currently prescribed locally. Offer complete revascularisation with PCI for people with acute STEMI and multivessel coronary artery disease (recommendation 1.1.16) Treating people who have an acute STEMI and multivessel coronary artery disease with a complete revascularisation with PCI at their initial admission reduces costs for downstream revascularisation, although the initial procedure is more costly than treating the culprit vessel only. Treating multivessel disease as well as the culprit vessel will reduce the need for future treatment. It is expected that there will be savings from reduced mortality, myocardial infarction and repeat revascularisation at year 1. People having a multivessel intervention at their initial admission rather than being admitted twice are also less likely to experience anxiety and to benefit from being able to start cardiac rehabilitation sooner. Offer prasugrel or ticagrelor, as part of dual antiplatelet therapy with aspirin, to people with unstable angina and NSTEMI who are having coronary angiography (recommendation 1.2.17); and Offer ticagrelor, as part of dual antiplatelet therapy with aspirin, to people with unstable angina and NSTEMI when PCI is not indicated, unless they have a high bleeding risk (recommendation 1.2.20). NICE found that as a part of dual antiplatelet therapy, using prasugrel or ticagrelor with aspirin is more clinically effective than using clopidogrel with aspirin. There is a significant resource impact for people who change from receiving low cost treatment with clopidogrel (around £26 per annum) to receiving higher cost treatment with prasugrel or ticagrelor (around £105 and £661 per annum, respectively).
The estimated annual cost of implementing this guideline from year 5 once steady state (100% rate) is reached is equivalent to around £9,000 per 100,000 population. Acute coronary syndromes fall under programme budgeting category 10A Coronary Heart Disease. There is likely to be an increase in cost for drugs relating to the treatment of people with unstable angina or NSTEMI. There may be a small saving or a small cost from the recommendation to offer complete revascularisation for people with multi vessel disease, depending on the scenarios with future practice as described within the resource impact report (page 11 and 12). The health economic evidence that supports the guideline suggests that complete revascularisation for people with multi vessel disease is cost saving. NB: the patent for ticagrelor is due to run out in December 2024. It is expected that generic equivalents may become available after this time at lower costs. However it is not known what the cost would be for the alternatives and this has not been included in the model.
What’s coming out from NICE in the next six months
December 2020 Title Type of Funding considerations and other comments guidance
SCWCSU/Clinical effectiveness/v1.0 Page 9 of 20
Title Type of Funding considerations and other comments guidance Zio XT for detecting cardiac Medical Zio XT is recommended as an option for people with suspected cardiac arrhythmias arrhythmias (MTG52) Technology who would benefit from ambulatory electrocardiogram (ECG) monitoring for longer than 24 hours only if NHS organisations collect information. NICE expect this guidance to be initially cost incurring due to the cost of the biosensor device used in the Zio XT service. However, this cost may be offset by the capacity benefits expected to arise from a reduction in repeat tests and outpatient attendances. Further downstream benefits are anticipated with a potential reduction in strokes. This would be offset by any additional treatment costs that would be incurred to prevent a stroke. Venetoclax with obinutuzumab for Single FAD published. Draft guidance states that Venetoclax plus obinutuzumab is untreated chronic lymphocytic Technology recommended as an option for untreated chronic lymphocytic leukaemia (CLL) in leukaemia [ID1402] Appraisal adults, only if: • there is a 17p deletion or TP53 mutation, or • there is no 17p deletion or TP53 mutation, and fludarabine plus cyclophosphamide and rituximab (FCR), or bendamustine plus rituximab (BR), is unsuitable, and • the company provides the drug according to the commercial arrangement. Liraglutide for managing overweight Single FAD published. Draft guidance states that Liraglutide is recommended as an option for and obesity [ID740] Technology managing overweight and obesity alongside a reduced-calorie diet and increased Appraisal physical activity in adults, only if: • they have a body mass index (BMI) of at least 35 kg per m2 (adjust accordingly using lower thresholds for members of minority ethnic groups known to be at equivalent risk of the consequences of obesity at a lower BMI than the white population) and • they have non-diabetic hyperglycaemia (defined as a haemoglobin A1c level of 42 to 47 mmol per mol [6.0 to 6.4%] or a fasting plasma glucose level of 5.5 to 6.9 mmol per litre) and • they have a high risk of cardiovascular disease based on risk factors such as hypertension and dyslipidaemia and • it is prescribed in secondary care by a specialist multidisciplinary tier 3 weight management service. Upadacitinib for treating moderate Single FAD published. Draft guidance recommends upadacitinib with methotrexate as an to severe rheumatoid arthritis Technology option for treating active rheumatoid arthritis according to specific criteria in the [ID1400] Appraisal guidance. Caplacizumab with plasma Single FAD published. Caplacizumab with plasma exchange and immunosuppression is exchange and immunosuppression Technology recommended, within its marketing authorisation, as an option for treating
SCWCSU/Clinical effectiveness/v1.0 Page 10 of 20
Title Type of Funding considerations and other comments guidance for treating acute acquired Appraisal an acute episode of acquired thrombotic thrombocytopenic purpura (TTP) thrombocytopenic purpura [ID1185] in adults, and in young people aged 12 years and over who weigh at least 40 kg. Treatment should be started and supervised by physicians experienced in managing thrombotic microangiopathies. It is recommended only if the company provides caplacizumab according to the commercial arrangement. Diabetes (type 1 and type 2) in Clinical Guideline Draft guidance is now available. More information will be provided as the development children and young people: of the guidance progresses. However, this guideline is not expected to result in a diagnosis and management significant resource impact. (update) Diabetes in pregnancy: Clinical Guideline Draft guidance is now available. More information will be provided as the development management from preconception to of the guidance progresses. However, this guideline is not expected to result in a the postnatal period significant resource impact. Pembrolizumab with pemetrexed Single Guidance is still in early development stage. More information will be provided as the and platinum-based chemotherapy Technology development of the guidance progresses. for untreated non-small-cell lung Appraisal cancer (CDF Review of TA557) [ID1584] Mexiletine for treating myotonia in Single Guidance is still in early development stage. More information will be provided as the adults with non-dystrophic myotonic Technology development of the guidance progresses. disorders [ID1488] Appraisal
January 2021 Title Type of Funding considerations and other comments guidance Encorafenib in dual or triple therapy Single FAD published. NICE has recommended encorafenib plus cetuximab, within its for previously treated BRAF V600E Technology marketing authorisation, as an option for treating BRAF V600E mutation-positive mutation-positive metastatic Appraisal metastatic colorectal cancer in adults who have had previous systemic treatment. It is colorectal cancer [ID1598] recommended only if the company provides it according to the commercial arrangements. KTE-X19 for treating relapsed or Single Guidance is still in early development stage. More information will be provided as the refractory mantle cell lymphoma Technology development of the guidance progresses. [ID1313] Appraisal
SCWCSU/Clinical effectiveness/v1.0 Page 11 of 20
Title Type of Funding considerations and other comments guidance The PLASMA system for Medical Draft guidance states that the evidence supports the case for adopting the PLASMA transurethral resection of the Technology system for bipolar transurethral saline resection and haemostasis of the prostate in the prostate (MT217) NHS. Clinical outcomes are the same as for monopolar transurethral resection of the prostate, but PLASMA avoids the risk of transurethral resection syndrome and reduces the need for blood transfusion and the length of hospital stay. Exploratory economic modelling of Diagnostic Guidance is still in early development stage. More information will be provided as the SARS-CoV-2 viral detection point of Technology development of the guidance progresses. care tests and serology tests Suspected neurological conditions Quality Standard Support for commissioners will be provided by adding audience descriptors to the quality standard. No additional resource impact is expected on top of the impact associated with implementing the underpinning guideline. Selinexor with low-dose Single Guidance is still in early development stage. More information will be provided as the dexamethasone for treating Technology development of the guidance progresses. refractory multiple myeloma ID1535 Appraisal PredictSURE IBD and IBDX to Diagnostic Draft guidance states that there is not enough evidence to recommend the routine use guide treatment of Crohn’s disease Technology of thePredictSURE IBD and IBDX tests to help identify people at high risk of severe Crohn’s disease and guide treatment. Chronic pain: assessment and Clinical Guideline Based on draft recommendations it is expected that there will be a saving due to not management offering pharmacological interventions for people with chronic primary pain. This may be partially offset by increased referrals to exercise programs and the use of acupuncture. Metreleptin for treating Highly Guidance is still in early development stage. More information will be provided as the lipodystrophy (ID861) Specialised development of the guidance progresses. Technology Evaluation Multiple myeloma - lenalidomide Single ACD produced. Draft guidance states that lenalidomide is not recommended, within its (maintenance, post autologous Technology marketing authorisation, as maintenance treatment after an autologous stem cell stem cell transplantation) [ID475] Appraisal transplant for newly diagnosed multiple myeloma in adults. Crizanlizumab for preventing sickle Single ACD published. Draft guidance states that crizanlizumab is not recommended, within cell crises in sickle cell disease Technology its marketing authorisation, for preventing recurrent sickle cell crises (vaso-occlusive [ID1406] Appraisal crises) in people aged 16 or over with sickle cell disease. Brigatinib for ALK-positive Single Guidance is still in early development stage. More information will be provided as the advanced non-small-cell lung Technology development of the guidance progresses. cancer that has not been previously Appraisal
SCWCSU/Clinical effectiveness/v1.0 Page 12 of 20
Title Type of Funding considerations and other comments guidance treated with an ALK inhibitor [ID1468] Leukomed Sorbact for preventing Medical Draft guidance states that evidence supports the case for adopting Leukomed Sorbact surgical site infection (MT496) Technology for closed surgical wounds after caesarean section and vascular surgery in the NHS. Dupilumab for treating severe Single ACD published. Draft guidance states that dupilumab as add-on maintenance therapy asthma [ID1213] Technology is not recommended, within its marketing authorisation, for treating severe asthma with Appraisal type 2 inflammation that is inadequately controlled in people aged 12 years and over, despite maintenance therapy with high-dose inhaled corticosteroids and another maintenance treatment. V.A.C. VERAFLO Therapy System Medical Draft guidance states that the VAC Veraflo Therapy system shows promise for treating for acute infected or chronic Technology acute infected or chronic wounds that are not healing. However there is not wounds that are failing to heal enough good-quality evidence to support the case for routine adoption in the NHS. (MT471) Acalabrutinib for treating chronic Single Guidance is still in early development stage. More information will be provided as the lymphocytic leukaemia [ID1613] Technology development of the guidance progresses. Appraisal Abortion care Quality Standard Support for commissioners will be provided by adding audience descriptors to the quality standard. No additional resource impact is expected on top of the impact associated with implementing the underpinning guideline. Trifluridine–tipiracil for treating Single ACD published. Draft guidance states that trifluridine–tipiracil is not recommended, metastatic gastric or gastro- Technology within its marketing authorisation, for treating metastatic gastric cancer or gastro- oesophageal junction cancer after 2 Appraisal oesophageal junction adenocarcinoma in adults who have had 2 or more systemic or more therapies [ID1507] treatment regimens.
February 2021 Title Type of Funding considerations and other comments guidance Mepolizumab for treating severe Fast Track Fast-Track Appraisal: within the evidence submission for this appraisal, the company eosinophilic asthma [ID3750] Appraisal made a case for the appraisal to follow the Fast-Track Appraisal (FTA) process. NICE have considered this topic in line with the selection criteria for a Fast-Track Appraisal and can confirm that the selection criteria are met, and that the appraisal can proceed as a FTA. Guidance is still in early development stage. More information will be provided as the
SCWCSU/Clinical effectiveness/v1.0 Page 13 of 20
Title Type of Funding considerations and other comments guidance development of the guidance progresses. Brolucizumab for treating wet age- Single Guidance is still in early development stage. More information will be provided as the related macular degeneration Technology development of the guidance progresses. [ID1254] Appraisal Niraparib for maintenance Single Guidance is still in early development stage. More information will be provided as the treatment of platinum-sensitive Technology development of the guidance progresses. ovarian, fallopian tube and Appraisal peritoneal cancer after response to 1 course of platinum-based chemotherapy [ID1680] Safeguarding adults in care homes Clinical Guideline Draft guideline is now available. However, provisional resource impact assessment work suggest that implementing the guideline may require changes to the existing policies and procedures, monitoring arrangements, and staff training in care homes. Any potential resource impact at a local level will depend on current practice and progress towards existing statutory guidance. Any costs will be offset by savings and efficiencies from: • reduced incidence of safeguarding concerns and abuses in care homes • improved health and wellbeing of residence, for example, reduced illnesses and associated medical and non-medical interventions. QAngio XA 3D QFR and CAAS Diagnostic Draft guidance states that QAngio XA 3D quantitative flow ratio (QAngio QFR) and vFFR imaging software for Technology CAAS vessel fractional flow reserve (CAAS vFFR) are not recommended for routine assessing coronary stenosis during use during invasive coronary angiography to assess coronary stenosis in stable invasive coronary angiography angina. QAngio QFR shows promise but its clinical effectiveness is uncertain. The diagnostic accuracy and clinical effectiveness of CAAS vFFR are uncertain. Nivolumab for treating squamous Single Guidance is still in early development stage. More information will be provided as the cell carcinoma of the head and Technology development of the guidance progresses. neck after platinum-based Appraisal chemotherapy (CDF Review TA490) [ID1585] Anakinra for treating active Stills Single This appraisal has been rescheduled. Technical Engagement is due to begin in early disease [ID1463] Technology October 2020. Appraisal Atrial fibrillation: management Clinical Guideline Draft guideline is now out for consultation. More information will be provided as the
SCWCSU/Clinical effectiveness/v1.0 Page 14 of 20
Title Type of Funding considerations and other comments guidance development of the guideline progresses.
March 2021 Title Type of Funding considerations and other comments guidance Secondary infection of common Antimicrobial Draft guideline is out for consultation. More information will be provided as the skin conditions including eczema: prescribing development of the guideline progresses. antimicrobial prescribing guideline Ozanimod for treating relapsing- Single Guidance is still in early development stage. More information will be provided as the remitting multiple sclerosis [ID1294] Technology development of the guidance progresses. Appraisal Chlormethine gel for treating Single ACD published. Draft guidance states that chlormethine gel is not recommended, mycosis fungoides-type cutaneous Technology within its marketing authorisation, for treating mycosis fungoides-type cutaneous T-cell T-cell lymphoma [ID1589] Appraisal lymphoma in adults. The next appraisal committee meeting has been scheduled for Tuesday 8 December 2020. Alpha Stim AID Medical Draft guidance states that Alpha-Stim AID shows promise for managing anxiety Technology disorders. However, there is not enough good quality evidence to support the case for routine adoption in the NHS. UroLift for treating lower urinary Medical Draft guidance supports the case for adopting the UroLift System for treating lower tract symptoms of benign prostatic Technology urinary tract symptoms of benign prostatic hyperplasia in the NHS. The UroLift System hyperplasia (MT241) relieves lower urinary tract symptoms, avoids risk to sexual function, and improves quality of life. Nivolumab for adjuvant treatment of Single ACD published. Draft guidance states that nivolumab is not recommended, within its completely resected melanoma with Technology marketing authorisation, for the adjuvant treatment of melanoma with lymph node lymph node involvement or Appraisal involvement or metastatic disease that has been completely resected in adults. metastatic disease (CDF Review of TA558) [ID1681] Supporting adult carers Quality Standard Support for commissioners will be provided by adding audience descriptors to the quality standard. No additional resource impact is expected on top of the impact associated with implementing the underpinning guideline. Fedratinib for disease-related Single Guidance is still in early development stage. More information will be provided as the splenomegaly and symptoms in Technology development of the guidance progresses. SCWCSU/Clinical effectiveness/v1.0 Page 15 of 20
Title Type of Funding considerations and other comments guidance myelofibrosis [ID1501] Appraisal Betibeglogene autotemcel for Single Guidance is still in early development stage. More information will be provided as the treating transfusion-dependent Technology development of the guidance progresses. beta-thalassaemia ID968 Appraisal Onasemnogene abeparvovec for Highly Guidance is still in early development stage. More information will be provided as the treating spinal muscular atrophy Specialised development of the guidance progresses. type 1 [ID1473] Technology Evaluation Caesarean section (update) Clinical Guideline Draft guideline is out for consultation, more information will be provided as the development of the guideline progresses. Mogamulizumab for previously Single ACD published. Draft guidance states that mogamulizumab is not recommended, treated mycosis fungoides and Technology within its marketing authorisation, for treating mycosis fungoides or Sézary syndrome Sézary syndrome [ID1405] Appraisal in adults who have had at least 1 previous systemic treatment.
April 2021 Title Type of Funding considerations and other comments guidance Postnatal care Clinical Guideline Draft guideline is out for consultation, more information will be provided as the development of the guideline progresses. Olaparib for maintenance treatment Single Guidance is still in early development stage. More information will be provided as the of recurrent, platinum-sensitive Technology development of the guidance progresses. ovarian, fallopian tube and Appraisal peritoneal cancer that has responded to platinum-based chemotherapy (CDF review of TA620) [ID3788] Fenfluramine for treating Dravet Single Fenfluramine for treating Dravet syndrome was due to pause , however the topic will syndrome [ID1109] Technology now continue on the original timelines and will no longer pause. The timelines are Appraisal subject to staff capacity and the ongoing management of the COVID-19 situation and NICE will continue to review its plans and update all stakeholders accordingly. Myalgic encephalomyelitis (or Clinical Guideline Draft guideline is out for consultation. More information will be provided as the encephalopathy)/chronic fatigue development of the guideline progresses.
SCWCSU/Clinical effectiveness/v1.0 Page 16 of 20
Title Type of Funding considerations and other comments guidance syndrome: diagnosis and management Sapropterin for treating Single Guidance is still in early development stage. More information will be provided as the phenylketonuria [ID1475] Technology development of the guidance progresses. Appraisal Subarachnoid haemorrhage due to Clinical Guideline Guideline is still in early development stage. More information will be provided as the ruptured aneurysms development of the guideline progresses. End of life care (QS update) Quality Standard Support for commissioners will be provided by adding audience descriptors to the quality standard. No additional resource impact is expected on top of the impact associated with implementing the underpinning guideline. Obstructive sleep Clinical Guideline Guideline is still in early development stage. More information will be provided as the apnoea/hypopnoea syndrome and development of the guideline progresses. obesity hypoventilation syndrome in over 16s Pembrolizumab for advanced, Single Guidance is still in early development stage. More information will be provided as the unresectable or metastatic Technology development of the guidance progresses. urothelial cancer (CDF review of Appraisal TA522) [ID1634] Ivosidenib for treating relapsed or Single NICE have been asked to consider an appraisal of ivosidenib for treating relapsed or refractory IDH1-positive acute Technology refractory IDH1-positive acute myeloid leukaemia. NICE have recently invited myeloid leukaemia ID1548 Appraisal stakeholders to respond to a written consultation on the draft scope for this appraisal. The consultation on the draft scope closed on Friday 01 May 2020. Following the receipt of an update from the company that market Ivosidenib, NICE has agreed that continuing the scoping exercise at this time would not be appropriate. As a consequence of this, the scoping exercise will not continue at this time and will be rearranged for a later date. NICE apologise for any inconvenience this may cause. Pembrolizumab for treating locally Single Following the appeal decision, NICE confirm that the next committee meeting advanced or metastatic urothelial Technology discussion will be held on 11 February 2021. carcinoma after platinum-containing Appraisal chemotherapy ID1536
May 2021
SCWCSU/Clinical effectiveness/v1.0 Page 17 of 20
Title Type of Funding considerations and other comments guidance Olaparib for previously treated Single The Committee for Medicinal Products for Human Use (CHMP) of the European hormone-relapsed metastatic Technology Medicines Agency (EMA) has recently issued a positive opinion for olaparib. The prostate cancer [ID1640] Appraisal indication in this opinion is narrower than the patient population included in the company’s submission. To ensure that the Committee will have the appropriate evidence on which to base a decision the company are submitting additional analyses. The Evidence Review Group (ERG) will then critique these. It will not be possible to carry out this work before the currently scheduled Committee meeting in November and the Committee would therefore be unable to make a decision. Non-bisphosphonates for treating Multiple In progress. This appraisal was delayed due to COVID-19 but has now been osteoporosis [ID901] Technology rescheduled. Appraisal Danis Stent for acute oesophageal Medical Guidance is still in early development stage. More information will be provided as the variceal bleeds (MT450) Technology development of the guidance progresses. Apalutamide for treating metastatic Single The appraisals of apalutamide for treating metastatic hormone-sensitive prostate hormone-sensitive prostate cancer Technology cancer [ID1534] and apalutamide for treating non-metastatic hormone-relapsed [ID1534] Appraisal prostate cancer [ID1174] have been combined into a single appraisal with the title apalutamide for treating prostate cancer.
What NICE guidance is in consultation?
To review and comment in a consultation, please register as a stakeholder with NICE.
Title Consultation Consultation end date
Stroke rehabilitation in adults Draft scope consultation Friday 4th December 2020 End of life care (QS update) Quality standard consultation Wednesday 9th December 2020 UroLift for treating lower urinary tract symptoms of benign prostatic Draft guidance consultation Wednesday 9th December 2020 hyperplasia (MT241) Melphalan chemosaturation with percutaneous hepatic artery perfusion Interventional procedure Thursday 17th December 2020 and hepatic vein isolation for primary or metastatic cancer in the liver consultation Electrohydraulic lithotripsy for difficult-to-treat bile duct stones Interventional procedure Thursday 17th December 2020 consultation
SCWCSU/Clinical effectiveness/v1.0 Page 18 of 20
Permanent His-bundle pacemaker implantation for heart failure Interventional procedure Thursday 17th December 2020 consultation Deep brain stimulation for chronic, severe, treatment-resistant Interventional procedure Thursday 17th December 2020 obsessive-compulsive disorder in adults consultation Crizanlizumab for preventing sickle cell crises in sickle cell disease Appraisal Consultation Thursday 17th December 2020 Venous thromboembolic diseases (QS update) Quality standard consultation Friday 18th December 2020 Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue Draft guidance consultation Tuesday 22nd December 2020 syndrome: diagnosis and management
Reference – a guide to NICE Products
NICE guidance (NG) - Clinical Guidelines CGs provide the NHS with advice on the management of specific health conditions, and are developed in association with National Collaborating Centres (NCCs) using the expertise of the royal medical colleges, professional bodies and patient/carer organisations. They are systematically-developed statements to assist professional and patient decisions about appropriate care in specific clinical circumstances. Status NICE guidance (NG) relates to a whole pathway of care and consequently makes a number of recommendations spanning all stages of care from diagnosis to treatment. In view of their complexity, NICE guidance are not subject to statutory funding directions, and their implementation is at the discretion of local commissioners of NHS care. NICE guidance (NG) - Public Health Guidelines Public Health guidance covers disease prevention, health improvement and health protection and seeks to influence policy and practice in the NHS and local government on issues of great importance to health and health service utilisation. NICE guidance (NG) - Social Care Guidelines SCG make evidence-based recommendations on "what works" in terms of both the effectiveness and cost-effectiveness of social care interventions and services.
NICE guidance (NG) - Medicines Practice Guidelines MPG provide recommendations for good practice for those individuals and organisations involved in governing, commissioning, prescribing and decision-making about medicines. The outputs have a wide range of audiences across both health and social care environments. NICE guidance (NG) - Safe Staffing Guidelines SSG is a new work programme for NICE to develop evidence-based guidelines on safe staffing levels in NHS care settings. From June 2015 NHS England will take forward staffing work as part of a wider programme of service improvement. Interventional Procedures Guidance (IPG)
SCWCSU/Clinical effectiveness/v1.0 Page 19 of 20
IPGs recommend whether interventional procedures are effective and safe enough for use in the NHS. IPGs do not consider cost effectiveness. Status IPGs are not subject to a mandatory requirement regarding funding but health care organisations should protect patients by following IPGs as outlined in the Department of Health's 'Standards for better health' (2004). Diagnostics guidance (DG) DGs focus on the evaluation of innovative medical diagnostic technologies in order to ensure that the NHS is able to adopt clinically and cost effective technologies rapidly and consistently. Medical Technologies Guidance and Diagnostic Technologies Guidance (MDG and DTG) MTGs and DTGs help facilitate rapid and consistent access to, and use of, potentially cost saving technologies in the NHS. Status Implementation is at the discretion of local commissioners of NHS care. Quality Standards (QS) QSs are concise statements, with accompanying metrics, designed to drive and measure priority quality improvements within a particular area of care. Status The NHS is expected to use QS to plan and deliver services as part of a general duty to secure continuous improvement in quality. Clinical Commissioning Groups might wish to use selected indicators to monitor provider performance. Technology Appraisal Guidance (TAG) TAGs assess the clinical and cost effectiveness of health technologies, such as new pharmaceutical and biopharmaceutical products. Status TAGs aim to ensure that all NHS patients have equitable access to the most clinically and cost-effective treatments that are available, and NHS commissioners are mandated to make funding available for the implementation of TAG recommendations within 3 months of the issue of guidance. If the product has received approval for the Early Access to Medicines Scheme (EAMS), CCGs and Trusts will be expected to implement the NICE TA within a 30 day period. The funding requirement is set out in the NHS Constitution, and compliance is monitored through the national provider contracts. Highly Specialised Technology Guidance (HST) HST evaluations are recommendations on the use of new and existing highly specialised medicines and treatments within the NHS in England. Status HSTs aim to notify the Department of Health and Social Care of key, new and emerging healthcare technologies that might need to be referred to NICE against the following timeframes: new drugs, in development, at 20 months to marketing authorisation and new indications, at 15 months to marketing authorisation.
SCWCSU/Clinical effectiveness/v1.0 Page 20 of 20