Date published

TA791: Romosozumab for treating severe osteoporosis

Commissioning: ICS/CCG, tariff-excluded

Romosozumab is recommended as an option for treating severe osteoporosis in people after menopause who are at high risk of fracture, only if:

• they have had a major osteoporotic fracture (spine, hip, forearm or humerus fracture) within 24 months (so are at imminent risk of another fracture) and
• the company provides romosozumab according to the commercial arrangement.

Add to formulary as a RED drug in this indication, with link to TA791.

TA807: Roxadustat for treating symptomatic anaemia in chronic kidney disease

Commissioning: ICS, tariff-excluded

Roxadustat is recommended as an option for treating symptomatic anaemia associated with chronic kidney disease (CKD) in adults only if:

• they have stage 3 to 5 CKD with no iron deficiency and
• they are not on dialysis at the start of treatment and
• the company provides roxadustat according to the commercial arrangement.

Add roxadustat to formulary as a RED drug, with link to TA807.

TA805: Icosapent ethyl with statin therapy for reducing the risk of cardiovascular events in people with raised triglycerides

Commissioning: ICS

Icosapent ethyl is recommended as an option for reducing the risk of cardiovascular events in adults. It is recommended if they have a high risk of cardiovascular events and raised fasting triglycerides (1.7 mmol/litre or above) and are taking statins, but only if they have:

• established cardiovascular disease (secondary prevention), defined as a history of any of the following:
  • acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation)
  • coronary or other arterial revascularisation procedures
  • coronary heart disease
  • ischaemic stroke
  • peripheral arterial disease, and
• low-density lipoprotein cholesterol (LDL‑C) levels above 1.04 mmol/litre and below or equal to 2.60 mmol/litre.

Add icosapent ethyl to formulary as a GREEN drug, with link to TA805.

TA803: Risankizumab for treating active psoriatic arthritis after inadequate response to DMARDs

Commissioning: ICS, tariff-excluded

Risankizumab, alone or with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is recommended only if they have:

• peripheral arthritis with 3 or more tender joints and 3 or more swollen joints
• moderate to severe psoriasis (a body surface area of at least 3% affected by plaque psoriasis and a Psoriasis Area and Severity Index [PASI] score greater than 10)
• had 2 conventional DMARDs and at least 1 biological DMARD.

Add risankizumab to formulary as a RED drug, with link to TA803.

South Tyneside and Sunderland APC recommendation summary here.

South Tyneside and Sunderland area prescribing committee recommendation summary here.

Dexcom ONE continuous glucose monitoring system (CGM) as an option in line with NICE guidance for patients with Type 1 and Type 2 diabetes.

Dexcom One is marketed as a real-time continuous glucose monitoring (rtCGM) device, which may be prescribed in primary care for the measurement of blood glucose levels by patients with type 1 or type 2 diabetes. Its functionality is very similar to the flash or intermittently scanned CGM (isCGM) e.g. FreeStyle Libre (FSL) 2, and clinical experts consider both devices should be equally positioned as treatment options.

Nov 2022

Approved the adoption of Dexcom One as an equivalent first-line alternative to Freestyle Libre 2, for patients in whom the use of isCGM or rtCGM is appropriate and in line with relevant NICE guidance.

Northern (NHS) Treatment Advisory Group CGM Position Statement here.

Review of NTAG recommendation on Transanal Irrigation

Approved removal of  Iry Pump by BBraun from the current NTAG transanal irrigation recommendation as it has recently been discontinued.

Northern (NHS) Treatment Advisory Group Treatment Appraisal Decision Summary here.

Review of NTAG recommendation on Vaginal devices for female urinary stress incontinence

Approved for use only as per NICE NG210: Pelvic floor dysfunction: prevention and non-surgical management:

• For women who are unable to perform an effective pelvic floor muscle contraction, consider supplementing pelvic floor muscle training with biofeedback techniques, electrical stimulation or vaginal cones.
• Consider a trial of intravaginal devices for women with urinary incontinence, only if other non-surgical options have been unsuccessful.

The product should only be initiated by a specialist pelvic health physiotherapist and only continue if evidence of continued benefit.

Audit of prescribing data to check update to carried out in 12 months time.

The Northern (NHS) Treatment Advisory Group does not recommend the use of Vaginal devices (e.g. Diveen®, Contiform® and Efemia®) for the routine management of female urinary stress incontinence on the NHS as per NICE NG123

Northern (NHS) Treatment Advisory Group Treatment Appraisal Decision Summary here.

Review of NTAG recommendation on Sodium oxybate (Xyrem®) in the management of narcolepsy with cataplexy in adult patients who have not received it as child.

RED drug for use as a child and in adults who have had it as a child.

Approved as per RMOC criteria for use in adults who have not received sodium oxybate as a child.

Sodium oxybate be approved for use in adults who have not received it as a child as per the RMOC criteria, noting that may sometimes be used in combination with other agents.

The following criteria for use to be approved:

• Patients presenting with narcolepsy with cataplexy according to International Classification of sleep disorders 3 (ICSD) criteria for Narcolepsy Type 1 AND
• Patients ≥ 19 years old AND
• Where patients have co-morbidities, which are also affecting sleep, these should be managed and adequately treated (for example moderate to severe obstructive sleep apnoea or restless legs syndrome) AND
• Failure to respond to non-pharmacological treatments consisting of behavioural and environmental adaptations, for example planned naps AND
• Inadequate response (within 3 months) to, or intolerable adverse effects from, or contra-indicated use of, more than one stimulant for narcolepsy, and more than one anticataplectic agent AND
• Assessed as being able to benefit from sodium oxybate via a specialist sleep centre.

Sodium oxybate is generally considered as a final treatment option for patients.

To remain as RED drug (i.e hospital only) as it an ICS commissioned tariff excluded drug.

Northern (NHS) Treatment Advisory Group Treatment Appraisal Decision Summary here.

TA814: Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis

Commissioning: ICS (adults) and NHSE (young people), tariff-excluded

Abrocitinib and upadacitinib are recommended as options for treating moderate to severe atopic dermatitis that is suitable for systemic treatment in adults and young people 12 years and over, only if:

• the disease has not responded to at least 1 systemic immunosuppressant, or these are not suitable
• the companies provide abrocitinib and upadacitinib according to the commercial arrangement.

Tralokinumab is recommended as an option for treating moderate to severe atopic dermatitis that is suitable for systemic treatment in adults, only if:

• the disease has not responded to at least 1 systemic immunosuppressant, or these are not suitable
• the company provides tralokinumab according to the commercial arrangement.

3^rd August 2022

TA815: Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs

Commissioning: ICS, tariff-excluded

Guselkumab, alone or with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is recommended only if they have had 2 conventional DMARDs and:

• have had at least 1 biological DMARD, or
• tumour necrosis factor (TNF)-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE's technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis).

Guselkumab is recommended only if the company provides it according to the commercial arrangement. Active psoriatic arthritis is defined as peripheral arthritis with 3 or more tender joints and 3 or more swollen joints.

Review formulary to review links to TA711 and replace with links to TA815.

TA820: Brolucizumab for treating diabetic macular oedema

Commissioning: ICS, tariff-excluded

Brolucizumab is recommended as an option for treating visual impairment due to diabetic macular oedema in adults, only if:

• the eye has a central retinal thickness of 400 micrometres or more at the start of treatment
• the company provides brolucizumab according to the commercial arrangement.

TA824: Dexamethasone intravitreal implant for treating diabetic macular oedema

Commissioning: ICS

Dexamethasone intravitreal implant is recommended as an option for treating visual impairment caused by diabetic macular oedema in adults only if their condition has not responded well enough to, or if they cannot have non-corticosteroid therapy.

14^th September 2022

TA826: Vedolizumab for treating chronic refractory pouchitis after surgery for ulcerative colitis (terminated appraisal)

Commissioning: ICS

21^st September 2022

TA829: Upadacitinib for treating active ankylosing spondylitis

Commissioning: ICS

Upadacitinib is recommended as an option for treating active ankylosing spondylitis that is not controlled well enough with conventional therapy in adults, only if:

• tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough and
• the company provides upadacitinib according to the commercial arrangement.

If patients and their clinicians consider upadacitinib to be one of a range of suitable treatments (including secukinumab and ixekizumab), choose the least expensive treatment, taking into account administration costs, dosage, price per dose and commercial arrangements.

Assess response to upadacitinib after 16 weeks of treatment. Continue treatment only if there is clear evidence of response, defined as:

• a reduction in the BASDAI score to 50% of the pre-treatment value or by 2 or more units and

30^th September 2022

TA828: Ozanimod for treating moderately to severely active ulcerative colitis

Commissioning: ICS

Ozanimod is recommended as an option for treating moderately to severely active ulcerative colitis in adults, only if:

• conventional treatment cannot be tolerated or is not working well enough and infliximab is not suitable, or
• biological treatment cannot be tolerated or is not working well enough, and
• the company provides it according to the commercial arrangement.

5^th October 2022

TA832: Relugolix–estradiol–norethisterone acetate for treating moderate to severe symptoms of uterine fibroids

Commissioning: ICS

19^th October 2022

TA834: SQ HDM SLIT for treating allergic rhinitis and allergic asthma caused by house dust mites (terminated appraisal)

Commissioning: ICS

12^th October 2022

TA835: Fostamatinib for treating refractory chronic immune thrombocytopenia

Commissioning: ICS, tariff excluded

Fostamatinib is recommended as an option for treating refractory chronic immune thrombocytopenia (ITP) in adults, only if:

• they have previously had a thrombopoietin receptor agonist (TPO RA), or a TPO RA is unsuitable
• the company provides fostamatinib according to the commercial arrangement.

19th October 2022

Nil

NENC Guidance: Management of Symptomatic Recurrent Uncomplicated Urinary Tract Infections in Adult Women.

Approve. Developed by the AMS workstream and approved by the ICS AMR board plus January 2023 NTAG.

Recurrent UTI ICS final guidance February 2023 here.

TA838: Slow-release potassium bicarbonate–potassium citrate for treating distal renal tubular acidosis (terminated appraisal)

Commissioning: NHSE

NICE is unable to make a recommendation on slow-release potassium bicarbonate–potassium citrate (Sibnayal) for treating distal renal tubular acidosis in people 1 year and over. This is because Advicenne considers that, at this time, there is not enough evidence to provide a submission for this appraisal.

TA839: Ruxolitinib for treating acute graft versus host disease refractory to corticosteroids (terminated appraisal)

Commissioning: NHSE

Listed as a RED drug for other indications.

No action: terminated appraisal.

TA840: Ruxolitinib for treating chronic graft versus host disease refractory to corticosteroids (terminated appraisal)

Commissioning: NHSE

NICE is unable to make a recommendation about the use in the NHS of ruxolitinib for treating chronic graft versus host disease refractory to corticosteroids in people aged 12 and over. This is because Novartis has confirmed that it does not intend to make an evidence submission for the appraisal. Novartis considers that the technology is unlikely to be a cost-effective use of NHS resources based on the current price in existing indications.

16th November 2022

TA841: Carfilzomib with daratumumab and dexamethasone for treating relapsed or refractory multiple myeloma (terminated appraisal)

Commissioning: NHSE

TA842: Tisagenlecleucel for treating follicular lymphoma after 2 or more therapies (terminated appraisal)

Commissioning: NHSE

TA843: Luspatercept for treating anaemia caused by beta-thalassaemia (terminated appraisal)

Commissioning: NHSE

NICE is unable to make a recommendation about the use in the NHS of luspatercept for treating anaemia caused by beta-thalassaemia in adults. This is because BMS has confirmed that it does not intend to make an evidence submission for the appraisal. BMS considers that there is not enough evidence to provide a submission for this appraisal.

24th November 2022

TA844: Luspatercept for treating anaemia caused by myelodysplastic syndromes (terminated appraisal)

Commissioning: NHSE

NICE is unable to make a recommendation on luspatercept (Reblozyl) for treating anaemia caused by myelodysplastic syndromes because BMS did not provide an evidence submission. NICE will review this decision if the company decides to make a submission.

24th November 2022

TA845: Mepolizumab for treating eosinophilic granulomatosis with polyangiitis (terminated appraisal)

Commissioning: NHSE

NICE is unable to make a recommendation about the use in the NHS of mepolizumab for treating eosinophilic granulomatosis with polyangiitis in people 6 years and over. This is because GSK has confirmed that it does not intend to make an evidence submission for the appraisal. GSK considers that there is unlikely to be enough evidence that the technology is a cost-effective use of NHS resources in this rare disease population.

29th November 2022

TA846: Mepolizumab for treating severe hypereosinophilic syndrome (terminated appraisal)

Commissioning: NHSE

29th November 2022

TA847: Mepolizumab for treating severe chronic rhinosinusitis with nasal polyps (terminated appraisal)

Commissioning: ICS

NICE is unable to make a recommendation about the use in the NHS of mepolizumab for treating severe chronic rhinosinusitis with nasal polyps in adults. GSK has confirmed that it does not intend to make an evidence submission for this appraisal. This is because the technology will not be launched in the UK for treating this indication.

29th November 2022

TA848: Cemiplimab for untreated PD-L1-positive advanced or metastatic non-small-cell lung cancer (terminated appraisal)

Commissioning: NHSE

1st December 2022

TA849: Cabozantinib for previously treated advanced hepatocellular carcinoma

Commissioning: NHSE

Cabozantinib is recommended as an option for treating advanced hepatocellular carcinoma in adults who have had sorafenib, only if:

• they have Child–Pugh grade A liver impairment and an ECOG performance status of 0 or 1, and
• the company provides it according to the commercial arrangement.

TA850: Amivantamab for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy

Commissioning: NHSE

TA851: Pembrolizumab for neoadjuvant and adjuvant treatment of triple-negative early or locally advanced breast cancer

Commissioning: NHSE

Pembrolizumab is recommended, within its marketing authorisation, as an option with chemotherapy for neoadjuvant treatment and then continued alone as adjuvant treatment after surgery for adults with triple-negative:

• early breast cancer at high risk of recurrence or
• locally advanced breast cancer.

It is recommended only if the company provides pembrolizumab according to the commercial arrangement.

TA852: Trifluridine–tipiracil for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma after 2 or more treatments

Commissioning: NHSE

Trifluridine–tipiracil is recommended, within its marketing authorisation, as an option for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma in adults who have had 2 or more treatment regimens. It is only recommended if the company provides trifluridine–tipiracil according to the commercial arrangement.

TA853: Avatrombopag for treating primary chronic immune thrombocytopenia

Commissioning: ICS

Avatrombopag is recommended, within its marketing authorisation, as an option for treating primary chronic immune thrombocytopenia (ITP) refractory to other treatments (for example, corticosteroids, immunoglobulins) in adults. It is only recommended if the company provides it according to the commercial arrangement.

TA854: Esketamine nasal spray for treatment-resistant depression

Commissioning: ICS

Esketamine nasal spray with a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) is not recommended, within its marketing authorisation, for treatment-resistant depression that has not responded to at least 2 different antidepressants in the current moderate to severe depressive episode in adults.

County Durham and Tees Valley area prescribing committee here.

North of Tyne area prescribing committee recommendations here.

TA861: Upadacitinib for treating active non-radiographic axial spondyloarthritis

Commissioning: ICS, tariff-excluded, 30 day TA

Upadacitinib is recommended as an option for treating active non-radiographic axial spondyloarthritis with objective signs of inflammation (shown by elevated C-reactive protein or MRI) that is not controlled well enough with non-steroidal anti-inflammatory drugs (NSAIDs) in adults. It is recommended only if:

• tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough and
• the company provides upadacitinib according to the commercial arrangement.

1st February 2023

Add to formulary as a RED drug in this indication, with a link to TA861.