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National Institute for Health and Care Excellence

• Ocrelizumab recommended for primary progressive multiple sclerosis in final guidance.
• Interventional procedures guidance published for:
  • Percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI – to be used with special arrangements only
  • Percutaneous mechanical thrombectomy for acute deep vein thrombosis of the leg – to be used with special arrangements/for research
  • Bronchoscopic thermal vapour ablation for upper-lobe emphysema – to be used for research only

Scottish Medicines Consortium

• • The following medicines have been accepted:
  • Nivolumab in combination with ipilimumab for advanced renal cell carcinoma
  • Patisiran for hereditary transthyretin-mediated amyloidosis
  • Brigatinib as monotherapy for anaplastic lymphoma kinase
  • Benralizumab as add-on maintenance treatment for severe eosinophilic asthma (restricted)
  • Fluticasone propionate/formoterol fumarate accepted for asthma in children
  • Fingolimod for highly active relapsing remitting multiple sclerosis
  • Durvalumab accepted for locally advanced, unresectable non-small cell lung cancer.
• Three medicines not recommended due to absence of submissions.

All Wales Medicines Strategy Group

• Fingolimod recommended for highly active relapsing remitting multiple sclerosis.

Medicines and Healthcare products Regulatory Agency

• Class 2 medicines recall: M&A Pharmachem, Paracetamol 500mg tablets, 1 x 1000

Department of Health and Social Care

• Supply disruption alert issued for Pfizer Epanutin® (phenytoin) 30mg/5ml oral suspension.

Public Health England

• Investigation launched into listeria cases. 

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

OCRELIZUMAB RECOMMENDED FOR PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

The National Institute for Health and Care Excellence (NICE) has published final guidance which recommends ocrelizumab (Ocrevus) within its marketing authorisation, as an option for treating early primary progressive multiple sclerosis with imaging features characteristic of inflammatory activity in adults, only if the company provides it according to the commercial arrangement. NICE says there are currently no disease-modifying treatments available for primary progressive multiple sclerosis. Results of one clinical trial show that ocrelizumab can slow the worsening of disability, although the size and duration of this effect are uncertain. Given the unmet clinical need, the most plausible cost-effectiveness estimates for ocrelizumab at the agreed price compared with best supportive care alone are in the range that NICE considers an acceptable use of NHS resources.

GUIDANCE ISSUED ON PERCUTANEOUS INSERTION OF A CEREBRAL PROTECTION DEVICE TO PREVENT CEREBRAL EMBOLISM DURING TAVI

NICE has published final guidance which finds the evidence on percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI raises no major safety concerns other than those associated with the TAVI procedure. However, it says the evidence on efficacy for preventing TAVI-related stroke is inconclusive. Therefore, NICE recommends that this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Clinicians wishing to do percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI should:

• Inform the clinical governance leads in their NHS trusts.
• Ensure that patients and their carers understand the procedure's safety and efficacy, as well as any uncertainties about these. Provide them with clear written information to support shared decision making. In addition, the use of NICE's information for the public is recommended.
• Details of all patients should be entered into the UK TAVI registry.

NICE encourages further research on percutaneous insertion of a cerebral protection device to prevent cerebral embolism during TAVI and suggests that this should include details of patient selection and risk stratification for TAVI-related stroke.

GUIDANCE ISSUED ON PERCUTANEOUS MECHANICAL THROMBECTOMY FOR ACUTE DEEP VEIN THROMBOSIS OF THE LEG

NICE finds the current evidence on the safety of percutaneous mechanical thrombectomy for acute deep vein thrombosis (DVT) of the leg shows there are well-recognised but infrequent complications.

• For acute iliofemoral DVT the evidence on efficacy is limited in quality and quantity, therefore this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
• For distal DVT that does not extend into the common femoral vein the evidence on efficacy is inconclusive, therefore this procedure should only be used in the context of research.

NICE says that clinicians wishing to do percutaneous mechanical thrombectomy for acute iliofemoral DVT should:

• Inform the clinical governance leads in their NHS trusts.
• Ensure that patients understand the procedure's safety and efficacy, as well as any uncertainties about these. Provide them with clear written information to support shared decision making. In addition, the use of NICE's information for the public is recommended.

Furthermore, NICE states that clinicians should enter details of all patients who have the procedure onto the BSIR Venous Registry, and that further research should report the patient selection criteria including the site of the clot, symptom severity and age of patients.

BRONCHOSCOPIC THERMAL VAPOUR ABLATION FOR UPPER-LOBE EMPHYSEMA FOR RESEARCH ONLY

NICE has published final guidance which finds the current evidence on the safety and efficacy of bronchoscopic thermal vapour ablation for upper-lobe emphysema is inadequate in quantity and quality. Therefore, NICE recommends that the procedure should only be used in the context of research. In addition, further research should evaluate safety and efficacy in the short and long-term and include details of patient selection.

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SCOTTISH MEDICINES CONSORTIUM

NIVOLUMAB ACCEPTED IN COMBINATION FOR ADVANCED RENAL CELL CARCINOMA

The Scottish Medicines Consortium (SMC) has accepted nivolumab (Opdivo®) for use within NHS Scotland, under a Patient Access Scheme (PAS), in combination with ipilimumab for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (RCC). Overall survival was significantly longer in the nivolumab plus ipilimumab group compared with a multiple receptor tyrosine kinase inhibitor in a phase III study in treatment naïve patients with intermediate/poor-risk advanced RCC.

PATISIRAN ACCEPTED FOR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

The SMC has accepted patisiran (Onpattro®) for use within NHS Scotland, under a PAS, for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy. In a phase III study of adults with hATTR amyloidosis and polyneuropathy, patisiran was associated with significant improvements compared with placebo, measured by the change in modified neuropathy impairment score +7 (mNIS+7) from baseline to 18 months.

BRIGATINIB ACCEPTED AS MONOTHERAPY FOR ANAPLASTIC LYMPHOMA KINASE

The SMC has accepted brigatinib (Alunbrig®) for use within NHS Scotland, under a PAS, as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. Brigatinib was associated with an objective response rate of 56% in a single-arm, open-label, phase II study in patients with ALK-positive NSCLC who had progressed on first-line targeted treatment with crizotinib.

BENRALIZUMAB ACCEPTED AS ADD-ON MAINTENANCE TREATMENT FOR SEVERE EOSINOPHILIC ASTHMA (RESTRICTED)

The SMC has accepted benralizumab (Fasenra®) for restricted use within NHS Scotland, under a PAS, as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists. The SMC has restricted this medicine to patients with blood eosinophils ≥150 cells/microlitre, and either ≥4 prior asthma exacerbations needing systemic corticosteroids in the previous 12 months or treatment with continuous oral corticosteroids over the previous six months. Benralizumab, compared with placebo, reduced asthma exacerbation rates and was associated with greater reductions in continuous oral corticosteroid dose while maintaining stable asthma in patients with severe eosinophilic asthma.

FLUTICASONE PROPIONATE/FORMOTEROL FUMARATE ACCEPTED FOR ASTHMA IN CHILDREN

The SMC has accepted fluticasone propionate/formoterol fumarate (flutiform®) for use within NHS Scotland, for the regular treatment of asthma in children aged five to 12 years where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate:

• for patients not adequately controlled with inhaled corticosteroids and 'as required' inhaled short-acting β2 agonist or
• for patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.

The SMC has previously accepted fluticasone propionate/formoterol fumarate for use in adults and adolescents aged 12 years and above with asthma where the use of a combination product is appropriate.

FINGOLIMOD FOR HIGHLY ACTIVE RELAPSING REMITTING MULTIPLE SCLEROSIS

The SMC has accepted fingolimod (Gilenya®) for use within NHS Scotland, under a PAS, as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of patients aged 10 to <18 years:

• Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy or
• Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by two or more disabling relapses in one year, and with one or more gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous MRI.

SMC has previously accepted fingolimod for use in adults in both of these patient groups.

Fingolimod has also been recommended in Wales, see All Wales Medicines Strategy Group.

DURVALUMAB ACCEPTED FOR LOCALLY ADVANCED, UNRESECTABLE NON-SMALL CELL LUNG CANCER

The SMC has accepted durvalumab (Imfinzi®), under a PAS, for use within NHS Scotland as monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 [programmed cell death ligand 1] on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy. Durvalumab, compared with placebo, improved progression-free survival and overall survival in adults who have locally advanced unresectable NSCLC with PD-L1 expressed on ≥1% of tumour cells and disease that has not progressed following platinum-based chemoradiation therapy.

THREE MEDICINES NOT RECOMMENDED DUE TO ABSENCE OF SUBMISSIONS

In the absence of a submission from the holder of the marketing authorization, the following medicines have not been recommended by the SMC:

• Alirocumab (Praluent®) for adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels.
• Brentuximab vedotin (Adcetris®) for the treatment of adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine.
• Golimumab (Simponi®) in combination with methotrexate for the treatment of polyarticular juvenile idiopathic arthritis in children two years of age and older who have responded inadequately to previous therapy with methotrexate.

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ALL WALES MEDICINES STRATEGY GROUP

FINGOLIMOD RECOMMENDED FOR HIGHLY ACTIVE RELAPSING REMITTING MULTIPLE SCLEROSIS

Fingolimod (Gilenya®) has been recommended as an option for use within NHS Wales as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of paediatric patients aged 10–17 years: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy; or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by two or more disabling relapses in one year, and with one or more gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI. This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS price.

Fingolimod has also been recommended in Scotland, see Scottish Medicines Consortium.

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MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

CLASS 2 MEDICINES RECALL: M&A PHARMACHEM - PARACETAMOL 500MG TABLETS, 1 X 1000

M&A Pharmachem is recalling specific batches of Paracetamol 500mg tablets, 1 x 1000, because a small number of pots from each batch have been found to contain discoloured tablets due to fungal contamination. Healthcare professionals and wholesalers should stop supplying the batch numbers 0110 and 0174 immediately. All remaining stock should be quarantined and returned to the supplier using the supplier’s approved process.

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DEPARTMENT OF HEALTH AND SOCIAL CARE

SUPPLY DISRUPTION ALERT ISSUED FOR PFIZER EPANUTIN® (PHENYTOIN) 30MG/5ML ORAL SUSPENSION

The Department of Health and Social Care has issued a supply disruption alert for Pfizer Epanutin® (phenytoin) 30mg/5ml oral suspension, which will be out of stock from the week commencing 10 June 2019 until late July 2019. The alert gives advice for all healthcare professionals who prescribe, dispense or administer Epanutin oral suspension. The alert also makes reference to unlicensed preparations, the Patient Information Leaflet (PIL) and product monograph.

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PUBLIC HEALTH ENGLAND

INVESTIGATION LAUNCHED INTO LISTERIA CASES

Public Health England (PHE) has reported the launch of an investigation into cases of listeria linked to pre-packed sandwiches, along with The Food Standards Agency, Public Health Wales, Food Standards Scotland, Health Protection Scotland and a number of local authorities (see OnMedica article). The cases of listeria infection were in six seriously ill hospital patients in England. Three of these patients have died. Currently there are no cases in Scotland or in Wales. Listeria infection in healthy people is usually either unnoticed or may cause very mild illness. However, it can have more serious consequences for some people, particularly those with pre-existing health conditions and pregnant women. PHE says the health risk to the public remains low.

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