Block scoping reports

Batch 40 topics

• Bevacizumab for treating recurrent, or persistent, or metastatic cervical cancer
• Nivolumab for previously treated locally advanced or metastatic non-small-cell lung cancer
• Lenalidomide for treating relapsed or refractory mantle cell lymphoma
• Carfilzomib for treating multiple myeloma in people who have received at least 1 prior therapy
• Talimogene laherparepvec for treating metastatic melanoma
• Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia
• Dinutuximab for treating high-risk neuroblastoma
• Lesinurad in combination with a xanthine oxidase inhibitor for treating chronic hyperuricaemia in gout

Batch 39 topics

• Ruxolitinib for treating polycythaemia vera that is resistant or intolerant to hydroxycarbamide
• Bevacizumab for treating relapsed, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer

Batch 38 topics

• Ibrutinib for treating relapsed or refractory mantle cell lymphoma
• Botulinum toxin type A for treating upper and lower limb spasticity associated with stroke
• Pembrolizumab for treating advanced melanoma previously untreated with ipilimumab
• Pembrolizumab for treating advanced melanoma previously treated with ipilimumab
• Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia (excluding homozygous familial hypercholesterolaemia)
• Evolocumab, ezetimibe and lomitapide for treating homozygous familial hypercholesterolaemia
• Ramucirumab for treating advanced gastric cancer or gastro-oesophagel junction adenocarcinoma previously treated with chemotherapy

Batch 37b topics

• Bortezomib for previously untreated mantle cell lymphoma
• Idelalisib for relapsed chronic lymphocytic leukaemia
• Ibrutinib for relapsed chronic lymphocytic leukaemia
• Nintedanib for treating idiopathic pulmonary fibrosis
• Liposomal cisplatin in combination with chemotherapy for treating inoperable advanced non small cell lung cancer
• Liposomal cisplatin in combination with gemcitabine for previously untreated locally advanced or metastatic pancreatic cancer
• Vorapaxar for the secondary prevention of atherothrombotic events after myocardial infarction

Batch 37a topic

• Daclatasvir for treating chronic hepatitis C

Batch 36 topics

• Olaparib for maintenance treatment of BRCA 1 or 2 mutated, relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer in people whose relapsed disease has responded to platinum-based chemotherapy
• ABT-450/ritonavir/ombitasvir with or without dasabuvir for treating chronic hepatitis C
• Sofosbuvir-ledipasvir for treating chronic hepatitis C
• Ofatumumab for the maintenance treatment of relapsed chronic lymphocytic leukaemia
• Naltrexone-bupropion (prolonged release) for treating obesity and overweight
• Ceritinib for previously treated anaplastic lymphoma kinase-positive non-smallcell lung cancer
• Panobinostat for treating multiple myeloma in people who have received at least 1 prior therapy

Batch 35 topics

• Aflibercept for treating diabetic macular oedema
• Ipilimumab for the adjuvant treatment of completely resected stage IV or high risk stage III melanoma
• Idelalisib for refractory indolent non-Hodgkin's lymphoma
• Edoxaban tosylate for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation
• Apixaban for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism
• Edoxaban tosylate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism

Batch 34 topics

• Omalizumab for previously treated chronic spontaneous urticaria
• Ospemifene for treating postmenopausal vulvo-vaginal atrophy
• Apremilast for treating moderate to severe plaque psoriasis
• Apremilast for treating active psoriatic arthritis
• Brentuximab vedotin for treating CD30-positive Hodgkin’s lymphoma after autologous stem cell transplant
• Cangrelor for preventing atherothrombotic events in people undergoing percutaneous coronary intervention or surgery
• TK cell therapy following haploidentical haematopoietic stem cell transplant for adults with acute leukaemia
• Thymosin beta-4 and ciclosporin for treating dry eye syndrome

Batch 33 topics

• Naloxegol for treating opioid-induced constipation
• Vinflunine for previously treated advanced breast cancer
• Ponatinib for treating chronic myeloid leukaemia
• Adalimumab and infliximab for treating moderately active Crohn's disease
• Vedolizumab for treating moderate to severe active Crohn's disease after prior therapy
• Enzalutamide for treating metastatic hormone-relapsed prostate cancer not previously treated with chemotherapy
• Faldaprevir in combination with peginterferon alfa and ribavirin for treating genotype 1 chronic hepatitis C
• Secukinumab for treating moderate to severe plaque psoriasis

Batch 32 topics

• Paclitaxel formulated as albumin-bound nanoparticles in combination with gemcitabine for previously untreated advanced pancreatic cancer
• Pomalidomide for treating relapsed and refractory multiple myeloma previously treated with both lenalidomide and bortezomib
• Nintedanib for previously treated locally advanced or metastatic non-small cell lung cancer
• Vedolizumab for treating moderately to severely active ulcerative colitis
• Obinutuzumab for previously untreated chronic lymphocytic leukaemia
• Simeprevir in combination with peginterferon alfa and ribavirin for treating genotype 1 or 4 chronic hepatitis C
• Serelaxin for treating acute heart failure

Batch 31 topics

• ChondroCelect for repairing articular cartilage defects
• Empagliflozin combination therapy for treating type 2 diabetes
• Everolimus in combination with trastuzumab and vinorelbine for treating locally advanced or metastatic HER2-positive breast cancer after treatment with trastuzumab and a taxane
• Nalmefene for reducing alcohol consumption in people with alcohol dependence
• Ofatumumab in combination with chlorambucil or bendamustine for previously untreated chronic lymphocytic leukaemia
• Pazopanib for maintenance treatment of epithelial ovarian, fallopian and peritoneal cancer
• Sofosbuvir for treating chronic hepatitis C
• Tolvaptan for treating autosomal dominant polycystic kidney disease

Batch 30 topics

• Paclitaxel as albumin-bound nanoparticles for the first-line treatment of metastatic melanoma

Batch 29 topics

• Lubiprostone for treating chronic idiopathic and opioid induced constipation
• Alendronate, denosumab, risedronate, strontium ranelate, teriparatide, and zoledronic acid for the prevention of osteoporotic fractures in men
• Collagenase clostridium histolyticum for the treatment of Dupuytren's contracture

Batch 28 topics

• Nimotuzumab for the first-line treatment of locally advanced and/or metastatic pancreatic cancer
• Masitinib for the treatment of unresectable or metastatic gastrointestinal stromal tumours after treatment with imatinib
• Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism
• Regorafenib for the treatment of metastatic colorectal cancer following prior treatment for metastatic disease

Batch 27 topics

• Canagliflozin for the treatment of type 2 diabetes
• Degarelix for the treatment of advanced hormone-dependent prostate cancer
• Enzalutamide for the treatment of metastatic hormone relapsed prostate cancer previously treated with a docetaxel-containing regimen
• INTRABEAM Photon Radiosurgery System for the adjuvant treatment of early or locally advanced breast cancer
• Trastuzumab emtansine for the treatment of locally advanced or metastatic HER2-positive breast cancer after treatment with trastuzumab and a taxane
• Vortioxetine for the treatment of moderate to severe major depressive disorder

Batch 26 topics

• Lung cancer (non-small cell, EGFR mutation positive, locally advanced or metastatic) - afatinib
• Macular oedema (central retinal vein occlusion) - aflibercept solution for injection
• Multiple sclerosis (relapsing-remitting) - alemtuzumab, dimethyl fumarate, laquinimod and terilunomide
• Melanoma (unresectable, advanced or metastatic BRAF V600 mutation-positive) - dabrafenib
• Melanoma (unresectable, advanced or metastatic BRAF V600 mutation-positive) - trametinib
• Bone metastases in prostate cancer (castration resistant) - radium-223 chloride
• Prostate cancer (metastatic, castration-resistant) - sipuleucel-T
• Psoriatic arthritis (active and progressive) - ustekinumab

Batch 25 topics

• Vintafolide in combination with pegylated liposomal doxorubicin hydrochloride for the treatment of folate- receptor-positive, platinum-resistant ovarian cancer
• Rituximab in combination with corticosteroids for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis
• Ranibizumab for the treatment of choroidal neovascularisation associated with pathological myopia
• Everolimus for the prevention of organ rejection in allogeneic liver transplantation
• Masitinib for the treatment of advanced or metastatic pancreatic cancer

Batch 24 topics

• Ocriplasmin for first line treatment of symptomatic vitreomacular adhesion

Batch 23 topics

• Mirabegron for the treatment of symptoms associated with overactive bladder
• Pertuzumab in combination with trastuzumab and docetaxel for the treatment of HER2 positive metastatic or locally recurrent unresectable breast cancer
• Everolimus for the treatment of advanced or metastatic HER2 negative, oestrogen receptor positive breast cancer
• Phentermine with topiramate for the treatment of obesity and overweight
• Tadalafil for the treatment of symptoms associated with benign prostatic hyperplasia

Batch 22 topics

• Bortezomib for induction therapy prior to high dose chemotherapy and autologous stem cell transplantation and for consolidation therapy after autologous stem cell transplantation for the treatment of multiple myeloma
• Canakinumab for the treatment of systemic juvenile idiopathic arthritis
• Mipomersen for the prevention of cardiovascular events due to homozygous and severe heterozygous familial hypercholesterolaemia
• Rivaroxaban for the prevention of adverse outcomes in patients after the acute management of acute coronary syndrome
• Tofacitinib for the treatment of moderate to severe active rheumatoid arthritis
• Zonisamide monotherapy for the treatment of partial onset seizures in epilepsy
• Bendamustine in combination with rituximab for the treatment mantle cell lymphoma (a formal referral recommendation for this topic was deferred from batch 15)
• Loxapine inhalation for the treatment of acute agitation and disturbed behaviours associated with schizophrenia or bipolar disorder (a formal referral recommendation for this topic was deferred from batch 19)

Batch 21 topics

• Aflibercept in combination with irinotecan and fluorouracil-based therapy for the treatment of metastatic colorectal cancer which has progressed following prior oxaliplatin-based chemotherapy
• Aflibercept solution for injection for the treatment of wet age-related macular degeneration
• Axitinib for the treatment of advanced renal cell carcinoma after failure of prior systemic treatment
• Pegloticase for the treatment of hyperuricaemia in people with symptomatic gout
• Pemetrexed for maintenance treatment following induction therapy with pemetrexed and cisplatin for non squamous non-small-cell lung cancer
• Ruxolitinib for the treatment of myelofibrosis
• Dapagliflozin for the treatment of type 2 diabetes

Batch 20 topics

• Abiraterone acetate for the treatment of chemotherapy naïve metastatic castrate-resistant prostate cancer
• Apixaban for the prevention of stroke and systemic embolism in people with atrial fibrillation
• Bosutinib for the first-line treatment of Philadelphia chromosome positive chronic myeloid leukaemia in the chronic phase
• Crizotinib for the treatment of non-small-cell lung cancer associated with an anaplastic lymphoma kinase fusion gene
• Denosumab for prolonging bone metastasis-free survival in castrate-resistant prostate cancer
• Lapatinib in combination with paclitaxel for the first-line treatment of HER2 positive metastatic breast cancer
• Rifaximin for the maintenance treatment of hepatic encephalopathy
• Romidepsin for the treatment of relapsed or refractory peripheral T-cell lymphoma
• Vorinostat in combination with bortezomib for the treatment of multiple myeloma in people who have received at least one prior therapy

Batch 19 topics

• Vemurafenib for the treatment of unresectable locally advanced or metastatic BRAFV600 mutation-positive malignant melanoma
• Ivabradine for the treatment of chronic heart failure
• Bevacizumab for the treatment of platinum-sensitive or partially platinum-sensitive recurrent advanced ovarian cancer (including fallopian tube and primary peritoneal cancer)
• Bevacizumab in combination with chemotherapy for the second line treatment on human epidermal growth factor 2 (HER 2) negative metastatic breast cancer
• Ridaforolimus for the maintenance treatment of metastatic soft tissue or bone sarcoma

Batch 18 topics

• Adalimumab for children and young people aged 6-17 with moderate to severe Crohn's disease
• Botulinum toxin type A of the for the prophylaxis of headaches in adults with chronic migrane
• Lenalidomide for the maintenance treatment of multiple myeloma after autologous stem cell transplantation
• Lenalidomide for the treatment of newly diagnosed multiple myeloma
• Lenalidomide for the treatment of myelodysplastic syndromes associated with deletion 5q cytogenetic abnormality
• Erlotinib for the first line treatment of EGFR-TK mutation positive non-small-cell lung cancer

Batch 17 topics

• Atrial fibrillation- vernakalant (recent onset- first line)
• Gout- canakinumab
• Hepatitis C (genotype 1) - boceprevir
• Hepatitis C (genotype 1) - telaprevir
• Prostate cancer (meta castration resistant)-abiraterone
• Venous Thromboembolism (prevention) hospitalisation - rivaroxaban

Batch 16 topics

• Pegaptanib sodium for the treatment of diabetic macular oedema
• Plerixafor for heamatopoietic stem cell mobilisation prior to autologous stem cell transplantation in the treatment of lymphoma
• Plerixafor for heamatopoietic stem cell mobilisation prior to autologous stem cell transplantation in the treatment of multiple myeloma
• Prolonged-release fampridine for the improvement of walking ability in multiple sclerosis
• Duloxetine for the treatment of chronic somatic pain
• Percutaneous vertebroplasty and percutaneous kyphoplasty for the treatment of osteoporotic vertebral fractures
• Adalimumab for the treatment of juvenile idiopathic arthritis
  (Rescoping to cover an application for a licence extension, not part of Batch 16)

Batch 15 topics

• Bevacizumab in combination with paclitaxel and carboplatin for the first-line treatment of advanced and/or metastatic ovarian cancer
• Asenapine for the treatment of moderate to severe manic episodes associated with bipolar 1 disorder
• Rivaroxaban for the treatment and secondary prevention of venous thromboembolism
• S1 for the treatment of advanced gastric cancer
• Bendamustine in combination with rituximab for the first-line treatment of low-grade non-Hodgkin's lymphoma
• Tapentadol for the treatment of severe chronic pain

Batch 14 topics

• Diabetic macular oedema - flucinolone acetonide intravitreal insert
• Lymphoma (relapsed or refractory follicular non-Hodgkin's)- bortezomib
• Non Hodgkin's lymphoma (relapsed refractory, 3^rd/4^th line)- pixantrone dimaleate
• Osteoarthritis (2^nd line) - naproxcinod
• Stoke prevention in atrial fibrillation - rivaroxaban
• Systemic lupus erythematosus (active seropositive) - belimumab

Batch 13 topics

• Cabazitaxel for the second line treatment of hormone refractory, metastatic prostate cancer
• Retigabine for the adjunctive treatment of partial onset seizures in epilepsy
• Eribulin for the treatment of locally advanced or metastatic breast cancer
• Adalimumab for the treatment of acute exacerbations of ulcerative colitis
• Adalimumab for the treatment of sub-acute exacerbations of ulcerative colitis
• Pralatrexate for the treatment of relapsed or refractory peripheral T-cell lymphoma

Batch 12 topics

• Diabetic macular oedema - ranibizumab
• Leukaemia (acute myeloid) - decitabine (1^st line)
• Leukaemia (chronic myeloid) - dasatinib (1^st line)
• Lung cancer (non-small cell) - BIBW 2992
• Rheumatoid Arthritis - abatacept (2^nd line)
• Chronic iron overload - deferasirox and deferiprone

Batch 11 topics

• Acute hypertension - clevidipine
• Biopolar 1 disorder - risperidone
• Chronic Iron overload - defasirox and deferiprone
• COPD- Roflumilast
• Cystic fibrosis- colistimethate sodium powder
• Depression - agomelatine
• Depression - quetiapine
• Generalised anxiety disorder - quetiapine
• Idiopathic pulmonary fibrosis - pirfenidone
• Macular oedema (retinal vein occlusion) - dexamethasone
• Macular oedema with central retinal vein occlusion - ranibizumab
• Myocardial infarction - bivalirudin
• Obesity- lorcaserin
• Venom anaphylaxis - immunotherapy pharmalgen

Batch 10 topics

• Diabetes (type 2) - exenatide (long acting 2^nd line in combination)
• Metastatic breast cancer - fulvestrant
• Non-hodgkin's lymphoma - bendamustine
• Multiple Myeloma - bendamustine
• Osteoarthritis- diacerein
• Rheumatoid Arthritis - rituximab
• Chronic lymphocytic leukaemia - bendamustine
• Urothelial tract carcinoma - vinflunine

Batch 9 topics

• Buccal insulin for the management of type 1 diabetes
• Apixaban for the prevention of venous thromboembolism in people undergoing elective knee and hip replacement surgery
• Apixaban for the prevention of venous thromboembolism in acute medical illness
• Aripiprazole for the treatment and prevention of acute manic and mixed episodes in bipolar disorder in children and adolescents