Medicine Industry's Gateway to NICE
The Innovation Observatory is the gateway to the NICE Technology Assessment (TA) Programme for industry, preventing delays in bringing new and repurposed medicines to the UK market through the early identification and tracking of new and repurposed medicines and health technologies.
The National Institute for Health and Care Excellence (NICE) TA programme provides UK healthcare guidance through Technology Appraisals and Highly Specialised Technologies assessments. A NICE recommendation is crucial for market access to the NHS in England and Wales. The Innovation Observatory is the first step in the process and we work closely with our pharmaceutical industry partners.
We provide the 'gateway' to NICE by submitting potential topics that meet the NICE Topic Selection criteria for medicines as set out in the NICE Topic Selection Manual. We follow the development of new and repurposed medicines from at least two years before estimated UK licence to provide a timely notification to NICE. This early notification triggers the NICE TA process and allows NICE to provide new guidelines as close to the licence date as possible.
The Innovation Observatory has a strict confidentiality agreement which means we only share confidential information with selected policymakers.
Human immunoglobulin with recombinant human hyaluronidase maintenance therapy for treating multifocal motor neuropathy
Human immunoglobulin with recombinant human hyaluronidase is currently in development for the maintenance treatment of patients with multifocal motor neuropathy (MMN). MMN is a rare disease that causes damage to the nerves in the arms and legs. The nerve damage is progressive and worsens over time. The cause of MMN is unknown, but it is […]
DownloadDarolutamide with androgen deprivation therapy for metastatic hormone sensitive prostate cancer
Darolutamide with androgen deprivation therapy (ADT) is in clinical development to treat prostate cancer that is metastatic (has spread to another part of the body) and hormone-sensitive, where the cancer is controlled by lowering levels of the hormone testosterone. Prostate cancer affects the prostate (a small gland only found in men), but symptoms generally do […]
DownloadNiraparib with abiraterone acetate and prednisone for treating homologous recombination repair-mutated metastatic castration-sensitive prostate cancer
Niraparib with abiraterone acetate and prednisone is in clinical development for patients with prostate cancer which is metastatic (has spread to other parts of the body) and hormone-sensitive, meaning the cancer is being controlled by keeping the testosterone level as low as would be expected if the testicles were removed. Prostate cancer is the most […]
DownloadHuman normal immunoglobulin for preventing primary infection in chronic lymphocytic leukaemia
Human normal immunoglobulin (IVIG) is in development for preventing primary infection in patients with chronic lymphocytic leukaemia (CLL). CLL is the most common type of leukaemia, which is a cancer that affects blood cells in the bone marrow and progresses slowly over time. In CLL, the bone marrow makes too many unusual white blood cells […]
DownloadTelmisartan-amlodipine-indapamide for treating hypertension
Telmisartan-amlodipine-indapamide is in development for the treatment of Hypertension. Hypertension is characterised by persistently high blood pressure. When a person’s blood pressure is too high, it puts extra strain on the blood vessels, heart and other organs, such as the brain, kidneys and eyes. The causes of high blood pressure are not always clear, but […]
DownloadCefepime-enmetazobactam for treating hospital-acquired pneumonia including ventilator-associated pneumonia
Cefepime-enmetazobactam is in clinical development for the treatment of adults with hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP). Pneumonia is a type of chest infection where tiny air sacs in lungs (alveoli) fill with fluid, making it harder to breathe. Symptoms include coughing, feeling tired, a high temperature, difficulty breathing, chest pain and loss […]
DownloadAlpha-1 antitrypsin for treating high risk, acute graft versus host disease in people aged ≥ 12 years
Alpha-1 antitrypsin is currently in development for the treatment of high risk, acute graft versus host disease (aGvHD) in people aged ≥ 12 years following an allogeneic haematopoietic stem cell transplant (HSCT) for any indication. A stem cell transplant replaces damaged blood cells with healthy ones from another person (a donor). GvHD is a frequent […]
DownloadSasanlimab with Bacillus Calmette-Guérin for treating high-risk non-muscle invasive bladder cancer
Sasanlimab in combination with Bacillus Calmette-Guérin (BCG) is in clinical development for BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). Bladder cancer is when cancerous cells develop in the lining of the bladder. NMIBC is the most common type of bladder cancer and is categorised by risk (low, medium and high). High-risk NMIBC is when cancerous […]
DownloadVutrisiran for treating transthyretin amyloidosis with cardiomyopathy
Vutrisiran is a medicinal product that is in development for the treatment of adults with transthyretin amyloidosis with cardiomyopathy (ATTR-CM). ATTR-CM is classified as either wildtype transthyretin (wtATTR) amyloidosis with cardiomyopathy (wtATTR-CM) or hereditary transthyretin (hATTR) amyloidosis with cardiomyopathy (hATTR-CM). ATTR-CM occurs when a protein called transthyretin (TTR) becomes defective and aggregates, forming amyloid deposits […]
DownloadDonidalorsen for the prophylactic treatment of hereditary angioedema
Donidalorsen is in clinical development for the preventive treatment of patients with hereditary angioedema (HAE). HAE is a rare inherited disorder characterised by recurrent episodes of the accumulation of fluids outside of the blood vessels, blocking the normal flow of blood or lymphatic fluid and causing rapid swelling of tissues in the hands, feet, limbs, […]
DownloadPonatinib for chronic myeloid leukaemia in paediatric patients
Chronic myeloid leukaemia (CML) is a rare type of cancer, especially in children. CML is characterised by the uncontrolled production of white blood cells called myeloid cells; this means cells divide but do not mature. These immature dividing cells, known as blast cells, fill up the bone marrow and stop it making healthy blood cells. […]
DownloadZolbetuximab with nab-paclitaxel and gemcitabine for previously untreated metastatic CLDN18.2-positive pancreatic adenocarcinoma
Zolbetuximab in combination with nab-paclitaxel and gemcitabine is in clinical development for the treatment of Claudin (CLDN) 18.2 positive metastatic pancreatic adenocarcinoma. Pancreatic cancer is caused by the abnormal and uncontrolled growth of cells in the pancreas, a large gland that is part of the digestive system. Metastatic cancer refers to a cancer where the […]
DownloadNirogacestat for treating desmoid tumours
Nirogacestat is in clinical development for the treatment of desmoid tumours (DT). DT is a rare condition called an intermediate tumour, which sit somewhere between non-cancerous and cancerous tumours. These types of tumours have the capacity to come back at or near the original tumour, but they do not spread. The main symptom of DT […]
DownloadPembrolizumab adjuvant for urothelial carcinoma and/or localised muscle invasive bladder cancer
Pembrolizumab is currently in clinical development for patients with localised muscle-invasive bladder cancer (MIBC) (where the cancer has grown into, but not through the muscle layer of the bladder) or and/or urothelial cancer (UC) which has spread from where it started to nearby tissue or lymph nodes (locally advanced), who are ineligible or refuse cisplatin […]
DownloadEszopiclone for treating insomnia
Eszopiclone has been developed for the treatment of insomnia in adults. Insomnia is difficulty getting to sleep or staying asleep for long enough to feel refreshed the next morning. It is a common problem thought to regularly affect around one in every three people in the UK and is particularly common in elderly people. Insomnia […]
DownloadMepolizumab add-on therapy for chronic obstructive pulmonary disease with eosinophil-associated exacerbations
Mepolizumab is in clinical development as an add-on therapy for chronic obstructive pulmonary disease (COPD) with eosinophilic disease. COPD is the name for a group of lung conditions that cause breathing difficulties. COPD is a long-term condition that is characterised by periods of acute exacerbations (worsening of respiratory symptoms) such as shortness of breath, cough […]
DownloadDepemokimab for treating chronic rhinosinusitis withnasal polyps
Depemokimab is in clinical development for the treatment of chronic rhinosinusitis with nasalpolyps (CRSwNP) in adults. CRSwNP is a combination of two conditions: chronic rhinosinusitisand nasal polyps. Chronic rhinosinusitis is a condition in which the sinuses (air-filled spaces in thebones around the nose) are inflamed causing difficulty in breathing due to nasal blockage. Nasalpolyps are […]
DownloadDepemokimab as adjunctive therapy for severe asthma with an eosinophilic phenotype in patients aged 12 years and older
Severe asthma is the most serious type of asthma where symptoms are hard to control, even with high doses of medicine. Severe asthma with an eosinophilic phenotype makes up approximately 50% of all severe asthmatic cases. It is characterised by tissue and sputum eosinophilia, which is when there are unusually high levels of eosinophils (a […]
DownloadBudesonide-glycopyrronium-formoterol fumarate for the treatment of severe and inadequately controlled asthma
Budesonide-glycopyrronium-formoterol fumarate is in development for the treatment of severe asthma. Asthma is a common lung condition that causes occasional breathing difficulties. It affects people of all ages and often starts in childhood, although it can also develop for the first time in adults. Asthma is caused by swelling (inflammation) of the breathing tubes that […]
DownloadBI 1015550 for treating idiopathic pulmonary fibrosis or progressive pulmonary fibrosis
BI 1015550 is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) in people aged 18 years and over. IPF is a long-term disease of the lungs characterised by the progressive deposition of collagen and fibrous tissue in the lungs. This causes the lung tissue to become inflamed […]
DownloadDupilumab for treating bullous pemphigoid
Dupilumab is currently in phase II/III development for adult patients with bullous pemphigoid (BP). BP is the most common form of blistering disorders of the skin. The first symptom of BP is usually redness and itching of the skin. BP primarily affects older people, with an average age around 80 years old. The burden of […]
DownloadEplontersen for treating transthyretin amyloid cardiomyopathy
Eplontersen is in clinical development for the treatment of adults with transthyretin amyloid cardiomyopathy (ATTR-CM). ATTR-CM occurs due to a build-up of abnormal proteins in the heart. These protein deposits can cause thickening and stiffening of the heart muscle, leading to heart failure. There are two types of ATTR, namely the hereditary and wild-type forms. […]
DownloadIgPro20 for treating dermatomyositis
IgPro20 is in clinical development for the treatment of dermatomyositis (DM). DM is an inflammatory disease of the muscles and the skin which causes muscle weakness and severe skin rash. Although skeletal muscle and skin problems are the most frequent signs of the disease, inflammation may also affect the muscles of the oesophagus (the food […]
DownloadTroriluzole for spinocerebellar ataxia
Troriluzole is in development for the treatment of adults with spinocerebellar ataxia (SCA). SCAs are a group of ataxias (lack of muscular control) which are inherited from parents. SCAs do not usually begin until adulthood and can affect people from the age of 25 up to 80, depending on the type of SCA. The symptoms […]
DownloadInebilizumab for neuromyelitis optica spectrum disorders
Inebilizumab is in clinical development for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare autoimmune condition in which the immune system attacks and damages one’s own spinal cord and optic nerves (nerves in the eyes). Autoantibodies (proteins that attacks own cells) against a cell surface protein found in neural […]
DownloadBrentuximab vedotin with cyclophosphamide, prednisone and doxorubicin for treating peripheral Tcell lymphoma
Brentuximab vedotin in combination with cyclophosphamide, prednisone and doxorubicin is in clinical development for the treatment of peripheral T-cell lymphoma (PTCL). Peripheral T-cell lymphomas (PTCLs) are a group of rare blood cancers. They develop in T-cells and affect the lymphatic system. PTCLs happen when the T-cells mutate and become cancerous cells that multiply uncontrollably. PTCL […]
DownloadLinaclotide acetate for treating Chronic idiopathic constipation
Linaclotide acetate is currently in clinical development for the treatment of adults with chronic idiopathic constipation (CIC). Constipation is defecation that is problematic because of infrequent and/or hard stools, difficulty passing stools (often involving straining), or the sensation of incomplete emptying or anorectal blockage. Chronic is when the symptoms are present for at least three […]
DownloadDatopotamab deruxtecan for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer
Datopotamab deruxtecan is in development for the treatment of patients with previously untreated, locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), who are not suitable candidates for PD-1/PD-L1 inhibitor therapy. TNBC is a subtype of breast cancer which lacks hormone receptor expression. The risk factors for TNBC include a history of breast disease […]
DownloadSarconeos for treating severe COVID-19 in people aged 45 years and over
Sarconeos is currently in clinical development for treating adults aged 45 or over who are hospitalised with COVID-19. COVID-19 is an infectious respiratory disease caused by the severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). The main symptoms of COVID-19 are fever, a new continuous cough, and loss of taste or smell. In some patients, COVID-19 may […]
DownloadTalazoparib with enzalutamide for previously untreated homologous recombination repair-mutated metastatic hormonal-sensitive prostate cancer
Talazoparib in combination with enzalutamide is in clinical development for the treatment of homologous recombination repair (HRR)-mutated metastatic hormonal-sensitive prostate cancer (mHSPC). Prostate cancer is a cancer of the prostate gland and is the most common type of cancer in men in the UK. The cancer is called metastatic when it has spread to other […]
Download
