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.
Degarelix acetate prior to or with radiotherapy for prostate cancer
Degarelix acetate is approved for the treatment of advanced hormone dependant prostate cancer and treatment of high risk localised or locally advanced prostate cancer, in combination with or prior to radiotherapy. Prostate cancer is a cancer of the prostate gland (a small organ in a man’s pelvis) and is the most common cancer in men […]
DownloadPembrolizumab-vibostolimab for previously untreated non-small-cell lung cancer (NSCLC)
Pembrolizumab-vibostolimab is in development for treatment-naïve patients with metastatic non-small cell lung cancer (NSCLC). A metastatic NSCLC is an advanced stage of NSCLC (stage 4), where the cancer has spread from the lungs. NSCLC is the most common form of lung cancer, accounting for about 80 to 85 out of every 100 lung cancer cases. […]
DownloadSacituzumab govitecan for previously treated advanced non-small cell lung cancer
Sacituzumab govitecan is in development for advanced or metastatic non-small cell lung cancer (NSCLC), that has progressed on or after previous therapies with platinum-based chemotherapy and immunotherapy. NSCLC is the most common type of lung cancer accounting for 80-85% of lung cancers. Most common symptoms include a cough, recurrent chest infections, coughing up blood, tiredness […]
DownloadDurvalumab with fluorouracil, leucovorin, oxaliplatin and docetaxel chemotherapy for neoadjuvant and adjuvant treatment of resectable gastric and gastro-oesophageal junction cancer
Durvalumab in combination with chemotherapy is in clinical development for the treatment of resectable gastric cancer and gastro-oesophageal junction (GEJ) adenocarcinoma. Gastric cancers and GEJ adenocarcinoma are cancers that form in the inner lining of the stomach or where the stomach and the oesophagus meet. Risk factors of these cancers include obesity, older age, gastro-oesophageal […]
DownloadImlunestrant with or without abemaciclib for treating ER-positive, HER2-negative locally advanced or metastatic breast cancer after endocrine therapy
Imlunestrant with or without abemaciclib is in development for the treatment of patients with locally advanced or metastatic oestrogen receptor positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Breast cancer is when abnormal cells in the breast begin to grow in an uncontrolled way and eventually form a tumour. Locally advanced […]
DownloadSelumetinib for treating symptomatic, inoperable plexiform neurofibromas associated with type 1 neurofibromatosis in adults
Selumetinib is currently in clinical development for the treatment of symptomatic and inoperable plexiform neurofibromas associated with type 1 neurofibromatosis in adults. Neurofibromatosis type 1 (NF1), caused by changes in NF1 gene, is a type of genetic disorders that primarily affects the cell growth of neural substance. Due to these changes, the gene is unable […]
DownloadCabozantinib with atezolizumab for treating metastatic castration-resistant prostate cancer after one novel hormonal therapy
Cabozantinib in combination with atezolizumab is in clinical development for the treatment of cancer thatstarted in the prostate, has spread to another part of the body (metastatic), and no longer responds tohormone treatment options (castration-resistant). The prostate is a small gland in a man’s pelvis and isinvolved in the male reproductive system. Symptoms of prostate […]
DownloadTopical rapamycin cream for treating facial angiofibroma
Topical rapamycin cream is in clinical development for the treatment of facial angiofibroma (FA) associated with tuberous sclerosis complex (TSC). TSC is a rare genetic disorder that affects genes that regulate cell growth. TSC is often associated with FA, which are pinkish or reddish bumps usually located on the cheeks, nose and chin. Although FAs […]
DownloadTransCon PTH for treating hypoparathyroidism
TransCon PTH is in clinical development for the treatment of hypoparathyroidism (HP). HP can be caused when the parathyroid glands do not produce enough parathyroid hormone (PTH). This causes low blood calcium levels (hypocalcaemia). The parathyroid glands are very small glands situated in the neck just behind the thyroid gland and they control calcium levels […]
DownloadGaradacimab for preventing attacks of hereditary angioedema
Garadacimab is in clinical development for preventing attacks in people with hereditary angioedema (HAE). HAE is a rare and potentially life-threating type of angioedema, a condition that causes sudden swelling. There are two types of HAE. Type I is more common and occurs because the body has abnormally low levels of proteins that help regulate […]
DownloadBifikafusp alfa-onfekafusp alfa neoadjuvant therapy for treating resectable stage IIIB and IIIC melanoma
Bifikafusp alfa-onfekafusp alfa is currently in clinical development for the neoadjuvant treatment of resectable stage IIIB and IIIC melanoma. Melanoma is a type of skin cancer. The stage of a cancer tells how big it is and how far it has spread. Stage IIIB and IIIC melanomas are regional, meaning the cancer has spread beyond […]
DownloadNivolumab adjuvant therapy for renal cell carcinoma
Nivolumab is in clinical development as adjuvant therapy for adult patients with localised renal cell carcinoma (RCC) who underwent surgical removal of partial or entire of a kidney. RCC (the most common type of kidney cancer in adults) is a disease that affects the lining of tiny tubes within the kidney which filter waste from […]
DownloadPembrolizumab with chemotherapy for platinum-resistant recurrent ovarian cancer after 1 or 2 therapies
Pembrolizumab in combination with paclitaxel with or without bevacizumab is in clinical development for the treatment of platinum-resistant recurrent ovarian cancer after one or two prior therapies. Ovarian cancer occurs when abnormal cells in the ovary begin to grow and divide in an uncontrolled way to eventually form a growth (tumour). Some of the symptoms […]
DownloadTarlatamab for relapsed/refractory small-cell lung cancer
Tarlatamab is in clinical development for the treatment of adults with refractory (unresponsive to treatment) or relapsed small cell lung cancer (SCLC) who have progressed or recurred following one platinum-based (chemotherapy) regimen and at least a prior line of therapy. SCLC is a disease in which malignant (cancer) cells form in the tissues of the […]
DownloadElinzanetant for the treatment of moderate to severe vasomotor symptoms (hot flashes) associated with the menopause
Elinzanetant is in clinical development for the treatment of vasomotor symptoms (hot flashes) in women undergoing the menopause. The menopause occurs between 45 and 55 years of age and is caused by declining hormone levels. The declining hormone levels mean that neurons (nerve cells) in the hypothalamus (small part in the brain) become hyperactive and […]
DownloadTezepelumab for treating severe chronic rhinosinusitis with nasal polyps
Tezepelumab is in clinical development for the treatment of severe chronic rhinosinusitis with nasal polyps. Chronic rhinosinusitis is a condition in which the lining of the sinuses (air-filled spaces behind the nose, eyes, and cheeks) becomes inflamed for more than 12 weeks. People with the condition may have nasal polyps which are growths inside the […]
DownloadMirvetuximab soravtansine for advanced, epithelial ovarian, fallopian tube, or primary peritoneal cancer with high folate receptor-alpha expression
Mirvetuximab soravtansine is in clinical development for the treatment of adults with advanced, platinum-resistant, high-grade epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer with high folate receptor-alpha expression. Epithelial ovarian cancer means the cancer started in the surface layer covering the ovary. The main symptoms are frequent swollen or bloated tummy, pain or […]
DownloadVanzacaftor / tezacaftor / deutivacaftor for the treatment of cystic fibrosis
Vanzacaftor/tezacaftor/deutivacaftor is in development for the treatment of cystic fibrosis in patients with at least one F508del mutation (faulty gene). Cystic fibrosis is a rare, chronic, and life-shortening genetic disease caused by a faulty gene that affects the movement of salt and water in and out of cells. It is a progressive, multi-system disease that […]
DownloadEvolocumab for preventing major cardiovascular events in adults with a high risk of cardiovascular events
Evolocumab is currently in clinical development for the prevention of major cardiovascular events in adults without prior heart attack or stroke who are at high risk of a cardiovascular event. Cardiovascular disease (CVD) is an umbrella term for all diseases of the heart and circulation. It includes everything from conditions that are inherited or that […]
DownloadApremilast for treating moderate to severe plaque psoriasis in children and young people
Apremilast is being investigated for the treatment of moderate to severe plaque psoriasis in children and adolescents (aged 6 to 17 years old). Psoriasis is a skin disease that causes a rash with itchy, scaly patches, most commonly on the knees, elbows, trunk, and scalp. Plaque psoriasis is the most common, and is characterised by […]
DownloadI-131-Apamistamab for acute myeloid leukaemia
I-131-Apamistamab is in clinical development for the treatment of adult patients with relapsed, or refractory acute myeloid leukaemia (AML), prior to bone marrow transplant. AML is a type of blood cancer where excess immature white blood cells are made by the bone marrow, these immature cells do not function like healthy blood cells in fighting […]
DownloadOmaveloxolone for the treatment of Friedreich's ataxia
Omaveloxolone is in development for the treatment of patients with Friedreich’s Ataxia (FA). FA is an inherited disease that causes a range of symptoms including difficulty walking, inability to coordinate movements, muscle weakness, speech problems, damage to the heart muscle and diabetes. Patients with FA do not have enough frataxin, a protein that regulates iron […]
DownloadPylera with omeprazole for treating helicobacter pylori associated ulcers
Pylera in combination with omeprazole is currently in development for the treatment of adults who test positive for Helicobacter pylori (H. pylori) with upper gastrointestinal symptoms. H. pylori infection occurs when H. pylori bacteria infect the stomach, which typically happens during childhood. The bacteria are usually passed from person to person through direct contact with […]
DownloadVepdegestrant for previously treated locally advanced or metastatic ER+/HER2– breast cancer
Vepdegestrant is in development for the treatment of patients with oestrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, who previously received endocrine-based treatment. A locally advanced breast cancer is a stage 3 breast cancer where the cancer has spread from the breast to lymph nodes close to the breast […]
DownloadPembrolizumab-vibostolimab with etoposide and platinum chemotherapy for previously untreated extensive-stage small cell lung cancer
Pembrolizumab-vibostolimab with etoposide and platinum chemotherapy is in clinical development for the first-line treatment of extensive stage small cell lung cancer (SCLC). Extensive stage SCLC is when cancer cells form in the tissues of the lung and spread beyond the lung to other places in the body. Symptoms include chest pain, a cough that does […]
DownloadDatopotamab deruxtecan for previously treated unresectable or metastatic HR+ HER2- breast cancer
Datopotamab deruxtecan is in clinical development for the treatment of inoperable or metastatic HR-positive HER2-negative breast cancer after one or two lines of systemic chemotherapy. Breast cancer is the growth of abnormal cells in the breast which divide uncontrollably to eventually form a tumour. Breast cancers can also be hormone receptor positive (HR+), meaning that […]
DownloadTrastuzumab deruxtecan neoadjuvant therapy for high-risk HER2-positive early stage breast cancer
Trastuzumab deruxtecan is in clinical development for the neoadjuvant treatment of high-risk HER2-positive early-stage breast cancer. Breast cancer is when abnormal cells in the breast begin to grow and divide in an uncontrolled way and eventually form a growth (tumour). Breast cancer that has not spread beyond the breast or the axillary lymph nodes is […]
DownloadObecabtagene autoleucel for treating refractory or relapsed B cell acute lymphoblastic leukaemia
Obecabtagene autoleucel is an advanced therapy medicinal product (gene therapy product) known as ‘Chimeric Antigen Receptor’ (CAR) T cell therapy which is in clinical development for relapsed/refractory B-cell acute lymphoblastic leukaemia (B-ALL) in adults. B-ALL is an aggressive type of leukaemia (cancer of the blood and bone marrow), that can progress rapidly without treatment and […]
DownloadSerplulimab with chemotherapy for treating previously untreated extensive stage small-cell lung cancer
Serplulimab with chemotherapy is currently in clinical development as a first-line treatment for extensive-stage small-cell lung cancer (SCLC). SCLC is a very aggressive form of cancer that forms in the tissues of the lungs and often goes undiagnosed until it’s more advanced, so the survival rate tends to be low. Extensive stage SCLC (ES-SCLC) is […]
DownloadNiraparib with pembrolizumab maintenance therapy for metastatic stage III or IV non-small cell lung cancer
Niraparib with pembrolizumab is in clinical development for the maintenance therapy of patients with later stages of non-small cell lung cancer (NSCLC) after first-line platinum-based chemotherapy with pembrolizumab. Lung cancer is the third most common cancer in the UK and about 47,000 people are diagnosed with it each year. When cancer starts in the lungs, […]
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