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.
Enfortumab vedotin with pembrolizumab for previously untreated locally advanced or metastatic urothelial cancer
Enfortumab vedotin in combination with pembrolizumab is in clinical development for the treatmentof patients with previously untreated locally advanced or metastatic urothelial cancer (UC). UC occurson the lining of the renal pelvis, ureter, bladder and urethra, and other parts of the urinary system.Metastatic UC occurs when the cancer has spread to other parts of the […]
DownloadOsimertinib maintenance therapy for treating stage III unresectable EGFR mutation positive non-small-cell lung cancer after definitive platinum-based chemoradiation therapy
Osimertinib is in development for the treatment of stage III, unresectable EGFR mutation positive non-small cell lung cancer (NSCLC) following definitive chemoradiation therapy. NSCLC is the most common form of lung cancer. Stage III lung cancer means the cancer is in more than one lobe of the lung, or it has spread to lymph nodes […]
DownloadDonanemab for treating early symptomatic Alzheimer's disease
Donanemab is currently in clinical development for the treatment of early Alzheimer’s disease(AD). AD is a progressive neurological disease which is caused by loss of function and death ofneurones in the brain. It is the most common type of dementia. One of the early symptoms of ADis mild cognitive impairment where a person may have […]
DownloadSelpercatinib for previously untreated advanced RET-fusion positive thyroid cancer
Selpercatinib is in clinical development for untreated advanced RET-fusion positive thyroid cancer in adults. Thyroid cancer is a rare form of cancer that originates in the thyroid gland located in the front of the neck. RET is a type of protein called a kinase, which is involved in various cell processes. RET-fusion positive cancer is […]
DownloadBenegrastim for treating chemotherapy-induced neutropenia in women with breast cancer
Benegrastim is being developed for the treatment of neutropenia in patients receiving chemotherapy treatment for breast cancer. Neutropenia occurs when an individual has low levels of neutrophils (a type of white blood cell), and it is a common side effect of cancer chemotherapy. Neutropenia can leave patients vulnerable to infections and cause complications such as […]
DownloadCAEL-101 for treating amyloid light chain amyloidosis
CAEL-101 is in clinical development for the treatment of amyloid light chain (AL) amyloidosis. AL amyloidosis belongs to a group of diseases called systemic amyloidosis in which deposits of proteins (called amyloids) accumulate and cause damage in tissues and organs, such as the kidneys, liver, gut, heart and nerves. In AL amyloidosis, the deposits are […]
DownloadNemolizumab for treating atopic dermatitis and prurigo nodularis
Nemolizumab is currently in development for atopic dermatitis and prurigo nodularis. Atopic dermatitis is the most common form of eczema, a long-term (chronic) condition that causes patches of the skin to become itchy, dry and cracked. In moderate-to-severe cases, the patches cover a large area of the skin and can be associated with an intense […]
DownloadLetetresgene autoleucel for treating synovial sarcoma and myxoid round cell liposarcoma
Letetresgene autoleucel is in clinical development for the treatment of advanced synovial sarcoma (SS) and myxoid/round cell liposarcoma (MRCLS) in children and adults. Both SS and MRCLS are two different types of soft tissue sarcomas, rare forms of cancer that develop in the tissues that connect, support, and surround other body structures and organs. Advanced […]
DownloadPotassium citrate-potassium bicarbonate prolonged release granules for treating cystinuria
ADV7103 is currently in clinical development for the treatment of cystinuria in patients aged 1 year and above. Cystinuria is an inherited metabolic condition where irregular changes to genes called SLC3A1 and SLC7A9 results in abnormal transport of the amino acid, cysteine, in the kidney. This results in excessive amounts of cysteine excreted in the […]
DownloadNivolumab with chemotherapy neoadjuvant followed by nivolumab adjuvant for treating early stage non-small-cell lung cancer
Neoadjuvant nivolumab in combination with chemotherapy followed by adjuvant nivolumab is currently in clinical development for early stage non-small-cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. Early-stage lung cancer is typically treated with surgery consisting of removing either part of or the whole of the lung, followed by chemotherapy and/or […]
DownloadZamtocabtagene autoleucel for treating relapsed or refractory diffuse large B-cell lymphoma
Zamtocabtagene autoleucel is currently in clinical development for adults with relapsed or refractory diffuse large B cell lymphoma (DLBCL), not eligible for high-dose chemotherapy and autologous stem cell transplantation. DLBCL is a cancer of B cells (a type of immune cell) and the most common type of fast-growing non-Hodgkin’s lymphoma. In DLBCL, abnormal B cells […]
DownloadDurvalumab with platinum-based chemotherapy for the neoadjuvant/adjuvant treatment of resectable non-small-cell lung cancer
Durvalumab in combination with platinum-based chemotherapy is in clinical development for the neoadjuvant/adjuvant treatment of resectable non-small-cell lung cancer (NSCLC). NSCLC is the most common type of lung cancer. Early-stage lung cancer is typically treated with surgery to remove the tumour, followed by chemotherapy and/or radiotherapy. However, survival rates are still poor. Symptoms include a […]
DownloadRisankizumab for moderate to severe ulcerative colitis
Risankizumab is in clinical development for moderate to severe ulcerative colitis. Ulcerative colitis is one of two major types of inflammatory bowel disease (IBD). It is a long-term immune-mediated inflammatory disorder where the colon and rectum become inflamed and small ulcers can develop on the colon’s lining, which can cause symptoms such as rectal bleeding […]
DownloadDaratumumab for the treating high-risk smouldering multiple myeloma
Daratumumab is in clinical development for high-risk smouldering multiple myeloma (SMM). SMM is an early form of myeloma which usually progresses to active myeloma, but at a slow rate. SMM is a precancerous condition that changes certain proteins in blood and/or increases plasma cells in the bone marrow but does not cause symptoms of disease. […]
DownloadApalutamide with primary radiation therapy for treating high-risk, localised or locally advanced prostate cancer
Apalutamide with androgen deprivation therapy (ADT), is in clinical development for patients with high-risk localised or locally advanced prostate cancer who are receiving primary radiation therapy. 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 in the UK. The symptoms […]
DownloadAtezolizumab with platinum-based chemotherapy and bevacizumab for epithelial ovarian cancer or fallopian tube cancer or primary peritoneal cancer
Atezolizumab in combination with bevacizumab and chemotherapy is currently in clinicaldevelopment for the treatment of patients with epithelial ovarian cancer or primary peritonealor fallopian tube cancer. Epithelial ovarian cancers are the most common type of ovarian cancer.Primary peritoneal cancer and fallopian tube cancer are similar to epithelial ovarian cancer. Allthree types show signs of pain […]
DownloadTirzepatide for treating obese or overweight adults
Tirzepatide is in clinical development for the treatment of obesity or overweight individuals with weight-related comorbidities (e.g., sleep apnoea, cardiovascular disease). Excess weight can place stress on both mental and physical health, leading to complications such as depression, low self-esteem, and increased risk of heart disease, stroke, and type 2 diabetes. Weight can be affected […]
DownloadIvosidenib with azacitidine for previously untreated acute myeloid leukaemia with an IDH1 mutation
Ivosidenib is in development with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukaemia (AML) who have an isocitrate dehydrogenase 1 (IDH1) mutation and are ineligible for intensive induction chemotherapy. AML is a rare form of blood cancer that affects the white blood cells resulting in frequent infections for patients. AML also […]
DownloadXevinapant with platinum-based chemoradiotherapy for previously untreated locally advanced squamous cell carcinoma of the head and neck
Xevinapant in combination with chemoradiotherapy (CRT) is currently in clinical development for previously untreated locally advanced squamous cell carcinoma of the head and neck (SCCHN). SCCHN is cancer that begins in the squamous cells (thin, flat cells that line various organs and skin) in areas of head and neck, including nasal cavity, sinuses, lips, mouth, […]
DownloadGlofitamab with gemcitabine, oxaliplatin and rituximab for treating relapsed or refractory diffuse large B-cell lymphoma
Glofitamab in combination with gemcitabine, oxaliplatin and rituximab is currently in clinical development for relapsed/refractory diffuse large B-cell lymphoma (DLBCL). DLBCL is a type of non-Hodgkin lymphoma. Most people with DLBCL first notice painless lumps, often in their neck, armpit, groin, or abdomen, or in testicles for men. These are enlarged lymph nodes. They usually […]
DownloadNeoadjuvant atezolizumab with chemotherapy followed by adjuvant atezolizumab for treating triple-negative breast cancer
Neoadjuvant atezolizumab in combination with chemotherapy followed by adjuvant atezolizumab is currently in clinical development for patients with triple-negative breast cancer (TNBC). TNBC develops in about 1 in 5 women with breast cancer and is one of the most difficult forms of breast cancer to treat due to the lack of receptors that are common […]
DownloadTeclistamab with daratumumab for previously treated relapsed or refractory multiple myeloma
Teclistamab, in combination with daratumumab, is in clinical development for the treatment of adults with relapsed or refractory multiple myeloma (MM) who have had previous treatment. MM is a form of cancer that occurs in immune cells found in bone marrow. The disease occurs due to uncontrolled duplication of these immune cells, known as plasma […]
DownloadAtezolizumab with cabozantinib for previously treated metastatic castration-resistant prostate cancer
Atezolizumab in combination with cabozantinib is in clinical development for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in male patients previously treated with one novel hormonal therapy (NHT). Prostate cancer is cancer of the prostate gland, which is part of the male reproductive system. When prostate cancer spreads to other parts of the body, […]
DownloadDurvalumab adjuvant therapy for treating hepatocellular carcinoma at high risk of recurrence after curative treatment
Durvalumab as an adjuvant therapy is in clinical development for treating hepatocellular carcinoma (HCC), the most common type of liver cancer, where there is a high risk of the cancer returning after curative treatment. It is common that people with HCC are asymptomatic (do not show symptoms related to the cancer). There is increased risk […]
DownloadHigh-dose aflibercept for diabetic macular oedema
High-dose aflibercept is in clinical development for the treatment of diabetic macular oedema. DMO is swelling of the macula caused by diabetes or by blockage of the veins behind the retina and it is the most common cause of sight loss in people with diabetes. DMO occurs when blood vessels damaged by high blood sugar […]
DownloadHigh dose aflibercept for treating neovascular age-related macular degeneration (nAMD)
High dose aflibercept is in development for the treatment of neovascular age-related macular degeneration (nAMD). nAMD is a condition that commonly affects people over the age of 50 and causes vision disturbance or blind spots in the centre of the visual field and progresses rapidly over several weeks or months without any treatment. Aflibercept is […]
DownloadNivolumab adjuvant for treating for stage IIB/IIC resected melanoma
Nivolumab is in clinical development as a therapy to be given to patients who have had stage IIB-IIC melanoma removed via surgery but who are at high risk of recurrence. Melanoma is a type of skin cancer that is commonly caused by sun exposure and is often first noticed as a new mole or a […]
DownloadIptacopan for paroxysmal nocturnal haemoglobinuria
Iptacopan is in development for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). PNH is a rare condition, which occurs due to a genetic change within cells in the bone marrow. In PNH, blood cells lack specific proteins on their surface which normally protect them from being destroyed (a process called haemolysis in red blood cells) […]
DownloadPembrolizumab perioperative therapy with neoadjuvant chemotherapy for treating cisplatin eligible muscle-invasive bladder cancer
Pembrolizumab perioperative (preoperative and postoperative) therapy in combination with neoadjuvant (before surgery) chemotherapy is in development for the treatment of patients with cisplatin eligible muscle invasive bladder cancer (MIBC). MIBC is when the cancer has spread beyond the lining of the bladder and into the muscle layer. The most well-known risk factor for MIBC is […]
DownloadLinzagolix choline for treating moderate to severe symptoms associated with uterine fibroids in adult women of reproductive age
Linzagolix choline is currently in clinical development for the treatment of moderate to severe symptoms of uterine fibroids (UFs) in adult women. UFs are the most common form of benign uterine tumours, causing heavy menstrual bleeding, pelvic pain, infertility, and pressure symptoms. They can also cause bleeding between periods, anaemia, abdominal pain and cramping, painful […]
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