- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
NICE changes decision on AstraZeneca’s olaparib
11 December 2015 • Author: Victoria White
The National Institute for Health and Care Excellence (NICE) intends to recommend AstraZeneca’s Lynparza (olaparib) for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube and peritoneal cancer in final draft guidance.
The drug is for cancers in people who have tested positive for the BRCA1 or BRCA2 mutations, and whose disease has responded to platinum-based chemotherapy.
Specifically, the draft recommendations say that olaparib should be available for people only if they have had 3 or more courses of platinum-based chemotherapy and the drug cost of olaparib for people who remain on treatment after 15 months is met by the company.
The independent Appraisal Committee which developed the draft guidance had previously asked the makers of olaparib to provide more information on the cost effectiveness of the drug. Specifically requested was information on the subgroup of patients with relapsed disease who have had 3 or more courses of platinum-based chemotherapy. The company provided this further information for the committee’s consideration. The analysis supplied by the company included both a patient access scheme in which the company meets the cost of the drug for people who remain on treatment after 15 months and a proposed reduction to the list price, which allowed the draft guidance to move from potentially not recommending the drug to instead saying that olaparib should be available for this particular group of people.
A ‘defining moment’
Meindert Boysen, NICE Programme Director – Appraisals, said: “We’re pleased to recommend olaparib for maintenance treatment of relapsed platinum-sensitive ovarian cancer in specific patients in this final draft guidance. The independent appraisal committee asked the company which makes olaparib to provide further information on this subgroup of patients. This further detail on the cost effectiveness of the drug for these patients means that this final draft guidance now recommends olaparib in specific circumstances, only if the company meets the cost of olaparib for people who remain on treatment after 15 months.”
Commenting on today’s announcement, Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said, “It’s great news that NICE has changed its decision, and made olaparib available for women with BRCA-mutated ovarian cancer. The development of olaparib was underpinned by translational research at the ICR, which was instrumental in developing the innovative concept of targeting BRCA-mutated cancers with drugs of its type. Today it becomes the first cancer drug targeted against an inherited genetic fault ever to be made available on the NHS. Its approval by NICE is a defining moment in the history of targeted cancer treatments, although it is still frustrating that under the terms of the judgement patients cannot benefit until they have had at least three rounds of chemotherapy.”
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd B&W Tek Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Metrohm Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics