In what is a big shake up of NICE procedure, the drug pricing watchdog will review the cost-effectiveness of drugs before they are launched.
Dubbed ‘evidence summaries: new medicines’, this new process will see NICE produce what it calls ‘quality-assured summaries’ around of the best available evidence for selected new medicines. It is also being used for existing medicines with new indications or a new formulation, which are considered to be of significance to the NHS.
The topics selected are medicines that have recently gone into the UK market, or medicines that may be marketed in the UK in the next six to 12 months.
But NICE stressed that these reviews will not be used as formal guidance, but rather to help NHS commissioners to make informed decisions, whilst aiding local planning on the introduction of key new medicines.
The formal health technology assessment of these medicines will still need to be carried out, but may be informed by the ESNMs.
Where there is no technology appraisal from NICE, these summaries will also help to ensure “consistent access to evidence for decision-makers”, the watchdog said in a statement.
NICE has already released a list of drugs that it will be carrying these reviews out upon, with several already nearing completion. In October, it will be publishing its assessment of Novo Nordisk’s insulin degludec, a new ultra long-acting basal insulin that is seeking a licence to be used for type I and II diabetics.
Novo’s drug product was filed with both the FDA and EMA in September last year, but has not yet been approved for use by either regulator.
This month it will also be publishing a review of Abbott’s Humira (adalimumab) for the treatment of moderately to severely active ulcerative colitis in adult patients. It already has a NICE recommendation for treating rheumatoid arthritis, but Abbott only received a European licence for ulcerative colitis in April, and has not yet been the subject of NICE guidance.
Over the next three months NICE will also be publishing its assessment of:• Eisai’s new drug Fycompa (perampanel) as an adjunctive treatment of partial onset seizures with or without secondarily generalised seizures
• Almirall’s Eklira Genuair (aclidinium) as maintenance treatment for COPD
• The generic form of glycopyrronium (formerly Robinul) as a maintenance bronchodilator treatment to relieve symptoms of COPD
• Sanofi’s Lyxumia (lixisenatide) for the treatment of type II diabetes in adults who have not achieved adequate glycaemic control with oral antidiabetic drugs, basal insulin, or a combination of both
• Roche’s HER2 breast cancer drug Herceptin (trastuzumab) as a subcutaneous (neo) adjuvant for early breast cancer and metastatic breast cancer.