biosectinvestor,
The chart shows us the data up to the middle of July 2021.
In September, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has conditionally approved Lumykras (Amgen’s first-in-class KRAS G12C inhibitor Lumykras (sotorasib)) and TEPMETKO® (Merck’s tepotinib for the treatment of advanced NSCLC with METex14 Skipping Alterations) under Project Orbis.
Flipper44 recently posted the criteria for interim access arrangements for oncology products licensed through Project Orbis. Very interesting IMO.
Edward Argar
Minister of State (Department of Health and Social Care)
October 25, 2021
In view of the rapid approval of Project Orbis medicines, NHS England and NHS Improvement and the National Institute for Health and Care Excellence (NICE) have developed an interim process to support patient access to medicines between Project Orbis licensing approval and publication of NICE guidance. It is anticipated that this will only be required in the short term. Consideration is given to:
- whether there is expected to be three months or longer between regulatory approval by the Medicines and Healthcare products Regulatory Agency and publication by NICE of its final draft guidance;
- if there are any direct competitors expected to go through the NICE technology appraisal process within the next six months;
- if the treatment will make a fundamental, positive change to the existing treatment pathway; and
- whether the company will offer the medicine or treatment on a cost neutral basis.
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