Thursday, December 04, 2008 5:05:43 PM
http://www.nice.org.uk/Guidance/TA/Wave17/11#projectTeam
The four parts that are linked at the bottom of the page are a great read and they really put things into perspective. Some interesting points are that there are more than 150 cases of osteosarcoma in the UK per year. Some quick math will show you that the UK has about one eight of the EU population and so the number of cases in Europe should be in excess of 1000 cases per year. It's also nice to see how the advisors are really pushing for a broader scope of use and it would be very encouraging if the EMEA adds metastatic osteosarcoma patients to the scope of treatment because this makes the leap to other cancer's with pulmonary metastases much easier. And last but not least is this quote from the economic analysis in the final scope:
"The reference case stipulates that the cost effectiveness of treatments should be expressed in terms of incremental cost per quality-adjusted life year."
Remember, osteosarcoma mostly effects the adolescent population and so preventing a death adds decades to the patients life and so the "cost per quality-adjusted life year," will easily be justified. The way I read this is that the UK won't have a problem paying for the cost of treatment and therefore, a six digit treatment cost is not out of the question. I also believe that Mepact will be a "first appraisal," which is a fast-track process in which the NHS quickly gears up the guidance process so that the drug is available as soon as possible after the official EMEA approval.
The next big date on your list should be the, "Summary of Opinions," which will be issued following the December CHMP meeting (Dec. 15-18), then the official EMEA approval will happen 60-90 days after, plus on Feb 18th the NICE will hold its First Appraisal Committee Meeting, and we will get more clarity on the scope of use/economic cost. Yes, it should be a bountiful spring indeed.
Maybacks Global Entertainment and ZEASN Technology Private Ltd. Sign Global Licensing Agreement • AHRO • Aug 8, 2024 7:00 AM
SANUWAVE Will Host a Conference Call on August 13, 2024 at 8:30 AM (ET) to Present Q2 Financial Results • SNWV • Aug 8, 2024 6:59 AM
Kona Gold Beverage Inc. Signs Letter of Intent with Bemax, Inc. to Sell Kona Gold, LLC • BMXC • Aug 7, 2024 10:00 AM
Btab Ecommerce Group, Inc. Launches Investor Connect AI Chatbot for Enhanced Investor Engagement and Lead Generation • BBTT • Aug 7, 2024 9:00 AM
Hydromer, Inc. Announces Preliminary Unaudited Second Quarter 2024 Financial Results and Provides Business Update • HYDI • Aug 7, 2024 8:52 AM
North Bay Resources Announces Mt. Vernon Gold Mine Startup, Sierra County, California • NBRI • Aug 5, 2024 9:00 AM