Wednesday, August 03, 2022 9:43:37 AM
The NICE review manual includes a significant section on "cost-effectiveness"
For your reference: https://www.nice.org.uk/process/pmg6/chapter/assessing-cost-effectiveness It is not my "opinion it is the NICE approval process. The approved SoC has already established a "const-effectiveness" standard that newer applications are compared too. Since many of them are generics it forces newer drugs to greatly reduce prices to be competitive with the current SoC "cost-effectiveness."
In a study comparing EU/NICE oncology drug approvals vs. FDA, here was the findings: "In a cohort of 93 cancer drug indications that received FDA accelerated approval over the past 25 years, 30 drug indications were not reviewed for coverage in the NHS, and 12 drug indications were denied authorization or coverage by either European regulators or NICE because of insufficient safety, clinical efficacy, or cost-effectiveness. Most recommendations for drug indication pairs in England were conditional on the negotiation of additional confidential price discounts or the collection of postmarket evidence for efficacy."
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2776284
Your point on Doctors influencing FDA approval -- any independent evidence other than your opinion?? I haven't seen any.
For your reference: https://www.nice.org.uk/process/pmg6/chapter/assessing-cost-effectiveness It is not my "opinion it is the NICE approval process. The approved SoC has already established a "const-effectiveness" standard that newer applications are compared too. Since many of them are generics it forces newer drugs to greatly reduce prices to be competitive with the current SoC "cost-effectiveness."
In a study comparing EU/NICE oncology drug approvals vs. FDA, here was the findings: "In a cohort of 93 cancer drug indications that received FDA accelerated approval over the past 25 years, 30 drug indications were not reviewed for coverage in the NHS, and 12 drug indications were denied authorization or coverage by either European regulators or NICE because of insufficient safety, clinical efficacy, or cost-effectiveness. Most recommendations for drug indication pairs in England were conditional on the negotiation of additional confidential price discounts or the collection of postmarket evidence for efficacy."
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2776284
Your point on Doctors influencing FDA approval -- any independent evidence other than your opinion?? I haven't seen any.
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