RE:RE:RE:RE:I wonder what this means?You are right, it's not a rejection in the sense that the drug remains authorized, but it does look like it's henceforth firmly parked in the last resort category by this decision of not considering a recommendation.
Reading further, a NICE recommendation brings those statutory advantages:
- NHS is legally obliged to fund and resource the drug or treatment.
- Patients have a right to the drug, if their doctor believes they are clinically appropriate.
- if recommended 'as an option' NHS must make sure it is available within 3 months of its date of publication.
So, difficult access, difficult or non-existent reimbursement, a drug just seen as a stop-gap measure until other drugs are approved. Those are enormous barriers to commercial success.
In comparison, back in May, France's Transparency Commission gave an unequivocal positive reply, with an evaluation of "important medical service" and "minor improvement on SOC" which guarantees state-paid 65% reimbursement before any additional private insurance reimbursement.
They did recommend that the decision to prescribe be taken by HIV specialists, and after approval of a multi disciplinary committee, but it's still a far cry in terms of normalcy, and not putting brilliant innovations straight in the attic.
A very poor, short-sighted decision by this british bureaucratic committee IMO.
qwerty22 wrote: There is a note here in this article that maybe clears things up. It likely is the 'process' that has been rejected rather than the drug.
"COMMENT
Fostemsavir had a long development history and it is important that ViiV Healthcare followed this through to approval after acquiring the compound from BMS in 2015.
Currently, the demand for drugs to use in multidrug resistance in the UK is too limited for a full NICE evaluation. Access however, will be available based on NHS recommendations from specialist HIV commissioning.
The significant increase in CD4 count, might deserve further researcher, including in cases of discordant responses to ART, where viral load is suppressed but CD4 count remains low, especially if this continues to present a risk for opportunistic infections.
Cases of urgent need should contact ViiV directly until this access is in place.
Similar commissioning arrangements are also being organised for access to ibalizumab which was also recently approved.
For people with a history of multidrug resistance and detectable viral load on current ART, using both fostemsavir and ibalizumab together might provide life-saving holding treatment until the next pipeline drugs.
Even though each drug is likely to be priced close to £100,000 per year, they would only need to be used during a window period until the next drug approvals."
https://i-base.info/htb/39703
It's not a ringing endorsement of either drug, interesting they say fostemsavir will be priced similarly. The suggestion seems to be it's actually available for prescription now.
qwerty22 wrote:
Don't believe the politicking around Brexit, the UK hasn't become a rogue state. They are still making evidence based decisions. NICE has often controversially rejected expensive treatment options I'm just struggling to believe they'd outright reject both drugs. They could take the French route and realize this will be very limited patient numbers and so the absolute financial burden is small.
It reads more like a rejection of the appraisal process for these particular drugs rather than a rejection of the drug itself.
Spartrap wrote: It does read like a flat out rejection of both drugs to me. ;-/
Now that they are not longer part of the EU, they are freeer to reject costly efficacious drugs and just let MDR HIV patients die instead.
Good for them!
qwerty22 wrote: NICE is the UKs assessment system for drugs to be used in the NHS. Looks like both fostemsavir and Trogarzo are going thru the process together. They both got the same outcome from a Nov 2020 meeting.
"Oversight Panel concluded that an appraisal of ibalizumab in combination with other antiretroviral treatment for multidrug-resistant HIV-1 would be of limited value to the NHS at this time and therefore the topic will not progress any further"
It sounds pretty negative but I can't believe both drugs are being blocked for use in the NHS so it must just mean there is nothing to be gained from further talking. What you think? Could there be a UK decision soon? Be interesting if both drugs become available together. Might we get a culture of double switching in UK?
https://www.nice.org.uk/guidance/proposed/gid-ta10657
https://www.nice.org.uk/guidance/proposed/gid-ta10605