[mulberryParticipant]

As you may know from the recent Myeloma UK statement, the pharmaceutical company Janssen have decided not to pursue NICE approval for either their CAR-T product Carvykti or their bispecific antibody treatment Tecvayli. This is in addition to Bristol Myers Squibb making a similar decision in respect of their CAR-T product, Ide-Cel in 2020.

Janssen says that the UK is not it’s key market. It is already supplying Carvykti CAR-T in Europe and USA, ie myeloma patients who have relapsed after 3 lines of treatment have had an opportunity to be treated with it since May 2022.
The new processing plant for Carvykti is being built in Belgium.

The UK, with its NICE hoop for pharmaceutical companies to jump through before NHS is allowed to prescribe, is being seen as too small a market to target.
The consequence? NHS patients will – no ARE- dying when some of us would have lived if we were in Europe.

So we have no foreseeable access to 1st world leading myeloma treatments,band instead are being offered Blenrep, which has been withdrawn from the USA market after a confirmatory trial failure. (And it is known to potentially cause eyesight problems)

[mich05Participant]

Thanks for this information Mulberry , so the only route for NICE to approve is for the drug company to request? If the drug company doesn’t request then NICE don’t ?

[sandy123Participant]

Thank you for your interesting post @mulberry This is indeed VERY frustrating! I had always hoped to remain in remission long enough for CAR-T to become approved as a third-line treatment but sadly not yet.

I believe there are various trials for bi-specific antibodies in progress in the UK e.g. MajesTEC-3 (Teclistimab) and MagnetisMM-9 (Elranatamab) but we will have to watch and wait to see how/when/if these clinical studies will translate into approved treatments in this country.

[mulberryParticipant]

Mich05, you are correct- the route for NICE approval does rely on the pharmaceutical companies submitting requests to supply drugs or treatments to the NHS.
Historically this has enabled NICE to negotiate advantageous financial agreements, which is seen as unfair by many US patients and health insurance companies.
So I suspect that there are various political agendas going on.

[mulberryParticipant]

Sandy123 is right that some UK patients will be able to have CAR-T cell treatment, Bispecific Antibody treatment or other novel treatments from one of the trials currently underway in UK hospitals. But with few exceptions there are comparatively few places in comparatively few trials, and of course not everyone in the trial will get selected for the arm that has the new treatment.

[spk2021Participant]

Another consequence of Brexit?

[Author]

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