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[Perinowpost]

I'm floundering a bit with that one CLKD, they haven't published guidance on it but I'm not sure exactly what that means. We could do with someone to translate x

[sheila99]

Sounds like a fob-off to me.

[pepperminty]

Yes a fob off and passing the buck, I will do a bit of digging and try to come up with something, a reply to NICE maybe the first step? I think thy recommend to the CCG?

PMX

[Perinowpost]

Yes will definitely do both x

[Nannyneet]

Just being totally cynical here but the main problem is this is a women's problem,if it was a mans problem it would have been sorted long ago

[Perinowpost]

You could be right Nannyneet but we can't let that stop us x

[Nannyneet]

You could be right Nannyneet but we can't let that stop us x

Oh no,I didn't mean it was a lost cause,it's worth pursuing

[pepperminty]

Not a lost cause agreed, but we need to find out how people have sucessfully got drugs re approved etc, there must be a process?

PMX

[Hurdity]

I've only just seen this thread in particular the discussion about dydrogesterone.

It's brilliant that you're looking into this and writing to the relevant bodies! Many of us would love to try this progestogen even though it is an oral HRT....

Forgive me if I'm a bit confused but I'm not quite sure in what capacity NICE are involved? As has already been mentioned on the thread, the drug itself, dydrogesterone, is already licensed - but at the moment only as part of Femoston combined HRT types. As far as I understand it therefore NICE would not be involved - are they even involved in specific HRT types at all? Sorry I don't know how all this works. I know drugs have to get a license through the European Medicines Agency and similar bodies and then can be released in UK but not sure where NICE comes into this re new products?

As far as withdrawal of existing products is concerned, I understood that this was a commercial decision by the company but I might be wrong here. I can see you wrote to the company who suggested writing to NICE but I'm not sure why they suggested this? Someone in the company (which has several subsidiaries it seems) should know the history behind why Duphaston was withdrawn as a separate progestogen in UK but I expect it was for commerical reasons eg when Orthgynest (vaginal) pessaries were withdrawn this was for the same reasons - nothing to do with NICE.

Also not sure why NICE mention the local CCG - because  I am sure they will only decide what their priorities are  locally on the basis of licensed available medicines nationally?

What we need to find out is, who is the body nationally in UK which decided that Duphaston should be available in UK as separate treatment (licensed)  when it is still being manufactured by the company. I haven't looked into which other countries it is available in but maybe someone else has?

Great work girls anyway and let's continue to try to make changes through badgering everyone concenred

Hurdity x

[Perinowpost]

Hi Hurdity

Didn't realise you had commented on this and answered you on another post.

Anyway you've pointed us in the right direction I think to getting to the bottom of this re your advice about Duphaston. I'll do some research into this as soon as I get some time and pursue it.

Thanks x

[Hurdity]

Hi there - well really I'm also in the dark about how the system works!

Anyway I found this as I remembered there was an entry in Netdoctor about it, and that must be where I remembered the comment about it being withdrawn ( although I don't remember reading that!): https://www.netdoctor.co.uk/medicines/a6626/duphaston-discontinued-in-the-uk-march-2008/

"Warning!
    March 2008: The manufacturer is withdrawing this medicine from the market for commercial reasons. If you regularly take this medicine you should make an appointment with your doctor to discuss alternative treatments."

Also looks like it's still available in Ireland:
https://www.medicines.ie/medicines/duphaston-10mg-film-coated-tablets-31942/

I would suggest that there may be a better commercial case for it now that body-identical oestrogen is now widely used, especially as a separate oestrogen, compared with 2007-2008 and options for progestogen are very limited. However I might be getting a distorted picture from this forum though - although meno specialists I'm sure would prescribe it....anyway the point is it is still being manufactured so as I said above aside from the company making a decision to release it in UK again, I presume there is another authorisation that is needed? Product licence or something? That's what we don't know?

Maybe we should all write to the manufacturer as members did with Femseven - I'm happy to as well, especially if you don't have the time, but don't want to take over your research in any way Perinowpost!

Hurdity x

[pepperminty]

Thanks Hurdity for your input,
I was having a conflab with my DH and he said the same, and also that it sounds like we are getting the run around.

Perinowpost has been fab in writing off. I will do a bit of research and try to find out which body to write to next. If you don't ask you don't get!


PMX

[Perinowpost]

Yes will you write Hurdity and I will too. Plus anyone else who would like to join in in finding a solution. Lack of options re progesterone + intolerance must be one of the most common problems on the forum if not the most common, wouldn't it be fantastic if we could effect a change x

[CLKD]

NICE appear to be involved in all drugs that are passed for UK use.  They also have the power to say 'no' to often essential medication i.e. cannibis for children with continual fits, even if it helps.

"in line with NICE's recommendations. However, as explained above we have not published technology appraisals guidance on dydrogesterone or progesterone. "  either they do recommend, or they don't.  Unless there's a hidden agenda?

[Hurdity]

CLKD - I am not totally clear about NICE's specific role in meds but I understand that when drug is first introduced - (and by this I mean the drug itself, the preparation containing a new active ingredient, not for example a new commercial preparation of a previously available drug) - then NICE Looks at all the evidence and makes recommendations. I think cost comes into it.

In the case of Duphaston - I don't think NICE would be involved - as I found on the netdoctor site - it was withdrawn for commercial reasons, nothing to do with NICE. The active ingredient of Duphaston - dydrogesterone must have been approved years ago  and is still available as part of Femoston.

In any case Duphaston is available elsewhere in Europe so I can't fathom why not in UK since it is obviously still commmercially successful.

I think we should write to Mylan again - and hopefully not be fobbed off!

Also I found that the MHRA licenses drugs depending on the category:
https://www.gov.uk/topic/medicines-medical-devices-blood/marketing-authorisations-variations-licensing

The closest category is for marketing  a product which already has a licence in other EU countries - and the process is very straightforward:
https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk#MRP

There doesn't seem to be a category for re-authorising a product that previously had a marketing licence but the company would know.

I wonder if other gynaes have also put pressure on the company or have made approaches? Dydrogesterone came across favourably in terms of breast cancer risk - and evidence so far shows it is the most "breast friendly" - lowest risk - of the synthetic progestogens as it is very close in structure to progesterone itself.

I'm rambling. I'll write. Let's all write (to Mylan). We may end up getting a standard response but we can but try....

I can't see on this page whether you put the e-mail address on the other page Perinowpost - but if not here it is: [email protected] .  Hopefully the e-mails don't just get ignored or lost in the ether....

Here's another one:
[email protected]

Maybe we should start another thread with dydrogesterone in the title so that other members see it?

Thankyou Perinowpost for starting all this off!

Hurdity x