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Abiraterone 2024

User
Posted 12 Apr 2024 at 15:40

The elephant in the room?

Lots of newspaper articles about it been not licensed for use for newly diagnosed high risk non-metastatic Pca patients in England, but not much comment on this forum, though I did see someone started a thread asking where it could be obtained a couple of weeks ago.

 

It does seem slightly ironic that the STAMPEDE trial that indicates its efficacy for use on high risk patients was conducted largely in England, yet that seems to be one of the few countries that it's not been approved for use in this context. However it's wider use is supposedly set to be reviewed this year. 

 

So what is going on?


I understand there's little financial incentive for the creators of the drug to go through the process of applying for it's non-purposed use through NICE as it's now off patent, but this hasn't stopped health authorities in Scotland and Wales taking a pragmatic approach.

 

A few questions if I may.

 

I believe it works by disrupting testosterone production in parts of the body other than the testes, but if someone managed to achieve an extremely low PSA count during current ADT therapy, would Abiraterone have made much difference or is there something else going on?

 

What drugs is it being used along side in Scotland and Wales?

 

Here's a piece the BBC did from last year.

 

 

Abiraterone: Thousands of men miss out on life-extending prostate cancer drug - BBC News

 

£250 per month seems pretty cheap, would it really be that simple, i.e. would an NHS Oncologist tailor a treatment plan around your private prescription?
I doubt it.

 

Has anyone in England broached the subject with an NHS consultant?

Edited by member 13 Apr 2024 at 01:43  | Reason: Not specified

User
Posted 14 Apr 2024 at 10:00

The use of some of the novel hormone therapy medications (Abiraterone, Enzalutamide, Daralutamide, Apalutamide) combined with the GnRH/LHRH injections for time-limited HT is increasing in the case of curative time-limited treatments for high risk disease. However, as you say, we've not seen this in the UK except for trials, and the case where these have been used instead of chemo for N1 (local lymph node) involvement.

I haven't been following this as it's not available in the UK, but there seems to be some thought that getting Testosterone levels very low (lower than the GnRH/LHRH injections sometimes achieve) may be beneficial in high risk cases, and this is where Abiraterone can help. It is also an anti-androgen, but it's main reason for use is to block other ways Testosterone is manufactured. The GnRH/LHRH injections only stop Testosterone produced by the Testicles - it's also produced by the adrenal glands, and the cancer cells can mutate to produce Testosterone or DHT themselves all of which Abiratrone interrupts.

Edited by member 14 Apr 2024 at 10:00  | Reason: Not specified

User
Posted 13 May 2024 at 12:23

I think it's fair to say that judging by the lack of comments on this thread or any others it remains the elephant in the room.

A few weeks ago a gentleman started a thread asking how he could obtain Abiraterone, a respected and long standing forumite questioned why he would even want it, as it had yet to be approved by NICE for use for men with high risk cancer, frankly given the STAMPEDE trial results and adoption of it's use in much of the developed world, I found the response absurd.

This is Prostate Cancer UK's view of the situation.

https://prostatecanceruk.org/about-us/news-and-views/2023/10/end-the-abiraterone-postcode-lottery-for-men-with-prostate-cancer

In some ways I can understand people's reluctance to comment on a treatment that isn't available to all, but I don't think adopting this position will help change the situation, I believe it is much better to be open and pro-active.

My enquiry with my NHS Radiologist led to an appointment with a consultant at Nova Healthcare and I was quoted £520 per month to supplement my ADT with Abiraterone, this includes the drug itself and the additional testing and consultations that would be required.

I asked if she ever brought up Abiraterone with high risk NHS patients, she told me it was a situation that was often discussed amongst consultants and that she does let patients know of the private option if she believes it would be greatly beneficial.

The following day I'd scheduled a meeting with my local MP. He is a big advocate of men's health, but was unaware of the particulars of the situation re Abiraterone. He said he will write to both NICE and the Health secretary to try help move things along.

 

A copy of the email I sent to my MP, if anything is incorrect or I've missed anything important out, please let me know, if anyone is minded to contact their MP they're more than welcome to use the relevant parts of it.

I am aware that my T3 and T4 definitions aren't entirely correct, but I was trying to keep things simple and not bring in further terminology and Letters.

 

Dear Mr Andrew,

 

Thank you for meeting me last Friday. There was quite a lot of information relayed so I thought it best to briefly document the most relevant with references.

 

After an MRI scan and a Prostate Biopsy men are given a cancer staging, these are as follows.

 

T1/T2 early stage cancer confined to the prostate with extremely good chance of cure or long term remission, usually considered low or intermediate risk of progressing.

T3 locally advanced cancer that has spread just beyond the prostate, but not metastasised elsewhere in the body, it has a high risk of progressing if untreated but is still treated with a curable intent.

T4 Advanced cancer that has metastasised to distant parts of the body, historically not considered to be curable but with advances in medicine men with this diagnosis have a variety of treatment options and many will live much longer than previously expected.

 

It's a bit more complicated than above as initial PSA levels and Gleason score following Biopsy are also taken into account when assessing cancer risk.

 

Abiraterone was developed in London.

 

 

Originally purposed to extend the lives of T4 patients, the case histories documented in the link are of men with T4 advanced cancer and I believe the information in the link is out of date as Abiraterone is now guidlelined for use in most cases of T4 cancer.

 

STAMPEDE was a large scale multi arm trial which started in 2005 and ended recruitment in 2022, though is still reporting results. It's aim was to investigate new approaches for T3 and T4 cancer.

 

Standard treatment for locally advanced cancer T3 is Radiotherapy plus first gen HT.

The Stampede trial indicated that adding Abiraterone to this treatment significantly improves overall survival and cancer free survival when measured at six years after treatment.

 

Summary of results as published in The Lancet

 

 

As a result of the trial Abiraterone has been added to SOC for T3 stage patients in much of the developed world.

 

BBC article

 

 

I attempted to contact the gentleman as I was sceptical of £250 per month quoted

 

 

 

NHS Wales adoption:

 

 

NHS Scotland adoption:

 

 

The patent for Abiraterone ended Oct 2022.

 

As mentioned in the BBC article there is no incentive for the manufacturers of the drug to apply to NICE for its repurpose to treat T3 patients, though NICE have said they may review the situation independently later this year.

 

I have a T3 Diagnosis and commenced standard HT with RT scheduled in around 3 months, I have been quoted £520 per month through Nova Healthcare to add Abiraterone plus associated blood tests and consultations to my SOC.

 

If I can be of any further assistance, please let me know.

 

Correspondence from yourself with the Minister for Health and NICE to try nudge things along for others who find themselves in a similar position to myself would be much appreciated.

 

Kindest regards

 

 

 

Edited by member 13 May 2024 at 18:26  | Reason: Not specified

User
Posted 12 Apr 2024 at 15:40

The elephant in the room?

Lots of newspaper articles about it been not licensed for use for newly diagnosed high risk non-metastatic Pca patients in England, but not much comment on this forum, though I did see someone started a thread asking where it could be obtained a couple of weeks ago.

 

It does seem slightly ironic that the STAMPEDE trial that indicates its efficacy for use on high risk patients was conducted largely in England, yet that seems to be one of the few countries that it's not been approved for use in this context. However it's wider use is supposedly set to be reviewed this year. 

 

So what is going on?


I understand there's little financial incentive for the creators of the drug to go through the process of applying for it's non-purposed use through NICE as it's now off patent, but this hasn't stopped health authorities in Scotland and Wales taking a pragmatic approach.

 

A few questions if I may.

 

I believe it works by disrupting testosterone production in parts of the body other than the testes, but if someone managed to achieve an extremely low PSA count during current ADT therapy, would Abiraterone have made much difference or is there something else going on?

 

What drugs is it being used along side in Scotland and Wales?

 

Here's a piece the BBC did from last year.

 

 

Abiraterone: Thousands of men miss out on life-extending prostate cancer drug - BBC News

 

£250 per month seems pretty cheap, would it really be that simple, i.e. would an NHS Oncologist tailor a treatment plan around your private prescription?
I doubt it.

 

Has anyone in England broached the subject with an NHS consultant?

Edited by member 13 Apr 2024 at 01:43  | Reason: Not specified

User
Posted 24 Apr 2024 at 22:43

Hi Richard,

Yes he was diagnosed last May, PSA 252, bone scan clear but hot spot on lymph node in pelvis, started Bicalutamide immediately for three weeks, then Prostap every 12 weeks, and Abiraterone and Prednisolone added in,then just leading up to Christmas last year had 20 sessions of radiotherapy. To stay on Prostap and Abiraterone until next July, PSA now 4. We were told there is a higher chance of recurrence as his PSA was so high, hence the Abiraterone.

Hope you are doing well.

Regards

Linda 

User
Posted 13 May 2024 at 19:00

Hi Richard,

I respect and admire your quest for fairness, but I suspect you'll end up feeling like you're wading through treacle. Let's hope your MP can expediate things.

Best of luck mate.

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User
Posted 14 Apr 2024 at 08:10

Hi Richard… I didn’t have any luck in finding anything other than an extremely expensive private prescription for Abiraterone.

This article may be of interest.

https://tackleprostate.org/nice-rejects-use-of-abiraterone-for-men-with-newly-diagnosed-metastatic-prostate-cancer/

Ian 

User
Posted 14 Apr 2024 at 09:31
The system is not allowing me to reply as a private message.

 

Following a private consultation with the oncologist who is also on the NHS team I was quoted…

 

Cost of day case room £550

Blood tests £290

Meds £2,930

Total £3,770 per monthly visit.

 

Treatment would be for up to two years with a likely cost £90K. The oncologist did not think an IFR - Individual Funding Request to the NHS would be successful. So Abiraterone is not an option I can afford.

 

 

User
Posted 14 Apr 2024 at 09:37

Yeah I think you have to have posted on the forum 10 times before you can use the messaging facility.

thanks for the info.

User
Posted 14 Apr 2024 at 10:00

The use of some of the novel hormone therapy medications (Abiraterone, Enzalutamide, Daralutamide, Apalutamide) combined with the GnRH/LHRH injections for time-limited HT is increasing in the case of curative time-limited treatments for high risk disease. However, as you say, we've not seen this in the UK except for trials, and the case where these have been used instead of chemo for N1 (local lymph node) involvement.

I haven't been following this as it's not available in the UK, but there seems to be some thought that getting Testosterone levels very low (lower than the GnRH/LHRH injections sometimes achieve) may be beneficial in high risk cases, and this is where Abiraterone can help. It is also an anti-androgen, but it's main reason for use is to block other ways Testosterone is manufactured. The GnRH/LHRH injections only stop Testosterone produced by the Testicles - it's also produced by the adrenal glands, and the cancer cells can mutate to produce Testosterone or DHT themselves all of which Abiratrone interrupts.

Edited by member 14 Apr 2024 at 10:00  | Reason: Not specified

User
Posted 15 Apr 2024 at 10:07

Thanks for your reply Andy, I didn't know cancer cells could mutate to produce testosterone, but Abiraterone's ability to interrupt this as well as testosterone produced elsewhere in the body probably explains the results from the trials.

I believe you're incorrect to state that Abiraterone hasn't been approved for use in the UK for non-metastatic high risk patients as the guidelines in Wales and Scotland now permits it's use, hence the use of the term postcode lottery by Prostate Cancer UK in the BBC piece. However I've not seen anyone from Wales or Scotland on this forum indicate they are been treated with Abiraterone in this setting.

I am still trying find out if the BBC article is factually accurate i.e. if Mr Giles is indeed benefiting from using Abiraterone to augment his standard NHS practice for £250 per month or if as I suspect it's not as simple as that.

 

User
Posted 22 Apr 2024 at 01:46

Abiraterone 

I live in Scotland and my husband is on Prostap injections 12 weekly as well as Abiraterone and Prednisolone for two years. His PSA was 252,

Linp

Edited by member 22 Apr 2024 at 01:49  | Reason: Not specified

User
Posted 22 Apr 2024 at 06:43

Thank you for your reply Linda, is he also scheduled for Radiotherapy?
Wishing you all the best with his treatment and hoping the HT is manageable for him.

User
Posted 24 Apr 2024 at 22:43

Hi Richard,

Yes he was diagnosed last May, PSA 252, bone scan clear but hot spot on lymph node in pelvis, started Bicalutamide immediately for three weeks, then Prostap every 12 weeks, and Abiraterone and Prednisolone added in,then just leading up to Christmas last year had 20 sessions of radiotherapy. To stay on Prostap and Abiraterone until next July, PSA now 4. We were told there is a higher chance of recurrence as his PSA was so high, hence the Abiraterone.

Hope you are doing well.

Regards

Linda 

User
Posted 13 May 2024 at 12:23

I think it's fair to say that judging by the lack of comments on this thread or any others it remains the elephant in the room.

A few weeks ago a gentleman started a thread asking how he could obtain Abiraterone, a respected and long standing forumite questioned why he would even want it, as it had yet to be approved by NICE for use for men with high risk cancer, frankly given the STAMPEDE trial results and adoption of it's use in much of the developed world, I found the response absurd.

This is Prostate Cancer UK's view of the situation.

https://prostatecanceruk.org/about-us/news-and-views/2023/10/end-the-abiraterone-postcode-lottery-for-men-with-prostate-cancer

In some ways I can understand people's reluctance to comment on a treatment that isn't available to all, but I don't think adopting this position will help change the situation, I believe it is much better to be open and pro-active.

My enquiry with my NHS Radiologist led to an appointment with a consultant at Nova Healthcare and I was quoted £520 per month to supplement my ADT with Abiraterone, this includes the drug itself and the additional testing and consultations that would be required.

I asked if she ever brought up Abiraterone with high risk NHS patients, she told me it was a situation that was often discussed amongst consultants and that she does let patients know of the private option if she believes it would be greatly beneficial.

The following day I'd scheduled a meeting with my local MP. He is a big advocate of men's health, but was unaware of the particulars of the situation re Abiraterone. He said he will write to both NICE and the Health secretary to try help move things along.

 

A copy of the email I sent to my MP, if anything is incorrect or I've missed anything important out, please let me know, if anyone is minded to contact their MP they're more than welcome to use the relevant parts of it.

I am aware that my T3 and T4 definitions aren't entirely correct, but I was trying to keep things simple and not bring in further terminology and Letters.

 

Dear Mr Andrew,

 

Thank you for meeting me last Friday. There was quite a lot of information relayed so I thought it best to briefly document the most relevant with references.

 

After an MRI scan and a Prostate Biopsy men are given a cancer staging, these are as follows.

 

T1/T2 early stage cancer confined to the prostate with extremely good chance of cure or long term remission, usually considered low or intermediate risk of progressing.

T3 locally advanced cancer that has spread just beyond the prostate, but not metastasised elsewhere in the body, it has a high risk of progressing if untreated but is still treated with a curable intent.

T4 Advanced cancer that has metastasised to distant parts of the body, historically not considered to be curable but with advances in medicine men with this diagnosis have a variety of treatment options and many will live much longer than previously expected.

 

It's a bit more complicated than above as initial PSA levels and Gleason score following Biopsy are also taken into account when assessing cancer risk.

 

Abiraterone was developed in London.

 

 

Originally purposed to extend the lives of T4 patients, the case histories documented in the link are of men with T4 advanced cancer and I believe the information in the link is out of date as Abiraterone is now guidlelined for use in most cases of T4 cancer.

 

STAMPEDE was a large scale multi arm trial which started in 2005 and ended recruitment in 2022, though is still reporting results. It's aim was to investigate new approaches for T3 and T4 cancer.

 

Standard treatment for locally advanced cancer T3 is Radiotherapy plus first gen HT.

The Stampede trial indicated that adding Abiraterone to this treatment significantly improves overall survival and cancer free survival when measured at six years after treatment.

 

Summary of results as published in The Lancet

 

 

As a result of the trial Abiraterone has been added to SOC for T3 stage patients in much of the developed world.

 

BBC article

 

 

I attempted to contact the gentleman as I was sceptical of £250 per month quoted

 

 

 

NHS Wales adoption:

 

 

NHS Scotland adoption:

 

 

The patent for Abiraterone ended Oct 2022.

 

As mentioned in the BBC article there is no incentive for the manufacturers of the drug to apply to NICE for its repurpose to treat T3 patients, though NICE have said they may review the situation independently later this year.

 

I have a T3 Diagnosis and commenced standard HT with RT scheduled in around 3 months, I have been quoted £520 per month through Nova Healthcare to add Abiraterone plus associated blood tests and consultations to my SOC.

 

If I can be of any further assistance, please let me know.

 

Correspondence from yourself with the Minister for Health and NICE to try nudge things along for others who find themselves in a similar position to myself would be much appreciated.

 

Kindest regards

 

 

 

Edited by member 13 May 2024 at 18:26  | Reason: Not specified

User
Posted 13 May 2024 at 19:00

Hi Richard,

I respect and admire your quest for fairness, but I suspect you'll end up feeling like you're wading through treacle. Let's hope your MP can expediate things.

Best of luck mate.

User
Posted 28 May 2024 at 04:50

My MP received what I assume to be the standard NICE reply.

I don't really understand the last paragraph. I'm thinking that it's not anything new and won't have any real world implications, but if anyone does have any success in persuading their consultant to prescribe Abi on this basis, please let the forum know.

Dear Mr Andrew,
RE: ABIRATERONE FOR PROSTATE CANCER IN ENGLAND
Thank you for your email of 30 May 2024 on behalf of your constituent regarding NICE 
guidance on abiraterone for the treatment of prostate cancer. 
I was sorry to read that your constituent is affected by prostate cancer, I hope the following 
information is helpful. 
Part of NICE’s role is to look at the clinical and cost-effectiveness of medicines within the 
terms of their marketing authorisation (also known as a product licence) and make 
recommendations on their use within the NHS in England. 
While we have been able to recommend abiraterone as an option for the treatment of some 
types of metastatic prostate cancer, it is not licensed for the treatment of non-metastatic 
prostate cancer and so, in line with our established processes, we cannot consider its use 
for this indication through our technology appraisals programme. 
NHS England, as the commissioner of specialised and highly specialised cancer services in 
England, has committed to review the use of abiraterone in people with non-metastatic 
prostate cancer as you have highlighted in your email. Your constituent, or you on their 
behalf may wish to contact NHS England directly, as NICE is not involved in this process.
It may also be helpful for me to explain that the absence of final NICE guidance, or the 
presence of guidance that does not recommend a treatment, is not the same as a ban on 
that treatment being provided by the NHS. If, having considered the available evidence, a 
health professional considers that the treatment would be the appropriate option in a given 
case, there is no legal bar on the professional recommending the treatment or on the NHS in 
England funding it. It would be a matter for clinical judgement and would be a local 
decision. 
I hope this information is useful to you and your constituent

User
Posted 28 May 2024 at 14:58

At least you got a quick response. I complained to the NHS about errors I felt they made to my treatment. I ended up having to involve the Parliamentary Health and Service Ombudsman and 2 years later the matter still hasn't been resolved.

However, during my crusade for justice 😄, I contacted NICE and their response, although very vague, was fairly quick. 

Its nice to see your MP did what he's paid for, and helped try and sort out your query. 

Edited by member 28 May 2024 at 19:42  | Reason: Typo

 
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