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Help get Xtandi (Enzalutamide) on the PBS BEFORE docetaxel chemotherapy


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The opportunity

There is a chance to have your voice heard on whether the drug Xtandi (enzalutamide) should be available on the PBS BEFORE chemotherapy.

 

Timing

Submissions are due Wednesday 8 February 2017, and no late submissions will be accepted.

 

Enzalutamide on the PBS

An important drug for men with advanced prostate cancer is Xtandi, also called enzalutamide.

 

The first evidence that enzalutamide worked looked at using enzalutamide AFTER the chemotherapy drug docetaxel.

 

A committee of experts looked at this evidence.

They recommended that it was worth spending taxpayer money on.

 

So, now men with advanced prostate cancer can get enzalutamide on the PBS at a low price, AFTER they have had chemotherapy with docetaxel.

 

Some new evidence has arrived showing that enzalutamide works well BEFORE chemotherapy with docetaxel.

 

The same committee of experts is now looking at this evidence to see if it is worth spending taxpayer money to put enzalutamide on the PBS for use BEFORE chemotherapy with docetaxel. 

This is the second time this has come up for consideration. The first time, the expert committee rejected the application:

because the submission was focused on a claim of survival advantage, which was small and uncertain, rather than on outcomes that clinicians and patients considered to be of most value.

 

The purpose of using enzalutamide earlier in the disease pathway would be:

1) to delay symptoms from developing and maintaining a better quality of life for longer in asymptomatic patients for whom placebo, or watchful waiting, is the appropriate comparator; and

2) delaying the toxicities of chemotherapy in symptomatic patients considered suitable for docetaxel.

 

That committee has asked for public submissions for a new application. 

 

Enzalutamide BEFORE chemotherapy 

The first thing you should understand that enzalutamide is not a miracle cure. 

About half the men on the PREVAIL clinical trial were still alive three years after they started on enzalutamide. Some of the men who responded will have a much longer survival. I have met a man whose cancer has been kept at bay for 6 years so far on enzalutamide.

 

But survival times pre-chemo and post-chemo are not different enough to convince the experts.

 

What is most important about this drug is the quality of life it makes possible during that two or three years.

 

Docetaxel chemotherapy vs enzalutamide side effects

The first thing you should understand is the current first treatment at this stage - docetaxel chemotherapy.

Many men report coping quite well with their docetaxel, finding the temporary hair loss and other side effects manageable.

But some men have a terrible experience with the side effects. It is so bad for some men that they give up the treatment. And, about one man in four hundred dies from the treatment.

 

On the other hand, enzalutamide treatment has far fewer reported side effects.

Fatigue and hypertension were the most common.

 

So, the first benefit of starting enzalutamide BEFORE  chemotherapy is that a man can delay the start of the docetaxel chemotherapy.

 

The PREVAIL clinical trial

In the PREVAIL clinical trial of enzalutamide before chemotherapy, men had to: 

  • have metastatic prostate cancer,
  • be castrate resistant, and
  • have no, or few symptoms (like pain).

Metastatic means that their prostate cancer had spread to other parts of their body. 

Castrate resistant means that the primary hormone therapy, with drugs like Zoladex, Lupron, and Eligard, was no longer able to keep the cancer in check by itself. In other words their PSA was rising, despite the hormone therapy keeping testosterone very low.

 

Men in this trial on enzalutamide did not need to start chemotherapy, on average, for more than two years - 28 months. The control group of men had to start chemotherapy after 11 months. So men on enzalutamide had 17 MORE months at a higher quality of life.

 

After 12 months of treatment, 65% of men treated with enzalutamide had scans which showed no progression of their cancer, compared to 14% of the control group.

 

The trial was finished early when it became clear that the enzalutamide was far more effective.

 

At that stage, 29% fewer men had died in the enzalutamide group.

 

The enzalutamide group also had a longer time until the first skeletal-related event (that is, problems with their bones).

 

Most prostate cancer metastases (about 89%) occur in bones. Of the men with metastases away from their bones, complete or partial soft-tissue response favoured enzalutamide 59% to 5%.

 

Time until PSA started going up again also favoured enzalutamide.

So did the number of men whose PSA dropped to at least half - 78% to 3%.

 

Submissions

The Prostate Cancer Foundation of Australia (PCFA) is making a submission on behalf of its members.

 

Some individual members have told me that they are going to put in an individual submission. If you also wish to have your say, a couple of points:

Firstly, while submission sounds grand, it is as easy as filling in a few boxes on a web page:

Click on this sentence for the submission form.

OR

Here.

 

Notes on the boxes on that page:

Medicine to which this submission relates: Enzalutamide

Date of PBAC meeting:

March 2017

Note: This is when the board meets. It is not the due date for submissions which is Wednesday 8 February 2017.

First declaration box:

Nil (unless you work for the manufacturer, hold shares in the company, etc.)

Second declaration box:

Say what you are: man with this disease, partner, friend, doctor, etc. Say where you are in your disease: having the drug, missed out on the drug, expecting to be needing the drug in the future.

What comments would you like the PBAC ...?

• How does this condition/disease affect quality of life?

• What would you most like to see from this treatment? Improved side effects? Slowing disease progression? More mobility? Other benefits?

• If you have used or prescribed this new medicine, what was your experience of the beneficial effects?

• If you have used or prescribed this new medicine, what side effects or toxicities did you experience or observe?

• If you haven't used the new medicine yet, what are your expectations of it?

• If you use other currently available therapies or medicines you use to manage your condition (or for prescribers, for your patient’s condition), what are the benefits and/ or the challenges?

Where did you obtain the information that helped form your views on this treatment?

◦ I have been a patient on this medicine;

◦ Your doctor;

◦ Other patients stories/experiences

◦ Professional colleagues;

◦ Support networks: PCFA, Australian Advanced Prostate Cancer Support Group, JimJimJimJim

◦ Own research;

◦ Other patient resources;

◦ Direct experience as a health professional or carer;

◦ Other – please provide details.

 

When your entry is complete be Very Careful not to press the wrong button.

Tick: Agree to terms and conditions

Click: Submit

 

Click on this sentence for the submission form.

 

Lets hope for a good result this time!

Jim

 
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