Xtandi BEFORE chemo on the PBS? Due date this Wednesday to have your say

[JimJimJimJim]

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

Some of you may have found out about this on JimJimJimJim.com. Others will have heard about it on Friday's phone-in meeting. For everyone else - sorry about the late notice, but submissions are due in a couple of days - this Wednesday 7 October 2015, 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.

 

That committee has asked for public submissions. 

 

Enzalutamide BEFORE chemotherapy 

The first thing you should understand that enzalutamide is not a miracle cure. On average, in the PREVAIL clinical trial, it added only 2 months to a man's life - 32.4 months versus 30.2 months. Some men did not respond to the drug at all, so for those men it added zero months. On the other hand, I have met a man whose cancer has been kept at bay for 6 years so far on enzalutamide.

 

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 one 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

Paul Hobson is working with other committee members of the Australian Advanced Prostate Cancer Support Group on a submission on behalf of the group.

 

The Prostate Cancer Foundation of Australia (PCFA) is making a submission as well.

 

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.

 

Notes on the boxes on this page:

Medicine to which this submission relates: Enzalutamide

Date of PBAC meeting:

November 2015

Note: This is when the board meets. It is not the due date for submissions which is this Wednesday 7 October 2015.

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;

◦ 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!

Jim

 

 

 

 

 

 

 

 

 

 

 

[Paul Edwards]

Today was the last day for submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) about the listing of Enzalutamide prior to chemotherapy.

 

The Committee had a meeting earlier today and finalised the submission that was made on behalf of the Group.

 

Here is a copy of the final submission that was lodged with the PBAC:

The Australian Advanced Prostate Cancer Support Group supports the listing of Enzalutamide on the PBS for the treatment ofmetastatic castration-resistant prostate cancer in chemotherapy-naïve patients. The reason for our support is the improved quality of life that Enzalutamide offers to us and the resulting benefits that flow not onlyto us, but also our families and the general community. We believe that Australian men with metastatic castration-resistant  prostate cancer should have the same access to best practice treatmentsas similar men in the United States and Europe.  Unless Enzalutamide is listed on the PBS, many Australians will be denied access to it becauseof a lack of financial resources.  ****************In the setting of metastatic castration-resistant prostate cancer, Enzalutamide has been shown to extend overall survival and significantlydelay tumour progression, to extend the first skeletal-related event, to  reduce pain, and to improve quality of life in men: See Fizazi K, Scher HI, Miller K et al. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase3 AFFIRM trial. Lancet Oncology, Volume 15, Issue 10. Pages 1147-1156, September 2014. doi:10.1016/S1470-2045(14)70303-1Enzalutamide is now recognised as a first-line therapy for men with metastatic castration-resistant prostate cancer: See the respectiveGuidelines on Castration-Resistant Prostate Cancer of the American Society of Clinical Oncology and Cancer Care Ontario, The NationalComprehensive Cancer Network Guidelines and The American Urological Association. The PBAC should take into account that the fact that regulatory authorities in the United States (September 2014), in the European Unionincluding the United Kingdom (December 2014) and in Canada (April 2015) have approved Enzalutamide for the treatment of metastaticcastration-resistant prostate cancer in chemotherapy-naïve patients.  The PBAC should have regard to the reasons for the decisions of thoseregulatory authorities and to the material on which their decisions were based. The clinical evidence supporting the proposed listing of Enzalutamide comes mainly from the PREVAIL, AFFIRM and TERRAIN clinical trials andwill no doubt be covered by the applicant and in other submissions.  We do not propose to go into the clinical evidence in detail.  As a supportgroup we intend to focus on the benefits that the proposed listing will provide to men with metastatic castration-resistant prostate cancer.Although the results from the PREVAIL trial showed that Enzalutamide on average added only 2 months to overall survival, some men survive formuch longer.  For example, we are aware of patients whose cancer has been kept at bay for 6 years so far on Enzalutamide. A drug which only prolongs life by a few months on average may vastly improve quality of life for a much longer period.  Clinical experienceand the data from the clinical trials show that this is the case with Enzalutamide.Chemotherapy is very unpleasant for many men.  With Enzalutamide, the time to chemotherapy can be delayed on average by 17 months. For somemen the delay is much longer.  This is very significant for patients.Enzalutamide can be self-administered at home, reducing the need for expensive hospital-based care.When men with prostate cancer became castration resistant, the majority still have a good performance status and are generally free fromsymptoms or are only mildly symptomatic from their prostate cancer.  At this stage of the disease the aim of treatment must be to improvesurvival as well as to allow the best possible quality of life.  The clinical data shows that, rather than waiting until after chemotherapy,the earlier Enzalutamide is used, the better the outcomes. By allowing men have their disease controlled without an increase in pain and without the need for chemotherapy, these men are able to getout into the community instead of being house bound or bed-ridden. Enzalutamide enables men to get extra years participating in thecommunity in business or as volunteers, as well as giving them extra years to enjoy their family role as husbands or partners, fathers,grandfathers and uncles.Our members who are being treated with Enzalutamide are grateful for being able to delay progression of their disease whilst maintainingtheir quality of life. Enzalutamide has been shown to be safe and well-tolerated.  Although side-effects vary from patient to patient, the side-effects experiencedby our members who are being treated with Enzalutamide have mainly been an increase in fatigue (although not sufficient to interfere with dailyfunctioning). The PBAC should not place a restriction on the listing of Enzalutamide that prevents men who have not responded to treatment with Abirateroneacetate from being treated with Enzalutamide. At the present time, the listing for Enzalutamide provides that this drug is not available under the PBS if the patient has previouslyreceived treatment with Abiraterone acetate.  The PBS listing for Abiraterone acetate provides that Abiraterone acetate is not availableunder the PBS if the patient has received treatment with Enzalutamide. These restrictions do not accord with clinical practice in the US andEurope.  Some patients who do not respond to Abiraterone acetate respond to Enzalutamide and vice versa.  Australian patients and theironcologists should not have to play Russian Roulette - pick the wrong drug and you are dead.  It is standard clinical practice in the US andEurope, where either Enzalutamide or Abiraterone acetate ceases to have benefit, the other drug will be used to see whether it provides benefit.