Jim represents us before Senate Inquiry

[Admin]

Our Convenor, Jim Marshall, has been invited, on behalf or the Advanced Prostate Cancer Support Groups, to Parliament House, Canberra, next Monday 20 April 2015 to appear before the: 

 

Senate Standing Committee on Community Affairs

as part of their inquiry into:

The availability of new, innovative and specialist cancer drugs in Australia

 

Jim, and the leaders of three other organisations advocating for cancer patients, will be given an hour to act as a panel for the Senate Standing Committee. This will include the opportunity for each to give a short opening statement outlining their position, and perhaps raising new issues for consideration.

 

Video of the session will be streamed live over the Internet. (These streams are sometimes picked up and shown live on ABC News 24 when hot topics come up.)

 

Jim met the other three leaders at the World Cancer Congress in Melbourne in December. He had the extra opportunity to work with one of them for a full day at a Masterclass before the conference.

 

This opportunity has been given to us for two reasons:

Firstly, our submission to the Senate Standing Committee, to which several members contributed, especially Committee members Paul Edwards and Alan Barlee.

You can see our submission by clicking here:

Advanced Group Senate Committee Submission.pdf

Secondly, the great response of our members in producing their own submissions. When you browse the list of submissions here:

http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Cancer_Drugs/Submissions

you will recognise many of our members' names. You can download submissions from that page.

 

Jim is grateful to all who contributed, and will endeavour to represent them to the Senate Committee as best he can.

 

Postscript

To see clips of some of Jim's contributions on YouTube:

Click here. (14 minutes)

 

Our submission

Advanced Group Senate Committee Submission.pdf

 

Other submissions

Click here.

 

Jim's opening statement

Jim Marshall Opening statement.pdf

 

Answers to questions on notice

Jim Marshall Questions on notice.pdf

 

Video of the whole event on the Parliamentary Channel

Click here.

 

Minister of Health announces review of PBAC

Click here.

 

PBAC review guidelines

Click here.

 

[DavidAbrahams]

Warmest Congratulations Jim, Wishing you every success and the Best of Australian and Scottish Luck.

[Admin]

David

Thank you for your kind words.

Both kinds of luck will probably come in handy.

Jim

[Admin]

Jim's opening statement on our behalf:

Thank you Senators for the opportunity to discuss these matters with you today.

 

Members of the Advanced Prostate Cancer Support Groups, and the people who care for them, live in all parts of Australia. We communicate by one-on-one phone calls, email, postings on our website forums at JimJimJimJim.com, and monthly teleconferences, usually with an expert guest speaker. Our affiliation with the Prostate Cancer Foundation of Australia (PCFA) supports these activities.

 

I would like to highlight four areas in particular where my members views may be useful to the Inquiry.

 

Firstly:

The chief reason our submission is before you is that some of my members have had direct, sometime painful, sometime expensive, experience of the impact of delays in the approval process for cancer drugs. Our frustration with the approval process for the drug abiraterone is perhaps the archetype of the problem. 

 

In April 2011 abiraterone gained approval for use after standard chemotherapy in the United States.

Part of the problem for my members is that there was an 18 month delay between the PBAC recommending listing on the PBS and the sponsor agreeing to supply the drug.

 

I see that the submission from the PBAC you have before you does specifically address the approval process for this particular drug, but I would welcome the opportunity to put to you further questions that you might wish to put to the PBAC about that extra year and a half.

 

Secondly:

Staying with the same drug, abiraterone, in December 2012, abiraterone was approved by the FDA in the US for use before chemotherapy. Its use in this way was turned down by the PBAC July 2014. Again, though this is a complex decision, I would welcome the opportunity to speak about the role of Quality Adjusted Life Years (QALYS) may have had, in particular how my members may have been disadvantaged by their average age.

 

Thirdly:

Partly because of members' experience of late diagnosis, or of less accurate diagnosis, my members wish to point out strongly that the cost of cancer drugs is a function of timely diagnosis and accurate treatment.

 

And fourthly:

I would welcome being asked to comment on the five recommendations made by the PBAC in their submission before you.

 

In short: Delays, QALYs, diagnosis, PBAC.

Thank you.

[Admin]

Questions on notice: Response from the Advanced Prostate Cancer Support Groups.

to the

Senate Standing Committee on Community Affairs

inquiry into

The availability of new, innovative and specialist cancer drugs in Australia

 

Item 1: The 18 month delay for abiraterone Eighteen months passed from the time that PBAC said the use of the drug Abiraterone was worth spending taxpayer's money on, and the drug being available on the PBS. What are some questions that the inquiry might ask the PBAC about this 18 month delay?

 

Response to Item 1

It seems that, while the PBAC considered the drug was a reasonable way to spend taxpayers' money, the sponsor was concerned with the wording of the rationale offered.

 

The Inquiry could ask the PBAC about this situation:

1. What benefit does the PBAC think the sponsor might have hoped to get from the suggested new rationale? A clearer path to acceptance of its product in other uses - perhaps pre-chemotherapy? Something else?

 

2. Is there a role for some sort of mechanism where supply can proceed on the approved basis, without prejudice to later change of the rationale?

If that is possible now, why does the PBAC think the sponsor may not have gone ahead?

 

Item 2: QALYs and the value of human lives 

Quality Adjusted Life Years sounds like a neutral way to judge cost effectiveness.

 

In judging between two drugs or treatments for the same group of patients, it is.

 

However, if used to judge between two drugs or treatments for different groups of patients, it places a lower value on some lives. In particular, QALYs place a lower value on older, or on disabled lives.

 

The youngest man to meet with our group was diagnosed with prostate cancer at age 30. Around 5 percent of our members were diagnosed in their late forties or early fifties. However, the average age at diagnosis is 69 years. Consequently the average age of advanced men is in the early seventies.

 

The impact of this on QALY calculations is that the QALY depends on ability to function in five areas - Mobility, Pain/discomfort, Self-care, Anxiety/depression, and Usual activities. Each is rated at one of three levels:

Level 1: no problem

Level 2: some problems

Level 3: extreme problems

 

The result of doing a calculation on the ratings is a fraction describing quality of life - somewhere between 0 (dead) and 1 (perfectly healthy). Multiplying this fraction by the years gives a rough measure of "healthy years".

 

People in their seventies, compared to people in their forties, report some problems in three of the five areas - Mobility, Pain/discomfort and Usual activities more than twice as much. 

 

As a result the people in their seventies who get an extra  year added to their life get a significantly lower value assigned to that year than people in their forties who have an extra year added to their life.

 

There is a large body of work on the problems with QALYs and associated measures, and methods to help overcome weaknesses in the systems.

 

Response to Item 2

The Inquiry could ask the PBAC about this situation: Given that Quality Adjusted Life Years (QALYs) can place lower values on some lives, what measures does the PBAC take, or could it take, so as not to be discriminate against patients with older onset cancers, like prostate cancer?

 

Item 3: PBAC recommendations

PBAC recommendations:

For plain language presentations for lay and professional audiences on the benefits, harms and costs of new drugs: Strongly supported

 

For improved transparency of PBAC evaluations, and for increased funding for stakeholder consultation are strongly support: Strongly supported

 

For collecting data on the outcomes of all patients treated with new drugs nationally, and monitored on a real-time basis: Strongly supported (see Note 1: Database privacy below)

 

Community consultation should be carried out to ascertain the value placed by society on very small improvements in survival or progression free survival for patients with cancer: Not supported (See Note 2: Value of a life below.)

 

 

Note 1: Database privacy

Some of the soundest data available about prostate cancer comes from databases of government agencies around the world - the USA medicare data, the data from the Scandinavian government health systems.

 

Technical privacy: No database in the world is guaranteed unhackable. But personal data would be much better protected in a large government database than in the smaller databases that are now distributed throughout the nation.

 

Personal privacy, personnel: Large organisations like Centrelink and Police already have personnel procedures for this. 

 

Personal privacy, technical: The Australian Bureau of Statistics has procedures to ensure that personal data is not definable from the results of searches it does for the public. The ABS will supply reports on some variables by very small area - say Statistical Local Area. Other variables it will not supply in such small areas because it may expose information that may identify an individual or small group.

 

Note 2: Value of a life

No one would dispute the fact that the PBAC has attracted some of the finest minds in the nation, and that the gains made in the past few years are impressive. Nevertheless, the loaded language in this proposal by the PBAC to consult the community about "very small improvements" shows that this group may not be appropriate to lead any consultation about the value of a life as it nears its end.

 

Even if you unload the title of the enterprise, and make sure that the questions asked are not loaded, exercises of this nature have shown that responses vary as people grow older. So, the views of the whole community age range may not only be different from those of older members, but may also be different from the views the younger members will have when they become older.

 

Finally, the way researchers and the PBAC report is statistically proper, but not often understood by community members.

 

Very few realise that the number usually reported for survival, or for progression free survival, is the median - the middle person.

 

So "added survival of five months" does not mean that at five months all will be dead, but that at five months half the people will be still alive, and some will be alive for much longer.

 

More, because not all respond to a drug, the number who get much longer survival is even greater than the median might suggest.

 

=============================

We would once again like to thank Senators for giving us this opportunity to present our views.

 

Jim Marshall

 

Convenor

[Admin]

Video from the Parliamentary Channel:

 

The whole afternoon is about 4 hours.

To find our bits:

Jim scoots in at 1:28:00

Jim starts to speak at 1:42:00

Jim scoots out at 2:34:00

 

Directly underneath the picture is a grey bar.

On the grey bar at the far left is a belt buckle.

Under the grey bar is a counter, showing 00.00.00 to start.

You drag the belt buckle on the grey bar until it shows the time you wish to view.

 

http://parlview.aph.gov.au/mediaPlayer.php?videoID=259023&operation_mode=parlview

[Admin]

Video on YouTube

Just some bits of Jim's evidence:

 

https://youtu.be/NS-zCoLB4G8

 

14 minutes