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  1. This is a platform for you to find tools and resources to help you have a voice in Australia's healthcare decision making processes. Consumer Comments for the March PBAC Agenda opened on the 24th of December. You have until February to make a comment or submission. This site has links to treatments being considered at the March meeting of the Pharmaceutical Benefits Advisory Committee.(PBAC) You can find the agenda via pinned posts on this site and have until February 12th to submit consumer comment. Note Well - No drugs or treatments have yet been put forward for Prostate Cancer - now is the time to have your say You can help Patient Voice Initiative reach people living with Prostate Cancer have their say by clicking on this link https://tinyurl.com/ukjmptt
  2. Currently the Pharmaceutical Benefits Scheme provides that Abiraterone (Brand name Zytiga) must be taken with prednisone or prednisolone. At its March 2017 meeting the PBAC approved an application that whilst Abiraterone must be taken with a corticosteroid, the corticosteroid does not necessarily have to be prednisone or prednisolone. Patients and their doctors are now able to choose the corticosteroid that they use with Abiraterone. There has been evidence that corticosteroids other than prednisone or prednisolone may have less side effects or greater benefits.
  3. Last Friday 10 March 2017 the Pharmaceutical Benefits Advisory Committee (PBAC) reached its initial decisions on drugs to go onto the PBS at reduced prices. This included whether to put Xtandi (Enzalutamide) before chemo on the PBS. The company will be told of the result next Friday 17 March 2017. If necessary, negotiations between the PBAC and the company continue for 4 weeks. The final results will be published on the PBAC website 21 April 2017. (If the company is not happy with the result, they have until July 2017 to appeal.)
  4. Details at the top of the page on: JimJimJimJim.com Click this sentence to go there. A gunner is a person who talks a lot about what he's going but doesn't' get around to doing it. "Gunna" (slang) = "going to" This is the last week before the public consultation closes next Wednesday 8 February. The Government is considering listing Enzalutamide (brand name Xtandi) on the Pharmaceutical Benefits Scheme (PBS) before chemotherapy. It's important that Australian men with prostate cancer, their partners,their families and their friends make submissions telling the Government that they support it making Enzalutamide available on the PBS before chemo. The more submissions that are received by the PBAC,the greater the prospect of Enzalutamide being listed on the PBS. It's not hard to make a submission. It doesn't take long. In his previous post Jim explains what to do. Your feedback is important & can make a difference. Please help us with our campaign. Don’t be a gunner.
  5. Some members needed more technological help to find the form and the video. Here 'tis. Cheers. Jim Help get Xtandi (Enzalutamide) on the PBS for use BEFORE chemotherapy Click on this sentence to go straight to the PBAC to fill out the form. Click this sentence if you wish to see a short YouTube video about this. Click on this sentence to read about the drug and the online form. Closing date for comments is Wednesday 8 February 2017
  6. You will have noticed that the other members of our Executive Committee (Alan Barlee, Nev Black, Paul Hobson, Tony Maxwell) make an enormous contribution to our monthly phone-in meetings, to information and discussion posted on our website (JimJimJimJim.com), and to general support of our members by phone, email, and at Face-to-a-name members' meetings. What you may not be aware of is that your Executive Committee also spends much time and effort in advocacy duties on behalf of the group. Below are some advocacy events held during the past year. Please be aware that where I am listed as the sole attendee below, most often, most of the background work has been done by other members of the Executive Committee. Health Week Launch This event, co-sponsored by the Prostate Cancer Foundation of Australia (PCFA) and Astellas (vendors of Xtandi (enzalutamide)) was a press briefing in Sydney to help the press focus on actual men with advanced prostate cancer in their Health Week reporting. After a formal presentation, Paul, Alan, Tony and I joined PCFA CEO Anthony Lowe in one-on-on discussions with members of the press about advanced prostate cancer and with Astellas staff about getting Xtandi (enzalutamide) on the PBS pre-chemotherapy. Later in the day I caught up with Sydney members of our group, and in the evening attended the Westmead Prostate Cancer Support Group. Before flying back next morning I met with Professor Peter Croucher at the Garvan Institute of Medical Research to discuss the research Professor Croucher's team is doing on finding and treating cancer that moves to bones. Multi-parametric MRI scan and biopsy The Medical Services Advisory Committee (MSAC) is an independent expert committee that recommends to the Minister which procedures should go on the Medicare Benefits Schedule (MBS). A multi-parametric MRI is a scan which can show more detail of prostate cancer, especially in the prostate. Australia's Radiation Oncologists made an application to have the multi-parametric MRI made a Medicare item. Your Executive Committee made a submission on your behalf to the MSAC supporting this application. Pharmaceutical Benefits Advisory Committee (PBAC) review The PBAC is the independent expert committee that recommends to the Minister which drugs should go on the PBS. You may remember that, as the result of submissions by our group and of many personal submissions on the drugs Zytiga (abiraterone) and Xtandi (enzalutamide) that I was invited to appear before the Senate Inquiry into the availability of new, innovative and specialist cancer drugs in Australia. Just one week after the Inquiry ended, Minister for Health Sussan Ley announced a review of the PBAC to "address technical methods issues raised by the PBAC and stakeholders". A team at the University of Adelaide prepared a new set of guidelines for the operations of the PBAC, and Tony Maxwell and I attended the PBAC Guidelines Review - Presentation Forum in Sydney. Amongst a large group of pharmaceutical and medical experts, Tony's contribution beginning "I am a patient ... " had a striking effect. With not enough room for my scooter in the morning tea room I had to stay in the main auditorium. The only other person there was PBAC Chair, Professor Andrew Wilson, setting up his slides. When he finished setting up, he came over and we had quite a long and productive talk. Office of the Minister for Health All members of your Executive Committee met with Mark Kinsela, Senior Advisor to the Minister for Health at the office of the Minister in Canberra to discuss issues of import to men with advanced prostate cancer. In the generous 1 hour 20 minutes we were given we were able to cover many issues, and felt we were given a well-informed and probing hearing. Access on the PBS to the drugs Zytiga (abiraterone) and Xtandi (enzalutamide) before chemotherapy, and access on medicare to the radiotherapy drug Xofigo (Radium-223) were, of course an important focus of the discussion. PCFA support groups meeting I met with PCFA senior staffers Amanda Pomery (National Manager, Support & Community) and Katie Dundas (Manager, Community Awareness and Education) a few weeks ago to talk about our issues as a support group. The changes that are happening to our website at the moment, and the new flexibility we have with our phone-in meetings are a couple of the results. (Our next phone-in meeting will be an early evening one - a roundtable at 5:30 pm on Friday 24 June 2016.) Getting Bayer Xofigo on Medicare Earlier this month when plans for a meeting at Bayer in Sydney fell through, senior staff of Bayer Pharmaceutical and PCFA CEO Anthony Lowe flew to Brisbane to speak to me about the problems of getting Xofigo (Radium-223) on Medicare, as a result of a letter your Executive Committee had sent to Bayer. It turned out that Bayer now feels able to re-reconsider an earlier approach they had abandoned, and that as a result of our discussion on Medical Services Advisory Committee (MSAC) guidelines they will more clearly identify the logjams and get back to us. Election 2016 Your Executive Committee had made suggestions to PCFA about presenting a comprehensive policy document to parties for their support. Meeting with PCFA CEO Anthony Lowe, I came to support his opinion that a single policy item presented to all party leaders in person by Anthony would be in the best interests of men with prostate cancer. Executive Committee members concurred later in the day. One week later, while visiting Launceston General Hospital in Tasmania, Shadow Minister King announced that the Labor Party has committed to securing the existing Department of Health funded prostate cancer nursing positions for a further 3 years from 30 June 2017 and will fund an additional 14 prostate cancer nurses across Australia. Anthony was scheduled to meet with other party leaders. Getting Zytiga (abiraterone) on PBS pre-chemotherapy Your Executive Committee sought to meet with Janssen (a Johnson & Johnson subsidiary) to discuss progress on getting Zytiga (abiraterone) on the PBS pre-chemotherapy. As a result, Janssen brought together a Prostate Cancer Patient Working Group meeting in partnership with PCFA last Friday 27th May 2016 in a meeting room at Sydney Domestic Airport. Anthony Lowe and Katie Dundas of PCFA, Paul Hobson, Alan Barlee, Nev Black, Graham Bloomfield, Kerry Drinkwater, David Abrahams, Zeni Muhiji and I attended. Several of those attending had abiraterone experience. We heard a presentation from Prof Gavin Marx on current therapeutics in advanced prostate cancer, and had some hours talking with Janssen staff about issues. Disclosure Your Executive Committee and other members taking part in the above advocacy activities above have signed various commercial-in-confidence agreements and will not be free to discuss details in those cases. Only one of the activities listed above included a financial recompense for time contributed. PCFA contributed travel costs in several cases, but travel and accommodation for the Canberra meeting were met by committee members themselves. Personal note An amazing thing about the Executive Committee members who assist me in running the Australian Advanced Prostate Cancer Support Group is that, as well as the enormous work they do for us, each takes a central role in their local Prostate Cancer Support Group, and on various research project teams, and general prostate cancer activities, stepping forward whenever a person is needed. We have made great strides with our advocacy in the past three years. Members' submissions to the PBAC have paid an important part. But on top of that, the vital part paid by the other members of the Executive Committee, especially in the past year, had laid an important foundation for the next year. We can look forward to the reform of the PBAC/PBS process and hopefully getting pre-chemo approval for Zytiga, Xtandi and Xofigo at least. I am proud to work with these men and with this group. Jim Marshall Convenor Australian Advanced Prostate Cancer Support Group
  7. “Of the cancer medicines being developed, 91% will be targeted therapies, which is likely to make these medicines more expensive. Pressure on budgets will therefore only increase if something is not done now about cancer drug prices.” Clink on this link to read an article in the online newsletter, MJA InSight, about the increasing costs of cancer drugs. Although the article doesn't offer any solutions to the problem, there are some interesting statistics about the number of cancer drugs (for all cancers, not just prostate cancer) that are likely to be on the market within 5 years. The fact that "Australia represents about 1% of the global pharmaceutical market" explains why Australians have to wait for access to drugs long after they have been approved overseas. We're a very small market in the scheme of things.
  8. At its November meeting the Pharmaceutical Advisory Committee (PBAC) considered an application to extend the listing of enzalutamide (brand name Xtandi) to include treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients who have not had prior docetaxel (chemotherapy). The PBAC has released its decision on the application. It is what the PBAC describes as a "1st time decision not to recommend". It's disappointing that the application was not successful but encouraging that the PBAC is asking Astellas to resubmit the application. Here is the full decision from the PBAC: "The PBAC decided not to recommend extending the PBS listing of enzalutamide to include treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients who have not had prior docetaxel 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. The PBAC noted the median time to initiation of cytotoxic chemotherapy in the PREVAIL trial was 28.0 months in the enzalutamide group versus 10.8 months in the placebo group, a median difference of 17.2 months, which was clinically meaningful. In contrast the overall survival gain of 4 months for enzalutamide in the same trial compared to enzalutamide in the post-docetaxel setting (4.8 months from the AFFIRM trial) highlighted the minimal impact of earlier enzalutamide treatment on overall survival. The PBAC therefore rejected the application because it did not appropriately reflect the value of early enzalutamide treatment. The PBAC encouraged a resubmission to evaluate the potential gains in quality of life based on the patient populations and outcomes described above". The Drug Company commented: "Astellas is disappointed not to have secured an extended PBS listing for patients with mCRPC who have not had prior docetaxel, but is grateful to the PBAC for their helpful feedback and advice."
  9. Paul Edwards

    Ipilimumab - Severe Side Effects?

    Ipilimumab (brand name Yervoy) is an immunotherapy drug which has been approved for the treatment of melanoma. There are currently clinical trials being conducted to see whether Ipilimumab is effective in treating prostate cancer. The South Australian Medicines Evaluation Panel has provided data to the Pharmaceutical Benefits Advisory Committee about patients treated with Ipilimumab in South Australian public hospitals. Between 1 August 2013 to 8 December 2014, 56 patients were treated with Ipilimumab. 8 of these patients suffered severe refractory colitis as a side effect of their treatment with Ipilimumab and were admitted to hospital. The average stay in hospital for treatment of the side effects was 21 days. The Pharmaceutical Benefits Advisory Committee commented that it didn't expect as many serious adverse events when it approved Ipilimumab on the Pharmaceutical Benefits Scheme. This emerging data may make it harder for Ipilimumab to be approved for the treatment of prostate cancer. Immunotherapy: Treatment to stimulate or restore the ability of the immune system to fight infection and disease. Melanoma: a type of skin cancer. Severe Refractory Colitis: Severe Bowel Inflammation which is resistant to treatment. Reference: http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2015-07/ipilimumab-psd-july-2015
  10. At its November meeting the Pharmaceutical Benefits Advisory Committee was considering whether Enzalutamide ( Brand name Xtandi) should be made available on the Pharmaceutical Benefits Scheme (refer to this previous post on the subject) One of the members in last week's teleconference asked when would we know the outcome of that meeting? Today the Pharmaceutical Benefits Advisory Committee published the outcomes from its July meeting. At this rate we won't know the outcomes of their November meeting until April next year. [Edit 18 December 2015 PBAC published its recommendation. Click on this link to find out more.]
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