Admin Posted May 13, 2019 Share Posted May 13, 2019 Members: Quality submissions to PBAC on Apalutamide (Erlyand®) required. The Pharmaceutical Benefits Advisory Committee (PBAC) is considering a second request from the vendor, Janssen, that the drug Apalutamide (Erlyand® in Australia, Erleada® in USA) be put on the Pharmaceutical Benefits Scheme (PBS) for men who need it. Didn't we just do that eight months ago? Yes we did. But the PBAC thought that the evidence and prices it was given by the company (Janssen) could not justify putting the drug on the PBS at that stage. The company can always come back to the PBAC with more evidence, or better prices, and that is what they are doing. But did the PBAC listen to us last time? Yes they did. In their report on the application they said: The PBAC noted and welcomed the input from individuals (9), health care professionals (1) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described the benefits of delaying metastasis and symptomatic progression in terms of maintaining and preserving quality of life and avoiding the pain associated with metastases. The comments also noted that adding apalutamide earlier in the treatment algorithm would help to address the current gap in treatment continuity which causes anxiety in men with prostate cancer. The comments also noted the favourable side effect profile compared with docetaxel. On MOGA's submission they said: The Medical Oncology Group of Australia (MOGA) also expressed its strong support for the apalutamide submission, categorising it as one of the therapies of “high priority for PBS listing” on the basis of the SPARTAN trial. The PBAC noted that the MOGA presented the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) for apalutamide, which was limited to 3 (out of a maximum of 5, where 5 and 4 represent the grades with substantial improvement)10, based on a comparison with placebo. Quality submissions We have always been careful that submissions to the PBAC from members are high quality and address the points the PBAC wishes. However, another disease last year flooded the PBAC with thousands of low quality submissions (because of a social media campaign), greatly increasing the workload. So the PBAC is now especially sensitive to lower quality submissions. To ensure your submission will interest the PBAC: 1. Tell clearly why you, or someone you care about, has an interest: you are currently non-metastatic, castrate resistant. you have been non-metastatic, castrate resistant in the past, but missed out on the benefits of Apalutamide, OR you may be non-metastatic, castrate resistant in the future. 2. The PBAC asks that your submission address: 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? 3. For your understanding (not for the submission): There is currently no other approved treatment for men who are castrate resistant, but have no metastases visible on a standard bone scan or CT scan. In the trial of Apalutamide (Erlyand® in Australia, Erleada® in USA), half the men on the drug still had no sign of metastases at 40.5 months. In contrast, half the men on the placebo (dummy tablets) reached this point after 16.2 months. Thats a bit over 2 years longer before moving to the next stage. A castrate resistant man whose metastases are smaller than would be found on a standard bone scan or CT scan may, I imagine, (and I am not a doctor) still qualify for this drug even if tiny metastases had been found by more sensitive scans like the PSMA Gallium-68 CT/PET scan. 4. Submissions may be made here: http://www.health.gov.au/internet/main/publishing.nsf/content/pbac_online_submission_form 5. Closing date for consumer comments is: Wednesday 12 June 2019. Jim The request from Janssen is here: Erlyand July 2019 PBAC Comments Letter_HCO.pdf Link to comment Share on other sites More sharing options...
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