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PBAC Call for Feedback - July 2018

30 May 2018 at 12:00 AM

Make your voice heard and have your say

In July, Professor Andrew Wilson will chair a meeting of the Pharmaceutical Benefits Advisory Committee (PBAC) to decide whether to recommend to the government certain drugs for reimbursement through the Pharmaceutical Benefits Scheme (PBS). If you are living with any of the cancer types under consideration there is an opportunity for you to write to the PBAC and tell them of your needs and experience. You must make your submission by 6 June, 2018.

How do I submit?

It doesn't take very long and it's important your voice is heard. It’s also important to understand what kind of info is most helpful to the PBAC process. On a recent Q&A we hosted, Professor Wilson, in his role as the Chair of the PBAC said:

“We get these submissions from people … [and] a lot of that information is actually not particularly informative. It just says “we would like to have access to this drug” – we understand that. But what's more informative is when people start to go down to addressing those questions about why: what are you going to get out of this? What does it actually mean in terms of your quality of life, in terms of what you think might do that?

…We have a framework in which we are legislatively required to work and while we understand that anybody who sees a promising drug out there that might help the disease would like a subsidy for it that's not the basis under which we make decisions…”

Some of the things you might want to mention are listed below.

  • How does your cancer affect quality of life?
  • What would you most like to see from this treatment being available? e.g. another treatment option for you
  • If you have used the medicine before or are using it, what was your experience of the beneficial effects and what was your experience?
  • How does it compare to other treatments you have received
  • If you haven't used the medicine yet, what are your expectations of it?
  • Where did you obtain the information that helped form your views on this treatment?
  • What does this medicine available on the PBS mean to you?

Please keep this in mind when submitting comments. The most helpful information is personal stories and concrete examples of how access to a drug would change your life for the better, especially if you’re already using the drug unsubsidised by the PBS.

Further details from the PBAC on submitting consumer info is here and you can find the specific steps for submitting your comments to the PBAC on their website here and we encourage all who can to do so before the June 6 deadline for any of the drugs listed below.

Full details of drugs being considered for July 2018 Meeting

Cancer: Metastatic merkel cell carcinoma (MCC)
Drug: AVELUMAB
Form: Powder for I.V. infusion 38.5 micrograms, Blincyto®
Sponsor: Merck Serono Australia Pty Ltd (with Pfizer Australia Pty Ltd)
Submission: New listing (Major Submission)            
Details: To request a Section 100 (Efficient Funding of Chemotherapy) Authority Required (STREAMLINED) listing for the treatment of patients with metastatic merkel cell carcinoma (MCC).

Cancer: Refractory or relapsed CD30 positive cutaneous T-cell lymphomas (CTCL)
Drug: BRENTUXIMAB VEDOTIN
Form: Powder for I.V. infusion 50 mg, Adcetris®
Sponsor: Takeda Pharmaceuticals Australia Pty Ltd
Submission: Change to recommended listing (Major Submission)
Details: To request a Section 100 (Efficient Funding of Chemotherapy) Authority Required listing for the treatment of refractory or relapsed CD30 positive cutaneous T-cell lymphomas (CTCL).

Cancer: Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) with a ROS1 gene rearrangement confirmed by fluorescent in situ hybridisation (FISH) testing
Drug: CRIZOTINIB
Form: Capsule 200 mg, Capsule 250 mg, Xalkori®
Sponsor: Pfizer Australia Pty Ltd
Submission: Change to listing (Minor Submission)
Details: Resubmission to request an Authority Required listing for the treatment of patients with Stage IIIB (locally advanced) or Stage IV (metastatic) NSCLC with a ROS1 gene rearrangement confirmed by FISH testing, in patients who have failed at least one treatment with platinum based chemotherapy.

Cancer: Acute myeloid leukaemia (AML)
Drug: MIDOSTAURIN
Form: Capsule 25 mg, Rydapt®
Sponsor: Novartis Pharmaceuticals Australia Pty Ltd
Submission: New listing (Major Submission)
Details: Resubmission to request a Section 100 (Highly Specialised Drugs Program) Authority Required listing of midostaurin for the treatment of patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3) mutation positive acute myeloid leukaemia (AML).

Cancer: Renal cell carcinoma (RCC)
Drug: NIVOLUMAB and IPILIMUMAB
Form: Nivolumab: Injection concentrate for I.V. infusion 40 mg in 4 mL, Injection concentrate for I.V. infusion 100 mg in 10 mL. Ipilimumab: Injection concentrate for I.V. infusion 50 mg in 10 mL, Injection concentrate for I.V. infusion 200 mg in 40 mL, Opdivo® and Yervoy®
Sponsor: Bristol-Myers Squibb Australia Pty Ltd
Submission: New listing (Major Submission)
Details: To request a Section 100 (Efficient Funding of Chemotherapy) Authority Required (STEAMLINED) listing for the concurrent use of nivolumab and ipilimumab for the treatment of Stage IV clear cell variant renal cell carcinoma (RCC).

Cancer: Locally advanced (Stage IIIB) or metastatic (Stage IV) epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC)
Drug: OSIMERTINIB
Form: Tablet 40 mg, Tablet 80 mg, Tagrisso®
Sponsor: Astra Zeneca Pty Ltd
Submission: New listing (Major Submission)
Details: Resubmission to request an Authority Required listing for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC) who have progressed on or after prior treatment with an EGFR tyrosine kinase inhibitor (TKI).

Cancer: Squamous cell carcinoma for the head and neck (SCCHN)
Drug: PEMBROLIZUMAB
Form: Solution concentrate for I.V. infusion 100 mg in 4 mL, Keytruda®
Sponsor: Merck Sharp & Dohme (Australia) Pty Ltd
Submission: Change to listing (Major Submission)
Details: To request a Section 100 (Efficient Funding of Chemotherapy) Authority Required (STREAMLINED) listing for the treatment of patients with recurrent or metastatic squamous cell carcinoma for the head and neck (SCCHN) who progress on or after platinum-based chemotherapy.

Cancer: First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC)
Drug: PEMBROLIZUMAB
Form: Powder for injection 50 mg, Solution concentrate for I.V. infusion 100 mg in 4 mL, Keytruda®
Sponsor: Merck, Sharp & Dohme (Australia) Pty Ltd
Submission: Change to listing (Minor Submission)
Details: Resubmission to request a Section 100 (Efficient Funding of Chemotherapy) Authority Required (STREAMLINED) listing as first line monotherapy in patients expressing PD-L1 for NSCLC.

Cancer: Locally advanced or metastatic urothelial cancer
Drug: PEMBROLIZUMAB
Form: Solution concentrate for I.V. infusion 100 mg in 4 mL, Keytruda®
Sponsor: Merck Sharp & Dohme (Australia) Pty Ltd
Submission: Change to listing (Major Submission)
Details: Resubmission to request a Section 100 (Efficient Funding of Chemotherapy) Authority Required (STREAMLINED) listing for the treatment of locally advanced or metastatic urothelial cancer after the failure of a prior platinum-based chemotherapy.


Category: Rare Cancers in the News
Tags: Andrew Wilson, Drugs, July, PBAC, PBS, subsidised, treatment,