Here’s the latest on PBS and MBS listings and some light reading for the extra-keen.
What treatments can your patients access on Medicare? It can be hard to keep across the comings and goings of the PBS, MBS, PBAC and HTA. Here are the changes that happened this month, at a glance.
The big news has been the introduction of MBS coverage for genetic testing.
Gene panel testing for at least 25 genes leading to haematological malignancies is now covered under items 73445, 73446, 73447 and 73448 for patients who are clinically suspected to be at risk. Patients previously had to shell out around $1,000.
“Sadly, previously many genomic diagnostics with regulatory approval were not publicly subsidised and therefore financially out of reach for many blood cancer patients in this country,” said Leukaemia Foundation CEO Chris Tanti.
“These new MBS items will allow more Australians to have a timely and accurate blood cancer diagnosis and will additionally have a major impact on the expenses people have to pay, hopefully decreasing their out-of-pocket costs.”
The MBS also covers testing for genetic variants in patients with non-squamous non-small cell lung carcinoma (items 73437, 73438 and 73439).
New items 71202 and 73310 will cover the detection of measurable residual disease in patients with acute lymphoblastic leukaemia after diagnosis, and after combination chemotherapy or salvage therapy.
Patients with estrogen receptor positive, HER2-negative, primary breast cancer will have access to the EndoPredict brand gene expression profiling test, used for treatment planning and prediction of recurrence for up to 10 years (item 73306).
Items 73296 and 73297 have been expanded to include germline testing for patients with fallopian tube or primary peritoneal cancer, in addition to breast or ovarian cancer, and their family members.
There have been changes to how PSA testing is covered. The interval between regular PSA tests has now been increased from 12 months to 23 months (item 66655) for men who’ve not had prostate disease before and don’t have an increased familial risk. For those at relatively high risk, the MBS now covers a test every 11 months (item 66654) rather than every 12. For people who’ve had prostate disease and are being monitored, there is a limit of four tests in an 11-month period (66660). Follow-up testing after an abnormal result is covered under item 66659, once every 11 months.
Why was that drug recommended by PBAC?
Or maybe you missed the fact that it was. PBAC publishes detailed reasoning for its decisions several weeks down the track from making them. Here’s a list for the oncologists in the room.
Trastuzumab deruxtecan, 100 mg injection, 1 vial (Enhertu), for treatment of metastatic (stage IV) HER2 positive breast cancer, has been added to the Efficient Funding of Chemotherapy (Private Hospital) and Public Hospital program. The PBAC has further recommended the drug for patients who have progressed following treatment with at least one prior HER2 directed regimen for metastatic disease, or relapsed during or within six months of receiving HER2 directed adjuvant therapy. This recommendation is for patients who would receive T-DXd in a third and later line setting.
The PBAC recommended listing nivolumab (Opdivo, Bristol-Myers Squibb Australia), currently listed for melanoma, in combination with chemotherapy as neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) in its July meeting. The documents are now available if you want the detail. It also extended the listing for gastro-oesophageal cancers, more info here.
It also recommended extending the listing of acalabrutinib (Calquence, AstraZeneca), as monotherapy or in combination with obinutuzumab, to include the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) (details now published here).
Here is why mobocertinib (Exkivity, Takeda) was recommended by PBAC for the treatment of adults with locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor exon 20 insertion (EGFR ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy (PBC).
After deferring its decision at the March meeting, PBAC gave the go-ahead to a PBS listing for niraparib (Zejula, GlaxoSmithKline Australia) for maintenance therapy in patients with newly diagnosed HRD-positive BRCA wild type advanced epithelial ovarian, fallopian tube or primary peritoneal cancer, given that MSAC did recommend HRD testing for determination of eligibility for poly-ADP ribose polymerase inhibitors for this indication. (Here was the original reasoning.)
This also led to the green light for PBS listing of olaparib (Lynparza, AstraZeneca) for use in combination with bevacizumab for maintenance therapy in patients with newly diagnosed HRD-positive BRCA wild type advanced epithelial ovarian, fallopian tube or primary peritoneal cancer, deferred until MSAC made its decision.
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- a new PBS listing for ibrutinib (Imbruvica, Janssen-Cilag) in combination with venetoclax, for treatment of previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
- new PBS listing for irinotecan (as sucrosofate) (Onivyde, Servier Laboratories Aust.) for use in combination with oxaliplatin, 5-fluorouracil and folinic acid/leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma
- new PBS listing for talazoparib (Talzenna, Pfizer Australia) in combination with enzalutamide, for the treatment of metastatic castration resistant PC in patients with a Breast Cancer Gene 1 (BRCA1) or BRCA2 mutation who have not received prior treatment with a novel hormonal agent
- a request for an increase of maximum amount for the existing listings of cetuximab (Erbitux, Merck Healthcare)to allow clinician choice of either weekly or fortnightly dosing regimen for the treatment of metastatic colorectal cancer (mCRC)
- consideration of the current treatment duration and the eligible population being treated with venetoclax (Venclexta, Abbvie) for chronic lymphocytic leukaemia (CLL)
- listing of a new form and strength of atezolizumab (Tecentriq, Roche) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), stage IV (metastatic) NSCLC, extensive-stage small cell lung cancer, advanced (unresectable) Barcelona Clinic liver cancer, stage B or stage C hepatocellular carcinoma, resected early stage (Stage II to IIIA) NSCLC, under the same conditions as the currently listed form and strengths of atezolizumab solution for IV infusion
- Unrestricted Benefit listing of Vegzelma under the same conditions as the PBS-listed bevacizumab biosimilars
- a Section 100 (Efficient Funding of Chemotherapy) Authority Required (Telephone/Online) listing for first-line treatment of advanced classical Hodgkin lymphoma with brentuximab vedotin (Adcetris, Takeda Pharmaceuticals Australia)
- a request for General Schedule Authority Required (STREAMLINED) listing for caozantinib (Cabometyx, Ipsen), in combination with nivolumab, for the first-line treatment of advanced clear cell RCC, and to remove the “clear-cell variant” histology requirement to allow treatment in patients with non-clear cell RCC
- a request for a General Schedule Authority Required (Telephone/Online) listing for dabrafenib (Tafinlar & Mekinist, Novartis Pharmaceuticals Australia) the treatment of paediatric patients with BRAF V600E mutation positive low grade glioma or high grade glioma
- a resubmission regarding larotrectinib (Vitrakvi, Bayer Australia), requesting a General Schedule Authority Required (Written) listing for the treatment of locally advanced or metastatic NSCLC or STS harbouring NTRK gene fusions.
This material is definitely also safe for perusal on public transport, supermarket queues, or a quiet moment on the loo.
Real world evidence is the holy grail when it comes to getting treatments publicly funded. But do we have it in Australia? Have we got the right conditions? And are decision-makers making the most of it?
The NHMRC Medicines Intelligence Centre of Research Excellence (MI-CRE) has delved into this issue for the HTA Policy and Methods Review and published a draft report: Optimising the availability and use of real world data and real world evidence to support health technology assessment in Australia.
Many in this community have already contributed to the consultations being undertaken by the Health Technology and Assessment Review. Find out what you had to say about the way treatments are made available to Australian patients in the Consultation 1 report by the Centre for Health Economics Research and Evaluation (University of Technology Sydney).