- 3 months ago
4 December 2023
Prashant Nikam arrived in Australia almost two years ago and quickly decided he needed to put a sign on the wall saying simply, ‘Patients can’t wait’.
Since then, not only has Nikam put up that sign but the MSD ANZ Vice President and Managing Director has also put a red chair in every meeting room at MSD to remind people working for the company that patients need access to new and effective medicines – and it is up to everyone to deliver.
The PBAC will meet on Wednesday to consider potentially game-changing submissions from MSD and BMS that, if recommended, would see all future TGA-approved indications for their blockbuster immuno-oncology drugs KEYTRUDA (pembrolizumab) and OPDIVO (nivolumab) plus YERVOY (ipilimumab) funded on the PBS for new indications on the day they are added to the ARTG.
In other words, the Patient Access Gap (PAG) will be zero, giving Australian patients rapid funded access to the world-leading treatments once they are found to be safe and effective.
“MSD is committed to finding innovative solutions so that Australian cancer patients have broad, equitable, and affordable access to the medicines they need,” a company spokesperson told MedNews.
“On average, it has taken 447 days for Keytruda to be funded through the PBS for specific cancer types after TGA registration. The proposal before the PBAC would reduce this delay by making Keytruda automatically available on the PBS for specific cancer types at the point of TGA registration.
“We look forward to partnering with Government to find ways to improve access for Australian cancer patients.”
Keytruda has been approved by the TGA for 29 different indications since it was first added to the ARTG in March 2016 as a treatment for melanoma.
Of those 29 indications, only 13 are funded on the PBS as each requires a separate PBAC submission. Five of those indications were added this year, including early-stage breast cancer on 1 December.
In comparison, the FDA has now approved Keytruda for 39 separate indications, meaning Australian patients with one of 26 other cancer types or stages are missing out on equitable access to a therapy found to be safe and effective against their cancer.
If the PBAC recommends MSD and BMS’ submissions on Wednesday – and the Government accepts PBAC’s advice as it has committed to do – it will mean patients with the 16 cancers for which Keytruda is approved but not funded will get access to the therapy for the price of a script, while patients with the 13 indications not yet approved in Australia will get access almost 15 months faster than they otherwise would.
Likewise, Opdivo in combination with Yervoy is approved for seven indications on the ARTG and funded on the PBS for four new indications in the past four years.
Many stakeholders have been pushing for the Patient Access Gap to be reduced to 100 days. MSD and BMS are looking to reduce it to zero, meaning no gap at all – and that patients don’t wait.
It is a ground-breaking move on the part of both companies’ market access and policy teams that both delivers on their purpose and builds on previous attempts to take a different approach to funding the PD(L)1 class of therapies that includes Keytruda, Opdivo, Roche’s TECENTRIQ (atezolizumab), AstraZeneca’s IMFINZI (durvalumab) and Merck/Pfizers’ BAVENCIO (avelumab).
Rare Cancers Australia is among those stakeholders that have led the fight for broad PBS listing of the PD(L)1 checkpoint inhibitor class. Its advocacy meant that in August 2018, the PBAC considered a pan-tumour listing across non-small cell lung cancer (NSCLC) but did not recommend it, largely as the evidence was not there to support the move at the time.
Almost four years later and with funded indications including melanoma, breast cancer and lung cancer spanning early-stage to metastatic disease, there is hopefully sufficient evidence to allay any concerns about the safety of the class, while the body of real world evidence likely provides the ability to determine a cost-effective price that can be automatically applied to all future indications.
This price is likely to be lower than the current average price as the process being offered by the companies removes the requirement for them to make a separate PBAC submission for each indication, including the numerous PBAC submission and pricing fees.
Given these add up to around $1 million for every listing, that’s potentially a big saving for the drug sponsors, which also don’t have to fund the endless man hours required to negotiate a successful listing, while the Government also wins. Essentially, that would be a win for both the company and for the government, and a win for the patient and for the taxpayer.
The PBAC potentially flagged a positive reception earlier this year when it recommended in July to list Opdivo for all advanced or metastatic oesophageal squamous cell carcinomas regardless of PD-L1 status, effectively giving it a pan-tumour PBS listing.
MSD and BMS’ ‘multiple indications’ submissions are far more ambitious, but also offer a much greater reward for patients.
We won’t know whether the PBAC has recommended their proposals until early next year, but there can be no doubt this is what visionary change and staying committed to your purpose looks like. Patients can’t wait and perhaps very soon, many cancer patients may not have to.