Australia's most trusted source of pharma news
No PBS for CAR-Ts says Novartis
Posted 23 January 2018
Novartis has filed an MSAC application for its US-approved CAR-T cancer therapy Kymriah in Australia, showing the pharma giant is keen to maximise its global lead in CAR-T but the revolutionary new therapy is ineligible for PBS reimbursement.
The MSAC application is the first document to emerge regarding plans for a CAR-T in Australia and revealed Novartis would not seek PBS-listing for Kymriah due to restrictions in legislation.
"Novartis understands that as tisagenlecleucel has been designated and will be registered as a class 4 biologic, rather than a drug, current legislation would not permit it to be funded via the PBS," it said in the public document.
Instead the company ticked "yes" to the question of whether "the proposed service [was] seeking public funding other than the MBS" in the document.
When asked by Pharma in Focus for more specific details regarding the pathway for approval and possible reimbursement of Kymriah, the company replied its plans were commerical-in-confidence.
Novartis applied to the MSAC for the drug's use in the treatment of patients with acute lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL) indications - both of which have already scored approvals in other jurisdictions or are under review overseas.
The document noted the therapy had not yet been submitted to the TGA for ARTG registration, though an application was being prepared with an undisclosed estimated submission date.
"This is a hybrid health technology that involves leukapheresis to harvest the patient's T cells, administration of lymphodepleting chemotherapy, controlled transportation of cryopreserved T cells to a centralised manufacturing facility, genetic reprogramming and expansion of the T cells to create tisagenlecleucel, strict quality control and release procedures, and transportation of finished product back to the hospital site for reinfusion into the patient," the application explains.
Novartis indicated the procedure would not be "entirely rendered in Australia".
The MSAC application comes after a big year for CAR-T therapies, which have been lauded by FDA commissioner Scott Gottlieb himself as a "new frontier" after Kymriah became the first of the class of products to gain approval, followed by Gilead's rival Yescarta.
The therapies work by extracting T-cells from patients and modifying them in a specialised process before they are reinfused into the patient's body.
While Novartis was first to market in 2017, competition in the space is heating up this year with Celgene reportedly looking at a CAR-T purchase while Gilead subsidiary Kite has announced a collaboration with Pfizer to evaluate a combination of its Yescarta and utomilumab in refractory large B-cell lymphoma.
Pfizer is developing utomilumab in blood cancers and solid tumours as a single agent and in combination with other anti-cancer therapies.
A phase I/II study of the Yescarta/utomilumab combination is expected to begin this year with results used to find options for further development of the combination, or similar combinations between Kite's engineered T-cell products and utomilumab.
With Gilead's Yescarta also potentially coming down the line in Australia, it remains to be seen how the therapies will traverse Australia's rigid reimbursement system.
"Other manufacturers of CAR-T therapies, for use in these and other indications, are likely to enter the Australian market in due course," Novartis said in its application, signalling the pharma giant is expecting to meet competition in bringing the new therapies to Australia.
Yajun Ma
Posted 23 January 2018
Novartis has filed an MSAC application for its US-approved CAR-T cancer therapy Kymriah in Australia, showing the pharma giant is keen to maximise its global lead in CAR-T but the revolutionary new therapy is ineligible for PBS reimbursement.
The MSAC application is the first document to emerge regarding plans for a CAR-T in Australia and revealed Novartis would not seek PBS-listing for Kymriah due to restrictions in legislation.
"Novartis understands that as tisagenlecleucel has been designated and will be registered as a class 4 biologic, rather than a drug, current legislation would not permit it to be funded via the PBS," it said in the public document.
The MSAC application comes after a big year for CAR-T therapies, which have been lauded by FDA commissioner Scott Gottlieb himself as a "new frontier" after Kymriah became the first of the class of products to gain approval, followed by Gilead's rival Yescarta.
The therapies work by extracting T-cells from patients and modifying them in a specialised process before they are reinfused into the patient's body.
While Novartis was first to market in 2017, competition in the space is heating up this year with Celgene reportedly looking at a CAR-T purchase while Gilead subsidiary Kite has announced a collaboration with Pfizer to evaluate a combination of its Yescarta and utomilumab in refractory large B-cell lymphoma.Pfizer is developing utomilumab in blood cancers and solid tumours as a single agent and in combination with other anti-cancer therapies.
A phase I/II study of the Yescarta/utomilumab combination is expected to begin this year with results used to find options for further development of the combination, or similar combinations between Kite's engineered T-cell products and utomilumab.
With Gilead's Yescarta also potentially coming down the line in Australia, it remains to be seen how the therapies will traverse Australia's rigid reimbursement system.
Drought, fire and now virus cut chance of PBS relief.
Don't do it for the accolades; do it for your kids.
New forms of rotavirus vaccine Rotarix.