MSAC rejects Janssen’s CAR T therapy despite clinical superiority, citing need for ‘substantial price reduction’

Pharma News: The Medical Services Advisory Committee (MSAC) has deferred its decision on whether Janssen’s CAR T-cell therapy Carvykti (cilta-cel) should receive government funding. This decision has left approximately 300 Australians with multiple myeloma in a state of uncertainty.

MSAC, in a re-evaluation of Janssen’s application since July 2022, has acknowledged the clinical superiority of Carvykti compared to standard of care for adult patients with relapsed or refractory multiple myeloma (RRMM) with at least four prior lines of therapy. Despite this positive acknowledgment, a “substantial price reduction” is deemed necessary for public funding to be endorsed.

Minister Butler, speaking on 3AW Mornings last year, expressed optimism about the therapy, stating “The response is extraordinary, even better than the first CAR-T cell therapy for myeloma that was approved in America. That had good results, but these results from the Janssen drug are very, very good.”

The weight of consumer support for Carvykti is evident, with major organisations such as The Leukaemia Foundation, Myeloma Australia, Haematology Society of Australia and New Zealand (HSANZ), The Australasian Leukaemia and Lymphoma Group (ALLG), and the Peter MacCallum Cancer Centre advocating for its availability.

Patients and healthcare professionals highlighted the challenges posed by existing treatment options, including the limitations of efficacy, difficulty and inconvenience of frequent hospital visits, procedural discomfort, ongoing side effects, multidrug resistance, and the substantial financial burden.

Despite the substantial support from patient groups and clinicians, MSAC noted that submissions from States and Territories, acting as joint funders through the National Health Reform Agreement (NHRA), were not supportive unless a significant reduction in the price of Carvykti was secured.

MSAC’s decision touched upon the Quality-Adjusted Life Years (QALYs) gained and the need for a revised economic analysis to provide a more accurate estimate of costs associated with Carvykti therapy. The committee stressed the importance of verified inputs from jurisdictions.

Urs Voegeli, Managing Director of Janssen Australia and New Zealand, expressed the pressing need for a decision, stating, “There are currently no effective treatment options available for patients who have exhausted four or more lines of treatment, and these patients are waiting in hope for the government to make a timely decision.”

With three CAR-T cell therapies already approved and subsidised for leukaemia and lymphoma, Carvykti represents a crucial step forward in advancing treatment options for myeloma patients.

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