PBAC's latest decision on Bezlotoxumab: Not recommended (2020). Considered for Prevention of Clostridium difficile infection (CDI) recurrence in patients aged 18 years or older with confirmed diagnosis of toxin B positive CDI, who are at high risk of CDI recurrence and receiving antibiotics for CDI.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
4
first 2017
Submissions
4
2017 → 2020
Eligible population
Patients aged 18 years or older with confirmed toxin B positive CDI, receiving oral antibiotics, at high risk of CDI recurrence defined as having one or more of: age ≥65 years, history of CDI in the past 6 months, or immunocompromised due to history of haematopoietic stem cell or solid organ transplant.
Therapy area
Infectious disease
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Prevention of CDI recurrence
Key trials
MODIFY trials
Comparator
Standard of care (SoC) antibacterial therapy including but not limited to vancomycin/metronidazole
Economic model
CUA
Eligible patients/year
600
ICER note
ICER value is redacted in the PSD; published price and effective price contain redacted figures (''''''''''''''), making the ICER calculation incomplete in the public document.
Risk sharing
Risk-sharing arrangement in place — The resubmission proposed a risk sharing arrangement with special pricing arrangements, but provided limited detail. The PBAC had previously advised that a risk sharing arrangement with a 100% rebate over financial caps would be needed to address uncertainty.
Why PBAC said no
Reasons cited in the latest PSD: modest clinical benefit, concerns about safety (particularly cardiac failure serious adverse events), uncertain and unfavourable cost-effectiveness, uncertain financial estimates, high opportunity cost, lack of clinical trial data for immunocompromised population with HSCT or SOT
Submission history
Nov 2017: Not recommended · Authority Required
Jul 2018: Recommended with restriction · Authority Required