Australia

PBAC and MSAC submissions, end-to-end.

Q: What's the difference between PBAC and MSAC?

PBAC (Pharmaceutical Benefits Advisory Committee) evaluates medicines for the Pharmaceutical Benefits Scheme. MSAC (Medical Services Advisory Committee) evaluates new medical services, procedures, and devices for the Medicare Benefits Schedule and other government programs. We cover both.

Q: What discount rate applies?

PBAC and MSAC base cases use 5% per year on costs and outcomes, with sensitivity at 0% and 3.5%. This differs materially from the NICE 3.5% and Pharmac 3.5% conventions, so model assumptions need to be re-cut accordingly.

Q: Section 100 vs general schedule?

Specialist listings (Section 100), including HSD, EFC, and IVF, have distinct evaluation conventions and budget contexts. We adjust the budget impact framing and uptake assumptions accordingly.

Q: Co-dependent submissions?

Some devices and diagnostics require a co-dependent MSAC application linked to a PBAC listing (or vice versa). We structure the evidence packs to land in lockstep.

Australian Health Technology Assessment covers two committees with two conventions. We build models for both (PBAC for medicines, MSAC for medical services and devices) and handle co-dependent submissions when the technology needs both.

PBAC vs MSAC: the two pathways.

PBAC evaluates medicines for the Pharmaceutical Benefits Scheme. Submissions cover clinical evaluation, economic evaluation, financial estimates, and a structured response to PBAC's clinical-need framework.

MSAC evaluates medical services, procedures, and devices for the Medicare Benefits Schedule and other government programs. Submissions cover clinical evaluation, comparative effectiveness, and a financial and utilisation analysis sized to the proposed MBS item.

Co-dependent submissions link a device or diagnostic at MSAC with a pharmaceutical at PBAC (companion diagnostics are the textbook case). The evidence base for both submissions has to be coherent across the two committees.

Where HEC fits in the pathway.

Strategy + pre-submission

Comparator selection, CUA vs CMA decision, identification of co-dependency, threshold framing for the relevant clinical area.

Model build on HEX Platform™

Cost-utility, partitioned-survival, or Markov. 5% discount, AUD currency, AU-specific resource use. Every parameter audited; probabilistic sensitivity analysis (PSA), deterministic sensitivity analysis (DSA), and scenario tables pre-baked.

Section 1 to 4 dossier

Section 1 (clinical case), Section 2 (clinical evaluation), Section 3 (economic evaluation), Section 4 (utilisation and financial estimates). Written to the PBAC / MSAC plain-English idiom.

Response cycle

PBAC and MSAC pre-meeting requests and post-meeting reconsideration responses turned around within the agency's published windows.

Section 100 / specialist listings

HSD, EFC, IVF, and other restricted listings have different budget contexts. We adjust the financial estimates accordingly.

Co-dependent coordination

Companion diagnostic + therapeutic submissions kept evidence-coherent across the two committees and timed to land together.

Common questions on PBAC and MSAC.

What's the difference between PBAC and MSAC?

PBAC evaluates medicines for the Pharmaceutical Benefits Scheme. MSAC evaluates new medical services, procedures, and devices for the Medicare Benefits Schedule and government programs. The evaluation conventions are similar in spirit but distinct in execution.

What discount rate applies?

5% per year on costs and outcomes in the base case for both committees. Sensitivity at 0% and 3.5% is conventional. Re-cutting from NICE / Pharmac 3.5% bases matters, because the answer changes.

Section 100 vs general schedule?

Section 100 specialist listings (HSD, EFC, IVF) have distinct evaluation and budget contexts. We adjust uptake, displacement, and resource-use assumptions to match.

Co-dependent submissions?

For companion diagnostics and similar device+therapy bundles, we structure the evidence packs to land at PBAC and MSAC in coordination.

Planning a PBAC or MSAC submission?

30 minutes to scope the work, including whether you need PBAC, MSAC, or both, and decide if an agreement fits.

Book a 30-minute call