Planning a MSAC Application? Don’t overlook the ‘PASC’ hurdle.
by Sarah Griffin, Director, MedTechnique Consulting.
To successfully diffuse a new medical technology and procedure into the desirable Australian market, an application to the Medical Services Advisory Committee (MSAC) is required in most cases. This is to attain a Medical Benefits Schedule (MBS) item number so that health professionals can be paid for the procedure under Australia’s universal Medicare system. An MSAC application requires a comprehensive health technology assessment (HTA) of the clinical and economic outcomes of the new technology compared to existing practice.
Possibly less understood by potential applicants is the role played by the PICO Advisory Subcommittee (PASC) PICO is an acronym for Population, Intervention, Comparator, Outcome. It may be difficult for applicants to fully understand the role of PASC as the PASC process is not outlined in much detail on the MSAC website. This is the explanation from the website:
‘The PASC oversees the development of a PICO Confirmation (formerly known as a Decision Analytic Protocol [DAP] and then Protocol) that uses the widely accepted PICO (population, intervention, comparator and outcome) approach that is intended to:
- capture current clinical practice and reasonably reflect likely future practice with the proposed new service;
- identify all potentially impacted healthcare resources; and
- present and justify the framework for evidence collection during the assessment phase of the MSAC process.’
Basically, this committee identifies the clinical and economic questions that must be addressed in the main HTA submission. It may be helpful for the uninitiated to break down the process into steps.
Step 1: Initial application
An initial application must be submitted to the MSAC secretariat to determine whether the application is eligible to proceed (more details in a later article). However briefly, eligibility includes determining whether there is evidence available for assessment, whether the application falls within MSAC’s remit and whether there is support from the relevant clinical professional body.
Step 2: Draft PICO Confirmation
The initial application is sent to a contracted HTA consultant who will prepare a draft ‘PICO Confirmation document’. The HTA consultant will conduct their own research and consult MSAC’s clinical experts to confirm that the information included in the application reflects Australian clinical practice. The document will include some of this research and will have some draft PICO parameters. The applicant has an opportunity to comment on the draft PICO. The draft PICO with the applicant’s comments is forwarded to the PASC.
Step 3: PASC meeting
The PASC meeting takes place three times a year. Its purpose is for the committee to discuss the application and the draft PICO and ultimately inform the final PICO Confirmation. The applicant is allowed to have three people present. It is best to have a local clinical expert, someone very familiar with the PASC process and a representative from the applicant. Additional people are welcome to join by teleconference. The applicant may include a 5-minute presentation with or without slides to present the new technology/procedure.
As PASC has a huge variety of medical technologies and procedures presented to it, it is not always certain that all members will fully understand your technology. It is important at this meeting that if there are obvious misunderstandings that the applicant take the opportunity to correct these. If there are proposed comparators or outcome measures that you don’t agree with, this should be discussed as well.
Step 4: PASC Outcomes
Following the PASC meeting, the applicant (after about 6 weeks) will receive a document outlining the outcomes of the meeting. Crucially, this document will specify the details of the Population, Intervention, Comparator, Outcome that must guide the HTA submission. The applicant then has another opportunity to comment, and the final ‘Ratified PICO Confirmation’ is given to the applicant who can then proceed to the main phase of the application process.
What to watch out for:
- PASC may specify an outcome measure that hasn’t been captured by your key clinical trials
- PASC may specify parameters of populations that haven’t been specifically addressed or evaluated separately in your key clinical trials
- A comparator may be identified that is possibly inappropriate or there is no comparative clinical evidence available.
How to deal with these issues:
Often these types of issues are unavoidable, however it is important that your reasons for not agreeing with these are included in your comments and brought up at the PASC meeting. Either way they must be addressed in the main submission as best as possible.
While the PASC process is lengthy, it does give the applicant a very clear outline of what is expected in the main submission.
For more information about the MSAC/PASC process please contact Sarah Griffin, Director of MedTechnique Consulting on email: firstname.lastname@example.org or phone:+ 61 448 058 00.
MedTechnique Consulting has helped many organisations to navigate the Australian healthcare landscape, gain market access and submit successful reimbursement applications. If you have any questions or would like to learn more about how we can help your organisation access the Australian market, contact us via email: email@example.com or phone:+ 61 448 058 00.
About the Author: Sarah Griffin, Director of MedTechnique Consulting – Experts in medical device reimbursement and market access in Australia.
Sarah is a health economist, reimbursement strategist, health policy advocate and experienced speaker.