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Co-dependent and Hybrid Technologies

Defining the technologies and determining the HTA approach
Co-dependent technologies
Applying for HTA for co-dependent technologies
Hybrid technologies
HTA Access Point
Transition Arrangements for Co-dependent Technologies in 2012
Next Steps

Co-dependent and hybrid technologies can range from a single product with several components to several types of services linked along a clinical pathway. The use of diagnostic testing, including genetic testing, to refine patient selection and eligibility for high cost procedures, devices and particularly medicines, and the continued development of pharmacogenomics (also called ‘personalised medicine’), will provide a new approach for tackling disease, and challenges for their assessment.

Defining the technologies and determining the HTA approach

Co-dependent Technologies

Health technologies are co-dependent if their use needs to be combined (either sequentially or simultaneously) to achieve or enhance the intended clinical effect of either technology. For example, a drug/test combination where a new medicine seeking listing on the PBS may have a related pathology test that helps to determine the population group for that medicine.

Approach to HTA

A co-dependent technology usually requires advice to the Minister from two different expert advisory committees because listing needs to occur under two separate funding programs (for example, PBS and MBS, or MBS and Prostheses List).

Co-dependent technologies’ assessments conducted to date have predominantly involved co-dependent pharmaceuticals and diagnostic tests. Each component is currently considered separately by the relevant advisory committees (PBAC and MSAC respectively in this instance) using different approaches to assessing evidence against the HTA criteria.

A critical element in the appraisal of a co-dependent technology is the need to consider the benefits of their joint use, as distinct to the benefit of each technology in isolation.

The department is currently revising its approach to HTA for co-dependent technologies, including the assessment pathway(s) and methodological processes and how to best streamline governance arrangements and timing for the consideration of the application by two different expert advisory committees.

Applying for HTA for Co-dependent Technologies

Applicants seeking to apply for funding for a co-dependent technology should address the department’s evidence requirements as set out in the Draft Information Requests for Assessing Co-Dependent Technologies (PDF 432 KB).

Hybrid Technologies

Hybrid health technologies combine the characteristics of different health technologies in one entity for example, a medicine or a biological or a medical device.

Approach to HTA

This type of technology can incorporate a combination of a medical procedure or a medicine or a biological or a device in the one intervention. Usually each of these components is assessed by a different advisory committee – MSAC, PBAC or PLAC (formerly PDC). This presents challenges as to which reimbursement scheme is appropriate and thus which assessment process should be used.

The current approach to determining the most appropriate assessment pathway is informed by the classification established by the Therapeutic Goods Administration (TGA) in assessing it for entry on the Australian Register of Therapeutic Goods.

HTA Access Point

The HTA Review recommended the establishment of a single entry point for applications for HTA for reimbursement. The department has established the HTA Access Point to assist potential applicants with co-dependent or hybrid technologies determine which is the most appropriate assessment pathway(s) and expert advisory committee(s) to undertake this type of specialised assessment.

Transition Arrangements for Co-dependent Technologies in 2012

Following discussions with stakeholders including Medicines Australia, the Department of Health and Ageing has decided to provide a formal transition period pending the introduction of integrated, coordinated arrangements for appraising co-dependent technologies across Health Technology Assessment (HTA) pathways for different funding programs, particularly in relation to medicines and their companion diagnostics.

Arrangements during the transition period

During the transition period which will expire in November 2012, it is proposed that:

• applicants with co-dependent technologies requiring both Pharmaceutical Benefits Advisory Committee (PBAC) and Medical Services Advisory Committee (MSAC) consideration may submit to these processes separately;
• applicants with a co-dependent technology where a medical service is involved will still be required to complete the MSAC assessment process;
• applicants may submit applications to the PBAC without first having completed the Protocol Advisory Sub-Committee (PASC) step in the MSAC process. Applicants should note, however, that this may result in an application to PBAC that does not fully address co-dependency issues to the satisfaction of the PBAC.
• if applicants choose to navigate the PBAC and MSAC paths separately, applicants need to be aware that a recommendation from the PBAC may be deferred until such time as MSAC has considered and provided its advice on the application.

PBAC will be able to make a recommendation as it sees fit including:

• defer a final decision to recommend Pharmaceutical Benefits Scheme (PBS) listing of the drug if the test information is crucial to informing a PBAC recommendation, especially if PBAC considers that MSAC advice is necessary; or
• reject because the application for the drug does not satisfy PBAC’s requirements regardless of the information about the test.

Applicants lodging with the PBAC before undertaking the pre-lodgment PASC step in the MSAC process will need to accept the risk that PBAC may wait for advice from MSAC before providing its final recommendations on the application. An applicant lodging a submission during this transition period will do so on the understanding that PBAC will consider its submission as usual on a case-by-case basis.

Upon cessation of transition period

Once the transition period ceases in November 2012:

• a major submission to PBAC which also involves a companion diagnostic test that is not funded on the Medicare Benefits Schedule (MBS), or requires an amendment to the MBS to fund it as intended, must be an integrated submission to both PBAC and MSAC in response to a final Decision Analytic Protocol (DAP) agreed by PASC.
• this integrated submission will therefore comprise a major submission for the PBS listing of the drug and a submission-based assessment (SBA) for the MBS funding of the companion diagnostic.
• intending applicants will need to be aware of the approximate 6-month lead time between lodging a proposed DAP to PASC and its second consideration by PASC following the consultation period.
• the Department will not accept any application for PBAC consideration involving a co-dependent diagnostic technology that requires MSAC consideration unless the PASC step in the MSAC process has been completed.

It should be noted that these arrangements may be subject to further change arising from consultation..

Next Steps

The department is currently developing comprehensive draft guidelines not only for co-dependent technologies but also for all other MSAC appraisals, taking into account all feedback that has been received. Work is well advanced and it is anticipated the new guidelines will be available in 2012. After the transition period, a single submission integrating modules for both committees will be required for both MSAC and PBAC. The MSAC Guidelines will address the issue of when a co-dependent therapeutic intervention for a medical service is to be considered by a committee other than MSAC. This may also include submissions for co-dependent services and devices requiring MSAC and PLAC advice to Government.


In the meantime, applicants are encouraged to continue to consider the Draft Information Requests for Assessing Co-Dependent Technologies to guide development of their application process, alongside the existing PBAC and MSAC Guidelines.

Page currency, Latest update: 29 November, 2011

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