MTAA agreement confirms 'stability' guarantee

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Publication of the agreement between government and the Medical Technology Association has revealed more information about what the deal means for medical device companies.

The five-page document describes the purpose of the agreement as promoting the sustainability and affordability of privately insured health care along with a viable, innovative and diverse medical technology sector.

The agreement's key inclusion is price cuts to devices included on the Prostheses List. The cuts are applied in two tranches, in February 2018 and then again in February 2020.

New groups added to a category from the August 2017 Prostheses List will be exempted from the cuts set out in the agreement. Government has also committed to making no other changes to benefits on the Prostheses List during the term of the agreement, "without agreement with the MTAA on behalf of the industry."

The agreement expires in January 2022.

It also includes measures designed to reduce the time to market for medical devices. The measures include, from February next year, applications for inclusion on the Prostheses List, which have been approved by the TGA, will not have duplicative safety and efficacy assessment by the Prostheses List Advisory Committee (PLAC) and its subcommittees.

The Department of Health will also advise the minister within six months on options for improved expedited pathways for listing appropriate applications with approval for safety and efficacy by the TGA.

The number of times devices are added to the Prostheses List will be increased from twice a year to three times - in March, July and November - to take effect by March 2019.

Government will also establish an industry working group by March next year, " develop a revised framework for benefit setting and benefit review, reflecting use of health technology assessment including evaluation of value, cost-effectiveness and innovation; use of post-market review and the operation of competitive markets in the Australian context."

PLAC will also review, "...ways of listing new targeted medical devices on the Prostheses List that do not meet the current criteria for listing, but are safe, clinically effective and cost effective to support private health insurance reimbursement for a wider range of medical devices taking into account overall costs associated with the listing. These include, but are not limited to, cardiac ablation catheters for atrial fibrillation."

A $30 million med-tech and biotech grants program will be established for small to medium size enterprises and researchers for conducting activities that support development of new and innovative device technologies, clinical trials and associated registries, support researcher exchanges and workforce development.

Government will meet with the medical device sector every six months to review the operation and progress of the agreement.