TAR - Left atrial appendage occlusion devices

PHARMAC health economic assessment of left atrial appendage occlusion devices (LAAO)

PHARMAC has been taking a greater role in the management of medical devices. PHARMAC is expected at some point in the future to take a role in assessing and managing access to new technology to ensure the introduction of new or modified devices is safe, consistent across the country, and targets limited investment funds to those technologies that deliver the best outcomes for patients.

Although PHARMAC has been assessing medicines for investment management purposes for many years, we are aware that aspects of medical devices assessment differ to medicine assessments, and may require different considerations and approaches. We are seeking advice and determining strategies for going forward in regard to managing future assessment, standardisation, prioritisation and procurement of medical devices, and expect to engage more widely on this later this year.

To assist with our work to determine appropriate strategies, we sought an example device for undertaking a technology assessment. In 2016 our Interventional Cardiology Advisory Group (ICAG) suggested Left Atrial Appendage Occlusion (LAAO) devices as a possible option.

The ICAG advised PHARMAC that:

• LAAO had been excluded from the Service Coverage Schedule(external link) since 1 July 2014
• That LAAO exclusion was based on an earlier National Health Committee (NHC) recommendation that LAAO should not be funded, due to insufficient evidence on safety and clinical effectiveness
• The earlier NHC review considered LAAO for a general population, based on the trial evidence publisehd at that time
• More recent evidence suggests that it is effective in a very specific patient group, and therefore that it may be more cost-effective to target the procedure to people with atrial fibrillation who are at a high risk of stroke, and who also have a contraindication to oral anticoagulants, including novel anticoagulants

PHARMAC therefore decided to use the LAAO as an example to test our current Technology Assessment approach on an implantable device. With input from the ICAG and the New Zealand branch of the Cardiac Society of Australia and New Zealand (CSANZ), PHARMAC reviewed recent data on effectiveness and safety. We then developed a health-economic model of the LAAO device and used it to:

• estimate the cost-utility of the LAAO procedure if it were used in New Zealand for the specific patient target group of AF patients at high risk of stroke and with a contraindication for OAC, including NOAC
• estimate the numbers of people likely to be eligible for LAAO procedure in each future year (incidence and prevalence of patient target group)
• estimate the number of people likely to be treated with a LAAO device (based on both eligibility and service capacity), and
• calculate the likely future budget impact if LAAO procedures were to be funded for the defined patient target group.

Our Technology Assessment has identified LAAO as a good investment relative to other options PHARMAC has previously funded via the Community Pharmaceutical Budget, if funding/use were focused to the defined patient target group.

We note that, given the test nature of our assessment, we are not in a position to compare the LAAO with other new investment options that DHBs may be considering (whether products or services), and we have not sought to compare it specifically with a wider set of possible medical device investment options.

The model and its results are fully described in the Technology Assessment Report 302. PHARMAC’s intent in releasing this assessment report is to assist DHBs to consider the LAAO technology in the context of their investment priorities. We do not make any recommendation as to funding.