Authors' objectives: In January 2010 an application was received from the Spine Society of Australia requesting Medicare Benefits Schedule (MBS) listing of artificial intervertebral disc replacement (AIDR) in patients with cervical degenerative disc disease (AIDR-C). AIDR-C had been considered by MSAC in 2006 and not supported at that time, although AIDR for the lumbar spine (AIDR-L) was recommended for interim MBS listing. It was agreed that the application be considered as a pilot for a submission based application in line with Recommendation 9 of the HTA Review that by July 2010 MSAC strengthen and streamline its operations and improve the flexibility of its regulatory processes by: (a) providing advice to the Minister based on a critique of an applicant's clinical and economic evaluations, as an alternative to the current process and in the context of agreeing specific timeframes for assessment with the applicant. MSAC initially considered the application at its 52nd meeting in March 2011 at which time, in recognition of the nature of the application as a 'pilot', it deferred a decision on its advice pending a request for further information from the applicant and from the department. The applicant, department and the assessment group contracted by the department to critique the report met to facilitate the information request by MSAC. The additional information was submitted to MSAC and taken into consideration in arriving at its advice. The applicant proposed that AIDR-C is indicated for the dynamic stabilisation of the spine following total discectomy for treatment of axial pain or neurological compression, in patients with degenerative disc disease (DDD) associated with radiculopathy (single level) and that AIDR-C is indicated for patients who have failed conservative therapy. This application seeks a new MBS listing of approved indications for AIDR-C for patients with DDD in the cervical spine where cervical disc arthroplasty is indicated for dynamic stabilisation of spine following total discectomy for treatment of axial pain or neurological compression in patients who have failed to respond to conservative care.

Authors' recommendations: After considering the strength of the available evidence in relation to the safety, effectiveness and cost-effectiveness of artificial intervertebral disc replacement for dynamic stabilisation of the cervical spine (AIDR-C), MSAC supports public funding of AIDR-C for symptomatic single level cervical degenerative disc disease in skeletally mature patients with a mechanically stable cervical spine who have not responded to conservative therapy and who have not had prior cervical spine surgery.

Project Status: Completed

Year Published: 2011

URL for published report: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1145-public

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: Medical Services Advisory Committee (MSAC)