Prostheses List

1. Prostheses List Information Session

2. This information session will cover: • An overview of the PL arrangements • Update on implementation of HTA Review recommendation 12b-e • Update on the Database • Criteria for listing • Update on Clinical Evidence Requirements • Expert Clinician Advice • PL Administration

3. August 2012 Prostheses List To be released in the second week of August 2012 with an effective date in the last week of August 2012. Includes: • Part A – approximately 9,900 • Part B – 272 • Part C – 17 • 479 new applications received • 985 amendments processed

4. HTA Review Implementation Update Now August 2012 PL • Phase 2 • Special purpose tumour products • Phase 3 • General/miscellaneous - Ligating clips, staples, tackers, Infusion pumps and some mesh groupings (polypropylene, composite, absorbable, PTFE/ePTFE), adhesion barriers • Vascular - Stent grafts, occlusion devices and long term vascular access devices

5. HTA Review Implementation Update Next February 2013 PL • Phase 2 • Biologically Active Bone Graft Substitute Products • Phase 3 • Specialist Orthopaedic • Review of the policies that underpin the PL arrangements

6. The New Database • At the February 2012 Prostheses Information Sessions – stakeholder feedback • Requirements revised Phase 1 – Implementation Phase 2 – Development

7. What is the Prostheses List? • Under the Private Health Insurance Act 2007 private health insurers are required to pay benefits for prostheses included on the Prostheses List: • for which an insured person has appropriate cover; • that are provided as part of an episode of hospital treatment or hospital substitute treatment; and • for which a Medicare benefit is payable for the professional service associated with the provision of the prosthesis.

8. Why do we have these arrangements? “The arrangements for listing products on the Prostheses list help to ensure that listed prostheses are clinically effective and the benefit paid by insurers is relative to clinical effectiveness.” Guide to listing and setting benefits for prostheses - Part 1

9. The Criteria for Listing There are two parts to the Criteria: 1. The “must” criteria 2. The “should” criteria

10. The Criteria for Listing The product MUST 1. be included on the Australian Register of Therapeutic Goods; & 2. be provided to a person as part of an episode of hospital treatment or hospital-substitute treatment; & 3. Have a Medicare benefit payable in respect of the professional service associated with the provision of the product (or the provision of the product is associated with podiatric treatment by an accredited podiatrist); &

11. The Criteria for Listing The product SHOULD 4. (a) be surgically implanted in the patient and be purposely designed in order to:(i) replace an anatomical body part; or (ii) combat a pathological process; or (iii) modulate a physiological process; or (b) be essential to and specifically designed as an integral single-use aid for implanting a product; or (c) be critical to the continuing function of the surgically implanted product; & 5. The product has been compared to alternate products on the Prostheses List or alternate treatments &: (i) assessed as being, at least, of similar clinical effectiveness; & (ii) the cost of the product is relative to its clinical effectiveness.

12. Clinical Evidence Requirements Released • Developed by the PLAC • Refine and clarify the minimum evidence requirements for applications • Consistent set of principles for the CAG and PoCE • Provides guidance on types and levels of evidence required

13. Clinical Evidence Requirements Next Steps • CAG and PoCE interpret principles in context of their specialties • May provide further guidance on evidence requirements for sub-sets of products if needed • PLAC will review the document June 2013 • Welcome feedback in the meantime

14. Clinician Perspective • What clinicians look for? • How can you assist clinicians • Professor Stephen Graves, Orthopaedic Surgeon • Current Chair of HPCAG • Founding and current members of KPCAG • Director, AOA National Joint Replacement Registry

15. Clinician Experience

16. What Clinicians look for in PLAC applications

17. What is the Clinician required to do? How can you make their task simpler ?

18. Clinician is required Assess clinical evidence to determine comparative clinical effectiveness Assess and determine grouping Are MBS procedure codes appropriate (where indicated) Make recommendations as to whether device should be listed and in which group Assess applications for superior clinical performance

19. Grouping Sponsor proposed grouping Sponsor listed comparators Assess group distinguishing features listed in the application Image

20. Difficulties in determining groupings Inadequate, incomplete or incorrect description Multiple components listed under a single application (a number of catalogue number ranges or more than one component listed in a single application) Inadequate, incomplete or incorrect comparators Inadequate or no picture

21. Minimum clinical information? Appropriately completed application form Product brochure (with specifications) Surgical technique Quality digital images (exploded, labeled, CD or DVD if the device is complex) Published clinical papers (well researched list of abstracts relevant to the prosthesis) Quality not quantity In English

22. Substantial clinical equivalence If the device is very similar (same) to comparators then similar performance and complications may be assumed in certain cases New item with technical change and/or improved functionality claimed i.e. there is an incremental change then evidence specific to that new prosthesis must be provided For some items it is not possible to claim equivalence

23. Substantial clinical equivalence Same intended use as the comparator Same or very similar technical features Does not raise questions of comparative safety or comparative clinical effectiveness The comparator has been demonstrated to be safe for a time that is commensurate with use It is not a high risk prostheses (load bearing, articulating, risk of death etc etc ) It is not new or novel in design

24. Assessing clinical evidence Relevance of comparators (equivalence) Is there a clinical advantage claimed and/or real Will the product be clinically effective Safety is assessed by the TGA This assessment is based entirely on the clinical information provided by the sponsor

25. What clinical evidence is required? Indications/inclusions Contraindications/exclusions Unless substantial clinical equivalence is claimed, then published evidence of clinical effectiveness of the actual device (as opposed to similar technology) should be provided Level of evidence required relates to the perceived risk of major complications and modes of failure for that device

26. What level of clinical evidence is required? Length of follow-up varies with the intended life of the product 12 months or less then for that period long life anticipated (many years) then at least 2 year follow up required

27. Difficulties in assessing outcome based on the claim of substantial clinical equivalence Not substantially clinically equivalent No clinical information on performance of comparators

28. Difficulties in Assessing Clinical Effectiveness of new product No pre-clinical testing results Unsuitable or no clinical outcomes data for required time for that device

29. The Prostheses List Advisory Committee The role of the PLAC is to make recommendations to the Minister for Health on the listing of Prostheses and the appropriate benefits for them. • PLAC recommendations are made following consideration of advice from its sub-committees: • Clinical Advisory Groups • Panel of Clinical Experts

30. Clinical Advisory Groups CAG’s The role of the CAG is to make recommendations to the PLAC on the listing of products on the prostheses list. • The CAG membership includes expert clinicians and a consumer representative. • CAGs also have advisors nominated from the medical device industry and the private health insurance industry

31. Clinical Advisory Groups CAG’s • Hip • Knee • Specialist Orthopaedic • Urogenital • Ophthalmic • Vascular • Cardiac • Cardiothoracic • Spinal

32. Clinical Advisory Groups New applications • Required at least 7 weeks prior to the CAG meeting • Allows applications to be processed by the secretariat and sent to the Clinicians for assessment • Applications are discussed by the CAG at the CAG meeting and a recommendation made to the PLAC

33. Clinical Advisory Groups New applications • If your application is not recommended for listing by the PLAC you have 10 days from the date of the letter to appeal the decision • Not an opportunity to provide additional information • Appeal and application will be reviewed by the assessing clinicians and considered at the next CAG meeting

34. Panel of Clinical Experts PoCE The role of the PoCE is to make recommendations to the PLAC on the listing of products on the prostheses list. • The PoCE is made up of around 60 expert clinicians • The PoCE clinicians do not generally meet

35. Panel of Clinical Experts PoCE • General & Miscellaneous • Ear Nose and Throat • Plastic and Reconstructive • Neurosurgical

36. Panel of Clinical Experts New applications • Required at least 8 weeks prior to each PLAC meeting • Applications are processed by the secretariat and sent to the Clinicians for assessment • Assessments sent back to the secretariat • If clinicians agree on a recommendation the application is sent to PLAC

37. Panel of Clinical Experts New applications • If clinicians disagree they are requested to confer and try and reach agreement • If they reach an agreement the assessments are presented to the PLAC • If they still disagree on the recommendation a third clinician is contacted to assess the application • All three recommendations are presented to the PLAC for their consideration

38. PL Administration – New Application • Part A1 Form • Part A2 Form • Part B Form (if CAG product) • Clinical Evidence • ARTG Certificate (when available) 5 complete copies

39. PL Administration - Fees • Application Fee - $600 To be paid when submitting an application. • Initial Listing Fee - $200 Once product is granted, sponsor will receive an invoice. • Ongoing Listing Fee - $200 Sponsor will receive an invoice for products to remain listed.

40. PL Administration – Amendment Amend to List Form • Change to details – Description, Sizes, Product Name, ARTG, Catalogue, Group. These changes will need to be clinically assessed. • What to include – Product Brochure.

41. PL Administration – Amendment Amend to List Form • Reduce Group Benefit • Delete Product Code/s These changes will be reviewed by the clinicians.

42. PL Administration – Amendment Duplication, Expansion, Compression, Transfer (DECT) Form • Transfer – change sponsor • Compression – multiple codes into one code • Expansion – one code into multiple codes • Duplication – duplicate a code under an additional sponsor. Both sponsors have the same product listed under different billing codes.

43. PL Administration - Amendment • How to submit your amendment forms? Amend to List and DECT forms can be submitted via email OR post. • What happens next? The secretariat will register and confirm receipt of the amendment. The CAG/PoCE will assess your submission A recommendation will be made to the PLAC

44. PL Administration - Amendment • If the PLAC do not agree with the Amendment/Compression/Expansion request • The secretariat will contact you • Opportunity to appeal the decision and provide any clarifying information requested by the CAG/PoCE • Amendment will be reassessed • A recommendation made to the PLAC

45. PL Administration – Making the List • Final PLAC meeting • Responses to Sponsor submissions • Cut-off date for ARTG • Applications granted/not granted by Ministers Delegate • Initial listing Invoices/Granting letters sent

46. PL Administration – Making the List • Draft list created – checked internally for errors • Draft list to sponsors – 2 week checking • Final Prostheses List created, incorporating changes identified by sponsors • Creation of Rules approved by Legal Section for listing on the Federal Register of Legislative Instruments (FRLI) • Published on website – list becomes effective 14 days after publishing on FRLI

47. If in doubt… • Call us (02) 6289 9463 • Check the guide • Email prostheses@health.gov.au