News Review
RCT = randomised controlled trial; SPAF = stroke prevention in atrial fi brillation; PE = pulmonary embolism; DVT = deep vein thrombosis; NOAC = non-vitamin K antagonist oral anticoagulant. Calculation based on IMS Health MIDAS, Database: Monthly Sales June 2016.
PBS Information: Authority Required( STREAMLINED). Refer to PBS Schedule for full authority information. from previous page
So there will be an extra layer of assessment— but only after the practice has formally enrolled the patient. It’ s a questionnaire completed by the patient to fill the information voids in the GP record, such as the patient’ s hospitalisation history.
All this will then be fed into the Health Care Homes algorithm, which will generate a score that determines the quantum of funding— low, medium or high— the practice receives for the patient’ s care.
PLEASE REVIEW THE FULL PRODUCT INFORMATION( PI) BEFORE PRESCRIBING. APPROVED PI AVAILABLE AT WWW. BAYERRESOURCES. COM. AU / RESOURCES / UPLOADS / PI / FILE9466. PDF OR UPON REQUEST FROM BAYER AUSTRALIA LTD.
Minimum Product Information. XARELTO ®( rivaroxaban) INDICATIONS: Prevention of venous thromboembolism( VTE) in adult patients who have undergone major orthopaedic surgery of the lower limbs( elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks); 10 mg tablet once daily. Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke; 20 mg tablet once daily( 15 mg for patients with CrCl 30-49 mL / min). Treatment of deep vein thrombosis( DVT) and pulmonary embolism( PE) and for the prevention of recurrent DVT and pulmonary embolism( PE); 15 mg tablet twice daily for 3 weeks, followed by 20 mg tablet once daily. Xarelto 15 mg and 20 mg tablets should be taken with food. Tablets may be crushed and administered orally( mixed with water or applesauce) or given through gastric tubes. See full PI for details. CONTRAINDICATIONS: Hypersensitivity to rivaroxaban or to any of the excipients, clinically significant active bleeding, lesions at increased risk of clinically significant bleeding and patients with spontaneous impairment of haemostasis, significant hepatic disease which is associated with coagulopathy, dialysis or severe renal impairment with a creatinine clearance < 15 mL / min for Xarelto 10 mg or < 30 mL / min for Xarelto 15 mg and 20 mg, concomitant treatment with strong inhibitors of both CYP 3A4 and P-glycoprotein, Pregnancy, Lactation. PRECAUTIONS: Increased bleeding risk such as general haemorrhagic risk( see PI for list), bronchiectasis or history of pulmonary bleeding, renal impairment, hepatic impairment, surgery and interventions, spinal / epidural anaesthesia or puncture, patients with prosthetic valves( no clinical data), haemodynamically unstable PE patients or patients who require thrombolysis or pulmonary embolectomy, lactose intolerance. INTERACTIONS WITH OTHER MEDICINES: Care to be taken if concomitantly used with medicines affecting haemostasis; concomitant administration with NSAIDs, platelet aggregation inhibitors, other anticoagulants. ADVERSE EFFECTS: Please refer to PI for a complete list. Very common and common adverse reactions( ≥ 1 %) include post procedural haemorrhage, increased transaminases, gingival bleeding, constipation, diarrhoea, nausea, pyrexia, oedema peripheral, contusion, pain in extremity, headache, dizziness, haematuria, menorrhagia, epistaxis, haematoma, anaemia, rectal haemorrhage, fatigue and ecchymosis, haemoptysis, pruritus, conjunctival haemorrhage, abdominal pain, dyspepsia, gastrointestinal haemorrhage, syncope, hypotension, increased gamma-glutamyltransferase, tachycardia, vomiting, asthenia, wound haemorrhage, subcutaneous haematoma and rash. Less frequent but serious adverse reactions include: urticaria, hypersensitivity, hyperglycaemia, cerebral, cerebellar and intracranial haemorrhage, haemorrhagic transformation stroke, jaundice, eye haemorrhage, loss of consciousness, angioedema, allergic oedema, cholestasis, hepatitis and thrombocytopaenia. DOSAGE AND ADMINISTRATION: see INDICATIONS above. BASED ON PI DATED: 01 June 2016.
References: 1. Patel MR et al. N Engl J Med 2011; 365:883 – 91. 2. Camm J et al. Eur Heart J. 2015 Sep 1. pii: ehv466. [ Epub ahead of print ]. 3. Tamayo S et al. Clin Cardiol 2015; 38:63 – 8. 4. Prins MH et al. Thrombosis J 2013; 11( 1): 21. 5. Beyer-Westendorf J et al. Blood 2014; 124:955 – 62. 6. IMS Health MIDAS, Database: Monthly Sales June 2015. 7. Calculation based on IMS Health MIDAS, Database: Monthly Sales June 2016. 8. Xarelto ®( rivaroxaban) Product Information, 01 June 2016.
Bayer Australia Ltd. ABN 22 000 138 714, 875 Pacific Highway, Pymble NSW 2073. Xarelto ® is a registered trademark of Bayer Group, Germany. BAY3962 / AD / L. AU. MKT. GM. 12.2015.0386
‘ I THINK, IN THE FUTURE, GOVERNMENTS WILL PAY YOU— AT SOME LEVEL— BASED ON HOW SICK YOUR PATIENT POPULATION IS.’
— Professor Michael Georgeff, CEO of Precedence Health Care
Confidence from Evidence and Real World Experience *
* Xarelto has evidence for its efficacy and safety profile for eligible patients from RCTs and real world studies in SPAF 1-3 and PE / DVT. 4, 5 Xarelto is the world’ s most prescribed NOAC, 6 with over 23 million patients treated across multiple indications. 7, 8
One key point worth emphasising is that doctors have no involvement in this sign-up process— GPs carry out no clinical assessment.
The reasons are twofold. First, it would be bureaucracy for red-tape-phobic doctors; and second, it has to be independent of the practice to stop potential rorting.
As reported by Australian Doctor, there will be some 20 or so IPN practices in the first wave of this reform. They may have an advantage. It turns out that five IPN practices based in Sydney have already been testing risk stratification tools similar to QAdmissions.
IPN, whose former boss Dr Malcolm Parmenter sat on the government’ s advisory committee for Health Care Homes, is also owned by Sonic Healthcare, which owns Precedence Health Care.
A conflict of interest? Will it be tempted to tweek the algorithm to ensure cash flows that can enhance IPN’ s cash flow?
Professor Georgeff stresses his company guards its independence. He also points out the algorithm is not being developed by his company. That work is being undertaken by boffins at CSIRO.
The effects of the algorithm on practices will only be known fully after the trial goes live next year. Reassurance that it won’ t cripple practices comes in part from the work CSIRO is doing.
Professor Georgeff says:“ We will give CSIRO hundreds of thousands, potentially millions of deidentified patient records that can be linked to hospital data.
“ CSIRO will then develop the algorithm and test it with this dataset to see if it is a good predictor of hospitalisations or not.”
Professor Georgeff also stresses that the government is running the trial as a continuous improvement process— the point is that the algorithm will be tested and adapted through the trial.
But there are wider issues here that will be relevant not just to those practices becoming Health Care Homes.
There are reasons for governments to embrace risk stratification tools for all general practices.
“ Inevitably, the health system will need to move to where practices focus on the patients who need more support,” Professor Georgeff says.
“ I think, in the future, governments will pay you— at some level— based on how sick your patient population is.
“ This risk calibration will become the norm.”
12 | Australian Doctor | 18 August 2017 www. australiandoctor. com. au