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