Leading the way to the elimination of hepatitis C

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1 Pre-budget submissin Nvember 2017

2 Abut Hepatitis Australia Our visin is an end t hepatitis B and hepatitis C in Australia. Our missin is t lead an effective natinal cmmunity respnse t hepatitis B and hepatitis C in Australia. Our members are the eight state and territry hepatitis rganisatins: Hepatitis ACT; Hepatitis NSW; Hepatitis Queensland; Hepatitis SA; Hepatitis Victria; Hepatitis WA; Nrthern Territry AIDS and Hepatitis Cuncil and, Tasmanian Cuncil n AIDS, Hepatitis and Related Diseases. Cntacts Helen Tyrrell - Chief Executive Officer Felicity McNeill PSM - President PO Bx Wden, ACT, 2606 felicity@perspicacite.cm.au helen@hepatitisaustralia.cm Page 2 f 16

3 Hepatitis Australia is seeking a gvernment investment f $75m ver the perid fr a variety f initiatives t significantly bst hepatitis C treatment uptake ver the next three years in the primary health setting. Enhancing treatment rates during this time maximises the landmark supply deal the Turnbull Gvernment negtiated t prvide universal access t these medicines t achieve eliminatin f hepatitis C as a public health cncern by 2030 in line with the gvernment s Natinal Strategy. There is n additinal flw n cst t the Pharmaceutical Benefits Scheme (PBS) by increasing treatment rates during this time. The requested investment represents a small fractin f the annual PBS csts that culd be averted in each f the ut years fllwing 2021 prvided treatment rates are significantly scaled-up nw. This submissin represents a unique pprtunity fr the gvernment t invest in the cmmunity s health and at the same time invest in cntaining the grwing csts f Australia s health system. Page 3 f 16

4 Cntents Executive Summary... 5 Current Situatin... 6 Predicting Future Treatment Uptake... 8 Ecnmic Ratinale fr Scaling Up HCV Treatment Fcus fr Actin Embedding Treatment in Primary Care Settings Innvative Digital Health Slutins Imprving Cmmunity Awareness and Supprt Cnclusin Page 4 f 16

5 Executive Summary Between 2018 and 2021 the Gvernment has an ecnmic incentive t significantly bst treatment uptake amng the 200,000 peple currently living with hepatitis C. Fllwing the Pharmaceutical Benefits Scheme (PBS) listing f the new cures, the rapid uptake f treatment fr hepatitis C exceeded all expectatins with 30,000 peple cured during Hwever, since then, treatment initiatins have drpped t less than half the riginal mnthly uptake, with indicatins that this trend will cntinue in 2018 and beynd. There were ver 200,000 patients already diagnsed with the disease in 2016 and expected new ntificatins f mre than 10,000 patients each year 1. Why aren t they accessing this curative treatment? A key ecnmic bjective is t facilitate the treatment f as many peple as pssible in the next three years t reduce the hepatitis C-related PBS csts frm 2022 nwards. Maximising treatment uptake ver the next three years will als maximise the Gvernment s return n investment n the five-year supply deal with the pharmaceutical cmpanies fr universal access t the new grund-breaking cures. T facilitate the treatment f as many peple as pssible the advantages f the Sectin 85 PBS listing f the new hepatitis C medicines need t be fully leveraged. This means that rutine hepatitis C treatment needs t be firmly embedded in primary healthcare settings. At the heart f high perfrming primary healthcare systems are well-infrmed cnsumers wh are able t access highly skilled primary health care prviders. With this in mind, there are three specific areas fr natinal investment t scale-up hepatitis C treatment: 1. Initiatives t help embed hepatitis C testing and treatment as a central rle fr general practitiners, nurses, allied health prfessinals and pharmacists wrking in primary care, supprted by their Primary Health Netwrks 2. Innvative digital health initiatives t imprve ease f access t hepatitis C testing and treatment including reginal, rural and remte areas 3. Targeted awareness and supprt initiatives fr peple at risk f hepatitis C, r living with hepatitis C, t help cnnect them t testing and treatment services. Withut additinal actin in this health area ver the next three years, the Gvernment will be faced with a higher prprtin f the ppulatin still requiring treatment in 2022, which in turn increases the risks f reinfectins and new infectins. Based n the current treatment frequency, Gvernment will be paying a higher annual price t maintain access t the treatments with n significant diminutin f peple needing treatment, and therefre n diminutin f csts t the PBS in the ut years. Mst imprtantly f all, the target f eliminatin f this disease in Australia by 2030 will likely be lst. There has cnsequently never been a mre cst-effective time t invest in cnnecting peple living with hepatitis C t treatment, r a better chance t imprve the health f 200,000 Australians and t d s cst-effectively. 1 mediarel yr2015 ley154.htm Page 5 f 16

6 Current Situatin Abut Hepatitis C Hepatitis C is a virus (HCV) fr which there is n prtective vaccine. It is transmitted thrugh bld-t-bld cntact, predminantly via sharing injecting equipment. Withut treatment, all peple with chrnic hepatitis C risk slwly prgressing liver disease, cirrhsis and liver cancer. Thse ver 40 years f age are at heightened risk f pr health utcmes due t an accelerated prgressin f liver disease. There are few defining symptms f chrnic hepatitis C infectin until liver damage has ccurred. The New Hepatitis C Treatments In March 2016, the first f the grund breaking direct-acting antiviral medicines (DAAs) which can cure ver 95% f chrnic hepatitis C infectins were listed n the Pharmaceutical Benefits Scheme (PBS). Treatment has cntinued t evlve and further medicines have been listed, including the first DAAs effective acrss all gentypes (strains) f the virus. All hepatitis C DAAs since March 2016 have been included in the five-year supply deal with pharmaceutical cmpanies. New DAAs are listed n a cstminimisatin basis against the relevant lwest priced alternative regimen. Gvernment Investment In 2016, the Australian Gvernment invested mre than $1billin ver five-years t prvide universal access t the new DAAs 2. The prvisin f universal access, cmbined with the Sectin 85 PBS listing (allwing nn-specialist prescribing), prvides the fundatin fr the eliminatin f hepatitis C as a public health cncern in accrdance with the Natinal Hepatitis C Strategy and 2030 glbal eliminatin targets. It is imprtant t nte that the supply deal negtiated with the pharmaceutical cmpanies caps the annual Gvernment expenditure each year regardless f the number f peple treated within that year. Treat mre peple each year, and the cst f treatment is reduced. Fail t either meet r exceed thse caps and Gvernment is paying a much higher price fr these medicines, and will cntinue t d s. Current Patterns f Treatment Uptake There was an initial rapid uptake in the new DAA hepatitis C treatments which exceeded all expectatins, and reflected the large number f peple wh were ready and waiting fr the new treatments when they were listed n the PBS. Analysis f data by the Kirby Institute in the fllwing graph cmpares the ld interfern-based treatment uptake t the new interfern-free (DAA) treatment uptake. With DAA cure rates f arund 95%, it is estimated that mre than 30,000 peple were cured f hepatitis C in Ibid. Page 6 f 16

7 Mnth by mnth breakdwns f the data shw that initiatins n hepatitis C treatment ran at 3,000-5,000 per mnth fr the first six mnths fllwing the PBS listing. Hwever, by 2017 it had mre than halved, running at little mre than 1,500 peple per mnth with dips ver hliday perids. Page 7 f 16

8 A hepatitis C mapping prject funded by the Australian Gvernment is currently being undertaken by the Dherty Institute in Melburne. The prject will prvide detailed infrmatin n treatment uptake by Primary Health Netwrk (PHN) and prvider type (specialist, GP r ther health care prfessinal). It is expected that the prject reprt will be released by early The reprt will incrprate infrmatin n the burden f chrnic hepatitis C within individual PHNs and review hw they are each perfrming in terms f hepatitis C treatment uptake against ther PHNs and a natinal average. Initial analysis suggests there is a wide variatin between PHNs, and the reprt will therefre be very useful in infrming individual PHNs f their pririty fr actin n hepatitis C treatment. The reprt will als assist in targeting Hepatitis Australia s prpsed cmmunity awareness and supprt effrts, t facilitate imprved testing and uptake f hepatitis C treatment, thereby cntributing t imprving the value f the Gvernment s investment. Predicting Future Treatment Uptake Mathematical mdelling has been undertaken by the Plaris Observatry 3 and validated by Australian experts t predict future trends in treatment uptake. Cuntries withut specific strategies in place t maintain high treatment rates have generally fllwed a pattern f high initial treatment uptake fllwed by a significant drp ff. This leads t a lnger perid f lwer treatment uptake befre eventually reaching eliminatin targets. Australia s treatment rate currently reflects treatment numbers nt much abve the rate f new ntificatins, and is nt adequately addressing the significant numbers in ur cmmunity living with established chrnic infectins, r substantially reducing the risk f reinfectins and new infectins. It can be seen frm Plaris Observatry mdelling belw, validated by Australian experts, that a similar pattern is predicted fr Australia (pale blue line). This predicts a lng perid f lw treatment uptake at arund 14,000 p.a. with eliminatin nt achieved until at least Plaris Observatry CDA Fundatin 3 Page 8 f 16

9 The Kirby Institute has undertaken mdelling wrk t examine the relatinship between treatment scale up at a lw, mderate and high rate and the expected impact n the timeline t eliminatin and achievement f health benefits. As expected, the mdelling demnstrates that a high annual treatment uptake (32,000 p.a. - purple line) prduces a much quicker reductin in new cases f hepatitis C infectin, rapid declines in the number f peple develping hepatcellular cancer (HCC) r dying frm cmplicatins f hepatitis C infectin with the eliminatin f hepatitis C achieved by In cmparisn, the Kirby mdelling scenari f a lw annual treatment uptake (13,890 p.a. - blue line), which matches the Plaris Observatry s predictin fr Australia, results in many mre avidable cases f liver cancer and deaths and pushes eliminatin ut by at least anther decade, well beynd All experts agree that the next few years are abslutely crucial t addressing the hepatitis C epidemic in Australia. It is imperative that high annual treatment rates are re-established t shrten the timeline t eliminatin and maximise the health benefits. Page 9 f 16

10 Ecnmic Ratinale fr Scaling Up HCV Treatment The scaling up f hepatitis C treatment ver the remaining three years f the five-year supply deal with pharmaceutical cmpanies ffers significant ecnmic benefits in the medium-term, withut any additinal PBS csts in the shrt-term. Essentially, the mre peple that achieve a cure under the current five-year supply deal the better. Bsting hepatitis C treatment uptake nw imprves the cst-effectiveness f the current PBS listing and results in a lwer verall cst because the Australian Gvernment has capped their annual expenditure ver the five-year term f the supply deal with pharmaceutical cmpanies. 4 Acknwledging the knwn financial pressures n the PBS in future years, supprt t scale up treatment nw als ffers the Australian Gvernment a significant pprtunity t maximise their return n the $1billin investment t 2021 as well as delivering additinal flw n benefits f reduced PBS csts in future ut years, nt t mentin reducing dwnstream csts assciated with treatment f avidable chrnic liver disease and cancer. A strng and sustained push t substantially scale up f treatment ver the next 3 years is essential t reduce demand fr treatment after 2021, when the supply deal ends. A sharp reductin in the prevalent ppulatin f peple living with hepatitis C wuld als enable a treatment as preventin f transmissin threshld t be reached at which pint the risk f new infectins ccurring is reduced. In cntrast, the mdelling data demnstrates that a d nthing apprach is likely t result in arund 14,000 peple requiring treatment ver each f the next furteen years resulting in a cntinuus PBS utlay f arund $300 millin per annum. Australia is in the unique psitin f having the tls and systems in place t bst hepatitis C treatment ver the next three years withut adding t the PBS csts. The nly cst t Gvernment is the investment in initiatives t scale up treatment nw. The cst f this prpsal is $75 millin ver 3 years. This is ntinally equivalent t 3,750 treatments at the market rate f $20,000. Essentially, if 3,750 additinal treatments are delivered prir t 2021 as a result f the requested $75millin investment, the Gvernment will break even. Any increase in treatments abve the 3,750 threshld will avert the need t pay fr these treatments after 2021, utside f the current supply deal with pharmaceutical cmpanies, and results in cnsiderable PBS savings. This submissin therefre ffers a very lw risk but high impact prpsal t significantly scale up hepatitis C treatment, maximise the value f tax-payers existing investment, reduce the future csts f hepatitis C treatment t the PBS beynd 2021 and deliver significant health benefits t arund 1 in every 100 Australians therapies may nt even be in the tp mediarel yr2016 ley014.htm Page 10 f 16

11 Fcus fr Actin The key t scaling up treatment lies in enhancing the engagement f primary care services in hepatitis C testing and treatment t fully leverage the advantages f the Sectin 85 PBS listing. Unlike previus treatments, the new DAAs can be safely delivered in primary care. Rutine hepatitis C treatment shuld therefre nw be undertaken by nn-specialist health practitiners and be firmly embedded as a key rle fr general practitiners as this is where the greatest gains can be achieved. The fall in specialist prescribing is starkly represented in the graph belw. Thse peple wh were being mnitred in liver clinics while waiting fr the new treatments t becme available were treated during The demand fr treatment f peple with hepatitis C in specialist liver clinics is nw lw, hwever the reductin in specialist prescribing has nt been cunterbalanced by an equivalent rise in GP prescribing and this is the crux f the current prblem. The rle fr hspital-based specialists has changed with the new DAAs. Their rle is nw largely cnfined t management f a much smaller number f peple with hepatitis C wh have mre advanced liver disease, cmplex c-infectins and cmrbidities, as well as fllw up f peple nt cured fllwing a curse f DAA treatment. Treatment fr the vast majrity f peple with hepatitis C can be safely managed by GPs. The prblem being that many thusands have nt yet cme frward fr treatment, s finding these missing thusands and cnnecting them t care is therefre critical t the scale up f treatment. Page 11 f 16

12 At the heart f high perfrming primary healthcare systems are well infrmed cnsumers wh can access highly skilled primary health care prviders. With this in mind, there are three specific areas fr natinal investment t assist the scale up f hepatitis C treatment: 1. Initiatives t help embed hepatitis C testing and treatment as a central rle fr general practitiners, nurses, allied health practitiners and pharmacists wrking in primary care, supprted by their Primary Health Netwrks 2. Innvative digital health initiatives t imprve ease f access t hepatitis C testing and treatment particularly in reginal, rural and remte areas 3. Targeted cmmunity awareness and supprt initiatives fr peple at risk f hepatitis C, r living with hepatitis C, t help cnnect them t testing and treatment services. Embedding Treatment in Primary Care Settings Funding request - $25millin ver 3 years frm 2018 Imprving the rates f hepatitis C diagnsis and initiatin f treatment in primary care needs t be a key public health perfrmance indicatr fr Australia t achieve eliminatin f this chrnic disease by It is exceedingly rare t be handed the pprtunity t eliminate any infectius disease and this pprtunity must nt be wasted. Hw the key perfrmance indicatrs are best set, targeted and achieved, must be determined in partnership with primary care health prfessinals that have the capacity t identify peple living with hepatitis C in their care, and deliver the required services t address their unmet clinical needs. Hepatitis Australia recmmends the Gvernment engages with Primary Health Netwrks and prfessinal bdies including the Ryal Australian Cllege f General Practice (RACGP), the Australian Practice Nurses Assciatin (APNA) and the Australian Medical Assciatin (AMA) t assess what types f initiatives are needed t firmly embed hepatitis C management in primary care. Types f initiatives that might be cnsidered include: Inclusin f hepatitis C key perfrmance indicatrs (KPIs) in gvernment funding agreements fr Primary Health Netwrks. Develpment f guidelines n hepatitis C early detectin and management in primary care t prevent prgressive liver disease, liver cancer and avidable deaths. The guidelines culd be included in the RACGP s preventive activities in general practice (Redbk). Develpment f a range f educatinal pprtunities fr GPs t assist in cmmunicatin with, and management f, their patients with hepatitis C. Develpment f decisin supprt systems t supprt best-practice management. Streamlining f the systems fr remte specialist cnsultatin. Cnsideratin f practice incentives t supprt early detectin and treatment f hepatitis C. Page 12 f 16

13 Review the rle primary care nurses culd play in supprting treatment uptake, fr example in patient identificatin, testing and pst-treatment fllws up. Placement f clinical pharmacists in key Primary Health Netwrks r GP clinics t supprt medicatin management fr patients underging treatment. Practive reviews f patient recrds t identify patients living with, r at risk f hepatitis C fr fllw up. The Dherty Institute wrk n the hepatitis C mapping prject, funded by the Australian Gvernment will prvide detailed infrmatin n treatment uptake by Primary Health Netwrk (PHN), and will incrprate infrmatin n the burden f chrnic hepatitis C within individual PHNs and review hw they are each perfrming against ther PHNs and a natinal average. Initial analysis suggests there is a wide variatin in treatment uptake between PHNs, and the reprt can therefre be used t ensure maximum impact in atrisk and untreated hepatitis C ppulatins. Innvative Digital Health Slutins Funding request - $25millin ver 3 years frm 2018 Digital health slutins are required t supprt the delivery f hepatitis C cures t all Australians in need regardless f where they live, nting that the gegraphical tyranny f distance can be a significant barrier t evidence-based care. Supprting GPs in reginal, rural and remte areas in the prvisin f diagnsis, treatment and management will be essential t achieve universal access t hepatitis C treatments prvided thrugh the PBS. Hepatitis Australia recmmends that innvative ehealth slutins are reviewed and supprted in cnjunctin with primary care practitiners t imprve access t essential hepatitis C care. One such initiative which is shwing great prmise is an e-health mdel f care t supprt primary care delivery f hepatitis C treatment HealthELink 6. This prduct was recently recgnised in the Access categry f the Australian Digital Health Awards 7 as the best digital slutin helping underserved scial and ecnmic grups and remte/rural cmmunities. The further develpment f the prduct is being supprted by DB Results. Hepatitis Australia has had the pprtunity t review this prduct and believes it is a high quality prduct with cnsiderable ptential t supprt the rllut f hepatitis C treatment in primary care. It is currently in a trial phase with plans t expand t crrectins settings in Nrthern Territry and Suth Australia. While the trial is fcused n hepatitis C, it als has ptential t be used acrss a range f disease areas, including hepatitis B Page 13 f 16

14 Imprving Cmmunity Awareness and Supprt Funding request - $25millin ver 3 years frm 2018 Unlike HIV, there has never been a cmprehensive natinal cmmunicatin campaign t raise awareness f hepatitis C. As a cnsequence, cmmunity knwledge and understanding f the transmissin risks, health impacts and the treatments available remains subptimal and des nt supprt decisin-making fr the best health utcmes. Any cmmunicatins campaign needs t be well targeted and resnate with the target audience fr best effect. The Natinal Hepatitis C Mapping Prject due t be released by the Dherty Institute will help infrm the gegraphical pririties fr rllut f a natinally crdinated cmmunity-based cmmunicatins campaign. This apprach will ensure funds are well targeted t achieve the maximum impact by fcusing n the areas f greatest need. Natinal crdinatin will be essential t ensure primary care prviders are well prepared t receive and manage existing and new patients driven t them thrugh the cmmunicatins campaign. Apprximately tw-thirds t three-quarters f thse living with hepatitis C n lnger inject drugs 8 and cnsequently cannt be reached thrugh harm reductin r drug treatment services. Fr varius reasns, many peple with a past histry f injecting drug use either d nt have a regular GP, r d nt disclse their past histry f injecting t their regular GP ften due t past experiences f stigma and discriminatin, and as a result they are nt being actively fllwed up t manage their hepatitis C infectin. Reaching the peple wh are either nt yet diagnsed r nt cnnected t care fr their hepatitis C infectin is vital t increase treatment uptake. Recent wrk undertaken by Hepatitis Australia will help infrm a cmmunicatins campaign t find the missing tens f thusands f peple wh are nt cnnected t care and nt cming frward fr hepatitis C treatment. The first part f Hepatitis Australia s Reaching Out Reprt 9 reveals the incredible diversity f this target ppulatin spanning a whle range f subppulatins including: substantial numbers f baby bmers wh injected drugs in their yuth but n lnger d s, peple in Abriginal and Trres Strait Islander cmmunities, peple brn in regins with a higher burden f hepatitis C, and a range f ther individuals and smaller grups nt receiving clinical care fr their hepatitis C. In Australia, the transmissin f hepatitis C ccurs predminantly amng peple wh currently inject drugs and it can ften be assumed that all cmmunicatins need t speak t this grup f peple. Hwever, as a high prprtin f peple wh wuld benefit frm hepatitis C treatment are nt peple wh currently inject, mre tailred cmmunicatins are required t link them t care. Building n the infrmatin elicited in the first part f the Reaching Out Reprt, the secnd part f the Reprt seeks t infrm and enhance the effectiveness f cmmunicatin and engagement effrts t cnnect peple t clinical care Page 14 f 16

15 The Reaching Out Reprt 10 was develped fllwing extensive cnsultatin with key stakehlders and relevant experts. It develps primary messages based n a Test, Cure, Live cncept, and recmmends supprting messages and strategies fr engagement. The use f imagery and channels f cmmunicatin are cnsidered, as well as specific recmmendatins fr a number f diverse language and cultural ppulatins. Flwing frm this reprt, we have since develped a Test, Cure, Live cmmunicatins framewrk and website. Pilt testing f cmmunicatin strategies is underway fcusing n sme f the sub-ppulatins which will cntinue thrugh t June Investment fr a natinal rllut f this well researched, evidence-based and pilt tested cmmunity awareness campaign has the ptential t reach many f the tens f thusands f Australians wh have nt yet cme frward fr treatment and cannt be easily reached thrugh ther avenues. The cnsiderable cllective skills and expertise f the cmmunity-based hepatitis rganisatins will cntinue t shape this campaign t ensure it resnates with the target audiences and cntributes t the scale up f treatment rates. Part f this investment will als allw Hepatitis Australia t take a leadership rle in cmbinatin with its state and territry membership t target imprvements in the diagnsis and treatment rates in Australia s prisns. The Turnbull Gvernment tk a practive stance t supprt access t these treatments in this setting by ensuring they can be prescribed under sectin 100 arrangements. Hepatitis Australia and its members want t maximise that investment by wrking with state and territry gvernments and key stakehlders t imprve the diagnsis and uptake f treatment in custdial settings a state and territry respnsibility. Hepatitis Australia acknwledges this is nt a federal respnsibility, but is seeking t use a small cmpnent f the cmmunicatin and access strategy funds fr the crdinatin f a practice imprvement grup s that the high value health utcmes and cst benefits f these treatments are realised by the federal gvernment. Every patient treated during these next three years imprves the cst-effectiveness f these listings regardless f the setting fr treatment. Specifically, Hepatitis Australia wuld cnvene a practice imprvement grup in partnership with the currently unfunded Natinal Prisns Hepatitis Netwrk t lead imprvements t the treatment pathways and prcesses fr this ppulatin. The bjective is t cllabrate in building rbust wrkable slutins t scaling up hepatitis C treatment in prisn settings, supprt best practice acrss the cntinuum f care including transitin and pst-release care t maximise health benefits and reduce risks f re-infectin Page 15 f 16

16 Cnclusin The Australian gvernment has a unique pprtunity t supprt the significant scale up f hepatitis C treatment thrugh investment in: Initiatives t embed hepatitis C testing and treatment as a central rle fr general practice supprted by Primary Health Netwrks Innvative digital health slutins t imprve ease f access t hepatitis C testing and treatment particularly in reginal, rural and remte areas Targeted cmmunity awareness and supprt initiatives fr peple at risk f hepatitis C, r living with hepatitis C, t help cnnect them t testing and treatment services $25 millin ver 3 years $25 millin ver 3 years $25 millin ver 3 years While this verall $75 millin funding request may appear large, nly 3,750 additinal treatments need t be initiated prir t 2021 as a result f this investment fr the Gvernment t break even. Any increase in treatment rates beynd 3,750 will translate t medium-term reductins in the required PBS investment in hepatitis C treatments beynd 2021 (when the current supply deal with pharmaceutical cmpanies ends). In summary, there is n ecnmic dwnside t this investment in the shrt-term and substantial health and ecnmic gains that can be readily realised in the medium-term. Hepatitis Australia has liaised with the each f the majr interested parties mentined in the submissin, including the Ryal Australian Cllege f General Practice (RACGP), the Australian Practice Nurses Assciatin (APNA), the Australian Medical Assciatin (AMA) and HealthELink. Initial respnses have been very psitive in their supprt f this submissin and we lk frward t future cllabratins t achieve the eliminatin f hepatitis C as a public health threat in Australia. Page 16 f 16

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