Lessons from ATRAS
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A report on findings from the AHOD Temporary Resident Access Study, which looked at access to HIV treatments for people not eligible for Medicare. This presentation was given at the AFAO Community Hub at the ASHM 2015 conference.
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Lessons from ATRAS
- 1. Lessons from ATRAS AFAO Hub: ASHM Aaron Cogle 17 September 2015
- 2. A AHOD T Temporary R Residents A Access S Study
- 3. ‘Medicare Ineligible’ • In Australia legally • No Access to PBS subsidised ARVs • Only 60% of HIV+ people who need treatment were getting it (before ATRAS) • 31% were on sub-optimal combinations (before ATRAS) • Existing provisions for this group vary across jurisdictions
- 4. Aims • To describe the population of HIV+ temporary residents • To describe the HIV disease status of this group • To model HIV transmission rates • To provide compassionate ARV access for up to 4 years (ends Nov 2015)
- 5. The Sample • Recruited 180 people from 21 sites • 74% male, 26% female • 46% SE Asia, 19% SS Africa, 11% S America, 11% S Pacific, 9% Europe, 6% N America • 31% Student visa, 33% Working visa, 14% Bridging visa, 13% Spousal Visa, 13% other visa • Route of transmission; 49% MSM, 39% Heterosexual contact, 12% Other
- 6. HIV Characteristics at Enrolment • The average CD4 cell count was 376 cells • 63% of recruits were receiving ART • Only 47% had an UDVL • 46% of those on treatment changed their regimen after enrolment into ATRAS
- 7. Changes in CD4 count Baseline Month 12 Month 24 No. Mean SD No. Mean SD No. Mean SD Total 161 376 227 151 475 198 106 534 235 Female 42 350 187 37 444 190 22 524 188 Male 119 385 239 114 485 201 84 536 247 Bridging 24 436 273 24 532 216 21 554 242 Other 21 357 296 15 430 191 11 465 157 Spouse 13 391 193 12 432 184 4 435 259 Student 56 328 162 56 479 195 42 511 182 Working 47 405 238 44 464 199 28 593 311 Asia/SE Asia 76 341 214 73 458 198 56 508 208 Europe 14 422 247 13 541 234 10 702 434 North America 9 526 318 7 449 160 5 506 254 South America 18 371 149 18 556 201 13 629 197 South Pacific 14 437 164 15 512 148 9 488 88 Sub-Saharan Africa 30 371 268 25 414 199 13 461 187
- 8. Changes in UDVL Baseline Month 12 Month 24 N % N % N % Total 76 47.2 126 88.7 99 94.3 Female 21 50.0 28 80.0 21 100.0 Male 55 46.2 98 91.6 78 92.9 Asia/SE Asia 32 42.7 63 91.3 52 94.5 Europe 7 50.0 12 100.0 11 100.0 North America 5 55.6 4 57.1 4 80.0 South America 5 27.8 16 100.0 12 92.3 South Pacific 8 57.1 10 76.9 8 100.0 Sub-Saharan Africa 19 61.3 21 84.0 12 92.3 Bridging 14 58.3 22 91.7 20 95.2 Other 12 60.0 13 81.3 11 100.0 Spouse 6 40.0 10 83.3 3 75.0 Student 21 38.9 45 93.8 38 95.0 Working 23 47.9 36 85.7 27 93.1
- 9. HIV transmission 53% detectable at baseline After 12 months (12% detectable) • 77.4% reduction in detectable viral load and who have a substantial risk of onward transmission After 24 months (6% detectable) • 93% reduction in the risk of onwards transmission
- 10. Transition to Medicare Eligibility • At July 2013 – 39 patients had left ATRAS • At July 2014 – 79 patients had left ATRAS • By November 2015 – 110 (estimated) patients will have left ATRAS Nearly two thirds of people return to C.O.O. or become eligible within 4 years.
- 11. Modelling • Estimated 450 Medicare Ineligible people in Australia at any time. • Treatment cost estimated at $29,642,230 • Potential to avert a median 81 new infections over 5 years. • Equivalent to a cost saving of $26,354,092 ($69,412,098 lifetime cost) Broadly cost-neutral
- 12. Lessons • Providing access to ARVs to PLHIV yields better health outcomes and a reduction in the risk of onward transmission • Treating Medicare Ineligible people is cost neutral over 5 years • Two thirds of Medicare ineligible become eligible within 2 years. • We can avert 81 new infections over 5 years. • Consistent with commitments in national strategy, legacy statement etc.
- 13. Gaps in the response • Medicare ineligible people are not recognised as a priority population by the national strategy • ‘Measured progress’ is not ‘actual progress’ • Federation vs State
- 14. Future ATRAS ends in November 2015: 70 people still on study Working with states to provide ongoing access for study participants Further reports imminent More advocacy
Notas del editor
- Today I have been asked to talk about the ATRAS study and what lessons have come out of it. ATRAS is a joint project of NAPWHA and The Kirby Institute and is supported by the seven pharmaceutical companies who provide HIV antiretroviral drugs in Australia and the Australian HIV Observational Database (AHOD) clinical sites. It’s designed to help us get a better understanding of ARV treatment and access for people who are HIV positive but Ineligible for Medicare in Australia. Before we get started;
- ATRAS stands for the AHOD Temporary Resident Access Study and And AHOD, in case anyone doesn’t know, is the Australian HIV Observational Database.
- Medicare Ineligible people are those people that are in Australia, perfectly legally, on various temporary student, business or employer sponsored visas that do not allow access to Australia’s Medicare scheme. This means no access to subsidised drugs through the PBS. So for HIV positive people who are Medicare ineligible that means; Delaying treatment commencement or stopping treatment Accessing medication through studies or compassionate access schemes where possible Accessing treatments from their country of origin OR paying the full unsubsidised price in Australia BUT obtaining ARVs from overseas can be problematic in terms of availability, supply reliability and drug quality. Cost estimates put the unsubsidised cost of a first line regimen like Atripla at $12,438 per year so it is prohibitive for most. In every State and Territory which has Medicare Ineligible residents there are now mechanisms for ARV access. However we haven’t quite solved the problem just yet because some of these mechanisms are still quite complex. This means patients have to be persistent and empowered to navigate them, and that’s not always the case. Also, clinical health professionals, and community organisations, still need to devote significant resources to assisting people onto trials or compassionate access schemes - which isn’t an optimal use of time. Before ATRAS only an estimated 60% of Medicare Ineligible people who needed treatment were getting in 2007. Around 31% them were receiving sub-optimal treatment because that is what was available.
- The ATRAS study was established to describe this population of HIV positive temporary residents To understand the disease status of that group To model transmission rates. And it was also a mechanism by which we could supply appropriate ARV access for up to four years - to a population that needed it.
- Between November 2011 and June 2012 we recruited 180 people from 21 AHOD sites – most came from Sexual Health Clinics (46%), then General Practices (27%), then Tertiary Referral Centres (27%). 74% were male, 26% Female Most came from SE Asia (46%), then Sub-Saharan Africa (19%), then South America and the Pacific (11%), Europe (9%) and North America (6%). The most common visas were student visas (31%) and working visas (33%), then Bridging visas (14%), Spousal Visas (13%) and other visas (13%). The most common mode of transmission was sex between men, then heterosexual sex then other. Less than 2% reported Injecting Drug Use as a mode of transmission.
- The median CD4 cell count at enrolment was 376 cells per microliter of blood. There were discrepancies for lower CD cell counts related to country of origin, with people from lower income countries having generally lower CD4 counts. 63% of recruits were on treatment with most accessing their treatment from overseas (47%), Australian compassionate access programs (22%), Australian clinical trials (11%), 18% not reported. Only 47% had an UDVL 46% changed their regimen once they enrolled because they were not on regimens consistent with those recommended under Australian ARV treatment guidelines.
- So, here are the results; There were positive changes in CD4 cell count after one year of treatment and then again after 2 years. There were improvements in all categories; across gender, visa status and region of origin. The average CD4 cell count increased from 376 at baseline to 475 after one year and then to 534 after two years.
- The proportion of people with an undetectable viral load also increased from 47% at baseline to 89% after one year and 94% after two. Again there were increases observed in most of the sub-categories as well.
- So, just to emphasise that point; From 53% detectable at baseline there was a 77.4% reduction in detectable viral load after 12 months and a 93% reduction in detectable viral load after 24 months. With a corresponding reduction in the risk of onward transmission. (This is exactly what the target in strategy is saying we should do)
- Also important to note is that a substantial percentage of people who are Medicare ineligible either return to their country of origin or they transition to a Visa which allows Medicare access… and this happens relatively quickly. At July 2013 39 patients were no longer receiving ART from ATRAS. 4 of those had left the country and 2 were lost to follow up so 33 of those had transitioned to Medicare Eligibility. By July 2014 79 patients were no longer receiving treatment - And by November 2015 we predict that there will only be about 70 people left on the study. That means nearly two thirds of people either transition to Medicare Eligibility or return to their country of origin within four years. That has a couple of implications that I think are worth mentioning; First it means that supplying cost free drug to this group is not a lifelong financial burden that Medicare must shoulder – rather, it is capped to a relatively small group of people for a limited time. AND secondly it means that complications caused by delays in treatment commencement, treatment cessation or sub-optimal treatment combinations will, in the most part, end up having to be resolved by the Medicare system in the end. Early treatment of this group therefore holds the potential for cost savings in the long run.
- As part of the most recent report there was also a number of pieces of modelling undertaken. We undertook two surveys one in July 2013 and again in October 2014 and we established that at any one time there are about 450 Medicare ineligible people living in Australia. It was calculated that providing treatment for that group would cost about $29 million over 5 years with the potential to avert 81 new infections over that same period. Avoiding these new infections 81 would mean a cost saving of about $26 million over five years, with further savings after that. So, what ATRAS has established is that providing free access to ARV’s for Medicare Ineligible HIV positive people is broadly cost neural over five years AND there are additional cost savings over that period.
- So, what did we learn? Providing ARV’s to PLHIV makes them healthier. Treating Medicare Ineligible people is cost neutral over 5 years Two thirds of Medicare ineligible become eligible within 2 years. We can avert 81 new infections over 5 years. Consistent with commitments in national strategy, legacy statement etc. Treating this group is a public health intervention.
- These are what I see are the remaining Gaps in the response; Medicare Ineligible people are not recognised as a priority population by the national strategy. This means that Without an understanding that they form part of the other identified priority populations; we could conceivably fully acquit the requirements of the strategy without ever addressing the needs of medicare ineligible people. Further, For the first time ever the National Strategy contains targets. BUT By their nature, targets represent only narrow aspects of what are in reality complex systems. This representative deficit has the potential to distort priorities because ‘measured improvements’ are prioritised by service providers over ‘actual improvements’. So because Medicare Ineligible people aren’t addressed directly by the strategy and because the way we measure prioritises things that are easy to measure, Medicare ineligible people become invisible. Our challenge is to ensure that the way we implement the Strategy recognises the diversity and breadth of the entire PLHIV population in Australia, regardless of visa status. Australia is a federation and this comes with a certain dynamic. Whether it’s hospitals, the GST, Medicare ineligibles OR any number of other COAG related issues the situation is the same. The Commonwealth pushes costs to the states and the states push costs back to the commonwealth. We have to recognise that this is a public health vulnerability because HIV is not a constitutional expert. If we leave a gap in the public health response it has the potential to become our Achilles heel.
- The ATRAS study officially ends in November this year. We have agreement from the States and Territories that existing study participants will be able to continue to access ARV’s, after November, through existing mechanisms at the State or Territory level. AND we are working with the State and Territory Health Representatives that sit on BBVSS to try to ensure a smooth transition to the new systems. There will be at least one further ATRAS report that will follow health outcomes for the 70 remaining patients. And of course, there will be Further advocacy around improving access to ARVs for Medicare Ineligible people who currently are in Australia but not on the study.