Universal Medicine Access through Lump-Sum Remuneration — Australia’s Approach to Hepatitis C

Moon, Suerie; Erickson, Elise N.

doi:10.1056/nejmp1813728

Cited by 52 publications

(41 citation statements)

References 2 publications

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“…( 10 ) In March 2016, Australia became the first country to offer universal access of DAAs to all persons infected with HCV, with no restrictions for fibrosis stage or high‐risk behaviors. The Australian Government negotiated a unique volume‐based agreement for unlimited access to HCV drugs, ( 11 ) the so‐called “Netflix Model.” ( 12 ) Prescribing by community health care providers was encouraged to facilitate treatment scale‐up and provide access for marginalized populations. These open access models are essential to achieve HCV elimination but at the same time increase the likelihood of poor adherence among patient groups who are usually excluded from clinical trials, including those from drug and alcohol and opioid substitution therapy settings.…”

mentioning

confidence: 99%

Impact of an Open Access Nationwide Treatment Model on Hepatitis C Virus Antiviral Drug Resistance

et al. 2020

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Direct acting antivirals (DAAs) have revolutionized hepatitis C virus (HCV) treatment, but drug resistance could undermine proposed global elimination targets. Real-world studies are needed to inform the impact of widespread DAA treatment on antiviral resistance in the community. The prevalence and range of posttreatment resistance-associated substitutions (RASs) was determined in Australian patients with open access to DAAs through a wide range of prescribers. NS3, NS5A, and NS5B regions were amplified by polymerase chain reaction and analyzed by population sequencing. Clinically relevant RASs were identified using online databases (ReCALL and Geno2Pheno[hcv]). Of 572 samples, 60% were from genotype 3 and 27% from genotype 1a. Ninety-two percent of people failed a DAA regimen containing an NS5A inhibitor, including 10% with a pangenotype regimen. NS5A RASs were detected in 72% of people with genotype 1 and 80% with genotype 3. For genotype 1, there was a range of RASs across the NS5A region, while for genotype 3, the Y93H RAS predominated (72%). The prevalence of NS3 RASs was higher in people exposed to an NS3 inhibitor (35% vs. 3.9%; P < 0.0001). NS5B resistance was rare, with a single case of sofosbuvir resistance. Multiclass drug resistance was found in 33% of people exposed to both NS3 and NS5A inhibitors. Conclusion: The high prevalence of NS5A RASs among people failing DAA therapy reinforces the importance of specific retreatment regimens, ideally guided by resistance testing. The impact of multiclass drug resistance on retreatment in people exposed to both NS3 and NS5A inhibitors needs to be assessed in real-world studies. Surveillance for increasing antiviral resistance during treatment scale-up is essential to maintain the efficacy of current DAA regimens. (Hepatology Communications 2020;4:904-915).

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mentioning

confidence: 99%

Impact of an Open Access Nationwide Treatment Model on Hepatitis C Virus Antiviral Drug Resistance

et al. 2020

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“…A similar model in Australia showed that providing unrestricted access to antivirals for hepatitis C at a cost of US$766 million over 5 years produced estimated savings of US$4.9 billion to the Australian government compared to conventional per-unit pricing. 19 Applying the subscription model at the state level in the United States would allow policymakers to pursue hepatitis C elimination without jeopardizing other public health priorities. For clinicians like Dr X, removing the financial barrier to treatment would allow him to make recommendations based solely on his clinical judgment and what's best for patients like Mr R.…”

Section: The Subscription Modelmentioning

confidence: 99%

How Should Physicians Steward Limited Resources While Ensuring That Patients Can Access Needed Medicines?

Croughan¹,

Gee²

2019

AMA Journal of Ethics

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Hepatitis C poses public health and fiscal crises for state Medicaid programs trying to respond to this epidemic. Meager funding streams, a lack of negotiating power, and escalating pharmaceutical prices exacerbate the financial strain placed on these programs as they struggle to meet public health priorities. The Louisiana Department of Health has adopted a subscription model for hepatitis C treatment, but costly medications continue to challenge states' capacities to cover patients who need costly drugs. Case Dr X serves as chief medical officer for the state Department of Health and sees patients at a local federally qualified health center. Recently, an exciting, expensive new drug was released, which cures all strains of hepatitis C. The state Department of Health approaches Dr X to help draw up Medicaid access guidelines for this new drug, citing that the state cannot afford to cover this drug for all patients with hepatitis C. The Secretary of the Department of Health asks Dr X to define clinical criteria, such as liver fibrosis stage or substance use status, to help prioritize which patients should have access to the drug under Medicaid. Dr X understands the reality of the state's financial restrictions and agrees to offer a prioritized list of clinical criteria. Later that week, upon examining the health record of a patient, Mr R, Dr X notices that Mr R has a prior hepatitis C diagnosis. A note in the record suggests that Mr R wasn't approved by Medicaid to receive therapy for hepatitis C because of his continued substance abuse. Mr R has gone through multiple substance abuse treatments in the past and has relapsed back into self-abusive behaviors soon after each treatment. Dr X also notices that Mr R is jaundiced, however, and remains concerned that Mr R has advanced liver damage. Dr X sends Mr R for liver function testing, fearing that Mr R will not qualify for a liver transplant if his test results show poor function. If that's the case, a pharmaceutical agent might be Mr R's best hope for treatment. Dr X wonders how to balance the need for population-level guidelines about access against interests of individual patients like Mr R.

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“…A subscription-based model, known as "the Netflix model," is a novel drug acquisition alternative that would make DAA access more affordable [13]. This has been tested on the country (Australia [14]) and US state level. In January 2019, Louisiana announced that Gilead, manufacturer of HCV drugs such as ledipasvir/sofosbuvir, velpatasvir/sofosbuvir, and sofosbuvir/velpatasvir/voxilaprevir, will supply the state with unrestricted access to DAAs for five years at a flat rate [15].…”

Section: Novel Strategies To Lower Costmentioning

confidence: 99%

“…This model was first tested at the national level in 2015 in Australia, where the government chose to pay a flat rate for unrestricted access to DAAs for five years [14]. One cost analysis of their program reports that the government will have saved AU$6.42 billion (US $4.92 billion) by the end of the fifth year when compared to traditional DAA pricing [14]. These findings not only show the economic favorability of such a model, but also demonstrate the logistical viability of its implementation at the national scale.…”

Section: Novel Strategies To Lower Costmentioning

confidence: 99%

Hepatitis C Behind and Beyond Bars

Ocal

Muir

Naggie

2019

North Carolina Medical Journal

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Universal Medicine Access through Lump-Sum Remuneration — Australia’s Approach to Hepatitis C

Cited by 52 publications

References 2 publications

Impact of an Open Access Nationwide Treatment Model on Hepatitis C Virus Antiviral Drug Resistance

Impact of an Open Access Nationwide Treatment Model on Hepatitis C Virus Antiviral Drug Resistance

How Should Physicians Steward Limited Resources While Ensuring That Patients Can Access Needed Medicines?

Hepatitis C Behind and Beyond Bars

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