In current clinical practice, an accurate assessment of hepatic fibrosis is a vital factor for the initiation of Hepatitis C virus (HCV) treatment strategies using direct acting antivirals (DAAs). Typically, patients who are diagnosed with severe fibrosis (>F3) are covered by most payers (both public and private), while patients that exhibit little or no fibrosis are advised to defer DAA treatment and elect for a “watchful waiting” regimen. However, recent evidence suggests that beginning treatment at a METAVIR score of F2 or lower could help reduce overall DAA costs and improve treatment outcomes, as measured by sustained virologic response (SVR).
In a December 2016 study by Bach and Zaiken[i], the authors present the first real-world data for DAA treatment costs for patients, including for patients cohorts below or above a METAVIR score of F2. Previously, the only studies that had considered the implications of starting treatment below F3 were simulations using projected medical costs and outcomes.
After analyzing data from 332 patients from 2011-2015, the study finds that the average DAA cost per SVR was $155,662 for all patients (across 36 clinical sites in Massachusetts). However, when patients began a DAA regime while their METAVIR score was F0-F2, their cost per SVR was $122,452, compared to $178,401 per SVR response when patients began treatment with a METAVIR score of F3-F4 – a difference of $55,949 per patient per treatment strategy.
In addition, outcomes were notably higher for the F0-F2 group than the F3-F4 group. For all patients, SVR was achieved in 83.5% (269/322) of all patients. However, that number rose to an impressive 92.2% (107/116) for patients that initiated treatment at F0-F2, while it dropped to just 78.6% (162/206) for patients with fibrosis scores of F3-F4.
The figures from Massachusetts are striking, as they represent the embodiment of value-based medicine: better outcomes at a lower cost. Moreover, they demonstrate how a highly accurate diagnosis (at fibrosis levels <F2) can yield significant gains, both in terms of quality of life and systemic value. To this end, it may be worth consideration of the value of
earlier treatment strategies that can be enabled through the use of more robust diagnostic technologies, including transient elastography and advanced imaging technologies such as MRE.
While the study here only looked at patient-level costs, it’s worth keeping in mind that the systemic savings could be massive on a population level. Modeling off of the Bach and Zaiken data, a $55,949 reduction in per patient DAA costs (by initiating treatment with fibrosis levels of F0-F2) would yield approximately $51.9 billion in total costs for every one million patients treated.[ii]
Additionally, because the treatment options after a failed DAA regime are costly (switching to a different DAA class, lengthening treatment course, or adding Ribovin), the systemic savings by improving outcomes by 13.6% would also be approximately $24.3 billion per one million patients treated[iii] – again, enormous in a population-based model.
In total, health systems could potentially save over $76.2 billion per every one million patients treated via DAA regimens if treatment is initiated at stages F2 or lower – a figure that greatly outweighs the marginal cost of the advanced diagnostic technologies that can enable such earlier treatment plans.
As health systems transition to rewarding outcomes over volume, the Bach and Zaiken data could spur providers and payers to make every effort to initiate DAA treatment plans as soon as possible - a win for patient groups and clinicians that advocate for earlier intervention. To this end, one strategy that may become front and center would be to better leverage advanced technologies, such as MRE, that can provide greater accuracy for liver fibrosis assessment at F2 or lower and deliver the long-term savings needed to implement such a strategy.
[i] Real-World Drug Costs of Treating Hepatitis C Genotypes 1-4 with Direct-Acting Antivirals: Initiating Treatment at Fibrosis 0-2 and 3-4. J Manag Care Spec Pharm, 2016 Dec;22(12):1437-1445.
[ii] This figure even takes into account approximately $4,000 per patient for advanced imaging – which at the target expected cost of a standalone MRE exam of $500-$1000, would allow for a number of staging exams during the early surveillance period. Therefore, the model would: ($55,949 savings per patient * 1,000,000 patients) – (1,000,000 patients * $4,000 MR imaging per patient) = $51.9 billion.
[iii] A 13.6% improvement in outcomes from earlier DAA treatment would translate to 136,000 fewer re-treatments per one million patients treated. Since re-treatments for these patients would typically be longer than standard treatments, or add additional therapeutics, we estimate the total cost of these re-treatments using the higher figure found by Bach and Zaiken ($178,401 per SVR). Therefore, 136,000 patients * $178,401 per re-treatment = $24.6 billion.