Using computer models, a group of researchers found that Sovaldi, which is sold by Gilead Sciences GILD -2.47%, is more cost effective than either an older combination of drugs or no treatment at all. Given its high price tag - Sovaldi costs $84,000 for a 12-week regimen, or $1,000 a pill- the researchers attempted to assess its value and used a metric known as QALY, or quality-of-life years, which measures both the quantity and quality of life generated by a health care intervention. One implication of the findings, according to Goldhaber-Fiebert, is that paying for Sovaldi while people are incarcerated should help prevent the spread of the disease once prisoners are later released, especially among those who are injectable drug users. Some prison officials, however, continue to voice the familiar fears over existing budget constraints."If we treated 26 patients, that would be equivalent to our entire drug budget for the country jail system - for everybody - for a year," David Woods, chief pharmacy officer in San Francisco's Public Health Department, tells The San Francisco Gate. In short, his rationale resembles an argument made by Gilead Sciences and its supporters that the short-term investment in the treatment can help offset greater long-term costs associated with treating infected people.
Meanwhile, Sovaldi is widely expected to be eclipsed by a still newer medication called Harvoni that costs about the same, depending upon the duration of treatment, but offers more convenience and an equally high cure rate for patients.
Harvoni was not part of the study, of course, and Goldhaber-Fiebert would not address that latest treatment directly. Sofosbuvir-Based Treatment Regimens for Chronic, Genotype 1 Hepatitis C Virus Infection in U.S.
Background: Prevalence of chronic hepatitis C virus (HCV) infection is high among incarcerated persons in the United States. Intervention: No treatment, 2-drug therapy (pegylated interferon and ribavirin), or 3-drug therapy with either boceprevir or sofosbuvir.
In the United States, more than 500 000 incarcerated persons have chronic hepatitis C virus (HCV) infection (1-3).
Sofosbuvir 3-drug therapy for treatment-naive, incarcerated men with chronic, genotype 1 HCV monoinfection is highly effective compared with alternative therapies. Affordability and divided benefits represent challenges to delivering sofosbuvir 3-drug therapy to incarcerated populations.
Substantial uncertainty surrounds sofosbuvir because it has only recently become clinically available. The cost-effectiveness of sofosbuvir was influenced by risks for reinfection that differ due to reincarceration (Table 10 of the Supplement) and by variation in prevalence and risk behaviors across prisons and communities (Table 11 of the Supplement). There is excitement among clinicians about such new treatments as interferon-sparing, all-oral sofosbuvir regimens, although none are currently FDA-approved and pricing data are limited (8, 10). In our analysis, sofosbuvir 3-drug therapy was highly effective in incarcerated, treatment-naive men with chronic, genotype 1 HCV monoinfection, including those whose remaining sentences were too short for other treatments. Although our study focused on sofosbuvir, it comments on the arrival of several highly effective, short-duration HCV treatments, including those given orally and without interferon. Expensive drugs, such as sofosbuvir, stress affordability and are victims of divided budget planning. In settings with high reinfection rates during or after incarceration, the cost-effectiveness of sofosbuvir was attenuated. Although health outcome estimates from model-based HCV studies vary widely (for example, remaining QALYs range from 4.5 to >20) (24, 60, 63-65), our estimates were consistent after we accounted for important features of the population considered and the modeling methods used. We did not directly consider telaprevir 3-drug therapy in addition to boceprevir 3-drug therapy for clarity of presentation.
Our analysis was conducted from the societal perspective, although the costs we used are from heterogeneous sources and may not perfectly capture the opportunity costs of all resources.
We used a decision analytic Markov model (16, 24, 29) to follow cohorts of treatment-naive, incarcerated men with chronic, genotype 1 HCV monoinfection. The model began with treatment-naive, 40-year-old men who had chronic, genotype 1 HCV monoinfection and were eligible for treatment, which is representative of most incarcerated persons (mean age, 40 years; 93% male [32]). We focused on aspects of our model (24) that were unique to incarcerated populations (Figures 1 and 2 of the Supplement). During and after incarceration, persons may be reinfected despite spontaneous clearance or cure. Incarcerated persons have higher mortality risks than similar persons in the general population (35-36). Although reinfection rates may be lower after release, early release can disrupt treatment. Treatment strategies during incarceration followed FDA-approved protocols and included no treatment, 2-drug therapy (pegylated interferon and ribavirin), or 3-drug therapy with either boceprevir or sofosbuvir (Supplement). There is substantial interest in other regimens for which trials have shown high efficacy (8, 10, 44-45).
For persons not achieving SVR after treatment, we did not consider retreatment because of evidence of low treatment uptake among formerly incarcerated persons (46) and a lack of retreatment data for sofosbuvir after prior unsuccessful sofosbuvir therapy. We stratified virologic response by race and IL-28B genotype for 2-drug therapy and boceprevir 3-drug therapy (24). We included background medical costs and costs related to chronic HCV infection and liver disease.
We assessed the effect of alternate plausible assumptions and used a probabilistic sensitivity analysis to examine the effect of parameter uncertainty. The funding sources had no role in the design, conduct, or analysis of the study or the decision to submit the manuscript for publication.
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The foundations of the alliance of Western states against the fighters of the Islamic state were asked at the Paris conference on Monday. The newest edition to Education Services’ course offerings—the Recovery-Oriented Approach online course—piloted in October 2013. The course used various instructional techniques, including large and small online discussion groups, case scenarios, video clips featuring former clients, self-assessment quizzes and self-reflection opportunities. Participant feedback received was positive, with 92.3% of the 13 respondents reporting that they would recommend this course to others and 100% reporting that the learning event met their learning needs. The course has received accreditation from the University of Toronto Continuing Education and Professional Development, Faculty of Medicine, including the College of Physicians and Surgeons of Canada’s Mainpro-M1 credits.
The next offering of the Recovery-Oriented Approach online course begins Monday, April 7, 2014. This blog is brought to you by the Centre for Addiction and Mental Health in Toronto, Ontario, Canada. Moreover, the findings, which were published in the Annals of Internal Medicine, suggest that providing the drug to infected inmates may have wider societal implications beyond prison walls. But the researchers found the cost per QALY for Sovaldi differed only slightly among those serving short sentences - defined as less than 18 months - and those serving longer sentences. Federal Bureau of Prisons recommends Sovaldi - and gets a hefty 44% discount through the U.S. This presumes, though, that a significant number of infected will later require costly treatment, such as extensive hospitalizations or even liver transplants. New, short-duration, high-efficacy therapies may expand treatment eligibility in this population.
Sofosbuvir produced the largest absolute reductions in decompensated cirrhosis (16%) and hepatocellular carcinoma (9%), resulting in 2.1 additional QALYs at an added cost exceeding $54 000 compared with no treatment.
Chronic HCV infection causes liver fibrosis, cirrhosis, hepatocellular carcinoma, and the need for liver transplantation (4).
Unplanned transfers and releases can disrupt treatment and may select for viral resistance (15).
Until recently, standard-of-care treatment was 2-drug therapy with pegylated interferon and ribavirin.
The additional costs of delivering sofosbuvir-based therapy to 500 000 incarcerated persons could exceed $27 billion to $30 billion (Table 8 of the Supplement). Assuming that its effectiveness was 70% of that observed in trials, we found costs of $45 100 per QALY gained for men with short remaining sentences but $178 400 for those with long remaining sentences given the availability of boceprevir-based treatment (Figure 3 of the Supplement).
In a scenario analysis, we assumed 90% efficacy, 180% of treatment costs (price of sofosbuvir and simeprevir), a duration of 12 weeks, and no treatment-related disutility. Sofosbuvir increased total expected cost per person by more than $54 000, but its additional benefits yielded a cost per QALY gained of less than $30 000. Total additional costs from treating 500 000 incarcerated persons with HCV infection could reach $30 billion for the Federal Bureau of Prisons and other entities, with approximately $2 billion to $5 billion in savings accruing primarily after release to such entities as Medicaid.
Models that start with older patient cohorts and more advanced fibrosis, use higher discount rates, and have shorter time horizons generally estimate fewer remaining QALYs.
In our previous cost-effectiveness evaluations of regimens containing boceprevir or telaprevir (24), we found that the former provides a more favorable cost-effectiveness profile, although we acknowledge the difficulty of direct comparisons of efficacy. For example, we multiplied drug prices by 0.64 to reflect the negotiating power of larger prison systems. The cohorts were stratified by liver fibrosis stage, interleukin-28B (IL-28B) host genotype, age, and race.
We analyzed men because they account for the vast majority of incarcerated persons and sufficient published information is available on their mortality risks during and after incarceration and on reinfection. Patients with chronic HCV infection have higher mortality risks from liver-related and other causes (37). All-oral, interferon-sparing, sofosbuvir-based treatment (8, 10) has garnered attention because it may be better tolerated.
We conservatively assumed that persons treated after release received the most effective regimen (sofosbuvir 3-drug therapy) regardless of the treatment strategy offered during incarceration because this minimized the ascription of benefits to treatment during incarceration. For sofosbuvir 3-drug therapy, the NEUTRINO trial provided efficacy data stratified by IL-28B genotype, which did not vary substantially by race (7). Developed by education specialists in collaboration with a multidisciplinary and interprofessional curriculum-development committee, the course can be taken on its own or as part of the Concurrent Disorders Online Certificate Program. The final module provided opportunities to integrate and apply knowledge from earlier modules through comprehensive case studies.
To wit, $25,700 for those serving shorter sentences and $28,800 for those locked up for longer stretches compared with no treatment.
Department of Veterans Affairs, the actual outlay in real dollars remains challenging for the prison system.
The recent availability of short-duration, highly efficacious treatments (5-10) may be advantageous for patients in this population given that they are less likely to be treated after being released. Higher reinfection risks after cure can reduce treatment benefits for incarcerated persons. Despite 48 weeks of treatment, sustained virologic response (SVR) rates can be as low as 45% for genotype 1 HCV (4) and even lower in black patients, who are overrepresented in incarcerated populations (17-18).
Sofosbuvir-based therapy resulted in approximately 2.1 QALYs gained for men with short and long remaining sentences compared with no treatment during incarceration (Table and Figure). Figure 4 of the Supplement shows the influence of sofosbuvir's price on its cost-effectiveness. Petta and colleagues did so within the Italian health care system (58), and Younossi and associates focused on interferon-sparing regimens (59). Our model began with a middle-aged male population with a moderate fibrosis distribution and followed it over a lifetime with a 3% annual discount rate.
Our analysis included men because they make up 93% of the incarcerated population and most studies relevant to mortality and reinfection of incarcerated populations are reported for them.
Given that the regimens have similar efficacy, costs, and QoL reductions from side effects and that sofosbuvir-containing regimens dominated boceprevir-containing regimens even in sensitivity analyses, we believe this decision is reasonable.


Better HCV care coordination across agencies could alter this, although shorter, highly effective regimens may make it less important. Its brief duration enables treatment of inmates with short remaining sentences and decreases risks for disruption or discontinuation.
The model allowed differential risks for reinfection during incarceration and after release and for treatment initiation after release. Although 34% of inmates are white, 39% are black, and 21% are Hispanic, the analysis considered only black and white inmates because data on effectiveness for Hispanic patients are limited. Treatment resulting in cure could leave patients with residual fibrosis consistent with their stage at the time but without additional progression, although this assumption was explored in sensitivity analyses. Data reported for inmates from 2001 to 2009 and life tables from the Centers for Disease Control and Prevention informed mortality rates specific to age, sex, race, and chronic HCV infection status (Table 3 of the Supplement) (38-39). We assumed that the 20-year cumulative probability of initiating postrelease treatment was 20% and increased it to 80% in sensitivity analyses. We represented side-effect profiles collectively as regimen-specific quality-of-life decrements capturing treatment duration and side-effect severity (48). Thirteen addiction, mental health and allied health professionals successfully completed the seven-week pilot. The study notes that the added cost of providing Sovaldi to 500,000 jailbirds could exceed $27 billion to $30 billion. The question is whether you pay for an additional benefit for a good value and can you afford to pay that additional amount of money?
Targeting chronic HCV infection in prisons, where the prevalence is 12% to 35% (nearly 10 times the overall U.S. Recent data suggest increases in testing, although many diagnosed inmates remain untreated (13-15).
Costs increased by approximately $54 000 for men with short remaining sentences and $58 000 for those with long remaining sentences compared with no treatment during incarceration. For persons who were interferon-intolerant, this strategy cost less than $39 000 per QALY gained for those with short remaining sentences and $49 000 per QALY gained for those with long remaining sentences. However, our population is at high risk for mortality and reinfection, which many prior models have not considered.
We did not include Hispanic persons because trials have not reported efficacy stratified by Hispanic origin.
Our study did not explicitly model reincarceration (32) because data to properly do so for HCV-infected and cured persons are limited or unavailable. We stratified cohorts by race-specific IL-28B genotype because this predicts treatment response (18).
Untreated and uncured persons progressing to compensated cirrhosis were at risk for decompensated cirrhosis and hepatocellular carcinoma and could then become eligible for liver transplantation. Previously published rates informed liver-related mortality among patients with advanced liver disease (22, 24). We assumed no release during HCV treatment and the effect of early release was that inmates could receive treatment earlier outside prison if there was no treatment program while they were incarcerated. In a scenario analysis, we allowed early release during treatment and assumed that patients were unable to continue after release but could start treatment outside prison at the same cumulative probability as noted earlier.
We further adjusted costs conditional on liver disease severity by accounting for nonliver comorbid conditions (53). Treatment initiation rules vary but often require remaining sentences of more than 18 to 24 months to enable completion before release (15).
Food and Drug Administration (FDA) has approved 4 directly acting antivirals with SVR rates exceeding 75% to 90% in trials: the protease inhibitors boceprevir, telaprevir, and simeprevir and the polymerase inhibitor sofosbuvir, each used in combination with interferon and ribavirin (7, 19).
For men with long remaining sentences, sofosbuvir 3-drug therapy dominated both 2-drug therapy and boceprevir 3-drug therapy, achieving additional health benefits at a more favorable cost per QALY gained. Inmates co-infected with HIV or hepatitis B virus were not included because natural history of co-infection is complex, and although data on sofosbuvir's effectiveness in this population are emerging, they are currently insufficient for accurate modeling of this group. We assumed that progression rates in the absence of treatment were the same during incarceration and after release.
Prior studies have shown that SVR decreases mortality risks from liver-related causes (38-39). We assumed that patients successfully treated in prison and released early had a lower risk for postrelease reinfection (26, 34, 42-43).
We assumed that close monitoring resulted in full treatment adherence during incarceration and varied this in sensitivity analyses.
Sensitivity analyses examined the effects of differing costs of health care delivery across correctional systems (14, 33).
Newer, all-oral, interferon-sparing regimens have shown high efficacy but are not yet FDA-approved (8, 10). Sofosbuvir 3-drug therapy cost $25 700 and $28 800 per QALY gained for men with short and long remaining sentences, respectively, compared with no treatment during incarceration. The liver disease distribution of the starting cohort, characterized by METAVIR scores ranging from F0 (no fibrosis) to F4 (compensated cirrhosis) (24), was based on studies of HCV-infected inmates (33). On the basis of several large, long-term observational studies, we assumed that SVR decreased non-liver-related mortality risks by 10% (29, 40). Background medical costs by age outside prison were similar to those in the general population (52).
We assumed that sofosbuvir cost $7000 per week (21) and adjusted to the Average Manufacturer Price with a factor of 0.64, and we explored alternative assumptions in sensitivity analyses (54).



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