scholarly journals Modeling Adherence Interventions Among Youth with HIV in the United States: Clinical and Economic Projections

2021 ◽  
Author(s):  
Anne M. Neilan ◽  
Audrey C. Bangs ◽  
Michael Hudgens ◽  
Kunjal Patel ◽  
Allison L. Agwu ◽  
...  

AbstractThe Adolescent Medicine Trials Network for HIV/AIDS Interventions is evaluating treatment adherence interventions (AI) to improve virologic suppression (VS) among youth with HIV (YWH). Using a microsimulation model, we compared two strategies: standard-of-care (SOC) and a hypothetical 12-month AI that increased cohort-level VS in YWH in care by an absolute ten percentage points and cost $100/month/person. Projected outcomes included primary HIV transmissions, deaths and life-expectancy, lifetime HIV-related costs, and incremental cost-effectiveness ratios (ICERs, $/quality-adjusted life-year [QALY]). Compared to SOC, AI would reduce HIV transmissions by 15% and deaths by 12% at 12 months. AI would improve discounted life expectancy/person by 8 months at an added lifetime cost/person of $5,300, resulting in an ICER of $7,900/QALY. AI would be cost-effective at $2,000/month/person or with efficacies as low as a 1 percentage point increase in VS. YWH-targeted adherence interventions with even modest efficacy could improve life expectancy, prevent onward HIV transmissions, and be cost-effective.

2019 ◽  
Vol 6 (7) ◽  
Author(s):  
Christopher F Carpenter ◽  
Annas Aljassem ◽  
Jerry Stassinopoulos ◽  
Giovanni Pisacreta ◽  
David Hutton

Abstract Background Herpes zoster (HZ) develops in up to 50% of unvaccinated individuals, accounting for >1 million cases annually in the United States. A live attenuated HZ vaccine (LAV) is Food and Drug Administration approved for those age 50 years or older, though Advisory Committee on Immunization Practices recommendations are only for those age 60 years or older. LAV efficacy is ~70% for persons 50–59 years of age, with lower efficacy in older adults. A new 2-dose adjuvanted subunit vaccine (SUV) has >95% efficacy in persons 50–69 years of age and remains ~90% efficacious in persons vaccinated at age 70 years. Methods To estimate the relative cost-effectiveness of SUV, LAV, and no vaccination (NoV) strategies, a Markov model was developed based on published data on vaccine efficacy, durability of protection, quality of life, resource utilization, costs, and disease epidemiology. The perspective was US societal, and the cycle length was 1 year with a lifelong time horizon. SUV efficacy was estimated to wane at the same rate as LAV. Outcomes evaluated included lifetime costs, discounted life expectancy, and incremental cost-effectiveness ratios (ICERs). Results For individuals vaccinated at age 50 years, the ICER for LAV vs NoV was $118 535 per quality-adjusted life-year (QALY); at age 60 years, the ICER dropped to $42 712/QALY. SUV was more expensive but had better ICERs than LAV. At age 50, the ICER was $91 156/QALY, and it dropped to $19 300/QALY at age 60. Conclusions Vaccination with SUV was more cost-effective than LAV in all age groups studied. Vaccination with SUV at age 50 years appears cost-effective, with an ICER <$100 000/QALY.


Pharmacy ◽  
2020 ◽  
Vol 8 (1) ◽  
pp. 32 ◽  
Author(s):  
Farah Raheem ◽  
Pauline Kim ◽  
Meagan Grove ◽  
Patrick J. Kiel

Recent advancements in molecular testing, the availability of cost-effective technology, and novel approaches to clinical trial design have facilitated the implementation of tumor genome sequencing into standard of care oncology practices. Current models of precision oncology practice include specialized clinics or consultation services based on a molecular tumor board (MTB) approach. MTBs are comprised of interprofessional teams of clinicians and scientists who evaluate tumors at the molecular level to guide patient-specific targeted therapy. The practice of precision oncology utilizing MTB-based models is an emerging approach, transforming precision genomics from a novel concept into clinical practice. This rapid shift in practice from cytotoxic therapy to targeted medicine poses challenges, yet brings exciting opportunities to clinical pharmacists practicing in hematology and oncology. Only a few precision genomics programs in the United States have a strong pharmacy presence with oncology pharmacists serving in leadership roles in research, interpreting genomic sequencing, making treatment recommendations, and facilitating off-label drug procurement. This article describes the experience of the precision medicine clinic at the Indiana University Health Simon Cancer Center, with emphasis on the role of the pharmacist in the precision oncology initiative.


2020 ◽  
Vol 45 (10) ◽  
pp. 1083-1086 ◽  
Author(s):  
Paul H. C. Stirling ◽  
Nicholas D. Clement ◽  
Paul J. Jenkins ◽  
Andrew D. Duckworth ◽  
Jane E. McEachan

The United Kingdom National Institute for Health and Care Excellence considers a procedure to be cost-effective if the cost per quality-adjusted life year gained falls below a threshold of £20,000–£30,000 (€22,600–33,900; US$24,600–$36,900). This study used cost per quality-adjusted life year methodology to determine the cost-utility ratio of A1 pulley release. Pre- and postoperative EuroQol 5 Dimensions 5 Likert scores were collected prospectively over 6 years from 192 patients. The median pre- and postoperative indices derived from the EuroQol 5 Dimensions 5 Likert scores were significantly different at 0.77 and 0.80. The mean life expectancy was 21 years. The mean number of quality-adjusted life years gained was 1 per patient. The mean cost-utility ratio per patient was £32,308 (€36,508; US$39,730) and £16,154 (€18,254; US$19,869) at 1 and 2 years, respectively. Provided the benefit of surgery was maintained over the remaining life expectancy, the cost-utility ratio decreased to £1537 (€1737; US$1891) per patient. A1 pulley release is cost-effective provided the benefit is maintained for 2 years. The procedure is also associated with a statistically significant improvement in quality of life. Level of evidence: III


Circulation ◽  
2020 ◽  
Vol 141 (15) ◽  
pp. 1214-1224 ◽  
Author(s):  
Dhruv S. Kazi ◽  
Brandon K. Bellows ◽  
Suzanne J. Baron ◽  
Changyu Shen ◽  
David J. Cohen ◽  
...  

Background: In patients with transthyretin amyloid cardiomyopathy, tafamidis reduces all-cause mortality and cardiovascular hospitalizations and slows decline in quality of life compared with placebo. In May 2019, tafamidis received expedited approval from the US Food and Drug Administration as a breakthrough drug for a rare disease. However, at $225 000 per year, it is the most expensive cardiovascular drug ever launched in the United States, and its long-term cost-effectiveness and budget impact are uncertain. We therefore aimed to estimate the cost-effectiveness of tafamidis and its potential effect on US health care spending. Methods: We developed a Markov model of patients with wild-type or variant transthyretin amyloid cardiomyopathy and heart failure (mean age, 74.5 years) using inputs from the ATTR-ACT trial (Transthyretin Amyloidosis Cardiomyopathy Clinical Trial), published literature, US Food and Drug Administration review documents, healthcare claims, and national survey data. We compared no disease–specific treatment (“usual care”) with tafamidis therapy. The model reproduced 30-month survival, quality of life, and cardiovascular hospitalization rates observed in ATTR-ACT; future projections used a parametric survival model in the control arm, with constant hazards reduction in the tafamidis arm. We discounted future costs and quality-adjusted life-years by 3% annually and examined key parameter uncertainty using deterministic and probabilistic sensitivity analyses. The main outcomes were lifetime incremental cost-effectiveness ratio and annual budget impact, assessed from the US healthcare sector perspective. This study was independent of the ATTR-ACT trial sponsor. Results: Compared with usual care, tafamidis was projected to add 1.29 (95% uncertainty interval, 0.47–1.75) quality-adjusted life-years at an incremental cost of $1 135 000 (872 000–1 377 000), resulting in an incremental cost-effectiveness ratio of $880 000 (697 000–1 564 000) per quality-adjusted life-year gained. Assuming a threshold of $100 000 per quality-adjusted life-year gained and current drug price, tafamidis was cost-effective in 0% of 10 000 probabilistic simulations. A 92.6% price reduction from $225 000 to $16 563 would be necessary to make tafamidis cost-effective at $100 000/quality-adjusted life-year. Results were sensitive to assumptions related to long-term effectiveness of tafamidis. Treating all eligible patients with transthyretin amyloid cardiomyopathy in the United States with tafamidis (n=120 000) was estimated to increase annual healthcare spending by $32.3 billion. Conclusions: Treatment with tafamidis is projected to produce substantial clinical benefit but would greatly exceed conventional cost-effectiveness thresholds at the current US list price. On the basis of recent US experience with high-cost cardiovascular medications, access to and uptake of this effective therapy may be limited unless there is a large reduction in drug costs.


2012 ◽  
Vol 2012 ◽  
pp. 1-10 ◽  
Author(s):  
Cristina Simona Strahotin ◽  
Michael Babich

Hepatitis C (HCV), a leading cause of chronic liver disease, cirrhosis, and hepatocellular carcinoma, is the most common indication for liver transplantation in the United States. Although annual incidence of infection has declined since the 1980s, aging of the currently infected population is expected to result in an increase in HCV burden. HCV is prone to develop resistance to antiviral drugs, and despite considerable efforts to understand the virus for effective treatments, our knowledge remains incomplete. This paper reviews HCV resistance mechanisms, the traditional treatment with and the new standard of care for hepatitis C treatment. Although these new treatments remain PEG-IFN-α- and ribavirin-based, they add one of the newly FDA approved direct antiviral agents, telaprevir or boceprevir. This new “triple therapy” has resulted in greater viral cure rates, although treatment failure remains a possibility. The future may belong to nucleoside/nucleotide analogues, non-nucleoside RNA-dependent RNA polymerase inhibitors, or cyclophilin inhibitors, and the treatment of HCV may ultimately parallel that of HIV. However, research should focus not only on effective treatments, but also on the development of a HCV vaccine, as this may prove to be the most cost-effective method of eradicating this disease.


Sarcoma ◽  
2018 ◽  
Vol 2018 ◽  
pp. 1-14 ◽  
Author(s):  
Santiago Zuluaga-Sanchez ◽  
Lisa M. Hess ◽  
Sorrel E. Wolowacz ◽  
Yulia D’yachkova ◽  
Emma Hawe ◽  
...  

Background. Standard first-line treatments for advanced soft tissue sarcoma (STS) have changed little for 40 years, and outcomes have been poor. Recently, the United States (US) Food and Drug Administration conditionally approved olaratumab in combination with doxorubicin (Olara + Dox) based on a randomized phase II trial that reported a significant 11.8-month improvement in median survival versus single-agent doxorubicin (Dox). The present study investigated the cost-effectiveness of Olara + Dox compared with Dox and five other standard-of-care regimens from the US payer perspective. Methods. An economic model was constructed to estimate costs and outcomes over patients’ lifetimes from start of therapy. Progression-free and overall survival were based on survival analysis of patient-level data and a meta-analysis. Adverse-event rates were based on trials. Costs were from published sources. Results. Olara + Dox resulted in an estimated additional 1.27 life-years (LYs) compared with Dox, with an increase in total expected lifetime costs of $133,653. The incremental cost-effectiveness ratio (ICER) was estimated at $105,408 per LY gained; in a fully incremental analysis, all other regimens were dominated (higher costs and lower LYs or a higher ICER). Conclusion. Olara + Dox is cost-effective for STS treatment compared with Dox and other standard-of-care regimens at willingness-to-pay thresholds of $150,000 per LY and above.


2019 ◽  
Author(s):  
Ching-Yu Wang ◽  
Phuong N. Pham ◽  
Sarah Kim ◽  
Karthik Lingineni ◽  
Stephan Schmidt ◽  
...  

ABSTRACTGeneric entry of newer anticoagulants is expected to decrease the costs of atrial fibrillation management. However, when making switches between brand and generic medications, bioequivalence failures are possible. The objectives of this study were to predict and compare the lifetime cost-effectiveness of brand dabigatran with hypothetical future generics. Markov micro-simulations were modified to predict the lifetime costs and quality-adjusted life years of patients on either brand or generic dabigatran from a U.S. private payer perspective. Event rates for generics were predicted using previously developed pharmacokinetic-pharmacodynamic models. The analyses showed that generic dabigatran with lower-than-brand systemic exposure was dominant. Meanwhile, generic dabigatran with extremely high systemic exposure was not cost-effective compared to the brand reference. Cost-effectiveness of generic medications cannot always be assumed as shown in this example. Combined use of pharmacometric and pharmacoeconomic models can assist in decision making between brand and generic pharmacotherapies.


Author(s):  
Anne M Neilan ◽  
Alexander J B Bulteel ◽  
Sybil G Hosek ◽  
Julia H A Foote ◽  
Kenneth A Freedberg ◽  
...  

Abstract Background Of new HIV infections in the US, 20% occur among young men who have sex with men (YMSM, ages 13-24), but >50% of YMSM with HIV are unaware of their status. Using Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) data, we projected the clinical benefit and cost-effectiveness of frequent HIV screening among high-risk YMSM from age 15. Methods Using a mathematical simulation, we examined 3 screening strategies: Yearly, 6-monthly, and 3-monthly, each in addition to the Status quo (SQ, 0.7-10.3% screened/year, stratified by age). We used published data (YMSM-specific when available) including: HIV incidences (0.91-6.41/100PY); screen acceptance (80%), linkage-to-care/antiretroviral therapy (ART) initiation (76%), HIV transmission (0.3-86.1/100PY, by HIV RNA), monthly ART costs ($2,290-$3,780), and HIV per-screen costs ($38). Projected outcomes included CD4 count at diagnosis, primary HIV transmissions from ages 15-30, quality-adjusted life expectancy, costs, and incremental cost-effectiveness ratios (ICERs, $/quality-adjusted life-year saved [QALY]; threshold ≤$100,000/QALY). Results Compared to SQ, all strategies increased projected CD4 at diagnosis (296 to 477-515 cells/µL) and quality-adjusted life expectancy from age 15 (44.4 to 48.3-48.7 years) among YMSM acquiring HIV. Compared to SQ, all strategies increased discounted lifetime cost for the entire population ($170,800 to $178,100-$185,000/person). Screening 3-monthly was cost-effective (ICER: $4,500/QALY) compared to SQ and reduced primary transmissions through age 30 by 40%. Results were most sensitive to transmission rates; excluding the impact of transmissions, screening Yearly was ≤$100,000/QALY (ICER: $70,900/QALY). Conclusions For high-risk YMSM in the US, HIV screening 3-monthly compared to less frequent screening will improve clinical outcomes and be cost-effective.


2019 ◽  
Vol 48 (1) ◽  
pp. 242-251 ◽  
Author(s):  
Joshua S. Everhart ◽  
Andrew B. Campbell ◽  
Moneer M. Abouljoud ◽  
J. Caid Kirven ◽  
David C. Flanigan

Background: Multiple knee cartilage defect treatments are available in the United States, although the cost-efficacy of these therapies in various clinical scenarios is not well understood. Purpose/Hypothesis: The purpose was to determine cost-efficacy of cartilage therapies in the United States with available mid- or long-term outcomes data. The authors hypothesized that cartilage treatment strategies currently approved for commercial use in the United States will be cost-effective, as defined by a cost <$50,000 per quality-adjusted life-year over 10 years. Study Design: Systematic review. Methods: A systematic search was performed for prospective cartilage treatment outcome studies of therapies commercially available in the United States with minimum 5-year follow-up and report of pre- and posttreatment International Knee Documentation Committee subjective scores. Cost-efficacy over 10 years was determined with Markov modeling and consideration of early reoperation or revision surgery for treatment failure. Results: Twenty-two studies were included, with available outcomes data on microfracture, osteochondral autograft, osteochondral allograft (OCA), autologous chondrocyte implantation (ACI), and matrix-induced ACI. Mean improvement in International Knee Documentation Committee subjective scores at final follow-up ranged from 17.7 for microfracture of defects >3 cm2 to 36.0 for OCA of bipolar lesions. Failure rates ranged from <5% for osteochondral autograft for defects requiring 1 or 2 plugs to 46% for OCA of bipolar defects. All treatments were cost-effective over 10 years in the baseline model if costs were increased 50% or if failure rates were increased an additional 15%. However, if efficacy was decreased by a minimum clinically important amount, then ACI (periosteal cover) of femoral condylar lesions ($51,379 per quality-adjusted life-year), OCA of bipolar lesions ($66,255) or the patella ($66,975), and microfracture of defects >3 cm2 ($127,782) became cost-ineffective over 10 years. Conclusion: Currently employed treatments for knee cartilage defects in the United States are cost-effective in most clinically acceptable applications. Microfracture is not a cost-effective initial treatment of defects >3 cm2. OCA transplantation of the patella or bipolar lesions is potentially cost-ineffective and should be used judiciously.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S166-S166
Author(s):  
Michelle Rose ◽  
John Allen Myers ◽  
Nicholas Ryan ◽  
Alissa Prince ◽  
Morgan Talbot ◽  
...  

Abstract Background Identifying asymptomatic individuals with hepatitis C virus (HCV) infection is challenging. Pregnancy presents a unique opportunity to screen women for HCV and then link those positive to care. Universal screening in pregnant women, however, is not recommended by CDC or ACOG. Further, treatment with direct antiviral agents (DAAs) are not currently approved for pregnant women but are warranted following delivery and breastfeeding. We sought to compare treatment uptake before and after universal screening in pregnant women was implemented as the standard of care in our institution and then determine if universal screening leads to increased treatment after pregnancy. Methods A retrospective analysis of risk-based HCV screening in pregnant women was used for the first period (2014–2015) and a prospective design was used following 18 months of universal screening (2016–2017). Prenatal data were collected from all pregnant women that sought care at our institution in the prospective part of the study. We tested for differences in relevant outcomes (e.g., screening rates, rate of those eligible for treatment, and those who actually received treatment) between the two periods. Finally, we performed a cost-effective analysis of universal screening considering treatment rates. Results During the universal screening period, more women were screened for HCV and diagnosed with chronic infection. Universal screening was not associated with a significant increase in the odds of women receiving treatment after pregnancy. The increased cost for universal screening was $1060 per patient, resulting in an ICER of $219,391 per additional treatment received or $57,734 per quality-adjusted life-year (QALY) gained, which is below the willingness-to-pay threshold to be cost-effective. Universal screening, however, is cost-effective with an ICER well below the established willingness-to-pay threshold of $100,000 per QALY gained, if all women eligible for treatment receive therapy. Conclusion Universal screening may not lead to a significant increase in the odds that pregnant women receive DAAs therapy after pregnancy. Barriers to linkage to care should be addressed in an effort to increase antiviral therapy for these women and universal screening should be implemented within this patient population. Disclosures All authors: No reported disclosures.


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