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The American Journal of Managed Care December 2019
Clinical Characteristics and Treatment Patterns Among US Patients With HIV
Julie L. Priest, MSPH; Tanya Burton, PhD; Cori Blauer-Peterson, MPH; Kate Andrade, MPH; and Alan Oglesby, MPH
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Terry E. Hill, MD
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Evan K. Perrault, PhD; Katie J. Schmitz, BA; Grace M. Hildenbrand, MA; and Seth P. McCullock, MA
Cost-Sharing Payments for Out-of-Network Care in Commercially Insured Adults
Wendy Yi Xu, PhD; Bryan E. Dowd, PhD; Macarius M. Donneyong, PhD; Yiting Li, PhD; and Sheldon M. Retchin, MD, MSPH
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Matthew E. Hirschtritt, MD, MPH; Vanessa A. Palzes, MPH; Andrea H. Kline-Simon, MS; Kurt Kroenke, MD; Cynthia I. Campbell, PhD, MPH; and Stacy A. Sterling, DrPH, MSW
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Heidi C. Waters, PhD, MBA; Charles Ruetsch, PhD; and Joseph Tkacz, MS
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Cost Burden of Hepatitis C Virus Treatment in Commercially Insured Patients
Christine Y. Lu, PhD; Dennis Ross-Degnan, ScD; Fang Zhang, PhD; Robert LeCates, MA; Caitlin Lupton, MSc; Michael Sherman, MD; and Anita Wagner, PharmD
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Jakub P. Hlávka, PhD; Pei-Jung Lin, PhD; and Peter J. Neumann, ScD

Cost Burden of Hepatitis C Virus Treatment in Commercially Insured Patients

Christine Y. Lu, PhD; Dennis Ross-Degnan, ScD; Fang Zhang, PhD; Robert LeCates, MA; Caitlin Lupton, MSc; Michael Sherman, MD; and Anita Wagner, PharmD
Rates of hepatitis C virus (HCV) treatment in a commercially insured population doubled after availability of new direct-acting antivirals. Member out-of-pocket spending was kept low while the health plan bore 99% of spending on HCV medications.
ABSTRACT

Objectives: New direct-acting antivirals (DAAs), introduced in late 2013, are effective for treating chronic hepatitis C virus (HCV) infection but may pose substantial financial burden on patients and health insurers. We examined HCV medication use and costs in a commercially insured population.

Study Design: Retrospective cohort study.

Methods: We used claims data for 3091 individuals with HCV infection (2012-2015). Outcomes included HCV medication use, inflation-adjusted out-of-pocket (OOP) and health plan spending, and predictors of receiving new DAAs.

Results: Cumulatively, 9% of members with a diagnosis of HCV were treated with HCV medications in 2012 and this increased to 32% in 2015. Of 3091, 589 received new DAAs and 80% (n = 465) completed a 12-week treatment regimen. After new DAAs became available, average annual health plan spending on HCV medications increased from $2869 to $16,504 per HCV-diagnosed member (relative change, 475%; 95% CI, 352%-598%), and OOP spending increased from $41 to $94 (relative change, 131%; 95% CI, 15%-247%). Age (being aged 50-64 years [adjusted odds ratio (aOR), 2.13; 95% CI, 1.29-3.53] and being ≥65 years [aOR, 2.01; 95% CI, 1.14-3.55] compared with being <30 years) and having liver cirrhosis (aOR, 3.34; 95% CI, 2.64-4.21) were positively associated with receiving new DAAs, and a diagnosis of alcohol abuse (aOR, 0.70; 95% CI, 0.53-0.92) was negatively associated with receiving new DAAs.

Conclusions: The proportion of a commercially insured population with HCV infection who were treated with HCV medications doubled within 2 years following availability of new DAAs. Member OOP spending was kept low while the health plan bore 99% of the cost of HCV medications. During our 2-year follow-up, we did not observe financial benefits to the health plan of the cure of HCV infection by new DAAs.

Am J Manag Care. 2019;25(12):e379-e387
Takeaway Points
  • New direct-acting antivirals (DAAs) are effective for treating chronic hepatitis C virus (HCV) infection but may pose substantial economic burden on patients and health insurers.
  • The proportion of a commercially insured population with HCV infection who were treated with HCV medications doubled within 2 years following availability of new DAAs.
  • In this health plan, member out-of-pocket spending was kept low while the health plan bore 99% of the cost of HCV medications. In our 2-year follow-up period, we did not observe financial benefits to the health plan of the cure of HCV infection by new DAAs.
The arrival of direct-acting antivirals (DAAs) started a new era of treatment for patients with chronic hepatitis C virus (HCV) infection.1-3 An estimated 80 million to 150 million individuals worldwide, including about 3 million to 4 million in the United States, have chronic HCV infection.4,5 If left untreated, chronic HCV infection can lead to cirrhosis, liver failure, and hepatocellular carcinoma6,7; it is the leading cause of liver transplantation and death from liver disease.2,8

Sofosbuvir (Sovaldi), approved by the FDA in late 2013, was the first DAA indicated for treatment of HCV as part of an interferon-free regimen. In clinical trials, 12 weeks of treatment with sofosbuvir-based regimens achieved a sustained virologic response (“cure” or undetectable HCV RNA 12-24 weeks after therapy) rate of approximately 90% in patients with HCV. These regimens show much-improved tolerability and safety compared with poorly tolerated interferon-based therapy regimens that resulted in virologic response in only 20% to 30% of patients.9-11 Recurrent viremia (detectable HCV RNA at follow-up week 24 after achieving sustained virologic response) is extremely rare with sofosbuvir and ledipasvir/sofosbuvir (Harvoni) (12/3004 [0.4%] patients across 11 phase 3 trials12). Furthermore, adherence rates for DAAs are substantially higher than for interferon-based therapy (99.8% vs 36%-60%).13,14 Studies indicate that new DAAs are cost-effective in patients with HCV genotypes 1 through 5 at a threshold of $100,000 per quality-adjusted life-year.15,16 Since 2013, 8 other DAAs for HCV have been approved17 (eAppendix Figure 1 [eAppendix available at ajmc.com]).

The availability of DAAs helped to fuel the discourse about ever-rising spending on pharmaceuticals, driven by spending on specialty medications like DAAs.18,19 The published wholesale acquisition cost of sofosbuvir was $1000 per day in 2014 (or $84,000 for a 12-week course), with additional spending for required concomitant treatments. A single tablet of ledipasvir/sofosbuvir was available at a published price of $1125 ($63,000, $94,500, and $189,000 for an 8-, 12-, and 24-week course, respectively).20 Although the high prices of specialty drugs are widely recognized, there were enormous concerns that demand for expensive DAAs for treatment of a prevalent condition might “bust” the health system budget.21,22 Concerns about budgetary impact and the need to contain pharmaceutical spending growth led payers to restrict initial access to DAAs to patients with higher liver fibrosis scores. However, even restricted subsidized access to DAAs could translate into substantial pharmaceutical spending for healthcare payers and/or out-of-pocket (OOP) spending for patients. In a commercially insured population with HCV infection, we examined the utilization of HCV medications, and health plan and member spending on them, both before and after the first availability of DAAs.

METHODS

Setting and Data Source

Harvard Pilgrim Health Care (HPHC) is a commercial health plan serving approximately 1.25 million members23 in Connecticut, Maine, Massachusetts, and New Hampshire; of these, about 700,000 members are fully insured with pharmacy data accessible to HPHC. Through prior authorization policies, HPHC, like many other health plans, initially restricted access to new DAAs to members with more advanced disease. Criteria for approval in 2014 and 2015 included age at least 18 years; a diagnosis of genotype 1/1b, 2, 3, 4, 5, or 6; liver disease staging within the past 3 years; evidence of stage 2 or greater hepatic fibrosis; being in the care of a gastroenterologist, infectious disease specialist, or hepatologist; and provider attestation that the patient was not currently participating in illicit substance abuse or alcohol abuse, or that the patient was receiving substance or alcohol abuse counseling services as an adjunct to HCV treatment (eAppendix Table 1). Once ledipasvir/sofosbuvir entered the market in 2014, it was the preferred medication in this health plan over other DAAs unless appropriate clinical justification was provided.

The study population consisted of fully insured HPHC members. We identified a rolling cohort of individuals who had at least 1 claim with an HCV diagnosis code (International Classification of Diseases, Ninth Revision [ICD-9] code 070.44, chronic hepatitis C with hepatic coma; or 070.54,24 chronic hepatitis C without hepatic coma)25 between January 1, 2012, and September 30, 2015 (end of the ICD-9 coding era), and had evidence of pharmacy utilization (to ensure membership in a plan that included pharmacy coverage). We then grouped individuals by calendar year according to their periods of enrollment. Individuals were included in calendar year totals if they had at least 1 day of enrollment in that year; individuals could thus contribute to multiple years during their enrollment. We analyzed medical and pharmacy claims from January 1, 2012, through December 31, 2015.

Outcome Measures

We first calculated numbers of patients receiving at least 1 dispensing of old and/or new medications for HCV by calendar year and the total number of days supplied for each medication. Old HCV medications were boceprevir (Victrelis), telaprevir (Incivek), interferon and peginterferon, and ribavirin. New HCV medications included in our analysis were interferon-free regimens: daclatasvir dihydrochloride (Daklinza), ledipasvir/sofosbuvir (Harvoni), simeprevir sodium (Olysio), sofosbuvir (Sovaldi), ombitasvir/paritaprevir/ritonavir (Technivie), and ombitasvir/paritaprevir/ritonavir/dasabuvir sodium (Viekira Pak). Our analysis did not include elbasvir/grazoprevir (Zepatier), sofosbuvir/velpatasvir (Epclusa), sofosbuvir/velpatasvir/voxilaprevir (Vosevi), and glecaprevir/pibrentasvir (Mavyret) because they were approved by the FDA after the end of our study period.

We assessed the percentage market share (ie, percentage of pharmaceutical spending) for HCV medications overall and for individual products. Among the cohort of HCV-diagnosed individuals, we calculated OOP and health plan spending for medical and pharmacy (HCV and non-HCV medications) services per member per month and per year. OOP spending included co-payments, coinsurance, and deductible amounts. We also calculated OOP spending among users of both old and new HCV medications.


 
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