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The American Journal of Managed Care February 2020
Care Coordination for Veterans With COPD: A Positive Deviance Study
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Discontinuation of New Hepatitis C Drugs Among Medicare Patients
Jeah Jung, PhD, MPH; Ping Du, MD, PhD; Roger Feldman, PhD; and Thomas Riley III, MD
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Discontinuation of New Hepatitis C Drugs Among Medicare Patients

Jeah Jung, PhD, MPH; Ping Du, MD, PhD; Roger Feldman, PhD; and Thomas Riley III, MD
Real-world discontinuation of hepatitis C drugs was low, but it was 3 times more likely than in clinical trials and varied by patient characteristics.
ABSTRACT

Objectives:
To examine factors associated with discontinuation of new hepatitis C drugs—second-generation direct-acting antivirals (DAAs)—among Medicare beneficiaries with chronic hepatitis C.

Study Design: A retrospective analysis using 2014-2016 Medicare claims.

Methods: The study population was patients with chronic hepatitis C in fee-for-service Medicare with Part D who initiated a DAA therapy between January 1, 2014, and September 1, 2016. We defined discontinuation of DAA therapy as filling prescriptions for fewer weeks than the expected duration of the DAA identified. We estimated adjusted odds ratios (aORs) of DAA discontinuation by patient characteristics using multivariable logistic regression. We estimated the model separately for patients with a Part D low-income subsidy (LIS) and those without an LIS.

Results: Of 82,056 patients who initiated a DAA therapy during the study period, 5171 (6.3%) did not complete the therapy. Discontinuation rates varied across DAAs, ranging from 4.7% (elbasvir/grazoprevir) to 11.8% (ombitasvir/paritaprevir/ritonavir/dasabuvir). Women with an LIS were more likely to discontinue DAA therapy than men with an LIS (aOR, 1.16; 95% CI, 1.08-1.25; P <.01). Non-LIS black and Hispanic patients had higher odds of discontinuation than non-LIS white patients (black: aOR, 1.49; 95% CI, 1.28-1.73; P <.01; Hispanic: aOR, 1.56; 95% CI, 1.01-2.44; P <.05). High comorbidity index score increased the odds of DAA discontinuation among patients with an LIS.

Conclusions: Real-world discontinuation of DAA therapy was low, but it was 3 times more likely than in clinical trials and varied by patient characteristics. Efforts to increase DAA adherence would help lower patients’ risk of developing resistance to future treatments and reduce potential waste of resources.

Am J Manag Care. 2020;26(2):84-88
Takeaway Points

We examined factors associated with discontinuation of new hepatitis C virus drugs—second-generation direct-acting antivirals (DAAs)—among Medicare beneficiaries with chronic hepatitis C between 2014 and 2016. We found:
  • Real-world discontinuation of DAA therapy among Medicare patients was low (6.3%), but it was about 3 times more likely than in clinical trials.
  • No racial/ethnic gap in DAA adherence existed among Medicare patients with a low-income subsidy (LIS); however, non-LIS black and Hispanic patients were more likely to discontinue a therapy than non-LIS white patients.
  • Discontinuation of DAA therapy was more likely among patients who had cirrhosis or more comorbidities.
Hepatitis C virus (HCV) infection is an important public health issue. It causes costly and serious liver diseases such as cirrhosis and liver cancer.1 HCV also aggravates other conditions, such as renal insufficiency, vasculitis, and rheumatoid arthritis, through its extrahepatic effects, decreasing patients’ quality of life and increasing economic burdens.2-5 In 2014, HCV caused more deaths in the United States than any other infectious disease, including HIV/AIDS.6,7

The introduction of new HCV drugs—second-generation direct-acting antivirals (DAAs)—has provided an unprecedented opportunity to address the HCV epidemic.8,9 They are highly effective and easy to administer and have a short treatment period compared with earlier therapies. These features help patients complete the recommended course of DAAs, after which most patients are cured. Randomized trials found that only 1% to 2% of patients did not complete DAA therapy, which is a significant improvement over earlier HCV treatments.10,11 However, drug adherence in real-world practice may be poorer than in clinical trials because real-world patients are not as closely followed up as those in trials. High patient cost sharing for DAAs, a potential deterrent to therapy completion, is also likely in the real world.

Discontinuation of DAA therapy may limit the health benefits from the therapy and can place the patient at risk of developing resistance to future HCV treatments.11 Furthermore, given the high costs of DAAs, discontinuation of DAA therapy adds to financial burdens on the healthcare system without corresponding health benefits.12 It is thus important to monitor continuation of DAA prescriptions and identify patient characteristics related to prescription discontinuity. However, real-world evidence on DAA prescription continuity is limited. One study of commercial insurance enrollees reported that discontinuation of the first DAA (sofosbuvir, launched in December 2013) was 4 times higher than in clinical trials.12 Another study of private plan enrollees also indicated higher DAA discontinuation in the real world than in clinical trials.13 No information exists on discontinuation of DAAs in Medicare, which has been the largest payer of DAAs.14

We examined factors associated with discontinuation of DAA therapy between 2014 and 2016 in a national cohort of Medicare patients with HCV. Many baby boomers—the group with the highest prevalence of HCV—are enrolled in Medicare.15 Medicare also covers patients with high HCV infection rates—nonelderly individuals who are disabled and/or dually eligible for Medicare and Medicaid. Discovering patient characteristics related to DAA discontinuation among Medicare patients can help clinicians and payers devise targeted interventions to improve drug adherence.

METHODS

Study Population and Data

We identified all patients with HCV who were continuously enrolled in fee-for-service Medicare with Part D in a given year between 2014 and 2016 using Medicare data (eAppendix Table 1 [eAppendix available at ajmc.com] lists diagnosis codes of all conditions used in the study). From these, we selected patients who initiated a DAA therapy between January 1, 2014, and September 1, 2016, and who were alive at least 4 months after initiating the therapy because most DAA users are on regimens with a therapy duration of 12 weeks or less. We used Medicare Prescription Drug Event files to identify initiation of 1 of the following DAAs: elbasvir/grazoprevir, ledipasvir/sofosbuvir, ombitasvir/paritaprevir/ritonavir plus dasabuvir, sofosbuvir, and sofosbuvir/velpatasvir. All DAAs except sofosbuvir are administered as monotherapy or in combination with ribavirin. Sofosbuvir is concomitantly used with peginterferon, ribavirin, simeprevir, or daclatasvir.

We obtained information on patient demographics and clinical characteristics from Medicare Beneficiary Summary Files.

Outcome

We defined discontinuation of a DAA as filling prescriptions for fewer weeks than the expected duration of the DAA identified from package inserts or randomized trials. Discontinuation for patients who switched to a different DAA was based on the last DAA used by the patient. Discontinuation for patients on a regimen of a DAA plus ribavirin was based on only the DAA because ribavirin is used as an adjunct therapy to DAAs.16,17

DAA regimens vary by genotype and prior HCV treatment experience, which could not be identified from Medicare claims. However, the recommended duration of therapy indicated by package inserts is 12 weeks for most patients regardless of DAA regimen. For patients who have prior experience with other HCV treatments, the recommended treatment duration is 24 weeks (16 weeks for elbasvir/grazoprevir). Results of recent randomized trials for patients without cirrhosis showed that 8-week treatments are effective for elbasvir/grazoprevir, ledipasvir/sofosbuvir, and ombitasvir/paritaprevir/ritonavir/dasabuvir.18-20 For these 3 DAAs, we required 8 weeks of treatment for patients without cirrhosis and 12 weeks for those with cirrhosis. For other DAAs, we applied 12 weeks to patients with and without cirrhosis. If patients filled prescriptions for more than 12 weeks (ie, patients were on regimens with expected duration >12 weeks), we applied 16 weeks for elbasvir/grazoprevir and 24 weeks for all other DAAs based on each drug’s package insert. We considered an interval between fills of fewer than 60 days as continuation of the therapy.


 
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