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HCV Drug Adherence, Discontinuations
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Download the PDF here
Jules Levin, NATAP
CVS Issued this Sovaldi adherence report in September stating that discontinuations rates were much higher in their study of patients using these regimens in 2014 vs discontinuations rates in clinical trial studies where discontinuation rates ranged approximately from 0 to 1% or 2%. First I would say if you look in Table 2 you will see in the simeprevir+sofosbuvir IFN-free regimen adherence was better compared to the other regimens, much better while for patients taking the other RBv & IFN based regimens discontinuations were much higher. So now we have newer regimens without interferon & some without Rbv & some with RBv, all with in general high SVR rates, so the situation has changed, easier to tolerate regimens in general. Still in the 'real-world' adherence & discontinuation will always be a greater problem than in clinical trials, particularly phase 3 pivotal trials, thats the case in HIV for sure, in the real world adherence is also an issue.
BUT in HIV for 20 years now adherence has been stressed & adherence support services have all greatly improved adherence compared perhaps to the earlier days in HIV from 1996-2005. Still, HIV is not HCV, we have not implemented strong adherence programs in HCV yet and patients all too often apparently may not yet understand adherence. And clinicians apparently may not yet be teaching & advising on adherence adequately with patients. Of interest in this report is that treatment-naives had higher rates of discontinuations vs treatment-experienced, which suggests to me & reinforces my opinion that adherence support & education is inadequate for patients & in the clinician's office because the treatment-experienced patients apparently understand why it is so important to be adherent. In addition, there might be other reasons for discontinuations in the current situation with HCV: are insurers stopping refill prescriptions if requirements are not met in a timely way, such as not submitting a viral load test; how about that some insurers may only be issuing a 4 week prescription at a time, does this inhibit patient refilling the prescription & making it harder for the patient to stick with it; the paperwork that insurers are requiring may be too difficult dis-incentiving patient adherence. Still, adherence education for patients & in the clinician's office needs to be improved.
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Analysis of "Real World" Sovaldi® (sofosbuvir)
Use and Discontinuation Rates
September 2014
See attached pdf full report
Discontinuation Rates and Correlates of Discontinuation
To study discontinuation rates, we created a cohort of patients who were continuously eligible with CVS/caremark insurance for 44 months in order to establish previous use of any Hepatitis C regimen.
We identified all patients who were continuously eligible and started a Hepatitis C regimen with Sovaldi on or before 5/15/14 in order to assess rates of discontinuation or completion of the regimen. A total of 1,965 patients met this eligibility criteria.
Among those patients who began Sovaldi in combination with other medications, Sovaldi discontinuation rates were approximately four times greater than the rates observed in clinical trials (Table 2): Sovaldi+Peg-IFN+RBV (10.2 percent of patients discontinued), Sovaldi+Olysio (4.2 percent), and Sovaldi+RBV (9.0 percent). Across regimens, treatment-naïve patients were 64 percent more
likely to discontinue therapy with Sovaldi than treatment-experienced patients: 8.7 percent treatment-naïve patients discontinued therapy vs. 5.3 percent for treatment-experienced patients (p<0.05).
Discontinuation rates also varied by the site of delivery. We evaluated discontinuation rates in the CVS Health organization, where specialty patients receive the same counseling and ongoing patient-centered support services from central specialists whether they access their medications through home delivery or at CVS/pharmacy retail stores through our Specialty Connect™ program.
We compared discontinuation rates for patients who filled Sovaldi regimens in CVS/pharmacy retail locations or CVS/caremark specialty pharmacies with patients who filled in non-CVS Health-related outlets. To conduct this analysis, we included members who initiated therapy between 12/1/2013 and 5/15/2014, with paid claims and continuous eligibility between 12/1/2013 and 8/24/2014
In general, discontinuation rates were considerably higher in non-CVS Health outlets. When patients filled their Sovaldi regimens at either CVS/pharmacy retail stores or CVS/caremark specialty pharmacies, through the Specialty Connect™ program, they discontinued their regimens 5.9 percent of the time. Patients who filled outside of CVS Health discontinued 8.5 percent of the time, a 44
percent increased rate of discontinuation compared with CVS Health sites. Discontinuation rates were 8.8 percent for non-CVS/pharmacy retail locations and 8.3 percent for non-CVS/caremark specialty pharmacies. (Table 3)
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CVS Health Research Institute Provides First Look at Treatment with New Hepatitis C Therapies
Data shows recent plateau and drop in therapy utilization, but experts suggest new surge upon pending approval of new regimens
Therapy discontinuation rates were nearly four times higher than in clinical trials, pointing to importance of focusing on medication adherence strategies
CVS/caremark specialty pharmacy support results in higher rates of medication adherence for patients undergoing therapy
WOONSOCKET, R.I., (September 17, 2014) - An analysis done by the CVS Health Research Institute provides insights regarding patients taking Sovaldi® (sofosbuvir), a new and expensive treatment for Hepatitis C introduced in December. The data shows that over the last several months (May through August 2014) there has been a plateau and actual downward trend in Sovaldi utilization. This suggests another surge of patients will begin therapy when a number of new therapeutic regimens of similar efficacy and shorter duration are introduced in the Fall.
"Despite the current plateau and decline in Sovaldi utilization, we expect to see another peak in spending for Hepatitis C medications upon the release of the new all-oral treatment," said Troyen A. Brennan, M.D., Chief Medical Officer of CVS Health. "While the simplicity of the new treatment regimen may help reduce discontinuation rates, careful follow-up such as that provided by pharmacies specializing in Hepatitis C in conjunction with the patient's physician, is still required to ensure patients are completing their course of therapy and deriving the maximum benefit."
In clinical trials for Sovaldi, more than 95 percent of patients achieved cure rates and almost all patients completed therapy, with only about two percent discontinuing treatment. However, clinical trials rarely capture the real-life challenges faced by patients taking a new drug. The new CVS Health data also provides a first look at the drug's use outside of the clinical trial setting and shows therapy discontinuation rates of 8.1 percent, approximately four times higher than in trials. Furthermore, patients who were completely new to Hepatitis C treatment were more likely to discontinue therapy, a finding which has substantial implications for clinicians and their patients.
"While Sovaldi represents a breakthrough in the treatment of Hepatitis C, this is an expensive drug that needs to be taken as directed for the full course of treatment in order to achieve the maximum clinical benefit demonstrated in the trials," added Dr. Brennan. "Our data suggest that in order to help patients achieve their treatment goals, we need to ensure that those patients who are prescribed Sovaldi are adherent to their full course of therapy."
The CVS Health Research Institute analyzed discontinuation rates for nearly 2,000 patients managed by CVS/caremark, the CVS Health pharmacy benefit management business, who filled prescriptions for Sovaldi since December. While overall discontinuation rates were around eight percent, discontinuation rates for treatment-naïve patients who had not previously been treated for Hepatitis C, were the highest at 8.7 percent. Patients who had been previously treated for Hepatitis C, and presumably failed previous therapy, only discontinued therapy 5.3 percent of the time.
A comparison of patients who received their Hepatitis C medications and care from CVS/caremark specialty pharmacy versus those who received their medications and care from pharmacies outside the CVS Health system finds that CVS/caremark specialty pharmacy patients achieved substantially improved adherence. The discontinuation rate for patients who filled their Hepatitis C medications at either CVS/pharmacy retail stores or CVS/caremark specialty pharmacies was 5.9 percent. Patients who filled at channels outside of CVS Health discontinued at a rate of 8.5 percent.
"These findings reiterate that outside of clinical trials, patients are at a higher risk of not completing their course of therapy, representing a substantial cost to the health care system without achieving the desired clinical benefit," said Alan Lotvin, M.D., EVP of CVS/specialty, CVS Health. "The data also suggest that the type of pharmacy care these patients receive can impact discontinuation rates, with those patients who have access to specialty pharmacies with expertise in managing Hepatitis C such as CVS/caremark specialty pharmacy, seeing improved adherence and outcomes."
CVS/caremark specialty pharmacy and its Specialty Connect™ program simplifies getting started on therapies for complex conditions such as Hepatitis C, and helps patients stay on therapy to support improved health outcomes. Patients can bring their specialty prescriptions to any CVS/pharmacy location as a complement to existing CVS/caremark specialty pharmacy processes and receive insurance guidance and dedicated clinical support by phone from a team of specialty pharmacy experts, who are available 24 hours a day, 365 days a year. The program also makes it easy for patients to access their specialty drugs, whether they choose in-store pickup at CVS/pharmacy stores or receive their medications in the mail.
The CVS Health Research Institute is focused on contributing to the body of scientific knowledge related to pharmacy and health care through research collaborations with external academic institutions, participation in federally-funded research, analysis and sharing of CVS Health data sources and coordination of pilot programs and initiatives. CVS Health Research Institute findings support a continuous quality improvement environment, which encourages product innovation and development to benefit CVS Health patients, clients and their members.
For more detail on the data, please visit the following link:
http://cvshealth.com/sites/default/files/hepatitisCutilization.pdf
About CVS Health
CVS Health (NYSE: CVS) is a pharmacy innovation company helping people on their path to better health. Through our 7,700 retail pharmacies, 900 walk-in medical clinics, a leading pharmacy benefits manager with nearly 65 million plan members, and expanding specialty pharmacy services, we enable people, businesses and communities to manage health in more affordable, effective ways. This unique integrated model increases access to quality care, delivers better health outcomes and lowers overall health care costs. Find more information about how CVS Health is shaping the future of health at www.cvshealth.com.
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