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CVS Health Research Institute examines treatment with new hepatitis C therapies

BY Antoinette Alexander

WOONSOCKET, R.I. — An analysis done by the CVS Health Research Institute provides insights regarding patients taking Sovaldi (sofosbuvir), a new and costly 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,” stated Troyen A. Brennan, 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% of patients achieved cure rates and almost all patients completed therapy, with only about 2% 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%, 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 that 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 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 PBM business, who filled prescriptions for Sovaldi since December. While overall discontinuation rates were around 8%, discontinuation rates for treatment-naïve patients who had not previously been treated for hepatitis C, were the highest at 8.7%. Patients who had been previously treated for hepatitis C, and presumably failed previous therapy, only discontinued therapy 5.3% 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%. Patients who filled at channels outside of CVS Health discontinued at a rate of 8.5%.

“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,” added Alan Lotvin, 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.”

The company stressed that CVS/caremark specialty pharmacy and its Specialty Connect program strives to simplify 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 clinical support by phone from a team of specialty pharmacy experts. 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.
 

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Family Dollar board recommends against Dollar General tender offer

BY Michael Johnsen

MATTHEWS, N.C. — Family Dollar Stores on Wednesday announced that its board of directors unanimously recommends that Family Dollar’s shareholders reject the unsolicited conditional tender offer made by Dollar General Corp. and not tender its shares. In conjunction with its rejection of Dollar General’s offer, Family Dollar’s board unanimously reaffirms its recommendation in support of the transaction with Dollar Tree. 
 
The terms of the tender offer are the same as those in the proposal made by Dollar General on Sept. 2, which the board of directors of Family Dollar unanimously rejected on Sept. 5, on the basis of antitrust regulatory considerations. 
 
“Our board of directors, with the assistance of outside advisors and consultants, reviewed all aspects of Dollar General’s tender offer and concluded unanimously that this highly conditional Offer is illusory because, as Dollar General is well aware, the Offer cannot close on the terms proposed," stated Howard Levine, chairman and CEO of Family Dollar. "Tenders into the Dollar General offer will be meaningless since there is no way that Dollar General can purchase shares that are tendered," he said. “There is a very real and material risk that the transaction proposed by Dollar General would fail to close, after a lengthy and disruptive review process. Accordingly, our board has rejected Dollar General’s tender offer and reaffirmed its support of the transaction with Dollar Tree, which delivers attractive value in the form of immediate upfront cash and upside participation in a combined Dollar Tree-Family Dollar entity, as well as closing certainty.” 
 
Ed Garden, a Family Dollar director and co-founder and chief investment officer at Trian Fund Management, a large shareholder of the company, stated, “We are focused on delivering to Family Dollar shareholders the highest value with certainty, and the Dollar Tree transaction does just that. Dollar Tree has taken the antitrust risk off the table by committing to divest as many stores as necessary to obtain antitrust clearance. We remain fully committed to the Dollar Tree transaction.” 
 
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Panelists at NACDS TSE examine in-store testing

BY Jim Frederick

Cheryl Miller and John Tamerius of Quidel, Karen Mankowski of Meijer, Michael Klepser of Ferris State and Alex Adams of NACDS discuss point-of-care screening in the pharmacy.

With diabetes and other diseases at epidemic levels, the need for more pharmacies to step up and offer accessible, convenient patient screening for a variety of serious and even life-threatening conditions is clear, a panel of pharmacists asserted at the NACDS Total Store Expo “Convenient Care — Point of Care Testing in the Pharmacy” Insight Session in late August. So, too, is the opportunity to drive new business to the pharmacy through point-of-care testing services.

(For the full report, including charts, click here.)

Panelists included Michael Klepser, professor of pharmacy practice with Ferris State University in Michigan; Karen Mankowski, VP pharmacy retail operations at Meijer; John Tamerius, SVP clinical and regulatory affairs for Quidel Corp.; and Cheryl Miller, Quidel’s director of strategic operations. The event was moderated by Alex Adams, National Association of Chain Drug Stores VP
pharmacy programs.

Point-of-care screening of patients at the pharmacy is rapidly gaining validity among patients and other health professionals, including doctors, as the need for more immediate and responsive health and preventive care
services grows.

To advance the concept, Ferris State collaborated with Meijer on a pilot project funded by the NACDS Foundation. Under the program, Meijer offered free testing for influenza and strep throat at 12 of its stores. Six of those stores were set up as collaborative practice sites integrated with a local physician.

The results showed real benefits both for patients and participating pharmacies, Mankowski said. Not only did pharmacists catch undiagnosed conditions among some patients, but “1-in-3 patients who came into the test program did not have a primary care physician,” she said.

Although there was “some apprehension” among some pharmacists and “some push back” from a few local doctors, Mankowski said resistance melted away as the value of point-of-care pharmacy-based health screenings became clear. “We view point-of-care testing as a very viable model,” she said.

Klepser added, “This is going to be bigger than immunizations” for retail pharmacy. “Pharmacists are essentially going to be the GPs (general practitioners) of the future.”

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