Newly approved hepatitis C treatment by Gilead Sciences said to offer major advance in treatment
FOSTER CITY, Calif. — The Food and Drug Administration has approved a new drug for hepatitis C made by Gilead Sciences, the drug maker said Friday.
Gilead announced the approval of Sovaldi (sofosbuvir) tablets in the 400-mg strength, intended to be taken once per day for chronic hepatitis C as part of a combination antiviral treatment regimen by patients with genotypes 1, 2, 3 and 4 of the virus. The FDA gave Gilead priority review and breakthrough therapy designations for the drug, which it does for experimental medications that may offer major advances in treatment over existing options.
According to Gilead, patients with genotype 1 or 4 should take the drug with pegylated interferon alfa and ribavirin for 12 weeks; those with genotype 2 should take it with ribavirin for 12 weeks; and those with genotype 3 should take it with ribavirin for 24 weeks. Chronic hepatitis C affects about 4 million people in the United States, mostly those born between 1945 and 1965, and it is the leading cause of liver cancer and liver transplants, in recent years surpassing HIV and AIDs as a cause of death. The current standard of care involves up to 48 weeks of treatment with pegylated interferon and ribavirin.
"I believe that Sovaldi will have a major impact on public health by significantly increasing the number of Americans who are cured of hepatitis C," Weill Cornell Medical College researcher and chief investigator in the Sovaldi clinical trials Ira Jacobson said. "In clinical studies, Sovaldi in combination with other agents achieved very high cure rates while shortening the duration of treatment to as little as 12 weeks and reducing or completely eliminating the need for interferon injections, depending on the viral genotype."
Retail clinics continue to gain strong momentum
Seattle-based regional pharmacy chain Bartell Drugs will open, in early 2014, retail-based clinics inside three of its stores under a partnership with local health organization Group Health Cooperative.
The importance of the news isn’t just the fact that this will mark Bartell’s foray into the convenient care clinic arena but also that it speaks to a much broader notion — 2014 will be the year of the clinics. Yes, we have said it before and we’re saying it yet again.
With healthcare reform bringing millions of Americans into the insurance fold, the anticipation is palpable and players within the community pharmacy space are increasingly stepping up to demonstrate the important part they play in improving patient outcomes. This is placing a renewed focus on the retail-based clinic model and operators are working to expand their scope of services, grow their footprints and forge clinical affiliations with major healthcare systems.
In fact, just days after Bartell’s announcement it was revealed that CVS Caremark’s MinuteClinic has expanded to its 28th state with the opening of clinic locations inside select CVS/pharmacy stores in New Hampshire, and the clinic operator also has formed a new clinical collaboration with Dartmouth-Hitchcock, the largest healthcare system in New Hampshire.
In addition, RediClinic, a Texas-based operator of care clinics based in H-E-B grocery stores, unveiled its newest version of Weigh Forward, its weight and lifestyle management program, which is being dubbed Weigh Forward 2.0.
Clearly, convenient care clinics are communicating their vital role as a provider of quality, affordable and convenient healthcare but what’s more important — patients and payors are listening.
As FierceHealthcare has reported, researchers found that if retail-based clinic visits make up for 10% of all outpatient primary care visits by 2015, national cost-savings would be $2.2 billion. If nurse practitioners in all 50 states practiced independently, that would add on an additional $810 million. That savings could grow even more — by $472 million — if nurse practitioners could prescribe on their own too. That is significant.
Health Mart: Putting the pestle where the mortar is, the franchiser is benchmarking community pharmacy success
McKesson’s Health Mart pharmacy franchisees recently gained access to a tool that has the potential of giving community pharmacy a leg up on the competition in the coming years. EQuIPP, from Pharmacy Quality Solutions, does just that — equips independents with individual store data that marks the performance of their pharmacy vs. a national benchmark.
It’s putting the pestle where the mortar is — retail pharmacy has the patient touchpoints and data-tracking wherewithal to make a material impact on patient outcomes. Important, because that’s what the new year will bring — more and more healthcare payers looking to improve their own patient outcomes. And what better way to do it than to partner with outperforming pharmacies?
It’s a message that’s reverberating throughout the industry. Community pharmacy has constructed the most efficient pathways to less costly modes of care. They do it through medication therapy management programs, medication adherence programs and medication reconciliation when patients are discharged from the hospital. For preventive care and wellness, pharmacies are one of the fastest-growing destinations for vaccinations as well as for disease-state screening services and retail clinics.
And across a sector of the industry where the patient and pharmacist are often on a first-name basis, community pharmacists won’t only be able to surmise their personal relationships help improve patient outcomes on a pharmacy-wide scale, they’ll be able to demonstrate what that personal touch can do through empirical data. The proof will be in the actual outcomes.
"This is a critical time for retail pharmacies to leverage their role as healthcare service providers, and we believe the pharmacies that will stay competitive will consistently deliver clinical interactions that improve patient health while managing costs," Health Mart president Stephen Courtman shared with DSN in an exclusive interview this summer.
This past summer’s McKesson IdeaShare featured an entire pavilion of nothing but compliance-improving solutions. Solutions extended from vaccination programs to adherence training and behavior coaching, refill reminders, medication synchronization and compliance packaging.
"Whether we look at it as an opportunity or a challenge, the growing movement to accountable care and performance-based networks will likely be the major focus over the coming year," Courtman said. "As payers transition from transaction-based reimbursement, their expectations also are shifting to focus on outcomes and results. In order to control the cost of care, payers will control where they send their ‘lives.’"
And now Health Mart operators have one more tool to help direct those lives through their doors.