PHARMACY

Adherence gets some stickiness

BY Rob Eder

“No one gets paid unless patients improve adherence.”

That’s what Aaron McKethan, SVP of strategy and business development for RxAnte, had to say in a Jan. 13 article on Forbes.com, “A digital health acquisition to watch.” The story focused largely on RxAnte’s recent acquisition by Millennium Laboratories in December — which the author described as a “little-known, private equity-backed urine drug testing company” — and the technology it uses to improve patient adherence.

Basically, RxAnte employs predictive analytics to mine patient data, applying variables like past refill history and the number of drugs a patient takes to determine on a scale of 0% to 100% the likelihood that the patient will be compliant with their medications. In July, the company began a pilot with Coventry Health to measure the impact of having doctors and nurses who are signed up for the program, reach out to their patients that RxAnte has identified as at-risk. The results of the study are expected to be released in the spring.

What DSN finds most interesting about the Forbes.com article is not the story itself — DSN covers companies like RxAnte and its partners all the time and has for years. Moreover, it is a strong sign that adherence is becoming part of the public conversation around health reform, including lowered costs and improved outcomes — it’s not just community pharmacy advocates saying it any more. And as the rubber meets the road on health reform this year, and payers demand better results and more transparency, and physicians need help managing the risk of delivering better patient outcomes, DSN expects more of these stories to emerge.


Rob Eder is the editor in chief of The Drug Store News Group, publishers of Drug Store News and DSN Collaborative Care magazines. You can contact him at [email protected].

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PHARMACY

Sun Pharma approved for generic Temodar

BY Ryan Chavis

MUMBAI — Sun Pharmaceutical Industries announced that the Food and Drug Administration has granted final approval for its generic version of Temodar temozolomide capsules in 5-mg, 20-mg, 100-mg 140-mg, 180-mg and 250-mg form.

Temozolomide capsules are used for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy. It also serves as a maintenance treatment and for adult patients with refractory anaplastic astrocytomas that have experienced disease progression on a drug regimen containing nitrosourea and procarbazine, according to the company.

Temozolomide capsules are therapeutic equivalents of Merck Sharp & Dohme’s Temodar capsules. The capsules have annual sales of approximately $400 million.

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FDA commissioner blogs regarding challenges facing Indian drug manufacturers

BY Michael Johnsen

SILVER SPRING, Md. — In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections. 

"I am happy to report that the FDA is working quickly to fulfil one of our commitments under the Generic Drug User Fee Act — reducing the backlog of generic drug applications that were pending when the new user fee program went into effect on Oct. 2, 2012," Hamburg reported. "As of the end of January 2014, our Center for Drug Evaluation and Research had taken a formal action on 45% of backlogged generic drug applications. In December 2013 alone, the center completed 174 actions, including 30 full approvals for generic drugs."

Participants of the roundtable meetings last week attended by Hamburg, which were organized by the Federation of Indian Chambers of Commerce and Industries also reported they were challenged by heightened inspectional activities. "I told them that every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective and of high-quality," Hamburg said. "I am pleased that as a global leader in the pharmaceutical and foods sectors, India will continue partnering with us to ensure that the companies exporting products to the United States adhere to established quality standards," she added. "On the home front, we at the FDA also will continue to increase our focus on quality. One way we are doing this is through the creation of a new Office of Pharmaceutical Quality that will create one voice for drug quality at the FDA and improve our oversight of quality throughout the lifecycle of a pharmaceutical product."

 

 

 

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