FDA approves Mekinist in combination with Tafinlar to treat patients with advanced melanoma
NEW YORK — The Food and Drug Administration recently approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (i.e., cannot be removed by surgery) or metastatic (i.e., late-stage), Onco360 announced last week.
Both Mekinist and Tafinlar are only available in limited distribution, and Onco360 is one of the few pharmacies with access to both medications.
Mekinist and Tafinlar are used to block signaling in different sites of the same molecular pathway that promotes cancer cell growth. They are specifically indicated as a combination therapy for patients with melanoma whose tumors express gene mutations called BRAF V600E and V600K1. Clinical trial results for the combination therapy were highly encouraging.
Results showed that 76% of participants treated with Mekinist in combination with Tafinlar had their cancer shrink or disappear (objective response) that lasted an average of 10.5 months. In contrast, 54% of participants treated with Tafinlar as a single agent experienced objective responses that lasted an average of 5.6 months.
Clinical trials are ongoing to determine whether Mekinist in combination with Tafinlar improves survival.
Medication synchronization affirms retail pharmacy’s value to overall health care
The National Community Pharmacists Association shared a proof of concept study that affirmed the value retail pharmacy can deliver in saving healthcare dollars. Patients who opted-in to medication synchronization programs offered through their community pharmacy averaged more than 100 additional days on therapy per year and were 30% more likely to take their medication as prescribed.
At a time when health systems and payers are actively seeking sound strategies to keep their patients from being readmitted to a hospital, pharmacy could very well be their panacea. Sticking to a prescribed drug therapy script does just that — it helps prevent re-hospitalizations, which will be a key metric with the implementation of the Affordable Care Act. The community pharmacist also sees the patients more often than other healthcare practitioners and has as many opportunities to provide appropriate course correction, if necessary, around a particular medicinal regimen if it isn’t working. And medication synchronization augments the pharmacists’ ability to keep their patients on point.
Nearly 90% of patients who received synchronized refills were considered adherent as measured by the proportion of days covered, compared with 56% of patients not receiving synchronized refills, NCPA reported. The gaps in medication coverage were reduced, along with the provision of adherence-supporting services from the community pharmacies.
That suggests medication synchronization programs represent a validated method to capture patients for the adherence counseling services that more and more pharmacies are offering. According to the latest NCPA Digest, 48% of independent community pharmacies are offering adherence counseling services, up from 39% last year. "We have encouraged that [developing adherence services] strongly because we believe adherence is a building block for pharmacists as they develop clinical services," suggested NCPA CEO Douglas Hoey during a press conference this past fall.
NCPA’s synchronization study comes on the heels of another medication synchronization success story — that of Thrifty White. The Nov. 11 issue of DSN reported results from Thrifty White’s medication synchronization program, which had at the time of publication enrolled 30,000 patients and was growing at clip of 250 additional patients per week. Patients enrolled in that synchronized refill program were on medication therapy 341 days out of a 12-month period, compared with 235 days of medication coverage averaged by patients in a control group.
Thrifty White also found that medication synchronization programs appeal to patient populations across the age spectrum. “You’d think a lot more of them would be the 65 years and older patients,” Tim Weippert, Thrifty White EVP pharmacy, told DSN. “But looking at all our data, the sweet spot for this model is between the ages of 40 years and 55 years.” One possible reason: folks in that age group are “very active, on the go and need reminders” to stay adherent and persistent with the meds, he suggested. But whatever the cause, with “10,000 people a day turning 65,” Weippert said, “there’s great potential” for growth of the med sync program.
Par Pharmaceutical to distribute authorized generic of Covis’s Lanoxin (digoxin) tablets
WOODCLIFF LAKE, N.J. — Par Pharmaceutical on Thursday announced that it has entered into an exclusive U.S. supply and distribution agreement with Covis Pharma S.a.r.l. to distribute the authorized generic version of Covis’s Lanoxin (digoxin) tablets.
According to IMS Health data, annual U.S. sales of digoxin tablets are approximately $44 million.
Digoxin tablets are indicated for treatment of mild to moderate heart failure in adults, increasing myocardial contractility in pediatric patients with heart failure, and control of resting ventricular rate in patients with chronic atrial fibrillation in adults.
Par has begun shipping 0.125 mg and 0.25 mg strengths of digoxin tablets.