Walgreens presents five clinical studies tracking pharmacy’s impact on adherence
DEERFIELD, Ill. — Walgreens will present the findings of five recently completed clinical studies at the 22nd Annual International Society for Pharmacoeconomics and Outcomes Research Annual International Meeting, May 20-24 in Boston. Clinical abstracts from the studies being presented focus primarily on Walgreens efforts to improve medication adherence and patient outcomes through various pharmacy initiatives.
“We’re continually seeking to uncover new and innovative approaches to help improve outcomes for our patients,” stated Chet Robson, medical director, clinical programs and quality, Walgreens. “The research we are presenting at ISPOR demonstrates the impact and effectiveness of various pharmacy programs and services and how they can serve to benefit patients and payers.”
The studies to be presented at ISPOR include:
- Analysis of 90-day prescription refill at retail programs, and their impact on improving adherence to medications included in the CMS Star quality measures, demonstrating significantly greater adherence among Medicare Part D patients;
- A study that observes adherence rates among Walgreens Medicare Part D patients for whom pharmacists initiated late-to-refill reminder calls. Greater impact is shown among patients with 90-day medication fills than on 30-day fills;
- An exploration of factors associated with medication self-synchronization (aligning multiple medications to be refilled on the same day), in which findings reveal medication self-synchronization is associated with age, copay amount, selected maintenance medication indicators, day supply indicators and total number of prescriptions;
- Examination of the Universal Medication Schedule as a means of standardizing prescriptions that demonstrates UMS prescribing is associated with significantly higher adherence to oral diabetic medications for older adults with low education who receive a multi-daily regimen. Walgreens collaborated with Northwestern University on this research; and
- A study exploring length of therapy and factors associated with HIV pre-exposure prophylaxis medication adherence, demonstrating significantly higher adherence among older age groups, males, users of HIV-specialized services, and those with private insurance. The study found that patients used PrEP on average for seven to eight months in the first year.
FDA expands approval for Vertex Pharmaceuticals’ cystic fibrosis drug
WASHINGTON — The Food and Drug Administration on Wednesday expanded the approved use of Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for treating cystic fibrosis. According to the FDA, the approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33, adding it based its decision, in part, on the results of laboratory testing, which it used in conjunction with evidence from earlier human clinical trials. The approach provides a pathway for adding additional, rare mutations of the disease, based on laboratory data.
“Many rare cystic fibrosis mutations have such small patient populations that clinical trial studies are not feasible,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “This challenge led us to using an alternative approach based on precision medicine, which made it possible to identify certain gene mutations that are likely to respond to Kalydeco.
Cystic fibrosis affects the cells that produce mucus, sweat and digestive juices. These secreted fluids are normally thin and slippery due to the movement of sufficient ions (chloride) and water in and out of the cells. People with the progressive disease have a defective cystic fibrosis transmembrane conductance regulator gene that can’t regulate the movement of ions and water, causing the secretions to become sticky and thick. The secretions build up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems, as well as other complications such as infections and diabetes.
Results from an in vitro cell-based model system have been shown to reasonably predict clinical response to Kalydeco. When additional mutations responded to Kalydeco in the laboratory test, researchers were thus able to extrapolate clinical benefit demonstrated in earlier clinical trials of other mutations. This resulted in the addition of gene mutations for which the drug is now indicated.
Kalydeco, available as tablets or oral granules taken two times a day with fat-containing food, helps the protein made by the CFTR gene function better and as a result, improves lung function and other aspects of cystic fibrosis, including weight gain. If the patient’s genotype is unknown, an FDA-cleared cystic fibrosis mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.
Cystic fibrosis is a rare disease that affects about 30,000 people in the United States. Kalydeco is indicated for patients aged 2 and older who have one mutation in the CFTR gene that is responsive to drug treatment based on clinical and/or in vitro (laboratory) data. The expanded indication will affect another 3 percent of the cystic fibrosis population, impacting approximately 900 patients. Kalydeco serves as an example of how successful patient-focused drug development can provide greater understanding about a disease.
Common side effects of Kalydeco include headache; upper respiratory tract infection (common cold) including sore throat, nasal or sinus congestion, or runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness. Kalydeco is associated with risks including elevated transaminases (various enzymes produced by the liver) and pediatric cataracts. Co-administration with strong CYP3A inducers (e.g., rifampin, St. John’s wort) substantially decreases exposure of Kalydeco, which may diminish effectiveness, and is therefore not recommended.
Consumer Reports research pinpoints reasons for rising drug prices
NEW YORK — High-deductible insurance plans, changes to “your formulary,” and a few “extremely high-priced drugs” are the main culprits behind increasing drug prices, according to Consumer Reports data released Tuesday.
“An estimated 28 million Americans — or 25% of those who regularly take prescription medications — saw a price increase in the past 12 months, according to the latest Consumer Reports “Best Buy Drugs” nationally representative survey of nearly 1,000 adults who regularly take prescription medication,” the magazine revealed.
The magazine acknowledged rising drug costs are not a new problem. It also provided strategies for consumers seeking to rein in drug costs. This is the advice the publication provided:
- Do a drug review with your doctor or pharmacist;
- Consider nondrug options for what ails you;
- Try a cheaper alternative;
- Don't always use your insurance;
- Ask for a lower price at the pharmacy; and
- Shop around.
To read the full report, click here.