FDA approves Kombiglyze XR
LONDON and PRINCETON, N.J. The Food and Drug Administration approved the first and only once-a-day metformin extended-release plus dipeptidyl peptidase-4 inhibitor combination tablet for the treatment of Type 2 diabetes.
Bristol-Myers Squibb and AstraZeneca’s Kombiglyze XR offers strong glycemic control across HbA1c levels, fasting plasma glucose and post-prandial glucose. Kombiglyze XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate, the drug companies said.
The FDA approved once-a-day Kombiglyze XR based on two phase-3 clinical trials and bioequivalence studies. The two clinical studies evaluated the efficacy and safety of saxagliptin and metformin IR as separate tablets compared with placebo added to metformin IR. Bioequivalence was demonstrated in healthy adults between Kombiglyze XR and saxagliptin plus metformin XR as separate tablets.
“Nearly half of adult patients remain uncontrolled on their current treatment regimen and may thus require additional medications,” said Elliott Sigal, EVP, chief scientific officer and president of research and development at Bristol-Myers Squibb. “With our heritage of bringing metformin — the most widely prescribed oral antidiabetic medication — and more recently saxagliptin to patients in the United States, we are committed to making Kombiglyze XR the newest building block in our long-term commitment to helping adult patients with Type 2 diabetes.”
NACDS brushes up new members of Congress on importance of community pharmacy to U.S. health care
ALEXANDRIA, Va. In a clear message to the newly elected lawmakers that pharmacies can be utilized even more effectively to help reduce healthcare costs and improve healthcare quality, the National Association of Chain Drug Stores sent a pharmacy briefing letter Friday to each of the new lawmakers.
“NACDS is highly engaged on issues that impact pharmacy and its patients. As the face of neighborhood healthcare, pharmacy is a convenient, accessible healthcare provider, with locations in every congressional district across the United States,” said NACDS president and CEO Steve Anderson.
In the letter, NACDS detailed ways in which “pharmacies are vital to healthcare delivery in the United States and can be utilized even more effectively to help reduce healthcare costs and improve healthcare quality.” The briefing letter invited the new members of Congress to tour pharmacies in their home states to get a firsthand look at the value of community pharmacy, and offered assistance through NACDS’ RxIMPACT program. It also included a copy of NACDS’ “Pharmacies: Improving Health, Reducing Costs,” which explains the role of pharmacy in greater detail.
“NACDS looks forward to working with the newly elected lawmakers in the 112th Congress to achieve pro-patient, pro-pharmacy policies,” Anderson said.
Affordable Care Act expected to deliver big savings to Medicare recipients
WASHINGTON Under the Affordable Care Act, the average savings for those enrolled in traditional Medicare is expected to amount to more than $3,500 over the next 10 years — and will be even higher for seniors and people with diabetes who have high drug costs — according to the U.S. Department of Health and Human Services.
"The Affordable Care Act makes Medicare stronger and reduces the burden of healthcare costs on some of our most vulnerable citizens," stated HHS secretary Kathleen Sebelius. "The law improves benefits for seniors and people with beneficiaries who rely on Medicare, and ensures that Medicare will be there for current and future generations by extending the life of the Medicare Trust Fund. These benefits and savings are only possible with the continued implementation of the Affordable Care Act."
While the average savings is pegged at more than $3,500 over the next 10 years, the savings will be even higher — as much as $12,300 over the next 10 years — for seniors and people with disabilities who have high prescription drug costs.
The analysis, released by the Office of the Assistant Secretary for Planning and Evaluation, shows that the Affordable Care Act helps lower costs for those on Medicare by slowing the growth of cost-sharing in Medicare.
Closing the Part D coverage gap known as the "doughnut hole" will produce the greatest cost savings. Already, more than 1.8 million seniors and people with disabilities who have reached the doughnut hole in 2010 received a one-time $250 rebate check, and checks will continue to be distributed to those who enter the doughnut hole this year. Next year, people in the doughnut hole will receive 50% discounts on covered brand-name Part D prescription drugs. Also starting next year, seniors and people with disabilities on Medicare will have access to a number of recommended preventive services and annual wellness visits at no additional cost.
Although all seniors and people with disabilities in Medicare are likely to see savings, the savings will be greatest for those with costly medical conditions or high prescription drug costs. Total savings per beneficiary enrolled in traditional Medicare are estimated to be $86 in 2011, rising to $649 in 2020. For a beneficiary with spending in the doughnut hole, estimated savings increased from $553 in 2011 to $2,217 in 2020.