FDA approves Noctiva
WASHINGTON — The U.S. Food and Drug Administration approved Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Noctiva is the first FDA-approved treatment for this condition.
Noctiva is marketed by Renaissance Lakewood for Serenity Pharmaceuticals.
“Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive, and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “It is important to know that Noctiva is not approved for all causes of night-time urination, so patients should discuss their symptoms with their health care provider who can determine the underlying cause of the night-time urination and whether Noctiva is right for them.”
Nocturia (wakening at night to urinate) is a symptom that can be caused by a wide variety of conditions, such as congestive heart failure, poorly controlled diabetes mellitus, medications, or diseases of the bladder or prostate. Before considering Noctiva, the FDA advised health care providers should evaluate each patient for possible causes for the nocturia, and optimize the treatment of underlying conditions that may be contributing to the night-time urination.
Noctiva is taken daily, approximately 30 minutes before going to bed. It works by increasing the absorption of water through the kidneys, which leads to less urine production.
Noctiva’s efficacy was established in two 12-week, randomized, placebo-controlled trials in 1,045 patients 50 years of age and older with nocturia due to nocturnal polyuria. Although these trials showed a small reduction in the average number of night-time urinations with Noctiva compared to placebo, more patients treated with Noctiva were able to at least halve their number of night-time urinations, and patients treated with Noctiva had more nights with one or fewer night-time urinations.
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NCPA endorses latest prescription transparency legislation
WASHINGTON — Reps. Doug Collins, R-Ga., and Dave Loebsack, D-Iowa, on Thursday introduced H.R. 1316, the Prescription Drug Price Transparency Act, to protect taxpayers and the community pharmacists who serve them by requiring greater transparency from pharmacy benefit managers.
“I’m introducing a bipartisan bill to ensure that PBMs update their MAC lists for Medicare Part D, TRICARE, and FEHBP every seven days to protect competitive pricing and to preserve pharmacy access and choice for patients," Collins stated. "The Prescription Drug Price Transparency Act provides essential oversight to prevent waste, fraud, and the abuse of taxpayer funds and better protects patient privacy.”
Support for this legislation extends across the aisle, Collins noted. Rep. Loebsack is the bill’s lead Democratic co-sponsor. Other original co-sponsors for H.R. 1316 include Reps. Brian Babin, R-Texas, Rod Blum, R-Iowa, Buddy Carter, R-Ga., John Duncan, Jr., R-Tenn., Cathy McMorris Rodgers, R-Wash., and John Sarbanes. D-Md.
“Whether it is in large cities, or small towns, pharmacists across the country serve as the first line of health care services for many patients. I appreciate all of their hard work to serve our communities and to provide quality, affordable and personal care,” Loebsack said. "However, I also recognize how challenging it can be for some small pharmacists to compete with bigger companies. One pressing challenge facing many community pharmacists is the ambiguity and uncertainty surrounding the reimbursement of generic drugs. To help address this problem, I am proud to join my colleague Rep. Collins to reintroduce the Prescription Drug Price Transparency Act, which also helps ensure federal health plan reimbursements to pharmacies to keep pace with generic drug prices.”
The National Community Pharmacists Association on Thursday announced its strong support for the legislation.
According to the association, H.R. 1316, the Prescription Drug Price Transparency Act would:
- Require pharmacy benefit managers which serve TRICARE and the Federal Employee Health Benefits programs, to provide the same updates and disclosures to pharmacies for the maximum allowable costs lists that are currently provided to pharmacies in Medicare Part D. These “MAC” lists determine generic reimbursements for pharmacies;
- Set a standard for how frequently those lists are updated;
- Prohibit sharing patient information with PBM-owned pharmacies (mail order and/or retail) unless a patient has chosen to fill that prescription there; and;
- Forbid PBMs from mandating patients use their affiliated pharmacies.
“Taxpayer-funded federal health programs should operate in a fair, efficient and cost-effective manner, but we are falling short of those objectives when it comes to the dispensing and reimbursement system for generic prescription drugs,” stated Douglas Hoey, NCPA CEO. “Building off of the Centers for Medicare & Medicaid Services transparency requirements for PBMs’ Medicare Part D plans, Reps. Doug Collins and Dave Loebsack have introduced [a] common-sense bill [that] extends many of those disclosure and privacy protections to federal employees and the military health programs.”
The bill would bolster patient access to the pharmacies of their choosing and ensure pharmacies that sign contracts with PBMs are no longer ‘flying blind’ when it comes to understanding the criteria for generic drug reimbursements, Hoey added. In addition, the bill will create more accountability for how these federal health programs deliver prescription drug services.