Novartis osteoporosis drug approved in the United States
EAST HANOVER, N.J. The Food and Drug Administration has approved Reclast (zoledronic acid) injection for the prevention of postmenopausal osteoporosis for two years with a single dose, Novartis Pharmaceuticals announced Monday.
Reclast already is approved as a once-yearly infusion for the treatment of postmenopausal osteoporosis. Reclast also is approved for the treatment of Paget’s disease of bone, the second most common metabolic bone disorder, in men and women.
“We are very pleased that this latest U.S. approval recognizes the large body of safety and efficacy data for Reclast and underlines its potential to protect patients with a number of bone disorders,” stated Trevor Mundel, global head of development at Novartis Pharma. “Women with low bone mass in the U.S. now have an important new option that is proven to strengthen their bones, and therefore help prevent the onset of osteoporosis, for a full two years with only one infusion.”
“It is very important to treat postmenopausal women with low bone mass to help prevent them from progressing to osteoporosis,” stated Mone Zaidi, professor of medicine, geriatrics and physiology at Mount Sinai School of Medicine. “The dosing of Reclast for the prevention of postmenopausal osteoporosis offers an advance over existing therapies since it can be given once every two years, instead of daily, weekly or monthly.”
The FDA decision is based on a study involving more than 500 postmenopausal women with osteopenia, or low bone mass, showing that a single infusion of Reclast significantly increased bone mineral density (BMD) at two years compared to placebo.
Approximately 22 million women in the U.S. have osteopenia, putting them at increased risk of osteoporosis, a disease that causes bones to break more easily. Osteoporosis is a major public health issue affecting an estimated 10 million men and women.
NCPA survey: Accreditation requirements hinders pharmacists from offering DME equipment
NEW YORK Almost one-third of those community pharmacists who already offered DMEPOS services responded that they would cease delivering Medicare services if Congress doesn’t act soon.
That should be a wake-up call for Congress.
The reality is the number of community pharmacies that would no longer supply products like diabetes test strips to their Medicare patients is a lot closer to 90% of all community pharmacies, or approximately 20,000 pharmacies, more or less, given that only one in 10 are currently accredited under Centers for Medicare and Medicaid Services guidelines, the fact that the accreditation deadline is only five months away and it takes on average more than six months to become accredited.
To be sure, the survey is a sample of about 1,000 self-reporting pharmacists and there may be a good number of community pharmacists currently pursuing accreditation not included in the 10%, but the bare fact remains that the vast majority of community pharmacies aren’t accredited and will decline to become accredited come Oct. 1.
What does it all mean? To quote Bruce Roberts, NCPA EVP & CEO, it means “the current policy could prevent patients, especially in underserved areas [such as rural communities], from accessing medical supplies that help navigate health challenges such as controlling diabetes.”
Approximately 17.9% of all Medicare households are located in rural communities, according to a Kaiser Foundation report released in February, which means that almost one in five of all Medicare recipients may have greater difficulty accessing their testing supplies.
And that should be a bigger wake-up call for Congress, as well as their Medicare-eligible constituents.
NCPA survey: Accreditation requirements hinder pharmacists from offering DME
ALEXANDRIA, Va. A survey of National Community Pharmacists Association members found that almost one-third (31%) of independent pharmacist-owners in the DMEPOS business would cease offering durable medical equipment, prosthetics, orthotics and supplies to their Medicare patients if new accreditation mandates take effect on Oct. 1.
That includes diabetes supplies.
“Pharmacists have been unfairly singled out for this accreditation rule, but patients will be the ones who truly lose out if this isn’t changed,” stated Bruce Roberts, NCPA EVP and CEO. “These findings illustrate that the current policy could prevent patients, especially in underserved areas, from accessing medical supplies that help navigate health challenges, such as controlling diabetes. We hope Congress will act swiftly with the accreditation deadline fast approaching.”
For those independents currently not in the DMEPOS business, mandated accreditation would significantly deter 67% of those respondents from participating in the future.
Currently, only 1-in-10 community pharmacies currently providing DMEPOS have become accredited. The accreditation fees, training and implementation costs are projected to total at least $5,000 to $7,000, over three years, which is cost prohibitive for many pharmacists.