ProAmatine to be pulled from market, Shire says
PHILADELPHIA Shire has decided to withdraw its blood pressure drug from the market, the drug maker said Tuesday.
The company said it would withdraw the drug ProAmatine (midodrine hydrochloride), used to treat the low blood pressure condition orthostatic hypotension, on Sept. 30. Shire has marketed the drug since 1999, when it gained rights to it as part of its acquisition of Roberts Pharma. Several companies also make generic versions of the drug.
Shire’s decision follows the Food and Drug Administration’s announcement Monday that it was considering rescinding approval of branded and generic versions of the drug after post-marketing studies showed that it did not improve patients’ conditions.
The drug was approved in 1996 under the FDA’s accelerated approval regulations for drugs that treat serious and life-threatening medical conditions, and according to the FDA, it was the first time the agency had issued a notice that it would withdraw approval for a drug approved under those regulations.
Independent pharmacy lobby weighs in as feds mull ‘grandfather’ status for plans
ALEXANDRIA, Va. Federal agencies enforcing new health-reform mandates must act to preserve patients’ access to the pharmacy of their choice and lower-cost generic medicines, the independent pharmacy lobby urged the government Tuesday.
In a written appeal to three federal agencies, the National Community Pharmacists Association asserted that health plans seeking Grandfathered Health Plan status under the landmark health-reform law enacted earlier this year must maintain patient freedom of choice and ease of access to generics in a reformed healthcare network. Otherwise, urged NCPA acting EVP and CEO Doug Hoey, those plans should lose their special status.
The NCPA sent a letter Tuesday to three agencies that currently are developing criteria for maintaining GHP status following implementation of the massive Patient Protection and Affordable Care Act. The appeal went to the Internal Revenue Service, Employee Benefit Security Administration and Department of Health and Human Services Office of Consumer Information and Insurance Oversight.
The NCPA’s goal, in its own words: to advance “patient choice and greater utilization of generic prescription drugs” as health plans jostle for a central role in a reformed healthcare system. “Providing quality patient care is vital to healthcare reform, and health plans that want to maintain grandfathered health plan status should not be allowed to alter their structure and benefits in ways that undermine those objectives,” Hoey said.
“For example, the face-to-face interaction patients get in their local pharmacies has a proven, positive track record in terms of health outcomes. Changes by health plans that steer patients against their will toward mail-order pharmacies represent more than just ‘reasonable routine changes’ to an existing health plan and should cause them to lose grandfathered health plan status,” Hoey asserted in his letter today. “Similarly, health plans should not be able to maintain grandfathered status when they change their prescription drug formulary designs by creating or expanding a list of ‘specialty medications’ in order to shift patients to a specific mail-order pharmacy.”
Such changes, Hoey added, would limit access to those drugs by plan beneficiaries, since many specialty drugs aren’t available to independent drug stores. “These are more than ‘reasonable routine changes’ and should also cause them to lose their grandfathered status,” he told the federal agencies.
“On the other hand,” Hoey added, “when generic alternatives become available, the brand-name prescription drug is routinely placed in a higher co-pay tier in the drug formulary to promote the use of the generic. That is indeed a ‘reasonable routine change’ and should not be grounds for a plan losing its grandfathered status.”
Vaccines sector of healthcare market expands, report finds
NEW YORK The global market for vaccines grew to more than $20 billion last year, according to a report by healthcare market research firm Kalorama Information.
The New York-based firm’s report, “Vaccines 2010: World Market Analysis, Key Players and Critical Trends in a Fast-Changing Industry,” indicated that the world market for preventative vaccines was $22.1 billion in 2009, compared with $19 billion in 2008.
“We’ve forecasted a high growth rate for vaccines over the past few years, and market events have matched our predictions,” Kalorama publisher Bruce Carlson said. “The vaccine business is not without its risks, but for some companies, vaccines were the only bright spot in their portfolio in 2009. It’s not a surprise therefore that development is heavy in this sector, and that will continue to contribute to growth over the next five years.”
Much of the market centers on five companies, namely Merck, GlaxoSmithKline, Pfizer, Novartis and Sanofi-Aventis division Sanofi Pasteur. GlaxoSmithKline took a quarter of the market, thanks largely to the influenza vaccines Fluvarix and Hiberix, Kalorama said.