FDA approves Zyclara
BRISTOL, Tenn. The Food and Drug Administration has approved a new drug made by Graceway Pharmaceuticals for treating a skin condition resulting from sun damage, Graceway announced Friday.
Zyclara (imiquimod) is a skin cream for treating actinic keratoses, a sign of skin damage resulting from long-term exposure to ultraviolet rays from the sun. The sun’s rays can cause changes in the size, shape and organization of the top layer of skin cells and the cells just below them. AK is considered a pre-caner and can be confused with age spots, eczema or psoriasis.
Zyclara has the same active ingredient as Aldara, a drug also used to treat AK that Graceway has acquire, though there are differences between the two, such as Zyclara’s approval for daily use.
New clinical trial will compare MS drugs
CAMBRIDGE, Mass. Swiss drug maker Biogen Idec and Irish drug maker Elan Corp. have started enrolling patients into a late-stage study to evaluate switching from two multiple sclerosis drugs to their own, the two companies announced Friday.
The phase 3b trial will enroll 1,800 MS patients in 27 countries to see how well they fare when switching from Teva’s Copaxone (glatiramer acetate) or Merck KGaA’s Rebif (interferon beta-1a) to Biogen Idec’s and Elan’s Tysabri (natalizumab). Merck KGaA operates in the United States under the trade name EMD to avoid confusion with Whitehouse Station, N.J.-based Merck & Co., a separate company.
“Despite being on therapy, many MS patients still experience disease progression, resulting in a loss of physical abilities and permanent damage to the central nervous system,” trial advisory committee chairman and Cleveland Clinic multiple sclerosis researcher Richard Rudick said in a statement. “Currently, there is limited data to inform decisions about how to switch in patients who have disease activity while on therapy.”
New challenges on the horizon as healthcare overhaul made official
WHAT IT MEANS AND WHY IT’S IMPORTANT After more than a year that spawned bitter debate, a tea party, a growing divide in Congress and a never-ending clash of ideas, charges, countercharges and soul-searching about the role of government and deficit spending, healthcare reform is law. Now comes an even tougher battle: the President and his administration must make the machinery of a new, more outcomes-centered healthcare system work within its $940 million budget, and they must do a thorough job of explaining what it will mean for every American and every employer-sponsored healthcare plan.
(THE NEWS: Health reform draws pharma’s support, but alarm from insurance industry. For the full story, click here)
Health reform will add as many as 32 million more Americans to the rolls of the insured, boosting revenues — if not profit margins — for retail pharmacy and the pharmaceutical industry. It will put new spending curbs on Medicare and impose new oversight on treatment regimens and their impact on patients. It could spur the use of, and reimbursement for, medication therapy management by pharmacists, while assuring a somewhat more equitable system for Medicaid prescription reimbursements and the sale of medical supplies by pharmacies.
Those are some of the obvious and most widely reported effects of the health overhaul bill President Obama signed into law Tuesday. But the law could have other profound long-term effects on how healthcare is paid for and delivered in the United States.
For one thing, the law eliminates the deductions that big employers can now take on the nontaxable subsidies they get from the federal government for providing prescription drug benefits to Medicare Part D beneficiaries. The subsidies — which can range as high as $1,300 for each retiree covered by an employer’s health plan, according to a report in The Wall Street Journal, were set up in 2006 to help employers defray the costs of the Part D program.
The tax-free subsidies will remain in place. But to account for the loss in tax deductions, big employers are now taking big one-time charges against their future earnings, according to the Journal.
The upshot is higher costs to employers. The outcome could be that more employers follow the lead set by companies like Caterpillar, which opted to eliminate the pharmacy benefit manager middleman in providing drug coverage to their employees and go straight to the provider. In Caterpillar’s case, that provider is Walgreens, which at the beginning of 2010 began filling scripts for Caterpillar employees and retirees covered by the big heavy equipment maker, at a significant discount to market price. More employers could follow suit, in a bid to save money through direct price negotiations with big pharmacy chains like Walgreens.
Also impacted by the new reform law will be drug makers. Bloomberg news service reported Thursday that the massive, 2,400-page bill signed by President Obama includes a little-understood, 43-page passage aimed at comparing the effectiveness of one medication over another.
The provision, according to Bloomberg, would provide $500 million a year to fund an institute that would scrutinize drug treatments and devices, as well as medical procedures, to determine the relative effectiveness of one product or treatment over another.
The goal: to begin bending down the ever-rising cost curve for health care in America.