Jennifer A. Web

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The decision was announced after months of negotiations with the American Academy of Ophthalmology (AAO) and the American Society of Retina Specialists (ASRS), as well as a vociferous outcry by retina specialists. 

The decision allows Genentech to remain true to its Oct. 11 announcement that it no longer would sell its drug to compounding pharmacies, in part over liability concerns about maintaining the drug's sterility. Compounding pharmacies are used by a majority of retina specialists to break down the large vials of bevacizumab packaged for cancer treatments into single-dose injections for off-label treatment of wet age-related macular degeneration (AMD). 

Wholesale prices of the medications ranged from $1,950 per dose for ranibizumab to about $5.50 per dose for bevacizumab, according to Genentech spokeswoman Dawn Kalmar. Most patients require monthly doses. 

After ophthalmologists' initial outcry, the company agreed to extend its initial Nov. 30 cut-off date to sell to compounding pharmacies to Jan. 1, to allow time for a solution to be devised. Under the agreement announced Dec. 20, physicians can purchase bevacizumab directly from authorized wholesale distributors, and physicians can designate a destination: hospital pharmacy, compounding pharmacy, or physician's office. 

"This process is one that the [AAO] and ASRS believe addresses the needs of most of their members," the medical groups said in a joint statement. "It is a significant step forward." 

C.P. Wilkinson, MD, a retina specialist and AAO president at the time the decision was announced, said he believes the company genuinely is trying to do what's right for patients, physicians, and shareholders. 

"This is a good company, and I don't think [it's] really out to [hurt] anybody," he said. "There are certain realities here that you have to respect. I don't think this is a smoke-and-mirrors or bait-and-switch kind of deal."  

Genentech said it believes that the decision reflects the "collaborative approach" taken by the company and physician groups. 

"Genentech continues to believe [that ranibizumab] is the most appropriate treatment for patients with wet [AMD] because it was specifically designed, formally studied, approved by the U.S. FDA and manufactured for intraocular delivery for the treatment of wet AMD," the company said in a prepared statement. "At the same time, Genentech does not interfere with physicians' prescribing choices and believes that physicians should be able to prescribe the treatment they believe is most appropriate for their patients." 

Dr. Wilkinson cautioned that implementation of this solution may vary because laws regarding compounding pharmacies differ from state to state. The AAO and ASRS recommended that physicians consult their legal advisers. 

 The company and the organizations all said that they would continue to work together to develop additional programs to "more efficiently facilitate and expedite patient access and physician reimbursement for [ranibizumab]."

Genentech spokeswoman Krysta Pellegrino said that new program details still were being determined. "We really want to ensure that all patients who need our therapies have access to it," she said. 

Dr. Wilkinson said the company intends to expand the number of patients eligible for financial assistance for ranibizumab and to speed up physician reimbursement from weeks or months to a matter of days. 

"I have no doubt that the original process was, indeed, very, very cumbersome and time-consuming and I don't think it solved the problem at all," he said. "I'm sure it will be vastly improved."

Articles

Genentech has agreed to allow its wholesale distributors to ship its bevacizumab (Avastin) to compounding pharmacies or other locations of a physician's choice.

Genentech decision expands access to bevacizumab

In a last-ditch maneuver in the federal House and Senate just before legislators departed the city for their winter holiday break, both houses averted the cut and approved a 0.5% increase for physicians through June 30.  

If Congress fails to act before that date, however, physicians will see a 10.6% cut in the fees paid by Medicare, because of the way the financing is structured, ASCRS officials said in its statement. 

The measure passed by Congress also extends the Physician Quality Reporting Initiative, that which gives ophthalmologists an extra 1.5% of the total allowed charges for covered Medicare physician fee schedule services for reporting if they report on four measures approved by the National Quality Forum. The American Medical Association, ASCRS, American Academy of Ophthalmology, and other medical groups have told legislators that they would rather see that money funneled into fixing the fee-payment issue. 

The groups were hoping change was on the way after the House passed, 225-204, its Children's Health and Medicare Protection (CHAMP) Act on Aug. 1. 

That legislation would have provided a fully funded positive update for 2 years and would have repealed the sustainable growth rate formula that has been at the center of the payment debate. Despite that momentum, advocates in the Senate were not able to get the 60 votes needed to overcome objections to a longer-term solution, ASCRS reported. 

The CHAMP Act would have allocated $20 billion over 5 years and $67 billion over 10 years to replace 15% cuts in Medicare payment rates for all physician services over the next 2 years with positive updates of 0.5%.  

The bill would have invested new money to improve payments in 2008 and 2009 and defray a portion of the cost by moving up some pay cuts that would have occurred in the longer term. Instead of physicians being hit with 9 years of 40% cuts, they would have faced about 3 years of 25% cuts. 

The act would have funded the program by raising taxes on cigarettes and reducing payments to private Medicare Advantage plans.  

Now, advocates are hoping that senators will find some success with a larger Medicare bill to be discussed under "budget reconciliation" rules, meaning that only 51 votes would be required for passage. Senate Finance Committee Chairman Max Baucus (D-MT) and Finance Committee ranking member Charles Grassley (R-IA) have pledged to work toward at least a 2-year "fix" in 2008, ASCRS reported. 

However disappointing it was for those working for a long-term change, Indianapolis retina specialist Ramana S. Moorthy, MD, said he is relieved that the cuts were stopped for now. 

"As Medicare physician providers, we are all grateful for the 11th-hour reprieve from Congress to postpone and re-evaluate the proposed 10.1% cuts," said Dr. Moorthy, who serves on his state's Medicare carrier advisory committee. "We hope this can eventually lead to a meaningful dialogue for a solution to the medical-care crisis, implementation of a fair reimbursement system to physicians, and [the provision of] needed medical care to all our citizens."

A 6-month reprieve on a proposed 10.1% fee cut for ophthalmologists and other physicians who treat Medicare patients will cause "great uncertainty" for patients and physicians, according to the American Society of Cataract and Refractive Surgery.

Medicare cut halted for 6 months; reprieve causes 'great uncertainty'

Ophthalmologists in more than 34 countries around the globe are busy planning events for World Glaucoma Day on March 6 to alert people to the devastating effects of glaucoma and the importance of having their eyes examined. 

The effort, led by four ophthalmologists in conjunction with the World Glaucoma Association (WGA) and the World Glaucoma Patient Association (WGPA), is one more attempt by physicians worldwide to make people aware that glaucoma is a blinding disease that largely can be prevented and treated. Across the world, glaucoma is the second-leading cause of blindness, behind cataracts in developing countries and behind wet age-related macular degeneration (AMD) in developed countries. 

Unlike wet AMD, for which a treatment only recently has been discovered and which remains "incredibly expensive," the incidence of glaucoma-related blindness is "infuriating," said George N. Lambrou, MD, of the Athens (Greece) Institute of Ophthalmology. He is global project leader for the observance. 

"Glaucoma has reliable diagnostic methods and cheap and effective treatments so that the incidence of glaucoma-related blindness could be significantly reduced if only patients would know about it and would care about getting screened and treated adequately," Dr. Lambrou said. "It is not an exaggeration to say that the main reason for glaucoma blindness is oversight, or, to be more provocative, sheer ignorance."  

More than 300 events are being planned at more than 50 sites, with more being added daily to a worldwide database being kept by Dr. Lambrou, who also is the executive vice chairman of the WGPA Physician Liaison Committee. 

Some ophthalmologists are planning free laser treatments; one ophthalmologist is running in the Geneva Marathon in Switzerland under the colors of the WGA; and a Colombian ophthalmologist is providing complimentary laser treatments to poor patients. Three countries-St. Kitts-Nevis, Dominica, and Antigua/Barbuda-are issuing commemorative postage stamps; Israel will use a special cancellation logo for all letters posted March 6. 

The number of glaucoma cases is staggering. Physicians are frustrated by the number of people worldwide who do not know they have the disease and do not know they may be at risk.  

According to Dr. Lambrou, specialists have predicted that by the year 2020, 80 million people worldwide will have glaucoma, and 11 million of these people will be blind in both eyes. In developed countries, only 50% of those with the disease are aware they have it; in underdeveloped countries, 90% or more of people with glaucoma are unaware that they have the disease or even have heard of it. 

Ophthalmologists in more than 34 countries around the globe are busy planning events for World Glaucoma Day on March 6 to alert people to the devastating effects of glaucoma and the importance of having their eyes examined.

Author | Jennifer A. Web

Articles

Genentech decision expands access to bevacizumab

Medicare cut halted for 6 months; reprieve causes 'great uncertainty'

World Glaucoma Day sets sight on disease awareness

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