October 1, 2004 - EPO, in the forms of Epogen and Procrit, is the second largest dollar-producing drug in the U.S. Lipitor tops the list. Article from AP via Yahoo.

Epogen/Procrit has orphan drug status, which consumer advocates have said allows Amgen and a few other companies to parlay government largesse into private fortunes. Article from Scientific American.

July 23, 2004 - Amgen's chief executive Kevin Sharer yesterday warned that the reimbursement that insurance companies and government programmes pay for drugs could soon become one of biggest threats to the biotechnology industry. Article from Financial Times. (link is no longer available)

The top donors to the Democratic convention committee, giving anywhere from $100,000 to more than $1 million (the exact amounts have not been disclosed), include at least 19 giant financial firms (including Fidelity, Bank of America and State Street Corporation), seven big pharmaceuticals (Amgen, Merck, Novartis, AstraZeneca, Bristol-Myers Squibb, Genzyme and Pfizer), four telecom corporations (IBM, AT&T, Nextel and Clear Channel), one defense contractor (Raytheon) and one tobacco company (Altria Group, formerly more infamously known as Philip Morris). Article from Common Dreams.

July 10, 2004 - While some analysts are saying that Medicare's proposed EPO reimbursement policy would hurt Amgen, others are saying it would help. On Friday, the day after the Centers for Medicare and Medicaid Services posted the proposed EPO policy, Amgen shares were up 29 cents to $53.61. Article from TheStreet.com.

July 9, 2004 - Sales of Amgen Inc.'s best-selling drug Epogen would fall if a new Medicare policy, released in draft form Thursday, went into effect, an agency official said. Story from Los Angeles Times (registration required, but viewing is free).

"This is not good for Epogen," said Geoffrey Porges, an analyst at Sanford Bernstein & Co. Here is the press release from the Centers for Medicare and Medicaid Services (CMS).

Here is the Request for Comments (2-page pdf) notice posted on the CMS web site. An excerpt from the notice:

The Dialysis Outcomes Quality Initiative recommends a threshold hematocrit value range of 33 to 36 percent. However, due to naturally occurring variability in hematocrit levels, it is very difficult to maintain a hematocrit within this narrow range without occasionally exceeding the target ceiling of 36. Further, starting and stopping EPO therapy can lead to dramatic dips in hematocrit levels that may require high doses of EPO to achieve the target level again. Thus, appropriate utilization of EPO should be monitored by considering both the hemoglobin/hematocrit level and the dosage. Contractors will conduct medical review on EPO claims for ESRD patients using the following methodology.

• Claims for EPO with hemoglobin levels below 13 (or hematocrit of 39) on a single claim should not be targeted for review.
• Claims with hemoglobin levels between 13.0 and 13.9 (or hematocrit of 39 to 42) should be reviewed if the patient has received a monthly dose of EPO greater than 40,000 IU. If the higher dosage has not been medically justified, contractors should limit payment to the 40,000 IU level.
• Claims with hemoglobin levels 14.0 or greater (or hematocrit equal to or greater than 42) should be reviewed if the patient has received a monthly dose of EPO greater than 20,000 IU. If the higher dosage has not been medically justified, contractors should limit payment to the 20,000 IU level.

July 7, 2004 - A Credit Suisse First Boston analyst downgraded Amgen Inc. on concerns that upcoming health care reforms could reduce federal reimbursement for the company's cancer and dialysis drugs. Update from Forbes.com.

When Amgen Sneezes, Dialysis Patients Get Pneumonia

April 7, 2004 - Amgen Inc. has recruited a respected pharmaceutical industry lobbyist to join its expanding lobbying efforts. Rodger Currie will become vice president for government affairs for Thousand Oaks-based Amgen, succeeding Rita Norton, who is retiring. Story via the Miami Herald.

December 11, 2003 - Amgen Inc. said it hired Washington lawyer David Beier to lead the biotech company's lobbying effort in the nation's capital, replacing longtime chief lobbyist Peter Teeley. Medicare is reviewing reimbursement for Amgen's mainstay anemia drug, Epogen, and analysts expect the program to reduce payments in 2005. Story from LA Times (link no longer available).

December 5, 2003 - According to an article in Business Daily News, an effect of the Medicare reform legislation could be that "EPO sales growth could slow from 5 percent annually to flat or "even slightly down growth as dialysis providers adjust their usage habits."" Story from Business Daily News. (link is no longer available)

November 1, 2003 - Amgen Inc.'s anemia drug Aranesp will receive greater reimbursement in the hospital outpatient setting, leveling the playing field with rival Johnson & Johnson, the company said Friday. Story from Dailynews.com. (link is no longer available)

August 7, 2003 - Medicare, the U.S. health program for the elderly and disabled, plans to continue to reimburse Amgen Inc.'s anemia drug Aranesp at a lower rate than rival Johnson & Johnson's Procrit for hospital outpatient care, according to a draft proposal issued on Wednesday. Story from Reuters/Yahoo (link no longer available).

July 23, 2003 - Strong growth in worldwide sales of its two flagship drugs, Epogen and Aranesp, pushed Amgen's net income up by 47 per cent to $607 million in the second quarter 2003. Story from FT/Yahoo. (link is no longer available)

Amgen is continuing its lobbying with the Medicare administrator CMS to allow for higher reimbursements for Aranesp. The clout of the Biotechnology Industry Organization has risen to the point where it simply presents President Bush with its agenda when he speaks at their annual convention. Story from the Washington Post (registration required, but free viewing).

July 16, 2003 - Led by Amgen, Inc., several biotechnology companies are suing Columbia University for trying to extend the life of a patent that has brought the institution hundreds of millions in revenue. Article from the New York Times (registration required, but viewing is free).

July 3, 2003 - Amgen became the second-biggest contributor to Senator Charles Grassley, an Iowa Republican, in the last election cycle. Grassley, chairman of the Senate's Finance Committee, appears to be leading the campaign to reverse Medicare's decision to cut payments for Amgen's drug Aranesp. Story from Providence Business News. (link is no longer available)

July 1, 2003 - Amgen Inc. would win a reversal of Medicare's decision to cut payments for its Aranesp anemia drug under the Senate version (S.1.RS) of the Medicare overhaul legislation now in conference committee.

Late last year Amgen sought an injunction to stop Medicare from lowering payments for its new anemia drug, Aranesp. Here is the press release from the Amgen web site.

To view Amgen's contributions to political campaigns, over $700,000 since year 2000, visit tray.com.

Type in "Amgen" in the 'Go Search' box and click on the yellow highlighted button for '2004, 2002, 2000 combined (takes a bit longer...)' election cycle.

View Amgen's Financials from Yahoo Finance.

The health care industry spends more on lobbying than an other industry sector.

In April 2002, Amgen raised the wholesale price of EPOGENŽ, which is routinely administered to dialysis patients to treat anemia, by 3.9 percent for a third consecutive year. These price increases drew criticism, as many dialysis providers - funded largely by the Medicare and Medicaid programs - felt they were being forced to absorb Amgen's research and development costs. News summary from RenalWEB.

April 30, 2003 - This op/ed piece comments on CMS Administrator Thomas Scully's use of drug 'functional equivalence' so that "lawyers, not doctors, lobbyists, not scientists, politicians, not patients are determining what drugs are used and paid for". The article expounds on the street fight over Aranesp and Procrit, two biotech products made by Amgen and Johnson and Johnson respectively. Opinion/editorial from the Washington Times. (link is no longer available)

April 21, 2003 - The Bush administration, in a fundamental change, has begun to weigh cost as a factor in deciding whether Medicare should pay for new drugs and medical procedures. This new approach was illustrated when Medicare refused to pay the full price for a new drug to treat anemia in cancer patients, saying it was functionally equivalent to an older drug with a lower price. Amgen, the maker of the new drug, Aranesp, contends that it is more effective than the older drug, Procrit, sold by Johnson & Johnson. NY Times story via SF Gate.

March 12, 2003 - Amgen may benefit from higher sales of its Aranesp anemia drug as Medicare reconsiders a cut in reimbursement for the treatment. Amgen has been lobbying Congress to reverse a recent Medicare decision cutting reimbursement for Aranesp and the agency is reconsidering. Story from Bloomberg Financial.(link is no longer available)

December 26, 2002 - Amgen Inc. announced that the United States District Court for the District of Columbia dismissed Amgen's recently filed complaint against the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS). Medicare is lowering payments for its anemia drug, Aranesp, when used in hospital outpatient procedures. Story from PRNewsWire/Yahoo. (link is no longer available)

December 9, 2002 - In hope of persuading Medicare to reverse a cut in payments for its new anemia drug Aranesp, Amgen has released data suggesting that patients can take the drug less frequently. Amgen also said the calculations used by the government to set compensation were based on higher quantities of Aranesp than most patients require, making Aranesp appear more expensive. Story from Bloomberg Financial. (link is no longer available)

November 16, 2002 - Amgen Inc. is seeking an injunction to stop Medicare from lowering payments for its anemia drug, Aranesp, when used in hospital outpatient procedures. Story from Bloomberg Financial News. (link is no longer available)

Here is the press release from the Amgen web site.

November 9, 2002 - Some U.S. lawmakers are questioning a decision that cut the 2003 Medicare reimbursement rate for Amgen's slow-release Aranesp EPO by more than half if it's given to patients in hospital outpatient clinics. (See Nov. 1 story below) Story from Bloomberg Financial News. (link is no longer available)

Robert Rubin, a Georgetown University kidney specialist, comments on a U.S. government review of rival anemia drugs sold by Johnson & Johnson and Amgen Inc. Story from Bloomberg Finanical News. (link is no longer available)

November 6, 2002 - The Centers for Medicare & Medicaid Services (CMS) published in the Nov. 5 Federal Register a notice of delay in publishing the Medicare physician fee schedule for calendar year 2003. The agency gave no estimate for how long the review will take. Story from the AHA (American Hospital Association).

November 1, 2002 - The Centers for Medicare & Medicaid Services (CMS) yesterday issued its 1,000-page final outpatient prospective payment system (OPPS) rule, which takes effect Jan. 1.

One of the surprising changes is that Medicare will pay 53 percent less next year for Amgen Inc.'s Aranesp (slow-release EPO) when used by patients in hospital outpatient clinics. The hospital outpatient setting accounts for approximately 10 percent of the current revenues of Aranesp. Reimbursement in the physician's office remains unchanged and continues to be set at 95 percent AWP. Story from Bloomberg Financial News. (link is no longer available)

Amgen is objecting to the new rate. Here are Amgen's comments on the new OPPS rule.

A Fact Sheet on the changes in payment for Epogen, Procrit, and Aranesp under OPPS can be downloaded by clicking here. (ZIP 8KB, 40KB decompressed)

Many other drugs and medical devices will be reimbursed by Medicare at lower rates in 2003. Story from Bloomberg Financial news. (link is no longer available)

The final payment rule for 2003 for physicians is being delayed. Physicians are scheduled to receive a 4.4% decrease in Medicare payments in fiscal 2003, on top of a 5.4% reduction in fiscal 2002. Story from Modern Healthcare. (link is no longer available)

Here is the calendar year 2003 Hospital Outpatient Prospective Payment System web page from CMS web site.