Amgen's platelet producer Nplate (romiplostim) does not need coverage restrictions from Medicare to ensure its safe use because it is already the subject of an FDA-mandated Risk Evaluation and Mitigation Strategy, the company told CMS in recent comments.

"At this time we believe that restrictions are not necessary for Nplate, based upon the recent FDA review of the product as well as the FDA-mandated REMS program, which will address any safety concerns that the agency may have," Amgen said.

The comments respond to a July 30 announcement that CMS is considering national coverage determinations for a number of drugs and diagnostics, including Nplate (¹ Also see "As Amgen Drops Some ESA “Overhangs,” New Payment Threat Appears" - Pink Sheet, 4 August, 2008., p. 5).

In its notice, CMS explained that platelet growth factors like romiplostim "may elicit safety concerns similar to the erythropoiesis-stimulating agents" and "long-term safety data are lacking."

The notice preceded FDA's Aug. 22 approval of Nplate ² Also see "Amgen’s Nplate Has First Mandatory Patient Registration Under REMS" - Pink Sheet, 22 September, 2008., p. 9). Amgen agreed to the REMS as part of the approval. PhRMA and BIO both objected to CMS proposing an NCD for a product before it was approved.

Under the REMS, Amgen is required to enroll and track health care providers who prescribe and dispense Nplate as well as patients who take the drug to monitor for any safety issues. The company will also report back to FDA periodically on its findings.

Amgen is well aware of how much of an impact Medicare coverage restrictions can have. In July 2007, CMS addressed safety concerns with ESAs when it announced it would pay for darbepoetin (Amgen's Aranesp ) and epoetin (Johnson & Johnson's Procrit ) for cancer-related uses only when they are given to patients with hemoglobin levels below 10 g/dL ³ Also see "Medicare ESA Coverage Will Not Experiment With Clinical Trial Approach" - Pink Sheet, 6 August, 2007., p. 21).

The move caused a sharp decline in sales for the two drugs and led to broad cost cutting at Amgen ⁴ Also see "Aranesp Bad Luck Catches Up To Amgen, Forces Pharma-Style Reorganization" - Pink Sheet, 20 August, 2007., p. 3).

- Cathy Kelly (c.kelly@elsevier.com)

Nplate REMS Precludes Need For Medicare Coverage Restrictions – Amgen

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