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Amgen reviews privacy of patient assistance program for cholesterol drug
October 26, 2015 10:09 AM
pic thx to owen moore on flickr creative commons

pic thx to owen moore on flickr creative commons

In response to criticism, Amgen is reviewing privacy provisions in a patient assistance program for its pricey new cholesterol medicine which is called Repatha.

Doctors and patient advocates recently chastised the program, complaining that it requires patients to surrender rights to their personal information, including personal health data. And the RepathaReady web site also states the information will be freely available, with few restrictions, to Amgen and unspecified third parties.  The criticism was first reported late last week by CardioBrief.

Now, the biotech is “assessing” the program to “determine whether we can improve it,” a spokeswoman wrote us. There was no further explanation about what changes are being  considered. However, Amgen maintains that the program fully complies with all federal and state laws.

Drug makers typically offer financial assistance programs to patients who have difficulty affording their medicines. Repatha is a new type of injectable treatment called a PCSK9 inhibitor, which significantly lowers bad cholesterol, and is priced at a hefty $14,100 a year. The price tag is much more than older cholesterol pills known as statins, which cost pennies per pill.

None of the critics contended that Amgen broke any privacy laws. But they were apprehensive that the biotech is asking patients to enter into a devil’s bargain by agreeing to unusual privacy requests in exchange for obtaining a needed medicine at an affordable price.

“Amgen’s policy seems to me to be an extraordinary overreach,” Peter Berger, senior vice president of clinical research at the North Shore Long Island Jewish Health Care System, told CardioBrief. “My concern is that most patients won’t read the small print, and sign to get the discount on their medication without realizing all their rights to privacy they are giving away.”

Another physician reportedly suggested that Amgen was attempting to gain a “novel” source of data and, perhaps, intending to profit from the information. But the Amgen spokeswoman denied that patient information is sold to third parties. “We are careful only to collect or use information that is necessary to provide the services and to operate the programs the patient chooses to enroll into,” she wrote.

By contrast, the terms of the assistance program run by Sanofi and Regeneron Pharmaceuticals, which jointly sell a rival drug called Praluent, are less onerous. Their partnership “respects your interest in keeping your personal information private,” the web site states. “We will not use your personal information for any other purposes nor sell or rent your information to any third parties or mailing lists.”

One patient advocate expressed cautious optimism that Amgen was assessing its program.

“I hope they revise it so that patients are able to participate in the copay assistance program without providing Amgen access to their medical records,” said Marilyn Mann, who has family members with familial hypercholesterolemia, a genetic form of high cholesterol. “Patient data should be kept confidential and should not be disclosed to third parties without the consent of the patient.”

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AmgenCholesterolPatient PrivacyPCSK9 InhibitorsPraluentRegeneron PharmaceuticalsRepathaSanofi
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Cholesterol  / Patient Privacy  / Pricing & Patient Access  / Uncategorized

Ed Silverman

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