Amgen Wants to Own Your Protected Health Information in Exchange for Copay Card

Amgen is the Rumpelstiltskin of the drug industry.

As reported by MedPage Today/CardioBrief, "Doctors, pharmacists, patients and others are now starting to learn that in order to receive financial assistance from Amgen for its expensive new cholesterol drug Repatha, patients are being required to surrender rights to their personal information, including their personal health information."

Not even HIPAA-protected health information is off limits.

"The agreement specifically states that by agreeing to the terms [of Amgen's privacy policy] patients may lose federal HIPAA protection," notes CardioBrief.

Patients must agree that they "understand that Amgen may use [their] personal information, including [their] personal health information, for 10 years once [they] accept this Authorization ..."

What other nasty things must poor people agree to in order to get a copay card?

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Et Tu, Amgen? Blincyto's Bling! Bling! Price Tag!

FDA approved Amgen's Blincyto (blinatumomab) on December 3, 2014, as a second-line treatment for Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, which affects around 6,000 patients in the US.

The price tag of $178,000 per two-cycle course makes it one of the most costly drugs on the market.

This is just one of the record number of 15 "orphan" drugs approved by the FDA in 2014 (read "43% of New Drugs Approved by FDA in 2014 were for Treatment of Rare Diseases").

FDA considers Blincyto a "breakthrough" therapy, which means preliminary clinical evidence demonstrates the drug "may have substantial improvement on at least one clinically significant endpoint over available therapy."

On FDA Voice (FDA's blog), commissioner Margaret A. Hamburg said "Consider for example, Blincyto, approved just last week to treat Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia. CDER employed all of its expedited review programs to help get this drug to market as early as possible, five months ahead of its review goal date. The sponsor also benefited from incentives for drugs that treat rare diseases."

Despite the extraordinarily high price of Blincyto, payers are not likely to complain about the price as much as they complained about the price of Sovaldi. Read on to learn why I believe that is true.

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