Column:  Need help paying for Amgen’s Repatha? Get ready to give up your privacy

For all the talk about new opportunities for consumers to make their own healthcare decisions, much remains out of their control. Nowhere is that more evident than in the prescription drug market, where stratospheric prices can sometimes keep patients from obtaining lifesaving therapies.

That’s why major drug companies have instituted programs to cover co-pays or other cost-sharing burdens for needy patients. And it’s why Amgen Inc. has triggered an uproar among cardiology specialists for imposing unusually onerous preconditions on its program to provide financial help for patients prescribed Repatha, a new drug that treats chronic high LDL cholesterol (that’s the “bad” cholesterol). Repatha costs more than $14,000 a year; many of its users are likely to need it all their lives.

But when it introduced its RepathaReady financial assistance program, Amgen required enrollees to provide it with access to all their personal medical information — encompassing their “entire medical file and complete patient history,” and “any information ... from a healthcare provider, healthcare plan, pharmacy, pharmaceutical company, and/or contractor.”

Patients are permitted to opt out at any time and end the flow of information to Amgen. If they do so, however, they will be shut out of the assistance program, which limits the cost to patients with commercial health insurance to $5 per prescription, including deductibles and co-pays. The company retains the right to use any information already submitted for 10 years.

“This is the most egregious example of overreach in the fine print that I’ve ever experienced,” says cardiologist Peter Berger, senior vice president of clinical research at North Shore-Long Island Jewish Hospital in New York. He and other critics say they were concerned that the terms would allow Amgen to sell patients’ private medical information without their further permission.

Amgen’s request appears far broader than what’s sought from patients taking a similar cholesterol drug, Praluent, which is jointly marketed by the firms Regeneron and Sanofi and costs about as much as Repatha. Their enrollment form seeks medical data related mostly to patients’ high-cholesterol condition and information about their health insurance and family income.

Amgen this week took steps to revise the terms of RepathaReady, after an article by Larry Husten of the medical journalism site CardioBrief and an inquiry from The Times. The company’s new privacy notice, which will go into effect by the end of this month and was reviewed by The Times, will specify that Amgen chiefly seeks “select information from or about [patients’] medical history and general health.”

The original enrollment terms left unclear the full extent of Amgen’s rights to use patients’ personal information. The new form states that the data will be used “only” to enroll patients in and administer the program; provide professional advice on how to use the injectable drug; share health information with patients’ medical providers; send patients marketing materials; and “improve, develop, and evaluate products, services, materials and programs related to [their] condition or treatment.” The enrollment form will now state explicitly: “Amgen does not and will not sell or rent your information to marketing companies or mailing list brokers.”

But the form warns that once provided to Amgen, personal medical information is no longer protected from further disclosure by the federal Health Insurance Portability and Accountability Act, or HIPAA, which places strict limits on what healthcare providers can disclose about patients’ medical conditions or care.

But Amgen’s policy still lays claim to “any ... personal health information” held by enrollees’ healthcare providers, insurers, laboratories or pharmacies. Although drug companies’ patient assistance programs almost always require applicants to disclose their name, age, address, insurance coverage, and sometimes their income, Amgen’s terms “take it to a completely different level,” says Joseph S. Ross of Yale School of Medicine, who has studied patient assistance programs. The terms “have the potential to go way beyond the clinical use of this drug if you’re essentially signing over all your health records.”

The industry typically paints these financial assistance programs as altruistic, but they carry a large component of self-interest. The programs expand the market for costly drugs by making it easier for physicians to prescribe them to financially strapped patients. They also undermine insurance firms’ efforts to use co-pays to steer patients to lower-cost alternatives to expensive brand-name drugs, such as generics. Drugmakers “face little resistance to setting higher prices as long as patients don’t have to pay for them out-of-pocket,” says David Howard, a pharmaceutical marketing expert at Emory University.

The patient assistance programs for Repatha and Praluent arguably gave their manufacturers leverage against pharmacy benefits managers who initially resisted covering both drugs, because of their high prices and the scant clinical evidence that they actually reduce heart attacks and strokes. As my colleague Stuart Pfeifer has reported Express Scripts, the nation’s largest pharmacy benefits manager, finally agreed last month to cover the drugs after the drugmakers offered discounts for the firm’s customers.

Manufacturer-funded co-pay subsidies have increased by roughly 50% from 2010 to 2011 alone, according to a 2013 survey by Ross and Aaron Kesselheim of Harvard Medical School. A study for the pharmacy management industry in 2010 found that 100 million dispensed prescriptions were covered by cost-sharing subsidies. That represented only 11% of prescriptions for brand-name drugs, implying that the opportunities for expansion remain great. The study forecast that by immunizing drugmakers from pressure to cut prices, co-pay programs could increase prescription costs for employers, governments, and consumers by $32 billion over 10 years.

The real danger is that patients may not fully understand how much of their privacy they’re waiving when they check a box on a form entitling them to a discount.

“The question is whether people in a vulnerable position are, in the end, exchanging personal information for the monetary benefit of reduced costs for the drug — and what risks they are incurring by doing it,” Harlan Krumholz, a professor of cardiology at Yale Medical School, told me by email. “Everyday health data is moving among business partners in ways that are not transparent to patients.”

The ethical issues raised by conditions placed on participation in patient assistance programs are heightened for specialty drugs for which patients don’t have lower-cost options. “If we started to see this in the rheumatoid arthritis or the cancer space, that would be a pretty slippery slope and not good for patient care,” Ross says. “There the patients are between a rock and a hard place: they can’t afford the medication but the companies are saying the only way we’ll allow them into the assistance program is if we get access to the data.”

Repatha may fall into that category. Like its rival drug Praluent, it’s aimed at patients with chronically high cholesterol that can’t be treated with common statins. These include patients with the inherited condition familial hypercholesterolemia, which causes abnormally high levels of LDL, or atherosclerotic heart conditions.

For those patients, the drugs may be crucial for lowering LDL. What’s still unclear is how much they may have to give up to obtain them.

Michael Hiltzik’s column appears every Sunday. His new book is “Big Science: Ernest Lawrence and the Invention That Launched the Military-Industrial Complex.” Read his blog every day at latimes.com/business/hiltzik, reach him at mhiltzik@latimes.com, check out facebook.com/hiltzik and follow @hiltzikm on Twitter.