Diabetics and those with failing kidneys may have gotten a glimmer of relief from the staggering costs of caring for their conditions, as Big Pharma relented a tad with news it will put out a less-costly insulin product and federal officials suggesting Uncle Sam soon may be upsetting the flush profits of the dialysis industry.
DaVita Inc. and Fresenius Medical Care AG run more than 5,000 U.S. dialysis clinics and control around 70 percent of the market, Reuters news service reported in a story describing how Alex Azar, the powerful head of the federal Health and Human Services department, wants “a new payment approach for treating kidney disease that favors lower cost care at home and transplants.”
Why? As Reuters explains, “The goal is to reduce the $114 billion paid by the U.S. government each year to treat chronic kidney disease and end-stage renal disease, a top area of spending.”
Modern Healthcare, an industry publication, reported that the Centers for Medicare and Medicaid Services (CMS) has an “outsize influence on kidney care policy. Kidney disease accounted for more than one-fifth of all Medicare spending in 2016 … and the program covers people under 65 who suffer from end-stage renal disease that can only be treated with dialysis or a transplant.”
Federal officials question why, especially as technology has advanced, so many Americans with kidney failure almost automatically get clinic care and are not treated at home. In contrast, home care is the approach for 80 percent of similar patients in Hong Kong, and, even in Guatemala, in the developing world, 56 percent of patients get therapies at home, they said.
Reuters reported that there are two workable forms of home dialysis now: “Hemodialysis, which requires a machine and special filter much like in clinics, and peritoneal dialysis, which utilizes the lining of the abdomen to filter waste from the blood.” Peritoneal devices have gotten as small as many home printers and can assist a slice of patients who now get sent to dialysis clinics.
CVS, the sprawling drug store chain, is considering an expansion into dialysis services, especially those that are home-based, as it morphs into a health care industry giant with its recent, $70 billion merger with Aetna.
Dialysis centers long have been the subject of complaints about their cost, quality of care, safety, hygiene, and inconvenience. The battles over them have been fought by regulators, in the civil justice system (leading to awards in the hundreds of millions of dollars), and at the polls. Dialysis companies recently fought off powerful employee unions, in a ballot issue to limit the firms’ profits, with jaw-dropping spending in California, the nation’s second-largest state and one of the biggest and most influential health care markets.
Questions also have burgeoned recently about older Americans and the reflexive push to get them hooked up and into dialysis centers, rather than undergoing “conservative management” when their kidneys start to fail. This approach, the New York Times reported, helps slow renal disease’s progression and treats its symptoms and complications. Patients follow a careful diet, control their blood pressure, avoid weight gain and give themselves hormone injections to ward off anemia. This can keep them from the draining and confining regimen of dialysis at a commercial center. It’s especially hard on older patients.
Besides moving to shift dialysis away from clinics and centers and more toward the home, federal officials also have pledged to push harder still to increase and improve kidney transplants. They said they’ll go full speed ahead on scrutiny of the current, geography-based system of transplants, as well as study of whether more organs might be suitable for procedures after advances in dealing with HIV- and hepatitis C-infection they may carry but may be resolved in patients.
Lower cost insulin
Big Pharma, meantime, blinked a bit in its hard-line tactic of shooting insulin prices sky high, a practice assailed in a recent U.S Senate committee hearing on the outrages of ever-rising prescription drug prices: Eli Lilly, the New York Times reported, will begin selling a cheaper version of its most popular insulin, Humalog, “in an effort to head off criticism about the rising costs of prescription drugs. Lilly will begin selling an ‘authorized generic’ of Humalog 100 for $137.35 per vial, a 50 percent discount off the list price. An authorized generic means that, except for the label, it is identical to the brand-name drug and manufactured in the same facilities.”
There is, of course, a twist in this deal that will keep the company’s cash registers ringing:
Lilly will continue selling Humalog at its regular price to the insurers and employers who want to keep pocketing the large discounts, or rebates, they receive for purchasing brand-name drugs, while also making available a cheaper version to patients who pay for their insulin out of pocket. As a result, people without health insurance should benefit most from the generic insulin, while those with drug coverage will either experience no change or see some decrease in their costs.
A consumer columnist has called this plan “skeevy,” giving Big Pharma a chance to deflect much justified criticism of an unsupportable price for a product whose discoverers declined patents and took just $1 for themselves to ensure patients who needed insulin might forever be able to afford it. It hasn’t happened that way as a cadre of Big Pharma firms have danced with patents and minor reformulations to, voila, send insulin’s price through the roof, all in a synchronized fashion that the firms deny. Patients have faced life-and-death struggles to afford insulin, with some harming their health by trying to ration costly supplies.
Lilly’s move on Humalog should be seen for what it is: The company is simply gouging patients in different ways. C’mon, Lilly, what’s the real and rock-bottom cost of insulin? It’s galling to know that insured patients will be billed far more than $137.35 for a vial, though with the intervention of pharmacy benefit managers and insurer negotiations, the drug’s actual cost may be lower still than that cut rate. Further, as Dick Durbin, the Democratic senator from Illinois pointed out in a letter to the Chicago Tribune, Lilly has never explained why it has increased Humalog’s price 35 times since 1996. It then cost $21. Canadians can buy it now for $38.
In my practice, I see not only the harms that patients suffer while seeking medical services, but also their struggles to afford and access safe, efficient, and excellent medical care. This is truer when the complexity and uncertainty about therapies and prescription medications are soaring, even as their costs explode. When you add in that too many drugs prove to be dangerous and the practices we allow with Big Pharma become all the more unacceptable.
Though it may seem as if there’s only stuff to complain about with federal health officials and lawmakers these days, they deserve credit and support for their efforts to deal with diabetes, dialysis, and abusive prescription drug prices. Although we must reject attempts to over-medicalize diabetes, in particular with the faux and Big Pharma-fostered designation of pre-diabetes, the nation is graying and Americans have serious problems with weight and obesity, as well as with excess consumption of a calorie- and sugar-laden diet. As Reuters reported of the interconnected national renal nightmare:
Nearly 15 percent of the U.S. adult population was suffering from chronic kidney disease in 2018, fueled by growing rates of diabetes and hypertension, according to the government’s U.S. Renal Data System. In 2016, more than 720,000 people were estimated to have progressed to kidney failure. That is forecast to climb as high as 1.26 million people by 2030.
We’ve got issues to deal with and we can do better.