Morning Briefing
Summaries of health policy coverage from major news organizations
A Review Of Insulin's 100-Year History Reveals A Complicated Story Where Many Share The Blame For Price Spikes
But a thorough review of the drug鈥檚 nearly 100-year history reveals a much more complicated story: one that makes it clear that the drug makers, their generic counterparts, doctors, and, increasingly, the Food and Drug Administration itself all share blame for the broken insulin market. And while there are a slew of ideas being floated for solving this problem 鈥 everything from seizing drug patents to capping how much people with diabetes can pay out of pocket for insulin 鈥 multiple policy experts told STAT that creating generic competition is likely the key to bringing costs down for the more than 7.5 million Americans who rely on the drug. (Florko, 2/19)
Lawmakers are zeroing in on the skyrocketing cost of insulin and putting pressure on manufacturers as they work to address high drug prices. Congressional Democrats, Republicans and the Trump administration say that lowering drug prices is a priority, and drugmakers are on the hot seat. Insulin could prove an easy target in that push. The drug hasn鈥檛 changed much since it was first discovered nearly 100 years ago, and as newer forms of the drug have been introduced, the price has climbed. (Weixel, 2/20)
The world鈥檚 largest maker of generic drugs is looking for growth in an unlikely place: high-price biotech medicines. Teva Pharmaceutical Industries Ltd., which supplies more than one in 10 drugs taken in the U.S., has struggled in recent years with slumping generics prices and heavy debt. Forced to cut thousands of jobs and shut research facilities, the Israeli company is now turning to biotech drugs to revive its fortunes. (Roland, 2/13)
Democrats and the Trump administration are beginning to hold talks on lowering drug prices as they look for a rare area of common ground. Both President Trump and congressional Democrats say that lowering drug prices is a priority, providing a potential area for bipartisan action in a government that is otherwise bitterly divided after a months-long fight over border security. But the political risks are high for both sides in a politically polarized atmosphere and with the 2020 elections rapidly approaching. (Sullivan, 2/16)
In one case, an executive at a pharmaceutical company had an employee email a competitor to discuss strategy. In another, a drug maker allegedly struck a bargain with another so that each company could maintain its respective market share. And in yet another, prosecutors say, two pharma companies compared notes while simultaneously boosting prices of their drugs. Those details, and many others, are laid out in the unredacted complaint of a lawsuit filed by several states that alleged generic drug makers schemed to fix prices, according to a copy we obtained. (Silverman, 2/19)
As the pharmaceutical industry churns out more cancer treatments, a new analysis finds that oncologists who receive payments over an extended period of time 鈥 mostly for speaking or consulting 鈥 are much more likely to prescribe a medicine made by the company that writes them a check. The physicians treating kidney and lung cancer as well as chronic myeloid leukemia typically wrote more prescriptions for drugs made by a company that paid them over a three-year period, according to the findings, which were published in The Oncologist. However, a cause-and-effect relationship was not established and the same sort of association was not found among doctors who treated prostate cancer. (Silverman, 2/13)
Novo Nordisk A/S and two other insulin makers must face claims they gouged diabetes patients through deceptive price lists for their life-saving drugs. U.S. District Judge Brian Martinotti in New Jersey on Friday allowed a proposed class-action lawsuit filed by 67 diabetics against Novo, Eli Lilly & Co. and the U.S. unit of French drugmaker Sanofi to proceed on consumer-fraud allegations tied to skyrocketing insulin prices. The judge threw out the plaintiffs鈥 racketeering claims. (Feeley and Langreth, 2/15)
Amid investor pressure to split up its CEO and chairman roles, embattled Allergan is giving in鈥攂ut only a bit. Allergan will聽support an investor resolution to split up the jobs, the company said聽on Tuesday, shortly聽after hedge fund manager David Tepper renewed his demand that it do so. The catch? The split wouldn't happen until Allergan's next CEO rotation鈥攎eaning current CEO and Chairman Brent Saunders would keep wearing both hats. (Sagonowsky, 2/19)
Under a new proposal, the Medicare program would pay for expensive new cancer therapies known as CAR-T for patients across the country. The Centers for Medicare and Medicaid Services on Friday released a so-called national coverage determination for the therapies that lays out exactly when, and for whom, Medicare will cover a given drug. The proposal specifies that Medicare will cover all FDA-approved CAR-T therapies as long as data is collected about how the patients fare, which could inform the government鈥檚 policies about paying for the therapy in the future. (Swetlitz, 2/15)
Drug shortages are alarmingly common in the U.S., with health care providers often scrambling to make do without sufficient supplies. Those shortages occur for any number of reasons 鈥 natural disasters at productions plants or surging demand caused by an outbreak, for instance. But there are also commercial forces at work. Companies have very little incentive to manufacture a drug like BCG. Although it鈥檚 been used to fight cancer since the 1970s, it isn鈥檛 easy to produce. And priced at a relatively modest $100-$200 a dose, it鈥檚 not a drug that companies are rushing to make, even if it鈥檚 no longer patented; right now, Merck is the only manufacturer for the U.S. and European markets. (Keshavan, 2/20)
Kaiser Health News: The High Cost Of Sex: Insurers Often Don鈥檛 Pay For Drugs To Treat Problems
For some older people, the joy of sex may be tempered by financial concerns: Can they afford the medications they need to improve their experience between the sheets? Medicare and many private insurers don鈥檛 cover drugs that are prescribed to treat problems people have engaging in sex. Recent developments, including the approval of generic versions of popular drugs Viagra and Cialis, help consumers afford the treatments. Still, for many people, paying for pricey medications may be their only option. (Andrews, 2/19)
The drugmaker Gilead Sciences has been hit with a whistle-blower suit accusing it of paying healthcare providers, government agencies and others organizations to boost sales of its hepatitis and HIV drugs. In an unsealed False Claims Act case in California federal court, a whistle-blower claimed Gilead's Frontlines of Communities in the United States program, which partners with other institutions to facilitate hepatitis and HIV screenings, resulted in billions of dollars in excess government spending. (Kacik, 2/14)
As federal authorities scrutinize relationships between drug makers and patient charities, Alexion Pharmaceuticals (ALXN) is the latest company to agree to settle allegations that donations amounted to kickbacks paid to Medicare patients as a way to cover their out-of-pocket costs. In a recent regulatory filing, Alexion disclosed that it agreed last December to pay $13 million to resolve civil claims concerning payments made to Patient Services and the National Organization of Rare Disorders, which provide financial assistance to Medicare patients taking its medicines. (Silverman, 2/19)
At least two Democrats are concerned with a provision in a new version of the North American Free Trade Agreement, the United States-Mexico-Canada Agreement, or USMCA, that grants 10 years of exclusivity to biologic drugs, the AP reported Tuesday. The provision would bar companies from selling copycat biosimilar drugs in Mexico and Canada for a full decade after a drug company launches a branded biologic drug. Right now, biologics only get 5 and 8 years of exclusivity in Mexico and Canada. In the U.S., biologics already get 12 years of exclusivity. (Swetlitz, 2/15)
Takeda predicts that climate change will help its Zika and Dengue fever vaccines find a larger market. Roche says it could ultimately make it attractive for the company to develop treatments for diseases like malaria. And AbbVie says extreme weather events might boost its immunology products. But the potential risks of climate change 鈥 and the attendant increase in natural disasters 鈥 stand to outstrip any of those incremental gains, as the companies described in recent risk assessment reports to the British nonprofit CDP. (Sheridan, 2/15)
A drug war is raging in the heart of Europe鈥攐ver pharmacies. Few businesses capture differences between Europe and the U.S. better than the humble drugstore. Today, people on both sides of the Atlantic are wired into U.S. giants Apple, Google and Netflix, and shop at European chains such as IKEA, H&M and Zara. But when it comes to personal care, contrasts abound, giving rise to an insurgency that is out to change Europe鈥檚 drugstore sector. (Michaels, 2/18)
Lawmakers from Mexico鈥檚 ruling party plan to send a bill to Congress that would set maximum drug prices, aiming to improve accessibility for poor patients and bring costs in line with cheaper countries in the region. The proposal for new pharmaceutical regulations, which MORENA lawmakers announced on Sunday, says it seeks to ensure 鈥渁ffordable prices that are in touch with the economic reality鈥 of Mexico. A source at the party said the bill will be introduced this week. (2/18)
Japanese doctor Yasushi Goto remembers prescribing the cancer drug Opdivo to an octogenarian and wondering whether taxpayers might object to helping fund treatment, which at the time cost hundreds of thousands of dollars, for patients in their twilight years. (Umekawa, 2/18)