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Wednesday, Apr 5 2017

Full Issue

By Engaging Payers Before Setting Price, One Drug Company Wins Praise Despite $37K-A-Year Cost

News outlets report on stories related to pharmaceutical drug pricing.

Shortly before his company won the right last week to sell a new drug for severe eczema, Dr. Len Schleifer made a brash promise. He vowed to price the medicine 鈥渞esponsibly鈥 and avoid the anger that high drug prices have stirred. 鈥淵ou鈥檒l get to judge me and see how we do,鈥 he told me. To his credit, Schleifer appears to have delivered.聽The drug, called Dupixent, has a list price of $37,000 a year. This isn鈥檛 cheap. But Regeneron Pharmaceuticals could have charged still more, since other companies charge roughly $50,000 a year for older, less effective psoriasis treatments. (Silverman, 4/3)

Two new drugs were cleared to hit the market last week: an eczema drug that will cost $37,000 per year and one for multiple sclerosis that will cost $65,000. The drugs drew both praise and criticism for their five-digit price tags. Researchers and patient organizations applauded the prices, which were cheaper than similar drugs on the market. They hoped the prices would please insurers and make the drugs more widely available. (Nedelman, 4/3)

On the same day the stockbroker for then-Georgia Congressman Tom Price bought him up to $90,000 of stock in six pharmaceutical companies last year, Price arranged to call a top U.S. health official, seeking to scuttle a controversial rule that could have hurt the firms鈥 profits and driven down their share prices, records obtained by ProPublica show. (Faturechi, 3/31)

President Donald Trump鈥檚 pick to head the U.S. Food and Drug Administration is among the most vigorous advocates of lowering drug costs by approving cheap generics faster, an initiative aimed directly at the profit centers of major companies. Scott Gottlieb, a former聽FDA deputy commissioner, would make streamlining approvals his top priority, according to a person familiar with the administration鈥檚 thinking.聽He鈥檚 particularly focused on complex medications that combine old drugs with newer delivery devices, as well as those with unusually complicated formulations. (Langreth and Edney, 3/29)

Dismissing drug-price concerns could leave investors with a surprise bill. Sixteen Senate Democrats sponsored the Improving Access to Affordable Prescription Drugs Act, a new legislative proposal that was introduced last week. It contains a familiar list of policy prescriptions such as enabling Medicare to dictate pricing more aggressively than is currently allowed, relaxing rules that govern importation of drugs and eliminating tax breaks for direct advertising to consumers. There are new wrinkles as well: The bill would require more disclosure from charities that help patients pay for high-cost medicines. (Grant, 4/3)

No surprise here: Breakthrough drugs remain expensive. But the latest round of regulatory approvals suggests that the pricing trend is moderating. Regeneron Pharmaceuticals and Sanofi announced Food and Drug Administration approval for their new dermatitis drug, Dupixent, on Tuesday morning. Later in the day, Roche announced it won FDA approval for the multiple sclerosis treatment Ocrevus. Analysts expect both drugs could top $4 billion in annual revenues by 2022, according to a recent analysis from the forecasting firm Evaluate Pharma. (Grant, 3/29)

Politicians have heaped fire and brimstone upon pharmaceutical companies for increasing the price of their products, some of which were聽approved decades ago. But far less ire has been directed at price tags on newly approved treatments 鈥 many of which continue to rise.聽New cancer drugs cost about 17 times more than they did 40聽years ago, according to Kaiser Health News, and a drug for spinal muscular atrophy approved in 2016 is one of the most expensive聽products on the market, the Boston Globe reported. (Swetlitz, 3/30)

Big changes could be coming to the way new drugs are approved by the Food and Drug Administration. The Trump administration and incoming new leadership at the FDA, coupled with the implementation of the 21st Century Cures Act, signed into law by President Obama in December, may shake up the status quo for the prescription drug approval process. The Cures Act enables faster drug approvals by expanding the kinds of evidence, beyond traditional clinical trials, that the FDA can consider when reviewing drug applications. (4/3)

Newer cancer drugs that enlist the body's immune system are improving the odds of survival, but competition between them is not reining in prices that can now top $250,000 a year. The drugs' success for patients is the result of big bets in cancer therapy made by Bristol-Myers Squibb Co, Merck & Co Inc and Roche Holding AG, among others in big pharma. The industry's pipeline of cancer drugs expanded by 63 percent between 2005 and 2015, according to the QuintilesIMS Institute, and a good number are reaching the market. (Beasley, 4/3)

Pharma stayed out of the bruising fight over Obamacare repeal, but the bill鈥檚 demise could turn into the industry鈥檚 worst nightmare: a big bipartisan fight over drug prices, with President Donald Trump leading the charge. Trump, who has repeatedly promised action on drug prices, is looking for a policy win after the repeal debacle 鈥 and drug pricing is an issue that Republican and Democratic voters care about. (Karlin-Smith, 3/31)

Over the past six months, more drug makers have begun posting their policies for gaining greater access to experimental medicines, according to a new analysis. However, more than half of all pharmaceutical manufacturers have yet to take this step to improve disclosure. Specifically, 47 percent of 98 drug makers have posted a compassionate use policy on their web sites, compared with 19 percent last October. However, 84 percent of the 25 companies with a market capitalization of greater than $10 billion posted policies. This was up from 52 percent last fall. (Silverman, 4/4)

A Nevada lawmaker has introduced a bill to fight the rising cost of medicines, one of dozens state legislators to attempt such a move. But this one has a twist 鈥 the legislation targets only companies that make diabetes drugs and insulin. Specifically, the bill requires drug makers to report pricing histories; disclose a slew of costs, such as research, manufacturing, and patient assistance; and notify state officials and insurers at least 90 days before prices are increased above the inflation rate for the preceding year. (Silverman, 3/30)

U.S. Senator Maggie Hassan was in Nashua Friday highlighting her new proposal to lower the cost of prescription drugs. Under the measure, the U.S. Department of Health and Human Services would be required to monitor pricing spikes to ensure drug costs aren鈥檛 rising unfairly. (Sutherland, 3/31)

In what some observers are calling a misguided effort, Arizona has become the first state in the nation to pass a law allowing drug makers to promote their medicines for so-called off-label uses 鈥斅爏o long as the information given doctors is truthful. Interestingly, the law was hatched by the Goldwater Institute, the same think tank that spearheaded the controversial Right to Try laws designed to give patients early access to experimental medicines. And the think tank is vowing to duplicate that campaign by introducing off-label bills around the country. (Silverman, 3/29)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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