Policy & Price

Orphan drug spending not as high as originally thought, study says

Orphan drug spending not as high as originally thought, study says

Total orphan drug spending represented approximately 1 percent of total U.S. health care spending, according to the authors. Rising concerns about spending on prescription drugs that treat rare diseases are not justified, according to a new analysis in the journal Health Affairs. “We wanted to focus on the true impact of orphan drugs,” said Victoria […]

Are You Just a Number? How New Healthcare Value Frameworks Miss the Point


By Tomas J. Philipson and Jason Shafrin New value frameworks in health care have emerged due to increasing cost pressures. Although value frameworks can be useful tools, they should be used to complement the patient-physician treatment decision-making process, rather than substitute for it. This entails getting away from “one size fits all” rules as well […]

Drugmakers’ Pricing Power Remains Strong


Price increases continue despite pushback from insurers, U.S. lawmakers By JOSEPH WALKER | July 14, 2016 5:30 a.m. Pharmaceutical companies’ power to raise prices is firmly intact despite pushback from health insurers, scrutiny by U.S. lawmakers and anxiety about rising prescription drug spending. More than two-thirds of the 20 largest​pharmaceutical companies said price increases boosted sales of […]

EP Vantage Shifting CAR-Ts Into a Higher Gear


Chimeric antigen receptor T cell (CAR-T) therapy has indisputably become one of the industry’s hottest topics and the next 18 months could see the first CAR-T drugs filed for US approval. But behind the excitement for all things CAR-T lie a number of obstacles in their path to approval. In its second deep-dive into the […]

Drug-Pricing Debate: Looking Past Big Pharma’s Nightmare Scenario


Government action might not be needed to pressure prices on some drugs   A comprehensive government crackdown on high drug prices isn’t likely soon. Still, investors shouldn’t let their guard down. Biotech and pharmaceutical stocks have struggled since last summer when the controversy erupted into a big political issue. Last week’s congressional hearing on the […]

UBS, MPM team up on $471 million cancer fund to speed drug development


A $471 million UBS venture fund aims to generate annual returns “north of 10 percent” for its European and Asian investors by financing new cancer drugs, helping speed them from the lab to the point where drug companies buy their rights. Mark Haefele, global chief investment officer at the Swiss bank’s wealth management unit, said […]

New York Insurers to Change Coverage of Hepatitis C Drugs


Seven health-insurance companies in New York will change their criteria for covering costly drugs that cure chronic hepatitis C under the terms of agreements with the office of State Attorney General Eric Schneiderman. The agreements, expected to be announced Tuesday, require the insurers to cover hepatitis C medications for nearly all patients who have commercial insurance […]

FDA Nominee Not All Good News for Drug Makers


An industry-friendly commissioner seems to be coming to the Food and Drug Administration. While he is favored by many executives, not all drug makers will be happy once he gets on the job. Read more here.

The Biotech Stock Safety Net


Call it the Pfizer put. The giant pharmaceutical company sold €4 billion ($4.22 billion) in bonds this week, paying a yield of almost nothing.The ease and low cost of Pfizer’s borrowing shows that it or any of its major rivals could easily fund the acquisition of almost any biotech. Read more here.

Facing Criticism, Drug Makers Keep Lid On Price Increases


Facing mounting criticism about prices, drug companies put some limits on their increases this year. Prescription-drug makers traditionally raise list prices in January. This year, they didn’t raise prices for as many drugs as last year and imposed fewer boosts of 10% or greater, according to an analysis by the investment firm Raymond James & Associates. […]

Big Pharma’s Offer to Trump: Discounts When Drugs Don’t Work


President Donald Trump says drug prices are astronomical and something needs to be done. Pharmaceutical giants have an answer that doesn’t involve lowering list prices: refunding some of the money to insurers if a drug doesn’t work as expected. Read more here.

Trump Says Health Law Replacement May Not Be Ready Until Next Year


President Trump said in an interview that aired on Sunday that a replacement health care law was not likely to be ready until either the end of this year or in 2018, a major shift from promises by both him and Republican leaders to repeal and replace the law as soon as possible. Read more […]

US health-reform legislation clears big hurdle

US health-reform legislation clears big hurdle

Legislation that would streamline research and development at the US National Institutes of Health (NIH) and drug regulation at the Food and Drug Administration (FDA) is one step closer to becoming law. The US House of Representatives approved a nearly 1,000-page bill — known as the 21st Century Cures Act — on 30 November. Read […]

The Four Legs of a New Health-Care System


Donald Trump announced this week that he had chosen Rep. Tom Price (R., Ga.), a leader in the efforts to replace ObamaCare, to be his secretary of Health and Human Services. This is a consequential choice. Mr. Trump’s election, and the political realignment it represents, offers a generational opportunity to pursue a new direction for […]

FDA floats new draft guidance, created by international group, on software as a medical device

FDA floats new draft guidance, created by international group, on software as a medical device

The FDA has entered into the federal register a new draft guidance pertaining to “software as a medical device” (SaMD). The guidance is presented as representing the FDA’s current thinking on establishing clinical evaluation guidelines for SaMD, but is written by an international organization of device regulators, the International Medical Device Regulators Forum, of which FDA is […]