Morning Briefing
Summaries of health policy coverage from major news organizations
The Cost Of A Miracle: Groundbreaking Treatments Becoming More Common, But Their Price Tags Remain Sky High
The Wall Street Journal: High Hopes For A Gene Therapy Come With Fears Over Cost
Just 4 years old, Caspian Soto uses a cane and headlamp to help him see when he walks. He can’t see in dark places like aquariums or movie theaters. He’s never seen the stars. Caspian was born with a rare, inherited eye disorder called Leber congenital amaurosis, which results in the progressive deterioration of the retina, the tissue at the back of the eye that detects light and color. He could lose all vision by the time he’s a teenager. (Reddy, 9/24)
The New York Times: Starring In That Drug Commercial? An Actual Patient
Several years ago, a casting director working on a commercial for the NovoLog FlexPen, a dial-a-dose insulin injector from Novo Nordisk, called a friend and urged her to try out. The friend, Vivicca Whitsett, a compliance administrator at a brokerage firm in Los Angeles and a stand-up comic, was game. Her audition went well, but Ms. Whitsett also filled an essential requirement: She has Type 2 diabetes. (Kaufman, 9/23)
Stat: Generic Drug Makers Face ‘A Silent Crisis,’ FDA Official Says
One of the Food and Drug Administration’s top officials says that consolidation in the drug distributor market has made it less attractive for companies to sell generic drugs — and that raising prices of the drugs might actually invite more competition. ... As politicians rail against drug companies for setting high prices and decry pharmacy benefit managers for negotiating secret rebates, they have largely left the health of the generics marketplace out of focus. (Swetlitz, 9/21)
The New York Times: A G.O.P. Senate Candidate Highlights His Drug Industry Career. Should He?
When Bob Hugin joined Celgene in 1999 as its chief financial officer, the company was a struggling biotech that sold just one product — a leprosy drug — and faced a shaky future. By the time he stepped down as executive chairman in February to run for United States Senate, Celgene had become a pharmaceutical powerhouse with a market value of nearly $80 billion. And that onetime leprosy drug? It had been transformed into Revlimid, a best-selling cancer drug that, with annual sales of $8.2 billion, made up nearly two-thirds of Celgene’s net sales in 2017. (Thomas and Corasaniti, 9/24)
Stat: Insulin Prices Could Be Much Lower And Drug Makers Would Make Healthy Profits
As prices for diabetes treatments continue to roil consumers, a new study suggests that manufacturers could make both human and analog insulins at low costs and still pocket a profit. After analyzing expenses for ingredients, production, and delivery, among other things, the researchers contend that the price for a year’s supply of human insulin could be $48 to $71 a person and between $78 and $133 for analog insulins, which are genetically altered forms that are known as rapid or long-acting treatments. Examples of analog insulins include Humalog, Lantus and Novolog. (Silverman, 9/25)
Stateline: Courts Force States To Provide Costly Hep C Treatment
A series of recent court rulings and settlements, including one last week in Indiana, have found that states cannot withhold potentially life-saving but expensive medications from Medicaid beneficiaries and prison inmates who have chronic hepatitis C. Hepatitis C kills far more Americans than any other infectious disease. But when new antiviral drugs that for the first time promised a cure for hepatitis C hit the market in 2014, states blanched at their eye-popping prices and took steps to sharply limit the availability of those treatments for Medicaid beneficiaries and inmates. According to one recent survey, only 3 percent of inmates in state penitentiaries with hepatitis C receive the cure. (Ollove, 9/25)
CQ: Drug Prices Could Become A Divisive Issue For Democrats
Democrats are making the cost of prescription drugs a pillar of the party’s health care agenda in the midterm elections, but if they win a majority for the 116th Congress, the party will have to grapple with internal divisions over the issue that might be magnified next year. This campaign season has been notable for candidates pushing the party to reject corporate influence. For an emboldened progressive wing of Democrats, the party’s current plans might not be enough. Their views compete with those of new candidates from politically moderate areas with a big pharmaceutical industry presence that might be more inclined to join with longtime incumbents who sympathize more with the industry’s perspective. (Siddons, 9/24)
CQ: House Debates Drug Price, Health Preparedness Bills
The House cleared late Tuesday afternoon on a pair of bills related to drug price disclosures at pharmacies, after passing another measure designed to update health emergency preparedness programs. The bills, which were brought up under suspension of the rules, all received voice votes. If President Donald Trump signs the drug pricing bills into law as expected, they would be the first enacted legislation related to a proposal on the issue that the administration released earlier this year. (Siddons, 9/25)
Stat: Trials That Help Drug Makers Win FDA Approval Have Median Cost Of $19 Million
Although developing a new drug is generally considered to be a pricey proposition, the median cost of the pivotal trials needed to win regulatory approval is just $19 million, according to a new study. In other words, the key scientific evidence used to persuade the Food and Drug Administration to endorse a new medicine is a small fraction of the overall development costs regularly attributed to the efforts undertaken to bring a new medicine to market. (Silverman, 9/24)
Marketplace: Kickbacks Or A Helpful Service? Here's Why Pharma Is Under Fire
Pharmaceutical companies spend a lot of money to develop new blockbuster drugs — for research, and then getting the meds through clinical trials. ...But some major drug companies are offering other, more indirect benefits to doctors and patients to pump up prescriptions. This week, the California insurance commissioner sued AbbVie, the maker of Humira, a top-selling arthritis drug, over alleged kickbacks. (Hartman, 9/21)
The Wall Street Journal: U.S. Probes Drugmakers Over Free Services
Federal prosecutors are probing whether big drugmakers including Sanofi SA, Gilead Sciences Inc. and Biogen Inc. potentially violated laws by providing free services to doctors and patients, according to a Wall Street Journal review of securities filings. Drug companies say the services, such as nurses and reimbursement assistance, help doctors and patients. But the practices, which have become more prevalent as drugmakers have introduced more complex and expensive drugs, are drawing scrutiny over whether they serve an illegal commercial purpose: inducing sales. (Loftus, 9/21)
San Francisco Chronicle: Federal, State Officials Probe Gilead’s Drug Marketing Practices
California insurance regulators and Alameda County prosecutors have subpoenaed Gilead Sciences for information regarding the Foster City drugmaker’s marketing practices and other services. The subpoenas, issued in October by the California Department of Insurance and the Alameda County district attorney’s office, were disclosed in a filing with the U.S. Securities and Exchange Commission in February. (Ho, 9/21)
The Wall Street Journal: Some Good News From Rite Aid? It Is Possible
Rite Aid, weighed down by too much debt, has a clear opportunity to fix itself. In doing so, the drug chain can reshape the pharmacy-benefits-manager business. The past two years have been difficult for Rite Aid. The pharmacy company pulled out of a planned merger with grocery chain Albertson’s in August, after significant shareholder opposition to the deal’s terms. Regulators had already nixed a sale of the company to rival Walgreens Boots Alliance in 2017, though Rite Aid was able to sell a large share of its stores to Walgreens. (Grant, 9/26)
The Wall Street Journal: Novartis To Cut 2,000 Jobs Amid Revamp
Novartis AG plans to cut more than 2,000 jobs as part of a global restructuring, the latest move by its new chief executive to refocus the pharmaceutical giant on higher-value drugs. The Swiss company said Tuesday that most of the cuts would fall in its home market, where it plans to eliminate a net 1,000 production jobs—after taking into account the creation of 450 positions—and 700 positions in business services. (Mancini, 9/25)
Marketplace: Novartis Moves Away From Mass-Market Drugs
Drugmaker Novartis announced it's cutting more than 2,000 jobs — most of them in Europe — as part of a global restructuring. The company plans to focus on producing and selling more innovative drugs, but these specified medicines require lots of research and carry higher price tags. (Babin, 9/25)
Kansas City Star: Pharma CEO Responds To McCaskill On 400% Drug Price Hike
Nirmal Mulye, the CEO of a small Kansas City pharmaceutical company, got Twitter-famous — or infamous — last week after he was quoted saying he had a “moral requirement” to raise a drug price 400 percent. ...After the story broke, U.S. Sen. Claire McCaskill, a Missouri Democrat, and U.S. Sen. Susan Collins, a Maine Republican, sent Mulye a series of questions about the price increase on nitrofurantoin, an antibiotic for treating urinary tract infections. This week Mulye responded, but it appears that won’t be the final word. (Marso, 9/21)
