Expensive Cholesterol Drugs’ Value Falls Short Of Their Eye-Popping Price Tag, Doctors Say

Stat: Prices For Cholesterol Drugs Would Have To Drop A Lot To Be Cost Effective
A new analysis of the latest type of cholesterol-lowering drugs finds that prices would have to drop by more than two-thirds — to about $4,500 a year — for the medicines to be cost effective. The findings were made after assessing discounted prices and results of a recent clinical trial that studied cardiovascular outcomes for one of the two available medicines, which are known as PCSK9 inhibitors. One drug is sold by Amgen (AMGN), while the other is marketed jointly by Sanofi (SNY) and Regeneron Pharmaceuticals (REGN). The analysis was published in the Journal of the American Medical Association. (Silverman, 8/22)

Kaiser Health News: ‘Breakthrough’ Leukemia Drug Also Portends ‘Quantum Leap’ In Cost
When doctors talk about a new leukemia drug from Novartis, they ooze enthusiasm, using words like “breakthrough,” “revolutionary” and “a watershed moment. ”But when they think about how much the therapy is likely to cost, their tone turns alarmist. “It’s going to cost a fortune,” said Dr. Ivan Borrello at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore. (Szabo, 8/23)

Stat: These Companies Actually Want To Pay Higher Fees — And The FDA Is Poised To Make That Happen
Makers of over-the-counter drugs may soon pay for federal review of their products, just like pharmaceutical makers. And they’re fine with the change. After years of discussion, the Food and Drug Administration — which is holding another stakeholder meeting on the topic Wednesday afternoon — appears poised to make that change as part of a sweeping overhaul of its regulations for OTC products. (Sheridan, 8/23)

Stat: How One Small Biotech Exploits A Loophole In A Federal Transparency Law
Agene therapy for a rare disease is unlikely to come cheap, so one fledgling biotech recently reached out to experts for insights into winning over cost-conscious hospitals. And to lure these experts to a so-called advisory meeting, the company used an enticing pitch — each attendee would be given a $3,000 honorarium, along with paid airfare and lodging for two-day session in November. However, AveXis (AVXS) dangled something else: The compensation would not be reported to a federal database to which industry must submit payments made to physicians. Known as OpenPayments, the database was launched three years ago in response to concerns that medical practice and research may be unduly influenced by financial relationships between doctors and drug and device makers. (Silverman, 8/22)

The Wall Street Journal: Biogen Treads Tricky Path Between Politicians, Investors
Michel Vounatsos, Biogen’s new chief executive, is in a tough position. A letter sent to the company by two House Democrats on Thursday as part of an investigation into high prices of multiple sclerosis drugs provides an illustration. Among other things, the congressmen are requesting information on rebates, discounts, coupons, and patient assistance charity programs that the company uses to help sell its products. (Grant, 8/18)

The Wall Street Journal: Samsung Broadens Its Drugs Business
The Samsung conglomerate is furthering its efforts to build a full-fledged prescription-drugs business, signing its first deal to develop novel drugs for hard-to-treat diseases. Samsung, best known for its smartphones and television sets, is forming a partnership with Takeda Pharmaceutical Co. of Japan to jointly fund and develop multiple treatments in coming years, the companies said in a written statement. The companies plan to begin immediate development of a drug to treat severe acute pancreatitis. (Martin and Rockoff, 8/21)

Reuters: U.S. Bioservices To Resolve Kickback Claims For $13.4 Million: Filing
Specialty pharmacy firm US Bioservices Corp has agreed to pay $13.4 million to settle U.S. government claims that it pushed patients to refill prescriptions of Novartis AG's iron overload drug Exjade in exchange for referrals from the Swiss drugmaker. (Pierson, 8/22)

The Wall Street Journal: Longevity Fund Raises $22 Million To Support Anti-Aging Therapies
Age isn’t just a number. For older people, it can often mean having one or several age-associated diseases. But a growing cache of research suggests that by homing in on the cellular mechanisms of aging, it is possible to ward off diseases associated with getting older. Likewise, a growing cadre of entrepreneurs and investors has emerged to support the quest for longer, healthier lives. (Mack, 8/22)

Bloomberg: Novartis Speeds New Anti-Malarial As Older Drug Loses Potency
Novartis AG began testing a new anti-malaria pill in Africa, advancing development of an alternative to its most effective treatment that billionaire philanthropist Bill Gates said risked losing potency. Patients in Mali infected with the mosquito-borne parasite began receiving the experimental drug, known as KAF156, in combination with another medicine, the drugmaker said Monday. More than 500 children and adults across nine countries in Africa and Asia will be enrolled in the mid-stage study over the next few months. (Paton, 8/21)

FiercePharma: Amid FDA Competition Push, Hikma Jacks Up A Handful Of Drug Prices As Much As 430%
Generic drug prices may be depressed enough to bring down the mood of many a copycat drugmaker, but that doesn’t mean prices on some unusual formulas aren’t going up. Just ask Hikma Pharmaceuticals, which posted a half-dozen big price rises just this month. (Staton, 8/21)

Stat: Advocacy Group Is Upset That India Granted Pfizer A Patent For A Vaccine
Over the objections of Doctors Without Borders, the Indian government has awarded a patent to Pfizer (PFE) for its best-selling Prevnar 13 pneumococcal vaccine, a move the advocacy group says will restrict access to many patients for nearly a decade. In reaching its decision, the Indian Patent Office determined the Pfizer patent was sufficiently unique to merit protection, even though Doctors Without Borders filed paperwork last year arguing otherwise. The patent “does not meet the inventive step requirement [and] it ought to have been rejected,” the advocacy group wrote in a statement after the government decision was announced. (Silverman, 8/22)

Los Angeles Times: With New Allies And Approaches, California Lawmakers Try Again To Confront High Prescription Drug Prices 
Less rowdy than the sputtered push for single-payer healthcare and less fraught than the battle over Obamacare’s future, the concern over the cost of prescription drug prices has been overshadowed for the past year by the marquee healthcare battles gripping Sacramento and Washington. ... The price disclosure bill , SB 17 by state Sen. Ed Hernandez (D-Azusa), is now one of five measures that have been proposed to tackle prescription costs, forcing the drug industry to fend off multiple threats. (Mason, 8/20)

KPCC: Will Transparency In Drug Pricing Force Down Costs?
As the state legislature returned to work in Sacramento Monday, lawmakers were considering a number of bills intended to restrain the rise of health care prices, including one that would require drug makers to notify the public before raising the price of certain medications.  ... If the bill passes, next year the state’s insurance regulators will keep an annual list of the 25 mostly costly drugs, the 25 most commonly prescribed drugs, and which 25 drugs’ prices went up the most. (Faust, 8/21)

Detroit Free Press: Drug Price Gouging In Michigan Targeted; House Dem Unveil Board Plan
Saying they’re tired of waiting for Congress to act, Democrats in the state House of Representatives unveiled a proposal today that they hope will stop pharmaceutical companies from boosting the prices of prescription drugs. They want to create a Prescription Drug Consumer Protection Board that would review increases in prescription drug prices and, if they find the price hikes unjustified, ask the Michigan Attorney General to investigate the matter. (Graym 8/21)

The Philadelphia Inquirer/Philly.com: Atlantic City Firefighter, Two Drug Reps Plead Guilty In Shore Rx Scheme
A retired Atlantic City firefighter and two pharmaceutical representatives pleaded guilty in federal court in Camden on Friday to their roles in a $28 million prescription drug benefits scheme that prosecutors say ensnared Shore firefighters, police officers, teachers, and a state trooper. Michael Pepper, 45, of Northfield, N.J., a 10-year veteran of the Atlantic City Fire Department, pleaded guilty to participating in a conspiracy to defraud public health benefits with a kickback scheme involving compounded prescription benefits. His role netted him $113,000, prosecutors said, which is now subject to forfeiture. (Rosenberg, 8/18)

The Washington Times: Ballot Battle Erupts In Ohio Over Health Care Costs
They lost in California, but that hasn’t stopped activists from waging a referendum war in Ohio against the big pharmaceutical companies. If approved by voters in November, Ohio agencies and state-assisted programs would be required to buy prescription drugs at prices no higher than what the U.S. Department of Veterans Affairs pays for them — typically 20 to 24 percent less than the usual price. (Howell, 8/21)

Detroit News: Michigan Democrats Pitch Prescription Drug Price Transparency Plan
State House and Senate Democrats on Monday called for creating a new “consumer protection” board to discourage prescription drug price spikes and shed light on costs they claim are “out of control” in Michigan. Legislation set for introduction next month would require pharmaceutical companies to provide the board with explanatory documentation if they want to raise wholesale prices on a drug here by 10 percent in one year or 30 percent over five years. (Oosting, 8/21)