Pricing And Drug Shortage Study Prompts Concerns That Pharma Is Leveraging Scarcity To Reap More Profit

Bloomberg: Prices Soar For Hospital Drugs After Shortages Hit, Study Finds 
Drug prices increased at roughly twice their usual rate after shortages developed, a study found, suggesting that pharmaceutical companies may be reaping additional profits when urgently needed medicines become scarce. Researchers at the University of Pittsburgh and Harvard Medical School examined the prices of 617 dosages and formulations of 90 different drugs that went in short supply between December 2015 and December 2016. They found that prices rose a cumulative 16 percent, on average, in the 11 months after the shortage began, compared with 7.3 percent in the prior 11 months. (Langreth, 9/17)

Stat: Drug Prices Rose Twice As Quickly As Expected During Shortages 
The findings come amid ongoing shortages blamed on drug makers that failed to build enough production capacity, maintain equipment, or ward off contamination in aging plants. At the same time, there is concern some manufacturers are manipulating production to bolster profits. (Silverman, 9/17)

Modern Healthcare: AHA Launches 340B Hospital Transparency Effort
The American Hospital Association has launched a new effort it hopes will bring more transparency to the 340B drug discount program. Under the so-called 340B stewardship principle initiative, the trade association plans to encourage hospitals to release information on their 340B savings and what they usually do with that money. (Dickson, 9/18)

Stat: Can Patient Advocates Help Make Akcea The Next Sarepta? 
Patients with a rare disease are asking the Food and Drug Administration a question the agency rarely hears: Is that really your final answer? A group for people with familial chylomicronemia syndrome (FCS), a genetic condition that causes fat to build up in a person’s blood, is circulating a petition that begs the FDA to reconsider its decision to reject the one experimental treatment for FCS, Akcea’s volanesorsen. As of Monday, the petition had more than 8,000 signatures. (Sheridan, 9/18)

Stat: CVS May Modify Its New Cost-Effectiveness Program For Setting Coverage
CVS Caremark may revisit a plan that allows its clients to exclude coverage of most new, high-priced drugs after advocacy groups complained the effort would discriminate against very sick or disabled patients. At issue is a cost-effectiveness program the pharmacy benefits manager touted last month for assessing value — in this case, any new drug exceeding $100,000 per QALY, or quality-of-life years, a benchmark that measures both the quantity and quality of life generated by providing a treatment. New drugs exceeding the threshold may be excluded from health plan and employer formularies, or coverage lists. (Silverman, 9/18)

Stat: AbbVie Accused Of Paying Kickbacks, Using A Stealthy Network To Promote Humira
In a wide-ranging scheme, AbbVie (ABBV) used a combination of old-fashioned kickbacks to doctors and a stealthy network of nurses to illegally boost prescriptions of its best-selling Humira treatment, according to a lawsuit filed on Tuesday by the California insurance commissioner. Over a five-year period, the drug maker offered physicians a familiar menu of tempting items, from cash, meals and drinks, to gifts and trips, along with patient referrals, in hopes they would write more prescriptions for its Humira rheumatoid arthritis treatment, a $12.3 billion seller in the U.S. last year. (Silverman, 9/18)

The Associated Press: California: Drugmaker Paid Doctors To Overprescribe Humira
"Ultimately, AbbVie gambled with the health and safety of thousands of Californians' lives, including children, by making sure patients continued to take Humira at any cost, all to protect their profits not the health and well-being of patients," Jones said. Humira is an injectable drug that is widely advertised as a treatment for rheumatoid arthritis and other inflammatory conditions and comes with a warning for cancer and serious infections that can turn deadly. It had sales of over $12 billion in 2017, according to the lawsuit. (Thanawala, 9/18)

Denver Post: Colorado Governor Race: Jared Polis Unveils Health Policy
Democrat Jared Polis pledged Monday to strengthen health care consumer protections, create a system to import prescription drugs from Canada and reform the state’s health insurance zones as part of his first 100 days if elected governor. Those new campaign promises are among more than a dozen policy proposals the Boulder congressman outlined in front of a doctor’s office in this mountain town and said that if put in place they would immediately drive down the cost for health care. (Garcia, 9/17)

The Associated Press: Jealous Backs Prescription Drug Affordability Measures
Democrat Ben Jealous is supporting proposals aimed at making prescription drugs more affordable in Maryland. Jealous, who is running for governor, announced his support for the measures Monday at a news conference. He is backing legislation to create a state board to focus on ensuring transparency and accountability in prescription drug pricing. He says companies would be required to provide advance notice before increasing prices and explain why. (9/17)

Reuters: Novo Nordisk Lays Off 400 Staff In Research & Development Unit
Novo Nordisk, the world's top maker of diabetes drugs, said on Tuesday that it will lay off 400 staff in Denmark and China as part of a broader restructuring of its research and development organisation. The firm, which employs more than 42,000 people in 79 countries, has seen growth slow due to pricing pressures in the United States, from where it sources about half its revenue. (Gronholt-Pedersen, 9/18)

Stat: Viking Therapeutics Is Thrust Into Race For Lucrative Fatty Liver Disease Treatment
In experimental pill from Viking Therapeutics (VKTX) reduced liver fat in patients with early signs of fatty liver disease, according to results from a mid-stage clinical trial announced Tuesday. The promising clinical trial results thrust Viking into the mix of companies racing to develop new treatments for NASH, the commonly used acronym for non-alcoholic steatohepatitis, a chronic disease in which fat accumulates in the liver. (Feuerstein, 9/18)

Stat: Biotech IPOs Are Yet To See Their Shadow, As The Biggest Deal Ever Awaits
Biotech’s run of successful initial public offerings is showing no signs of fatigue. Five companies are queued up to go public before the month is out, and the industry is on an IPO pace not seen since its most recent boom resulted in a painful correction. Forty-three biotech companies have gone public in 2018, raising about $4.2 billion in the process. If all six of September’s planned IPOs succeed, biotech will be on pace for 60 Wall Street debuts on the year, which would be the most since 2015, when there were 68. (Garde, 9/19)

Stat: Clovis Oncology Pays $20 Million To Settle Charges Of Misleading Investors
Clovis Oncology (CLVS), its chief executive, and a former chief financial officer will collectively pay more than $20 million to settle civil charges of misleading investors about a lung cancer drug that was being developed. During a four-month period beginning in July 2015, the drug maker and chief executive Patrick Mahaffy made various misleading statements about the effectiveness of its rociletinib drug compared with another treatment. (Silverman, 9/18)

Stat: In Unlikely Alliance, PhRMA Sides With Landlords In Calif. Referendum On Rent Control
The pharmaceutical industry’s most powerful lobbying group is opening its war chest to try to sway a policy fight with no clear connection to medicine or health care, spending a half-million dollars here to oppose a California ballot measure that would expand rent control protections across the state. (Facher and Robbins, 9/19)