September 8, 2017
Drug cost conversation continues
Companies seek patents to ward off generics
Drug companies that make biologics, a class of more complicated medications, are using patents to prevent generic competition. Some companies are not only patenting the drugs themselves, but also the processes used to make them. If a company changes the process and seeks a new patent, it can further delay a generic—and price cut—from the market. The approval process for biologic generics is relatively new and there are few generic biologics on the market. Regulatory structures in place might not be able to handle issues that are rising with the new drugs coming to market.
Cancer survivors more likely to skip medication due to finances
Cancer survivors tend to have more difficulties accessing drugs due to cost than other demographics, according to a new study from the U.S. Department of Health and Human Services (HHS). The researchers found that while overall fewer people reported skipping medication doses because of finances, those with a history of cancer were more likely to report forgoing prescription drugs due to cost. Cancer drug costs continue to rise in the U.S., with some medications costing $100,000 or more per year. In addition, AARP’s Public Policy Institute find retail prices for 101 widely used specialty drugs increased nearly 10 percent in 2015, the largest yearly increase since 2006.
Insulin prices on the rise
Insulin prices have more than tripled since 2003, with Eli Lilly earlier this year increasing the prices of Humalog and Humilin nearly eight percent. Eli Lilly has promoted its work to keep prices in check, but patients are saying more needs to be done to ensure affordability and access to essential daily medication to treat diabetes.
California to vote on drug pricing bill
The California state legislature will vote on a bill to require drugmakers to provide notice to purchasers 60 days before a price increase, if the cumulative price increase over the prior two years is more than 10 percent. It would also require health plans to report to the state the top 25 drugs prescribed most often, those that cost the most and those with the highest year-to-year increase in spending.
NVO pays more than $58 million in settlement
Novo Nordisk (NVO) has agreed to pay more than $58 million for failing to comply with an FDA program that requires companies educate doctors and monitor distribution of drugs that may have serious side effects. Regulators required NVO to set up a program to adequately alert doctors its diabetes drug Victoza may be associated with thyroid cancer. Instead, the company created the impression that the FDA program would be unnecessary, leaving some doctors unware of the drug’s connection to cancer. In a statement, NVO said the company’s priority “will always be to ensure that those caring for patients have the data they need to make the most informed treatment decision.”
FDA says Vertical Pharmaceuticals failed disclosure requirements for promoting opioid
The FDA issued a warning letter to Vertical Pharmaceuticals last month over how the company promoted the opioid painkiller ConZip to doctors. According to the FDA, Vertical omitted key risk factors associated with the drug and failed to remind doctors to only prescribe the treatment when alternatives are ineffective. The FDA notes these omissions gives a false impression that the drug is safer than it is and imperils patient safety. Vertical Pharmaceuticals has not commented on the warning.
Drug products may require evaluation similar to medical devices
In a speech this week, FDA Commissioner Scott Gottlieb said new types of medical technology, many which have long-term effects, may need to be evaluated similarly to the FDA’s current process for evaluating medical devices. Gottlieb also announced FDA plans to speed up product development of new medical technology before the clinical trial stage by working to prevent unnecessary testing and recommending research trial designs.
Warren and Capito push partial fill policies
Sens. Elizabeth Warren (D-MA) and Shelley Moore Capito (R-WV) are encouraging health officials at all levels of government to support partial fill policies to curb over-prescription and help address the opioid epidemic. The policies—which are allowed thanks to the 2016 Comprehensive Addiction and Recovery Act—permit pharmacists to dispense portions of a prescription; patients can return for the rest of the prescription if necessary.
McCaskill report highlights Imsys’s fraudulent sales tactics for painkillers
Sen. Claire McCaskill (D-MO) has released a report revealing a major drugmaker engaged in deceptive practices to influence PBMs and insurers into authorizing reimbursement for unneeded drugs—including opioids. Employees at Imsys frequently encouraged doctors to prescribe cancer pain drugs as an off-label treatment and, in some cases, directly called PBMs and insurers and provided misleading patient information to acquire prior authorization. Consultants had warned Imsys that the organization needed tighter guardrails to prevent such fraud. Six former executives at Imsys are under indictment, and one pleaded guilty to wire fraud conspiracy. McCaskill believes Congress should continue investigating sales and marketing practices in the pharmaceutical industry, and has not ruled out introducing legislation on the topic.
Opioid drugmakers sued by New Mexico over marketing practices
New Mexico is suing prescription drug manufacturers and distributors for helping fuel the opioid epidemic. The state accuses drugmakers of engaging in deceptive marketing that downplays risks associated with opioids. The state also alleges distributors failed to properly detect and investigate large opioid orders that have been diverted for illicit uses. New Mexico is just the latest in a wave of state and local governments pursuing legal action against drugmakers for their role in the opioid crisis.
Analysis suggests opioid addiction has fueled drop in labor force
Research conducted by Princeton University economist Alan Krueger suggests opioid addiction may be partially responsible for a decline in labor-force participation. Krueger’s research indicates opioid addiction may be responsible for as much as 20 percent of the workforce reduction among working age men and 25 percent among working age women. While Krueger acknowledges most of the decline in labor-force participation is due to an aging population and broad population trends, his analysis suggests the opioid epidemic is having a broader economic impact than initially thought.
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