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FDA recently approved the first biosimilars for adalimumab (Humira—AbbVie) and etanercept (Enbrel—Amgen), known as adalimumab-atto (Amjevita—Amgen) and etanercept-szzs (Erelzi—Sandoz), respectively. These approvals came after unanimous votes of support by FDA’s Arthritis Advisory Committee in July. Unfortunately, the launch of both biosimilar products will be delayed because the manufacturers of the reference products are involved in litigation against biosimilar manufacturers for patent infringement...A recent meta-analysis...suggest these products have nearly identical pharmacokinetics, efficacy, and toxicity…Although the trials cited by this meta-analysis involved limited numbers of patients, there is no reason to suspect these biosimilars will not be nearly identical to their reference product...

Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.

The rising cost of medicines may be a growing problem for many Americans, but a new survey finds that cost is generally not a key factor when doctors decide which treatments to prescribe their patients. Among six different types of doctors queried, only primary care physicians cited cost as among their most important considerations. Forty-seven percent ranked the issue as a key concern, behind evidence that a drug is safe, effective and well-tolerated…many physicians remain more concerned with finding the best medicine for the ailment at hand, as they should. But this will also place more of the onus on patients to talk to their doctors about affordability when reviewing treatment options...

Teva is trying to clean the slate on its history of allegedly paying bribes in foreign countries to boost sales. Having revamped its governance programs and set a new tone about bad behavior, it has now put aside more than half a million dollars to cover anticipated settlements with U.S. authorities...Teva revealed it was in “advanced discussions” to settle investigations by the Justice Department and SEC into violations of the Foreign Corrupt Practices Act and set aside about $520 million to cover the expected settlements. It said those discussions concern matters that occurred in 2007-2013 in Russia, Mexico and Ukraine...Teva emphasized that none of the conduct involved its U.S. business, inferring instead that it was problems with third parties and subsidiaries. It pledged to do whatever it can to prevent a repeat...The compliance program that Teva has in place now is serious, rigorous, and comprehensive and is designed to protect the company and its subsidiaries against future violations…

In hopes of reducing inappropriate opioid prescribing, the Chicago City Council...passed an ordinance that requires all pharmaceutical sales reps to become licensed...The ordinance, which the pharmaceutical industry opposed, will require sales reps to undergo training for ethics, marketing regulations, and applicable laws. Reps will also have to file reports with the city that disclose the names of doctors they visit as part of their work, the number of visits, and any samples, materials, or gifts provided, along with their value. Reps will also have to pay a $750 licensing fee and renew the licenses annually...The move is the latest effort by the city to combat an epidemic of deaths and overdoses attributed to opioid painkillers...The city expects to collect more than $1 million in licensing revenue and will use that to support ongoing efforts to educate doctors and the public about opioids, and cover the cost of regulation...I think will be hard to prove its an effective way to control the prescribing, so I don’t think it’s really going to solve the problem directly. It might help indirectly if the city can say that overprescribing is caused by aggressive sales tactics...I’m not sure how they can manipulate the data to prove anything. But they may be able to squeeze something out of the data. They’re asking for a lot...

On Nov. 8 voters in California, Maine, Massachusetts and Nevada approved ballot measures to legalize recreational cannabis. It is now legal in a total of eight states. And this creates potential problems for road safety. How do we determine who’s impaired and who’s not?...The effects of alcohol vary based on a person’s size and weight, metabolism rate, related food intake and the type and amount of beverage consumed. Even so, alcohol consumption produces fairly straightforward results: The more you drink, the worse you drive. Factors like body size and drinking experience can shift the correlation slightly, but the relationship is still pretty linear, enough to be able to confidently develop a blood alcohol content scale for legally determining drunk driving. Not so with marijuana...Second to alcohol marijuana is the drug most frequently found in drivers involved in crashes...But how do you know when you’re too stoned to drive? How can police tell?...the Center for Medicinal Cannabis Research at UC San Diego...received a...$1.8 million grant from the state of California to gather data about dosages, time and what it takes to impair driving ability...then create a viable roadside sobriety test for cannabis...

One day before Walgreens Boots Alliance severed its relationship with the blood-testing laboratory Theranos in June 2016, Theranos acknowledged to Walgreens executives that more than 10% of the test reports —  totaling 31,000 test reports altogether —  that were provided to Walgreens customers who used Theranos' services had to be voided. "[Theranos] stated that 31,000 Walgreens customers had received voided test reports, which was 11.3% of total Walgreens customers," Walgreens alleged in court papers filed Tuesday...According to Walgreens, Theranos broke each of the promises made to the Chicago-based retail pharmacy operator, which had entered into an exclusive arrangement with Theranos in July, 2010, and which was later amended in June, 2012. The 2012 agreement provided the framework under which Theranos Wellness Centers could operate inside Walgreens' stores...

In the latest struggle over pharmaceutical costs, Pfizer has filed a lawsuit against a Texas state agency for releasing Medicaid rebate data to a pair of state lawmakers, claiming the move violated federal and state laws that protect its confidential information...By releasing the data, Pfizer argued the Texas Health and Human Services Commission compromised “valuable and commercially sensitive trade secrets” that could hurt its ability to compete with rivals, according to the lawsuit…The drug maker...contended that disclosure can lead to “uniform pricing” that could harm Medicaid. How so? Pfizer maintained that, if other large purchasers were to know about — and then demand — the same prices offered to the Texas Medicaid program, the company “would not be able to provide such pricing and rebates to every entity due to their unique differences in size, market and particular needs.”...the cat is out of the bag, Pfizer asked the court for a temporary restraining order and a preliminary injunction to prevent the Texas Health and Human Services Commission from releasing data in response to any additional requests...This is likely to be a closely watched case, given the tremendous interest in pharmaceutical costs and the mystery surrounding rebates.

The Federal Trade Commission just cracked down on an unusual product that has long enjoyed exemption from regulation: homeopathic drugs. Available everywhere...homeopathic products are advertised as an effective way to treat a wide range of conditions...Americans spend over $3 billion a year on homeopathy, and the market appears to be growing steadily...companies selling these products have never been required to show they are effective at doing what they claim...the FTC announced its “enforcement policy statement” about homeopathic product labeling...the recommendations are pretty minimal...the agency produced a report that concluded customers were likely to be deceived by labels that did not carry the appropriate disclaimers, and therefore disclaimers stating that these products are untested will now be required. The requirement is not technically a law like…The rules require packaging to effectively communicate two key disclaimers:

•     “There is no scientific evidence that the product works.”
•     “The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”

Teva has halted production at the Rimsa plant in Mexico and idled some of the workers, laying the blame for the issues at the feet of the brothers with whom they are battling in court over the $2.3 billion buyout...Teva acknowledged today that Mexican authorities suspended manufacturing at the plant in October saying the action followed...discovery of the serious violations committed under the Espinosa brothers, Rimsa's former owners....We are working closely with the Mexican authorities in order to restore production and products to the market…Mexico’s Federal Commission for Protection against Health Risks...took its action in response to a complaint by Teva. The agency is now said to be verifying that the 140 products manufactured at the plant in Guadalajara meet quality, safety and efficacy standards. COFEPRIS expects to complete its analysis by year-end...