- Updating drug labels would greatly help patients — but few companies do it (statnews.com)
Unfortunately, information contained in the label often lags far behind the evolution of a drug’s use. Drug makers can update product labels to include additional uses when new data supports such modifications. In many cases, though, they don’t do this because there’s little incentive to do so, especially when a drug is no longer being actively marketed or when its patent has expired and it faces generic competition...The problem is widespread...Friends of Cancer Research, found that leading oncologists recommended additional uses beyond those listed on product labels for 79 percent of cancer drugs approved between 1999 and 2011. This means that a large number of well-accepted uses of cancer drugs that emerge over time are completely absent from drug labels...Take the drug methotrexate. Despite being the standard of care for a large number of rheumatologic conditions, the drug label lists only three. When labels are missing critical information like this, particularly regarding diseases other than cancer, insurers often refuse coverage, putting added strain on patients...In the long run, letting labels fall out of date will do a lot of damage by undermining reliance on the drug approval process, which was put in place to protect patients and safeguard public health…
- Doctors, nurses among hundreds charged with defrauding U.S. health programs (reuters.com)Sessions to Unveil Health-Care Fraud Crackdown This Week, Sources Say (bloomberg.com)
A total of 412 people, including almost 115 doctors, nurses and other medical professionals, have been charged in the sweeping enforcement action, the biggest ever by the multi-agency Medicare Strike Force, the Justice Department said...More than 120 people were accused of illegally prescribing and distributing opioids and other dangerous narcotics...Amazingly, some have made their practices into multi-million-dollar criminal enterprises...Those charged participated in schemes that billed Medicaid, Medicare and TRICARE...for unneeded drugs and treatments that were often never provided...In many cases, healthcare providers paid cash kickbacks to patients and others in exchange for medical data that would allow them to file fraudulent bills to Medicare...In addition to the hundreds charged, the Department of Health and Human Services has launched suspension procedures against almost 300 medical service providers, including doctors, nurses and pharmacists...
- Computer-Simulated Tests Eyed at FDA to Cut Drug Approval Costs (bloomberg.com)
Computer simulations may get a role alongside human testing as part of an effort to bring new medications and medical devices to market more quickly and cheaply...The...Food and Drug Administration outlined a proposal...to help integrate computer modeling and virtual testing as part of the regulatory approval process for manufacturers -- a step the agency said could save money while helping find cures for puzzling conditions such as Alzheimer’s disease...The average cost of developing a new medication is about $2.56 billion...and much of that goes to fulfilling the FDA’s rigorous demands for proving safety and effectiveness...The price of new technology affects the ability of people to access these new treatments...We therefore need to be mindful of the costs of our regulatory processes, to the degree that these costs also affect the availability of new innovations, and the way that they are ultimately priced…The idea of computer simulated experiments, sometimes called in silico trials, has been around for years but the FDA hasn’t provided guidance to allow the drug industry to use it in testing...The FDA has begun using computer modeling to build databases to help researchers predict how new treatments...will perform. And the agency is developing a family of "virtual patients" for testing new devices…
- How AI Is Transforming Drug Creation (wsj.com)
Pharmaceutical companies hope computers can help them find new medications that are faster, cheaper—and more likely to be effective...The idea is that machines, which are adept at pattern recognition, can sift through vast amounts of new and existing genetic, metabolic and clinical information to unravel the complex biological networks that underpin diseases. That, in turn, can help identify medications likely to work in specific patient populations, while simultaneously steering companies away from drugs that are likely to fail...In the past, drug companies have used artificial intelligence to examine chemistry—whether a drug might bind to a particular protein, for instance. But now the trend is to use AI to probe biological systems to get clues about how a drug might affect a patient’s cells or tissues...Biological insights driven by machine learning also could help pharmaceutical companies better identify and recruit patients for clinical trials of therapies most likely to work for them, perhaps boosting the chances of those medications’ getting approved by regulatory agencies...The big difference between AI-driven drug trials and traditional ones...is "we’re not making any hypotheses up front. We’re not allowing [human] hypotheses to generate data. We’re using the patient-derived data to generate hypotheses."
- Desperate for addiction treatment, patients are pawns in lucrative insurance fraud scheme (statnews.com)
Drug users, desperate to break addictions to heroin or pain pills, are pawns in a sprawling national network of insurance fraud...They are being sent to treatment centers hundreds of miles from home for expensive, but often shoddy, care that is paid for by premium health insurance benefits procured with fake addresses...Patient brokers are paid a fee to place insured people in treatment centers, which pocket thousands of dollars in claims for each patient. They often target certain Blue Cross Blue Shield plans, because of their generous benefits and few restrictions on seeking care from out-of-network treatment programs...The fraud is now so commonplace that brokers use a simple play on words to describe how it works: "Do you want to Blue Cross the country?"...Patients from across the United States have been taken in by these profiteers capitalizing on the surge in opioid addiction..
- Pharmacy Week in Review: July 13, 2017 (pharmacytimes.com)
Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Why Drugmakers Aren’t Sweating the Next Wave of Patent Losses (bloomberg.com)
Drugmakers plunged off a patent cliff earlier this decade, losing billions in sales as lucrative branded drugs lost exclusivity. An expensive lobbying effort aimed at preventing a repeat is paying off...The loss of a series of key patents for cholesterol fighters and other widely used medicines cost big-name drug companies about $82 billion in sales...forcing large-scale job cuts and a wave of deals to make up for lost revenue...Once again, the pharmaceutical industry is peering over the ledge. Over the next three years, roughly $60 billion of drug sales for companies including Roche Holding AG, Sanofi, and Eli Lilly & Co. are threatened by potential rivals…Roche may have the most at stake. It’s facing the loss of exclusivity for its three top-selling cancer drugs over the next two years, which account for more than $20 billion of its $51.4 billion in annual sales…Many of the drugs expected to lose their patent shields in coming years...are complex medicines produced by living cells, which makes replicating them more difficult...Drugmakers’ main lobbying groups, PhRMA and BIO, successfully watered down efforts to give biosimilars an easier approval process...Analysts say that given the longer approval arc for biosimilars, major drugmakers are less likely to be whipsawed by generic rivals when key medicines drop off patent. But over time, political pressure over high drug costs is expected to undercut the dominance of branded biologic drugs...
- Biosimilar Uptake Challenges: Low-Cost Specialty Drugs Reduce Provider Profits (specialtypharmacytimes.com)
Biosimilars are heralded as an affordable alternative to expensive biologic medications. Despite their potential to reduce the overall cost of treatment, prescriber uptake has been slow. The primary barrier points towards the current reimbursement model: "buy-and-bill."...CMS incentivizes biosimilar use through differential reimbursement, but private payers generally do not use this approach...In new study...investigators examined the dynamics across provider types to determine the impact of provider setting and payer mix on biosimilar adoption...The health care system uses the "buy-and-bill" reimbursement model because biosimilars are administered by injection or infusion. Under this structure, providers are reimbursed for biologics with an additional percentage of the product price added to cover acquisition, storage, and dispensing costs associated with care...This environment disincentives providers from favoring lower-cost biosimilars because reimbursement for biologics typically ranges from 6% of the drug’s average sales price under Medicare coverage to a more robust 9% to 10% reimbursement from typical commercial plans…In designing this coverage model, CMS...mandated that physicians who dispense biosimilars will be reimbursed at ASP plus 6% of the...price,"..."While this mandate was enacted to remove a disincentive for prescribing biosimilars for patients on Medicare, it does not address considerations for patients covered by commercial insurers."...Patients with commercial insurance represent the majority of billings for most providers in the United States…
- The Booming 340B Contract Pharmacy Profits of Walgreens, CVS, Rite Aid, and Walmart (drugchannels.net)
Pharmacies continue to ride the 340B Drug Pricing Program’s explosive growth...Our latest...analysis finds that nearly 20,000 pharmacy locations now act as a contract pharmacy for the hospitals and other healthcare providers that participate in the 340B Program. Fewer than 3,000 pharmacy locations were in the program in 2010...Large retail pharmacy chains' rapid expansion into 340B suggests superior profits...How many prescriptions do contract pharmacies provide at discounted prices to uninsured, underinsured, and low-income patients? Are pharmacies engaged in profit-sharing agreements with 340B hospitals? Are they earning fees that far exceed fair market value standards? Who is really benefiting from the contract pharmacy boom?...For instance, an Office of Inspector General study of 340B contract pharmacies found that two out of three hospitals did not offer the 340B discounted prescription price to uninsured patients via these pharmacies…we...have no transparency into the behavior of these 340B contract pharmacies. None of the public companies reports any information about its participation in the 340B program.
- New on the streets: Gabapentin, a drug for nerve pain, and a new target of abuse (statnews.com)
Ohio’s Board of Pharmacy began reporting sales of gabapentin prescriptions in its regular monitoring of controlled substances. The drug, which is not an opioid nor designated a controlled substance by federal authorities, is used to treat nerve pain. But the board found that it was the most prescribed medication on its list...surpassing oxycodone by more than 9 million doses. In February, the Ohio Substance Abuse Monitoring Network issued an alert regarding increasing misuse across the state...Gabapentin’s ability to tackle multiple ailments has helped make it one of the most popular medications in the U.S. In May, it was the fifth-most prescribed drug in the nation...law enforcement officials and drug counselors say the addition of gabapentin adds a new obstacle. As providers dole out the drug in mass quantities for conditions such as restless legs syndrome and alcoholism, it is being subverted to a drug of abuse. Gabapentin can enhance the euphoria caused by an opioid and stave off drug withdrawals. In addition, it can bypass the blocking effects of medications used for addiction treatment, enabling patients to get high while in recovery...