Author: Peter

Treatment cost for the average patient would go down by 16 to 20 percent, but for 40 percent of patients, the cost may go down by as much as 50 percent...Hepatitis C patients are often cured before completing a treatment regimen, suggesting patients require less of the drugs needed to fight the disease, according to a recent study...Researchers at Loyola University devised a mathematical model that predicts the length of time patients need direct-acting antiviral drugs, potentially limiting the cost of being treated with an expensive drug...Using more frequent blood testing, the researchers were able to determine hepatitis C levels and predict when the drug sofosbuvir, combined with one of three others, could be stopped...Treatment currently is standardized to be given for a set period of time, not tailored to the patient...In many cases, this may result in the prolonged use of expensive drugs with essentially no additional positive effect...

Last week, Express Scripts released its new 2015 Drug Trend Report...For the first time, the Express Scripts data account for rebates—a meaningful and welcome improvement in reporting methodology. After accounting for rebates, the 2015 report reveals that drug spending growth is comparable to growth in other parts of the healthcare system. For some payers, utilization (script growth) was a bigger driver of spending than drug prices...So much for the myth of exploding drug costs! Our politicians may not believe it, but Martin Shkreli et al. are the exception in the pharmaceutical industry. Below, I review the four key highlights about traditional and specialty drug spending, trend patterns for different payers, and a red flag from upcoming biosimilar launches.

FOUR TAKEAWAYS

1. Commercial payers were better able to control costs.
2. More people are getting access, which is “good” spending.
3. Specialty growth continues.
4. Hunker down for the biosimilar formulary wars.

Less than two years after University Medical Center received $25.5 million in loans and eliminated hundreds of positions, the hospital is in the midst of a financial "rebirth," according to CEO Mason VanHouweling...At a meeting of the Clark County Commission...the county revealed UMC is expected to receive a $31 million subsidy — the same subsidy it received for the 2016 fiscal year and far less than it requested in years past...VanHouweling said the hospital has been able to "turn a financial corner"...As a facility that serves a large number of indigent patients, the hospital requires at least some funding from the county to function...It was never designed to generate the type of revenue that private hospitals today can generate...UMC is planning to modernize and remodel infrastructure at its main campus as well as at its primary and quick care facilities. The hospital also plans to move to a new electronic health records system and upgrade technology in operating rooms...the hospital is carefully watching for any possible reductions to disproportionate share hospital, or DSH payments, which help to offset the costs of care given to indigent patients. DSH payments are expected to be reduced nationwide, which would hurt UMC.

The Poison Prevention Week Council aims to educate consumers about the prevention of unintentional poisonings and accidental exposures around the home. This year’s National Poison Prevention Week focuses on preventing accidental medicine ingestions by young children. The Up and Away and Out of Sight campaign reminds consumers that storing medicines safely is an important part of preventing poisonings in the home...This year National Poison Prevention Week is March 20 through March 26...Additional information and poison prevention educational resources are available on the Poison Prevention website...NABP’s AWARxE Prescription Drug Safety Program website has advice on properly storing medications to prevent accidental ingestion...in the Secure Storage section. The AWARxE website also has a Drug Disposal Locator Tool that provides locations of permanent drug disposal sites in the US. Safely disposing of unwanted medications can help prevent exposing young children to accidental ingestion.

India has defended its right to grant licenses allowing local firms to override patents and make cheaper copies of drugs discovered by big Western drugmakers, and said reports to the contrary were "factually incorrect"...The Commerce Ministry statement comes weeks after...media in India quoted the...U.S.-India Business Council, as saying India had given private assurances that it would not grant such "compulsory licenses"..."In this regard, it may be noted that India has a well-established TRIPS (Trade-Related Aspects of Intellectual Property Rights) compliant legislative, administrative and judicial framework to safeguard IPRs (intellectual property rights). Under the Doha Declaration on the TRIPS Agreement Public Health, each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted."...The USTR (U.S. Trade Representative) has placed India on its "priority watch" list for two years in a row, saying the country's patent laws unfairly favor local drug makers. A legal provision that allows granting of "compulsory licenses" has been a key bone of contention.

Centers for Disease Control and Prevention...issued a new guideline for prescribing opioids...for chronic pain that is not related to cancer or end-of-life care. The document’s goal is to curb...a doctor-driven prescription overdose epidemic...Of the guideline’s 12 recommendations, the top one states that non-drug or at least non-opioid drug approaches should be tried before opioids...the Office of the Assistant Secretary for Health at the Department of Health and Human Services released a national pain strategy that emphasized the need to treat chronic pain with a variety of well-tested approaches, not just medication...Non-drug approaches to relieving chronic pain, such as exercise, weight loss and talk therapy, have the advantage of not needing warning labels, and research suggests that they can be as effective as NSAIDs. But they take more time and effort than swallowing a pill.

...Anthem Inc said it had sued pharmacy benefit manager Express Scripts Holding Co to recover damages from drug pricing it believes was too high...latest development in a months-long dispute over Anthem's contract with Express Scripts...The lawsuit also seeks to recover damages from operational issues and for a declaration of Anthem's right to terminate its contract with Express Scripts…Anthem, which has been seeking $3 billion in annual cost savings through a repricing provision in its 10-year contract with Express Scripts, said it had not yet decided whether to end the contract...The latest news has taken a very unhealthy turn and we see it unlikely that Anthem renews its contract with Express Scripts past 2019, and is likely to leave sooner to the extent it can manage the transition for consumers smoothly...Express Scripts...said in a statement that it believed the lawsuit to be without merit. The company has consistently acted in good faith and in accordance with the terms of its agreement with Anthem…

If a drug does a good job of treating lung cancer, but is less effective at combating pancreatic cancer, you might think that the price should be lower for pancreatic cancer patients. But it doesn’t work that way in the convoluted world of pharmaceutical pricing, where a one-size-fits-all approach is generally used...Now, though, a new drug pricing scheme is gaining traction that would base payments on how well a medicine actually works...The concept, which is known as indication-specific pricing, would set different prices for the same drug to reflect the extent to which a medicine is effective for multiple purposes. The goal is to calibrate spending with performance and, in turn, lower overall health care costs.

New safety warnings also added to all prescription opioid medications to inform prescribers and patients of additional risks related to opioid use...Food and Drug Administration...announced required class-wide safety labeling changes for immediate-release opioid pain medications...the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death...actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

According to PDS (PDS Life Sciences), SEND Express is a "turnkey solution for the generation of Standard for Exchange of Nonclinical Data datasets."...We aggregate and harmonize data from multiple organizations, information systems and file formats...to produce one set of harmonized SEND files, including define.xml and define.pdf, as required by the FDA...The platform's launch parallels the FDA's deadline for standardized electronic data submissions, which will require all datasets from studies supporting new drug applications, biologics license applications, and abbreviated new drug applications to be submitted in SEND format by Dec. 17...Having an industrywide, harmonized model allows for efficient analysis by regulatory authorities...The common formats assist in enabling the exchange of nonclinical data within companies and consortiums...this consistency of data makes it easier for vendors to develop tools that can use this data...