Author: WorkCompAcademy

The ever increasing public outcry over the high price of medicines did little to stop drugmakers from raising prices again for 2020.

Drugmakers including Bristol-Myers Squibb, Gilead Sciences, and Biogen hiked U.S. list prices on more than 50 drugs on Wednesday, bringing total New Year’s Day drug price increases to more than 330 drugs, according to data analyzed by healthcare research firm 3 Axis Advisors.

Companies may be delaying some of those increases to later this month to escape early January scrutiny.

The drug price increases include some blockbuster drugs: the price of Humira, which treats arthritis and other conditions, rose 7.4 percent, and the price of Revlimid, which treats multiple myeloma, rose 6 percent, according to the data.

Drugmakers have traditionally raised prices at the start of a new year, and the data shows that the price increases are continuing, even as outcry over high drug prices rises in Washington. Nearly all of the price increases are below 10%, with the median price increase around 5%, according to 3 Axis.

Under pressure from politicians and patients, many makers of branded drugs have pledged to keep their U.S. list price increases below 10% a year.

“Double-digit increases largely appear to be a thing of the past,” Bloomberg Intelligence analyst Brian Rye said. Many drugmakers have vowed not to increase drug prices by more than 10%. People with insurance generally pay much less than the list price of a drug.

Soaring healthcare costs for U.S. consumers, and prescription drug prices in particular, are expected to again be a central issue in the 2020 presidential campaign for both parties.

The United States, which leaves drug pricing to market competition, has higher prices than in other developed countries where governments directly or indirectly control the costs, making it the world’s most lucrative market for manufacturers.

The mandatory reserve estimate for a lifetime medical award requires an estimate of the remaining life expectancy of the worker. There are many actuarial tables and other information that can be used to justify an estimate.

But, as modern medicine continues to improve and advance at an increasingly rapid rate, people all over the world are enjoying longer lifespans, on average, than ever before. Consequently, age-related dementia and Alzheimer’s disease are becoming common diagnoses in older adults. For example, in the United States alone Alzheimer’s is estimated to affect 5.7 million people.

Now, it appears help may soon be on the way in the form of a potential new vaccine that has shown success in mice testing.

Researchers from the University of California, Irvine believe that this immunotherapy combination vaccine should be ready for human trials within the next few years. The initial version of the vaccine was created by Flinders University professor Nikolai Petrovsky in South Australia, and it works by removing “brain plaque” and tau protein aggregates, both of which have been extensively linked to the development of Alzheimer’s disease.

The study is published in the scientific journal Alzheimer’s Research & Therapy.

Success in 2019 with mice models has opened the door towards more extensive research and development in 2020, researchers say.

If the vaccine can in fact remove accumulated beta-amyloid plaques and tau protein aggregates from human subjects brains, just as it was able to in mice that had already shown signs pathologies, that should, in theory, stop the development of Alzheimer’s disease.

“Taken together, these findings warrant further development of this dual vaccination strategy – for ultimate testing in human Alzheimer’s disease,” the study reads.

According to professor Petrovsky, researchers are hopeful they can proceed with human clinical trials in about two years.

This isn’t the first time a possible preventative drug for Alzheimer’s has shown promise, but every one of these drugs has ultimately faltered when it came time for human trials. With this in mind, the research team say they are determined and motivated to establish a successful vaccine that can, at the very least, delay and slow down the progression of Alzheimer’s.

At a time when bacteria are growing more resistant to common antibiotics, many companies that are developing new versions of the drugs are hemorrhaging money and going out of business, gravely undermining efforts to contain the spread of deadly, drug-resistant bacteria.

Melinta Therapeutics, founded in 2000 as Rib-X Pharmaceuticals, is an American publicly traded biopharmaceutical firm that focuses on the design and development of novel broad-spectrum antibiotics for the treatment of antibiotic-resistant infections in hospital and community settings.

On December 27, Melinta filed for bankruptcy protection, becoming the latest casualty of a persistent cash burn in the antibiotic industry. The drugmaker, which has four antibiotics on the market, warned that it was running out of cash last month.

Melinta has entered into a Restructuring Support Agreement with the lenders. Under the Agreement, the Supporting Lenders would acquire the Company as a going concern by exchanging $140 million of secured claims arising under its senior credit facility for 100 percent of the equity to be issued by the reorganized Company pursuant to a pre-negotiated chapter 11 plan of reorganization.

The Company’s Agreement with the Supporting Lenders positions the Company to emerge from Chapter 11 on an expedited basis under new ownership and continue operating as a going concern on sound financial footing. At the same time, the Supporting Lenders’ proposal to acquire the Company remains subject to a Court-supervised competitive process, which could result in higher and better offers.

The Agreement will be filed with the Securities and Exchange Commission in a current report on Form 8-K.

Global health officials have repeatedly warned about the rise of bacteria and other microbes that are resistant to most drugs due to their overuse, prompting health agencies to push for newer versions of antibiotics.

However, antibiotics are relatively cheap and are more effective the less they are used, making profitability hard to achieve.

Most of Big Pharma shuns the antibiotic space. Larger drugmakers, including AstraZeneca Plc, Novartis and Sanofi SA, have stopped developing antibiotics.

While smaller players such as Achaogen Inc have already failed and filed for bankruptcy. Bankrupt and running out of cash after going $186 million in the red last year, Achaogen has sold off the global rights to Zemdri (plazomicin for multidrug-resistant, gram-negative pathogens) along with its lab equipment for just $16 million.

The California biotech Aradigm filed for bankruptcy after a major knockback from the FDA for its lead inhaled antibiotic product and protracted efforts to try to resurrect the program.

“This is a crisis that should alarm everyone,” said Dr. Helen Boucher, an infectious disease specialist at Tufts Medical Center.

The California Attorney General announced the terms of a settlement agreement reached with Sutter Health, the largest hospital system in Northern California. The Sutter network consists of some 24 acute care hospitals, 36 ambulatory surgery centers, and 16 cardiac and cancer centers. It also includes some 12,000 physicians and over 53,000 employees. In addition, Sutter negotiates contracts on behalf of the Palo Alto Medical Foundation and many affiliated physician groups.

The settlement resolves allegations by the Attorney General, the United Food and Commercial Workers International Union and Employers Benefit Trust, and class action plaintiffs, that Sutter’s anticompetitive practices led to higher healthcare costs for patients in Northern California compared to other places in the state.

As a result of the settlement, Sutter will pay $575 million in compensation and make significant changes in its operations and practices to restore competition in Northern California’s healthcare market.

This litigation against Sutter began in 2014 when the United Food and Commercial Workers International Union and Employers Benefit Trust and numerous individual plaintiffs – later consolidated into a class action – filed their lawsuit challenging Sutter’s practices in rendering services and setting prices.

They sought compensation for what they alleged were unlawful, anticompetitive business practices, which caused them to pay more than necessary for healthcare services and products.

In March of 2018, the California Attorney General filed a similar lawsuit against Sutter on behalf of the people of California principally seeking injunctive relief to compel Sutter to correct its anticompetitive business practices moving forward. The separate lawsuits were combined by the court into one case.

In October of 2019, on the eve of trial, the parties reached an agreement to settle the lawsuits. The settlement must be approved by the court. The court has set a hearing on the settlement for February 25, 2020.

Under the terms of the 122 page settlement agreement, Sutter will be required to pay $575 million to compensate employers, unions, and others covered under the class action and to cover costs and fees associated with the legal efforts.  And limit what it charges patients for out-of-network services, helping ensure that patients visiting an out-of-network hospital do not face outsized, surprise medical bills.  And increase transparency by permitting insurers, employers and self-funded payers to provide plan members with access to pricing, quality, and cost information, which helps patients make better care decisions.

Sutter has also agreed to cease anticompetitive bundling of services and products which forced insurers, employers, and self-funded payers to purchase for their plan offerings more services or products from Sutter than were needed. Sutter must now offer a stand-alone price that must be lower than any bundled package price to give insurers, employers, and self-funded payers more choice

San Diego chiropractor, George Reese was indicted in 2014 for referring patients to a Los Angeles area medical service provider. Foremost Shockwave Solutions in return for bribes. The bribes were $100 per patient and paid through an intermediary. After taking a cut amounting to $25 per patient, the intermediary would pay the remaining $75 per patient to Reese.

Foremost Shockwave Solutions was allegedly controlled by attorney Lee Mathis and Fernando Valdes its president. Both were also indicted. Although disguised as “office rent” payments, the illegal bribes were allegedly paid in cash during clandestine exchanges in restaurants and parking lots.

According to the indictment, Reese and his codefendants generated and submitted bills to insurers totaling in the tens of millions of dollars. Most of these treatments involved the providing of “Shockwave therapy,” which uses low energy sound waves to initiate tissue repair. Proceeds from the insurance claims generated through this scheme were paid to Mathis and Valdes.

Reese pleaded guilty in June 2016. and began serving a one year one day sentence. His plea agreement remains sealed. Valdez entered into a plea agreement in July 2017. His plea agreement also remains sealed.

In 2018 attorneys claimed that Mathis has been interviewed and administered standardized psychological and neuropsychological, memory, malingering and motivation and he has been interviewed regarding competency factors for a total of 16 hours between February and July 2018. Dr Veronica Thomas concluded Mathis was unable to assist counsel at trial.

The Government engaged Dr. Matthew Carroll to evaluate Mr. Mathis’ competency to stand trial. In his interviews with Dr. Carroll, Mr. Mathis was able to provide a detailed personal and professional history. They discussed the pending charges and Mr. Mathis provided a summary of the Workers’ Compensation system, his role in the system and he discussed the Government’s case. Mr. Mathis demonstrated a reasonable appreciation of the charges against him. He described “his side of the story in a coherent and logical manner.”

It was Dr. Carroll’s opinion that Mathis understands the nature and consequences of the proceedings against him and can assist properly in his defense and testify on his own behalf. Thus, in March 2019 Mathis was found competent to stand trial.

Mathis subsequently pleaded guilty on September 12, 2019 to count two of the nine count indictment, Honest Services Mail Fraud. He was sentenced to 14 month is federal prison and is scheduled to surrender on January 21, 2020. He will be on 3 years supervised release thereafter.