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November 30, 2015 Download print version

Cost of skin drugs rising rapidly, study shows

Roche pulls out of 'superbug' antibiotic project

Ebola will always return unless we develop the tools to end it

Continuing the shift from volume to results in American healthcare

Looking for a way to share your knowledge and expertise with the CS community?

A ‘superbug’ emerges in China to remind us that antibiotics won’t last forever

Hospital reduces Norovirus outbreaks by 91%

Med students call resident work trials unethical


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Self Study Series:
December 2015

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Cost of skin drugs rising rapidly, study shows

A new study published by the Journal of the American Medical Association reveals retail prices of 19 dermatologic drugs have more than quadrupled between 2009 and 2015. Retail prices of 19 brand-name prescription drugs for dermatologic conditions ranging from acne to cancer increased fivefold on average between 2009 and 2015, according to a study that adds new fuel to the burgeoning debate over the cost of medicines.

In the most dramatic case, a 2-ounce tube of gel called, Targretin marketed by Valeant Pharmaceuticals International Inc. for a type of skin cancer, jumped to $30,320 this year from $15,708 last year and $1,687 in 2009, the report found—an 18-fold jump in six years. The retail price of another Valeant skin-cancer drug, Carac cream, also was 18 times higher this year, at $2,865, than in 2009.

Valeant is already under fire for drug-pricing practices, but the researchers said their results show big price jumps are a common occurrence in the industry. Prices for drugs made by companies such as GlaxoSmithKline PLC and Novartis AG at least doubled or tripled over the same time frame, far outpacing inflation and growth in healthcare expenditures.

Valeant said it sets prices based on development or drug acquisition costs, the availability of alternatives including generics and other factors, and offers patient-assistance programs when possible keep drugs affordable. Glaxo said it is “committed to helping ensure patients can access the medicines they need” and to “thoughtfully handle price increases.” Novartis had no comment.

Drug companies say few patients or insurers pay full retail prices for prescription medicines and that actual costs are often further reduced with discount coupons, rebates and other programs. Cheaper generic versions of the medicines in the study, including four of five Valeant products covered in the report, were and remain available in many cases.

The researchers said higher list prices at the pharmacy still affect consumers’ out-of-pocket costs, especially as insurers impose higher copayments and deductibles in response to increasing costs.

The study found that a 100-gram dispenser of Olux-E foam, which had an average retail price of $308 in 2009, listed this year for $842, a 174% increase. A person answering the phone at the drug’s maker, Prestium Pharma, of Newtown, PA, declined to comment.

The findings come amid growing criticism of industry pricing practices, sparked by such factors as hepatitis C drugs that hit the market at $1,000-a-pill; six-figure-a-year cancer treatments with marginal survival improvements; and companies’ use of price increases to maintain sales growth in some products despite flagging demand.

Valeant, a major player in dermatology, has encountered criticism in part for sharply raising the price of old drugs immediately upon acquiring them from other companies, despite a limited commitment to investing profits in research for new drugs. Retail prices of both Targretin and Carac in the current study rose sharply after Valeant bought or licensed the medicines.

Retail prices for two Glaxo drugs, Altabax for impetigo and Soriatane for psoriasis, doubled over the six-year period, the study showed.

The antifungal Oxistat cream for jock itch and athlete’s foot, marketed by Novartis, jumped to $545 this year from $76.50 in 2009, a sevenfold increase, the report found.

The authors said they didn’t set out to expose drug price increases. Their plan was to establish a database for dermatologists in Florida with price information on drugs they typically prescribe for patients.

Prices increased relatively modestly between 2009 and 2011. When the 2014 results came in, the price increases were “just astronomical,” the researchers said.

Visit the Wall Street Journal for the article.

Roche pulls out of 'superbug' antibiotic project

Swiss drugmaker Roche Holding has dropped out of a high-profile project to develop an antibiotic for treating "superbug" infections, the company announced.

Roche had agreed in 2013 to pay privately held partner Polyphor up to 500 million Swiss francs ($485.3 million) for rights to the product, marking a rare foray by a major pharmaceuticals company into the battle against superbug infections in hospitals. The deal included milestone payments of up to 465 million francs.

"Roche has decided to discontinue its involvement in the clinical development of the investigational antibiotic RG7929/POL7080 for the treatment of patients with severe Pseudomonas aeruginosa infections and will return the asset to Polyphor," a company spokesman said by email when asked about a report to this effect by the NZZ am Sonntag newspaper.

The spokesman cited Roche's assessment that "a streamlined development path as originally planned is no longer an option for Roche".

Superbug infections, including multi-drug-resistant typhoid, tuberculosis and gonorrhea, kill hundreds of thousands of people a year and the rise of antibiotic resistance has been described by the World Health Organization as "one of the biggest health challenges of the 21st century".

The Roche spokesman said that antimicrobial resistance remained a major threat to public health and Roche would continues to focus on this unmet medical need as part of its infectious disease research and development strategy.

NZZ said that the experimental product, which is in phase II clinical trials, will now be developed alone by Polyphor.

Read more at Reuters.

Ebola will always return unless we develop the tools to end it

On November 7, the World Health Organization declared that Sierra Leone is officially Ebola-free for the first time in over a year. The biggest lesson learned with Ebola is that it will return, and we have to be prepared for – and prevent – the next epidemic.

Since history’s worst Ebola epidemic began in rural Guinea in December 2013, it has killed more than 11,300 people worldwide, devastating communities and families, and leaving behind a generation of Ebola orphans. Health systems in the affected countries have been severely damaged, resulting in even more deaths from preventable diseases such as measles and malaria. Ebola has also set back economies across West Africa, and cost the countries and the world billions of dollars in humanitarian aid.

And, despite the rapid decline in case numbers in recent months, and the good news from Sierra Leone, the outbreak isn’t over yet – we continue to see a steady trickle of new cases in Guinea. We have seen the price of waiting, of losing focus, of downplaying the seriousness of emerging epidemics.

The Ebola virus has broken out at least 24 times since 1976. Liberia was declared Ebola-free in March, but then the disease came back. The country was declared free of the disease again in July. Last week, three new cases of Ebola were confirmed in Liberia, the country’s health ministry and the World Health Organization said.

The reason Ebola keeps returning is that the world doesn’t yet have the tools to stop it. As yet, there is no approved vaccine and more research is needed to develop a vaccine to protect healthcare workers and populations. There is no rapid point of care test widely available to diagnose it. There is no approved drug to cure it.

We are now closer than ever to filling these gaps, because governments, global health institutions and biomedical researchers have spent the past year in emergency mode. Pharmaceutical companies, in collaboration with health authorities, have been running phase I, phase II and phase III vaccine trials (progressively testing safety) and manufacturing vaccines simultaneously, instead of treating them as separate steps in a drawn-out process. They have worked closely with governments in affected countries to get trials up and running in fewer than six months, a speed that is unheard of.

The London School of Hygiene & Tropical Medicine is working with partners to coordinate a number of these studies, including a new trial in Sierra Leone testing a candidate Ebola vaccine regimen in development at Janssen Pharmaceutical Companies, part of Johnson & Johnson. This prime-boost vaccine is designed with the goal of potentially strengthening and optimizing the duration of immunity – it involves giving two shots, the first to prime the immune system and the second to boost it. It is just one of a number of promising vaccine candidates now being investigated in numerous clinical trials around the world.

Visit the Guardian for the article.

Continuing the shift from volume to results in American healthcare

Almost a year ago, the Administration announced a vision for the future of the Medicare program, including clear goals and a timeline for shifting Medicare payments from volume to value. CMS is continually working to turn this vision into reality through annual rulemaking and the CMS Innovation Center, building on bipartisan ideas, initiatives and legislation from both Congress and the states.

CMS recently published the final 2016 Medicare provider payment rules. Woven into those very detailed payment rules and regulations are new examples of the administration’s commitment to quality, value, and patient-centered care.

These include:

·         Creating the Home Health Value-Based Purchasing model. This model will link home health payments to quality performance with the goal of improving health outcomes.

·         Replacing the Sustainable Growth Rate (SGR) update formula for physician services with one that supports patient- and family-centered care. CMS is taking the first steps to implement the Merit-Based Incentive Payment System (MIPS) and incentives for participation in Alternative Payment Models (APMs).

·         Paying for advance care planning. A wide range of stakeholders and bipartisan members of Congress supported our proposal to make separate payments to doctors and other practitioners who provide elective advance care planning services to Medicare beneficiaries in a variety of settings.

In addition to the efforts mentioned above, the CMS Innovation Center is testing a variety of models that build on the Administration’s measurable goals and timeline to move the Medicare program, and the healthcare system at large, toward paying providers based on the quality, rather than the quantity of care they give patients. The CMS Innovation Center opened its doors five years ago to test new payment and service delivery models that either improve quality while keeping costs the same, maintain quality and lower costs, or – best case scenario – improve quality and lower costs. 

CMS says they have seen some positive results from models that the Innovation Center is testing. Savings in the Pioneer ACO Model were so significant – and coupled with positive results on improved quality of care and better patient experience – that the independent CMS Office of the Actuary certified that expansion of the model as it was tested in the first two years would reduce net program spending under Medicare.

They have also incorporated elements of the Pioneer ACO Model into the Medicare Shared Savings Program, which reaches more beneficiaries in more areas of the country.

One of the most promising trends is the significant improvement in patient safety and decreased adverse incidents in the hospital setting. Several CMS programs that are improving patient safety in hospitals, such as the Partnership for Patients, from 2010 to 2013, there has been 1.3 million fewer hospital acquired conditions and 50,000 patient deaths avoided, leading to an estimated $12 billion savings in health care costs. This translates into a 17 percent reduction in patient harm nationally over the three-year period. This is a promising start, but we are committed to doing more.

The recently finalized Comprehensive Care for Joint Replacement model, a bundled payment model for hip and knee replacements for Medicare beneficiaries set to begin in April 2016. The model’s goal is to give hospitals a financial incentive to work with physicians, home health agencies, skilled nursing facilities, and other providers to ensure beneficiaries get the coordinated care they need.

Primary care models, including the Comprehensive Primary Care Initiative and Independence at Home Demonstration, are demonstrating the ability of redesigned primary care to improve quality and patient experience while lowering costs. The Independence at Home demonstration saved over $3,000 per beneficiary in its first year through coordinated care for beneficiaries with multiple chronic conditions.

To date, over 4,000 individuals and 610 organizations have committed to participate in the Learning and Action Network, and 50 partners have set organization-specific goals to encourage adoption of value based payment. These efforts have contributed to putting Medicare and Medicaid on stronger financial footing with improved quality. Per enrollee Medicare spending growth has been low, averaging 1.3 percent over the last five years.

The Medicare trust fund will remain solvent 13 years longer than the Medicare Trustees projected in 2009, before the passage of the Affordable Care Act.

The end of Medicare bonus program will cut pay to primary care doctors and because of that many primary care practitioners will be a little poorer next year because of the expiration of a health law program that has been paying them a 10 percent bonus for caring for Medicare patients. Some say the loss may trickle down to the patients, who could have a harder time finding a doctor or have to wait longer for appointments. But others say the program has had little impact on their practices, if they were aware of it at all.

Medicare generally pays lower fees for primary care visits to evaluate and coordinate patients’ care than for procedures that specialists perform. The difference is reflected in physician salaries. Half of primary care physicians made less than $241,000 in 2014, while for specialists the halfway mark was $412,000, according to the Medical Group Management Association’s annual provider compensation survey.

The incentive program was an effort to address shortcomings in Medicare’s system of paying providers mostly a la carte for services, which tends to undervalue primary care providers’ ongoing role in coordinating patients’ care.  Earlier this year, Medpac proposed that Congress replace the expiring primary care incentive program with a per-beneficiary payment to primary care physicians that would be paid for by reducing payments for non-primary care services. That proposal hasn’t made any headway. Meanwhile, physician trade groups have lobbied unsuccessfully for an extension of the Medicare bonus program.

Visit CMS for the article.

Looking for a way to share your knowledge and expertise with the CS community?

Poster displays at the 2016 IAHCSMM Annual Conference and Expo in San Antonio, TX are an important educational experience for conference attendees, providing information and facilitating productive discussions among viewers.

IAHCSMM invites you to submit a CS-related poster for IAHCSMM's Annual Conference and Expo, April 24-27, 2016. Now's the time to showcase your research and learning experiences your company has established. For examples, review past submissions in our Poster Gallery.

Deadline: February 8, 2016

Contact Patti Koncur, IAHCSMM Education Specialist, 800.962.8274 ext. 402, for more information or visit

A ‘superbug’ emerges in China to remind us that antibiotics won’t last forever

According to a study published in Lancet Infectious Diseases, a gene dubbed MCR-1 is becoming more common in bacteria found in China. MCR-1 gives bacteria the ability to resist antibiotics called polymyxins. These harsh antibiotics are considered a last line of defense — a treatment when bacteria have shown resistance to everything else. But with MCR-1 in tow, bacteria can thwart our most aggressive drugs. That means they're basically invincible. And MCR-1 could theoretically end up jumping to all manner of bacteria.

"Polymyxins were the last class of antibiotics in which resistance was incapable of spreading from cell to cell," co-author Jian-Hua Liu, a professor at Southern Agricultural University in Guangzhou, told the AFP.

So much for that.

The researchers tested slaughterhouse pigs and raw meat from markets for the gene. MCR-1 was found in 20 percent of the sampled pigs and 15 percent of the meat, and in increasing abundance from year-to-year. The gene was also found in E. coli K. pneumoniae samples taken from 16 of 1,322 patients at two Chinese hospitals.

Antibiotic resistant bacteria is already implicated in at least 700,000 deaths per year worldwide, and some estimate that the death toll could skyrocket to 10 million per year by 2050, if trends continue.

Polymyxins are meant to be reserved for dire medical cases — after all, these drugs are too toxic for a human to want to consume. But in China, their rare usefulness in humans has led to a secondary use: animal husbandry. Chinese pigs are some of the biggest consumers of the drug colistin, a kind of polymyxin, which is used to fatten them up. The researchers report that this is almost certainly the breeding ground of the resistance, and that the Ministry of Agriculture has launched an investigation to assess this.

An estimated 70 percent of the antibiotics important to health are used in livestock in the United States.

Visit the Washington Post for the story.

Hospital reduces Norovirus outbreaks by 91%

Norovirus outbreaks have dropped by 91% at the Queen Alexandra Hospital in Cosham, Portsmouth, England as shown in a study published in BMJ Quality & Safety. The hospital implemented a multidimensional quality improvement initiative based on the use of Bioquell’s hydrogen peroxide vapor, a superbug-killing automated room disinfection technology, to stop the spread of one of the most contagious pathogens in existence.

International discussions frequently focus on sharing methods for containing outbreaks, with this study offering insight on the latest, most effective techniques and technologies.

Every winter, norovirus outbreaks can create chaos in hospitals as it can rapidly lead to frequent outbreaks amongst patients, staff sickness, and general disruption. The CDC reports that there are 19-21 million cases annually in the United States with a price tag of nearly $2 billion in the US for treatment and productivity lost. About 63% of norovirus outbreaks occur in a healthcare facility.

This multidimensional quality improvement initiative led by the use of Hydrogen Peroxide (HP) Vapor bio-decontamination technology from Bioquell also includes education, enhanced patient surveillance, early automated detection and notification of infected patients as well as proactive care and control measures.

The cleaning robots (Bioquell Q-10 suite) used at the Queen Alexandra Hospital rely on Hydrogen Peroxide (HP) Vapor to decontaminate rooms. This technology has been proven to kill 99.9999% of pathogens. A smaller and faster version (Bioquell BQ-50) of this HP Vapor generator is now available from Bioquell.

Visit Bioquell for the study.

Med students call resident work trials unethical

Two organizations are demanding an investigation into what they say are unethical clinical trials that have required first-year medical residents around the country to work up to 28 hours or more at a time.

In letters sent to the Office for Human Research Protections at the department of Health and Human Services and the Accreditation Council for Graduate Medical Education (ACGME), the American Medical Students Association (AMSA) and the watchdog group Public Citizen claim the studies exposed both the medical trainees and patients to a wide range of risks, including exposure to blood-borne pathogens.

The letters demand an immediate halt to iCOMPARE, which is an ongoing study, as well as an investigation of that trial and the FIRST study, which was completed in June 2015. They also want sanctions implemented against all the institutions that took part in the trials.

"The 2011 work-hour restrictions were put in place because of clear evidence of risk to resident physicians," Deborah Hall, MD, a physician and national president of the medical student association, said in a statement. The groups cited a 2010 survey of the general public in which 81% said that patients should be informed if a treating resident was working more than 24 hours and, if so, 80% would want a different doctor.

"Few patients would voluntarily agree to be enrolled in such trials if given the opportunity to choose," said Michael Carome, MD, director of public citizen's Health Research Group.

Thomas Nasca, MD, and CEO of the ACGME, said other safeguards have remained in place for the trials. They include a maximum work week of 80 hours, a mandatory one day off every seven days, and no more than one night shift every 3 days. He said institutional review boards at all the participating hospitals reviewed the trial protocols and determined that patients did not need to be informed. Nasca noted that since 2003 second and third year residents have been working up to 28-hour shifts. Prior to that, they worked shifts of up to 36 hours.

New residency work hours adopted by the ACGME limit shifts to 16 hours, but critics of those reduced hours said shorter work shifts diluted the training experience, a hallmark of which was long hours with little sleep and high demands. They also pointed out that shorter shifts mean more frequent patient "hand-offs," a known risk to patient safety.

In the letters, AMSA and Public Citizen note that primary goal of the two trials -- one of which is ongoing -- is to determine whether the rates of death and serious complications for patients "unwittingly enrolled in the trials" are higher at hospitals where residents are required to work shifts for as long as 28 hours than the rates at hospitals that follow the current 16-hour work shift standard.

The University of Wisconsin Hospital and Clinics took part in a limited way in the FIRST study, which ended in June. In a statement, UW spokesperson Lisa Brunette, said first-year residents were allow to work up to 18 hours, not the 28 cited by the organizations. She said evidence about longer work hours is incomplete and often contradictory.

"Recent studies, including several in Europe, have yielded worrisome trends, including residents who report feeling less prepared to go into private practice, who do less follow-up on their patients, and have many more 'hand-offs' or transitions between caregivers – the latter being a known risk factor for medical error," she said.

Visit Med Page Today for the story.