#Inflamed Brain Is depressed a Brain Researchers at the Centre for Addiction and Mental health (CAMH) in Toronto have found a possible link between inflammation in the brain and clinical depression.
Since more than half of patients suffering from major depression disorder (MDD) do not respond to antidepressant treatment,
and standard of care for mental health issues. The results from this study, published today in JAMA Psychiatry in an article entitled ole of Translocator Protein Density,
a Marker of Neuroinflammation in the Brain During Major depressive episodes showed that there was a 30%increase in inflammation among patients experiencing a major clinical episode."
"This finding provides the most compelling evidence to date of brain inflammation during a major depressive episode,
"says Jeffrey Meyer, M d.,Ph d.,of CAMH's Campbell Family Mental health Research Institute and senior author of the study."
They conducted brain scans using positron emission tomography (PET), which produces a three-dimensional image of functional process within the brain,
Currently, there are no therapies that address inflammation as part of regimen to treat depression and the CAMH team believes that using anti-inflammatories as a treatment option needs to be explored further. his finding provides the most compelling evidence to date of brain inflammation,
because it implies that therapeutics that reduce microglial activation should be promising for MDE, the paper concludes c
and placental barriers act as critical ramparts to infections from microbial pathogens, yet some have evolved mechanisms to breach the cellular obstacles that lie in their path.
Unlocking the underlying mechanisms of host barrier permissiveness to microbes is critical to understanding the etiology of many infectious diseases.
The common foodborne bacteria Listeria monocytogenes (Lm) can survive and proliferate within the intestinal lumen of the host,
causing meningitis and encephalitis, as well as the placental barrier, resulting in severe neonatal infection or miscarriage.
Researchers at the Pasteur institute in Paris have discovered the protein pathways that are responsible for allowing Listeria to circumvent host barriers.
The results from this study were published today in the Journal of Experimental Medicine within an article entitled I3-kinase activation is critical for host barrier permissiveness to Listeria monocytogenes Listeria relies on two surface proteins called
Marc Lecuit, M d.,Ph d.,Head of the Biology of Infections Unit at the Pasteur institute and senior author on the study,
results illustrate how microbial pathogens have evolved to invade mammalian tissues, taking advantage of both similarities and differences of host barriers.
They also suggest that the absence of placental constitutive PI3-K activity may reinforce its barrier function toward pathogens
funded by the Movember Foundation and conducted by scientists at The Institute of Cancer Research (ICR) in London,
has revealed several genetic mutations that may trigger the development of testicular cancer, in addition to uncovering a gene that may aid tumors in promoting resistance to existing drug therapies.
According to the authors, this is the first study of its kind to use whole-exome sequencing to probe testicular germ cell tumors,
which constitute the majority of testicular cancer cases.""This study has used the latest DNA sequencing technologies to provide a window into the development of testicular cancer,
and reveals some potentially important clues as to how the disease could be treated more effectively, stated Paul Workman, Ph d.,chief executive of ICR.
The investigators, whose research was published today in Nature Communications in an article entitled, hole-exome sequencing reveals the mutational spectrum of testicular germ cell tumours,
examined tumor samples from 42 patients with testicular cancer. They report previously unidentified chromosome duplications and confirmed data from earlier findings that associated these tumors with the KIT gene,
which has been linked to an array of other cancerous tissues.""Our study is the largest comprehensive sequencing study of testicular tumors published to date,
describing their mutational profile in greater detail than has been possible using previous technologies, says Clare Turnbull, Ph d.,senior author and team leader in predisposition and translational genetics at ICR.
Interestingly, Dr. Turnbull and her team also found defective copies of the DNA repair gene XRCC2 in a patient who had become resistant to platinum-based chemotherapy.
Their preliminary finding of a link between XRCC2 and platinum drug resistance was validated once they sequenced a sample from an additional platinum-resistant tumor. e have identified new potential driver mutations for this type of cancer
and provided new evidence of a link between mutations in the gene XRCC2 and platinum treatment-resistant tumours.
We now need additional studies with a larger number of patients, focusing in particular on platinum-resistant tumour,
whose cancer progresses in spite of the best available treatments,"said Dr. Turnbull Despite the fact that testicular cancer responds well to chemotherapy,
This study provides essential general knowledge concerning testicular germ line cell tumor development but more importantly, valuable insight into the genetic underpinnings as to why certain patients develop resistance to chemotherapy h
The goal of the new procedure is to avoid the transmission of mitochondrial diseases. Under the decision, the embryo would receive nuclear DNA from its mother and father along with healthy MITOCHONDRIAL DNA from a female donor.
Researchers at the Wellcome Trust Centre for Mitochondrial Research at Newcastle University estimate that about 2, 500 women of childbearing age in Britain carry mitochondrial disease.
We have great sympathy for families affected by mitochondrial disease and are opposed not in principle to mitochondrial replacement.
while the research center in Newcastle is expected to serve as the site for the first procedure. ur findings have considerable implications for all countries that are
director of the center at Newcastle University. his novel approach would allow women who carry these mutations greater reproductive choice. e
#Data sharing Takes Two steps Forward Two small but significant steps forward were taken yesterday in the direction of open access to clinical trial data.
A committee of the Institute of Medicine (IOM) yesterday called for the sharing of supporting data for clinical trials results within six months after publication, with a full analyzable data set shared no later than 18 months
after study completion or 30 days after regulatory approval. Also yesterday, Johnson & johnson (J&j) joined the Yale Open data Access (YODA) Project in agreeing to share data from clinical trials for medical devices and diagnostics.
The YODA Project said in a statement that the agreement stablishes a fully independent intermediary to manage requests
and promote data use, as J&j has done with pharmaceutical clinical trial data since last year.
Under the agreement, the YODA Project will approve or deny requests from investigators for de-identified patient data associated with the pharmaceutical, medical device,
and diagnostic clinical trials conducted by J&j companies. his action will benefit society and represents a major step forward in the effort to promote data sharing,
as Johnson & johnson leadership in this area now extends from sharing its drug data to sharing its device
and diagnostics data, said Dr. Harlan Krumholz, professor of medicine and leader of the YODA Project. e hope this action serves as a catalyst to others to join the momentum on open science.
The two new developments join what the IOM report acknowledged was progress toward data sharing in recent years.
Eleven drug developers have committed to sharing clinical trial data through clinicalstudydatarequest. com and allow an independent review panel to decide data requests:
Astellas, Bayer, Boehringer ingelheim, Glaxosmithkline, Lilly, Novartis, Roche, Sanofi, Takeda, UCB, and Viiv Healthcare. Three industry groupspharmaceutical Research and Manufacturers of America (Phrma), the European Federation of Pharmaceutical industries and Associations (EFPIA),
and the Biotechnology industry Organization (BIO) ignaled support for sharing clinical trial data beyond recent industry norms,
but not the open-access sought by Europe chief drug regulator and Glaxosmithkline. The European Medicines Agency in October issued a more expansive data sharing policy last October,
though not the full open-access sought by advocates. The IOM Committee on Strategies for Responsible Sharing of Clinical Trial Data similarly said its recommendations were intended to balance data sharing benefitsaximizing knowledge
stimulating new research ideas, and avoiding duplicative trialsith its challenges. The panel defined those challenges as protecting privacy and consent for trial patients;
providing researchers adequate time to analyze and publish their data, safeguarding commercially confidential information, and assuring research institutes that requirements for sharing clinical data will not be nfunded mandates.
Also included among challenges was uarding against invalid secondary analyses, which could undermine trust in clinical trials
or otherwise harm public health? whether through inadvertent errors in data analysis or, in the U s.,the prospect of monetary gain through qui tam lawsuits, the report stated.
The panel expressed fear that such invalid analyses ill lead to claims of risk that are not scientifically valid,
which may in turn lead to lawsuits for negligence that, while without merit, are expensive to respond to
and defend against. IOM committee cited criticism from outside researchers over the PLATO trial, whose data led to approval of Astrazeneca Brilinta (ticagrelor).
Questions about geographic discrepancies of outcomes, study-site monitoring, and the timing of deaths prompted the U s. Department of justice to investigate the trial.
Doj closed its investigation last year without carrying out any action. he sharing of clinical trial data needs to be carried out in a way that maintains incentives for sponsors
and researchers to develop new clinical trials and therapies and that sustains patientswillingness to participate in them,
said committee chair Bernard Lo, president of the Greenwall Foundation, a funder of bioethics research. ur recommendations attempt to balance the interests of different stakeholders with the public interest in having the best information possible regarding the effectiveness and safety of therapies.
The committee said clinical trial takeholdersshould mitigate the risks and enhance the benefits of data sharing by employing ata useagreements;
creating independent review panels with members of the public to decide sharing requests, and maintaining transparency in data-access policies.
The panel defined stakeholders to include funders and sponsors, as well as disease-focused patient advocacy groups, regulators,
and overseers such as institutional review boards, research ethics committees, investigators, their research institutions or universities, journals,
and membership and professional societies. takeholders in clinical trials should foster a culture in which data sharing is expected the norm,
and should commit to responsible strategies aimed at maximizing the benefits, minimizing the risks, and overcoming the challenges of sharing clinical trial data for all parties,
the IOM panel stated. IOM committee said that data-use agreements should include provisions aimed at protecting clinical trial participants,
advancing the goal of producing scientifically valid secondary analyses, giving credit to the investigators who collected the clinical trial data, protecting the intellectual property interests of sponsors,
and ultimately improving patient care. lthough it is unclear whether and how data use agreements will be enforced,
the committee believes these agreements have significant normative, symbolic, and deterrent value, setting professional expectations and standards for responsible behavior, the committee concluded.
The 13-member committee included experts in key scientific and research-related domains including academia, industry, funding bodies, regulatory activities, scientific publications, clinicians,
and patients, the IOM said e
#New Microchip Design Captures Circulating Tumor Cells Circulating tumor cells (CTCS) represent the metastatic seed that can break away from the primary tumor site,
move through a patient bloodstream, and spread to other parts of the bodyften causing more pathological symptoms than the primary cancer from which the CTCS were derived.
Single CTCS are extremely rare, typically fewer than 1 in 1 billion cells, with clusters being even less common.
While the existence of CTC clusters has been known for more than 50 years, isolating and investigating their role in metastasis has been difficult.
However, researchers from Harvard Medical school have developed a microfluidic chip that can capture CTC clusters which could yield important new insights into how different cancers spread."
"Very little is known about CTC clusters and their role in the progression and metastasis of cancer.
This unique technology presents an exciting opportunity to capture these exceptionally rare groups of cells for further analysis in a way that is minimally-invasive,
"explained Roderic Pettigrew, M d.,Ph d, . director at the National Institute of Biomedical Imaging and Engineering who helped find the current study."
"This is the kind of breakthrough technology that could have a very large impact on cancer research."
"The findings from this study were published recently in Nature Methods through an article entitled"A microfluidic device for label-free, physical capture of circulating tumor cell clusters."
"The investigators used this new technology, which they dubbed Cluster-Chip, to capture and analyze CTC clusters from a group of 60 patients with metastatic breast, prostate,
and melanoma cancers. The researchers observed CTC clusters ranging from 2-19 cells among 300%of the patients."
"The presence of these clusters is far more common than we thought in the past, "said senior author Mehmet Toner, Ph d.,professor of surgery and health sciences and technology at Harvard Medical school,
Massachusetts General Hospital. he fact that we saw clusters in this many patients is really a remarkable finding."
"The chip is designed to funnel blood through a field of microscopic triangle-shaped posts. The posts are arranged so that every two posts channels cells towards the tip of a third post.
At the tip, single cells easily slide to either side and continue through the chip until reaching the next tip.
However, CTC clusters are left stuck at the tip due to forces pulling them down the post in opposite directions.
After initial tests provided information that the Cluster-Chip design was efficient at capturing cell clusters composed of 3 cells or greater,
Dr. Toner and his colleagues went on to test the technique in a small trial of 60 patients with metastatic cancer.
The assay was able to capture CTC clusters from 40%of breast cancer, 31%of prostate and 30%of melanoma patientsuggestive of a greater role for CTC clusters in metastatic cancers than previously thought.
Interestingly, the data from this small study also showed a rare presence of non-tumor derived immune cells within clusters,
for less than 5%of patients"The fact that some CTC clusters contain immune cells is of particular interest,
"said Dr. Pettigrew.""Given the increasing number of cancer therapies that engage the immune system, the ability to monitor tumor-immune cell interactions via the blood could be of great value."
"Dr. Toner and his colleagues anticipate that the Cluster-Chip will have an increasingly important role in stimulating new research on CTC cluster biology,
stating that"it's like poking a sleeping bear. It could really awaken the field to go after clusters
and to develop even better technologies to understand their biology in cancer metastasis. t
#Inexpensive Technique Developed to Manufacture Nanofibers Scientists at the University of Georgia say they have developed an inexpensive way to manufacture nanofibers,
which are made polymers from natural materials like proteins or from human-made substances to make plastic,
rubber or fiber, including biodegradable materials. The new method, dubbed"magnetospinning, "provides a simple, scalable,
and safe means for producing large quantities of nanofibers that can be embedded with a multitude of materials,
including live cells and drugs, according to the researchers. Thousands of times thinner than the average human hair, nanofibers are used by medical researchers to create advanced wound dressings and for tissue regeneration
drug testing, stem cell therapies, and the delivery of drugs directly to the site of infection."
"The process we have developed makes it possible for almost anyone to manufacture high-quality nanofibers without the need for expensive equipment,
"said Sergiy Minko, Ph d.,study co-author and the Georgia Power Professor of Polymers, Fibers and Textiles in UGA's college of family and consumer sciences."
"This not only reduces costs, but it also makes it possible for more businesses and researchers to experiment with nanofibers without worrying too much about their budget."
"Currently, the most common nanofiber manufacturing technique, called electrospinning, uses high-voltage electricity and specially designed equipment to produce the polymer strings.
Equipment operators must have extensive training to use the equipment safely.""In contrast to other nanofiber spinning devices, most of the equipment used in our device is said simple
Dr. Minko.""Essentially, all you need is a magnet, a syringe, and a small motor."
"At laboratory scale, a v simple handcrafted setup is capable of producing spools containing hundreds of yards of nanofibers in a matter of seconds.
Polymer that has been melted or liquefied in a solution is mixed with biocompatible iron oxide or another magnetic material and placed inside a hypodermic needle.
This needle is positioned then near a magnet that is fixed atop a spinning circular platter. As the magnet passes by the tip of the needle,
a droplet of the polymer fluid stretches out and attaches to the magnet, forming a nanofiber string that winds around the platter as it continues to spin.
The device can spin at more than 1 000 revolutions per minute, enough time to create more than 50 kilometers (or about 31 miles) of ultra-thin nanofiber.
It's a relatively simple process, but it produces a high-quality product, said Alexander Tokarev, Ph d,
. a postdoctoral research in Dr. Minko lab and co-author of the study (Magnetospinning of Nano-and Microfibers)
which appears in Advanced Materials. he product we can make is just as thin and just as strong as nanofibers created through other methods,
"he said.""Plus, users don't have to worry about the safety issues of using high voltages or the complexity of other machines."
"The researchers can use this method to create a variety of nanofibers simply by changing the polymer placed in the syringe.
They can, for example, create specially designed nanofibers that will promote the growth of stem cells.
Fibers like these are used currently to create scaffolding for lab-grown tissues and organs. Nanofibers can also be loaded with proteins, nanotubes, fluorescent materials and therapeutic agents."
"We can use almost any kind of polymer with this platform, and we can tailor make the nanofibers for different applications,
"explained Dr. Minko.""It's like cooking. We just change the ingredients a bit, and the kind of fiber we get is very different. n
#Researchers Discover New ain Sensinggene An international scientific team led by the University of Cambridge reports the identification of a gene essential to the production of pain-sensing neurons in humans.
The study (ranscriptional regulator PRDM12 is essential for human pain perception, published in Nature Genetics,
could have implications for the development of new methods of pain relief. Pain perception is conserved an evolutionarily warning mechanism that alerts us to dangers in the environment and to potential tissue damage.
However, rare individuals are born unable to feel pain. These people accumulate numerous self-inflicted injuries, often leading to reduced lifespan.
Using detailed genome mapping two teams of researchers collaborated to analyze the genetic make-up of 11 families across Europe
and Asia affected by an inherited condition known as congenital insensitivity to pain (CIP). This enabled them to pinpoint the cause of the condition to variants of the gene PRDM12.
Family members affected by CIP carried two copies of the variant; however, if they had inherited only one copy from their parents,
they were unaffected. The team looked at nerve biopsies taken from the patients to see what had gone wrong and found that particular pain-sensing neurons were absent.
From these clinical features of the disease, the team predicted that there would be a block to the production of pain-sensing neurons during the development of the embryo.
They confirmed this using a combination of studies in mouse and frog models, and in human induced pluripotent stem cells.
PRDM12 had previously been implicated in the modification of chromatin a small molecule that attaches to our DNA
and acts like a switch to turn genes on and off. The researchers showed that all the genetic variants of PRDM12 in the CIP patients blocked the gene's function.
As chromatin is particularly important during formation of particular neurons, this provides a possible explanation for why pain-sensing neurons do not form properly in the CIP patients.
RDM2 emerges as a key factor in the orchestration of sensory neurogenesis and may hold promise as a target for new pain therapeutics,
wrote the investigators.""The ability to sense pain is essential to our self-preservation, yet we understand far more about excessive pain than we do about lack of pain perception,
"says Geoff Woods, M d, from the Cambridge Institute for Medical Research at the University of Cambridge,
#New Gene Subgroup Driving Aggressiveness in Prostate Cancer Identified Prostate cancer is the most commonly diagnosed malignancy among males within developed countries.
Most often the majority of prostate cancer is thought of as an organ-confined disease with little genetic variation.
However, data in recent years is beginning to bring into focus that many prostate tumors display substantial amounts of genetic heterogeneity, leading to differential mortality rates.
Now, prostate cancer researchers in Canada have sketched a molecular portrait providing a complete picture of
what they describe as a localized, multi-focal disease within the prostate gland, as well as identifying a new gene subgroup acting as a molecular driver for tumor progression. ur research shows how prostate cancers can vary from one man to anotherespite the same pathology under the microscopes well as how it can vary within one man who may have multiple
tumor types in his prostate, "explained Robert Bristow, M d.,Ph d.,clinician-scientist at Princess Margaret Cancer Centre,
Toronto and senior author on the study. hese sub-types may be important to determining the response to surgery or radiotherapy between patients."
"The findings from this study were published recently in Nature Genetics through an article entitled patial genomic heterogeneity within localized, multifocal prostate cancer.
Specifically, the study involved the molecular profiling of 74 patients with relatively high aggressiveness scores.
From this group, whole genome sequencing was performed on samples from five patients whose prostates were removed surgically.
The investigators carefully analyzed the genetic backgrounds of each tumor sample, assigning individual aggression scores to the discreet cancer foci regions they identified.
The data revealed that even small cancers within the prostate can contain very aggressive cells capable of varying long term disease prognosis.
Additionally Dr. Bristow and his colleagues identified two members of the MYC oncogene family that played essential roles in tumor development.
The researchers identified C-MYC as being the driver of aggressiveness for the disease and L-MYC,
which has already been implicated in lung cancer development, playing a critical role in tumor progression.""This discovery of a new prostate cancer-causing gene gives researchers a new avenue to explore the biology of the disease
and improve treatment,"stated Paul Boutros, Ph d, . principal investigator at the Ontario Institute for Cancer Research and lead author on the current study."
"By showing that mutations in prostate cancer vary spatially in different regions of a tumor,
this study will aid in the development of new diagnostic tests that will improve treatment by allowing it to be personalized further."
"Interestingly, the researchers determined that half of all prostate patients have either C-MYC or LMYC mutations,
but never both. Dr. Bristow thinks that this study takes an important step forward in identifying new biomarkers for prostate cancer and developing novel treatment options for patients."
"Our findings suggest we are getting closer to subtyping prostate cancer based on which gene is present to determine a patients'disease aggression in terms of the risk of spread outside the prostate gland at time of treatment,
said Dr. Bristow. n developing this research tool into a clinical test within three years,
we hope to inform doctors and patients about specialized treatments for each prostate cancer patient. e
#Ensuring the Price Is Right for Cancer drugs The biopharma industry was rattled in 2012 when oncologists at Memorial Sloan-Kettering Cancer Center (MSK) refused to prescribe Zaltrap (ziv-aflibercept) for metastatic colorectal cancer due to its initial $11, 000-per-month cost.
Zaltrap developer Sanofi responded with 50%discounts while maintaining its official price. A year later, some 120 investigators and other experts in chronic myeloid leukemia (CML) publicly demanded lower cancer drug prices.
The group faulted high U s. prices in part on the failure of insurers and officials to negotiate drug prices with developers.
Now years of talk is finally translating into action on bringing down the price of cancer drugs.
Express Scripts, a pharmacy benefit manager that processed some 1. 3 billion U s. prescriptions last year,
recently disclosed it is in talks with several developers of cancer drugs to base the prices of several treatments on their effectiveness.
The payer won say which drugs or companies are the subject of discussions, first reported last month by The Wall street journal. Brian Henry, Express Scriptsvp,
corporate communications, told GEN the results of those talks will begin to be reflected in its 2016 National Preferred Formulary,
which covers 25 million customers. He said drug developers have responded largely positively to the payer overtures.
Cancer was the third most expensive category of specialty drugs last year measured per-member-per year, according to Express Scripts;
Multiple sclerosis (MS) was second, and inflammatory conditions such as rheumatoid arthritis (RA), the priciest. However, cancer accounts for 32%of drugs costing more than $100, 000 a year,
and is among a handful of key drivers of rising costs here are drugs in cancer that may give five months of life in one indication and 12 days of life in another.
Yet payers are being asked to pay the exact same amount for both, Henry said June 3. hen you get to the point where you have orphan drug pricing for non-orphan drugs,
Drug makers have resisted traditionally value-based pricing, arguing they need to recoup R&d costs. The about-face reflects the convulsive changes wrought by U s. healthcare reform
and Europe embrace of government-led value-based drug pricing. In the U k.,the National Institute for Health and Care Excellence (NICE) makes formulary determinations through a ost-effectivenessthreshold assessing estimated costs of treatments or services in relation to their expected health benefits.
Germany Institute for Quality and Efficiency in Health care (IQWIG) applies eference pricing setting reimbursements for new drugs at the same level as the best existing comparator unless the new drugs show superiority to that comparator;
U s. payers can be expected to approve higher prices for cancer drugs than the European agencies, in part given the greater size and affluence of the nation economy.
Yet payers should also reward developers for innovation, and for treating smaller populations, Peter B. Bach, M d.,MAPP,
director of MSK Center for Health policy and Outcomes, told GEN. Last year, Dr. Bach published a commentary in Journal of the American Medical Association supporting indication-based pricing for cancer drugs.
Based on value per indication the price of Erbitux (cetuximab) would dip from a typical treatment cost of $14, 292 to $10, 319 for locally advanced squamous cell carcinoma (SCC) of the head and neck.
But for its least effective indication of first-line treatment of recurrent or metastatic SCC of the head and neck, according to Dr. Bach, the price would plunge from $42, 875 to $471. ervoy and Keytruda, theye
not just important new drugs. Theye also a new idea. I also think it true for Gleevec.
Under his value model, Herceptin price for metastatic breast cancer would drop from a typical $54, 118 to $905.
As for pricing rare-disease drugs higher, Dr. Bach added: dispassionate economist would say that inefficient.
But I think as a society, we want to invest to make sure that smaller groups of people aren left behind just
They can be expected to take different paths to pricing, hich means that there will not be a one-size-fits-all approach,
Ph d.,research associate professor with the Tufts Center for the Study of Drug Development, told GEN. Having numerous payers,
the U s is less likely to see drug developers offer the extent of free trials or money-back guarantees,
Numerous payers is one reason why prices set by U s. payers will likely be more palatable to drug developers than
then, will indication pricing have on cancer drug prices? ringing down the growth rate, yes. Actually reducing cancer drug prices across the board, very unlikely, Dr. Cohen concluded. n comparison to Europe, U s. prices will likely remain relatively high.
The growth rate will said shrink, he, as payer cut prices for less-effective treatmentsven after developers invest in IT systems, drug utilization programs,
and post-marketing clinical trials to gather data on clinical and cost-effectiveness. he less effective a treatment,
The flipside of this is that the better treatments will still be commanding high prices, Dr. Cohen said.
Pricing decisions will hinge on data from providers: his is being presented as a way to manage money,
but in reality we should be doing this as a standard of care to create a continuous loop of improvement, Harry Glorikian,
a life sciences and healthcare industry consultant, told GEN. Express Scripts is hoping to repeat the success it enjoyed last year in hepatitis C. In December 2014,
the company immediately added Abbvie Viekira Pak to its National Preferred Formulary as the exclusive option for patients with genotype 1 hepatitis Cust three days after the FDA approved the drug.
Abbvie agreed to an undisclosed lower price for Viekira Pak, which lists at $83, 319 per 12-week course.
Henry said the lower price is consistent with discounts given for the drug in Europe for Sovaldi,
%In February, Gilead agreed with German insurance regulators to charge#41,000 ($45, 560 as of June 5) for Sovaldi, a 45%discount.
Express Scriptsindependent Pharmacy & Therapeutics Committee concluded that Viekira Pak was at least clinically equivalent to two Gilead sciences drugs, Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir.
and only covers Sovaldi for non-genotype 1 hepatitis C. ur clients will save more than $1 billion this year on hepatitis C medications,
and we will financially guarantee that their patients will adhere to their therapy. Due to the industry-wide ripple effect of our decision,
That price brought upon Gilead criticism from Express Scripts and three members of Congress, all Democrats in the Republican-majority House of representatives.
000-a-pill pricing by noting that the cost of Sovaldi is lower than the cost of complications associated with hepatitis C treatment, such as liver damage or liver failure.
A Congress that can do little surely cannot lower cancer drug prices as effectively as payers could.
Cancer treatments marketed by eight companies accounted for six of the Top 25 Best-selling Drugs of 2014 as listed by GEN,
and its Genentech subsidiary from marketing the top three cancer treatments: Rituxan (rituximab, co-marketed with Biogen and ranked#4), Avastin (bevacizumab;#
and have had discussions with several stakeholders about alternative pricing and payment models. Our discussions about pricing
and we will not disclose discussions with specific stakeholders, Genentech spokeswoman Susan Willson told GEN. Roche has based an indication pricing system in Italy,
Genentech provided its medicines to more than 180,000 people last year for free or reduced cost. Willson noted that the Genentech Access to Care Foundation recently changed its financial criteria with the goal of helping more people, n recognition of the changing healthcare environment and the increasing number of people with high out
-of-pocket costs. The cancer drug placing lowest on the list of top sellers was Novartisgleevec (imatinib mesylate,#15),
In a statement to GEN, Novartis said it is looking into linking payment to patient outcomes
and two other innovative pricing models: e understand that the cost of medicines can be challenging for some patients,
Novartis said. he majority of CML patients in the U s. pay less than $100 out of pocket per month for our CML treatments,
and we are committed to ensuring that patients have access to their medicines. To that end, Novartis said,
its patient assistance program provides the company medicines for free or at a reduced cost to those who can afford them,
or provides support for their copays. The company CML medicines have been provided free to an average of 5
000 uninsured or underinsured patients in the U s. annually for the past six-and-a-half yearsore than $1 billion in free medicine. ecause the cost of drugs is one of the few transparent healthcare costs,
drugs get much public attention, yet are only a small percentage of spending and demonstrate remarkable rewards,
Peter B. Bach, M d.,MAPP, director of MSK Center for Health policy and Outcomes cautioned that some alternative pricing programs have helped developers skirt the prior-authorization rules of payers.
For example, he told GEN, such rules may require treatment with a cheaper drug whose patent protection will expire soon,
yet developers can win payer approval for a costlier medicine by agreeing to allow limited-time use,
Representatives of two other top-selling cancer drug developers, Celgene and Amgen, at deadline had responded not to GEN queries on indication pricing
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