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Old 01-13-2011, 09:24 AM
gdpawel gdpawel is offline
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Default Projections of the Cost of Cancer Care in the United States: 2010-2020

Researchers at the National Cancer Institute have new estimates of U.S. cancer-cost growth over the next decade.

Projections of the Cost of Cancer Care in the United States: 2010-2020

Angela B. Mariotto, K. Robin Yabroff, Yongwu Shao, Eric J. Feuer and Martin L. Brown

Angela B. Mariotto, PhD, Surveillance Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Ste 504, MSC 8317, 6116 Executive Blvd, MSC 7344, Bethesda, MD 20892-7344
Background

Current estimates of the costs of cancer care in the United States are based on data from 2003 and earlier. However, incidence, survival, and practice patterns have been changing for the majority of cancers.

Methods

Cancer prevalence was estimated and projected by phase of care (initial year following diagnosis, continuing, and last year of life) and tumor site for 13 cancers in men and 16 cancers in women through 2020. Cancer prevalence was calculated from cancer incidence and survival models estimated from Surveillance, Epidemiology, and End Results (SEER) Program data. Annualized net costs were estimated from recent SEER–Medicare linkage data, which included claims through 2006 among beneficiaries aged 65 years and older with a cancer diagnosis. Control subjects without cancer were identified from a 5% random sample of all Medicare beneficiaries residing in the SEER areas to adjust for expenditures not related to cancer. All cost estimates were adjusted to 2010 dollars. Different scenarios for assumptions about future trends in incidence, survival, and cost were assessed with sensitivity analysis.

Results

Assuming constant incidence, survival, and cost, we projected 13.8 and 18.1 million cancer survivors in 2010 and 2020, respectively, with associated costs of cancer care of 124.57 and 157.77 billion 2010 US dollars. This 27% increase in medical costs reflects US population changes only. The largest increases were in the continuing phase of care for prostate cancer (42%) and female breast cancer (32%). Projections of current trends in incidence (declining) and survival (increasing) had small effects on 2020 estimates. However, if costs of care increase annually by 2% in the initial and last year of life phases of care, the total cost in 2020 is projected to be $173 billion, which represents a 39% increase from 2010.

Conclusions

The national cost of cancer care is substantial and expected to increase because of population changes alone. Our findings have implications for policy makers in planning and allocation of resources.

JNCI J Natl Cancer Inst 10.1093/jnci/djq495

[url]http://jnci.oxfordjournals.org/content/early/2011/01/12/jnci.djq495.full

Best health care in the world? Certainly the costliest.

[url]http://www.pbs.org/newshour/rundown/2012/10/health-costs-how-the-us-compares-with-other-countries.html
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Old 01-13-2011, 09:45 AM
gdpawel gdpawel is offline
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Default Use technologies wisely, not because you can be reimbursed for them

It's been pointed out that the increase is influenced by a projected rise in the number of prostate and breast cancer patients. Ironically, these are the very two cancers presently involved with the early cancer detection controversy, that is raising uncomfortable questions about how aggressively to treat early growths and in some cases, even how aggressively to test.

Today's cancer screenings can unearth tumors that scientists say never would have threatened the person's life. The problem is there are not surefire ways to tell in advance which tumors won't be dangerous. Even the staunchest supporters of screening call overdiagnosis a problem that needs tackling.

Nowhere is the disconnect more obvious than with prostate and breast cancer screening. Researchers have reminded us that a lack of solid evidence doesn't seem to hamper doctors' use of new technology as long as they can get reimbursed for it.

New targeted treatments and diagnostics are likely to be more expensive that what is already available now. It is suspected that those costs might be mitigated somewhat through the use of genomic-based prognostic markers to more accurately match therapies with those likely to respond.

However, as the NCI has concluded (J Natl Cancer Inst. March 16, 2010), these genomic-based technologies cannot determine treatment plans for patients. It cannot test sensitivity to any of the targeted therapies. They just test for "theoretical" candidates for targeted therapy.

Cancer dynamics are not linear, Cancer biology does not conform to the dictates of molecular biology. We are forced to confront the realization that genotype does not equal phenotype. Cancer cells utilize cross talk and redundancy to circumvent therapies. They back up, zig-zag and move in reverse, regardless of what the sign posts say. The building blocks of human biology are carefully construed into the complexities that we recognize as human beings.

However appealing gene profiling may appear to those engaged in this field, it will be years, perhaps decades, before these profiles can approximate the vagaries of human cancer.

Functional profiling analyses, which measure biological signals rather than DNA indicators, will continue to provide clinically validated information and play an important role in cancer drug selection. The data that support functional profiling analyses is demonstrably greater and more compelling than any data currently generated from DNA analyses. Functional profiling remains the most validated technique for selecting effective therapies for cancer patients.

Functional profiling assesses the activity of a drug upon combined effect of all cellular processes, using several metabolic (cell metabolism) and morphologic (structure) endpoints, at the cell "population" level, rather than at the "single cell" level, measuring the interaction of the entire genome.

The original Human Genome Project (the world's most expensive telephone book*) dealt with a homogeneous population of normal diploid cells. This is different from primary tumors, which are heterogeneous and have a genomic signature unique to each and every patient. Functional profiling is a biomarker of heterogeneous cancer cells and genomic signatures unique to every individual patient.

* The sequencing of the entire human genome gave us the address and the next door neighbors of every human gene, yet we don't know what they do, how they do it, why they do it, or who they do it with. - Dr. Robert A. Nagourney

Sources:
JNCI J Natl Cancer Inst (2010) doi: 10.1093/jnci/djq306
Eur J Clin Invest, Volume 37(suppl. 1):60, April 2007
BMJ 2007;334(suppl 1):s18 (6 January), doi:10.1136/bmj.39034.719942.94
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Old 01-13-2011, 12:32 PM
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Default Oncologists Value Survival Over Quality Of Life, Duke Study Finds

How Long and How Well: Oncologists' Attitudes Toward the Relative Value of Life-Prolonging v. Quality of Life-Enhancing Treatments

Drugs that help cancer patients live longer are worth more for oncologists than drugs that help patients live well, according to a research by Duke University's Fuqua School of Business and several health-related centers.

On an average, oncologists are willing to prescribe treatments that cost almost $245,000 to prolong life for one year, but the cost threshold dropped to about $119,000 per year for treatments that improve quality of life, without prolonging patients' lives.

The study results are based on a survey of 768 physicians, considered two hypothetical scenarios involving a patient with metastatic cancer and a year to live. The first scenario asked the doctor how much benefit, in months of survival gained, a new drug would need to provide for them to prescribe it. The new drug cost about $75,000 more than standard treatment. The second scenario asked the doctor to indicate the highest cost at which they would prescribe a medication to improve the quality of life without prolonging survival.

The respondents consistently chose to spend more on life-prolonging treatments than on quality-enhancing treatments.

"Oncologists are understandably focused on survival, but they need to pay equal attention to the quality of life that people experience during and after treatment," said senior author Peter Ubel, a professor of business administration at Duke University's Fuqua School of Business.

The researchers also found a wide range in what cancer doctors considered reasonable treatment costs. The threshold varied from about $10,000 to about $5 million per quality adjusted life year (QALY), a standard for assessing the cost-effectiveness of medical interventions. The spending thresholds assessed in the study were also measured in QALYs.

The results highlight a critical problem in the struggle to control health care costs, Ubel said. Increasingly, doctors are being asked to consider whether very expensive cancer drugs - some of which offer only small gains in survival - are worth prescribing. But according to Ubel, the data on cost-effectiveness comes without guidelines for determining appropriate financial value in cancer care.

"Currently, individual oncologists are left to decide whether the benefits of expensive new drugs justify their costs," said Ubel. "Cancer care spending is unlikely to drop when there is such a broad range in what oncologists consider reasonable."

"The fact that these highly trained, wonderful doctors are confused about the issue is reason enough to reinforce the dialogue on the cost of cancer care explicitly. With health care spending emptying patients' pocketbooks, and putting pressure on governments worldwide, we need to decide how much we should spend for small improvements in the quantity or quality of patients' lives."

Additional authors of the study include Michael A. Kozminski and Aleksandra Jankovic of the Center for Behavioral and Decision Sciences in Medicine, University of Michigan Medical School in Ann Arbor, Mich.; Peter J. Neuman of the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center in Boston; and Eric S. Nadler of the Charles Sammons Cancer Center, Baylor University Medical Center in Dallas.

Source: Duke University's Fuqua School of Business
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Old 02-11-2011, 07:44 PM
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Default The Role of Public-Sector Research in the Discovery of Drugs and Vaccines

With a $31 billion budget, the National Institutes of Health is the largest funder of biomedical research in the world. Some in Congress want to cancel $1 billion the Administration wanted to add to their budget. The purpose of this budget cutting is to rein in spending to help our economy grow and our businesses create jobs.

However, if creating jobs is the goal, some in Congress may want to look at a new study that appeared in the New England Journal of Medicine, which found that publicly-funded research is a far more important contributor to the creation of new drugs and vaccines than previously thought. The classical view of innovation is that government funds basic science, while industry comes up with the new and innovative products based on that science.

But innovation never was solely the province of private actors pursuing their self interest. Nearly one out of every five important medical advances approved by the Food and Drug Administration between 1990 and 2007 was invented in a federally-funded lab, according to the study, which previous estimates had put at closer to one in 15.

Moreover, those inventions, which included 40 new drugs for cancer, are currently generating in excess of $100 billion a year in sales for drug and biotechnology firms. That’s about one-sixth the total revenue for the entire global pharmaceutical industry.

“These federal grants are not for product development, they’re for advancing basic science,” said study author Ashley J. Stevens, a senior researcher at Boston University’s School of Management. “But they happen to have both significant public health benefits as well as economic development benefits.”

The transmission belt that allows transfer of government-funded inventions from grant recipients to the private sector was built in 1980 with passage of the Bayh-Dole Act. The law became a core element of the U.S. innovation system, and a major source of the U.S.’s competitive advantage in global commerce.

It allows scientists and their institutions to patent government-funded inventions and license them to the private sector. Prior to Bayh-Dole, those breakthroughs were put in the public domain, which eliminated the incentive for commercialization since no firm would invest in developing the product when another company could simply copy the invention.

In the wake of that law, the role of the public sector in spurring biomedical innovation surged, the study found. Over the past 40 years, 153 new FDA-approved drugs, vaccines or new indications for existing drugs were discovered through research carried out at public institutions with federal funding. More than half were used to treat or prevent cancer and infectious diseases.

NIH had recently announced plans to take its efforts to spur biomedical innovation to a higher level by creating a new institute specifically aimed at generating new products for industry. The NIH director stripped $700 million from existing NIH science budgets to get the project up and running, and asked the Secretary of Health and Human Services to seek an additional $1 billion from Congress for the program.

The once-powerful lobbying groups that push for increased NIH funding – ranging from patient advocacy groups to university medical centers to drug and biotech firms – fear the cancellation of the proposed increase is just the first wave of what will shortly become a major assault on federally-funded biomedical science.

It is said that this will undercut U.S. competitiveness in biomedical research in a very big way. Other countries have learned from the U.S. that putting resources behind biomedical research will lead not only to better health outcomes but economic growth.

Source: Gooznews

[url]http://healthpolicyandreform.nejm.org/?p=13730&query=home
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Old 02-22-2011, 12:34 PM
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Default Demythologizing the high costs of pharmaceutical research

Pharmaceutical companies continue to claim that high research and development (R&D) costs make it necessary for them to charge high prices and retain long ownership of patents to recoup costs. But a new study co-authored by health economists Rebecca Warburton and Donald W. Light demonstrates that high R&D estimates have been constructed by industry-supported economists to support the companies’ claims.

The widely accepted figure promoted by industry-supported economists is $1.3 billion to discover and develop a new drug. This estimate, however, was done on a costly subsample and then generalized to all drugs, inflating the estimate for the average new drug by about 7 fold.

TAXPAYERS CONTRIBUTIONS

The $1.3 billion estimate also does not include the substantial contributions by taxpayers through R&D-related tax write-offs. Taxpayers indirectly pay for about 39 percent of company R&D, a substantial reductions in a company’s net costs.

The industry-based figure also includes a large sum inserted for the cost of discovery, even though no one has solid figures on what those costs are. The cost of discovery can range from serendipity to 30 years of frustrating research to find a key compound. Light and Warburton conclude that cost estimates can only be done for development and not basic research.

Light and Warburton also found that independent evidence showed the $1.3 billion estimate was based on trials much larger than reported by the Food and Drug Administration and the National Institutes of Health. The estimate was also based on trials lasting longer than the lengths that companies reported under audit. Finally, the percent of trials that failed was higher than independent sources showed, which multiplies the costs of trials that succeed.

FOREGONE PROFITS AS “COSTS”

Half the $1.3 billion estimate is not real costs but a high estimate of profits that companies would have made if they had not developed drugs but just put their money in bonds or equities. Industry-supported economists used an estimate of those profits more than twice the return on capital conventionally used and counted this high estimate as a “cost of R&D.” “Estimated profits get converted to ‘costs’, and then companies press to get that money back as well as a good return on it,” explained Light. “This amounts to charging high prices to get profits on profits.”

Light and Warburton used the median cost because a few very expensive drugs skew the average and result in a misleading figure. They corrected for inflated numbers and multipliers. The median net corporate R&D cost per new drug was only $59.4 million, plus the unknown cost of discovery, which varies 30 fold. This estimate is in line with audited figures submitted by companies. “We found that the net median corporate costs varied greatly, from $13 million to $204 million, depending on the kind of drug,” Light said.

GOVERNMENT PROTECTED PRICES NOT WARRANTED

“The European Parliament is increasing market protections that will delay generic competition and extend monopoly prices,” Warburton said. “Lobbyists have persuaded European leaders that companies need more time to recover billions in research costs, when R&D costs are really a fraction of the $1.3 billion average claimed.”

PRACTICAL IMPLICATIONS

This study strengthens the view that drugs companies do not need prices as high as they are to recover R&D costs, and their corporate risks are much lower than claimed. Most of their R&D products are scores of drugs with few proven advantages over existing drugs that can command higher, government-protected prices. Gross profits are spent more for marketing than research in order to maximize the number of patients taking these drugs. A large number of clinical trials are conducted for marketing and signing up lead clinicians. These form elements of The Risk Proliferation Syndrome described in a new book, The Risks of Prescription Drugs. The result is millions of patients exposed to adverse side effects with few offsetting benefits. Prescription drugs are now the 4th leading cause of death and result in about 2 million hospitalizations a year. They have also become a major cause of auto and trucking accidents.

[url]https://www.documentcloud.org/documents/81465-col-drugcosts-new-study.html
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Old 05-19-2011, 02:09 PM
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Default Cancer Drug Spending in U.S. May Climb 42 Percent by 2013

Medco Health Solutions, Inc. reports that spending on cancer drugs by U.S. employers and health insurers may climb as much as 42% by the end of 2013 as the number of patients rises and new medicines reach the market.

Specialty drugs that are among the costliest cancer medicines and that lack generic equivalents will drive most of the spending increases.

Revlimid and Gleevec are among cancer drugs contributing to the spending growth as disease detection improves and the treatments prolong patients’ lives. The number of cancer survivors in the U.S. may rise by more than 30% to 18 million by 2020, Medco said in the annual analysis of prescription-drug spending among its clients.

“We’re really expecting to see an explosion in innovation in treating cancer, and many types of cancer are going to go from catastrophic to chronic diseases. The challenge is managing that, such that the costs are not completely out of control," says Medco's Chairman and Chief Executive Officer.

Worldwide sales of oncology drugs may reach $80 billion in 2012, and more than 900 other potential cancer medicines are in development, according to the findings. Health-plan spending on specialty cancer drugs such as

[url]http://www.drugtrendreport.com/2011-report

Physicians Identify Reasons For High Cost Of Cancer Drugs, Prescribe Solutions

A virtual monopoly held by some drug manufacturers in part because of the way treatment protocols work is among the reasons cancer drugs cost so much in the United States, according to a commentary by two Mayo Clinic physicians in the October issue of the journal Mayo Clinic Proceedings. Value-based pricing is one potential solution, they write.

Cancer care is not representative of a free-market system, and the traditional checks and balances that make the free-market system work so efficiently in all other areas are absent when it comes to most cancer treatment," write authors, Mustaqeem Siddiqui, M.D., an oncologist and Vincent Rajkumar, M.D., a hematologist.

For example, when it comes to antibiotics to treat a given infection or over-the-counter painkillers, a physician or patient can choose between multiple drugs that do the same thing. But cancer drugs are administered to patients sequentially or in combination, creating a virtual monopoly for each drug. This is one of the principal reasons for the high cost of cancer therapy.

Other factors include the expense of drug development; the high price that patients and insurers are willing to pay for even modest improvement in outcomes; and a lack of regulations such as a cost effectiveness analysis to account for economic and value-based considerations in the drug approval and pricing process, the physicians write.

Solutions the authors recommend include:

Value-based pricing that includes discrete metrics such as an incremental cost effectiveness ratio per quality-adjusted-life-years gained, as a result of a particular treatment. Quality-adjusted-life-years is an estimate of the number of years added to a patient's life by a specific drug intervention, adjusted for quality of life.

A U.S. Food and Drug Administration mandate requiring drug companies to submit a value dossier when seeking drug approval. This information would give patients and physicians the ability to make better-informed decisions about treatment.

Centers for Medicare and Medicaid Services powers to negotiate payments for cancer drugs.

Improved national cancer guidelines providing evidence-based analysis of quality of life, mortality data, benefits, risks and cost for all possible treatment options.

Monopoly rules to determine if a particular drug will operate in a monopoly situation. Such drugs would be subject to legally mandated or voluntary price controls in exchange for expedited approval or other remedy.

Non-profit generic drug companies to manufacture and distribute generic cancer drugs at a very low cost.

Reference: Mayo Clinic. "Physicians Identify Reasons For High Cost Of Cancer Drugs, Prescribe Solutions." Medical News Today. MediLexicon, Intl., 2 Oct. 2012.
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Old 05-23-2011, 12:51 PM
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Default Abandoning oral oncolytic prescriptions at the pharmacy

A new analysis shows that 10% of patients are abandoning prescriptions for their oral cancer drugs. The reasons: higher cost-sharing for insurance coverage, a larger number of overall prescriptions for different medications, Medicare coverage and incomes, according to Avalere Health, which reviewed pharmacy transaction data between 2007 and 2009. The study was published in the Journal of Oncology Practice and American Journal of Managed Care.

Prescriptions with cost sharing of more than $500 were four times more likely to be abandoned than claims with cost sharing of $100 or less. The study found the abandonment rate rose with cost sharing (scrips with cost sharing above $500) had a 25% as compared with a 6% rate for scrips with cost sharing of $100 or less. Seventy-three percent of new patients had cost sharing of $100 of less, while 16% required an out-of-pocket cost more than $500.

The number of concurrent prescriptions also had an impact, according to the study. Patients with more than five claims for non-cancer meds in the previous month had an abandonment rate of 12%, as compared to 9% for patients with no claims in the previous month. And those with annual incomes below $40,000 had an 11% abandonment rate, which fell to 10% for incomes between $40,000 and $75,000 and 9% for incomes above $75,000. Abandonment rates for Medicare claims were 16%, versus 9% for those with commercial insurance.

The findings are not surprising, given rising costs. A report issued by Medco Health Solutions noted that prices for oncology meds rose 11.5% last year and the pharmacy benefits manager forecast that expensive new cancer drugs used to treat a growing number of patients could drive spending on cancer meds by up to 15% a year through 2013.

Medco also cited statistics from the Journal of the National Cancer Institute, which found more than 90% of anti-cancer drugs approved since 2004 cost more than $20,000. Medco predicts that at this accelerated rate, oncology drugs will likely rise to the second or third largest trend-driving category by 2015.

The Avalere findings are significant for another reason, oral cancer meds now account for 25 to 35 percent of the current oncology pipeline, notes Michael Johnsrud who leads the Health Economics and Outcomes Research group at Avalere, which reviewed pharmacy benefit claims, not medical claims. However, he does not suggest patients are abandoning their entire cancer therapy.

The wake up call is, ultimately, that cost sharing drives whether a patient abandons an oral cancer drug. At the end of the day, a 10% number should be as low as possible and pharmacy benefit designs need to be sensitive to this.

The drugs that were reviewed by Avalere included Roche’s Xeloda; Gleevec from Novartis; Bayer’s Nexavar; Celgene’s Revlimid; Pfizer’s Sutent; Roche’s Tarceva; Merck’s Temodar and GlaxoSmithKline’s Tykerb.

Source: PharmaLive.com's Pharmalot

Abandoning oral oncolytic prescriptions at the pharmacy: Patient and health plan factors influencing adherence.

Sub-category: Health Services Research
Category: Health Services Research
Meeting: 2011 ASCO Annual Meeting
Abstract No: 6036
Citation: J Clin Oncol 29: 2011 (suppl; abstr 6036)

Author(s): L. S. Schwartzberg, S. B. Streeter, N. Husain, M. Johnsrud; The West Clinic, Memphis, TN; Avalere Health, Washington, DC
Abstract:

Background:

Oral oncolytic agents are an increasingly important component of cancer therapy. Adherence with therapy begins with filling the prescription in a timely manner. Little is known of the factors associated with abandonment of oral oncolytics at the initial or subsequent prescription.

Methods:

This cross-sectional study analyzed a nationally representative pharmacy claims database and identified 10,508 Medicare and commercial patients initiating oral oncolytic therapy between 2007 and 2009. We calculated the rate of abandonment of the initial claim, where abandonment was defined as the reversal of an adjudicated pharmacy claim without a subsequent paid claim for any oncolytic (oral or IV) within the subsequent 90 days. The likelihood of abandonment was assessed using bivariate and multivariate logistic regression analyses including patent demographic factors, plan type, drug type, cost-sharing and number of other prescriptions.

Results:

The abandonment rate of newly initiated oral oncolytic agents was 10.0%. Unadjusted bivariate analyses found that high cost-sharing, larger prescription burden, lower income, and Medicare coverage were associated with a higher abandonment rate (p<0.01). Our logistic regression model found that as both cost-sharing and concurrent prescription use rose, there was a significantly higher likelihood of abandonment. Claims with cost-sharing over $500 were 4 times more likely to be abandoned than claims with cost-sharing of $100 or less (OR=4.46, p<0.001). Medicare patients were more likely to have cost-sharing over $500 than patients with commercial plans (p<0.001). Patients with 5 or more prescriptions in the previous month had 50% higher likelihood to abandon than patients with no prescription burden (OR=1.50, p<0.001).

Conclusions:

Abandonment of newly prescribed oral oncolytic therapy is not uncommon, and the likelihood increases for patients enrolled in plans with pharmacy benefit designs that require high cost sharing. Higher prescription burden was also associated with a larger abandonment rate. These factors should be taken into account when considering likely adherence to cancer therapy.
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Old 05-28-2011, 01:30 PM
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Default Oncologists Hold Key To Curbing Cancer Costs

The cost of cancer care is threatening to bankrupt our healthcare system. New drugs are prolonging life, but at staggering costs. This coupled with aging baby boomers and an increasing population mean the U.S. will spend $173 billion annually on cancer care by the year 2020. This trend is not sustainable; however, there are evidence-based ways to maintain or improve the quality of care while saving money for the new therapies being discovered every day.

So argue VCU Massey Cancer Center researchers Thomas Smith, M.D., and Bruce E. Hillner, M.D., in an article in The New England Journal of Medicine, in which they present 10 changes medical oncologists can do to flatten costs, maintain or improve care and save money for future medical advances. Smith is a nationally recognized oncologist and Endowed Chair of Palliative Care Research at VCU Massey Cancer Center, and Hillner is a professor and eminent scholar in the Department of Internal Medicine at the VCU School of Medicine and member scientist at VCU Massey Cancer Center.

In a challenge to their colleagues one week before the annual meeting of the American Society of Clinical Oncologists (ASCO), the authors suggest changes in the behaviors and attitudes of medical oncologists that could save the nation billions of dollars.

"First, we take curative care and clinical trials off the table. They are vital to advances and save lives," says Smith. "However, we must critically examine our current practices for ways to reduce costs in order to maintain quality cancer care for all of our patients while continuing to advance medicine. This raises difficult issues that impact physician income and requires a new level of open and honest communication between doctors and patients. But the longer we wait to address these issues, the worse it will be for future patients."

The authors focus on the treatment of patients with incurable solid tumors, and many of their recommendations reinforce current ASCO and National Comprehensive Cancer Network (NCCN) evidence-based guidelines. Some of their proposals call for more frank discussions about end-of-life care between physicians and patients, and others urge increased scrutiny when using expensive treatments and surveillance tests. They argue that by establishing these guidelines, oncologists would be less likely to continue treatments in situations where the treatments no longer beneficial for the patient.

"It is important that we are compassionate and honest with our patients about when continuing chemotherapy causes more harm than good," says Hillner. "Two simple but critically important points: we should stop routinely giving chemotherapy to patients who are so weakened by the disease that they cannot walk unaided into the clinic. And when the cancer has grown through three successive regimens, it is time to switch teams and use hospice. Research has shown that for patients in these situations it is highly unlikely that continued chemotherapy will prolong life."

The authors suggest the following changes in oncologists' behavior:

- Limit surveillance testing or imaging to situations in which a benefit has been shown.

- Limit second-line and third-line treatment for metastatic cancer to sequential single-agent chemotherapy for most solid tumors.

- Limit chemotherapy to patients with good outcomes, with an exception for highly responsive disease.

- In metastatic solid cancers, replace the routine use of white-cell-stimulating factors with a reduction in the chemotherapy dose.

- For patients who are not responding to three consecutive regimens, limit further chemotherapy to clinical trials.

The authors suggest the following changes in oncologists' attitudes and practice:

- Recognize that the costs of care are driven by what we do and do not do.

- Set more realistic expectations both for doctors and patients.

- Realign compensation to value cognitive services, rather than chemotherapy, more highly.

- Better integrate palliative care into usual oncology care (concurrent care).

- Accept the need for cost-effective analysis and for some limits on care.

"Our recommendations redefine current oncology practices, and we recognize that these raise tough questions," says Hillner. "But now is the time to talk about how we can preserve money to ensure all patients receive the best available care while setting aside funds for new and advanced therapies. We have outlined the starting points for discussion and hope a much-needed national dialogue will follow."

Source:
VCU Massey Cancer Center
VCU Medical Center

Earnings Are Down but Oncologists Still Do Well

[url]http://www.medscape.com/viewarticle/804366
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Old 05-28-2011, 01:31 PM
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Default How to Lower Cancer Care's Costs?

It looks like Smith and Hilner have taken up the challenge by creating a top five list of common oncology practices, which if limited to situations where they are truly clinically useful, would sharply lower the cost of cancer care. In many cases, the cost-effectiveness ratios far exceed commonly accepted thresholds, according to Merrill Goozner, of The Fiscal Times. Goozner also wished they had addressed the issue: Why are cancer drugs of marginal efficacy so expensive? Why does a drug that extends life by a month or two cost $5,000 to $10,000 a month for the last year or two of a patient's life, thus adding up to a quarter million dollars to the cost of end-of-life care?

The challenge facing pharmacogenetics – the study of genetically determined variations in responses to drugs in humans – is the number and complexity of interactions a drug has with biological molecules in the body. Variations in many different molecules may influence how someone responds to a medicine. There is a great degree of variation in how people absorb drugs. Individuals have different levels of enzymes in the intestines and liver that breaks down drugs before they even have the chance to get into the bloodstream.

Teasing out the genetic patterns associated with particular drug responses could involve some intricate and time-consuming scientific detective work. Unfortunately, the introduction of these new drugs has not been accompanied by specific predictive tests allowing for a rational and economical use of the drugs. However, there are a number of laboratory tests that are better able to predict the ability of targeted drugs, to produce positive clinical responders (outcomes). To exploit the full potential of targeted anticancer therapies, physicians need laboratory tests that actually match patients to specific drugs.

No pharmaceutical company relishes turning over sizeable pieces of profitable business because a diagnostic test suggests it should. An article in Pharmaceuticalcommerce.com, Drew Fromkin, CEO of Clinical Data warned us that drug makers must drive growth, revenue, and profitability, and personalized medicine runs against their prevailing business model. But many realized that personalized treatments were inevitable and tried to find their way within a new paradigm.

In cancer medicine, that new paradigm established a requirement of a companion diagnostic as a condition for approval of these new targeted therapies. However, it put such great pressure that the companion diagnostics that were approved often had been mostly or totally ineffective at identifying clinical responders to the various therapies. That is because genomics are far too limited in scope to encompass the vagaries and complexities of human cancer biology.

However, Fromkin believed that the impetus for personalized medicine would come from payors, not drug firms. Insurers were paying for drugs that do not provide value, and have been desperate to eliminate the shotgun approach to cancner medicine. But how would drug companies respond when these tests show their drug to be highly effective, but only in 11% of the potential patient population? What can medicine offer patients whose test results suggest no medicine will help?

A $1.5-billion-a-year drug is a blockbuster. Five $300-million drugs, taken together, do not add up. Unless the costs for developing a $300-million new chemical entity can be harmonized with the expected financial return, no one will develop such drugs. Charging significantly more for targeted therapies will work only to a point.

Unfortunately, the introduction of these new drugs has not been accompanied by effective genetic predictive tests allowing for a rational and economical use of the drugs. Pharmacogenetics is not going to transform the market any time soon. However, given the technical and conceptual advantages of Oncologic In Vitro Chemoresponse Assays, together with their performance and the modest efficacy of therapy prediction based on analysis of genome expression, there is reason for a renewal in the interest for these pre-tests for optimized use of medical treatment of malignant disease.

More help navigating end-of-life options can improve care for dying patients.

[url]http://bostonglobe.com/opinion/2012/06/14/more-help-navigating-patients-life-options-reduce-improve-care-costs-dying-patients-and-reduce-costs-how-improve-care-for-dying/2dTAnmpRLQ3Y7vB3770MMO/story.html
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Old 05-28-2011, 11:11 PM
gdpawel gdpawel is offline
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Default Pharmaceutical Development: The Critical Path from Bench to Bedside

According to an analysis conducted by Tufts University, it requires 11 years and nearly $1 billion to take a drug from concept to FDA approval (1). A substantial portion of these expenses occurs in late stage development, during Phase II and III clinical trials. Yet, half of the new drugs that show evidence of activity and safety in earlier phases fail at the Phase III clinical trial level (2).

In response, the pharmaceutical industry has dedicated hundreds of millions of dollars to study human biology and personalized medicine. Yet, virtually all of these resources are being expended in the field of genomics. While the analysis of gene expression, mutation, amplification and SNPs can provide useful information and prognostic tools, virtually no gene expression profile can connect an individual patient to an active treatment. Genomic platforms cannot adequately interrogate the complexity, redundancy and indiscriminant nature of human tumor biology.

To address these needs, we have applied “functional profiling,” a platform that captures the complexities of human tumor biology at the level of the cellular phenotype.

Functional profiling conducted on human tumor samples utilizes native microspheroids replete with vascular, stromal and inflammatory cells to analyze cellular responses in the context of the tumor microenvironment. This snapshot of cellular response recapitulates patient response to cytotoxic compounds, signal transduction inhibitors and growth factor antagonists in real time.

Having proven the capacity of this platform to predict the activity of drugs like 2-CDA (3), the Gemcitabine plus CDDP combination (4) and the EGFr antagonists (5), Rational Therapeutics is actively engaged in the study of the newest classes of compounds, which target a wide variety of cellular signaling pathways.

The Rational Therapeutics Ex-Vivo Analysis – Programmed Cell Death (EVA-PCD) platform offers the pharmaceutical industry the opportunity to conduct Phase II trials in the laboratory. By streamlining the path from promising compound to clinically active therapy, the EVA-PCD platform has the capacity to substantially reduce the cost of drug development and shorten the development cycle by years. Our most precious resource *— our patients — should never be exposed to drugs and combinations until they have been thoroughly vetted in the laboratory setting. With almost 20 years experience we are qualified and well-positioned to explore novel uses of the newest agents.

1.Tufts University, Drug Development Cost Analysis, 2001
2.Roberts TG, The Phase III Trial in the Era of Targeted Therapy: Unraveling the “Go or No Go” Decision, J Clin Oncol 21 (19), 2003
3.Nagourney RA et al, British Journal of Cancer, 1993
4.Nagourney RA, Deoxynucleoside Analogs In Cancer Therapy, (ed) G Peters, Human Press, 2006
5.Nagourney, RA, et al Functional Profiling of Human Tumors In Primary Culture: A Platform for Drug Discovery and Therapy Selection: Proc AACR, 2008
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