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Old 09-30-2011, 03:54 PM
gdpawel gdpawel is offline
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Default Is Rationed or Rational Medical Care In Our Future?

[Dr. Nagourney is medical and laboratory director at Rational Therapeutics, Inc., in Long Beach, California, and an instructor of Pharmacology at the University of California, Irvine School of Medicine. He is board-certified in Internal Medicine, Medical Oncology and Hematology.]

We are witness to a sea change in medicine. Doctors and nurses are being replaced by “healthcare providers;” medical judgment is being phased out in favor of therapeutic algorithms; and the considered selection of treatments is giving way to rigid therapy guidelines. All the while, the regulatory environment increasingly precludes the use of “off label” drugs. It is understandable why insurers, governmental entities and hospital chains might welcome these changes. After all, once therapies have been reduced to standardized formulae, one can predict costs, resource allocations and financial exposures to the twentieth decimal place. For many medical conditions, these approaches will provide adequate care for the majority of patients.

But, what of the outliers? What of those complicated disease entities like cancer, whose complexity and variability challenge even the best minds? How do we bang the round peg of cancer therapy into the square hole of formulaic care?

There are several answers. The first is the least attractive: In this scenario, predicated upon cancer’s incidence in an older population, at the end or beyond their productive (and reproductive) years, we simply don’t allocate resources. Most civilized modern societies haven’t the stomach for such draconian measures and will seek less blunt instruments.

The second is a middle of the road approach. In this scenario, standardized guidelines that provide the same treatment to every patient with a given diagnosis are developed. Every medical oncologist knows the drill: FOLFOX for every colon cancer, Cytoxan plus Docetaxel for every breast cancer and carboplatin plus paclitaxel for ovarian cancer. The treatments work adequately well, the schedules are well established, the toxicities are well known and no one is cured. The beauty of this approach is that the average patient has an average outcome with the average treatment. By encompassing these regimens into standardized algorithms, we may soon be able to eliminate physicians entirely — first, with nurse practitioners and physician’s assistants and, ultimately, with computers. What is perhaps most surprising about this scenario has been the willingness of the medical oncology community to embrace it, a sort of professional self-induced extinction. At the time of this writing, this is the predominant model and is becoming increasingly entrenched under the auspices of NCCN and related guidelines. The operative term being guidelines, in as much as these “guidelines” are rapidly becoming “dictates.”

The final approach, and the one I find most appealing, is that which utilizes the clinical, scientific, laboratory and technical acumen of the physician to the maximum. Combining diagnostic skill with scientific insight, the physician becomes the captain of the ship, who must assume control from the autopilot once the vessel has entered the tempest and use his/her experience and training to guide the patient to a soft landing. This requires the capacity to think and demands an up-to-date knowledge of many disciplines. The judicious application of laboratory-directed approaches can further enhance the skillset, introducing objective data that is then used to guide drug and treatment selections. Predicated upon an understanding of the patient’s tumor biology, cancer therapy becomes an intellectual exercise that draws upon literature, and a knowledge of pharmacology and physiology. Adding the wealth of newly developed signal inhibitors to the mix only enhances the odds of a good outcome.

This approach improves responses and eliminates futile care. It provides patients the opportunity to participate in their own management. Correctly delivered, it would make available to every patient any FDA-approved drug. While it would seem to some that this would open the floodgates of drug use, I would strenuously disagree. It would instead limit drug administration to those patients most likely to respond, a goal currently pursed by virtually every major institution, yet accomplished by none. While a handful of targeted approaches have come to fruition in the last few years — erlotinib for EGFR mutation, and sunitinib in kidney cancers — most of the molecular profiling being done today doesn’t aid in the selection of therapy but instead provides negative information (e.g. RAS in colon cancer, ERCC1 over expression in lung) enjoining the physician against the use of a given agent but then leaving the unfortunate patient to fend for themselves amidst a panoply of randomly chosen options.

This is the approach that I have chosen to adopt in my own care of cancer patients. Our rapidly growing successes in ovarian, breast, lung, melanoma, leukemias and other diseases could and should serve as a model for others.

Is it a harbinger of the coming conflict between patients-in-need and society's capacity to cover the increasing costs of cancer?

Among the more interesting discoveries in recent years have been two breakthroughs in the management of malignant melanoma. One drug, vemurafenib, a tyrosine kinase inhibitor, acts specifically in patients who carry the BRAF (V600E) mutation. The second drug ipilimumab, offered as Yervoy, is a monoclonal antibody that acts by blocking CTLA-4, thereby enhancing T-cell response to tumor antigens. While venurafenib has a somewhat narrow target population, ipilimumab targets may extend to a broader range of melanoma patients and will likely find a role in other cancers.

The data supporting ipilimumab’s use in advanced melanoma was reported in a 2010 Phase III trial, which provided a superior median survival for those treated with the drug over those who received a placebo. Superior one and two-year survivals were also reported. Unfortunately, this did not rise to the level that met the standards the National Institute for Health and Clinical Excellence (NICE). The chief executive of NICE did admit that the drug could “potentially be very effective for a small percentage of patients.” Unfortunately, under current NICE guidelines, that small percentage of patients will not have access to the drug.

This is not the first time that a drug, found effective for the treatment of a subpopulation of patients has been denied approval based upon cost efficacy and the comparatively limited population of patients who stand to gain.

The role of Avastin in breast cancer represents a similar dilemma for those patients who might benefit but cannot afford the out-of-pocket expenses. Indeed, NICE originally denied approval to bortezomib, a highly active drug for the treatment of multiple myeloma, based upon similar cost considerations.

What ipilimumab, Avastin and bortezomib have in common is that they are harbingers of the coming conflict between patients-in-need and society’s capacity to cover the increasing costs of cancer therapy. Cost efficacy questions will only be resolved when we have the capacity to identify likely responders prior to therapy, enabling us to use drugs only in those patients with the highest expectations of response. Marginal overall benefits that come at high price will continue to fail until we redouble our efforts to refine the process of drug selection for individual patients.

Janet Woodcock, MD, from the FDA once said, that we need “a critical path” from bench to bedside to guide clinical decisions. The human tumor primary culture functional analyses that we employ can provide that critical path and we would hope limit the need for the broad-brush policy decisions that are being handed down by NICE and similar entities both here in the U.S. and abroad.
Gregory D. Pawelski

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Old 01-24-2012, 09:57 AM
gdpawel gdpawel is offline
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Default The High Price of New Cancer Drugs

Julie Grabow, an oncologist at the Fred Hutchinson Cancer Center in Seattle, recently prescribed an exciting new therapy for a 60-year-old woman with metastatic breast cancer. Three-and-a-half years into her battle against the disease, the patient had already exhausted three different anti-estrogen therapies, each of which only put a temporary check on the spreading tumors.

The newly prescribed drug, Novartis’ Afinitor, is one of the recently approved targeted therapies that have generated a lot of excitement among cancer patients and oncologists in recent years. Drugs that target just the cancer cells promise the same or better results as toxic chemotherapy, but with far fewer side effects.

There was a catch, though. Like many of the latest cancer drugs, Novartis is charging exorbitant amounts for the treatment – in this case, $10,000 per month. That quickly put an end to that possibility for Grabow’s patient. Her monthly co-payment, even after her insurance company agreed to pay its share of the off-label use the drug (the Food and Drug Administration has only approved Afinitor for kidney and pancreatic cancer, not breast cancer), was $2,900.

“She can’t afford this, even though it’s potentially a less toxic and potentially equally effective regimen,” Grabow said. “Chemo will help her, and it’s a reasonable choice. But that choice is 100 percent driven by economics.”

Over the past year, official Washington and candidates on the campaign trail have locked horns over the best way to curb rising health insurance costs. The public has been bombarded with dueling slogans – Republicans vowing to fight the “death panels” and “rationing” of Obamacare while Democrats promise “guaranteed access” and “affordability” with the Affordable Care Act.

But an economic drama that neither side wants to confront is playing itself out in cancer wards and oncologists’ offices across the country. Unaffordable new drugs, even when they’re covered by insurance, are being rationed by price as patients, doctors and hospital officials struggle with what is likely to be the most pressing problem for the nation’s health care system over the next decade: how to pay for the spectacular rise in the cost of cancer care, especially drugs and diagnostic tests.

“In the real world of private practice where most care is delivered, it would be a mistake to say rising costs haven’t affected care,” said Eric Nadler, a head, neck and lung cancer specialist at Baylor University Medical Center. A recent survey published in Health Affairs found a stunning 84 percent of oncologists say their patients’ out-of-pocket spending influences treatment recommendations.

The growing cost of cancer care will impose its greatest burden on the nation’s Medicare system, since 55 percent of all cancers are diagnosed in individuals 65 or older. A recent study by the National Cancer Institute projected the cost of treating the 29 most common cancers in men and women will rise 27 percent by 2020, even though incidence of the disease is going down due to successful public health campaigns like the war on smoking.

That estimate is based on a relatively static cost of care per case. If costs increase just 2 percent more a year than previous trends in the first and last years of care, the study said, then costs would soar to $173 billion, a 39 percent increase. The study pointed out that its projections were based on 2006 Medicare claims data, which predated the development of most of the latest targeted therapies.

There’s no doubt that there will be many new therapies for cancer coming to market in the years ahead. The nation’s $150 billion public investment in understanding the biology of cancer – the science side of the War on Cancer launched by President Richard Nixon in 1971 – is beginning to bear fruit.

The pharmaceutical industry, which draws on that publicly funded science to develop drug candidates, now has 887 new cancer drugs in development, over 30 percent of its total portfolio of new drug candidates, according to the Pharmaceutical Research and Manufacturers of America, the industry trade group. That’s up from 646 or 26 percent of the total devoted to cancer in 2006.

The industry is pouring increased research and development resources in cancer therapeutics in hopes that it will replace the revenue being lost from the expiration of patents on blockbusters like Lipitor. However, since there are fewer cancer patients than there are people with chronic conditions like elevated cholesterol, and many don’t live very long, the prices needed to support the industry’s current size and structure, and profits must be substantially higher.

“They’re trying to maximize profits given their incentives,” said Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, which receives funding from the drug industry. Possible solutions, he said, include letting Medicare set prices based on the medical value of adding extra months to life. That’s a variation on Great Britain’s cost-effectiveness model, which has been roundly condemned by most U.S. politicians and the press.

The other path is to turn to a bundled payment for every for every episode of cancer care and let the health care delivery organizations and private insurers sort it out. (Bundled payments account for all medical services associated with a given episode of care—doctors, nurses, technicians, etc.) That approach, in essence, would force the marketplace to execute the rationing.

“Bundled payment isn’t a panacea, but it does create incentives,” Neumann said. Some private insurers are experimenting with bundled payments for cancer care.

A quick review of the new cancer drugs approved by the Food and Drug Administration last year reveals how fast drug prices are rising. Most of the older chemotherapy regimens for cancer, some of which have been around since the 1950s, are generic and relatively inexpensive. But among the six new drugs approved in 2011, the cheapest – Johnson & Johnson’s Zytiga for advanced prostate cancer – cost $44,000 a year. The drug extended life by an average of less than 5 months to 16 months, according to a company spokesperson.

At the high end of the spectrum was Adcetris, a biotech product from Seattle Genetics that treats recurrences of Hodgkin’s lymphoma. A highly curable disease when initially treated in the 8,830 mostly middle-aged patients who get the disease every year, it is usually fatal if a drug-resistant strain emerges later in life. Adcetris, the first new treatment to come along since 1977, kept the cancer in check for nearly 7 months in the single small trial that led to its quick FDA approval. It’s price tag: $216,000 for a full course of treatment.

Skin cancer specialists had a lot to cheer about in 2011 with two new therapies coming on the market for metastatic melanoma, which is fatal within one year for about 75 percent of the 10,000 people stricken each year. But Roche/Genentech’s Zelboraf cost $61,400 a year and Bristol-Myers Squibb’s Yervoy, which nearly doubled the one-year survival rate from 25 percent to 46 percent, cost $120,000 for a four-month course of treatment.

“We price our medicines based on a number of factors including the value they deliver to patients and the scientific innovation they represent,” said Sarah Koenig, a spokeswoman for Bristol-Myers. “We have one of the most robust patient assistance programs for cancer patients in the industry.”

Most drug companies have patient assistance programs for poor or struggling patients, but many only come into play if patients are poor or families have exhausted their savings. And since many of the latest therapies, like the older chemotherapies they are replacing or supplementing, extend life for brief periods of time, patients wind up weighing whether they want to deplete their children’s inheritances for a couple extra months of being very, very sick.

A study released at last June’s annual conference of the American Society of Clinical Oncology, which represents the nation’s 25,000 oncologists, revealed that patients with co-payments over $500 a month were four times more likely to refuse treatment than those whose co-payments were under $100 a month. “The price of drugs can’t be set so outrageously high,” study author Lee Schwartzberg told Reuters. Schwartzberg is the chief medical officer at Acorn Research, which conducted the study.

“All stake holders have to get together and compromise to translate this great science into great patient care without breaking the bank.”

Source: Gooznews

Gregory D. Pawelski

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Old 10-15-2012, 12:13 PM
gdpawel gdpawel is offline
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Default Curbing Overpriced Treatments for Cancer Care

Top health care experts meeting at the Institute of Medicine last week delivered a stern message to the nation’s 15,000 oncologists and their patients: Either learn to deliver care at lower costs or watch the government and insurance companies impose limits.

“If you think this is a tough reimbursement environment, just wait a year or two,” said Mark McClellan, who headed the Centers for Medicare and Medicaid Services during the George W. Bush administration. “Leadership is needed to show how to get to better care on a more sustainable fiscal path.”

The sentiment was echoed by Ezekiel Emanuel, an oncologist and top adviser to the Obama administration during the battle to enact the Affordable Care Act, which imposed a first round of payment restrictions on Medicare providers. “We can never get too much cost control,” he said. “There’s $700 to $800 billion of waste in the health care system. We have a long way to go.”

Oncology has become a focal point in the health care cost control debate because its claims are rising faster than other specialties. New drugs coming on the market, many of which only extend life for a month or two, now cost $100,000 a year or more. They have become a major driver of rising cancer care costs, especially when used in terminally-ill patients nearing the end of life.

A top official from UnitedHealthcare, the nation’s largest insurer, told the forum reimbursement for cancer care now accounts for 12 percent of all payments for patients not on Medicare and Medicaid. That’s up from 10 percent five years ago. Cancer care has now pulled even with cardiovascular care as the insurer’s biggest expense.

The company’s fastest growing expense within cancer care is drugs, which continue to rise at about 10 percent a year. While drug costs are about 10 percent of all health care costs, according to CMS, they account for about a quarter of all cancer care costs.

“There is no market. It is sellers dictating the price when a new drug comes out,” said Lee Newcomer, chief oncologist at UnitedHealthcare. “I don’t have a substitution effect I can enforce because just about every state in the nation requires that I pay for the latest drugs.”

With 80 to 85 percent of the 1.64 million Americans who get diagnosed with cancer every year receiving their treatment at community-based oncology practices, the IOM meeting focused on potential changes in those settings that might lower costs. Most practices pay the bills by selling chemotherapy treatments and charging Medicare and insurers a mark-up on the wholesale cost of the drugs – 6 percent in the case of Medicare and 20 to 40 percent for private insurers, according to one community oncologist at the meeting.

UnitedHealthcare has an experiment underway that would get rid of the cost-plus model because it provides a powerful incentive for oncologists to use not only more drugs, but the most expensive drugs. It has signed contracts with five community practices where the insurer now pays for drugs directly while the oncologists get paid extra for adhering to agreed-upon treatment strategies and drug regimens that clinical practice guidelines say will deliver the best outcomes. The approach not only eliminates the incentive to prescribe more drugs, it eliminates variations in care that provide no benefit or, in some cases, cause harm.

“We need standard approaches,” Newcomer said. “Where we can shift to the less expensive therapies that have no difference in outcomes, we should do that.”

Peter Bach, an oncologist at Memorial-Sloan Kettering Cancer Center in New York and former CMS official, offered an alternative model. He suggested Medicare and insurers could shift to a system where oncologists are paid for episodes of care – a bundled payment – rather than fees for the various services. Besides eliminating the incentive to order duplicative or unnecessary tests, imaging and office visits, it encourages physicians to use the most cost-effective chemotherapy regimens that deliver comparable results.

Bach cited the example of the initial chemotherapy regimen for patients diagnosed with lung cancer, which will account for 226,000 or 14 percent of all new cancer cases this year. Lung cancer, which is caused by smoking in about 80 percent of cases, is still America’s number one cancer killer.

There are seven approved chemotherapy regimens for the first round of treatment, which range in price from less than $1,500 to over $7,000. The guidelines produced by the National Comprehensive Cancer Network, which brings together experts from across the country to evaluate best practices, say there is no material difference in outcomes between the various regimens, although they do have different side effect profiles.

By having the bundled price for the episode include the average price of the different possible regimens, oncologists will be incentivized to use the lower-priced drugs. “Episode-based payment is all about shifting risk,” Bach said. “It puts the provider – the oncologist – at risk for performance. This is very different from fee-for-service, where the only risk is if someone doesn’t pay you.”

In his keynote address, McClellan lauded the growth of accountable care organizations (ACOs) and bundled payment pilot projects set up under the ACA. He expressed hope that they would be rapidly expanded after the election.

“We don’t have five years to see if these work,” he said. When asked what would happen if Obamacare is repealed because Republicans win the White House and both houses of Congress, he said “I don’t see that going away. There has been past Republican support for ACOs and bundled payments.”


- Merrill Goozner

In 1995 oncology patients and their insurers paid $54,100 for an additional year of life, but by 2013 the price had jumped to $207,000, according to a study sponsored by the National Bureau of Economic Research.
Gregory D. Pawelski

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Old 10-15-2012, 12:14 PM
gdpawel gdpawel is offline
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Default Rational Or Rationing? Saying No To A Cancer Med

With all the talk of rising prices for cancer medications, the cost of healthcare and comparing the value and benefit of competing drugs, Memorial Sloan-Kettering Cancer Center has decided not to use a newly approved treatment for metastatic colorectal cancer. Specifically, the cancer center will not give patients Zaltrap, which is marketed by Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) (see this).

Why? The price tag. “The reasons are simple: The drug, Zaltrap, has proved to be no better than a similar medicine we already have for advanced colorectal cancer, while its price — at $11,063 on average for a month of treatment — is more than twice as high,” write three doctors from the cancer center in an opinion piece in The New York Times.


In explaining their case, they note that FDA, Medicare and organizations that set physician guidelines pay attention to effectiveness; private insurers then follow suit, since they are expected to be held to the same standard. “Ignoring the cost of care, though, is no longer tenable,” they write, adding they feel obligated to consider financial strains that result.

“This is particularly the case with cancer, where the cost of drugs, and of care over all, has risen precipitously,” they continue. “The typical new cancer drug coming on the market a decade ago cost about $4,500 per month (in 2012 dollars); since 2010 the median price has been around $10,000. Two of the new cancer drugs cost more than $35,000 each per month of treatment.”

“In 2006, one-quarter of cancer patients reported that they had used up all or most of their savings paying for care; a study last year reported that 2 percent of cancer patients were driven into bankruptcy by their illness and its treatment. One in 10 cancer patients now reports spending more than $18,000 out of pocket on care,” they continue.

As for Zaltrap, they explain that the drug offers the same survival benefit as Roche’s Avastin, which has a similar mechanism of action. “When compared with the standard chemotherapy regimen alone, adding either medicine has shown to prolong patient lives by a median of 1.4 months. Major clinical practice guidelines, like those from the National Comprehensive Cancer Network, agree that Zaltrap is no better than Avastin in this setting,” they write.

But Avastin offers some advantages – a monthly cost of $5,000, which is less than of the cost for Zaltrop, and it is takes less time to administer, while side effects are roughly equal. They then note that “an older colorectal cancer patient without extra insurance would have to pay more than $2,200 out of pocket for a month’s treatment with Zaltrap.”

The problem, they say, is that the “medical culture equates new with better, which can make a decision not to cover Zaltrap seem out of step. And they then complain that “political rhetoric today is similarly slanted. Our refusal to adopt this remarkably expensive therapy risks being labeled rationing, not rational.”

They recognize that the decision may not have any meaningful effect, given that health care spending is so high and Zaltrap sales in the US are expected to amount to 0.005 percent of all dollars spent on health care next year. “But it is a step in the right direction — one of many we need to take,” they conclude.

Such sentiments are hardly uncommon these days, but they note that the rhetoric over health care explains why the Affordable Care Act precludes Medicare from changing its coverage or payment amounts based on cost comparisons. Comparative effectiveness has become a nasty phrase in some quarters and few insurers are willing to openly discuss the issue.

- Ed Silverman

OIG finds widespread Herceptin overcharges

The government's ongoing probe of hospitals and physicians overbilling Medicare for the breast-cancer drug Herceptin found errors in more than three-quarters of all claims that it audited.

Three audits released recently by HHS' inspector general's office concluded many providers have been billing Medicare for full multiuse vials of the drugs when patients actually needed only some smaller portion. Medicare doesn't pay healthcare providers for any part of the drug that is discarded because Herceptin from opened multiuse vials can be preserved for up 28 days and used in other patients.

For example, 85% of the 1,073 Herceptin vials used between 2008 and 2010 (PDF) in Ohio and Kentucky were billed incorrectly, a recent audit found. Auditors recommended recouping the $1.2 million spent on the drugs for those cases.

CGS Administrators, the Medicare contractor that processes claims in those states, acknowledged the errors and said it would reconcile and recoup all overpayments. The company, a subsidiary of Blue Cross and Blue Shield of South Carolina, said in written comments that it has already administered a program to correct future overpayments and has posted a note about it on its website.

In Florida, HHS auditors found overcharges in 78% of bills for 1,330 vials of Herceptin (PDF) submitted to the local contractor, totaling $1.3 million in overpayments to providers. First Coast Service Options—a subsidiary of Blue Cross Blue and Shield of Florida—said in written comments in the audit that it is now auditing healthcare providers' Herceptin claims for certain doses before it will pay the bills as Medicare intermediary.

And in the Medicare jurisdictions covering Illinois, Indiana, Michigan and Wisconsin, the government auditors found that 78% of 713 claims investigated were incorrect (PDF), totaling $682,000 in overpayments. Administrative contractor National Government Services, a subsidiary of WellPoint, said providers in those regions have since been warned that they must verify claims for certain dosages of Herceptin before bills will be paid.

Three reports last year (PDF) on use of the drug in other jurisdictions found similarly high rates of errors by healthcare providers that were not corrected before Medicare bills were processed by the local administrative contractors.

Gregory D. Pawelski

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Old 01-23-2013, 01:02 PM
gdpawel gdpawel is offline
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Default What is the goal of doing economic analysis of new cancer treatments?

Bernardo Goulart, M.D.
Affiliate Investigator, Clinical Research Division, Fred Hutchinson Cancer Research Center. Acting Instructor, University of Washington School of Medicine.

The goal is to provide information that will assist health organizations make important decisions about the use of new cancer therapies, assuming that all healthcare systems operate on a fixed budget. In other words, every healthcare system has to decide what treatments they will be able to provide to patients using a limited and fixed amount of money. Trade-off decisions are often necessary in this setting, including cancer. Economic evaluations of cancer therapies represent one tool to make informed trade-off decisions when it comes to new cancer interventions, including cancer drugs.

These decisions may include, for example, adopting or not a new treatment. Other decisions may relate to resource allocation (how much money is necessary to provide patients with coverage for a new drug). Another important type of decision is prioritization: suppose an organization has to decide about how to cover treatments for different diseases, but the limited budget forces the organization to prioritize one disease first. Economic analysis of cancer therapies can assist organizations make all these tough decisions as it applies to cancer therapies by informing them which of the therapies are more cost-effective (i.e., provides the best health outcomes for the money spent).

Many different types economic analysis exist, the most common being cost-effectiveness analysis (CEAs). CEAs consist of an explicit measurement of additional costs and additional health benefits provided by a new treatment, let’s say, a new cancer drug. By definition, all CEAs must include a comparator, i.e., a drug treatment alternative against which the new drug will be compared. In conducting a CEA of a new cancer drug, investigators use data from multiple sources, including clinical trials and databases, to estimate the additional benefits offered by the new drug compared to the alternative drug. In addition, investigators have to obtain data to estimate the additional costs that result from using the new drug compared to the alternative drug. By additional costs, we should consider not only the costs of acquiring the drugs, but also the costs of treating drug side-effects, costs of treating the cancer when the drugs stop working (i.e., second-line therapies), and costs of end-of-life care in the case of advanced cancers. Some analyses also include the indirect costs of treatment, including, for example, costs associated with loss of work productivity that result from treatment.

Cost studies represent the second most common type of economic evaluations. These are simpler analyses that focus only on the costs of a new treatment, and do not consider the health benefits. Cost studies are helpful to determine the direct impact of a new cancer drug on the budget of a healthcare system. A typical cost study estimates the net costs of a treatment, which consist of the costs of treatment implementation minus the costs of illness (COI). Other cost studies only describe the costs of illness and are also called Burden of Disease studies. Some cost studies only evaluate the costs of treatment implementation. Costs of treatment implementation may or not include a comparator (i.e., costs of drug A vs. drug B).

Below is a list of commonly used economic evaluations in healthcare, including cancer:

• Cost-effectiveness analysis (CEAs)
• Cost-Utility analysis (CUAs).
• Cost-Benefit analysis (CBAs - yes, this is different than CEAs).
• Cost-minimization analysis.
• Cost-consequence analysis.
• Cost Studies (Net cost studies, Burden of disease studies, treatment cost studies).

In a cost-effectiveness analysis (CEAs) of a new cancer treatment, we must compare both the costs and the health outcomes of the new treatment (say drug A) against the best known alternative (drug B). The investigator needs to estimate the lifetime additional benefits of drug A versus drug B, and the lifetime additional costs of drug A versus drug B. Typically, we need to obtain data from multiple sources to estimate these costs and benefits, including, for example, survival and quality of life outcomes from randomized clinical trials, non-randomized trials, or retrospective studies. For costs, we need to know the unit price for all medical resources that are utilized as part of treatments with drugs A and B. These not only include the price of the drugs themselves, but also the unit prices for all medical tests, procedures, and medical visits that go along with the treatment (e.g., CT scans, blood tests, use of nausea pills, visits to the doctors, etc.). Once we know the unit costs for all these utilized services, we multiply them by the frequency that these services are provided over the lifetime of patients and obtain the total costs of treatments A and B.

Because most sources of data provide information over a limited period of time, we often have to use decision modeling techniques to project lifetime costs and outcomes. In decision analytic models, we use the data available to project future costs and outcomes over the lifetime of patients. This usually requires us to make some assumptions regarding, for example, how long patients will live and how much medical resources they will consume beyond the point of time informed by the data sources. At the end of the process, we obtain the mean lifetime benefit of drug A versus drug B, and the mean lifetime total cost of drug A versus B. This allows the investigators to calculate the Incremental Cost-Effectiveness Ratio, which is the metric we use in CEAs to determine if a cancer drug is cost-effective. More on this in question 4.

After we complete a CEA and make a conclusion whether drug A is or is not cost-effective, we should publish these results and show them to health organizations, who would hopefully take this information into account when making decisions in regards to coverage for drug A. As a reminder, CEAs are only one tool in the decision-making process for drug coverage. By no means should these decisions rely entirely on a cost-effectiveness analysis. Many other issues deserve consideration when deciding about coverage for new cancer treatments, including the prevalence of the cancer, the availability of other treatment options, and equity issues, including the sociodemographic characteristics of the population affected by the cancer. At the policy level, all these issues need careful consideration for decision-making, and CEAs represent just one piece of information that can help in this process.

The key metric, when determing the cost effectiveness of a new cancer treatment, is the Incremental Cost-Effectiveness Ratio or ICER. The ICER consists of the difference in mean lifetime costs between the new treatment (drug A) and the best known alternative (drug B), divided by the difference in mean lifetime outcomes of drug A and B. Mathematically, the ICER is defined as follows:

ICER = (Cost of drug A – Cost of drug B) / (Outcome of drug A – Outcome of drug B)

Cancer Treatments Increase Patients' 'Financial Toxicity'

Costs of cancer drugs are not captured in clinical trials or required by the United States Food and Drug Administration (FDA) for approval (Meropol NJ, et al. J Clin Oncol. 2009;27(23):3868-3874).

Of the 12 drugs approved by the FDA for various cancer indications in 2012, 11 were priced above $100,000 per year (Kantarjian H. The price of drugs for chronic myeloid leukemia (CML); a reflection of the unsustainable cancer drug prices: perspective of CML experts. Blood. April 25, 2013;doi 10.1182/blood-2013-03-490003).

Just as research has focused on limiting the physical toxicity resulting from treatment, future research should focus on mitigating the negative effects of financial toxicity without affecting disease-related outcomes.

In a two-part article in Oncology, S. Yousuf Zafar, MD, MHS, and Amy P. Abernethy, MD, of the Duke Cancer Institute, Durham, NC, described the patient-level impact of the cost of cancer care, what is called ‘financial toxicity,' with data having identified both objective financial burden and subjective financial distress as key components of financial toxicity.

They wrote, “most of us have not considered financial distress in the same vein as chemotherapy-induced toxicity, nor do we have the training to alleviate that distress.” However, “out-of-pocket expenses related to treatment are akin to physical toxicity, in that costs can diminish quality of life and impede delivery of the highest quality care.”

Gregory D. Pawelski

Last edited by gdpawel : 05-22-2013 at 02:27 PM. Reason: additional info
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Old 01-23-2013, 01:04 PM
gdpawel gdpawel is offline
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The question then becomes: what is the outcome of interest? This is a source of continuous and heated debates, but at least two outcomes are accepted by most health economists. The first is life expectancy (or Life-Years as some may refer to), which consists of the mean survival associated with drugs A and B, respectively. Most people would agree that a cancer drug is beneficial if it prolongs life expectancy. However, life expectancy does not inform anything about the quality of life that patients experience under treatment with drugs A or B. In addition, drug A may conceivably improve quality of life when compared with drug B, even if it does not improve life expectancy. Many people could see value in this quality of life again, even in the absence of a survival benefit. To address the limitation imposed by using life expectancy as the outcome measure in CEAs, health economists in the UK developed another metric called Quality-Adjusted Life Years or QALY. QALY is a bi-dimensional metric that incorporates both life-expectancy and quality of life information into one variable. One component of QALY is survival, and the other is health-related quality of life, also called utilities. Utilities area measures of how patients (or the population) value living in a certain disease state. This value ranges from 0 (death) to 1 (perfect health). To calculate a number of QALYs for a patient population, we multiply the mean life expectancy (in years) by the mean utility score. One QALY equals one year of life at perfect health (1 year X utility of 1), but one QALY also equals two years of life with some impact in quality of life (in this case reflected by anutility of 0.5; 2 years X 0.5 = 1 QALY).

To understand how we calculate total costs for drugs A or B, refer to the answers for Questions 2 and 3. Once we have estimated the outcomes as Life-Expectancy (Life-Years) or QALYs, we can re-define ICERs as follows:

ICER = (Cost of drug A – Cost of drug B) / (LIFE-YEARS of drug A – LIFE-YEARS of drug B)


ICER = (Cost of drug A – Cost of drug B) / (QALYs of drug A –QALYs of drug B)

Of note, the use of QALYs has become more popular in the past 15 years, since it takes into account both survival and quality of life. Most health economists use the term Cost-Utility Analysis (CUA) when the outcome of interest is QALY. This is more of a semantic difference, since the methods of a CEA or CUA are essentially the same other than the use of QALYs versus Life-Expectancy.

Most health economists consider a treatment cost-effective when the ICER is $100,000 per LY or QALY gained or less. This means that a treatment will be cost-effective if, compared to the best alternative, the new treatment adds $100,000 dollars (or less) per additional QALY it provides in comparison with the alternative. This is certainly another area of controversy. Some argue that society would be willing to pay more than $100,000 dollars for 1 QALY if the disease affects a vulnerable segment of the population (e.g., the elderly). For advanced cancer, others argue that we should consider cost-effective a treatment that results in additional $250,000 (or less) for 1 QALY gained, suggesting that at least some members of society are willing to pay more for cancer treatments, even if the treatments will not result in cure. In addition, the threshold to define cost-effectiveness is country and health-system dependent. In the UK, a treatment is cost-effective if the ICER is £30,000/QALY or less.

Other outcome measures also exist, but are much less popular. For those who are interested, refer to the term Disability-Adjusted Life Years (or DALYs).

These models used to assign a dollar value or other metric to health outcomes typically consist of decision-analytic models. Decision analytic models stem from decision sciences as techniques to explicitly project costs and outcomes into the future, thereby allowing the comparison of lifetime costs and benefits (the later measured as life-expectancy or QALYs) for both a new treatment and a comparator or best known alternative. In general, the inputs for these models include observed data from several sources about costs and outcomes of the new and alternative treatments, whereas the outputs are future projections of lifetime costs and outcomes for both the new and alternative treatments, under some assumptions.These projections then inform how much a new treatment will add in costs and benefits, compared to the alternative treatment.

Decision analytic models vary substantially in their complexity and skills required to conduct them. Examples of common decision analytic models include, in an increasing order of complexity:

• Decision Tree models.
• Markov models.
• Patient-level simulation models (or microsimulation models).
• Probabilistic models.

Some websites that are good resources for learning more about cost effectiveness of cancer treatments:

- International Society for Pharmacoeconomics and Outcomes Research (ISPOR) website: [url] This is the main website for all those involved with outcomes research and health economics. For those who want to become more familiar with the research methods used in economic evaluations, this is one rich resource. The language may be often too technical, but the information is accurate.

- National Institute for Health and Clinical Excellence (NICE) website: [url] The NICE website provides extensive information about the process to approve or adopt a new health technology, including cancer drugs. The website also explains how they use cost-effectiveness analysis in the process of recommending in favor or against the adoption of a treatment by the UK healthcare system.

- Wikipedia -

The organizations that decide whether a new cancer treatment is economically acceptable to society depends on the country or healthcare system. In the United States, federal law prohibits any public agencies from using economic evaluations to decide about coverage of any health treatments. As a result, no public agencies in the US decide whether a cancer treatment is cost-effective, including Medicare or the FDA.These agencies usually make coverage decisions based on evidence that a cancer treatment is both effective and safe.

Private insurances can and often do use economic evaluations to make coverage decisions of cancer therapies for their enrollees. Economic evaluations frequently inform private insurances about inclusion of a new drug in their formulary, drug co-payments, tiered systems, whether a drug will be covered for all enrollees or to a certain pre-specified group, whether pre-authorization is necessary, and how insurance premiums should increase as a result of covering new cancer treatments.

Other countries commonly use health economic evaluations to decide about coverage of new cancer treatments, including Great Britain, Australia, and Canada. These countries typically operate under government-funded healthcare systems, or “single-payer” systems. In order to rationally decide about how to allocate scarce resources, governments employ public independent agencies who in turn determine which cancer interventions are cost-effective and should be adopted at a national level. The classic example is the National Institute for Health and Clinical Excellence (NICE), which is an independent public agency that reports to the British National Health System (NHS).

Regardless of what agencies decide about the economic value of cancer therapies, all healthcare systems operate under a limited amount of money to pay for cancer treatments, or any disease treatments. However, all healthcare systems currently face escalating costs of cancer care. This trend in healthcare costs will have one unequivocal consequence. One way or the other, choices will be made, and societies will not be able to afford any treatments for any diseases at any given cost. If we pay $93,000 dollars per patient for a prostate cancer drug that increases survival by on average 4 months, soon enough we will run out of money to pay for a smoking cessation program that could prevent several lung cancer cases. This may be an over-simplistic example, but it does give a sense of the choices that we are now facing.
Gregory D. Pawelski
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Old 02-14-2013, 01:27 AM
gdpawel gdpawel is offline
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Default The 340B Drug Pricing Program

The 340B Drug Pricing Program required drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices.

The program enabled covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.

When a private oncology practice in Memphis formed a partnership with a nearby hospital in late 2011, the organizations proclaimed that the deal would “transform cancer care” in the region.

What they did not emphasize was that the deal would also create a windfall for them worth millions of dollars a year, courtesy of an obscure federally mandated drug discount program.

The program, known as 340B, requires most drug companies to provide hefty discounts — typically 20 to 50 percent — to hospitals and clinics that treat low-income and uninsured patients.

But despite the seemingly admirable goal, the program is now under siege, the focus of a fierce battle between powerful forces — the pharmaceutical industry, which wants to rein in the discounts, and the hospitals, which say they might have to cut services without them.

One issue is that the program allows hospitals to use the discounted drugs to treat not only poor patients but also those covered by Medicare or private insurance. In those cases, the hospital pockets the difference between the reduced price it pays for the drug and the amount it is reimbursed.

That is what happened in Memphis. When the West Clinic teamed with Methodist Healthcare, the huge volume of chemotherapy drugs used by the clinic suddenly qualified for the hospital’s discount, while reimbursement remained the same.

In a report issued on Tuesday, pharmaceutical industry trade groups say that some hospitals have gone overboard in using the program to generate revenue, straying from the original intent of helping needy patients. The report, which was supported by groups representing pharmacies, pharmacy benefit managers and oncology practices, called for the discounts to be more narrowly focused.

Some senior Republicans in the House and Senate are investigating the program, which they say has suffered from murky rules and lax enforcement.

“If ‘nonprofit’ hospitals are essentially profiting from the 340B program without passing those savings to its patients, then the 340B program is not functioning as intended,” Senator Charles E. Grassley, Republican of Iowa, said in letters sent to three medical centers last October.

One reason for the scrutiny is that the program — named after the section in the law that created it in 1992 — now includes one-third of the nation’s hospitals, triple the number in 2005. About $6.9 billion worth of drugs, or about 2 percent of the nation’s total, are sold through the program annually, reducing revenue for the pharmaceutical companies by hundreds of millions of dollars a year.

The industry report says sales could grow to $12 billion by 2016. That is in part because the nation’s new health care law will make more hospitals eligible for the discounts by increasing the number of Medicaid patients they treat, even as the need for the discounts should arguably diminish because fewer people will be uninsured.

Hospitals say 340B was never meant to merely provide cheap medicines to poor people. Rather, it was meant to help the hospitals that treat such patients, and to stretch federal resources. Making money from the spread helps keep the hospitals operating, which in turn helps needy patients, they say.

“If we didn’t have our 340B program, I seriously doubt we could have our outpatient cancer center,” said Burnis D. Breland, director of pharmacy at the Columbus Regional Healthcare System in western Georgia.

Nevertheless, with the program under scrutiny, the organization representing 340B hospitals, Safety Net Hospitals for Pharmaceutical Access, has warned its members to avoid using terms like “increasing profits” and “revenue enhancement.”

A 2011 report by the Government Accountability Office, the investigative arm of Congress, said that federal oversight of the program was insufficient to ensure that hospitals and drug companies were adhering to the rules.

In response, the Health Resources and Services Administration, which oversees the program using an annual budget of only $4.4 million, audited 51 hospitals last year, its first audits since the program began. It also made all hospitals recertify themselves as eligible for the program.

As a result, some 271 treatment sites belonging to 85 hospitals were ejected from the program, said Krista Pedley, the federal official in charge of the 340B program. She said that three hospitals acknowledged receiving discounts for which they were ineligible and were repaying manufacturers.

Some drug companies — Genentech is the only one that has publicly identified itself — are also auditing hospitals or considering doing so.

Previous studies have shown drug companies do not always offer the full discount, though no drug companies are being audited.

“Basically the pendulum has swung so aggressively toward oversight of the hospitals, with little concern about the drug companies,” said Ted Slafsky, president of Safety Net Hospitals for Pharmaceutical Access.

With so much money at stake, the 340B program has given rise to a cottage industry of companies that help hospitals increase their savings, and two big conferences are held each year on the program. The most recent one, in San Francisco last month, drew 800 people and about 50 exhibiting companies.

Some oncologists say the 340B program is one reason that more than 400 oncology practices have become part of hospitals in the last several years. The 340B discounts apply to all drugs, but oncologists use a lot of costly ones, providing a potentially larger spread.

A single oncologist might use $2.5 million to $4 million in drugs a year, according to the Community Oncology Alliance. If those drugs can be acquired for a 25 percent discount, that is a potential profit of up to $1 million.

“It’s the loophole that’s made cancer drugs profitable again,” said Dr. Peter B. Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan-Kettering Cancer Center and a former adviser to Medicare.

Dr. Lee S. Schwartzberg, medical director of the West Clinic in Memphis, said the 340B program “definitely was a factor” in the decision to form the partnership with Methodist Healthcare.

The hospital and clinic say they will donate $5 million a year from the 340B proceeds to the University of Tennessee, which is building a cancer center with which they are affiliated.

The money is also being used to help pay for nursing and genetic counseling, Dr. Schwartzberg said.

Some prison systems, meanwhile, save on drug costs by making a 340B hospital their official health care provider.

If inmates “become ‘patients’ of the hospital, a ‘win-win’ arrangement can be negotiated with the state, county or city,” said a slide from a 2010 presentation by Safety Net Hospitals for Pharmaceutical Access.

A big increase in the use of 340B occurred in 2010, when the government allowed hospitals to use an unlimited number of neighborhood pharmacies to fill 340B prescriptions. Before that, patients generally had to go to the hospital pharmacy, which can be inconvenient.

The University of California medical centers, which now have 240 pharmacies under contract, expect 35 percent of eligible prescriptions to go through the 340B program this year, up from only 10 percent in 2011, said Lynn Paulsen, director of pharmacy practice standards.

In these arrangements, needy patients typically get the drugs at little or no cost.

But if a patient is insured, the hospital keeps the difference between the reduced price it paid for the drug and the higher price reimbursed by the insurer, and pays the neighborhood pharmacy a dispensing fee.

There are already about 25,000 arrangements between a treatment site and a pharmacy, according to the Health Resources and Services Administration.

“It’s morphed into a big revenue-capture game — how can we get as many 340B prescriptions filled at a 340B price,” said Aaron Vandervelde of the Berkeley Research Group, a consulting firm to pharmaceutical companies.

It is too early to say what, if any, changes will be made by Congress.

Hospitals say that restricting the discounts to drugs actually consumed by poor patients would eviscerate the benefits of the program. The hospitals are hoping the program might be expanded to help balance the federal budget.

Ailing hospitals might garner more sympathy than profitable drug companies. It is perhaps telling that no Democrats have joined the investigation of the 340B program.

“It’s saving the government money, so they don’t have an incentive to change it,” said Carlton Sedberry, senior director at Medical Marketing Economics, a pharmaceutical industry consulting firm.

“It’s making the hospitals money, so they don’t have an incentive to change it.” And patients, for the most part, are unaware of 340B.

“The only people this smacks are the manufacturers.”

Citation: "Dispute Develops Over Discount Drug Program" February 12, 2013, Andrew Pollack; New York Times
Gregory D. Pawelski
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Old 10-08-2015, 03:55 PM
gdpawel gdpawel is offline
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Default US cancer doctors drop pricey drugs with little or no effect

(Reuters) - U.S. oncologists, aware that patients are paying more of the costs of expensive cancer drugs, are increasingly declining to prescribe medicines that have scant or no effect, even as a last resort.

At least half a dozen drugs, including colon cancer treatments Cyramza, from Eli Lilly & Co, and Stivarga, sold by Bayer AG, aren't worth prices that can exceed $100,000 a year, top cancer specialists said in interviews with Reuters.

If specialists do start considering a drug's cost in their prescribing habits, such decisions could dent the multibillion-dollar cancer drug business of companies from Roche Holding AG to Celgene Corp. Worldwide spending on cancer medicines reached $100 billion in 2014, a year-over-year jump of more than 10 percent.

Doctors are unimpressed with so-called "me too" drugs developed by companies looking to grab market share from a more established product. They are also less likely to use a drug outside of its approved indication for patients who have exhausted other types of treatment.

"There are drugs that don't make much sense given how much they cost, given their small benefits," said Dr Peter Bach, director of Memorial Sloan Kettering's Center for Health Policy and Outcomes in New York. "There are drugs that can cost up to $10,000 a month that provide, at the median, a few weeks or less than a month of additional life, but with substantial toxicity."

More than one-quarter of spending by Medicare, the federal health insurance plan for seniors, is for services provided to beneficiaries in their last year of life, according to the Kaiser Family Foundation.

Doctors say that, even with harsh side effects, a few more weeks of life may be well worth the price to some patients. For others, the potential benefits may not outweigh the costs.

Lilly's Cyramza was approved by U.S. regulators in April to treat advanced colorectal cancer in combination with chemotherapy. It works similarly to Roche Holding AG's much older drug Avastin and to Sanofi SA's Zaltrap.

"Lilly got it on the market in stomach cancer (in 2014), which was a very nice strategy since it was one of the few indications where Avastin missed," said Dr. Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering. But when Lilly put it on the market for colon cancer, where it does compete with Avastin, they kept its price at double the rate of the Roche drug.

"In colon cancer, I don't know anyone who is using it," Saltz said of Cyramza. Even Avastin, which extends colon cancer survival by about 1.4 months compared to chemotherapy alone, is "massively overused and massively overpriced," he said.

Dr. Lowell Schnipper, chief of hematology-oncology at Beth Israel Deaconess Medical Center in Boston, also described Cyramza as providing limited benefit at a cost of $7,000 to $9,000 a month.

Lilly said in an emailed statement that Cyramza addresses a high unmet medical need, while Bayer said that Stivarga is an important, and competitively priced, treatment option. Genentech, the U.S. biotechnology unit of Roche, said it limits the annual cost of Avastin to about $69,400 for its approved uses.


U.S. patients are paying a larger portion of their own health costs, in the form of higher deductibles, co-payments and premiums. Some insurance plans require patients pay up to 30 percent of the cost of cancer drugs, although most also put a cap on those expenses. Under President Barack Obama's Affordable Care Act, insurance policies have total out-of-pocket limits of $6,600 for individual consumers and $13,200 for families.

Major medical groups including the National Comprehensive Cancer Network and the American Society of Clinical Oncology are developing ways to consider a drug's affordability in their treatment decisions. But as they wait for firmer guidelines, some cancer doctors are making what they view as some obvious changes.

"In the past, the cost implications of care were not on our radar until the patient brought it up ... now we are much more sensitized to the issue," said Dr. Neal Meropol, chief of hematology and oncology at University Hospitals Seidman Cancer Center in Cleveland.

Showing how inefficient the current pricing system is, even when a drug is less effective than a competitor, it doesn't necessarily cost less. Of 51 cancer drugs approved between 2009 and 2013, 21 treatments classified as "novel" had a median annual price of $116,100, while the 30 deemed "next-in-class" had a median price of $119,765, according to a recent study in the Journal of the American Medical Association Oncology.

At the same time, the cost of treatment is rising steadily. In 1995 oncology patients and their insurers paid $54,100 for an additional year of life, but by 2013 the price had jumped to $207,000, according to a study sponsored by the National Bureau of Economic Research.

Saltz at Memorial Sloan Kettering said Cyramza for colon cancer is a clear example of "a drug that costs much more and does absolutely nothing," but said doctors may find it harder to decide on a drug that "costs a lot and does very, very little."

He views Stivarga in that category.

"It costs around $12,000 to $13,000 a month and makes people feel tired, causes skin rash on hands and feet," he said. Insurers cover it, but require patients pay a substantial amount upfront. "I used it a fair amount when it first came out, but noticed that people didn't feel too good. I now discuss it with patients and most decide not to use it."

Anthem Inc, the second largest U.S. health insurer, has a program to steer oncologists toward effective treatments deemed to offer the best value, paying them a monthly fee for adhering to a recommended treatment regimen. Anthem cited drugs like Avastin and Celgene's Abraxane as overused relative to their value.

"Abraxane is a newer version of an older (generic) drug called paclitaxel - they basically do the same thing," said Dr. Jennifer Malin, medical director for oncology at Anthem and an attending physician at the Veterans Affairs Greater Los Angeles Health Care System.

One advantage of Abraxane is that it is less likely to cause numbness. But Malin notes that a doctor can use paclitaxel first and only switch to the more expensive drug if the patient experiences that side effect.

Paclitaxel costs around $200 per dose compared with $10,000 for Abraxane, she said. Celgene, which makes Abraxane, said it believes the drug is a valuable treatment option.

(Reporting By Deena Beasley; Editing by Michele Gershberg and John Pickering)
Gregory D. Pawelski
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Old 03-04-2016, 10:16 AM
gdpawel gdpawel is offline
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Default Good News and Bad News

The good news: The FDA approved a record 71 new cancer drugs in just 12 months.

The bad news: The average increase in survival was 2 months and the drugs cost an average of $100,000 per course of treatment.
Gregory D. Pawelski
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Old 01-13-2017, 11:40 AM
gdpawel gdpawel is offline
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Default The Cost of Cancer Therapy: How Much is Too Much?

Robert A. Nagourney, M.D.

There has been much written about the cost of cancer chemotherapy. In the US alone over 2.5 trillion dollars are spent on healthcare each year. Among the most expensive drugs are cancer therapies. This came to light in an analysis in JAMA Oncology.

What Are We Getting for Our Money?

The article examined the impact of modern cancer therapy on quality of life and survival (Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated with New Cancer Medicines. Salas-Vega, S: JAMA Oncology, December 29, 2016). Using the years 2003 to 2013 they found that fewer than half of new treatments improved overall survival by three months or more. This varied by disease from breast at 8.48 months to thyroid with no improvement whatsoever. The overall average was only 3.43 months. Once again the high cost of cancer therapy did not seem to correlate with significant improvements in survival.


This was the subject of a previous paper in the Journal of Clinical Oncology (Cancer Drugs in the United States; Justum Pretium – the just price, Kantarjian H. M. et al, J Clin Oncol 2013). In this analysis the authors noted that of the 12 anticancer drugs approved by the U.S. FDA in 2012 only three prolonged survival and 2 of those 3 by less than 2 months. More concerning was the average drug price at greater than $10,000 per month.


Is the cost of cancer chemotherapy too high? Should we ration agents to prevent over-expenditure? Should Medicare's solvency be placed above the needs of individual patients?

Is Molecular Profiling the Answer?

Most institutions in the United States have responded to this dilemma by expanding molecular profiling programs. Using DNA, it is reasoned, they will identify candidates for the newest treatments and limit drug use to only those most likely to respond. This lofty ideal however has not been met.

For one reason a relative minority of patients actually carry identifiable targets.

More troubling however is that fact that even those patients who are identified as candidates for novel therapies by gene profile often fail to respond.

This was made abundantly clear by a study that examined the outcome of patients who carried a mutation in the gene BRAF V600, the specific target for the drug Vemurafenib (Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations. Hyman, DM et al NEJM August 20, 2015). Of the 27 colon cancer patients identified as candidates for Vemurafenib by gene profile, only 1 of 27 actually responded, providing an overall objective response rate of 4%. If we were to add the cost of screening thousands of patients for actionable mutations to the actual cost of treatment, this patient could prove to be the single most expensive clinical response in history.


Functional Platforms Already A Proven Approach

One approach that has been grossly under-appreciated is the application of three-dimensional organotypic analyses like those conducted in our laboratory. These functional platforms gauge the biological responsiveness of human tumors to drugs regardless of the tumor’s genomic profiles.

With a two-fold improvement in a response and a 44% improvement in survival these functional analyses offer a unique opportunity to address the growing cost and toxicity of therapy, provide better outcomes and lower costs. As the newest classes of drugs cost over $10,000 per month, saving patients just two weeks of ineffective therapy more than pays for the entire cost of the analysis.


With 2017 upon us and a new administration about to take the reins in Washington, is it now time for us to examine better approaches to cancer therapy and to use validated technologies like the EVA-PCD platform for drug selection. We certainly hope so.
Gregory D. Pawelski
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