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Chemotalk NewsletterChemotalk Newsletter, Vol. 55: November 1, 2012 My favorite month (November), because of my favorite holiday (Thanksgiving), starts today! So here goes ... From The New York Times, an interesting Op-Ed piece focusing on drug pricing, something patients hardly ever think of in the abstract when they're actually being patients. But when we're not patients anymore, it behooves us to pay attention: IN CANCER CARE, COST MATTERS By Peter B. Bach, Leonard B. Saltz and Robert E. Wittes* At Memorial Sloan-Kettering Cancer Center, we recently made a decision that should have been a no-brainer; we are not going to give a phenomenally expensive new CANCER drug to our patients. 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. In most industries something that offers no advantage over its competitors and yet sells for twice the price would never even get on the market. But that is not how things work for drugs. The Food and Drug Administration approves drugs if they are shown to be "safe and effective." It does not consider what the relative costs might be once the new medicine is marketed. By law, Medicare must cover every cancer drug the F.D.A. approves. (A 2003 law, moreover, mandates payment at the price the manufacturers charge, plus a 6% cushion.) In most states private insurers are held to this same standard. Physician guideline-setting organizations likewise focus on whether or not a treatment is effective, and rarely factor in cost in their determinations. Ignoring the cost of care, though, is no longer tenable. Soaring spending has presented the medical community with a new obligation. When choosing treatments for a patient, we have to consider the financial strains they may cause alongside the benefits they might deliver. This is particularly the case with cancer, where the cost of drugs and of care over all, has risen precipitously. 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. The burden of this cost is borne, increasingly, by patients themselves -- and the effects can be devastating. 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% of cancer patients were driven into baruptcy by their illness and its treatment. One in 10 cancer patients now reports spending more than $18,000 out of pocket on care. Which brings us back to our decision on Zaltrap. The patients with advancing, metastatic colorectal cancer, the new drug, approved by the F.D.A. in August and jointly marketed by Sanofi and Regeneronm offers the same survival benefit as Genentech's Avastin, which works through a similar molecular mechanism. When compared with the standard CHEMOTHERAPY regimen alone, adding either medicine has been shown to prolong patient lives by a median of 14 months. Major clinical practice guidelines, like those from the National Comprehensive Cancer Network, agree that Zaltrap is no better than Avastin in this setting. (Full disclosure: Two of us, Dr. Bach and Dr. Saltz, have been paid consulting fees by Genentech) But Avastin costs roughly $5,000 a months: every expensive in its own right, yet less than half of Zaltrap's price tag. And while the side effects in both drugs are roughly equal, doses of Avastin generally take less time to administer than those of Zaltrap, which makes Avastin more convenient or patients. Consider that colorectal cancer is typically diagnosed in older individuals and the cost issue b4ecoes starker still. Many patients are on Medicare and living on fixed incomes. And because Medicare requires patients to co-pay for cancer drugs, 20% of the cost of drugs like Zaltrap and Avastin is passed on -- absorbed either by supplemental insurance or by the patients themselves. To put these percentages in perspective, an older colorectal cancer patient without extra insurance would have in pay more than $2,200 out of pocket for a month's treatment with Zaltrap. That's greater than the monthly income for half of Medicare participants. Once you take all this into account it may seem surprising that the decision to exclude Zaltrap from our hospital's formulary was a hard one to make. But because our medical culture equates "new" with "better" so unequivocally, a decision like this one can seem out of place at a leading cancer center. Political rhetoric today is similarly slanted. Our refusal to adopt this remarkably expensive therapy risks being labeled "rationing" not rational. This political climate also helps explain why the Affordable Care Act precludes Medicare from changing its coverage or payment amounts based on cost comparisons lie the one we have outlined even when two drugs appear to work equally well. And it is probably why neither presidential candidate has addressed runaway cancer drug prices. But if no one else will act, leading cancer centers and other research hospitals should. The future of our health care system, and of cancer care, depends on our using our limited resources wisely. The current level of spending on health care, estimated to be $2.8 trillion this year, is already too high. The growth rate in health spending is unsustainable. Of course, we know our decision about Zaltrap will not meaningfully address these larger problems. Projected United States sales of Zaltrap in 2013 are less than $150 million, or 0.0005 percent of all dollars spent on health care Our use would account or a very small percentage of even that number. But it is a step in the right direction -- one of many we need to take. * The writers are doctor at Memorial Sloan-Kettering Cancer Center. Peter B. Bach is the director of the Center or Health Policy and Outcomes, Leonard B. Saltz I chief of the gastrointestinal oncology service and chairman of the pharmacy and therapeutics committee, and Robert E Wittes is the physician in chief. * * * MULTIPLE SCLEROSIS DMT APPROVALS "TO DOUBLE BY 2012" By Lynne Taylor The number of disease-modifying therapies (DMT) approved for the treatment of MULTIPLE SCLEROSIS is expected to double to 2021, and this will intensify market fragmentation, according to new forecasts. In this new era of enhanced therapeutic potential and complex treatment choices, fragmentation of the world's leading markets - France, Germany, Italy, Japan, Spain, the UK and the US - will intensify, as the MS field strives towards a more individualized approach to treatment, says the study, from Decision Resources. Investigational MS therapies comprise a diverse mix of oral and parenteral agents, novel compounds, next-generation products and reformulations. Among the new oral agents which are expected to launch during this time, Biogen Idec's oral immunomodulator BG-12 will have the greatest commercial success, with major-market sales of around $3 billion in 2017 as a result of clinical data that support a highly-favorable risk/benefit profile. Genzyme/Sanofi/Bayer HealthCare's anti-CD52 monoclonal antibody (MAb) Lemtrada (alemtuzumab) and Roche/Genentech's anti-CD20 MAB ocrelizumab will serve as important alternatives for MS patients who respond suboptimally to prior therapy, or for patients who exhibit aggressive or worsening disease activity. However, outstanding safety concerns will likely constrain the adoption of these potentially high-risk/high-reward therapies by a generally conservative neurologist prescriber base. In response to this influx of promising new targets, clinicians' reliance on platform injectable therapies such as the interferon-betas and Teva's Copaxone (glatiramer acetate) is projected to wane over time. It expects follow-on products from Biogen Idec - pegylated interferon-beta-1a - and Teva - Copaxone 40mg, three times weekly - to represent useful (albeit somewhat incremental) advances in this evolving market. Moreover, by way of risk-factor stratification, the study expects Biogen Idec/Elan's Tysabri (natalizumab) to remain a valuable treatment option in the face of growing competition. "A clear takeaway from the recently-concluded 28th Congress of the European Committee for Treatment and research in multiple sclerosis is that the MS field remains primed for new disease-modifying alternatives to treat patients across the clinical spectrum," comments Decision Resources analyst Jonathan Searles. "However, while each new product will establish a role in treatment, we forecast a continued reliance on time-tested mainstays, owing to near-term gaps in clinical experience and long-term data with new entrants, coupled with the absence of prognostic or therapeutic response markers to guide more-precise treatment selections." * * * FDA APPROVES LEUKEMIA DRUG The U.S. Food and Drug Administration said it has approved a new leukemia treatment to be sold under the brand name Synribo. The drug, also known as omacetaxine mepesuccinate, is approved to treat a type of the blood and bone marrow cancer called CHRONIC MYELOGENOUS LEUKEMIA, or CML, in patients whose cancer has progressed after treatment with at least two drugs from a class called tyrosine kinase inhibitors. "This approval provides a new treatment option for patients who are resistant to or cannot tolerate other FDA-approved drugs for chronic or accelerated phases of CML," Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research, said in a statement. Synribo, which is injected under the skin twice daily for 14 consecutive days over a 28-day cycle until white blood cell counts normalize, works by blocking proteins that help the development of cancerous cells. It is the second CML drug approved by the FDA in recent weeks after the September approval of Pfizer Inc's Bosulif. An estimated 5,430 Americans will be diagnosed with CML in 2012, according to the National Institutes of Health. Synribo received an accelerated approval based on the disease response to the drug in studies. However it has yet to demonstrate an improvement in disease symptoms or an increased survival benefit in a clinical trial, the FDA and company said. * * * This goes into the "It's About Time! Department": LAWS ADD DIMENSION, AND QUESTIONS, TO BREAST CANCER SCREENING By Denise Grady In a move that has irked medical groups and delighted patient advocates, states have begun passing laws requiring clinics that perform mammograms to tell patients whether they have something that many women have never even heard of: dense breast tissue. Women who have dense tissue must, under those laws, also be told that it can hide tumors on a mammogram, that it may increase the risk of BREAST CANCER and that they should ask their doctors if they need additional screening tests, like ultrasound patients against the medical establishment. Advocates say women have a right to know, but medical groups argue that the significance of tissue density is uncertain and that reporting it may panic women and lead to an avalanche of needless screening tests an biopsies.* Laws requiring disclosure have been passed in Connecticut, Texas and Virginia, and most recently in California and New York where they will take effect next year. A bill calling for a federal law has been introduced in the House. The laws owe their existence mostly to Nancy M. Cappello, 59, of Woodbury, Conn. She was not told that she had dense breast tissue until after doctors found an advanced cancer that mammograms had missed. She took her story to legislators, and I 2009, Connecticut became the first state to require that women be told if they have dense breasts and that insurance companies cover ultrasound scans for those women. "I want to help other women," said Ms. Cappello, formerly the state's chief of special education. "I can't help myself. My cancer should have been detected at a much earlier stage" "Dense" breasts have a relatively high proportion of glandular or connective tissue, which blocks X-rays. Non-dense breasts have more fat, which X-rays penetrate easily. Over all, about 40% of women who have mammograms have dense breast tissue. It is not abnormal, just one of nature's variations. Younger women are more likely to have dense tissue, but as many as 25% of older women do too. Density cannot be judged by touch; it shows up only on mammograms. For many women, the legislation will bring about a big change. Though some radiologists already tell women about density, in most cases the letters sent to patients about mammogram results do not mention it. Though some doctors favor the laws, others resent them, and professional societies of radiologists, gynecologists and cancer experts have raised medical concerns The medical groups say telling a woman she has dense breasts may not help her and might even do harm by propelling her into unnecessary tests and treatment. The groups argue that identifying dense breast tissue is subjective, and so two doctors reading the same mammogram may rate the tissue differently. And information about density may confuse women, scare some needlessly and give others a false sense of security, the groups say. Detractors also warn of a flood of phone calls to already-overburdened doctors and a demand for additional tests that will strain the health care system. There is already a shortage of experts in ultrasound screening, and many doctors simply bristle at the idea of laws controlling what they tell patients. "I'm always worried when politicians start legislating the medical conversation, especially when it's a medical conversation where the experts don't know what needs to be said," said Dr Otis Brawley, the chief medical officer and executive vice president of the American Cancer Society an a professor of medicine at Emory University in Atlanta. But Dr. Brawley said doctors should tell women if they have dense breasts, and he freely admitted that his position seemed contradictory. "I'm saying I object to legislation that says doctors should have a conversation with their patients that I believe they should have with their patients," he said. The National Cancer Institute calls dense breasts "a strong risk factor for developing breast cancer." Various studies have estimate that compared with other women, those with dense breasts are two to six times as likely to develop breast cancer. The reason is not known. But dense breasts have more milk ducts an lobes, where most cancers form, so some researchers think the added risk may come from having more of that tissue. On mammograms, dense breasts look white, and so does cancer, so the tissue can hide tumors. Fatty breasts show up mostly black, so tumors stand out. Studies have found that when women with dense breasts were given mammograms and then ultrasounds, the ultrasound found tumors that the mammograms missed -- but also produced many false positives that led to biopsies. Studies of women with dense breasts that were published in the Journal Radiology an The Journal of the American Medical Association found that for every 1,000 women screened, adding ultrasound found three to five cancers that mammograms missed. But in one study, 63 biopsies or other invasive procedures were performed to find three tumors. M.R.I. exams can also find tumors that mammograms miss, but they produce even more false positives. Despite its shortcomings, mammography does find some tumors in women with dense breasts -- including some that ultrasound misses -- so doctors emphasize that these women should not skip mammograms. No studies have been conducted to determine whether finding the hidden cancers with ultrasound or M.R.I. scans saves women's lives. In theory, the tumors found could be the kind that never would have killed the patients anyway. The United States Preventive Services Task Force, which makes recommendations about screening tests, has not given any advice on breast ultrasound. This year, 226,870 new cases of breast cancer and 39,510 deaths from the disease are expected in the United States. Dr. Thomas Kolb, a radiologist in Manhattan, said that like mammography, ultrasound can find early cancers and therefore should reduce the death rate. "It doubles the detection rate in women with dense breasts," he said But Dr. Carol H. Lee, a radiologist at Memorial Sloan-Kettering Cancer Center in New York an a spokeswoman for the American College of Radiology, says that while there is an increased overall cancer risk for women with dense breasts as a group, it is not known whether the risk is borne equally by every woman in the group. So the best advice for an individual woman is not clear. Dr. Lee said that the radiology group did not oppose the idea of informing women but did not think it should be mandated by law. The group issued a statement warning of "possible harms and unintended consequences" of the state laws, including confusion, "undue anxiety," a loss of faith in mammograms and "demands for additional non-mammographic screening". Some insurers may not cover the additional tests, so women who cannot pay out of pocket may not be able to afford them. Even when insurance does pay, the reimbursement rate is often so low that many doctors say it does not come close to covering the time and expertise needed to perform an interpret the exams. In addition, while mammography centers must meet strict standards, there are no such requirements for ultrasound screening, so the quality may vary. Ms. Cappello, the woman who started the movement to inform patients, began having yearly mammograms at age 40. In 2004, when she was 51, her doctor felt a lump in her breast -- only six weeks after a mammogram had looked normal. Even after the lump was detected, mammography still could not find it Only then was Ms Cappello told that she had dense breast tissue. The cancer had already spread to 13 lymph nodes. She needed a mastectomy, chemotherapy, radiation and hormone treatment. Ms. Cappello was outraged. If she had known she had dense breast tissue, she said, she would almost certainly have had an ultrasound exam. She believes that the tumor would have been found earlier perhaps 3even before it had begun to spread. "It was probably growing or four or five years," she said, "and it was missed." EDITOR'S NOTE: Once again, women are reduced by "medical professionals", to mindless nitwits given to "panic" responses. When will they get it? We're entitled to make our own decisions, without being forced to yield to those who think they know what's best for us. Clearly, in this case it requires a law. And forgive my cynicism, but I bet people who have invested in mammography equipment, have a very effective lobbying group. * * * I will try to calm down by next month ... * * * And if you have any thoughts of how this newsletter could be improved, please email me directly, at Elaine@elainejesmer.com. Elaine Jesmer
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