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England Makes Tough Decisions About Which Multiple Myeloma/Cancer Drugs To Allow

Home/England Makes Tough Decisions About Which Multiple Myeloma/Cancer Drugs To Allow

England Makes Tough Decisions About Which Multiple Myeloma/Cancer Drugs To Allow

Here is an in-depth, candid look at the English system of state controlled health care, where recommendations from a group of English physicians and medical experts known as NICE sometimes limits patient access to some drugs the group deems ineffective or too expensive.

For example, NICE allows use of Thalomid or Velcade, but not Revlimid in newly diagnosed multiple myeloma patients.  Revlimid use is permitted in relapsed patients, just like here in the U.S.  The difference is here in America, oncologists are allowed to use Revlimid on newly diagnosed patients “off label.”  As long as insurance companies approve the therapy–and most do–then Revlimid can be used in newly diagnosed patients.   I hope Clinical Oncology News doesn’t mind me reproducing their article here for my readers in its entirety.  But I thought it was important to share the entire article with you so you could get a feel for the advantages, disadvantages and complexities of this timely issue:

Controlling Health Care Costs: U.S. Versus England

Steve Frandzel

As leaders argue about how to control the skyrocketing costs of cancer care, some say it is worthwhile to look at how other countries, such as England, cope. Over the past year and a half, England’s National Institute for Health and Clinical Excellence (NICE) has rejected a number of cancer drugs for certain indications, concluding that patients would derive minimal benefits at an excessively high cost. The rejection list includes erlotinib (Tarceva, OSI/Genentech) for maintenance therapy of non-small cell lung cancer, sorafenib (Nexavar, Bayer Healthcare/Onyx Pharmaceuticals) for advanced hepatocellular carcinoma, and lapatinib (Tykerb, GlaxoSmithKline) in combination with capecitabine (Xeloda, Roche Pharmaceuticals) for women with advanced or metastatic HER2-positive breast cancer. In contrast, the FDA has approved these drugs for these indications in the United States.

Health Care Rationing
The rejections mean that England’s National Health Service will not pay for the costly treatments, or will pay only under narrowly defined circumstances. Patient advocacy and physician groups in England have lambasted NICE as insensitive to severely ill patients. NICE insists that the money would be better spent on treatments with more demonstrable benefits.

Nothing comparable to NICE exists in the United States. The FDA evaluates drugs for safety and efficacy compared with placebo; it considers neither cost nor comparative efficacy against other treatments in determining what to approve. NICE considers all four factors in calculating what to cover, after the European Medicines Agency (the European equivalent of the FDA) has approved a drug. NICE is free to negotiate drug prices with suppliers, and whereas physicians in the United States can choose to prescribe drugs for off-label indications, NICE’s guidance is binding.

NICE has become increasingly skeptical of drugmakers’ claims about the efficacy and economics of newer antineoplastic agents. The institute’s decision to reject bevacizumab (Avastin, Genentech) for breast cancer characterizes that trend. In early July, NICE estimated that the drug, in combination with a taxane for metastatic breast cancer (MBC), extends life by only seven weeks at a cost per quality-adjusted life-year (QALY) of at least $175,000. This is far above its threshold approval range of $30,000 to $45,000 per QALY. According to NICE, “the cost of bevacizumab is too high for the limited and uncertain benefit it may offer patients.” The FDA approved bevacizumab in combination with paclitaxel for MBC in 2008 based on a trial showing the drug improved progression-free survival. In July 2010, however, an FDA advisory panel overwhelmingly recommended that this indication be revoked because further trials showed the drug did not improve overall survival. At press time, it was unknown whether the FDA would follow this recommendation.

Other drugs gaining approval in the United States, but rejected in the last year and a half by NICE, include azacitidine (Vidaza, Celgene) for chronic myelomonocytic leukemia and temsirolimus (Torisel, Pfizer) for advanced kidney cancer.

Access to Drugs
The disparate systems of the United States and England have resulted in differences in access to cancer drugs. One study comparing access to pharmaceuticals between the United States and the United Kingdom, including about two dozen oncology drugs, found that “the U.S. provides faster more flexible access to most, but not all, of the U.K.–approved pharmaceuticals” (Appl Health Econ Policy 2006;5:177-187, PMID:17132032). According to lead author Joshua P. Cohen, PhD, a senior research fellow at Tufts University Center for the Study of Drug Development, NICE takes an average of 52 weeks to make a decision regarding reimbursement, leaving affected patients in medical limbo. Dr. Cohen explained that life expectancy for cancer patients in the United Kingdom is lower than it is in the United States and much of Europe, and this is partly attributable to decreased access to newer therapies. But, he added, “there are a lot of confounding factors.” These include higher per capita spending on cancer in other countries and the relatively late start of concerted anti-cancer campaigns in the United Kingdom.

But things are loosening up in England. A recent report, “Extent and Causes of International Variations in Drug Usage,” by the national cancer director at the U.K. Department of Health ranked the nation 12th out of 14 developed countries in the use of cancer drugs introduced in the last five years. Use was highest in the United States, followed by Spain and France. In response, England’s health secretary announced a $78 million interim fund to pay for cancer drugs not approved by NICE. A permanent and larger fund is scheduled for April 2011. The report also emphasized that higher drug expenditures do not necessarily correlate with longer survival.

One major tradeoff for better access to costly treatments is, of course, that costs borne by patients are higher in the United States than in other countries—sometimes dramatically so. The cost of bevacizumab for the average patient in England is $5,000 per month; in the United States, it often exceeds $8,000. The amount that patients actually pay for any prescription drug differs widely as a function of whether they have health insurance and the tremendous variability in reimbursement rates for those who do.

Something Has To Give
Despite incessant railings against the skyrocketing costs of prescription drugs, the United States tolerates the status quo. One reason is that any medical decision carrying large financial ramifications is as much a social issue as it is a medical one, according to Peter Bach, MD, a pulmonologist and director of the Center for Health Policy at Memorial Sloan-Kettering Cancer Center, in New York City. At least for now, the consensus in the United States is to provide medical treatment that prolongs life, no matter how much it costs. “That’s what our society has decided, and it’s certainly our behavior,” Dr. Bach said. “Most state legislatures have passed laws requiring insurers to cover these treatments. The health care reform legislation prominently addresses issues like rescission [cancellation of health care policies] and preexisting conditions, which anchors to this notion that insurers should cover people who are sick irrespective of the costs of doing so.”

Knowing the overall cost of cancer drugs would be an essential step in plotting a strategy to reduce them, but unearthing that information is daunting, said Dr. Bach. “Go find the number for how much we spend on oncology drugs in the U.S. each year,” he challenged. “You can’t.”

Something has to give, said Leonard Saltz, MD, head of the Colorectal Cancer Section, Department of Medicine, chairman of the Pharmacy and Therapeutics Committee at Memorial Sloan-Kettering Cancer Center, and professor of medicine at Weill Cornell Medical College, in New York City. “What we Americans ideally want is unlimited access to all care, with full coverage and no consideration of cost versus benefit. Of course, economically such an approach is unrealistic,” he said. The way he sees it, only when individuals must make economic choices when costly treatments with marginal benefits are involved will there be a financial incentive to evaluate just what these drugs offer for their cost.

And frequently, what these drugs offer is less than impressive, and far less than most people realize. “What we fail to do as a society is set targets in terms of what is a clinically significant benefit,” Dr. Saltz continued. “Meanwhile, all too many of the newer cancer drugs are marketed at prices that suggest they represent substantial advances, when often the benefits offered by these drugs are extremely modest.” He points to erlotinib for pancreatic cancer. In a pivotal Phase III clinical trial, the drug, when added to standard chemotherapy, prolonged survival by a median of 12 days over chemotherapy alone (J Clin Oncol 2007;20;25:1960-1966, PMID: 17452677). The FDA approved the drug for pancreatic cancer on the basis of this trial. “Yes, it was a statistically significant improvement in survival, but not a clinically significant one; and at an additional cost of around $4,000 per month, it doesn’t meet the criteria that most people would accept for cost-effective medicine,” said Dr. Saltz.

That’s the point at which NICE makes blunt decisions. “They say we can’t afford everything, so if we spend money on a marginal therapy, we can’t spend it on something else,” Dr. Cohen said. The United States, he continued, avoids that debate because many Americans recoil at the prospect of explicit health care rationing. Yet, the country’s own arrangement of copayments and coinsurance, not to mention the inability of millions to find affordable health insurance, looks to some like rationing in another guise. “We ration all the time by geographic variation and across socioeconomic and insurance status, and we do accept that,” said Dr. Cohen.

A study (J Clin Oncol 2010;28:3234-3238, PMID: 20498408) out of the United Kingdom says as much: “anticancer drug coverage decisions that consider cost-effectiveness are associated with greater restrictions and slower time to coverage.” However, “because newer oncology medicines can cost the patient thousands of dollars each month, these copayments [in the U.S.] can represent substantial barriers to access.” The authors also said that “in life-threatening conditions such as cancer, evidence suggests that patients’ decision making is unlikely to be well informed.”

Considered in that light, NICE’s rejections often make both medical and economic sense, in Dr. Saltz’s opinion. Similar judgments, made through some as yet unformed mechanism, will ultimately be necessary to keep our health care system financially viable. “NICE is a necessary evil,” he said. “I wish there were a better way, but I don’t believe there is. Some form of it is probably going to be necessary for our health care system to survive. Without meaningful limitations on ineffective or marginally effective health care expenditures, our system will eventually collapse, and then we’ll have a real health care tragedy. But it’s political suicide to tell people what the reality is.”

These are not black and white issues.  Controlling costs always sounds good–until you are the patient denied a particular drug or therapy.

Something to think about.  Too bad there aren’t easy answers.
Feel good and keep smiling!   Pat