Condemned to an early death: British rationing body tells liver cancer victims that life-prolonging drug is 'too costly'

Liver cancer sufferers are being condemned to an early death by being denied a new drug on the Health Service, campaigners warn. They criticised draft guidance that will effectively ban the drug sorafenib - which is routinely used in every other country where it is licensed. Trials show the drug, which costs £36,000 a year, can increase survival by around six months for patients who have run out of options.

The Government's rationing body, the National Institute for Health and Clinical Excellence (Nice) said the overall cost was 'simply too high' to justify the 'benefit to patients'. However, relatively few would be eligible for the treatment - around 700, or one in four of those diagnosed each year with primary liver cancer.

Nice had claimed it was approving more drugs under End of Life policies introduced in January meant to benefit small numbers of terminally ill people. So far two drugs have been approved for three cancers. But two drugs have been banned under the rules, with a ban pending on three further drugs including sorafenib.

Its treatment of sorafenib contrasts sharply with that of breast cancer drug herceptin, which has received far more funding and attention after successful campaigns. Herceptin, under separate Nice criteria, has been judged to be cost effective. It currently costs £22,000 to administer an annual course of the drug to around 7,000 women - around £154million.

In contrast, the treatment for sorafenib would potentially cost £25million a year. Sorafenib, also called Nexavar, was assessed on different rules but still failed to meet the Nice threshold.

Kate Spall, founder of the Pamela Northcott Fund, which assists cancer patients denied new therapies, last night said cancer sufferers had been sold down the river. She said: 'These policies were specifically designed to help patients with rarer cancer such as liver to access new treatments for a previously untreatable disease. 'This decision will condemn patients to an earlier death than was necessary.' Only 20 per cent of patients with primary liver cancer - where the tumour originates in the liver - are alive one year after diagnosis.

Bayer, which makes the drug and plans to appeal the decision, had offered a scheme where it would provide every fourth packet for free. Dr Harpreet Wasan, a cancer consultant at London's Hammersmith Hospital, said: 'This cancer is not like any other cancer. There is no alternative treatment. Every other drug that has been tried fails to work. 'British doctors were heavily involved in the trials of this drug yet NICE will say we can't prescribe it.'

Nice rates the cost-effectiveness of a drug using a complicated measurement called a 'quality adjusted life year' or QALY. This determines the cost of new treatment by working out how much it improves and extends a life compared with existing treatments. Andrew Dillon, chief executive of Nice, said: 'We have recently changed our approach to appraising high cost treatments which can extend life for terminally ill patients. 'This has meant that more of them are now recommended.'

Professor Jonathan Waxman, a cancer specialist at Imperial College, London, said: 'The only reason Nice has approved any drugs under End of Life rules is because of a High Court ruling and doctors' protests. 'We must have a public debate about how it treats cancer patients.'

The Nice guidance applies to England and Wales. Scotland's equivalent body is yet to make a decision on sorafenib but tends to follow Nice.

Tony Almond, 46, went to the doctor complaining of indigestion in September. Three days later he was diagnosed with terminal liver cancer and told he had a month to live. Mr Almond, a truck driver living in Brackley, near Northampton, and his long-term partner Sharon immediately got married by special licence on October 16. He said: 'We'd been talking about getting married at Christmas but now I was told I had two to four weeks to live. 'It was pretty horrendous, especially when I found I couldn't have the only drug that would help because it was too expensive.'

Cancer specialists applied to Northamptonshire Primary Care Trust for funding, which is a necessary procedure for such drugs prior to approval by Nice, the drugs rationing body. But the request was rejected. With the backing of an NHS consultant in Birmingham, however, he appealed the decision and won. Mr Almond has been taking the drug for two weeks. He said: 'I can honestly say I no longer feel ill. It's a wonder drug and I feel angry that others may be denied the chance we had to fight so hard for.'

Could the Herceptin victory offer hope? It is three years since Ann Marie Rogers won her famous court victory which forced the Health Service to give her - and other breast cancer victims - access to the wonder drug Herceptin. The drug had been turned down by rationing watchdog Nice but Health Secretary Patricia Hewitt told trusts that they could not deny the drug on grounds of costs.

Now another group of cancer sufferers are facing a similar battle but it is unlikely that we will see Andy Burnham, the current Health Secretary, taking a similar stance --because this time the drug that has been turned down, Nexavar, is one that helps against liver cancer. The problem for campaigners is that liver cancer is not as high profile as breast cancer. This is partly down to the fact that fewer people get cancer of the liver than are diagnosed with breast cancer - around 3,000 a year compared with 45,000.

But that is not the whole story. Breast cancer has two charities fighting its corner - Breakthrough Breast Cancer and Breast Cancer Care - both of which attract millions of pounds in donations, and help boost the profile. Other cancers tend to fade into the background. There is, for example, still no prostate cancer screening programme that compares to the major screening programme for breast cancer. Yet around 10,000 of the 35,000 men in the UK diagnosed with prostate cancer each year die from their disease - a similar number to the 11,900 breast cancer victims.

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Bending the Health-Care Cost Curve--Upward

Remember when President Obama said that the goal of health-care reform was to save money? The bill that passed the House a week and a half ago, according to the Senate Budget Committee, would cost a whopping $3 trillion after being fully implemented--more than three times the $900 billion that the president had promised. It turns out that Obama's oft-stated pledge that reform would "bend the cost curve" was accurate: the House bill would bend the curve straight up. Expect more of the same from the Senate's version when Democrats' bill in that chamber emerges, probably later today--earlier drafts came equally loaded with budget gimmicks, phantom cuts, and taxes on the middle class to go along ! with massive subsidies to the uninsured to buy government-mandated health plans. The Congressional Budget Office scored the cost of the coverage expansions in an earlier Senate version as rising at 8 percent annually. President Obama has repeatedly promised that health reform would lower costs, yet independent observers, from the CBO to Richard Foster, the chief actuary of the Centers for Medicare and Medicaid Services, have repeatedly said just the opposite. What gives?

Part of the reason is that whenever Washington micromanages markets, the pleasing of interest groups tends to take priority over good policy. (Republicans are no more immune to the temptation than Democrats: President Bush and congressional Republicans passed a drug benefit for Medicare without paying for it and without reforming the broader Medicare program.) Declaring victory requires greasing lots of palms, like those of California congressman Dennis Cardoza. Politico reports that Cardoza wheedled $500 million for rural medical centers (including a promise to fund one in his district) from Nancy Pelosi and the White House in return for his "yes" vote on the House bill.

Giving congressmen pork is surely expensive, but more costly still is the billions of dollars in subsidies that the bill would direct to the uninsured to buy government-approved (read: expensive) health insurance. The bill would also create over 100 new commissions, boards, and committees to dictate (among other things) what benefits and services your health insurance must cover--including, by 2018, all employer-provided health insurance. That's 100 new committees for lobbyists to jostle for handouts from Uncle Sam.

Meanwhile, Obamacare does almost nothing to control costs or fundamentally reform the government's massive Medicare and Medicaid entitlements. In fact, Foster estimates that 60 percent of the expansion of coverage in the House bill would come from new Medicaid enrollments. (The earlier Senate version did contain a tax on unions' "Cadillac" health plans, a measure that might slow health-care inflation. But in deference to union complaints, Senate Majority Leader Harry Reid is likely to replace the tax with a new Medicare levy on upper-middle-class families.) When it comes to cost containment, Democrats tout the bill's hundreds of billions of dollars in cuts to reimbursements for doctors, hospitals, and nursing homes. But these will undoubtedly be lobbied out of existence. Medicare doctor payments have been slated for deep cuts under a "sustainable" growth formula since 2003, but every year since then, Congress has voted to rescind those cuts. In fact, Reid already tried to! pass just such an adjustment (for $200 billion) separately from the Senate's health-reform bill, so that it wouldn't be scored as part of the bill's cost. Thankfully, 12 Democrats and one independent voted with Republicans to kill the charade.

Democrats also rely on a "super-committee" that's supposed to pass more automatic changes to rein in Medicare spending--unless the president and Congress override it. Count on them to do so whenever it's politically convenient.

In the end, the problem with Obamacare is that the president and his allies assume that the way to drive costs down is through price controls and committees, rather than market preferences. And that's an assumption that a century's worth of failed statist experiments should have buried. Sure, markets aren't perfect; businessmen cheat, lie, and steal, just as politicians do. But markets have one virtue over command-and-control systems: where competition, transparency, and consumer choice drive markets, bad actors go out of business, prices decline over time, and quality improves. If I want your business, I have to sell you something that's worth buying, and at a good price.

Health care, we are told repeatedly, is different. But it's only different because the government has made it different. Our health-care "system" is based on an IRS ruling from World War II that confers tax-deductible status on health insurance only if it's purchased through an employer. Health insurance is regulated in 50 separate sclerotic state markets--rather than in one big, truly competitive national one--thanks to the 1945 McCarran-Ferguson Act. Medicare sets prices for thousands of physicians. Government decisions have transformed what could have been a price-lowering market like any other into an expensive, convoluted mess.

Such old systems are notoriously difficult to change. But they can change, and there are some promising templates. The Dutch are shifting from a command-and-control system to one in which insurers compete and prices for hospital care are allowed to fluctuate, driving innovation. Closer to home, in Indiana, nearly 50 percent of state employees have Health Savings Accounts--saving taxpayers $42 million to date. Companies like Safeway and Whole Foods have created insurance plans that reward healthy behavior and lower health-care costs.

Neither Congress nor the president seems to be paying much attention. But until every American gets control of his or her own portable, affordable, private health insurance--until, that is, a true market exists in health care--costs will continue to spiral upward. And voters will get more of the same, packaged as hope and change.

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U.S. health plans have history of cost overruns

As President Obama and Congress craft the largest national health insurance program since the creation of Medicare and Medicaid in 1965, they insist that the final product will add "not one dime" to the federal deficit. But cost projections are notoriously unreliable, and history is filled with examples of federal programs - especially in health care - that cost far more than originally predicted.

In 1965, the House Ways and Means Committee estimated that the hospital insurance program of Medicare - the federal health care program for the elderly and disabled - would cost $9 billion by 1990. The actual cost that year was $67 billion.

In 1967, the House Ways and Means Committee said the entire Medicare program would cost $12 billion in 1990. The actual cost in 1990 was $98 billion.

In 1987, Congress projected that Medicaid - the joint federal-state health care program for the poor - would make special relief payments to hospitals of less than $1 billion in 1992. Actual cost: $17 billion.

The list goes on. The 1993 cost of Medicare's home care benefit was projected in 1988 to be $4 billion, but ended up at $10 billion. The State Children's Health Insurance Program (SCHIP), which was created in 1997 and projected to cost $5 billion per year, has had to be supplemented with hundreds of millions of dollars annually by Congress.

Barely two weeks in office, Mr. Obama signed a $33 billion bill that will add 4 million mostly low-income children to the SCHIP program over the next 4 1/2 years.

All of these numbers were assembled and published in July by the Senate Joint Economic Committee.

The White House and Democratic leaders insist that the proposed health care reform being debated on Capitol Hill will be different. They also note that the costs of some federal health care programs, including the Medicare prescription-drug program, have come in below projections. But the official arbiter of costs in Congress, the Congressional Budget Office, hints that comprehensive health care reform could go the way of most other health care initiatives from Washington.

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Government Will Fail on Health Care Record Keeping

As the era of Big Government begins to wear on people, a multitude of evidence has come to the fore to show us just how inefficient and even dangerous the growth of government can be.

While many debate the role of Government in Health Care, one issue has emerged that should the argument to rest. Can the Government effectively manage the Health Care records of over 300 million people in an online database--as called for in the Obama Health Care bill?

This week we all learned that the Government couldn't keep track of the Stimulus spending on what they branded a revolutionary website, Recovery.gov. How, then, will they be able to keep track of all 300 million plus Health Care records in their “revolutionary” Health Care database? One must ponder this as we are being sold a bill of goods.

What will happen when the system inevitably collapses as the Recovery.gov system has? Will we simply get an explanation over Twitter? If that sounds outlandish, that’s exactly what they did yesterday when the buffoons behind Recovery.gov tweeted that “Unless an egregious error is noted, Recovery.gov posts data exactly as it is reported by the recipients.” Apparently no apparatus exists to provide the needed oversight. Troubling.

The current administration reminded us for the better part of the last year about a lack in oversight, a claim which is completely false. However, judging from the performance of the record keeping at Revovery.gov and by those in charge of the Stimulus spending, it’s hard to assert that there is oversight in any form. It appears that Government cannot provide quality oversight.

Fear of the new Health Care overhaul is natural. Claims that the Government will be able to provide accurate and efficient record keeping of our medical records is not natural in light of recent events.

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Medicare paid $47 billion in suspect claims

The government paid more than $47 billion in questionable Medicare claims including medical treatment showing little relation to a patient's condition, wasting taxpayer dollars at a rate nearly three times the previous year.

Excerpts of a new federal report, obtained by The Associated Press, show a dramatic increase in improper payments in the $440 billion Medicare program that has been cited by government auditors as a high risk for fraud and waste for 20 years.

It's not clear whether Medicare fraud is actually worsening. Much of the increase in the last year is attributed to a change in the Health and Human Services Department's methodology that imposes stricter documentation requirements and includes more improper payments — part of a data-collection effort being ordered government-wide by President Barack Obama this coming week to promote "honest budgeting" and accurate statistics.

Still, the fiscal 2009 financial report — covering the first few months of the Obama administration — highlights the challenges ahead for a government that is seeking in part to pay for its proposed health care overhaul by cracking down on Medicare fraud. While noting that several new anti-fraud efforts were beginning, the government report makes clear that "aggressive actions" to date aimed at reducing improper payments had yielded little improvement.

In recent years, the suspect claims have included Medicare prescriptions from doctors who were dead, and requests for payment for medical supplies such as blood glucose strips for sexual impotence and diabetic shoes for leg amputees. Patients, many of them new citizens who barely speak English, are sometimes recruited by brokers who go door-to-door offering hundreds of dollars for use of their Medicare numbers.

Obama is expected to announce new initiatives this coming week to help crack down on Medicare fraud, including a government-wide Web site aimed at providing a fuller account of health care spending and improper payments made by various agencies. The Centers for Medicare and Medicaid Services also will launch a Web interactive next month that will allow users to track Medicare payment information by categories such as state, diagnosis and hospital.

According to the report, the Bush administration from 2005-2008 reported improper payments of roughly 4 percent in the fee for service program, or about $17 billion total in 2008. Government officials at the time, however, typically did not consider a Medicare payment improper if the medical documentation was incomplete or a doctor's signature was illegible. Since these were flaws that ordinarily bar payment, that methodology drew complaints from government auditors that the figures were understated.

For fiscal year 2009, the Obama administration began counting those claims as improper, but was unable to complete an official tally based on the new methodology. As a result, it officially reported improper payments for its fee for service program at 7.8 percent, representing a partial tally under the new formula. But it considers the unofficial tally of 12.4 percent to be more representative.

Beginning next year, the 12.4 percent figure — or a total of $47 billion in improper payments when counting both Medicare fee for service and managed care — will be used as the baseline estimate. The federal report sets a target of reducing improper payments in the fee for service program to 9.5 percent by next year, which would represent a savings of roughly $9.7 billion.

The findings come as the Obama administration is making Medicare anti-fraud efforts an important priority. In recent months, HHS has said it was multiplying by 10 the number of agents and prosecutors targeting fraud in Miami, Los Angeles and other strategic cities where tens of billions of dollars are believed to be lost each year. The new partnership seeks to have better sharing of real-time intelligence data on health care fraud patterns.

Officials say they also want to increase training and outreach among Medicare providers to reduce documentation errors, while proposed health overhaul legislation would increase background checks on Medicare claimants and impose stiffer penalties for false claims.

Other findings:

_In the Medicaid program for the poor, roughly $18.1 billion, or 9.6 percent of claims, are believed to be improper payments.

_Using a baseline of 12.4 percent in improper payments in the Medicare fee for service program, HHS is setting targets of reducing fraud and waste to 9.5 percent, 8.5 percent, and 8.0 percent, respectively, for fiscal years 2010 through 2012.

Records released in the past week showed that CMS for three years ignored internal watchdog warnings about swindlers stealing millions of dollars by scamming several Medicare programs. The agency received roughly 30 warnings from inspectors but didn't respond to half of them, even after repeated letters.

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Reid finally has a bill

Setting up a historic year-end health care debate, Senate Majority Leader Harry Reid unveiled long-awaited legislation Wednesday night to extend coverage to all but 6 percent of eligible Americans and bar private industry from denying insurance because of pre-existing medical conditions. The Democrat's $849 billion measure is designed to remake the nation's health care system, relying on cuts in future Medicare spending to cover costs—as well as on higher payroll taxes for the well-to-do and a new levy on patients undergoing elective cosmetic surgery.

Aides said the mammoth, 2,074-page bill would reduce deficits by $127 billion over a decade and by as much as $650 billion in the 10 years that follow, citing as-yet-unreleased estimates by the Congressional Budget Office. "Tonight begins the last leg of this journey," said Nevada Sen. Reid, less than two weeks after the House approved its version of a sweeping remake of the health care system— and nearly 10 months after President Barack Obama's Inauguration Day summons to action.

Obama welcomed Reid's action, saying, "Today, thanks to the Senate's hard work, we're closer than ever to enacting solutions to these problems. I look forward to working with the Senate and House to get a finished bill to my desk as soon as possible." There was no mention of Obama's longtime goal of signing legislation by year's end.

Republicans vowed a protracted struggle to block the legislation and deny the president a victory that would cap a tumultuous first year in office. "This bill has been behind closed doors for weeks," said Sen. Mitch McConnell of Kentucky, the Republican leader. "Now, it's America's turn, and this will not be a short debate. Higher premiums, tax increases and Medicare cuts to pay for more government. The American people know that is not reform."

An early showdown on the Senate floor is expected by week's end.

Reid's Senate measure would require most Americans to carry health insurance and would provide hundreds of billions of dollars in subsidies to help those at lower incomes afford it. Medium and large companies would not be required to offer coverage, but they would be forced to pay fees if the government ended up subsidizing their employees' insurance.

Beginning in 2014, the bill would set up new insurance marketplaces—called exchanges—primarily for those who now have a hard time getting or keeping coverage. Consumers would have the choice of purchasing government sold insurance, an attempt to hold down prices charged by private insurers.

After weeks of secretive drafting, Reid outlined the legislation to rank-and-file Democratic senators at a closed-door meeting. "Everyone was positive," said Sen. Amy Klobuchar, D-Minn. That didn't mean there weren't problems—far from it. At his news conference, Reid pointedly refrained from saying he had the 60 votes necessary to propel the bill over its first hurdle.

Reid met privately earlier in the day with Sens. Ben Nelson of Nebraska, Mary Landrieu of Louisiana and Blanche Lincoln of Arkansas, moderate Democrats who have expressed concerns about the measure. Nelson later issued a statement strongly suggesting he would vote with fellow Democrats on an initial showdown expected within days. Aides have said privately that Reid decided to retain an existing antitrust exemption for the insurance industry as a way of satisfying the Nebraskan's concerns.

Landrieu said, "I'm not going to be for anything that doesn't drive down costs over time." Lincoln, the only one of the three who faces re-election next year, told reporters, "We'll wait and see."

With the support of two independents, Democrats have 60 seats, the precise number needed to choke off any delaying tactics by the 40 Republicans who appear united in opposition to the bill in its current form.

In general, Reid proposed an outline that is similar to the House-passed bill, but there were important differences. He called for an increase of a half percentage point in the Medicare payroll tax for individuals with income over $200,000 a year, $250,000 for couples. He also included a tax on high-value insurance policies, meant to curb the appetite for expensive care. The House bill contains neither of those two provisions, relying on an income tax surcharge on the wealthy to finance an expansion of coverage.

Reid's measure also calls for hundreds of billions of dollars in cuts in future Medicare spending, an attempt to satisfy Obama's call to curtail the growth of health care spending that is fiercely opposed by Republicans.

On another controversial issue, Sen. John Kerry, D-Mass., told reporters Reid had decided to require the side-by-side sale of insurance policies that cover abortion services and do not, an attempt to satisfy both sides. That is far less restrictive than a House-passed provision that left liberal Democrats angry.

Ahead lie weeks—if not more—of unpredictable maneuvering on the Senate floor, where Reid and his allies will seek to incorporate changes sought by Democrats and repel attempts by Republicans to defeat the legislation and inflict a significant political defeat on the president.

Reid released his legislation more than a week after the House approved its version of the health care bill on a near party-line vote of 220-215. According to estimates from the Congressional Budget Office, that House bill, with a price tag of about $1.2 trillion, would result in coverage for tens of millions of uninsured, and provide 96 percent of the eligible population with insurance.

Two Senate committees approved different versions earlier in the year, and while Reid has said he would produce a blend of the two proposals, in fact he had a virtual free hand to come up with a plan that could command the 60 votes needed to pass.

Anticipating a major struggle, the White House deputized Interior Secretary Ken Salazar and former Senate Majority Leader Tom Daschle to join Vice President Joe Biden in trying to clear the way for the bill's approval over the next several weeks. Salazar, a former Colorado senator, is viewed as a bridge to moderate Democrats who are far outnumbered by liberals inside the Democratic caucus.

Daschle was Obama's first choice for secretary of health and human services, a position from which he was to try and oversee the administration's drive to enact health care legislation. He withdrew his nomination when it was disclosed he had not paid more than $120,000 in federal taxes over several years.

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