UK allows private top-ups, privately


The UK department of health has published guidance for the national health service on
how to handle patients who want to pay out-of-pocket for licensed drugs that are not
funded by their local health authorities.
Private top-ups to publicly funded healthcare became the subject of heated political
debate after the health technology assessment agency for England and Wales, NICE,
refused to recommend several expensive anticancers for routine use in the NHS on the
grounds of cost.
Patients in some hospitals were allowed to purchase drugs privately and have them
administered at public expense, but other hospitals refused to combine public and private
treatments, insisting that patients choose one system or the other for all of their care.
Some public figures objected to these uneven policies - a postcode lottery, they said -
while others denounced top-ups as the beginning of a two-tier healthcare system. Still
others called for NICE to be abolished, arguing that no patient should be denied
treatment on the grounds of cost.
Professor Mike Richards, the national cancer director, studied the problem and
recommended last year that private payments should be allowed within the health
service. After a consultation period, the government accepted his proposals; the new
policy took effect on March 23rd.
The main principles of the department's guidance are that NHS care should not be
withdrawn from patients who choose to buy additional private care, and that the NHS
should continue to provide free of charge all care that the patient would have been
entitled to had he or she not chosen to have additional private care. But it says the NHS
should never subsidise private care with public money.
It calls for a strict separation of private and public healthcare. "Private care should be
carried out in a different place to NHS care, as separate from other NHS patients as
possible," it advises. By "a different place", it means private facilities or part of an NHS
organisation that has been "permanently or temporarily designated for private care, such
as a private wing, amenity beds or a private room."
Among several illustrations, the department's guidance describes a cataract patient who
wants to pay for a multifocal replacement lens rather than have the NHS standard single
focus lens inserted during surgery. The patient should be informed "that it is not possible
to pay for the multifocal lens while carrying out the surgery on the NHS as it is not
possible to separate the private element from the NHS element of care". SCRIP - World
Pharmaceutical News - www.scrippharma.com FILED 26 March 2009 COPYRIGHT
PHIND: Pharma & Healthcare Ind News - today only (PHID)
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Informa UK Ltd 2009


Drug-Industry Shakeout Hits Small Firms Hard

Another Wave of Acquisitions Is Likely as Companies Worry About Their Drug Pipelines and Health-Care Change – March 10, 2009

Drug makers have begun a frenzied consolidation drive that is redrawing the industry landscape.
Merck & Co.'s $41.1 billion agreement to acquire Schering-Plough Corp., announced Monday, follows Pfizer Inc.'s $68 billion January takeover deal for Wyeth. Roche Holding AG's seven-month pursuit of Genentech Inc. was also nearing an agreement Monday, according to people familiar with the situation.
The push to consolidate is being driven by the knowledge that the big companies' pipelines aren't producing enough new moneymakers to keep growth going when major products lose patent protection over the next couple of years. As a result, the drug giants are looking to consolidations that will cut costs by combining research and sales efforts and eliminating other overlaps.
What will be left is an industry dominated by behemoths, raising questions about the fates of smaller drug companies, as well as the countless small biotechs hungry for suitors. Even though their labs aren't what they used to be, the major pharmaceutical companies have product lineups that still command fat margins, giving most of them the cash to pursue deals.
"There are too many companies chasing smaller revenue opportunities, so there's got to be a shakeout," says analyst Tim Anderson at Sanford C. Bernstein & Co. "If you've got cash and the value of the companies you want to buy is lower, it's the perfect setup."
Johnson & Johnson seems most likely to be involved in the next wave of consolidation in the drug industry, analysts say.
There could also be pressure tied to moves in Washington, where health-care reform could eat into margins. Bigger drug companies might be in a better position to bundle their products and negotiate with the government, analysts say.
The wreckage on Wall Street is also a factor: The health-care sector is traditionally viewed as a relatively safe bet, making it easier for drug companies to get financing than other industries.
But megadeals haven't cured industry problems in the past. Pfizer paid $116 billion for Warner-Lambert in 2000 and an additional $54 billion for Pharmacia in 2003, yet still needed to acquire Wyeth this year to help replenish an anemic pipeline.
As the dust settles, Eli Lilly & Co., Bristol-Myers Squibb Co., AstraZeneca PLC, Sanofi-Aventis SA and Johnson & Johnson seem most likely to be involved in the next wave of consolidation, analysts say. Factors including existing partnerships, the timing of patent expirations and how well drug makers can absorb multiple acquisitions could affect who will be a buyer and who will be a seller.
"Bristol and Lilly stand out in terms of size versus the rest of the industry," says Les Funtleyder, an industry analyst at Miller Tabak. "They'll have to do something, because it's a consolidating industry."
Lilly, based in Indianapolis with a market capitalization of $32 billion, will lose patent protection on its bestselling antipsychotic Zyprexa in 2011. It just bought ImClone for $6.5 billion. Mr. Anderson suggests it could merge with Bristol-Myers, whose chief executive, James Cornelius, came from Lilly.
Lilly, which has strong ties to Indiana and an undesirable series of patent losses coming up, would be more likely to buy than sell. "There's no way Lilly's a takeout," says Mr. Anderson.
Mark Taylor, a Lilly spokesman, says, "We're not interested in large-scale M&A activity in pharma and believe small and medium scale acquisitions, licensing and internal development" are the best way forward for Lilly.
Bristol-Myers faces a similar dilemma, because Plavix, the bloodthinner it sells with Sanofi-Aventis, faces generic competition in 2011. A merger with Lilly could face antitrust hurdles because both companies have clotting drugs and antipsychotics. A tie-up with Sanofi-Aventis is frequently rumored because of Plavix.
Bristol-Myers sold its ConvaTec wound-care business last May for $4.1 billion and offered a $720 million partial initial public offering for its nutritional business last month -- divestitures that could either add to its war chest for deals or make it a more attractive takeover target. Bristol-Myers declined to comment.
Sanofi-Aventis's new chief executive, Christopher Viehbacher, said in an interview last week that he isn't seeking a megamerger but would consider deals of under $19 billion. Some analysts say that could leave Sanofi-Aventis open to buying the U.S. biotech company Biogen Idec Inc., which has a market value of $13.3 billion. Both companies have declined to comment.
Another possibility for Bristol-Myers could be a deal with Britain's AstraZeneca because the companies are co-developing a drug for diabetes called saxagliptin. One rationale for the combination of Merck and Schering-Plough is to run the companies' joint venture selling the cholesterol medicines Vytorin and Zetia under one roof. AstraZeneca declined to comment, but has said in the past it's not interested in big deals.
Catherine Arnold, a drug-industry analyst at Credit Suisse, says that hasn't stopped companies in the past. "Sanofi, Glaxo and Novartis have said they're not interested in big deals, but Jeff Kindler said that nine months ago," she said, referring to a statement in March 2008 by Pfizer's chief executive that he did not see a megamerger on the horizon.
Meantime, 180, or 45%, of publicly traded biotech companies have less than a year of cash on hand, and about half are trading below $1 a share, according to BIO, the trade group for the biotechnology industry based in Washington.
But biotech acquisitions aren't a panacea. One reason is that small companies offer little opportunity for cost savings. Another is the worry that founders and scientists will leave if their companies are taken over.
In the interview last week, Mr. Viehbacher indicated his preferred strategy would be to enter partnerships with biotech companies rather than acquire them. "You don't want to bring them in to the mother ship because then you ruin it," he said.
The severe funding crunch facing small biotech companies is prompting worries that important new drugs won't make it to market, impeding the progress of medicine. "Innovation has been on the biotech side, but now the money is gone," says Edward Saltzman, president of industry consultant DefinedHealth. "We're in a pickle."
Meanwhile, the next target could actually be Schering-Plough. Johnson & Johnson, an historically acquisitive company, could throw a wrench in Merck's plan by making a more attractive offer for Schering. J&J sells Remicade, an anti-inflammatory drug, with Schering-Plough, and a deal for the company could give it full rights to the drug.
--Jeanne Whalen contributed to this article.
Write to Avery Johnson at avery.johnson@WSJ.com and Ron Winslow at ron.winslow@wsj.com
Printed in The Wall Street Journal, page A12


Drugs to be approved for NHS use within six months, ministers announce

Patients will get approved drugs on the NHS within six months instead of waiting up to two years, as ministers announce plans to speed up the National Institute for Health and Clinical Excellence.

by Rebecca Smith, Medical Editor, The Daily Telegraph
Last Updated: 2:12PM GMT 03 Mar 2009

The drug rationing body, Nice, has been accused of being too slow in its appraisals of drugs meaning patients are forced to wait years for medicines which may prolong their lives.

Ministers have announced a package of measures to speed up the process including adding another committee of experts to consider the drugs and 'horizon scanning' earlier in the drug development programme for medicines that will need to be referred to Nice.

The move comes after Nice ordered its committees to put extra weight on the final months of life when appraising drugs for terminal patients with rare conditions.

This followed public outcry over draft guidance which did not approve four kidney cancer drugs, including Sutent, which can extend the lives of sufferers by months.

Guidance is being issued to primary care trusts which decide whether to fund drugs where Nice has not appraised the drug or has not yet come to a decision.

PCTs have their own panels which consider individual patients for 'exceptional case' funding but this has led to a postcode lottery where all people in one area may be funded but none in a neighbouring area. The guidance is aimed at making the decisions more consistent and training will be provided to help.

Health Minister, Lord Darzi, said: "Last year in High Quality Care for All I set out our commitment to speed up the Nice process. Together, the measures set out today build on this commitment and will help provide faster and fairer access to new drugs and treatments – great news for patients.

"We are delighted to be working in partnership with Nice to ensure that new drugs and treatments are assessed sooner and more quickly in future, leading to improved and higher quality care for patients.

"The guidance for PCTs will help the NHS to ensure that local decisions are robust and transparent, leading to more consistency in those exceptional cases where there is no existing NICE guidance."

Andrew Dillon, Chief Executive of Nice, said: "This is an important consultation on the way that topics are chosen and referred for Nice's world-leading appraisals of new drugs and treatments. We are very keen to ensure that our guidance is produced as quickly as possible to benefit patients and the NHS.

"Speeding up non-cancer appraisals by at least three months to come in to line with the cancer appraisals, and increasing transparency by clarifying topic selection criteria, are just some of the potential improvements we and the Department of Health are suggesting.

"The views of patients, the public, health professionals and other stakeholders on the proposed changes to the topic selection process will be very helpful, and we look forward to receiving their comments."

A consultation on the proposals will run for three months.


Obama aims big with healthcare drive

by Stephen Collinson - Mon Mar 2, WASHINGTON (AFP)

President Barack Obama Monday launched a high-stakes drive to remake US healthcare, in his latest attempt to ensure his sweeping agenda is an antidote to and not a victim of the economic crisis.
The president unveiled Kansas Governor Kathleen Sebelius as his new pick to be secretary for health and human services (HHS) ahead of a bi-partisan White House healthcare summit on Thursday.
He also picked health expert Nancy-Ann DeParle as his counselor to coordinate White House efforts to achieve healthcare reform.

"If we are going to help families, save businesses, and improve the long-term economic health of our nation, we must realize that fixing what's wrong with our health care system is no longer just a moral imperative, but a fiscal imperative," Obama said in a written statement.
"Healthcare reform that reduces costs while expanding coverage is no longer just a dream we hope to achieve -- it's a necessity we have to achieve."
Both appointments replaced that of former senator Tom Daschle, originally nominated to simultaneously serve as HHS secretary and White House health czar but who was forced to pull out over a storm over unpaid taxes.
Obama shone a spotlight on healthcare after he placed the issue, a political gamble which has dogged previous Democratic presidents, at the center of his budget last week.
The president asked Congress for 634 billion dollars over 10 years as a "down payment" on refashioning a largely private system which offers some of the world's best care, but leaves nearly 46 million Americans uninsured, according to the National Coalition on Healthcare, an umbrella reform group.
His insistence on pushing the legislation confounds critics who warn Obama must curtail his political wish list because of the economic turmoil and Republicans who charge his plans are too expensive.
Sebelius, 60, who will require Senate confirmation and was once said to be in the running to be Obama's Democratic vice presidential nominee, is serving in her second term as governor of her heartland state.
News of her nomination was welcomed by Democratic Senator Max Baucus, who with ailing Democratic legend Senator Edward Kennedy, plans to pilot healthcare reform through Congress.
"Passing comprehensive health care reform is an absolute imperative this year, and as a former insurance commissioner Governor Sebelius really gets what needs to be done," Baucus said.
But the arrival of Sebelius in Washington was heralded by newspaper stories delving into the questionable success of her past efforts to reform healthcare in Kansas and Republican criticisms.
The Republican National Committee distributed research accusing the president of plotting billions of dollars of new taxes on Americans to pay for healthcare.
It accused Sebelius of being "in the pocket" of labor unions and of also being a prophet of high taxation.
White House officials have already warned Republicans would try to derail the president's healthcare plan and force a victory which would severely diminish his political clout.
Former president Bill Clinton's failed healthcare reform drive, under the direction of his wife Hillary Clinton, still sends shudders down the spines of leading Democrats.
But Obama's budget chief Peter Orszag warned on Sunday that there was no alternative to reforming healthcare -- a priority he said could end up being one of the primary drivers of economic recovery.
"We're going to get health care reform done this year. I think this proposal will get enacted," he said.
The plans are guaranteed a rough ride in Congress where attempts to cover all Americans are often derided by minority Republicans as European-style "socialized medicine."
Obama plans to finance the reforms by letting tax breaks for the rich expire in 2011, and to streamline other healthcare programs.
One of Obama's first actions after taking office in January was signing into law expanded healthcare coverage for low-income children -- a measure vetoed by former president George W. Bush.
With the US economic recession deepening, there are fears that millions more could be added to the ranks of the uninsured, since many rely on employers or their own wage checks to pay for coverage.