domingo, março 1

Obama’s health budget


O presidente Obama, pretende através da implementação de medidas de política fiscal, obter o financiamento necessário destinado a melhorar o acesso do sistema de saúde.

«President intends to release a budget tomorrow that creates a 10-year, $634 billion "reserve fund" to partially pay for a vast expansion of the U.S. health system, an overhaul that many experts project will cost as much as $1 trillion over the next decade.
Obama would pay for the expansion by trimming tax breaks for the wealthy and tightening payments to insurers, hospitals and physicians, according to a senior administration official.»

Efectivamente, o orçamento proposto pela administração Obama prevê a dotação de uma verba de 634 mil milhões destinado à reforma do sistema de saúde, proveniente do aumento de impostos e corte de despesa: $318 mil milhões, aumento de impostos sobre rendimento mais elevados (redução das deduções fiscais, aumento das comparticipações do medicare), $175 mil milhões de corte de financiamento ao Medicare HMO e $141 mil milhões de cortes dos gastos federais com a saúde (durante dez anos).

Entre as fontes de financiamento deste fundo, Interessante a expectativa do Presidente Obama em relação à poupança gerada pela introdução de medicamentos biosimilares.
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«President Obama’s budget, released today, is set to remove barriers to creating generic biologics. The administration is expecting to use the money the federal government would save through use of biogenerics to help pay for a major overhaul of the healthcare system»

Acontece que nos EUA, não existe legislação sobre a aprovação e comercialização de medicamentos biosimilares .
Na EU, a Comissão Europeia adoptou em 2004 uma directiva a autorizar o desenvolvimento de similares de medicamentos biológicos. Na EU, os biosimilares são aprovados sem grandes estudos clínicos, apenas com testes de equivalência.

Enquanto isso, nos EUA, sucessivas propostas de lei com vista à aprovação de biosimilares, esbarraram nos múltiplos conflitos de interesses, nomeadamente dos laboratórios de biofármacos .
Estamos, pois, perante um objectivo extremamente difícil. Para contar com esta poupança, o presidente Obama vai ter muito que esperar (suar).

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4 Comments:

Blogger tambemquero said...

Biosimilar medicines are now a reality in the European Union. The necessary legal framework for biosimilar medicines has been solidly established in the EU and the first biosimilar medicines were approved by the European Commission in April 2006, with the endorsement that each of them “has been compared to and matches the reference medicine [...] in terms of quality (how it is made), safety (for example the side effects that can occur when receiving treatment are similar), and effectiveness.” Guidance on risk management systems has also been developed which assures safe market entry and post-marketing monitoring of these medicines.
In addition, a legal framework has been in place since 30 October 2005, which allows the performance of tests and trials in view of obtaining authorisation for a biosimilar medicine in the European Union without breaching patent law. This will facilitate the development of biosimilar medicines on the European territory. link
link

Biosimilares: Um tema interessante para discussão.

1:25 da tarde  
Blogger tambemquero said...

Arlington, VA, February 26, 2009 – The Generic Pharmaceutical Association (GPhA) today applauded President Obama’s budget proposal for including a workable approval pathway for biogenerics that will substantially reduce health care costs by increasing access to quality care at affordable prices. The President’s budget proposal would ensure that this process mirrors the proven Hatch-Waxman market exclusivity model, by ensuring that brand companies cannot extend exclusivity using “ever-greening.”

“For patients across the country suffering from cancer, diabetes and other diseases, the support stated by President Obama today for a workable biogenerics approval pathway is lifesaving news. With countless patients struggling to pay the high costs of brand biopharmaceuticals, an approval pathway for safe, effective and affordable biogeneric medicines that provides access sooner rather than later is desperately needed. GPhA applauds the President’s budget message specifically stating that a workable scientific, regulatory and legal pathway with exclusivity provisions consistent with the Hatch-Waxman model must be enacted. The exclusivity provisions of Hatch-Waxman have been a successful model, fostering innovation and competition while saving hundreds of billions of dollars, and this same success can be achieved with biogenerics,” stated GPhA President and CEO Kathleen Jaeger.

As empresas do sector aplaudem, como seria de esperar, esta iniciativa do presidente Obama.
Esta guerra promete.

1:38 da tarde  
Blogger helena said...

O FDA não tem aprovado uma regulamentação porque considera que o perfil de segurança e eficácia das cópias dos biofármacos representam um desafio que eles não podem garantir posto que:
• Os métodos analíticos atuais não podem predizer com exatidão as propriedades biológicas dos biossimilares;
• O sistema imune pode detectar alterações nos produtos biossimilares que não são detectadas pelos métodos analíticos;
• A imunogenicidade dos biofármacos pode ter efeitos negativos sobre a eficácia do medicamento e conseqüências clínicas no paciente.

4:08 da tarde  
Blogger ochoa said...

The President's Budget
By MAGGIE MAHAR

Earlier this week, I suggested that the Commonwealth Fund’s recent proposal for healthcare reform underlines just how difficult it will be to build a sustainable, effective, safe healthcare program for all Americans.

President Obama’s budget reinforces the message. His ten-year $634-billion plan for funding healthcare reform depends on “asking the wealthy to pitch in a bit more” (budget director Peter Orszag’s happy phrase), wringing some of the waste out of Medicare and Medicaid (cuts that are needed, but that will not be popular ); and strong-arming drug makers to raise discounts on Medicare drugs from 15 percent to 21 percent. About half of the money will come from changes in government programs, half from tax increases.

As the Congressional Quarterly reports , “the new proposals for tax hikes on couples earning over $250,000 “will immediately test the limits of the new political dynamic on Capitol Hill in the midst of a recession.” And even then, the budget provides only a “downpayment” on healthcare reform-- roughly half to two-thirds of what is likely to be needed to cover everyone.

With this sobering news, the discussion of healthcare reform both in the blogosphere and in the mainstream press is becoming more realistic. This is both refreshing and encouraging. No more rose-colored glasses. No more “we’ll worry about how to fund it later.” Or “it will pay for itself.”

This is an administration that is based in reality (in contrast to the faith-based governance that we enjoyed for the past eight years.) The Washington Monthly's, Steve Benen notes “The administration seems well aware of the fact that a $634 billion over 10 years would not cover literally everyone. Neera Tanden, a top Obama health adviser, acknowledged , ‘We know that this is not enough to achieve our overall goal of getting health care for every American, but it is a significant down payment.’”

A hard-headed administration is dragging, us, however reluctantly, into a world where numbers matter. At the New Republic, the usually optimistic Jonathan Cohn acknowledges that “the amount [set aside in the budget] will not be enough to finance full universal coverage . . .The budget will call for finding that money, although that obviously raises another question: Just how much more would it cost to get everybody (or nearly everybody) covered ?”

“The answer,” Cohn writes, “depends in part upon how you define ‘decent’ and how quickly you want to get there. Passing a universal coverage plan in 2009 wouldn't necessarily mean covering everybody in 2010. Or 2011. Or, well, you get the idea . . .”

Cohn and other reformers are beginning to admit the enormous difference between passing a very broad piece of legislation that sets goals-- and implementing that legislation, which means hammering out the details, admitting to mistakes, recognizing failures, and making changes.

Health care reform will be a work in progress for a long, long time.

As I have said repeatedly, it’s unlikely that we can achieve universal coverage before 2013. The politics are just too tough. And finding the money—this will require sacrifices and hard trade-offs

In the past, Cohn, and reformers such as Jacob Hacker have suggested that we could fund healthcare reform with more deficit spending. You know, just keep our fingers crossed that China will pay for MRIs all around, by continuing to buy our Treasuries at, say, 1 percent. As I noted yesterday in my analysis of the President’s speech, this is not what Obama plans to do.

The AP’s Ricardo Alonso-Zaldivar confirmed what I've heard recently: “The president’s 10-year, $634-billion healthcare plan makes some key political and policy statements. For starters, any expansion of health care coverage has to be paid for — it can't just be tacked onto the deficit.”

Worrying About the Money First

Alonso-Zaldivar notes that President Obama is focusing first on controlling healthcare inflation: “Clinton started out with the goal of covering everyone. Obama has framed the problem in a different way: slowing the increase in costs, so that eventually everybody can be covered.

“Obama is asking Congress: If you're going to cover 48 million uninsured people in the world's costliest health care system, how do you pay for it?” As I wrote in a comment on the president’s speech published on the New York Times’ “Room for Debate” yesterday, Obama is bouncing the funding problem back to Congress. He has come up with suggestions that will not be popular with everyone. Now it’s their turn. Fair enough.

"’The approach he's taking is to put some tough decisions on the table, and then bring people together to have a conversation,’ " Christine Ferguson, former senior Republican health policy aide at the federal and state levels told AP. "’You put those on the table, and if people want to have this discussion, they have to propose alternatives .’"

Where the Money Comes From

How will the wealthy “pitch in”? Obama’s budget lets the Bush administration's tax cuts for more affluent households expire, allowing the marginal rate on household incomes above $250,000 to rise from 35% to 39.6%. His blueprint also asks wealthier Medicare beneficiaries to shell out higher premiums to participate in the prescription drug plan, much as they now pay higher premiums to be in the Medicare plan that covers doctors’ visits.. (This worries me; anything that might undermine solid support for Medicare by dividing beneficiaries by class could prove a problem.)

In addition, the president proposes reducing the value of itemized tax deductions for everyone in the top income tax bracket, ( 35 percent,) and many of those in the 33 percent bracket — roughly speaking, starting at $250,000 in annual income for a married couple. The administration’s budget slices the value of deductions for these families by about 20 percent .

“Under existing law,” the New York Times explains, “the tax benefit of itemizing deductions rises with a taxpayer’s marginal tax bracket (the bracket that applies to the last dollar of income). For example, $10,000 in itemized deductions reduces tax liability by $3,500 for someone in the 35 percent bracket. Mr. Obama would allow a saving of only $2,800 — as if the person were in the 28 percent bracket.

“The White House says it is unfair for high-income people to get a bigger tax break than middle-income people for claiming the same deductions or making the same charitable contributions.” The changes also would trim the value of mortgage deductions.

As expected, the president plans to slash the windfall bonus for insurers that offer Medicare under Medicare Advantage. Under current law, payments for Medicare Advantage plans are set by a formula, and the result is that private companies are paid, on average, 14% more to care for a Medicare patient than the government would normally spend through the traditional Medicare plan.

The Obama plan would have private insuers bid to offer coverage to people in a given geographic areas: they would be paid on an average of the bids in the area. He hopes to save $175 billion over 10 years with the new bidding system. (I hope this also means much stricer regulations about what Medicare Advantage plans can cover- restricting cost-shifting to very sick patients.).

Requiring drug-makers to boost discounts for Medicare patients to 21 percent should cent save another $19.5 billion. Finally, Bob Laszewski reports that the “the president’s budget would reduce Medicare hospital payments by $17 billion over ten years by bundling inpatient and outpatient reimbursements to include the 30 days after discharge, and save another $8.4 billion in hospital reimbursements by refusing to pay for readmissions that result from substandard care.” By bundling payments, the administration hopes to encourage hospitals and physicians to work together to make sure that patients receive follow-up care and do not need to be readmitted.

Redistributing Income

As I have noted in recent posts, today wealth and income is concentrated among American families at the top of the income ladder. This has led, not only to growing inequities, but financial speculation that has had disastrous results for the economy. When too much money chases too few things, the very wealthy begin blowing bubbles . . . .

This budget begins to redistribute income, not only by raising taxes on the wealthy, but by lowering taxes for low-income and middle-income workers while extending the new “Making Work Pay” tax credit beyond two years .

According to the Times, “the administration will argue that this tax relief, will offset households’ higher costs for utilities and other products and services." The current tax credit provides $400 to individuals earning less than $75,000 workers and $800 to couples earning less than $150,000. (Individuals earning up to $100,000 and couples earning up to $200,000 also receive a break, but not the whole credit.”

Going forward, the president would like to lift the credit to $500 for individuals and $1,000 for couples.

Resistance

The administration knows that its budget will face fierce resistance, from drug-makers, from some Medicare providers, and from Republicans who will object to the fact that, after 29 years of redistributing income upstream, this administration plans to reverse course. Already, Republicans have begun to sputter about the idea of afflicting the affluent, particularly during a recession.

Many voters will agree, arguing that for a family living in many cities and suburbs, a joint income of $250,000 just doesn’t make you "rich." (It does however, mean that the household is hauling home more than 98 percent of all American families; it’s hard to call the top 1.9 percent “middle-class.”)

Today, even Democratic Finance Chairman Max Baucus waffled on the tax increases: “Mr. Baucus acknowledged that ‘there has to be revenue’ to offset the costs of expanded coverage initially,” the New York Times reported, “but he did not endorse the proposal for limiting wealthy taxpayers’ deductions.”

“’There will be lots of options to pay it, not necessarily that one,’” Mr. Baucus said. “He would not say what revenue options he would support.” In the past, sources in Washington have told me that Baucus would like to find a “pain-free” way to pass healthcare reform. I wish him the best, but--- he need to spend more time with the reality-based folks.

With this budget, President Obama has tried to spread the pain, but even so , he will have to use his considerable powers of persuasion to convince some Democrats, as well as Republicans, that if we want universal coverage, we must pay for it—and the only people who are in a position to pay for it are those that have the money. I suspect that the public will understand this. And if the president appels to voters, they will persaude their Congresmen. Or vote them out of office.

President Obama might begin by pointing out that, when compared to the citizens of other developed countries, our tax burden is not heavy. As the chart below reveals, the U.S. government’s total revenues—from taxes and other sources—represent a much smaller share of GDP than in most European countries. And note that in countries with some of the best healthcare systems (Germany, France, Denmark government revenues, measured as a share of the economy, are 30 percent to 50 percent higher. Of course those taxes fund an entirely social safety net which includes education and pensions, not just healthcare.

RevenueSpending2007

But 21st century healthcare accounts for a large chunk of social spending in any country. If we want to high quality universal coverage—just like those other countries—it seems only logical that taxes will have to rise, particularly in the early years of healthcare reform.

Make no mistake, covering everyone will cost more. In an earlier post , I quoted Paul Ginsburg, of the Center for Healthcare Systems Change, pointing out that “over the past decade, the decline in the percentage of Americans who have insurance has slowed the rate of health spending growth. “ If everyone had been insured, our national health care bill would be even higher..

Why? The uninsured die sooner –and so we save the money we would have spent if they had lived to develop expensive chronic diseases like Alzheimer’s or cancer.

Over the long term, we can learn to redistribute our health care dollars and get better value for those dollars, paying some doctors more, others less; depending on how much their treatments benefit patients, paying hospitals and doctors for better outcomes, not volume; and agreeing to accept evidence-based guidelines for care. But this means experimenting —finidng out what works and what doesn’t. It also means changing our expectations—and turning our backs on the excesses and self-indulgence that have created a bloated, profit-driven health care system.

I believe we can do that. But the solutions are not simple.President Obama understands this.

12:23 da manhã  

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