The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Health Care Reform

Biotech Trends Update — Biosimilars: FDA Meeting in November to Discuss BCPI Act Implementation

Adam Feuerstein at reported this morning on a draft FDA notice for a planned November meeting on implementation of the Biologics Price Competition and Innovation Act, which was passed as part of the healthcare reform legislation.

The BPCI Act (42 U.S.C. 262(k)(8)) provides for the FDA to author guidance “with respect to the licensure of a biological product” — pretty broad, so we’ll have to stay tuned for the actual meeting notice. However, the legislation provides some hint in permitting “product class-specific guidance” specifying criteria that will be used to determine whether a biological product is highly similar to a reference product in such product class.

If the FDA decides to move ahead with product class guidance, it would likely specify the criteria that will be used to determine whether a biological product meets the standards for “interchangeability”.

In other cases, the FDA may determine that “the science and experience [to date] … with respect to a product or product class … does not allow approval of a [biosimilar] for such product or product class.”

Bottom line: following the FDA’s November meetings, biosimilars will be one step closer in the U.S.

P.S. Adam Feuerstein cites Alec Vachon (@HEALTH_NOTES) on Twitter for breaking the story Friday. Not sure why I haven’t found him before, but Alec is now added to my Biopharma-IT-Health Twitter list.

Biotech Trends Update — Personalized Medicine: The Case for Diagnostics Focuses on Cost and Effectiveness

A report in FierceBiotech today distilled the views of three life science VCs on trends to watch in 2010.  Along with other worthwhile observations (and I’d encourage you to read the whole thing) was this bullet pointing out the value of personalized medicine in addressing comparative effectiveness concerns:

“Interest in molecular diagnostics is heating up. It’s one of the most attractive areas because physicians are increasingly demanding test that can tell them which treatments have the best chance of working before expensive medicines are issued. And diagnostics fit well with the healthcare reform efforts. Bloch adds that any technology that improves the efficacy of how care is delivered will be attractive to investors.”

The business case is eminently obvious.  Earlier this week AstraZeneca announced a collaboration with Dako Denmark A/S that will see Dako developing companion diagnostics for products in AstraZeneca’s oncology pipeline.  Key quotes from the announcement highlight the companies’ focus on “health care costs” and “reimbursable products”:

“Targeted treatment with personalized medicine is the future, and … is also a significant contributive factor in cutting health care costs” (Dako CEO)

“This agreement … will enable us to develop novel, reimbursable products that … predict which patients are most likely to respond to treatment, ensuring that we are giving the right treatment, to the right patient, the first time.” (AZ Head of Oncology Development)

The economic case for personalized medicine was one of this blog’s top biotech trends in 2009 and looks to continue at a strong pace through 2010.  To reach its full potential, though, the industry will have to convince policy makers and clinicians that personalized medicine can live up to its promise.

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In Praise of Universal Coverage From a Genomics Perspective

This could be the last chance in the U.S. to make good decisions about health care.  Why? Because now, before genome sequencing is fast and cheap and universal, we are in a political position rarely experienced outside philosophy books: we are still in the “original position,” behind the “veil of ignorance.”  I’ll try to make this quick, so forgive my mangling of Rawls.

Making “Just” Decisions

Rawls says that in order to make “just” decisions, you need decision-makers who do not know their “fortune in the distribution of natural assets and abilities, [their] intelligence, strength and the like.” 

That’s very close to the situation we have now — politicians don’t know much (beyond family history) about their own genomes or about their constituents’.  It has led to some good decisions, like the passage of the Genetic Information Nondiscrimination Act, but it’s temporary. 

Lifting the Veil with Genomics

Soon, genome sequencing will be fast and cheap and universal and there will be no more veil of ignorance.  Absent that, “[m]ore powerful parties rely on knowledge of their ‘threat advantage’ to extract favorable terms from those in less advantaged positions.”

For Example

A good example comes from the UK this week (via @jensmccabe).  According to The Times, new guidance from the General Medical Council (GMC) says that when a patient is found to have certain genetic diseases, doctors will be obliged to inform relatives about potential risks to their health.  As with any public health notification, there is a need to balance privacy concerns against public health concerns, but when you’ve struck that balance, should you have to re-visit the decision because of coverage gaps? 

Universal Coverage is the Cure

Universal coverage makes a just decision possible.  People with genetic diseases can be informed of their risk because they won’t lose their insurance or be forced into a high-risk high-cost pool as a result.  If there is no adverse coverage consequence — not availability and not cost — then there is very little “threat advantage” and people remain (functionally) genomic equals when deciding on healthcare policy.

My bottom line: If the U.S. moves into the genomic era without universal coverage, it will exacerbate existing inequalities and create new ones we haven’t even imagined.

First time here? Welcome! The Trends in 2009 page is a great place to start. Also check out the Twitter stream @crossborderbio.

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White House Weekly Address: The Pitch for Health Reform

With the critical Senate Finance bill still pending, here’s the pitch from the White House:

The only two things I heard Obama describe as requirements for a bill he would sign:

  • No addition to the deficit over 10 years; and
  • Insurance exchange: one-stop shop to compare prices, coverage and, interestingly, track record.

He definitely advocated a public plan option, but it wasn’t clear whether that was inside or outside the list of requirements.

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BIO 2009: Wednesday Keynote Lunch Panel on Health Reform Live-ish Blog Part 2

BIO 2009More from panelists Tom Daschle, Bill Frist, Karl Rove and Howard Dean, and moderator health journalist Susan Dentzer (Editor-in-Chief, Health Affairs). Click here for part 1.

Next topic: process. Regular legislative process or reconciliation?

TD – No reconciliation needed as long as current process (esp. Senate Finance Committee) continues to work well in a bipartisan manner.

BF – shouldn’t need to resort to reconciliation.

TD – reconciliation/filibuster go together.

SD says Michael Steele spoke yesterday about taking on the President head on – does that apply?

KR throws Steele under the bus, saying something to the effect that Steele’s statement was about Steele as Chair of the party, not about this debate.

Next: Biosimilars. Will we see a 10-12 year period?

The panel is afraid of tomatoes (or shoes) because both HD (quite explicitly) and TD (less so) get universal nods of assent (and applause) for long exclusivity periods, everyone having temporarily forgotten about the last 45 minutes of universal nods of assent for cost containment. Yay innovation!

SD Wrapping up: looking forward, what can we expect?

BF – A big plan will pass, but not until next year. $1.5 trillion, universal coverage.

HD – This year, public plan.

KR – Congress will not pass a public plan with any Republican support. Totally supportive of a plan that costs no new money and relies entirely on private sector solutions. Can’t fight something with nothing, though, so look for substantive alternatives from Republican participants. Oh, and HD is an “ignorant twit”. Ha ha, he’s just kidding though. The end.

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BIO 2009: Wednesday Keynote Lunch Panel on Health Reform Live-ish Blog

BIO 2009The panelists today are Tom Daschle, Bill Frist, Karl Rove and Howard Dean, and the moderator is health journalist Susan Dentzer (Editor-in-Chief, Health Affairs).

First topic: Harry and Louise (Susan calls them The Two Horsepeople of the Healthcare Apocalypse). Where are they today?

TD – Want to get something done, concerned about costs of healthcare.

BF – Cost. Is a changed system going to be more expensive for them.

HD – Need a public option (not replacement).

KR – Cost, portability, relationship with doctor. 70% with insurance view their current healthcare as good or excellent.

Second topic: current plans on the legislative table.

BF – Responsibility to insure uninsured (a number he puts at 15-18 million). Mirrors a point KR made in response to HD – the risk of “crowd-out”, i.e., people being “dumped” from private plans and other market-distorting effects of having a public plan.

SD – Public plan in House bill, not clear in Senate. Outcome?

HD won’t prognosticate. Comes back to putting both options on the table.

KR – Don’t need public plan to provide choice, cf Medicare drug plan.

Panel drinking game: take a shot every time someone cites a poll with obviously biased question language. Seriously, people, room full of empiricists here.

Third topic: how to pay?

BF – wins for working “taxes” and “spending” into a single sentence.

HD – Gas tax at 10 cents a gallon would pay the whole thing.

TD – Will lose the debate if people believe the reforms won’t create savings overall.

HD and KR fight about whose deficit is bigger, and I’ll move the rest to a new post.

 Click here for Part 2…

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What You Missed While You Were at BioFinance

A lot to catch up on over the last few days…

And last but not least:

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Health Care Reform: Party’s Over for Medical Imaging

mri-kneeWell…it could be worse, but one could argue it’s the beginning of a slow decline for the medical imaging market in the U.S.  On Tuesday, Senator Baucus (D-Montana) and Senator Grassley (R-Iowa), Chairman and Ranking Member of the Senate Finance Committee, released a description of policy options for healthcare reform

The options included “Transparency and Evidence-Based Decision-Making for Imaging Services,” proposing a system that sets “national appropriateness criteria” for imaging procedures (see page 7).  Good so far. The system also includes standarized reporting to monitor rates of adherence to appropriateness criteria.  Uggh, but fine. Then, in 2013,  the Secretary would designate the imaging procedures for which reporting and differential payment will be mandatory and imaging procedures for which reporting will be voluntary based on baseline rates and amount of progress toward goals. This creates a system whereby access to specific imaging services and reimbursement can be further curtailed, and it will. Soon, we might see the term “medically necessary” thrown around in the U.S., a term many Canadians waiting months for an MRI have learned to hate.

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BioFinance Lunch Keynote: U.S. Health Reform

Just finished listening to Scott Gottlieb at the BioFinance lunch keynote. Scott was Deputy Commissioner at the FDA in the Bush administration, and is now a Fellow at the American Enterpirse Institute.

Here’s what he had to say. Stay tuned for questions from the audience, including Dani and I, at the end…

Healthcare in the U.S.

First, good flu vaccine news: current surge capacity for vaccine production is up to half a billion (500,000,000) doses, much better than even a few years ago.

Update: the MaRS Blog has a video of this part of Scott’s talk.

Health care reform:

FOB: Waxman can’t get his bill out of committee. Likely booted to next year.

Comparative Effectiveness: will be a committee in the fall that sponsors research and promulgates guidelines.

1) Medicare has tried to implement some CE: functional equivalence (legislated away), least costly alternative (e.g., wheelchairs) tried to apply to Sepracor, got sued, lost on appeal; tried to take accelerated approval drugs out of reimbursement, didn’t fly. Legislation likely to pass giving CMS back authority to do least costly alternative reimbursement.

Large private plans have hundreds of physicians and thousands of clinicans, CMS has at best 25 physicians. E.g., have made 160 decisions on cancer product reimbursement without a single oncologist on staff.

2) Price controls: private market will be increasingly able to pay off medicade pricing schedules. Drug benefit for dual-eligible patients will be moved to medicade best price schedule.

Similar changes: medicare advantage plans will want to be able to price off medicare if their reimbursement rates are cut.


“Regulatory creep” at the FDA: balance shifts on approval metrics debates because of increased public desire for and tolerance of regulatory caution.

Medical devices: changing regulatory paradigm for diagnostics. Laboratory-developed tests will likely be regulated as devices. Kennedy has a bill pending.

I asked about the regulatory environment for personalized medicine, and Scott pointed interestingly to different regulatory approaches taken in the U.S. vs EU to screening HER-2 as a precursor to Erbitux treatment for colon cancer. EU uses it based on retrospective data, U.S. has wanted to do dedicated prospective controlled trials.

Dani asked about drug reimportation: Scott thinks it will happen, but regulatory structure and currency changes will increase cost, and increased drug reimbursement in the U.S. will decrease demand.

Brian Bloom, a banker at Bloom Burton, asked about how the Obama administration’s vocal support for innovation meshes with the health care reforms and comparative effectiveness initiatives. Scott diplomatically focussed on the administration’s support for basic reseach, then segued less diplomatically to predict the end of cancer drug development that he says could follow if the NICE model in the UK is globalized.

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