Back when I wrote my book during
2009-10, I was disappointed and frustrated with the US efforts at antibiotic
regulation compared to the rational and advanced view in Europe. Europe made
the development of new antibiotics against resistant infections a top priority
for their regulatory body – and the EMA (European Medicines Agency) came
through. The US had no such stance and it took the frustration of a few leaders
in the upper management of the FDA to finally realize that they were driving on
the wrong side of the road and taking us into a head-on collision. Although the results of their “reboot” are not
perfect, and there are a number of things I would like to change (particularly
their endpoints for trials), I think that as far as regulatory reform goes, we
have come a long way since those dark days when I was hammering away at the
keyboard.
Our next challenge is to do the
best we can to contain resistance and at the same time to be prepared for its
inevitable emergence. In facing this challenge, no one, not the US, not Europe,
not Asia, no one is anywhere near ready. We have task force after task force
working on the problem and mostly coming up with the same old same old. The
GAIN act in the US is a great example.
Politicians crow about how they are helping in the fight against
resistance while not spending precious taxpayer dollars. But the GAIN act has not been sufficient to
entice large pharmaceutical companies to get back in to the antibiotic R&D
effort. And that result was predictable and predicted by yours truly among many
others. The best thing about the GAIN act was that it required the FDA to get
its act together. But on the business side, it offered only a patent
exclusivity extension that was modest at best for antibiotics active against
resistant strains. This benefited only a
small number of small companies that had products facing the end of their
patent lives when they were introduced to the market.
If we want to restrict the use of
antibiotics to avoid the emergence of resistance for as long as possible, the
first thing to do is to restrict their use in agriculture. In spite of statements by the PCAST – I
believe this is a no-brainer. Next - we
have to provide a business model that makes sense. The GAIN act is not going to cut it and the
industry has demonstrated that by, for the most part, voting with its feet.
Although two companies have re-entered the antibiotics game in recent years
(Sanofi and Roche), many more have left. Now we have AstraZeneca threatening to
depart as well.
In an article that appeared in the
New
York Times today, the industry decries the increasing cost of bringing new
therapies to market and notes that antibiotics are on the bottom of their
priority list because their return on investment is so low. But it doesn’t have to be that way. In the same article, the ex-head of R&D
at Pfizer, John LaMantina says that firms are pursuing niche diseases and
orphan indications where the return is lower but where the costs are much
lower. Antibiotics of the future are going to fit in exactly that scenario –
they will be niche products that will cost less to develop and will bring in
less total dollars, but where the value will be attractive. If, that is, we can get our societal act
together and make sure that happens.
What business models would work
and how would this effect taxpayers and governments? First – we all must realize that there is no
free lunch. Either we spend money on
antibiotics that can cure resistant infection, or we pay the price in longer hospital
stays, more time on ventilators and in lives lost. My choice is the former- I
don’t know about you.
1.
The traditional pricing model.
This is what Gilead is doing with Solvadi – its new drug for Hepatitis C
infection. In this scenario, small numbers of patients with demonstrated
infection with a resistant pathogen or with a high risk for such would receive
an antibiotic active against the resistant strain and pay up to $30,000 for a
course of therapy. The cost would be
covered by health insurance, medicare, Medicaid, government and other payers in
the US and by the national health authorities in Europe (good luck there).
2.
Guaranteed government purchases.
Here, governments would guarantee a certain upfront purchase of the
antibiotic at the time of approval by the regulatory agencies. The price
charged per course of therapy in each country would depend partly on the amount
of its advance purchase. This serves to de-link the drug to some extent from
the need for the company to spend money on marketing. Marketing costs about 25-30% of total sales
of any antibiotic. Also, the guaranteed purchase, coming right after approval,
not only saves marketing spend that is normally especially intense at launch,
but also increases the overall value of the antibiotic by decreasing its
associated costs.
3.
The wild card patent exclusivity.
This is something I pushed with the Infectious Diseases Society during
the preparation of their Bad Bugs No Drugs white paper. In this formulation, a
drug company that brought forward a new antibiotic would be allowed to have 6
months to two years of additional patent exclusivity on another drug of their
choice. For example, Pfizer might have
been able to have additional time to sell its branded Lipitor that was selling
$15 billion per year. When the IDSA tried to lobby this in congress, they met a
brick wall. The generic manufacturers,
insurers, and almost everyone else was against it.
But look – we have to pay
somehow. I offer a few choices for how
we might pay – but I am sure there are lots of other choices that I have not
considered.
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