Although drug regulators aren’t supposed to
be concerned with pricing when making decisions on products’ safety and
efficacy, they’re increasingly being drawn into what two
representatives of the European Medicines Agency (EMA) and the heads of
two national regulators call an “acrimonious debate” over drug costs.
In a
New England Journal of Medicine
editorial published Thursday, EMA’s Executive Director Guido Rasi, its
Senior Medical Officer Hans-Georg Eichler, the Executive Director of
the
Dutch Medicines Evaluation Board Hugo Hurts and President of the
German Federal Institute for Drugs and Medical Devices Karl Broich cautioned against the growing sentiment that the value of regulators is declining.
“Without
evidence that has been vetted by regulators, why would anyone pay more
for any drug than they would for, say, a dietary supplement?” they
write. “If we eliminated regulation, the current biopharmaceutical
business model would collapse — and so would science-based drug
development.
Without a requirement for regulatory approval, companies
would have no incentive to conduct expensive clinical trials of their
products. Lowering regulatory standards would be unwise for both
patients and organizations that invest in pharmaceutical R&D. Robust
regulation improves public health and creates economic value.”
And
for the sake of affordability, they also argue that regulators should
not yield to pressure to lower standards or be oblivious to the growing
budget pains caused by newly authorized products.
The article
comes just a day after former US Food and Drug Administration (FDA)
Commissioner Margaret Hamburg and former National Institutes of Health
Director Elias Zerhouni
called for more regulatory harmonization worldwide. The European Commission also
released a report in February on drug pricing, regulators and policy options.
The EU authors also call for fast-tracking
additional generic approvals when “companies are taking advantage of
monopoly conditions.”
And while consumer advocates criticize the
number of me-too drugs that provide limited or no added value over
available drugs, the authors say that “some me-too products that were
originally criticized have benefited patients and provided additional
treatment options.
More important, sometimes the availability of these
products can drive down prices almost as much as the availability of
generics.”
The regulators use the example of the entry of
hepatitis C medications similar to Gilead’s Sovaldi (sofosbuvir), which
reduced prices and expanded access to treatment.
Thirdly, the EU
authors point to the idea of including payers at the table when
regulatory decisions are made in order for drugmakers to provide more
information upfront on measures of quality of life or health care
resource utilization.
EMA, and some EU member states, have hosted
nearly 70 “parallel scientific advice” sessions so far, during which
regulators, health technology assessment experts and drug developers
discuss premarket clinical trial designs.
And finally, the authors say that regulators can facilitate the collection of other kinds of data that payers need.
“Increasingly,
payers and pharmaceutical companies are considering outcome-focused
deals tying a drug’s price to the results achieved,” Rasi, et al. write.
“Although pay-for-performance schemes are attractive in theory,
practical hurdles have prevented widespread adoption.
Most important is
the difficulty of collecting and interpreting the relevant patient-level
data in a given health care system. Regulators, at least in some
countries, can facilitate data collection by considering payers’ needs
when asking companies to conduct post approval studies.”
And the
EMA is now exploring with HTAs new ways to collaborate on collecting
postmarket data. In conclusion, the authors are wary of placing all of
the onus for drug pricing on regulators, particularly because as price
gouging continues.
“Regulators alone cannot solve the growing
problem of high drug prices. We understand that new drugs should command
prices that reward and provide incentives for R&D investment.
However, we fail to comprehend prices that, like Sovaldi’s, recoup the
entire investment within the first few months after a product’s launch
but are so unaffordable that patients in need are denied access. We are
committed to doing our part to facilitate continued access to effective
and safe treatments.”
Read more: European Regulators Drawn Into Debate on Drug Pricing | RAPS