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My name is Dr. David Charles, and I’m the chairman of the Alliance for Patient Access.
It’s an organization that ensures patients have access to available therapies, and one
of the things we’re working on is Biologics. Biologics are an incredibly new -- and innovative
-- class of therapeutics that offer promise to patients with conditions such as breast
cancer, rheumatoid arthritis, and multiple sclerosis, and they represent some of the
most significant advances in healthcare. When I began my residency, patients diagnosed with
multiple sclerosis, often at the prime of their life, were dealing with an illness that
was incredibly disabling and relentlessly progressive. Now, today, because of Biologics,
the diagnosis of MS, again coming at the prime of life, means that the person -- along with
their doctor -- has a treatment that can really control the illness and can mean that they
are productive for years to come.
Biologics are a new class of therapeutics created from living organisms or cells and
they’re often very complex in their manufacturing process and in the final product that’s
given to patients. They’re entirely different than the traditional pharmaceutical, which
would be a small molecule that could easily be reproduced as a generic. Biologics, on
the other hand, have no generics. They are so complex and their manufacturing process,
each step critically important to their safety. Biologics therefore are entirely different
than a traditional pharmaceutical that can be made as a generic.
They’re often tailored for the individual patient – sometimes after the patient has
been tested, just to know the patient is going to respond to this therapy
One of things we’re working on at the Alliance for Patient Access is the issue of therapeutic
substitution. Now this is different than generics. Therapeutic substation is when your doctor
writes a prescription, you go to the pharmacy and it’s actually switched to a different
drug, not a generic, but actually a different drug. In the case of biologics, this is unacceptable
because biologics are so precise to the particular condition that you’re treating. It could
be multiple sclerosis or breast cancer or a particular type of arthritis. The particular
biologic that your doctor subscribes has to be filled just the way you and your physician
have decided. Decisions like this that you make with your physician are not decisions
that can be left to an insurance company.
As the chairman of the Alliance for Patient Access, I understand the importance of how
policy affects the development of new therapeutics such as biologics. In the case of biologics,
simply stated, there is no short cut.
One of the important things to consider concerning biologics is cost, and everyone is concerned
about cost. However, in this particular class of therapeutics, the incredible promise that
they hold for the future, the promise that they’re paying off right for patients with
cancer, with multiple sclerosis, and other conditions is incredible. There is significant
cost, but that cost is worth it.
The federal government purchases well over half of all health care in the United States.
When you combine the centers for Medicare and Medicaid services –Medicare, Medicaid
– Veterans Administration, the Department of Defense, and federal workers – it’s
an incredible investment the government is making in healthcare.
So it’s critically important that as a nation, we get these policies right. The physicians,
the patients, the regulatory agencies and manufactures all come together to find policies
that ensure an environment where these new biologics that hold so much promise can come
to market and help our patients, and at the same time as nation, we can afford these therapies
and that they’re available to all that need them.
It is so important that our policymakers take up the issue of biologics in seriousness and
understand the importance of this class of therapeutics.