According to PhRMA, 901 biotech medicines are currently in
development. Of these, 300 are monoclonal antibodies and 298 are vaccines,
followed by recombinant hormones and proteins (78), cell therapies (64), and
gene therapies (50). In today’s medical pipeline, the vast majority of
investigational products (>350) are biologics aimed at treating cancer and
related disorders, and these have been covered most often by the medical
benefit, as they are commonly administered in hospitals or provider’s offices.
Health technology assessment describes the evaluation performed by
informed professionals to decide on the safety, efficacy, effectiveness, and
value of medical interventions. This is the principal activity of Pharmacy
& Therapeutics Committees. The P&T Committee traditionally focuses on pharmaceuticals
like anti-infective agents or hypercholesterolemia drugs, which are readily
available through the pharmacy (or through “specialty pharmacies” in some
cases) and are covered under the health plan’s pharmacy benefit.
A problem exists for many health plans and insurers: Many do not
have a body similar to a P&T Committee to evaluate products and
interventions potentially covered by the medical benefit, such as biologics, diagnostic
tests (including new genetic tests), and medical devices. Often, their P&T
Committees will be asked to review these interventions, although they are not well
structured to do so. Without others to turn to, the P&T Committee may
become the de facto decision-making
body for products covered by the medical benefit in many smaller organizations.
There are several exceptions. The Technology Assessment Committee of
the Blue Cross Blue Shield Association is a structured unit whose sole purpose
is to evaluate treatments that will be covered through the medical benefit, and
any member Blues plan can access and utilize its recommendations. UnitedHealthcare
has its own Technology Assessment Committee for its regional affiliates. Some
integrated health systems have the resources to make these coverage decisions,
based on the available hospital and health plan staff.
It is important to understand and recognize the difference between a
P&T Committee and a Technology Assessment Committee; this goes well beyond
the type and number of panelists at the meetings. Clearly, pharmacy
professionals cannot contribute as much to decision making on diagnostic
testing or medical devices (other than drug delivery systems), so a Technology
Assessment Committee will be more heavily represented by medical professionals
compared with a P&T Committee. Since the breadth of diseases treated with medical
devices and diagnostics is wide (and those treated with biologics is
increasing), there may well be more physician specialists asked to serve on a
Technology Assessment Committee.
Another key difference is that many P&T Committees will not only
decide on coverage but will recommend where the new agent will be placed on its
copayment tiering system. The Technology Assessment Committee will recommend whether
the product should be covered—not necessarily how it will be covered or if
patients will be asked to share part of the costs (which may not exist at all
for interventions covered by the medical benefit).
The Technology Assessment Committee sometimes be asked to consider
expensive new technologies for which there are limited similar interventions for
comparison. As a result, their decisions can have great implications for health
plans and insurers’ budgets, their member populations, and the manufacturers’
bottom lines. Therefore, it is critically important to understand how the technology
assessment committee will approach newly introduced technologies before they
are actually reviewed.
SM Health Communications
provides marketing research and specialized communications for healthcare
services and pharmaceutical companies. Our comprehensive capabilities provide
clients with the essential insights and competitive intelligence that are
critical in today’s healthcare environment.
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