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.
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