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Case
Study Opposing
Restrictive Formulary Situation:
The
pharmaceutical industry needed to respond to the Department of Veterans
Affairs’ national formulary that was restricting access to novel medicines
through silo-budget driven cost containment processes. The industry needed to
explain the quality of care and market destabilizing problems of this
formulary, and to refute the population-based cost-effectiveness arguments
that the VA’s Pharmaceuticals & Therapeutics (P&T) Committee had
created to justify their budget driven formulary decisions and treatment
guidelines.
Actions:
Conducted economic analyses refuting the VA’s hyper-inflated cost
estimates.
Created good working relationship with key patient and physician advocacy
groups.
Resurrected a
patient-focused coalition by working with company alliance development staff
and patient advocates. This coalition advocated for increased research and
analysis about access problems within the VA healthcare system.
Worked with company sales representatives responsible for the VA to collect
information about problems with the VA’s national formulary, including
information from physicians who felt that the quality of clinical care was
being compromised. As one physician wrote, "We need to stop
this before someone is killed."
Initiated and managed a survey of VA physicians conducted by a national
polling firm that provided quantitative data
on access and quality problems arising from the formulary’s restrictions,
and identified case reports of poor outcomes and adverse effects.
Initiated an investigative TV news story about adverse events from the VA’s
therapeutic substitution practices.
Produced an extensive briefing binder documenting the quality of care problems
with the VA’s national formulary, and use it in discussions with many
Veterans advocates.
Worked directly with Members of Congress, Congressional staff and other allies
to scrutinize and challenge the health system’s actions.
Supported allies advocacy efforts to directly challenge the VA’s formulary practices.
Outcome:
Effective established ally
relationships, and engaged them to create advocacy activities that increased formulary access within VA
health system.
Members of Congress directed that the Institute
of Medicine
and the General Accountability Office
study the effects of VA’s access restrictions on the quality of care.
These studies documented the VA’s problems in monitoring and
evaluating quality issues and problems related to their national formulary.
Tens of millions of dollars of
sales for two of the company’s novel medicines were preserved.
There was accelerated formulary
adoption (and sales) for the company’s new medicine that was eagerly sought
by – and appropriate for – many VA patients.
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