Abstract
Summary
"it must be acknowledged that few pharmaceutical manufacturers, let along
biotech companies are equipped to meet these new health technology assessment
guidelines"
This essential report will help you:
- Prepare a global dossier to ensure successful formulary listing
- Understand formulary submission guidelines in Australia, UK and USA
- Respond to emerging evidentiary and analytical standards
- Structure your organisation to make a convincing case to the regulators
The rapid uptake of formulary submission guidelines in the last decade is
forcing pharmaceutical manufacturers and biotechnology companies to comply
with more rigorous evidentiary and analytical standards in clinical and
cost-effectiveness evaluations.
Two developments in 2004 further transformed the situation:
- 1. The introduction of a revised health technology assessment guideline by
the National Institute for Clinical Excellence (NICE) in the UK; and
- 2. The introduction of revised technology assessment guidelines for new
products and for the re-evaluation of products by WellPoint Pharmacy
Management (WPM) in the USA.
Where the NICE and WPM guidelines represent a major change in requirements
with the need:
- (i) to accommodate adequately uncertainty in modelled cost-effectiveness
claims and the requirement for a reference case (NICE); and
- (ii) the requirement for naturalistic, active comparator trials together
with ongoing monitoring and validation of claims for cost-effectiveness and
systems impact (WPM).
Put together, the NICE and WPM guidelines present formidable challenges to
manufacturers in both the UK market and in the US managed care sector. If
other health technology assessment and reimbursement gatekeepers adopt these
new evidentiary and analytical standards, then manufacturers will have to
rethink seriously not only how they adapt their clinical development programs
to accommodate the reference case and active comparator requirements in Phase
III trials, but the ways in which they present cost-effectiveness and system
impact claims to meet monitoring and validation standards.
Preparing health technology submissions for pharmaceutical products - Meeting
Formulary Submission Requirements for New Product Assessments and Disease Area
and Therapeutic Class Reviews, considers how manufacturers should respond to
emerging evidentiary and analytical standards as exemplified by the NICE and
WPM guidelines for formulary submissions.
The report considers, in particular, the implications of the standards
required in the NICE and WPM guidelines for manufacturers preparing
reimbursement submissions and it goes beyond being simply a review of
evidentiary and analytical standards required by reimbursement and pricing
authorities that have mandated a formulary submission dossier as part of the
technology assessment of new products, to establishing the standards required
of a global dossier. Meeting the NICE and WPM requirements ensures that
specific or targeted dossiers can be assembled to satisfy the requirements of
other jurisdictions. A global dossier, therefore, if structured to meet the
standards of NICE and WPM, will also meet the requirements of other
jurisdictions - where individual formulary submissions are customized to meet
the needs of individual health systems.
"a poorly constructed and self-serving case, where the modelled case has
clearly been driven by the need to justify cost-effectiveness, seldom stands
up to a critical review."
Reasons you company should invest in this report:
- Understand the published guidelines from the major evaluation agencies
- Benefit from over 40 detailed case studies of technology appraisal
guidelines
- Learn to prepare an excellent global dossier to ensure formulary acceptance
- Forecast how technology appraisals will develop over the next few years
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