The Evolution of HTA in Emerging Markets Health-Care ... - TREE

OHE Consulting Report for PhRMA
5 January 2011
In Brazil, the CITEC works slowly and appears to be under-­‐resourced. This has the effect,
intentional or otherwise, or delaying reviews of, and decisions on, access to new technologies.
There are aspects of the HTA process that could be improved, notably around transparency of
process and of selection criteria. However, it is also unclear how the role of CITEC fits alongside a
constitutional right of access to healthcare (which is clearly not consistent with the levels of
funding available) and regulation by the ANS of the minimum requirements of the private
insurance package. If emerging markets allow marketing authorisation, their citizens will have
expectations of access. The situation in Brazil exemplifies this, as once products are approved
for marketing authorisation and a price is set via external reference pricing rules, then citizens
can sue for access even though the public system has not yet approved the product for use in
the public plan.
In Taiwan, the role of HTA appears to be exclusively in the area of drug reimbursement, and here
it is unclear how it fits logically alongside an international reference price system. In theory,
drugs showing incremental value can get higher prices within the range of reference price
comparisons. There are also some issues around process such as the degree of transparency of
the assessment and the relationship between the assessment and the drug licensing process.
Our understanding is that expertise for the conduct of pharmacoeconomic assessments is drawn
from the licensing body but used separately. However, this arrangement clearly causes concern
for the industry that assessments of safety and efficacy may be conflated in some way with
assessments of relative effectiveness and cost-­‐effectiveness.
9.3 An industry perspective on HTA: IFPMA, PhRMA and EFPIA Principles
In order to help put HTA developments in the context of industry thinking, we reviewed the
following published industry statements on HTA:
PhRMA’s Health Outcomes Principles and also its Principles for Use of Evidence-­‐Based
Medicine: Advancing Patient Care and Health Care Value;
EFPIA’s The Use of Health Technology Assessments (HTA) to Evaluate Medicines. Key
Principles
IFPMA’s Position Statement. Health Technology Assessment and the Value of Medicines.
There is a substantial amount of overlap among the statements, as would be expected. The key
points that stand out and are of concern for industry are as follows:
1. HTA should not just be applied to medicines but to all health technologies and interventions.
It should be undertaken as part of a broad agenda to improve health care quality and
efficiency, rather than used as a cost containment tool. Likewise “silo budgeting,” where
medicines are put into a separate cost bucket, runs counter to optimising health gains across
the system;
2. A broad perspective of value should be used including the impact on productivity, and on
caregivers and personal time, and societal health priorities, for example in terms of disease
burden, should be recognised.
3. HTA when applied to determine access to or reimbursement for pharmaceuticals should be
kept separate from marketing authorisation.
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