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

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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. 64
OHE Consulting Report for PhRMA 5 January 2011 4. HTA should be inclusive, open, transparent and balanced, involving external experts and all stakeholders. It should include rights of appeal. The evaluating body should be independent of the payer. 5. Payers should commit to rewarding value. Positive HTA appraisals should attract the budgetary resources necessary to fund use. 6. Appraisals should recognise that value emerges through use and additional evidence over the product life cycle and recognise the need to include new data. To this same point, uncertainty around cost-‐effectiveness has to be dealt with in a flexible way, including the use of in-‐market data collection, which requires putting in place the necessary infrastructure. A full range of types of evidence including observational data can play an important role. It is important that patients get speedy access to new technologies. 7. Patient preferences and needs matter in any choice of medicine. HTA guidance should give clinicians enough freedom to address individual clinical situations. In this context, the incremental nature of innovation should be recognised as should the importance of having multiple treatment options. The Drummond, et al. (2008) criteria are similar. They are set out below, together with the assessment from Neumann, et al. (2010) of the performance against these criteria of Anvisa (CITEC) and DHTA (CDE). In the case of Brazil, Anvisa (CITEC), they find that it subscribes to a number of key principles but there is no evidence of adoption. In the case of Taiwan, the DHTA (part of the CDE), they found more evidence of adoption. However, there are clear gaps in both cases as we have discussed: CITEC is lacking transparency of process and of priority setting; CDE is part of the marketing authorisation body; Neither body takes a societal perspective; Neither body addresses implementation, and there is no clear link between findings and decision making. 65
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