India's new clinical trial rules establish an accelerated pathway for new drug approvals, but affordability remains… https://t.co/uhVXDZGLfr
Hurdles encountered in transferability of health economic evidence to middle- and low-income countries
As more emerging economies seek to establish HTA agencies to inform pricing and reimbursement (P&R) decisions, I was curious to attend a workshop on this theme ("How to transfer economic evidence to low and middle-income countries? Working under capacity restrictions") while at ISPOR Vienna. Zoltan Kalo, professor at the Hungarian Eotvos Lorand University, revealed in this workshop that a survey of heads of HTA agencies in middle-income countries in Central and Eastern Europe (CEE), Latin America and Asia showed reservations about international data transferability in the context of manufacturer drug submissions.
According to the 2015 survey, the predominant view from decision-makers is that models developed with data from other jurisdictions usually require adaptation to local contexts. HTA decision-makers were less optimistic about submission of international epidemiological data and baseline risk, but would accept relative treatment effect. These stakeholders had a pragmatic approach to health state preference values/utilities, as they would prefer local data when possible but realised they are difficult to generate. Less optimism was also exhibited towards using resource use or unit costs/prices data from other countries.
International data transferability is a hot topic in the CEE region, in particular, because of limited budgets, human resources and local data for HTA implementation. However, Kalo believes that Western European drug prices are usually not cost-effective and are in fact often unaffordable in CEE countries. Frequently, the Quality Adjusted Life-Years (QALY) gain submitted for a drug in a CEE country is significantly higher than that in a NICE appraisal. When a lower QALY is not published in higher-income jurisdictions, it is very difficult to demonstrate the cost-effectiveness of a drug in a CEE country. He controversially argued that a fair or value-based price is not being submitted to CEE countries due to extensive use of international reference pricing and the encouragement of parallel trade by higher-income countries.
The reality of many CEE countries is the presence of a weak HTA agency coupled with mandatory criteria for local cost-effectiveness evidence. In most cases, the new drug is not cost-effective, except where 1) health burden is superior in CEE countries compared to Western Europe, but local epidemiological data is very rarely available, or 2) a non-cost-effective drug is already listed due to past mistakes. However, in this context, Kalo claims that lack of cost-effectiveness may not prevent listing of a new drug due to inexperience of the appraisal team in economic modelling, along with lack of mandatory submission of economic models, non-publication of HTA reports, and absence of follow-up or revision of previous recommendations.
To increase transferability, a pharmacoeconomics advisor from the Dutch National Health Care Institute, Saskia Knies, recommended during the workshop that economic evaluations should be transparent and clear with regards to five factors: epidemiology, relative treatment effect, resource use, unit costs and utilities. These factors can influence the incremental cost-effectiveness ratio (ICER) calculation that might impact the final P&R decision. This largely falls in line with the recommendations issued by the ISPOR Good Research Practices Task Force that have reviewed the advice on dealing with transferability in a range of international guidelines.
However, Olena Mandrik a researcher from the Dutch Institute of Health Policy & Management highlighted that even when national guidelines on transferability are available, they are not mandatory in middle- and low- income countries. Furthermore, implicit requirements for data transferability tend to be guided by decision-makers opinion/acceptance and by data and personnel capacity. These aspects are particularly more important to middle- and low- income countries without standardized HTAs or where the HTA process is not obligatory.
The workshop take home message was that international data transferability makes perfect sense after taking into account limitations and local context adaptations, if there are HTA capacity constraints and to avoid duplications. Adopting good practices for transferability will contribute towards strengthening HTA implementation, which could lead to a more appropriate value-based price for the jurisdictions concerned. This will ultimately result in greater pricing pressure on manufacturers that could be potentially explored through confidential pricing mechanisms and managed entry agreements. Besides pricing issues, manufacturers should also take note of discussions about the transferability of the economic model structure itself that has extensive consequences for those operating globally, although in most cases models can be re-populated with local data (where available).
At the EU level, beyond EUnetHTA's Joint Action 3, the European Commission has published a series of documents with the aim of harmonising HTA and creating a common assessment. In the first plenary session at ISPOR Vienna, there was mention of the EUnetHTA collaboration option on the joint production of relative effectiveness assessment (REA) reports, whereby if a country does an evaluation it could be transferable to the 28 EU countries, unless the local data indicate differently. Another option is the production of a joint full HTA report, including an REA and economic evaluation. By 2020, the EU should have established some rules about how to continue collaborating in this arena, and the greatest beneficiaries of a collaborative approach are likely to be the CEE countries.
Tania Rodrigues is a Consultant in the IHS Life Sciences consulting team specializing in healthcare policy, market access, pricing and reimbursement and corporate strategies.
Posted 5 January 2017
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