Towards Transparency

Health Technology Assessment (HTA) bodies evaluate whether new medical technologies, such as pharmaceuticals or medical devices, represent “good value for money” for national public payer institutions. Naturally, transparency is important; HTAs must assure a level playing field between various stakeholders involved in evaluating medical technologies and also ensure that decisions are sound and taken based only on the best available scientific evidence.

Piotr Ozieranski, a lecturer in the Department of Social and Policy Sciences at the University of Bath, is particularly interested in the Polish healthcare system. Despite being one of Europe’s largest pharmaceutical markets, Poland has had some trouble with conflicts of interest when it comes to drug evaluations. Ozieranski’s previous research pointed to challenges in Poland around drug company lobbying, both direct and via seemingly independent third parties, such as patient organizations, as well as conflicts of interests of experts and public officials working for the Ministry of Health and the Agency for Health Technology Assessment (AHTAPol).

In a new study, a multi-institutional team wanted to know whether there had been any improvement in the country over time. Ozieranski explains the results...

How do HTAs work?

Evaluations undertaken by HTA bodies are complex, and involve clinical and economic data (cost-effectiveness and budgetary impact analyses) – and sometimes ethical considerations. The outcomes of these processes may be informed by explicit thresholds of cost effectiveness; for example, NICE in England will normally approve drugs whose cost effectiveness falls between £20,000 and £30,000 per quality-adjusted life year gained; in Poland the cost effectiveness threshold is three times GDP per capita.

It’s also important to note that the evaluation of medical technologies by HTA bodies usually involves two phases: i) assessment – an earlier and more technical phase, primarily driven by health economists, that focuses on analyzing data submitted by manufacturers; and ii) appraisal, which draws on the outcomes of the assessment phase but also involves a range of external stakeholders, such as clinicians and patient experts. In our study, we focused on the assessment phase, which is a new development in research on HTA, as most studies with a social science perspective focus on the appraisal phase and, in particular, on the operation of appraisal committees.

Has the situation in Poland improved?

The transparency of AHTAPol’s assessment reports has, in many ways, reached the transparency standards set out by NICE. A key indication of this is that the AHTAPol has redacted a decreasing share of its assessment reports (these redactions are normally requested by manufacturers to protect their commercial interests).

Perhaps surprisingly, and certainly against our initial expectations, the AHTAPol turned out to be more transparent than NICE in certain aspects of the HTA process, such as providing summaries of expert opinions and explaining rationales for redacting assessment reports (in other words, the AHTAPol tends to be clearer than NICE in explaining why certain parts of reports have been redacted).

That said, the AHTAPol is still less transparent in other areas of the HTA process, such as including information on expert potential conflicts of interest. More specifically, it is often difficult to ascertain how many experts whose opinions were considered in assessment reports, had reported any potential conflicts of interest, and of what kind (or how serious these potential conflicts of interest had been). NICE, by contrast, is considerably more open in this respect – we know which experts reported potential conflicts of interest and what their nature was.

Importantly, these findings are consistent with our earlier research around the challenges associated with potential conflicts of interests of some stakeholders in the HTA, and reimbursement processes. The findings also correspond with research funded by the EU commission that shows a high degree of tolerance for conflicts of interest in Poland’s healthcare sector more generally.

How closely do HTAs and the pharma industry interact?

When it comes to “light” HTA bodies (such as the Scottish Medicines Consortium, NICE’s Single Technology Appraisal process, the AHTAPol), the evidence submitted by drug manufacturers to support their products is the key source of data for HTAs. “Heavy” HTA bodies, by contrast, develop their own analyses from scratch (for example, the multiple technology appraisal process model used by NICE). Light HTA approaches are increasingly prevalent, so the role of industry and its evidence, by implication, is increasing. 

Collaborations between the pharmaceutical industry and clinicians or patient advocates often involve financial ties (such as grants or donations). It is, therefore, important that any such potential conflicts of interests are disclosed during the HTA process – this way, it is possible to evaluate whether expert contributions might have been unduly influenced.