Market access: How to meet both marketing authorisation and HTA needs
Leela Barham looks at the costs and benefits of taking a more collaborative approach towards marketing authorisation and Health Technology Assessments.By Jul 13, 2010 on
Leela Barham looks at the costs and benefits of taking a more collaborative approach towards marketing authorisation and Health Technology Assessments.
During the lifecycle of a new pharmaceutical, there are considerable hurdles to overcome before the product successfully reaches market.
Traditionally, there has been a distinction between the first three hurdlessafety, efficacy, and quality, which lead to marketing authorisation (MA)and the fourth, a formal or informal Health Technology Assessment (HTA) conducted by payers when making reimbursement decisions.
Now, efforts are under way to take a more collaborative approach across MA and HTA decisions.
Comparing MA and HTA
There are some good reasons for making the link between MA and HTA.
The decisions are, in fact, very similar: Should a new product be available?
However, the perspectives behind the decisions are different.
MA is about whether the product is safe, whether it can be shown to do what is expected under trial circumstances, and whether it can be produced to a high quality.
Assessing value-for-money and determining whether to approve a new medicine have always been separate decisions, says Ian Johnson, technical director at Complete Market Access.
The MA agencies are concerned with whether trials are rigorous enough. HTA is increasingly about looking at the added value of a new product. Does it meet a previously unmet need? Can it show benefit over and above existing treatments? And just how good is it in real-life use? And that can never be considered at the time of authorisation.
According to Dr. Chris Henshall, pro vice chancellor at the University of York and founding chair of the HTAi Policy Forum, there is scope to increase co-ordination even though MA and HTA are different decisions.
Not least so that these agencies can understand the implications of their respective requirements, he says, and explore ways of minimizing the burdens for industry, consistent with the agencies differing roles and remits.
Meeting regulators needs
There is more certainty in the approach to getting regulatory approval, Henshall suggests, reflecting the longer evolution of regulatory standards compared to the relatively young HTA.
Regulatory standards are also more harmonized across the globe than those underpinning HTA, so companies have a clearer understanding of the expectations of MA agencies compared to the many and varied HTAs/payers.
These factors help explain why many companies are geared up to focus on meeting regulators needs.
Plus, of course, if you cant get past the MA hurdles, you wont have the luxury of worrying about reimbursement at all.
In terms of process, there are commonalities. Both the MA and HTA decisions are, for example, concerned with health outcomes.
Dealing with differences
Key differences include what outcomes are acceptable; in some cases, the MA agencies will accept a surrogate outcome marker, which may not be accepted by the HTA agency.
This may not be clear at the outset though and, according to Henshall, the scope for more coordination in these types of factors could be one of the key drivers for bringing MA and HTA closer together.
There are efforts in some countries to provide earlier access to genuinely innovative new medicines, and this is playing out in both the MA and HTA fields, he says.
There could be scope to bring together the current interest in coverage with evidence development (CED) schemes, where outcomes are monitored over time to help understand real-life cost effectiveness, [with] traditional post-MA surveillance to inform the risk-benefit profile of new products.
The power of registries
Registries are an obvious approach, since they can collect information on side effects and hospitalizations, including whether patients are able to work.
Registries are powerful, but perhaps dont link up the post-MA surveillance needs with cost-effectiveness needs as well as they could, Johnson says. And some lack a comparator, so dont give the full picture.
The key question then becomes: How can companies optimize their approach to commercial research to best meet both MA and HTA needs?
Thats not an easy question to answer, as Ansgar Hebborn, head of the Global Payer & HTA Program Policy at Roche, notes: There are potentially different views from different agencies/payers. Companies need to trade perspectives, [and that] will be a reflection of the importance of markets.
The way forward is for companies to look at value-based arguments much earlier in development and invest in comparative trials, according to Johnson.
They need to be confident in their product. Companies have to take a view on what are the markets of benefit, and make the right go/no go decisions.
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