by Thomas Meek at the ISPOR European Congress

VIENNA, Nov 1 (APM) - The current separation of health technology assessment (HTA) and regulatory decisions in Europe is not sustainable, according to Jens Grueger, vice president and head of global pricing and market access at Roche.

Speaking on Monday at a conference, Grueger said that the fragmentation of the current system, involving approving new products and then assessing their cost-effectiveness for reimbursement leads to “confusion, duplication and delays” in getting new drugs to market.

“The status quo is not sustainable. We acknowledge that regulatory and HTA questions are different, but to maintain separate unaligned evidence expectations is not doing justice to the science. It is not recognising the technology development process and leads to unacceptable outcomes for patients,” said Grueger during a presentation in Vienna at the European Congress of pharmacoeconomic body ISPOR.

The problem has been exacerbated in recent years by the surge of innovative medicines in more targeted disease areas. Grueger said that regulatory systems had been able to adapt to these changes with new frameworks for earlier access, but that HTA systems tended to have been designed 10 to 15 years ago when the focus was on assessing drugs with incremental benefits for chronic diseases - making them unsuitable to assess new products.

Discussing the disparities between the HTA and regulatory processes, Grueger said that regulators have adopted context-specific evidence expectations, while some HTA bodies still insist on traditional evidence to determine final outcomes.

“We need to find ways that HTA and payers are more accepting of non-traditional ways of generating evidence,” he said.

This includes the use of real-world data, which Grueger said have greatly improved - but HTA bodies have been reluctant to accept.

Grueger acknowledged that some efforts have been made to pilot joint assessment models for HTA and regulatory decisions, but said the industry has been frustrated that in countries which have participated in these pilots, the conclusions have not been accepted.

Grueger also advocated for a more "joined-up" approach to HTA in Europe, saying that submitting the same clinical evidence to HTA authorities and payers in 28 separate European countries is “inefficient, duplicative and leads to very confusing results”.

He mentioned that some countries in Europe lack the scientific understanding to adequately assess new products, where the science is very complex. “We need to bring our expertise and our resources together at a European level.”

In terms of assessing the price of a medicine, Grueger added that pricing mechanisms are very rigid and do not allow acknowledgement of uncertainty about long-term outcomes for new medicines. “We need more flexible processes for looking at prices in a dynamic way,” he said.

The industry is willing to collaborate with HTA bodies, regulators and payers on these issues and to move towards a sustainable model for joint/parallel EMA/HTA scientific advice, said Grueger, noting that Roche has 10 products due to reach the EU market in the next three years.

He said that industry and payers could agree on adaptive evidence generation as well as price-setting procedures that reflect remaining uncertainty over patient benefit.

A more joined-up approach would lead to significant synergies, Grueger said, arguing that many aspects of relative efficacy are already implicitly or explicitly answered within the regulatory process .

He added that where patient access is granted early, additional evidence generation post-approval can cover both regulatory and HTA evidence needs.

Decisions on reimbursement should still be made nationally, however, he said, noting that having one European assessment of relative clinical benefit stills allows countries to make local decisions on price and affordability.

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