Pharma engages HTA bodies in early-stage drug discussions
pharmafile | October 27, 2010 | News story | Research and Development, Sales and Marketing | Andrew Witty, AstraZeneca, EMA, European Medicines Agency, GlaxoSmithKline, Johnson & Johnson, health technology assessment, hta
Three pharma companies are taking part in a new pilot to harmonise European standards in health technology assessment (HTA).
AstraZeneca, GlaxoSmithKline and Johnson & Johnson are funding and taking part in the new initiative, which aims to move closer to a common definition of what evidence is needed to demonstrate safety, efficacy and ‘value’.
Also taking part are clinicians, health technology assessors (HTAs), patient representatives, payers, regulators from France, Germany, Italy, the Netherlands, Sweden, the United Kingdom and the European Medicines Agency.
Drugs currently in early-stage drug development to treat breast cancer or type II diabetes will be under discussion in the pilot, which could be expanded if it proves successful.
The EMA says the initiative aims to bring “clarity and alignment” about what constitutes a medicine’s value and the evidence required to demonstrate that value most effectively.
Consultations are planned to take place over the next four months, and will engage all stakeholders on the issues of therapeutic value. A smaller group of HTAs and payers will be asked to examine questions of economic value deriving from therapeutic benefits.
The partners stress that the recommendations produced by the groups will be non-binding and will not supercede existing advice processes. But all sides expect the experiment could lead to further pilots and broader initiatives for early consultation.
The pilots arose from the European Healthcare Innovation Leadership Network. The Network comprises healthcare leaders from across Europe, which the EMA says are “committed to improving patient health outcomes and enhancing the climate for innovation while acknowledging pressures to control healthcare costs”.
GSK’s involvement is reflected by the championing of greater European harmonisation by its chief executive Andrew Witty. The pharma industry has frequently opposed greater European harmonisation in HTA, fearing it will create a ’Euro-NICE’, but GSK’s Witty has declared the need for reform to make Europe more attractive to pharma and more competitive internationally.
The HTA project is being co-ordinated by Tapestry Networks in accordance with its principles and guidelines for public-private networks.
Andrew McConaghie
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