BRUSSELS, Jan 24 (APM) - The "unpredictable environment" of health technology assessment in Europe leaves patients confused and frustrated in "a profoundly unequal situation" in the face of divergent decisions on the same medicines in different member states, and even within the same country, according to the European Patients Forum.
The EPF submission to the European Commission's consultation on the future of HTA (APMMA 51365), seen by APM, is a catalogue of failings in the current system.
It says that patient involvement in HTA is still very limited, and so far there is no agreement on the best method of involving patients, with European suffering from "a general assumption by industry and HTA bodies that patient organisations do not need full information".
Patients are also not always aware of what criteria are used and who is involved, or how to engage in the process. Yet, it adds, patients' engagement is vital to arrive at meaningful definitions of "value" and "added therapeutic value".
EPF supports its arguments with illustrations from member states - notably the Netherlands.
Here patients are involved "in a limited way in the reimbursement decision-making process regarding pharmaceuticals", but this is "at a late stage" and does not include HTA.
"This important stakeholder group is usually involved for the first time when the HTA is already finished and the results included in a report," it says.
And in France, despite some small recent improvements, "the lack of full access by patients and healthcare users' organisations to the information and data submitted by the industry in the framework of the HTA procedure remains a critical issue."
The patients' grouping is dismissive of the efforts so far in EU-level collaboration through the EUnetHTA programme. "Very few results translate into a real impact on the society and member states at large," and it has "not led to improved patient involvement at national level."
It cites "a persistent lack of trust between HTA bodies" because of enduring cultural and structural differences.
But EPF nonetheless believes that over time, EU collaboration on HTA can improve the standards of assessments, and joint work can avoid inequalities.
The cooperation should have wider aims, too, says EPF. "HTA should aim at influencing private and public R&D priorities to ensure that investments are directed towards actual unmet needs", it urges.
For EPF, the future structures for HTA in Europe should be based within the European Medicines Agency.
"Joint work involving EU member states should be facilitated by EU agencies, either an existing or new one, while the European Commission could have a more strategic and supporting role, content and policy-wise. It would be pragmatic to co-host a European HTA Agency with the European Medicines Agency," it says.
The form of centralisation envisaged by EPF is contrary to views expressed in many other submissions. EMA involvement is flatly rejected by European health insurance agencies and by drug information organisations such as Prescrire, and acceptable only subject to tight conditions by European consumer organisations.
The European Public Health Alliance, which has also just sent its views to the Commission, is equally resistant. "A new centralised HTA agency would be counter-productive keeping in mind the existing extensive expertise across member states," it says.
"Providing the EMA with HTA competences would be equally counter-productive as it would mean an excessive and unchallenged concentration of power."
EPHA also wants a broader agenda for HTA.
"HTA systems have gained prominence in the medical innovation debate in recent years because of the access & innovation crises Europe faces primarily due to the exorbitant prices of medicines," it says.
Collaboration or harmonisation "should not be discussed without considering the broader access to medicines debate in Europe," says EPHA, seeing "a unique opportunity to use HTA bodies as an enabler for affordable and accessible medical innovation".
It warns of undue industry influence on decision-making: "Notions of value and benefit in the context of the assessment of medicinal products should by no means be used to justify high prices for medicinal products."
For EPHA, "HTA systems should act as gatekeepers", with safeguards against "regulatory capture and conflicts of interest", and guarantees of "integrity and independence of HTA bodies".
This would induce manufacturers "to invest in real innovation and not towards a proliferation of me-too medicines."
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