Indeed, Stockholm Network claimed that VBP could serve to discourage innovation altogether. The proposed reforms, it argued,
are likely to focus unnecessarily on lowering the price of drugs that the government believes have no value. "In doing so,
VBP will reduce revenue for manufacturers and thus counterproductively decrease the amount reinvested in R&D." The reforms
would also install a "dangerous concept," the Network said, whereby governments are relied upon to decide what the investment
priorities of the pharmaceutical industry should be.
For its part, NICE responded that the case for seeking a price premium, related to the innovative nature of a new treatment,
is often based on future value, rather than patient benefit that can be measured now. The Institute agreed with therapeutic
innovation and improvement adjustment as a 'step-change' relative to current management, but maintained that the approach
NICE is already taking "allows products that demonstrate a high magnitude of QALY gain to be priced more highly than those
that do not."
Access to Medicines
On the issue of access to medicines, the responses showed equal concern that VBP could fail to improve on—or indeed worsen—the
current situation in the UK.
Tackling the consultation document's announcement that "we would not anticipate the need to continue the 2009 PPRS Patient
Access Scheme arrangements for new medicines assessed under value-based pricing," ABPI pointed out that, in allowing for freedom
of pricing at launch for new medicines, PPRS already enables early introduction and thus quicker access to (new) medicines.
Maintaining that patient outcomes will only improve if uptake of medicines follows the granting of access, the Association
further warned that the NHS reforms, especially in the "challenging fiscal climate" of the next three years, will negatively
impact the uptake of medicines.
For the MS Society, the DH document not only failed to determine how access to drugs will be improved, but gave no provisions
for the involvement of patients and patient groups in its development and implementation. To avoid a "postcode lottery" when
it comes to access, the MS Society instead recommended a central drugs fund to bankroll the additional price of treatments
that have been given a value-based price, taking pressure away from individual health authorities to restrict high-cost treatments.
Stockholm Network stated bluntly that it is empirically unrealistic to expect that a rationale that aims to further decrease
UK expenditure on pharmaceuticals—and, specifically, on innovative pharmaceuticals—can lead to improved and more effective access. "The maintenance of pricing ceilings in itself implies that
patients will still be denied medicines that are deemed too expensive," the Network said.
If It Ain't Broken ...
The interesting consensus that has emerged from the VBP consultation process—especially from the more vociferous responses
from ABPI and Stockholm Network—is that the UK's current pricing system, for all its faults, is preferable to VBP.
PPRS has, over many years, provided a stable and predictable environment for the regulation of branded medicines, enabling
improvements to be made to it at each successive renegotiation, ABPI says. "This stability and predictability must stay in
place for companies with existing medicines and with those that undergo value-based pricing."
Stockholm Network, while also praising PPRS's "stability and flexibility," pointed out that it has also "opened a regular
dialogue between the government and the pharmaceutical industry" that has engendered pharma's willingness to agree to voluntary
price cuts for the NHS and in the government's acceptance of a greater number of patient access schemes. "Certain merits of
the PPRS deserve to be considered, given that this system has existed now for 54 years," the Network added.
UK Reforms in Crisis?
The debate surrounding value-based pricing has been less newsworthy in the UK of late than other controversies dogging Andrew
Lansley and the Department of Health. Last month he was humiliated at a Royal College of Nursing conference when 96 percent
of delegates passed a motion of no confidence in the planned NHS upheaval. Lansley was forced to accept the rebuke, and the
government has since promised to undertake a 'listening exercise' to take on board concerns from healthcare providers and
With high-profile issues—such as the establishment of GP Consortia and the abolition of Primary Care Trusts—set to dominate
the UK healthcare agenda in the coming weeks, whether the government will extend its listening exercise to VBP remains to
be seen. But value-based pricing takes its place in an atmosphere of dissatisfaction and dissent among the various stakeholders,
who see themselves on the receiving end of an increasingly faltering policy of reform.
By Julian Upton, European and News & Online Editor