Breaking Out of the Best-Practice Cycle

Some of the radical thinking on healthcare spending from a new EC specialist group offers robust food for thought, writes Reflector.

The European Union is winding itself into ever more contorted postures as it struggles to cope with rising demand for ever more expensive healthcare at the same time as its economic affairs ministers are calling for prudence in public spending. The last few weeks have seen the debates intensify over how to square this circle, and many of the recommendations now being hotly discussed focus on different forms of exchange of best practice and collaboration - among national authorities, between member states, and with industry and patients - to boost the efficiency of healthcare spending.

But a new approach is championed by a specialist group appointed by the European Commission. The laboriously-named 'Expert panel on effective ways of investing in health' has been reflecting on alternative ways of responding to the well-known and widely-recognized challenges, and it is urging more radical solutions based on theories of disruptive innovation. The approach could, if adopted in policy, lead to a more conducive environment for bringing useful new products to the market in Europe.

Three of the star turns in the expert group's cast as it builds up its historical case for the merits of disruptive innovation are antibiotics (which "revolutionized medicine in the 20th century"), insulin (which "transformed the  management of diabetes, giving patients responsibility for self-management"), and anti-ulcer drugs ("which provided primary care physicians with a new, effective, low cost technology" in the 1980s).

There is a lot of theory in the group's document, which was published just at the end of October. But there are hardcore and recent practical examples in it that offer some robust food for thought. It claims that the best way ahead is for health systems to be more open to game-changing breaks with the traditional methods – citing the shift from hospital care to community-based health delivery, new technologies that allow early diagnostics, or personalised medicine.  A further example - which still has to be turned from an invention into an innovation, says the expert group - is the latest drug therapy "breakthrough", the new generation of hepatitis C treatments.

Because of the high cure rate and high tolerability of Sovaldi and its peers, a major transformation in tackling a major disease becomes possible, argues the group. But to turn the hardware of the invention into a real innovation will require wide access to the medicine - and that in turn requires new approaches to calculating value, it continues. A new process of price determination will have to support treatment strategies that deliver maximal benefit for patients and health care systems. "Disruptive innovation will come when the new drugs are available and affordable", it says.

The group does not come up with the magic formula for making the drugs available and affordable, but it does pinpoint some of the factors that turned Tagamet and Zantac into game-changers three decades ago.  H2 blockers were the result of an advance from intuitive to precision medicine in the diagnosis and treatment of duodenal and gastric ulcers - an improved understanding of the causes and mechanisms of the disease, combined with a development process that provided evidence of effectiveness. The parallel with the emergence of direct-acting antivirals to combat hepatitis C is clearly suggested.

The parallel is extended to the impact of these new medicines. H2 blockers replaced less effective trial-and-error treatments, such as less effective medication with anti-acids, recommendations for lifestyle or dietary changes, and occasionally hospital care and surgery. Similarly, DAAs (Directly Acting Antivirals) now hold out the prospect of mastering the leading cause of liver cancer and liver transplants, as well as diabetes and depression for the approximately 8 million patients in the EU. These new medicines can replace previous limited treatments – for which many patients were ineligible, and where the success rate was in any case only around 50 percent, partly because of the high rate of drop-outs from side effects of depression, nausea, severe anemia, and flu-like symptoms.

So like H2 blockers, DAAs replace other technologies (cheaper but less effective medicine, and hospital technologies, mainly surgical operations for stomach and duodenal ulcers). They also transfer treatment from hospital to ambulatory care and self-medication. And they empower the patient while saving costs, says the expert group approvingly.

What is needed now, the group goes on, is a vision of this new option that takes account of the overall cost of care, and not just the customary silo-based view of departmental profit and loss. Realising the potential depends on using the health care system more proactively, taking into consideration the opportunities for cost savings, both in terms of direct health care and in reduced loss of production. But, it warns, that vision cannot be taken for granted.

As disruptive innovation is essentially the creation of new networks and organisational cultures with new players and new perspectives that displace older systems and ways of doing things,  acquiescence among the establishment may not be automatic; indeed vested interests can represent a barrier: "There is evidence that many potential disruptive innovations fail to be adopted and diffused," it alleges.

The group offers the example of the education and training of health professionals, which underwent radical change at the beginning of the 20th with the acceptance of science-based curriculums and public health-related sciences, and again after World War II with the expansion of tertiary hospitals and academic health centres and the introduction of departments of primary health care and community health, the group recounts. Nowadays, a third regeneration is required to respond to demographic and socio-economic challenges and to exploit opportunities in epidemiology and pharmacogenomics. But there is resistance, it notes, in workforce reluctance to change, in cultural barriers and professional silos, and the sort of disruptive innvoation that could pay dividends risks being impeded.

So too for a new technology such as DAAs, prices present a major and potentially crippling obstacle. This is aggravated by the difficult economic context, by a tendency for reimbursement controls to force providers to become more financially efficient without necessarily improving health care, and by payment models that - particularly in hospitals - focus on fee-for-service and ignore issues of overall quality of care. "These payment models are creating barriers to innovation by rewarding volume, not value for the money spent", inhibiting innovative care delivery based on an integrated view of care.

Acknowledging the reasoning that underlies resistance, the group concedes that there is always a degree of uncertainty when introducing a disruptive innovation. "Only after an innovation is implemented, allowing its utilization by a significant number of  users, is it possible to realistically analyse its positive or negative impacts", it recognises. So the implementation of any disruptive innovation in healthcare should address head-on issues such as its relevance, its impact on access, and quality and cost-effectiveness. But this assessment should be made with a readiness to admit that improvements may be possible over current methods. "Policy makers should analyse how to enhance the enablers and to address the already identified possible barriers for implementing a disruptive innovation within a health system," they say.

If public authorities turn their faces against change, valuable changes may be stifled, the group warns. Discarding much of the currently fashionable talk of seeking consensus among stakeholders, it makes a bold plea for bold and incentive-driven action to embrace future opportunities, rather than to remain contentedly cruising timidly through ineffectual exchanges of unambitious best practices. "Just informing about best practices seldom creates any change", it says. It does not specify what incentives should be put in place, but it is convinced that public authorities need to reflect urgently on how to seize this opportunity: "Unless proper incentives are put in place it will probably not happen."