Are new models needed to optimise the utilisation of new medicines to sustain healthcare systems?Godman B 1,2,3 , Malmström RE 4 , Diogene E 5 , Gray A 6 , Jayathissa S 7 , Timoney A 8 , Acurcio FA 9,10 , Alkan A 11 , Brzezinska A 12 , Bucsics A 13 , Campbell S 14,15 AbstractIntroduction: Medicines have made an appreciable contribution to improving health. However, even high income countries are struggling to fund new premium-priced medicines. This will grow necessitating the development of new models to optimise their use. Objective: Review case histories among health authorities to improve the utilisation and expenditure on new medicines. Subsequently, use these to develop exemplar models and outline their implications. Challenges and proposed models: A number of issues and challenges have been identified including the limited innovation level of new medicines alongside increasing requested prices for their reimbursement especially for oncology, orphan diseases, diabetes and HCV. Models centre on the three pillars of pre-, peri, and post-launch including critical drug evaluation and multi-criteria models for valuing medicines for orphan diseases alongside potentially capping pharmaceutical expenditure Discussion: Proposed models which involve all key stakeholder groups are critical for the sustainability of healthcare systems or enhancing universal access. The models should help stimulate debate as well as restore trust between key stakeholder groups.

Older patients are at high risk of suboptimal prescribing (overuse, underuse and misuse of drugs), which can lead to serious adverse drug reactions (ADR). About one in four patients admitted to hospital are prescribed at least one inappropriate medication and up to 20% of all inpatient deaths are attributed to potentially preventable ADR. Lists of drugs to avoid (unnecessary or where risks outweigh benefits) and drugs not to be omitted (strong indications if there are no contraindications) can assist in identifying suboptimal prescribing although, to date, no trials have established the ability of such screening, by itself, to improve prescribing quality. Remedial strategies proven to be effective in randomized trials include detailed appraisal of medication lists by multidisciplinary teams, which involve geriatricians and close liaison with specialist clinical pharmacists. A multifaceted quality improvement strategy is proposed that includes an aspirational target of no more than five different drugs be regularly prescribed to vulnerable older patients. Achieving this target involves prioritizing drug selection on the basis of strength of indication which may run counter to current disease-specific clinical guideline recommendations based on trials that have excluded most older patients. Such a strategy is worthy of further evaluation in a multicentre randomized trial.

Background: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are effectiveness, safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies showed dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. These concerns resulted in extensive activities pre- to post-launch to manage its introduction.Objective: To (i) review authority activities across countries, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications based on post-launch activities.Methodology: (i) Descriptive review and appraisal of activities regarding dabigatran, (ii) development of guidance for key stakeholder groups through an iterative process, (iii) refining guidance following post launch studies.Results: Plethora of activities to manage dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions and monitoring of prescribing post launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. Post-launch activities include increasing use of patient registries to monitor the safety and effectiveness of new drugs in clinical practice.Conclusion: Models for introducing new drugs are essential to optimize their prescribing especially where concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

Improving quality and safety of hospital care is now firmly on the health-care agenda. Various agencies within different levels of government are pursuing initiatives targeting hospitals and health professionals that aim to identify, quantify and lessen medical error and suboptimal care. Although not denying the value of such 'top-down' initiatives, more attention may be needed towards 'bottom-up' reform led by practising physicians. This article discusses factors integral to delivery of safe, high-quality care grouped under six themes: clinical workforce, teamwork, patient participation in care decisions, indications for health-care interventions, clinical governance and information systems. Following this discussion, a 20-point action plan is proposed as an agenda for future reform capable of being led by physicians, together with some cautionary notes about relying too heavily on information technology, use of non-clinical quality personnel and quantitative evaluative approaches as primary strategies in improving quality.