Table 1 Priority-setting and implementation tools: definitions, criteria for decision-making and purpose

Priority-setting tools

 WHO Model list of essential medicines (EML)

The Model EML is a select list of medicines developed by the WHO. Essential medicines are those that satisfy the priority healthcare needs of the population [8]

Safety, efficacy, quality, affordability, population need and evidence of market registration

Guides several steps, from production, through procurement to prescribing in primary, secondary and tertiary care settings [5]. It is also used for medicine procurement by UN agencies and international non-governmental organisations (NGOs) [8]

 National/Regional/Local EML

National EMLs contain medicines that the country has deemed essential and should be accessible to all people. They may be based on the WHO Model EML. Some countries also have provincial, state or local lists [5]

Safety, efficacy, quality, affordability (cost and budget impact) and population need

Guides several steps, from production, through procurement to prescribing in primary, secondary and tertiary care settings [5]

 Health technology assessment (HTA)

A systematic approach to evaluate the properties, effects, and impacts of health technologies; medical devices, medicines, vaccines, procedures, health services, and public health interventions [15, 17, 29]

Budget impact, clinical effectiveness, disease burden, ethical or legal implications, timeliness of review, health economics data and cost-effectiveness [30]

In most national settings, HTA appraisals inform pricing and reimbursement decisions [31]. New technologies, which include medicines, are often compared to the next available alternative

Implementation tools

 Formularies

These are lists of medicines, often organised by drug class or groups of diseases. They contain details of medicines with reference to their uses, cautions, contraindications, side-effects, doses, and costs. They may contain guidance on prescribing, monitoring, dispensing, and administering medicine [5]

Registration status, cost, budget impact and clinical effectiveness

In some settings, a formulary is simply a list of all registered medicines. In others, it aims to guide prescribing behaviour to facilitate effective, efficient, and cost-conscious prescribing. Private insurers may have their own formularies [5]

 National reimbursement list (NRL)

A reimbursement list is an instrument used by countries to manage their benefits packages or dictate which medicines will be reimbursed by the government or provided for free [8]

Safety, efficacy, quality, affordability (cost and budget impact) and population need

Provides a list of drugs that are reimbursed by the government and are free to patients. A list may specify medicines selected for coverage (positive list) or those excluded from reimbursement (negative list) [8]

 Standard treatment guidelines (STGs)

These are a list of recommendations for medical professionals, normally organised by disease group that specifies which medicines should be used to treat specific illnesses. Countries may develop and use national, regional, or local guidelines [32]

Clinical effectiveness and population need at the relevant level of use

Aims to promote appropriate prescribing behaviour [5]