Fixed dose drug combinations – are they pharmacoeconomically sound? Findings and implications especially for lower- and middle-income countries

ABSTRACT

Introduction

There are positive aspects regarding the prescribing of fixed dose combinations (FDCs) versus prescribing the medicines separately. However, these have to be balanced against concerns including increased costs and their irrationality in some cases. Consequently, there is a need to review their value among lower- and middle-income countries (LMICs) which have the greatest prevalence of both infectious and noninfectious diseases and issues of affordability.

Areas covered

Review of potential advantages, disadvantages, cost-effectiveness, and availability of FDCs in high priority disease areas in LMICs and possible initiatives to enhance the prescribing of valued FDCs and limit their use where there are concerns with their value.

Expert commentary

FDCs are valued across LMICs. Advantages include potentially improved response rates, reduced adverse reactions, increased adherence rates, and reduced costs. Concerns include increased chances of drug:drug interactions, reduced effectiveness, potential for imprecise diagnoses and higher unjustified prices. Overall certain FDCs including those for malaria, tuberculosis, and hypertension are valued and listed in the country’s essential medicine lists, with initiatives needed to enhance their prescribing where currently low prescribing rates. Proposed initiatives include robust clinical and economic data to address the current paucity of pharmacoeconomic data. Irrational FDCs persists in some countries which are being addressed.

KEYWORDS:

• Fixed dose combinations
• pharmacoeconomics
• adherence
• medicines
• non-communicable diseases
• infectious diseases
• lower and middle income countries

Article Highlights

• Fixed dose combinations (FDCs) are welcomed across countries illustrated by endorsement from the World Health Organisation

• However there are concerns including their rationality, potential to increase adverse drug reactions, dosing schedules with peak effectiveness at different times, lack of titration and potentially higher prices

• There is a paucity of data among low- and middle-income countries assessing their value and cost-effectiveness in routine clinical care affecting availability and funding

• Perceived benefits regarding FDCs among senior-level personnel working in LMICs include simplifying the treatment schedule – especially important in complex disease areas, improved adherence rates and tolerability, reduced overall costs and reduced chances of stock-outs

• Additional perceived concerns include the potential for overtreatment if physicians and patients are not fully aware of their constituents, potential to increase polypharmacy and missed doses have a greater impact on subsequent patient care

• Initiatives to enhance the prescribing and dispensing of FDCs where valued include physician and patient education, developing quality indicators around their use, accelerating their registration and companies having realistic pricing expectations

• Possible initiatives to reduce or negate the availability of FDCs where there are concerns include a requirement for companies seeking registration to provide robust health technology assessment data to support the application as well as improved physician education and greater interaction with national patient organisations

Declaration of Interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer Disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.