Introduction
Many middle-income countries such as Egypt, South Africa, Malaysia, Thailand, and Brazil have pharmacoeconomic guidelines. These follow the recommendations by the International Society for Pharmacoeconomics and Outcomes Research but include country-specific differences. The variations respond to changes in how governments apply pharmacoeconomics and determine market access to pharmaceuticals and medical devices. This is also determined by differences in healthcare structure, disease area priorities, and sociopolitical preferences.
This post answers three questions:
- What are the main features and differences among pharmacoeconomic guidelines?
- How do health technology assessments in high-income countries impact pharma market access?
- What are the challenges with applying pharmacoeconomics in middle-income countries?
To answer the first question, we review the pharmacoeconomic guidelines in South Africa (middle-income country) as a basis to compare with other countries. In the second question, we review the role of the National Institute for Health and Care Excellence (NICE) in England. In the last question, we find important themes for our work.
Figure 1: Global Pharma Market Access: Pharmacoeconomics in Middle-income Countries
What are the main features and differences among pharmacoeconomic guidelines?
In a published study, we compared the key features of the pharmacoeconomic guidelines in South Africa with other countries.
We chose five upper middle-income countries (Brazil, Colombia, Cuba, Malaysia, and Mexico), one lower middle-income country (Egypt), and six high-income countries (Germany, Ireland, Norway, Portugal, Taiwan, and the Netherlands).
We found that the pharmacoeconomic guidelines in South Africa differ in important areas when compared with other countries.
- It limits the study perspective and costs to private health insurance companies.
- It discourages complex modelling.
- Models submitted by manufacturers need pre-approval.
- They do not specify equity issues.
- They do not need a budget impact analysis.
- Pharmacoeconomic submissions in South Africa are voluntary.
These key differences reflect the challenges pharmaceutical market access teams have in South Africa when applying pharmacoeconomics. Over the years, we have also learnt that these challenges are not specific to South Africa. They apply to other middle-income countries impact how market access strategies are developed.
How do health technology assessments in high-income countries impact pharma market access?
Most middle-income countries have underdeveloped evidence review and health technology assessment databases to support value assessments. So governments and private health insurance companies use HTA assessments in high-income countries for local decisions.
The sequence of events unfolds as follows – they plan introducing a new medicine in a middle-income country, but payors are uncertain of its economic and clinical benefits. So they turn to the National Institute for Health and Care Excellence (NICE) in England for guidance. They download technical appraisals, distribute these, and NICE’s guidance becomes a shortcut to rationalise reimbursement decisions.
NICE is England’s health technology assessment agency tasked with evaluating the economic impact of health technologies for the National Health Service (NHS). NICE evaluates disease severity, estimated health benefit, patient numbers, and clinical priorities of the NHS. Their aim is to balance the costs and benefits of new medicines before enabling access to innovations in the NHS.
However, NICE is not the only health technology assessment agency. Others just as IQWiQ (Germany), AIFA (Italy), ZIN (Netherlands) and AOTMiT (Poland) also apply health economics and pharmacoeconomics methods to determine access to pharmaceuticals and medical devices.
So, why would governments and health insurance companies in middle-income countries choose NICE over the others for reimbursement guidance on new medicines? It may be because NICE guidance documents are available in English.
Very few HTA agencies in Europe (including those listed above) have websites and technical documents in English. This is an important barrier for middle-income countries to decide how HTA agencies evaluate new medicines. Payors in middle-income countries also have limited knowledge of German, Polish, or Italian to work with the technology appraisals of IQWiG, AOTMiT, and AIFA.
The answer may also lie in NICE’s ambition to globalise technology appraisals through NICE International – a non-profit division of NICE. NICE International provides technical support and consulting services to governments and funding agencies in low and middle-income countries.
NICE International closed in September 2016 and then relaunched in November 2019. HTA agencies rarely have ambitions to globalise health technology appraisals. Here lies the danger.
The global use of technology appraisals by NICE assumes that England’s social value and prioritisation system for new medicines applies to other countries. Governments and private health insurance companies in middle-income countries adopt NICE appraisals. They seldom critique the criteria for reimbursement decisions in England.
If health technology appraisals were available in English then reimbursement decisions may be more comparative than at present. Or if payors in middle-income countries knew how to read German, Polish and Italian, that too would help.
Situations arise when England declines reimbursement of a new medicine while Germany, Italy, and Poland issue a positive appraisal of the same medicine. That means that significant variations exist between countries in HTA recommendations. The use of NICE guidance is a limited perspective on reimbursement decision-making.
Figure 1: Global Pharma Market Access: Pharmacoeconomics in Middle-income Countries
What are the challenges with applying pharmacoeconomics in middle-income countries?
We could improve the pharmacoeconomic guidelines in South Africa and other middle-income countries if payors:
- Include a societal perspective with limitations,
- Incentivise complex and transparent models,
- Integrate equity issues,
- Address conflicting objectives with other health policies,
- Incentivise private health insurance companies to disclose reimbursement data, and
- Require a budget impact analysis.
Many middle-income countries have voluntary pharmacoeconomic guidelines that limit access to innovations. Our work involves healthcare consulting on the impact of mandatory pharmacoeconomic submissions in middle-income countries.
Governments and private health insurance companies in middle-income countries could improve access to new medicines if only they looked beyond England. Middle-income countries could develop local institutions and the capacity to synthesise international evidence using various languages. Our work also involves supporting stakeholders to apply health economics and pharmacoeconomic methods.