A comparative review of the pharmacoeconomic guidelines in South Africa

Figures & data

Figure 1. Flowchart of inclusion/exclusion criteria applied to ISPOR comparative table of pharmacoeconomic guidelines.

Table 1. Key features of the pharmacoeconomic guidelines in South Africa.

Key features	Notes
Title and year of the document	Guidelines for Pharmacoeconomic Submissions. December 2012.
Affiliation of authors	Department of Health, Republic of South Africa.
Purpose of the document	To establish whether a medicine represents fair value for money by creating a standard for conducting economic evaluation, describing a process of compiling a submission, describe the process to be followed when submitting an application, provide an overview of the principles and methods to be applied, promote transparency regarding the value of medicines, create a room which provides an objective review of the value of medicines, and ensure a common understanding of the criteria and information that is required.
Standard reporting format included	Yes.
Disclosure	Yes.
Target audience of funding/author’s interests	Submissions by applicants who are the license holders as per the registration certificate issued by the Medicines Control Council. Private sector in South Africa, including health insurance companies.
Perspective	Third-party payer perspective. Strong case can be made for adopting a broader perspective. Generally, indirect costs should not be included in the submission.
Indication	New chemical entities, new clinical indications for an existing medicine.
Target population	A clear description must be provided of the patient group.
Sub-group analysis	Therapeutic value may be determined in specific patient groups. Sub-group analysis within a randomized controlled trial where the trial is powered to detect a difference within the general population of the trial will not be considered.
Choice of comparator	The main comparator is the therapy which is deemed to be the standard of care for local practice such as those described in the prescribed minimum benefits (PMB) and essential drugs list (EDL). The comparators should also include the lowest cost alternative available for the same indication.
Time horizon	Based on the natural course of the condition and sufficient to capture all relevant clinical outcomes and future costs.
Assumptions required	Yes.
Preferred analytical technique	CMA, CEA, CUA, CBA.
Costs to be included	Only costs relevant to the third-party payer perspective. Resource use should be based on South African practice and adjusted to local setting if based on international practice.
Source of costs	Cost sources must be systematically identified that are relevant to the study perspective.
Modeling	Complex models are discouraged where a simple model will adequately support the economic argument.
Systematic review of evidences	Yes, meta-analysis if appropriate.
Preference for effectiveness over efficacy	Yes.
Preferred outcome measure	Final outcomes preferred: e.g. deaths prevented, LYG, QALY. Use of surrogate outcomes should be avoided.
Preferred method to derive utility	No golden standard for quality-of-life instruments, no preference, but details must be provided on the measurement instrument.
Equity issues stated	None stated.
Discounting costs	Discount rate of 5%, SA 0–10%.
Discounting outcomes	Discount rate of 5%, SA 0–10%.
Sensitivity analysis—parameters and range	Sensitivity analysis must be carried out on total costs as well as individual costs, which are likely to substantially impact the outcomes of the model.
Sensitivity analysis—methods	One-way, Two-way and Probabilistic Sensitivity Analysis for complex models.
Presenting results	Present the results of the evaluation first in disaggregated form then in increasingly aggregated form, separately for outcomes and resources.
Incremental analysis	Yes.
Total costs vs effectiveness (cost/effectiveness ratio)	Yes.
Portability of results (Generalizability)	Not specified.
Financial impact analysis	Not specified.
Mandatory or recommended or voluntary	Voluntary submissions.

Table 2. Private health expenditure by country as a percentage of GDP and at market prices.

	Private health expenditure (% of GDP, 2013)	Private health expenditure at 2013 market prices (USD)
High-income country
Germany	2.62	98,113,464,076
Netherlands	1.67	14,417,012,704
Portugal	3.43	7,756,981,113
Norway	1.39	7,268,297,990
Ireland	2.88	6,871,924,192
Taiwan	Not available^a	Not available^a
Middle-income country
Brazil	5.01	119,858,523,148
Mexico	3.01	37,898,119,012
South Africa	4.61	16,870,707,224
Egypt, Arab Rep.	3.00	8,164,652,849
Colombia	1.63	6,204,574,633
Malaysia	1.82	5,882,162,232
Cuba	0.62	479,085,377

^a Taiwan, China, is not listed as a separate country for World Development Indicators, World Bank.

Figure 2. Complexity and transparency in pharmacoeconomic submissions.