Pharmacoeconomic Guidelines in South Africa: A Comparative Review.

Around this time last year, we published a comparative review of the Pharmacoeconomic Guidelines in South Africa (PGSA) in the Journal of Medical Economics. The paper compared the PGSA with other middle- and high-income countries and concluded that they differ in important ways. The paper has been viewed 2791 times on the C&C site by visitors across the globe, debated by policymakers in South Africa, utilized by industry staff, and shared by some patient organizations in their effort to improve access to medicines. The purpose of the paragraphs that follow is to review the results of the paper and outline some of the post-publication debates.

The research set-out to compare the key features of the PGSA with Brazil, Colombia, Cuba, Malaysia, Mexico, Egypt, Germany, Ireland, Norway, Portugal, Taiwan, and the Netherlands. The study found that the PGSA differ in important areas when compared with other countries. In South Africa, the study perspective and costs are limited to private health-insurance companies, complex modeling is discouraged, and models require preapproval by staff at the Department of Health. Unlike other countries, equity issues are not explicitly stated in the PGSA, and a budget impact analysis is not required.

The paper highlight some key improvements needed to the PGSA, such as:

  1. permitting the use of a societal perspective but with limitations,
  2. incentivizing complex and transparent models,
  3. integrating equity issues,
  4. addressing conflicting objectives with policies on National Health Insurance,
  5. incentivizing private health insurance companies to disclose reimbursement data, and
  6. requiring a budget impact analysis in all pharmacoeconomic submissions.

Industry staff and patient organizations have broadly accepted the study conclusions and motivated for improvements in the PGSA. A key discussion point has been the alignment of the PGSA with international standards reflected in the pharmacoeconomic guidelines of other middle and high-income countries. Another key issue is that South Africa is the only country that limits the scope of the pharmacoeconomic guidelines to the private healthcare sector, and a limited third-party payer perspective. This narrow perspective limits the usefulness of pharmacoeconomic evaluations and perpetuates the inequitable distribution of new technologies in South Africa.

On the other hand, the staff at the Department of Health (DoH) have questioned the validity of the study results and suggested that the current form of the PGSA reflects the voluntary and “developmental” nature of pharmacoeconomic submissions in South Africa. Staff at the DoH have been unwilling to clarify their concerns other than occasional and brief email correspondence on the subject. We assume that factors such as capacity at DoH to evaluate submissions, lack of financial resources, and the narrow focus of the Pricing Committee on the private sector are the developmental (and structural) issues that hamper improvements to the PGSA.

Overall, the PGSA is comparable to other countries but differ in important areas. Some of the issues highlighted in the study can be addressed through better partnerships with industry, civil society, payors, academia and consulting firms.

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