Why are necessities for diabetes management, particularly insulin, unattainable to many globally, and how can we improve availability?
Access to essential medicines for diabetes, especially insulin, needs a sharper focus globally, according to a new in-depth review.
The new review, written by three public health experts led by David Beran, PhD, of the division of tropical and humanitarian medicine, Geneva University Hospitals and the University of Geneva in Geneva, Switzerland, outlines the challenges to insulin access and issues a call to action.
“Substantial attention has been given to the issue of access to medicines for communicable diseases; however, access to essential medicines for diabetes, especially insulin, has had insufficient focus,” they stated.
Insulin, discovered 95 years ago, is unattainable to many globally. “Manufacturers' selling prices of various insulin formulations and presentations, duties, taxes, mark-ups, and other supply chain costs affect the price of insulin,” they stated.
The authors noted that unlike drugs for HIV and AIDS, the production of generic or biosimilar insulin has not had an effect on the overall market. Other factors contributing to poor availability of insulin include: quantification at the national level, in-country distribution, and determination of needs at lower levels of the health system.
For those with type 1 diabetes, insulin has become essential for survival. For some people with type 2 diabetes, insulin helps manage their disease. However, “very little has been done globally to address the issue of access, despite the UN's political commitment to address non-communicable diseases and ensure universal access to drugs for these disorders,” they stated.
Access to insulin and poor health outcomes is not restricted to low-income and middle-income countries. Even in the United States, discontinuation of insulin use because of drug costs has led to diabetic ketoacidosis in an inner city setting.
The authors pointed out that insulin alone is not enough for proper diabetes management; syringes, blood glucose meters, education, information, and family support are also required.
Their call to action includes:
• Diabetes funders to allocate 5% of funds for innovation in the delivery of care and insulin.
• Inclusion of insulin in universal health coverage benefit packages.
• An investigation by the World Health Organization to include prequalification of insulin, develop a regulatory framework for biosimilars and insulin, and promote existing guidelines and methods for effective purchasing of quality assured, safe, efficacious, and cost-effectiveness drugs for insulin therapy.
• Development of a global compact with the insulin industry to guarantee that human insulin and insulin in vial form will not be removed from the market.
• The need for organizations and academics to speak with a unified voice when calling for better diabetes care.
They noted that the insulin market is dominated by three multinational companies, which might restrict price competition and enable these companies to shape the market with, for example, the substantial increase in higher priced analogue insulin.
Other barriers to access include regulatory aspects around biosimilars, the cost of production, and shifts to the use of insulin from pen devices, which are patented. Prices of insulin are affected by an increase in use of analogues and pen devices as well as mark-ups and taxes within the supply chain, they stated.
Reference: Beran D, et al. Constraints and challenges in access to insulin: a global perspective. Lancet Diabetes Endocrinol. 2016 Feb 5. [Epub ahead of print]