Given that any use of S/D plasma will likely result in an increased cost to the Canadian health care system, open access will mean that there will be a more significant impact on the system’s ability to spend on other health care priorities than if a restricted access model is chosen. When using the CBS projections of incremental cost, 100% replacement of demand with S/D plasma will result in a significant increase in health care spending (Assessment: Initiating the distribution of Octaplas (S/D Plasma). Ottawa: Canadian Blood Services: unpublished data, 2010 Apr 7 (Redacted)). Using the 20% replacement of supply figure, which CBS suggests would represent a cap in a restricted-access model (Assessment: Initiating the distribution of Octaplas (S/D Plasma). Ottawa: Canadian Blood Services: unpublished data, 2010 Apr 7 (Redacted)), would limit the budgetary impact of funding S/D plasma, although this approach could potentially be associated with “indication creep” (Briefing note for provinces and territories. Ottawa: Canadian Blood Services: unpublished data, 2010 June 14). In this sense, open-access will cost more than the projected upper-level cost in a restricted access model. Ethically, the residual question is whether this would be an appropriate use of these additional health care funds. For example, are there other health care interventions that can be purchased for that price? Do those same interventions result in greater benefits to Canadians for similar costs? If so, what would the justification be for choosing to spend those excess funds on S/D plasma? These broader questions around distributive and procedural justice need to be considered when making a final decision.
This is not to say that it would be “unethical” to replace 100% of demand with S/D plasma. As the evidence suggests, S/D plasma is safer than FFP, and will result in less transmission of certain diseases. However, it appears as though the risks associated with use of FFP are extremely low already15 and may or may not constitute an acceptable level of risk. Based on the A4R framework, discussion around these issues can result in greater consensus and ethical legitimacy when making a final decision. Particularly, the notion of “acceptable level of risk” should be reflected on, and those impacted by the risks in question should be consulted, if possible.
Canadian Agency for Drugs and Technologies in Health, Ottawa (ON)
Kekewich M, Foreman T. Ethical Assessment: Open versus Restricted Access and Optimal Use of Solvent/ Detergent-Treated Human Plasma (Octaplas): Pilot Project [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2011 May. 4, CONSIDERATIONS: OPEN ACCESS TO SOLVENT/ DETERGENT-TREATED HUMAN PLASMA.