Government mandate to Swedish Medical Products Agency regarding off-label prescribing

In April 2019 the Government gave the Swedish Medical Products Agency directives to conduct a pilot project regarding a risk-benefit assessment of off-label prescription of drugs. The project will submit a finalized report by 31 December 2019.

The project also includes an analysis of the potential advantages and disadvantages of risk-benefit assessments of off-label prescription for other types of medicines within different therapy areas where the Swedish Medical Products Agency (Sw. Läkemedelsverket) (MPA) considers the need for such an assessment to be particularly large.

In the project description, the Government notes that over the past year several organisations – including the Swedish pharmaceutical insurance (LFF), the Swedish Association of Local Authorities and Regions (SKL) and the Network of Pharmaceutical Committees in Sweden (Lok) – have contacted the Government to point out the importance in selected cases of having the MPA carry out a risk-benefit assessment. In this context, it should be noted that in 2018 LFF tightened its conditions regarding prescription of medicinal products for indications other than those for which they are approved in a general recommendation regarding such use.

The Government notes that the project will play a key role in the effort to clarify the current state of scientific knowledge regarding such prescription. The assignment is expected to help facilitate the choice of medically safe and efficacious treatment options for patients, as well as it will be easier to discover and stop systematic use where the risk-benefit balance has been shown to be negative. 

Based on the picture that emerges, the MPA will submit a recommendation as to whether it is desirable to continue working with risk-benefit assessments for selected medications that are prescribed for off-label use. If recommended, the MPA will propose a process and method for implementation.

The use of the antibody Rituximab for treatment of multiple sclerosis (MS) will likely be reviewed in the pilot project. Rituximab is used extensively to treat MS, even though MS is not an approved indication for Rituximab.

Anders Blanck, CEO of Läkemedelsindustriföreningen (LIF), the trade association for the research-based pharmaceutical industry in Sweden, strongly criticises the project in LIF’s publication LIFe-time.se. He questions why the project description does not state that the pilot project is about off-label prescription for MS, even though it is obvious that it is the case.

Moreover, Blanck notes that the pharmaceutical companies alone determine whether an application for expanded indication should be submitted. The same high standards are imposed during this application process as when the drug was first approved. Clinical trials must have been conducted and the safety and efficacy requirements are just as tough for the new indications. According to Blanck, the MPA’s assignment is to explore whether Sweden should have a parallel system with lower requirements for medicinal products, noting that such a system would risk ignoring the high standards for safety and efficacy required by EMA approval.

Setterwalls is monitoring the progress as it is an issue of principal importance.