Insurance coverage when medications are prescribed off-label

As off-label prescriptions become increasingly common, the Swedish Pharmaceutical Insurance (Läkemedelsförsäkringen) is questioning insurance coverage in relation to incidents after off-label use.

Sweden has a unique system that involves the industry taking joint responsibility for patients that suffer from medication-related illness or injury. This means that patients who suffer adverse effects from pharmaceutical treatment can receive financial compensation from the Swedish Pharmaceutical Insurance. The requirement for such insurance is that patients are treated with prescribed medication or medication purchased from a legitimate dealer in Sweden. In addition, patients who receive medication at hospitals or through clinical trials that results in adverse reactions or side effects may also be covered by the insurance. The insurance is funded by pharmaceutical companies, research and development companies, clinical research organisations and other entities.

However, this year the insurance made some changes to its application of certain conditions, limiting patients’ right to compensation from the insurance. One of the new rules is that the insurance does not cover organised off-label use that has its origin in a general recommendation from an authority or healthcare organisation. The reasoning behind this change is that all medications have been evaluated from a risk/benefit perspective when approved by the competent authority and the Pharmaceutical Insurance is not to make such an evaluation.
In Sweden, physicians has a freedom to prescribe medication (fri förskrivningsrätt), including the prescription of medication for uses other than those for which it approved by the authorities (off-label prescription). At the same time, it is becoming increasingly common for healthcare organisations to recommend off-label prescriptions for certain conditions. This may be for cost reasons.

This has also been the case in other jurisdictions such as the UK. In a recent case at the High Court of Justice, Case No: CO/5288/2017, Bayer and Novartis challenged the lawfulness of a policy adopted by the UK’s 12 Clinical Commissioning Groups as the available medications for the indication in question were 30 times more expensive than Avastin, according to the Guardian newspaper. The policy was called ‘Treatment for Age-related Macular Degeneration’ and it referred to three different drugs for treating patients with the neovascular form of that condition, known as ‘wet AMD’. The three medications were Eylea, Lucentis and Avastin. The companies challenged the policy on several grounds, including that: it fundamentally undermines the objective of Directive 2001/83/EC and constitutes a breach of the duty of sincere cooperation in Article 4(3) of the Treaty of the European Union; it undermines patients’ rights of access to treatments recommended by the National Institute for Health and Care Excellence; and it introduces information for patients that is materially misleading and inaccurate. The court rejected the challenge on all grounds and the application for judicial review was consequently dismissed. As a result of the ruling, the National Health Service will save £13.5 million a year.

In Sweden, the Pharmaceutical Insurance believes that insurance risk is uncontrolled when medications are used off label and it has therefore ruled that its insurance coverage must be clarified for situations where healthcare organisations recommend off-label prescriptions. On the other hand, other groups such as patient organisations are concerned that this more restrictive insurance coverage approach may result in patients being uninsured or in physicians not prescribing off-label use of medication that patients may need for fear of not being covered by the insurance. There have consequently been calls for the insurance coverage to be provided when medications are prescribed off-label. The Swedish Association of Local Authorities and Regions, SKL, has asked the government to task the Medical Products Agency with assisting the county councils and the Pharmaceutical Insurance on risk/benefit evaluations of medications in off-label use.

The Swedish Pharmaceutical Insurance has stated that it will adopt a generous approach to physicians’ right to prescribe and for health conditions for which no new medication has been approved for a long time. It has been stressed that the change is for situations where healthcare organisations, not individual physicians, recommend off-label use. A more generous approach in such situations also requires further instructions from the authorities. The Swedish Pharmaceutical Insurance has therefore requested a risk/benefit evaluation for specific situations where medications are used off-label. This issue is currently in the hands of the Ministry of Health and Social Affairs. Off-label prescription is a frequent topic of discussion and it is now also being discussed from this new perspective. 
We will continue to follow developments in this area.