Last week PharmaDispatch said it was time to move on from the debate over pharmacy-level substitution of biosimilars. In a special comment, Matt Little, AbbVie's biologics strategy manager, says the issue remains important but it is time to broaden the discussion beyond the letter 'a'.
The time is now to broaden discussion so that biosimilar policy in Australia doesn’t begin and end with the letter ‘a’.
The Government’s reimbursement of biologic medicines has transformed the lives of many Australians living with chronic and often debilitating health conditions.
While the substitution of biologic medicine with biosimilar versions is a concern for specialists, patients and many in industry because of the limited evidence regarding the safety and efficacy of this practice, the issue of ‘a’ flagging is distracting attention from the need also for a more comprehensive policy discussion.
We need to shift focus to the two key objectives that are no doubt shared by all stakeholders: 1. upholding the primacy of optimum patient outcomes and 2. ensuring that taxpayer funds are spent in the most efficient and effective manner – i.e. securing savings when biologic patents lapse.
It’s time for a different conversation – one where Government sits down with patient and physician groups, the manufacturers of originators and biosimilars, and other key stakeholders to agree on the smartest way to deliver on these two objectives. Clearly, there are significant opportunities to deliver savings from off-patent biologics and create an environment conducive to biosimilar participation – outcomes that can be achieved through a balanced market and with patients at the forefront.
Yes, AbbVie has a direct interest. That’s what happens when you are a leader in biologic innovation and when around 17,000 Australians rely on your biologic medicine every day[1]. For these patients, let alone their doctors, we have a responsibility to advocate for a robust biosimilars policy that combines patient wellbeing and prescriber oversight with the long-term sustainability of the PBS.
Can collaborative health policy achieve these outcomes? We believe so.
As just one example, the creation of the F1 and F2 formularies clearly established that collaboration between key stakeholders can produce innovative health policy. In the case of biosimilars, good health policy requires fresh thinking, including consideration of whether the generics model is an appropriate fit for biosimilar medicines. It will also require the views of medical experts and patient advocates – people unencumbered by financial interest – to be given greater credence.
In the short-term and while broader discussions are ongoing, there are a number of clear and tangible steps that can be taken – steps that AbbVie believes would be supported by medical experts and patient advocates.
A logical starting point is the naming of biosimilars. By not assigning unique names to individual biosimilars, we add confusion, undermine the internationally established principles of pharmacovigilance and hinder the ability to collect robust real-world data that will ultimately shape market confidence. Opponents of this proposal will object on the basis that unique naming somehow impedes uptake. This viewpoint is inconsistent with the mutually agreeable goals of cost savings and optimum patient outcomes. Surely we can agree that the use of a naming qualifier – as recommended by WHO[2] – is in the interests of patients and in a fit-for-purpose model will not diminish the scope for PBS savings.
Critically, the importance of prescriber oversight must not be lost in the biosimilars debate. Specialists treating complex and serious conditions cannot be left in the dark; they must be informed when medicines are changed and registries should be developed to aid prescribers in monitoring health outcomes. The technology exists to connect pharmacists and prescribers; ensuring a decision to substitute is understood, recorded, and, ideally, jointly agreed. Establishing such a system would support patient outcomes, while also building prescriber confidence in the use of biosimilars.
Finally, pharmacists have a key role in delivering their expertise to support patients with serious conditions as they navigate an increasingly complex medication environment. As pharmacists continue their role as trusted and valued healthcare providers, we need to ensure they are supported and equipped to accurately explain biosimilars to their customers. This requires a concerted education campaign and agreement on the language, and perhaps even standardised documentation, which will be used when biosimilar substitution is discussed.
In coming together we can refocus our energy and efforts to develop innovative health policy that achieves the two key objectives that are shared across key stakeholders: upholding the primacy of optimum patient outcomes while securing savings when biologic patents lapse.
[1] Data on File - AbbVie
[2] http://www.who.int/medicines/services/inn/inn_bio_bq/en/
