Irish HTA Official Calls for All New Patients to Start With Biosimilars

Clinical director of the Irish health technology assessment (HTA) body National Centre for Pharmacoeconomics (NCP), Michael Barry, MB, FRCPI, PhD, recently said in an interview with Irish media that the lack of uptake of biosimilars in Ireland is “an issue that should be tackled.”

He went on to explain that “The [Health Service Executive, HSE] needs to take this one seriously and to have a good quality team producing a policy and also implementing it and, in addition, empowering excellent pharmacy units in our hospitals.”

Click here to read more about biosimilars in Ireland.

Barry explained that, among his colleagues, there is an appreciation that safety and efficacy of drug products is important, but prescribers should not overlook the cost issue of medicines. He also had recommendations for how to approach the issue, beginning with the creation of a policy that states that, unless there are extenuating circumstances, a patient starting treatment on a biologic should begin with a biosimilar.

“Then you’ve got to put in the structures to enable this to happen at a hospital level. We have spent the last 5 years concentrating on community expenditure because that is where most of it takes place, but we need to get to grips with hospital prescribing,” he said.

Though the United States has also seen a similar lack of biosimilar uptake, the nations differ in terms of their challenges and approaches to addressing them. While CMS recently announced that it would allow Medicare Advantage plans to use step therapy that could involve starting patients on biosimilars, that policy initiative does not extend to commercial plans (and experience with step therapy used in commercial plans to date has shown that biosimilars are not typically used first). Neither has the United States made special initiatives to address hospital- versus community-based biosimilar prescribing.

Furthermore, in the United States, there are just 4 biosimilars on the market, compared with Ireland’s 11 reimbursable biosimilars (as of the date of Ireland’s Minister for Health publication of a consultation paper on developing a national policy on biosimilars).

The slow biosimilar uptake in both the United States and Ireland has cost each country’s respective health system greatly, however. Last month, Medicines for Ireland released a report stating that Ireland’s policies are keeping the nation from benefitting from €25m (approximately $29 million) in annual savings to its national health system. Similarly, in the United States, biosimilars had been projected to save nearly $54 billion from 2017 to 2026, but the actual realized savings thus far are only “a fraction of even the most conservative initial estimates,” said FDA Commissioner Scott Gottlieb, MD, in a recent statement.

What remains the same throughout any market looking to increase the use of biosimilars is that it is not a feat that can be accomplished by a single organization or government entity. During the announcement of the FDA’s Biosimilar Action Plan, Gottlieb stated that achieving the cost savings projected for biosimilars will require actions from both the public and private sector. Barry is of a similar mindset, explaining that the benefits of biosimilars are obvious, but “resources are needed to put the strategy in place.”