Post-Brexit: The U.K. Biosimilar Market
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
In recent weeks, the U.K. made the seismic decision to leave the E.U. This was an impactful move for pharma — and especially for those involved in biosimilar development. In a recent article, Tim deGavre, chair of the British Biosimilars Association (BBA), argued that “Brexit would be very bad for business.” There is no regulatory pathway for biosimilars (or indeed, any pharmaceuticals) in the U.K. Now, moving forward post-Brexit, the country must choose how it will regulate and approve drugs and encourage a strong life sciences industry within its borders. Naturally, this raises concerns about how the biosimilar market in particular will fare in the face of such regulatory uncertainty.
But biosimilars aren’t without support. Prior to Brexit, the U.K. celebrated the launch of the BBA. There have been biosimilars in the U.K. since 2006. But in the past decade, there’s been a shift. Biosimilars are no longer being made solely by generics manufacturers. As such, deGavre said the BBA was launched as a semi-autonomous group of the British Generic Manufacturers Association (BGMA) in order to attract companies developing biosimilars — whether they be pure-plays, generics companies, or innovators. As the U.K. prepares for Brexit and continually rising healthcare costs, the BBA will be working closely with the National Health Service (NHS) and a number of other key stakeholders to lead the charge on biosimilars in the country.
Challenges Facing Biosimilars In The U.K.
The first biosimilar, Sandoz’s Omnitrope, was launched 10 years ago. As deGavre describes, he has seen the nation go through a variety of stages toward a broader acceptance of biosimilars. (Though, this is obviously still an ongoing journey in and outside of the U.K.). At the time of Omnitrope’s launch, biosimilars were relatively unheard of. There was little knowledge of what Omnitrope was, and physicians and payers approached it with caution. Now, the U.K. is part of a growing global conversation on the topic of biosimilars.
However, in the U.K., decision-making is done on a local level, which causes a number of challenges for biosimilar uptake. As deGavre explains, decisions are made between the local payers, the Clinical Commissioning Groups (CCGs), and the local trusts. “The relationship between these parties is ultimately what determines whether a biosimilar is used,” he adds. And, as is the case in many different health systems, the biggest factor influencing these relationships is how the savings are distributed. (This distribution of savings is also known as gainsharing.) The ability to gainshare is based on the local willingness of the CCG and the trusts to work together. In locations where gainsharing occurs between payers, commissioners, the hospital department, and/or trust, physicians and pharmacists are more likely to prioritize a switch in medicines.
Take, for instance, the situation witnessed in London. While London was expected to be a prime location in which to see quick biosimilar uptake, this was not the case because several payers chose to keep 100 percent of the savings. And in northern England, biosimilar uptake was low because of physician resistance, deGavre explains. “There has been a lot of variation in the uptake of biosimilars in the U.K. because decision-making and negotiations were based on the abilities of local organizations to work together,” he adds. When physicians are able to rationalize that changing to a more cost-effective therapy will enable them to gain more support from nurses and pharmacies, as well as benefit patients, they will be more likely to pursue a change in therapy. Similarly, when the pharmacist realizes savings through the trust or for the hospital, the better value therapy will become more of a priority.
What Can Manufacturers Do?
Trade groups representing biosimilar manufacturers have primarily highlighted the importance of stakeholder education. This includes emphasizing the importance and safety of biosimilars to physicians, patients, and governments. As deGavre says, the BBA is similarly dedicated to the education of physicians and patients. But it’s also incredibly important for manufacturers to be working on a macro-level with the government. This will ensure that senior people within the U.K.’s NHS, Medicines and Healthcare products Regulatory Agency (MHRA), and the National Institute for Health and Care Excellence (NICE) are paying attention to biosimilars and driving support for them in the market.
In order to build biosimilar support, the BBA would like to see the MHRA take a more definitive stance on the use of biosimilars. For instance, deGavre references the Finnish regulator, Fimia, which, in May of 2015, recommended that biosimilars be considered interchangeable with the reference. (The regulator has not, however, come out in support of pharmacy-level substitution.) This is far ahead of the EMA, which has dictated that local countries are to determine their own interchangeability positions. The MHRA has stated in the past that there is not enough information currently to come out with a firm position on the topic. “I would love to see the MHRA do the same thing as Femia,” deGavre says. “The MHRA has a strong understanding of biosimilars, but we need to continue engaging across all the organizations to ensure the right processes and systems are put into place for procurement, interchangeability, and the other macro questions the industry has yet to answer.”
In fact, procurement is one of the biggest topics the BBA hopes to address in the upcoming years. As deGavre explains, “We need to have a sustainable system that enables pharma companies to make a reasonable return on their investment, but that also ensures the NHS gets the necessary savings.” The biosimilar market, because of the manufacturing expenses, will not be sustainable if biosimilars are priced at a 90 to 95 percent discount like most small molecule generics.
As in most markets currently, manufacturers are faced with setting the appropriate price for their biosimilars. This price has to enable the NHS to garner the savings needed to invest in future therapies and to incentivize payors and providers to use biosimilars and drive uptake. However, should price discounts be too steep, this could diminish the market’s luster, leading to a loss of investment and companies willing to develop biosimilars. This is a tricky balance to determine and maintain, and, as deGavre admits, there are no clear answers to this challenge. However, the BBA is currently collaborating with the Association of the British Pharmaceutical Industry (ABPI), which also has an interest in supporting the future of biosimilars. “We’re continuing to have conversations with the ABPI, as well as with policymakers to ensure that biosimilar procurement is at the forefront of their minds,” deGavre says.
It is essential that the biosimilar opportunity is maximized in a post-Brexit Britain, to support cost-savings in the NHS and to ensure a sustainable industry. But as deGavre adds, “It’s also important to continue to demonstrate that our regulator, the MHRA, remains at the cutting edge of medical science and is pioneering the way in areas like biosimilars.”