From The Editor | March 12, 2018

The U.K. Biosimilar Commissioning Framework: The Path Toward Implementation

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By Anna Rose Welch, Editor, Biosimilar Development
Follow Me On Twitter @AnnaRoseWelch

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During my time writing in the biosimilar space, I’ve particularly enjoyed digging into the different healthcare and reimbursement frameworks. Being from the U.S., which has a frustratingly complex system, it’s easy to look abroad at how other systems have benefited biosimilars (and from biosimilars) and assume it’s because there are fewer complications structure-wise. But after speaking with experts charged with policy work, it becomes clear just how complex the systems abroad are in their own right.

In an article published last week, I highlighted some biosimilar developments that have caught the eye of Sandoz U.K.'s head of the specialty business, Kavya Gopal, who was recently appointed chair of the British Biosimilars Association (BBA). As we discussed in the previous article, a number of regulatory and legal decisions being made in the U.S. could impact the overall business case for biosimilars, and, in turn, the growth of the market abroad. But we also touched upon some recent evolutions in the British biosimilar market. It’s been hard to miss some of the good buzz coming out of the U.K. as the acceptance and adoption of biosimilars continues to be one of the strongest across Europe, and the National Health Service (NHS) published its highly anticipated framework to help guide the use of biosimilars.

But how the new framework will shape the U.K. biosimilar market is only just being seen. While biosimilars are, for the most part, increasingly accepted by the NHS and its various parts, questions remain about how the NHS plans to implement the new framework at a local level — and how to do so efficiently. The NHS and BBA are both aware of the lost opportunity should there be significant lag time in biosimilar penetration in the U.K.

“Having the right implementation plan means you can do it quicker and faster, in turn achieving savings in more efficient ways,” Gopal said. “A delay of a month or two could mean a loss of millions for the NHS. But one of the biggest challenges to efficiency will be recognizing how each biosimilar product is slightly different on a product-specific level and determining the best method of action to address their unique implementation needs.”   

Unpacking The U.K. Healthcare System

In the U.S., one of the biggest challenges facing companies is engaging with the wide array of payers and the government to bolster biosimilar uptake. However, working with the NHS, despite the fact it is the central healthcare body in the U.K., has its own complexities. For instance, depending on the type of care, the NHS commissions services and treatments centrally (e.g. cancer care) or locally through one of the 200-plus Clinical Commissioning Groups (CCGs) which provide primary care (i.e. Rheumatoid Arthritis.) There are other dedicated groups within the NHS which also influence biosimilar use, such as NHS Improvement, which has a role in overseeing data collection (among other things), and the Regional Medicines Optimization Committees (RMOCs) that inform medicine use on a regional level.

“Depending on the product, you’re dealing with two different types of commissioning, which may mean two different types of what would be called formularies in the U.S., and, hence, payments, reimbursement, and payer setup for the products,” said Gopal. “It’s as complicated as the U.S., but all the pieces are under one large umbrella, rather than multiple, different umbrellas, like the U.S.”   

Because of the wide array of stakeholders within the NHS itself, the BBA has been working closely with these different NHS groups to help inform decisions about the implementation of future biosimilars. “We are trying to keep in close alignment with what they’re doing and provide input where appropriate,” Gopal said. “We want the biosimilar market to work. It’s as simple as that.”

One of the key talking points has been ensuring the NHS approaches each biosimilar individually. Gopal put it best when she said, “Every single biosimilar is going to have a different type of implementation plan, which is impacted by a number of factors outside of the different therapeutic areas.”

For instance, in the U.K., rituximab is a hospital product, and the majority of use has always been via IV administration in a hospital setting. When the time came to decide to move to a biosimilar, which can only be administered via IV, it was relatively simple to make that decision. But as the market faces the launch of other biosimilars, there are some administration-related questions in the U.K. For example, in the use of etanercept, different CCGs within the NHS have taken different approaches to adoption, and there is no uniform approach across the NHS. In regard to this, Gopal asks the million-dollar question: “How do you find an efficient way to drive biosimilar uptake when methods of administration for different products are in play?”

Reimbursement On The Local Level

In addition to the complexities of the NHS, it’s important to note the regional dynamics in the U.K. Two years ago, I spoke with Gopal’s predecessor at the BBA, Tim deGavre, who highlighted some of the trade organization’s ongoing efforts, as well as the challenges facing biosimilars in the U.K. During that discussion, deGavre shared that biosimilar uptake had been particularly challenged by the treatment decision-making process. For instance, decision making is done at the local level and requires great collaboration amongst local payers, CCGs, and trusts. The locations in England with the greatest biosimilar uptake were communities where the aforementioned stakeholders most successfully collaborated and shared savings. (And at that time, there was a lot of regional variability in uptake.)

Developing productive relationships among the different commissioning groups and trusts throughout the U.K. is still a work in progress. To some extent, this is made more challenging because of the complex interconnectivity and varied incentives amongst groups within the NHS.

Though the savings from biosimilars are alluring for both the CCGs and the NHS Central Commissioning, these two parties approach those savings somewhat differently. For instance, while gainsharing has been a particularly useful tool for CCGs, “Gainsharing does not apply to NHS-commissioned products, which, instead, are incentivized by a national Commissioning for Quality and Innovation (CQUIN) program,” Gopal explained. “In fact, if you look at the uptake of an NHS-commissioned hospital product, like rituximab, it’s going to look very different than the uptake you’d see in a CCG-driven situation, where CCGs are decentralized and have greater autonomy in decision making.”

One area Gopal highlighted as needing additional attention moving forward is greater collaboration between the NHS and CCGs in order to see better implementation of the NHS’ new commissioning framework. “Overall, the NHS needs to figure out how to better work with the CCGs and build a system which benefits all parties,” Gopal offered. “The NHSE Commissioning Framework for Biological Medicines (including biosimilars) has initiated this. The question right now is how do you work with the CCGs and encourage them to partner with their local hospital pharmacist and lead clinicians to provide the best-value biologic?”

It’s widely accepted amongst the different stakeholders in the U.K. — the CCGs, BBA, and NHS — that biosimilars will provide savings that can be reinvested in patient care, creating space for innovative treatments and providing greater patient access. And from what Gopal shared throughout our conversation, it’s clear all parties have the desire to bolster cooperation on a larger scale. After all, without arriving at a common solution, there will only be more lost savings.

“Every month or two where you’re not potentially moving to the best-value biologic, including biosimilars, is extra money you’re unnecessarily spending,” Gopal said.  “Keeping that in mind, one of the biggest questions in the U.K. right now is how do you make these savings more efficient and more consistent across the country?”