ViewPoints: The UK proves its worth at the vanguard of European biosimilar policy making

(Ref: ViewPoints Desk)

The backstory

Earlier this week, Jatinder Harchowal - chief pharmacist at London's Royal Marsden hospital - confirmed that biosimilar versions of rituximab have assumed an 80 percent share of the UK market since launching last year.

This clarifies reports that have drip-fed out of the UK in recent months pointing to impressive biosimilar adoption at the expense of Roche's MabThera; data previously provided to FirstWord by a source within England's National Health Service (NHS) show that it took less than six months to switch all patients from MabThera to biosimilar rituximab in one of London's largest NHS trusts.

Similarly, when the Swiss company announced its fourth-quarter 2017 results last month, it reported steeper than expected erosion of MabThera revenues, pointing to strong biosimilar penetration in other key European markets.

The bigger picture

According to data compiled by Bernstein analyst Ronny Gal, biosimilar rituximab products have gained a 21 percent volume share of the total EU market since the first biosimilar – Celltrion's Truxima - was launched in April 2017. Rixathon, from Novartis' Sandoz unit, was subsequently approved and launched last July. Gal notes that the "early adoption slope for biosimilar rituximab continues to be sharper than those for infliximab (Remicade) and etanercept (Enbrel) biosimilars."

In addition to the UK, adoption of biosimilar rituximab has been strong in Germany and though launch occurred later in the French market, rapid adoption was seen in the fourth quarter of 2017, notes Gal, citing a 16 percent share of the market after two months. All signs indicate growing confidence and experience with biosimilars facilitating increasingly faster adoption as new products reach the market.

The expert view

There is definitely evidence of this in the UK, Harchowal tells FirstWord, and in the case of rituximab, lessons were sought from the "quite variable uptake of biosimilar infliximab and etanercept," which saw some trusts adopt biosimilars very quickly and others yet to embrace them at all. Some of this experience was due to infliximab being the first complex biosimilar to reach the market, "so people were slightly wary of using it," one payer told FirstWord, adding "I also think that in the early days, education around the product was not consistent."

Payers also suggest the lack of a national gain-share agreement was partly to blame for inconsistent adoption rates and with rituximab biosimilars there was a push to use national procurement tendering versus regional decision making.

Harchowal says the innovative role of the NHS Cancer Vanguard - a partnership between RM Partners, Greater Manchester Cancer Vanguard Innovation and UCLH Cancer Collaborative set up in 2015 - was critical in facilitating this, through a joint working agreement with Sandoz. 

Last September, a national commissioning framework for biological medicines, including biosimilars, was published in partnership with industry, patients, clinicians, the National Institute for Health and Care Excellence and regulators. In particular, this document sought to highlight the importance of a collaborative approach, but also described policies than can be easily implemented or adapted at a regional level.

Why this matters

At current prices with an 80 percent penetration rate for biosimilar rituximab, full-year savings amount to approximately 80 million pounds ($113 million) across NHS England, versus the 160 million pounds ($226 million) spent on MabThera during the 2016/17 financial year.

Payers note the rate of spending growth on biologics has begun to level off, from a 12 percent to 15 percent year-on-year increase to a 2 percent to 3 percent increase in the last financial year, mainly due to the availability of biosimilars. The introduction of biosimilar rituximab is considered to have had the biggest impact to date, allowing treatment rates to be maintained (with no reported decline in response rates or safety issues raised) and significant cost savings achieved.

One UK payer noted "I've got to say that the experience [with rituximab biosimilars] has been very good. All of the initial worries about safety and lack of efficacy have all been unfounded. Significant cost savings have been made against that part of the budget, which has been passed through to NHS England. Their expectation is that where a biosimilar is available we will use it wherever we can. So we're very much compliant with that requirement."

Harchowal believes savings of up to 300 million pounds ($425 million) a year is achievable by 2020/21, based on current biosimilar discounting. However, there could be room for upside if biosimilar manufacturers compete more aggressively on price, he argues.

Final thoughts

The role of NHS Cancer Vanguard created something of "a perfect storm," which has allowed rapid adoption of biosimilar rituximab, says Harchowal, though he is hopeful the approach can be replicated once biosimilar trastuzumab (Herceptin) products become available later in 2018.

The blueprint should also be adaptable for biosimilar versions of biologic treatments outside of oncology, adds Harchowal, and payer eagerness to utilise biosimilar versions of adalimumab (Humira) - which will also potentially become available later this year - is known to be high.

Could a similar approach be utilised in other countries? Harchowal is "hopeful but wary," given differing market characteristics, though the role of the UK in influencing drug expenditure policy in other markets is well recognised.