On 8 April, the UK’s National Institute for Health and Care Excellence (NICE) published guidance from a recent appraisal consultation on the use of Leo Pharma’s anti-IL-13, Adtralza/Adbry (tralokinumab); AbbVie’s oral Janus kinase (JAK) 1 inhibitor, Rinvoq (upadacitinib); and Pfizer’s oral JAK 1 inhibitor, Cibinqo (abrocitinib). NICE does not recommend these agents for the treatment of moderate to severe atopic dermatitis (AD) and has highlighted that this recommendation does not affect patients already using these treatments. This preliminary decision was based on the uncertainty relating to the comparison of these therapies’ efficacies with those of standard treatments available for AD and their relative cost-effectiveness.
Adtralza was approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) last June and both Rinvoq and Cibinqo were approved in September last year. Their use will now be limited as the committee has requested further information to determine the cost-effectiveness of these therapies and will consider the topic again at a meeting next month. This decision benefits early entrants to the market, Sanofi and Regeneron’s anti-IL-4/13, Dupixent (dupilumab) and Eli Lilly’s JAK 1/2 inhibitor, Olumiant (baricitinib), which remain part of the UK treatment hierarchy, to be used after broad systemic immunosuppressants, temporarily protecting their UK market share from the recent EU-approved therapies.
Both Dupixent and Olumiant were not initially recommended for use in AD due to their high costs of therapy, but these decisions were reversed in the final appraisal consultation with both Sanofi and Lilly entering a commercial agreement with NICE to provide discounted therapy. Although NICE has not recommended these therapies, Scotland’s health technology assessment body, the Scottish Medical Consortium (SMC), is reviewing their use in adults with moderate to severe AD, but with the caveat that the NHS Scotland patient access scheme arrangement delivers cost-effectiveness results upon which the temporary decision was based.
On top of this decision, the EU-approved JAK inhibitors are still under threat regarding safety concerns, as the European Medicines Agency’s (EMA) pharmacovigilance risk assessment committee initiated a review assessing their safety in February this year, with the potential of future marketing authorisation amendments for these therapies based on results of the review. This will likely lead to further disruption to the uptake of these inhibitors as safety becomes more of a key differentiating factor in this market. AbbVie, Pfizer and Leo Pharma must respond to NICE’s request for further information in order to secure approval in the UK for their respective assets, with the final decision expected next month. There remains hope, however, as the respective companies could have their preliminary decision reversed by entering a commercial agreement with NICE, similar to Dupixent and Olumiant.
Such recent events have further highlighted that strong safety and efficacy profiles are important to justify the reimbursement of such expensive medicines. GlobalData anticipates that the uptake of Adtralza, Rinvoq and Cibinqo will be slow in the UK unless an agreement is reached, despite the clear lack of therapies for the treatment of moderate to severe AD. As the market competition intensifies, these decisions will have more of an impact on reimbursement and treatment hierarchy.