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HTA And Clinical Assessments

Olumiant was the first JAK inhibitor to receive positive published guidance from NICE and an advice statement from the SMC4,5

Olumiant is a selective and reversible JAK1/JAK2 inhibitor,1,2 and is the first JAK inhibitor approved for RA in the EU.3


Olumiant is indicated for the treatment of moderate to severe active RA in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. Olumiant may be used as monotherapy or in combination with MTX.1


Olumiant is also the first JAK inhibitor to receive positive published guidance from NICE and an advice statement from the SMC,4,5 making it now available to treat patients in your RA practice.


Watch Dr. David Walker talk through the guidance from NICE and advice from the SMC

NICE Recommendations4

1.1

Baricitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs), only if:

  • Disease is severe (a disease activity score [DAS28] of more than 5.1) and
  • the company provides baricitinib with the discount agreed in the patient access scheme.

1.2

Baricitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to or who cannot have other DMARDs, including at least 1 biological DMARD, only if:

  • Disease is severe (a DAS28 of more than 5.1) and
  • they cannot have rituximab and
  • the company provides baricitinib with the discount agreed in the patient access scheme.

1.3

Baricitinib can be used as monotherapy for people who cannot take methotrexate because it is contraindicated or because of intolerance, when the criteria in sections 1.1 and 1.2 are met.

1.4

Continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. After an initial response within 6 months, withdraw treatment if at least a moderate EULAR response is not maintained.


© NICE (2017) TA466. Available from www.nice.org.uk/guidance/ta466. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.



SMC advice5


Following a full submission:

Baricitinib (Olumiant®) is accepted for restricted use within NHS Scotland.


Indication under review: is accepted for restricted use within NHS Scotland.


Indication under review: treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Baricitinib may be used as monotherapy or in combination with methotrexate.


SMC restriction: In patients with severe disease (a disease activity score [DAS28] greater than 5.1) that has not responded to intensive therapy with a combination of conventional DMARDs. In patients with severe disease inadequately controlled by a TNF antagonist, it may be used in patients ineligible to receive rituximab.


Baricitinib, compared with placebo and with a tumour necrosis factor (TNF) antagonist, significantly improved signs and symptoms of RA in patients with an inadequate response to conventional DMARDs and, compared with placebo, in patients who had an inadequate response to a TNF antagonist.


This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of baricitinib. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

References

  1. Olumiant (baricitinib) Summary of product characteristics, January 2018.
  2. Shi JG, et al. J Clin Pharmacol 2014;54(12):1345-61.
  3. European Medicines Agency. Available at ema.europa.eu [Accessed September 2017].
  4. © NICE (2017). TA466: Baricitinib for moderate to severe rheumatoid arthritis (Updated August 2017). Available from www.nice.org.uk/guidance/ta466 [Accessed September 2017]. All rights reserved. Subject to notice of rights.
  5. Scottish Medicines Consortium – baricitinib 2mg and 4mg film-coated tablet (Olumiant®). SMC No 1265/17, August 2017. Available from scottishmedicines.org.uk/SMC_Advice/Advice/1265_17_baricitinib_Olumiant/baricitinib_Olumiant [Accessed September 2017].

©2017 Eli Lilly and Company. All rights reserved. The Olumiant mark and Olumiant design are the trademarks of Eli Lilly and Company.


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