Rheumatoid Arthritis (RA) Biologic

Eligibility criteria for bDMARD/tsDMARD in rheumatoid arthritis (RA) are defined by NICE MTA 375 technology appraisal endorsed by HIS and subsequent SMC advice as summarised below:

Biologic agents included in Table 1, all in combination with methotrexate, are options for treating rheumatoid arthritis, only if:

• disease is severe, that is, a disease activity score (DAS28) greater than 5.1 and
• disease has not responded to intensive therapy with a combination of conventional diseasemodifying anti-rheumatic drugs (csDMARDs): i.e. at least two csDMARDs including methotrexate (unless contraindicated)
  1. Adalimumab, etanercept, certolizumab pegol, tocilizumab & tsDMARDS can be used as monotherapy for people who cannot take methotrexate because it is contraindicated or because of intolerance, when the criteria above are met. Off- label monotherapy for other biologics may be appropriate in some clinical circumstances.
  2. Rituximab is suitable as a second line biologic drug in specific clinical scenarios provided the above criteria are met.
  3. tsDMARD (JAK inhibitors) can be used based on the above criteria as an alternative to first line biologic treatment or as second line treatment where patients are ineligible for rituximab (SMC) or where the clinician anticipates better clinical response over other MOA’s

*Biosimilar drugs of the originator product are available for these agents. The table above should guide treatment selection. Where there are no clear clinical reasons for selecting a particular MOA then the lowest cost option taking account of route of administration and dosing schedule should be selected. A medicine annotated as ‘most cost effective’ should generally be selected initially.

Currently adalimumab is the most cost effective TNFi and should be used in preference to other biologic agents unless specific clinical considerations require a specific TNFi or medicine with a different mechanism of action.

• Confidential drug costs are emailed to all biologic prescribers on a 6 monthly basis from GGC public health pharmacy.

Continue treatment only if there is at least a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy or DAS reduction of >1.2.

After initial response within 6 months, withdraw treatment if a moderate EULAR response is not maintained, or DAS reduction of >1.2

The most cost-effective drug in class should be used unless clinical need requires a specific agent.

A decision to prescribe a biologic drug for an approved condition but using doses that are ‘off label’ e.g. tapering, is a decision for the rheumatologist and patient.

Increasing the interval of dosing or dose reduction at same frequency could be considered when:

1. patients have maintained remission/LDA for a sustained period
2. Infection concerns have developed
3. Tolerability/patient request

All bDMARDS and smDMARDS are not included in near patient testing arrangements. Responsibility for any blood monitoring remains with the prescriber.

Use of biologic drug level monitoring (for infliximab and adalimumab) could be considered when adjusting dose, or where secondary failure has occurred to inform choice of subsequent therapy. Advice can be found at https://www.nhsggc.org.uk/about-us/professional-support-sites/laboratorymedicine/laboratory-disciplines/biochemistry/biological-therapy-monitoring/