Infliximab (Biosimilar to be used 1st line) (Remicade® (until end Mar16 only); Remsima® ▼) – Rheumatoid arthritis – after other DMARDs including a TNF inhibitor – as per NICE TA 195

NICE recommendations, summary of meeting discussions, links to additional supporting docs etc.

September 2010: The TAG noted NICE TA 195: which states that adalimumab, etanercept, infliximab and abatacept, each in combination with methotrexate, are recommended as treatment options only for adults with severe active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab therapy because they have a contraindication to rituximab, or when rituximab is withdrawn because of an adverse event.

Adalimumab monotherapy and etanercept

monotherapy are recommended as treatment options for adults with severe active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab therapy because they have a contraindication to methotrexate, or when methotrexate is withdrawn because of an adverse event.

Treatment with adalimumab, etanercept, infliximab and abatacept should be continued only if there is an adequate response (as defined in the guidance) 6 months after initiation of therapy. Treatment should be monitored, with assessment of DAS28,at least every 6 months and continued only if an adequate response is maintained.

January 2011: The TAG noted NICE’s algorithm (November 2010) on biologic drugs for rheumatoid arthritis.

September 2015: The TAG noted NICE HTTA 329 – a resource developed to provide practical information and advice on the use of biosimilar versions of infliximab. This underpins the commissioning decision regarding the transition to biosimilar treatments.

October 2015:

The Norfolk & Waveney Drugs & Therapeutics Commissioning Group (D&TCG)  noted  NICE HTTA 329 and stated that Remsima® has not been commissioned for use locally for any indication.

Inflectra® is the locally commissioned biosimilar infliximab for agreed indications.

Inflectra® is to be used for any new patients requiring treatment with infliximab from October 2015 and will be used for all existing patients requiring treatment with infliximab from April 2016 – i.e. Trust invoices for infliximab will be paid at the Inflectra® price only from that time.

March 2016:

The D&TCG was advised that Remsima® is now the most cost-effective biosimilar infliximab product and that the Trusts will now be reimbursed against its price rather than for Inflectra® as previously agreed.

September 2018:

The TAG noted NICE NG 100 (July 2018) – Management of rheumatoid arthritis in adults, which included new and updated recommendations on:

*           investigations following diagnosis

* treat-to-target strategy and initial pharmacological management

* symptom control and monitoring

and also:

* investigations for diagnosis and referral from primary care

* non-pharmacological management and the multidisciplinary team

* communication and education

September 2018:

NICE NG 100 (July 2018) was noted by the N&W CCGs’ Drugs & Therapeutics Committee

September 2018:

The TAG noted and a revised Specialist Treatment Pathway for Rheumatoid Arthritis which had been updated with the most recent advice on adalimumab. The place of baricitinib was also clarified.

The TAG was advised that (biosimilar) adalimumab (once available) would remain as the CCGs’ preferred 1st line (biologic) treatment option; a JAK inhibitor would be considered only where biologics are contraindicated.

Any further comments from the Trusts regarding the order of use of NICE-recommended therapies within the pathway to be submitted to the CSU’s Specialist Interface Pharmacist.

The TAG otherwise agreed with the treatment pathway in principle.

September 2018:

The N&W Drugs & Therapeutics Committee (D&TC) noted and supported the TAG’s recommendations