2 Information about adalimumab, etanercept, infliximab and abatacept

2 Information about adalimumab, etanercept, infliximab and abatacept

This technology appraisal includes 4 different biological medicines as either the originator medicine (the medicine first authorised for use) or a biosimilar product (see table 1). A biosimilar medicine is a medicine that is developed to be similar to an existing biological medicine.

Table 1 Information about the technologies

Technology

Originator

(company)

Biosimilar (company)

Mechanism of action

Method of administration

Adalimumab

Humira (AbbVie)

  • Amgevita (Amgen)

  • Imraldi (Biogen)

  • Idacio (Fresenius Kabi)

  • Hyrimoz (Sandoz)

Tumour necrosis factor (TNF)‑alpha inhibitor

Subcutaneous injection

Etanercept

Enbrel (Pfizer)

  • Benepali (Biogen)

  • Erelzi (Sandoz)

TNF‑alpha inhibitor

Subcutaneous injection

Infliximab

  • Flixabi (Biogen)

  • Remsima (Celltrion Healthcare)

  • Inflectra (Pfizer)

  • Zessly (Sandoz)

TNF‑alpha inhibitor

Intravenous injection

Abatacept

Orencia (Bristol-Myers Squibb)

Selective modulator of the T‑lymphocyte activation pathway. Inhibits activation of T lymphocytes

Subcutaneous or intravenous injection

The subcutaneous formulation of Remsima was not considered in this partial review because it was not included in the final scope for NICE technology appraisal guidance 375. The originator product for infliximab (Remicade) was also not considered because the manufacturer of this technology did not participate in this appraisal

Adalimumab

2.1 Adalimumab (Humira, AbbVie; Amgevita, Amgen; Imraldi, Biogen; Idacio, Fresenius Kabi; Hyrimoz, Sandoz), in combination with methotrexate, is indicated 'for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate'. Adalimumab can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

2.2 The dosage schedule is available in the summary of product characteristics.

2.3 The list price of originator adalimumab (Humira, AbbVie) is £352.14 per 40 mg pre-filled pen or pre-filled syringe (excluding VAT; BNF online, accessed March 2021). The list price of adalimumab biosimilars per 40 mg pre-filled pen or pre-filled syringe are £316.80 (Amgevita, Amgen); £316.93 (Imraldi, Biogen); £316.93 (Idacio, Fresenius Kabi); £323.09 (Hyrimoz, Sandoz; all prices exclude VAT; BNF online, accessed March 2021).

2.4 The companies have each agreed a regional or nationally available price reduction for adalimumab with the Commercial Medicines Unit. The prices agreed through the framework are commercial in confidence.

Etanercept

2.5 Etanercept (Enbrel, Pfizer; Benepali, Biogen; Erelzi, Sandoz) in combination with methotrexate, is indicated 'for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate'. Etanercept can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

2.6 The dosage schedule is available in the summary of product characteristics.

2.7 The list price of originator etanercept (Enbrel, Pfizer) is £89.38 per 25 mg pre-filled pen or pre-filled syringe (excluding VAT; BNF online, accessed March 2021). The list price of etanercept biosimilars per 25 mg pre-filled pen or pre-filled syringe are £82.00 (Benepali, Biogen); £80.44 (Erelzi, Sandoz; all prices exclude VAT; BNF online, accessed March 2021).

2.8 The companies have each agreed a nationally available price reduction for etanercept with the Commercial Medicines Unit. The prices agreed through the framework are commercial in confidence.

Infliximab

2.9 Infliximab (Flixabi, Biogen; Remsima, Celltrion Healthcare; Inflectra, Pfizer; Zessly, Sandoz), in combination with methotrexate, is indicated 'for the reduction of signs and symptoms as well as the improvement in physical function in: adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate'.

2.10 The dosage schedule is available in the summary of product characteristics.

2.11 The list price of infliximab biosimilars per 100 mg vial are £377.00 (Flixabi, Biogen); £377.66 (Remsima, Celltrion Healthcare); £377.66 (Inflectra, Pfizer); £377.66 (Zessly, Sandoz; all prices exclude VAT; BNF online, accessed March 2021).

2.12 The companies have each agreed a nationally available price reduction for infliximab with the Commercial Medicines Unit. The prices agreed through the framework are commercial in confidence.

Abatacept

2.13 Abatacept (Orencia, Bristol-Myers Squibb), in combination with methotrexate, is indicated for 'the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX) or a tumour necrosis factor (TNF)-alpha inhibitor'.

2.14 The dosage schedule is available in the summary of product characteristics.

2.15 The list price of abatacept (Orencia, Bristol-Myers Squibb) is £302.40 per 125 mg pre-filled pen or pre-filled syringe and £302.40 per 250 mg vial (excluding VAT; BNF online, accessed March 2021).

2.16 The company has a commercial arrangement. This makes abatacept available to the NHS with a discount and it would have also applied to this indication if the technology had been recommended. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)