Commissioned by LEO Pharma

Information intended for healthcare professionals only.

This formulary decision guide was developed from content provided by LEO Pharma in a format developed by Guidelines in Practice

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Key points

Kyntheum FDG

  • Kyntheum® (brodalumab) is the first and only treatment for moderate to severe plaque psoriasis that targets IL-17 receptor A1,2
  • Cost-effectiveness estimates for brodalumab compared with other biological treatments,* and with apremilast▼ and dimethylfumarate, show that it is generally more cost-effective (that is, depending on the comparator, it costs less but is more effective, or costs more but is considerably more effective).3

* adalimumab, etanercept, infliximab, ixekizumab, secukinumab, ustekinumab

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Drug name

Kyntheum® (brodalumab) 210 mg solution for injection

Indication

  • Brodalumab is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.1

Dose

  • The recommended dose is 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks.1

Place in therapy

  • Brodalumab is the first and only treatment for moderate to severe plaque psoriasis that targets IL-17 receptor A1,2
  • Role of the cytokine IL-17 in therapy:
    • inhibition of the IL-17 pathway is associated with the rapid normalisation of cells involved in psoriasis lesions.4

Recommendations from NICE TA511

Clinical trial results show that brodalumab improves severe psoriasis more than placebo and ustekinumab. When compared indirectly, it appears to be as effective as other anti-interleukin-17 agents. Cost-effectiveness estimates for brodalumab compared with other biological treatments, and with apremilast and dimethyl fumarate, show that it is generally more cost effective (that is, depending on the comparator, it costs less but is more effective, or costs more but is considerably more effective). Brodalumab can be offered as an option to people with severe psoriasis that has not responded to other systemic non-biological therapies.3

  • Brodalumab is recommended as an option for treating plaque psoriasis in adults, only if:3
    • the disease is severe, as defined by a total PASI of 10 or more and a DLQI of more than 10 and
    • the disease has not responded to other systemic therapies, including ciclosporin, methotrexate, and PUVA, or these options are contraindicated or not tolerated and
    • the company provides the drug with the discount agreed in the PAS
  • Stop brodalumab at 12 weeks if the psoriasis has not responded adequately, defined as:3
    • a 75% reduction in the PASI score (PASI 75) from when treatment started or
    • a 50% reduction in the PASI score (PASI 50) and a 5-point reduction in DLQI from when treatment started.

NICE systemic biological therapy pathway

© NICE 2018 Brodalumab for treating moderate to severe plaque psoriasis. Available from www.nice.org.uk/guidance/ta511

Adapted from © NICE 2018 Systemic biological therapy for psoriasis. Available from https://pathways.nice.org.uk/pathways/psoriasis

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. See www.nice.org.uk/re-using-our-content/uk-open-content-licence for further details.

Recommendations from the SMC

  • Brodalumab (Kyntheum®) is accepted for restricted use within NHS Scotland:6
    • Indication under review: for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy 
    • SMC restriction: for patients who have failed to respond to standard systemic therapies (including ciclosporin, methotrexate, and phototherapy), are intolerant to, or have a contraindication to these treatments
  • Brodalumab was superior to placebo and to an alternative interleukin inhibitor at improving symptoms in adults with moderate to severe plaque psoriasis6
  • This advice takes account of the benefits of a PAS that improves the cost-effectiveness of brodalumab. It is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.6

Trial evidence

  • Brodalumab has demonstrated superior skin clearance efficacy at 12 weeks compared with ustekinumab:
    • twice the number of patients achieved complete clearance (PASI 100) of all skin symptoms with brodalumab 210 mg compared with the ustekinumab group (37–44% vs. 19–22%, p<0.001) in the AMAGINE-2 and AMAGINE-3 trials7
    • brodalumab 210 mg was superior to ustekinumab in terms of 75% skin improvement in AMAGINE-3 (p=0.007), and clear or almost clear sPGA ratings in AMAGINE-2 and AMAGINE-3 (p<0.001)7
    • complete skin clearance was maintained and increased in patients receiving a constant dose of brodalumab (41.6% at 12 week induction and 51.0% at 1 year) in pooled data of AMAGINE-2 and AMAGINE-31
    • the effects of brodalumab were observed as early as 2 weeks following treatment, and PASI 75 scores at week 12 were significantly better than ustekinumab in the AMAGINE 2 and 3 studies.7

Acquisition cost

  • £1280 per pack of 2 syringes of 210 mg/1.5 ml solution8
  • The company has agreed a PAS with the Department of Health. This scheme provides a simple discount to the list price of brodalumab, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence.§ The Department of Health considered that this PAS does not constitute an excessive administrative burden on the NHS.3

§ Any enquiries from NHS organisations about the patient access scheme should be directed to ukmarketaccess@leo-pharma.com (01844 347 333). Brodalumab for treating moderate to severe plaque psoriasis (TA511)

Safety and tolerability

  • Brodalumab is generally well tolerated1
  • The Summary of Product Characteristics lists the following most commonly reported adverse reactions in all brodalumab-treated patients:1
    • arthralgia (4.6%); headache (4.3%); fatigue (2.6%); diarrhoea (2.2%); oropharyngeal pain (2.1%).

Abbreviations

IL-17= interleukin-17; PASI=psoriasis area and severity index; DLQI=dermatology life quality index; PUVA=psoralen and long-wave ultraviolet A radiation; PAS=patient access scheme

References

  1. Leo Laboratories Ltd. Kyntheum 210 mg solution for injection—summary of product characteristics. September 2017. www.medicines.org.uk/emc/product/751
  2. Papp K et al. Br J Dermatol 2016; 175: 243–244.
  3. NICE. Brodalumab for treating moderate to severe plaque psoriasis. Technology Appraisal TA511. NICE. Available at: nice.org.uk/guidance/ta511
  4. Russell C et al. J Immunol 2014; 192: 3828–3836.
  5. NICE. Systemic biological therapy for psoriasis. Available at: pathways.nice.org.uk/pathways/psoriasis
  6. Scottish Medicines Consortium. Brodalumab 210mg solution for injection in pre-filled syringe (Kyntheum®). SMC No 1283/17. Available at: www.scottishmedicines.org.uk
  7. Lebwohl M et al. N Engl J Med 2015; 373: 1318–1328.
  8. BNF online. Brodalumab solution for injection. Available at: bnf.nice.org.uk

MAT-16656

Date of preparation: June 2018