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Use the map to view DUPIXENT reimbursement for the specific regions.

NICE Technology appraisal guidance (TA534)2

NICE recommends DUPIXENT as a treatment option for adults with moderate-to-severe atopic dermatitis (AD)2

DUPIXENT is recommended as an option for treating moderate-to-severe AD in adult patients whose disease has not responded to at least one other systemic therapy, such as ciclosporin, methotrexate, azathioprine and mycophenolate mofetil, or when systemic therapies are contraindicated or not tolerated.

NICE recommends discontinuing DUPIXENT in patients who have not shown an adequate response after 16 weeks of treatment. Patients with an adequate response at 16 weeks and beyond should maintain treatment as needed.

  • At least a 50% reduction in the Eczema Area and Severity Index score (EASI-50) from when treatment started
  • At least a 4-point reduction in the Dermatology Life Quality Index (DLQI) from when treatment started
When using the EASI, appropriate clinical adjustments should be made based on patients’ skin colour which could affect the EASI score.
When using the DLQI, appropriate adjustments should be made based on any physical, psychological, sensory or learning disabilities, or communication difficulties that could affect patients’ responses to the DLQI.

Scottish Medicines Consortium (SMC) advice3

  • DUPIXENT is accepted for restricted use within NHS Scotland
  • SMC reviewed DUPIXENT under the context of its indication: the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy
  • SMC have restricted use of DUPIXENT to patients who have had an inadequate response to existing systemic immunosuppressants such as ciclosporin, or in whom such treatment is considered unsuitable
  • The SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of DUPIXENT. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower
  • This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting

Northern Ireland formulary advice4

In Northern Ireland, DUPIXENT, in combination with topical corticosteroids, is accepted for use as an option for treating moderate-to-severe AD in adults, only if:

  • The disease has not responded to at least 1 other systemic therapy, such as ciclosporin, methotrexate, azathioprine and mycophenolate mofetil, or these are contraindicated or not tolerated
  • The company provides DUPIXENT according to the commercial arrangement

Stop DUPIXENT at 16 weeks if the AD has not responded adequately. An adequate response is:

  • At least a 50% reduction in the EASI-50 from when treatment started
  • At least a 4-point reduction in the DLQI from when treatment started

For further information see NICE TA534 for adults

Use the map to view DUPIXENT reimbursement for the specific regions.

Commisioning Medicines for Children (M4C) in Specialised Services5,6

  • NHS England will commission treatments for patients aged less than 18 years where specific commissioning conditions within a NICE Technology Appraisal or NHS England policy are met, in accordance with the criteria outlined5
  • This policy applies to adolescents (12 years and older) in relation to the NICE Technology Assessment 534 (TA534) for DUPIXENT in adults with moderate-to-severe AD6
  • This policy for adolescents (aged 12 years and older) is applied in NHS England Specialist Dermatology Centres6

TA534 states:

DUPIXENT is recommended as an option for treating moderate-to-severe AD in adults, only if:

  • The disease has not responded to at least 1 other systemic therapy, such as ciclosporin, methotrexate, azathioprine and mycophenolate mofetil
  • These are contraindicated or not tolerated

NHS England will fund requests for medicines for children within a specialised service that are approved in adults by a NICE TA or NHS England clinical commissioning policy when one of the three following criteria are met and all of the conditions listed apply:

  • The medicine has a license for use in children and both the indication for use and the age of the child fall within those specified in the adult license
  • The medicine is listed in the BNF for Children with a recommended dosage schedule relative to the age of the child
  • The child is post-pubescent

In addition to the above criteria, ALL of the following conditions must apply:

  • The patient meets all the NICE TA/NHS England clinical commissioning policy criteria for the proposed medicine/indication
  • The patient does not meet any exclusion criteria for the medicine/indication in question
  • The use of the drug has been discussed at a multidisciplinary team (MDT) meeting which must include at least two consultants in the subspecialty with active and credible expertise in the relevant field of whom at least one must be a consultant paediatrician
  • The MDT should include a paediatric pharmacist and other professional groups appropriate to the disease area
  • The patient has been registered via the NHS England prior approval web-based system

Scottish Medicines Consortium (SMC) advice8

  • DUPIXENT is accepted for restricted use within NHS Scotland
  • SMC have reviewed the indication of DUPIXENT in the treatment of moderate-to-severe AD in adolescents ≥12 to <18 years who are candidates for systemic therapy
  • SMC have restricted the use of DUPIXENT to patients who have had an inadequate response to existing systemic immunosuppressants such as ciclosporin, or in whom such treatment is considered unsuitable
  • SMC has previously accepted DUPIXENT under the orphan medicine process for the treatment of moderate-to-severe AD in adult patients who are candidates for systemic therapy. This advice takes into account the views from a Patient and Clinician Engagement (PACE) meeting
  • The SMC advice applies only in the context of an approved NHS Scotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/list price that is equivalent or lower

All Wales Medicines Strategy Group (AWMSG) advice7

  • DUPIXENT is recommended as an option for restricted use within NHS Wales
  • DUPIXENT is restricted for the treatment of moderate-to-severe AD in adolescents ≥12 to <18 years who are candidates for systemic therapy, only if the disease has not responded to at least one other systemic therapy, or these are contraindicated or not tolerated
  • DUPIXENT is not recommended for the use within NHS Wales outside of this subpopulation
  • This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contracted price is equivalent or lower than the PAS price

Northern Ireland formulary advice4

  • In Northern Ireland, DUPIXENT is accepted for use in the treatment of moderate-to-severe AD in adolescents ≥12 to <18 years who are candidates for systemic therapy. Use is restricted to patients who have had an inadequate response to existing systemic immunosuppressants such as ciclosporin, or in whom such treatment is considered unsuitable
  • This advice applies only in the context of a Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/list price that is equivalent or lower
  • Where infrastructure is in place and the service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis
  • For further information see SMC advice for adolescents

Use the map to view DUPIXENT reimbursement for the specific regions.

Commisioning Medicines for Children (M4C) in Specialised Services5,6

  • NHS England will commission treatments for patients aged less than 18 years where specific commissioning conditions within a NICE Technology Appraisal or NHS England policy are met, in accordance with the criteria outlined5
  • This policy applies to adolescents (12 years and older) with moderate-to-severe AD and children (6–11 years old) with severe AD in relation to the NICE Technology Assessment 534 (TA534) for DUPIXENT in adults with moderate-to-severe AD6
  • This policy for adolescents (aged 12 years and older) and children (6–11 years old) is applied in NHS England Specialist Dermatology Centres6

TA534 states:

DUPIXENT is recommended as an option for treating moderate-to-severe AD in adults, only if:

  • The disease has not responded to at least 1 other systemic therapy, such as ciclosporin, methotrexate, azathioprine and mycophenolate mofetil
  • These are contraindicated or not tolerated

NHS England will fund requests for medicines for children within a specialised service that are approved in adults by a NICE TA or NHS England clinical commissioning policy when one of the three following criteria are met and all of the conditions listed apply:

  • The medicine has a license for use in children and both the indication for use and the age of the child fall within those specified in the adult license
  • The medicine is listed in the BNF for Children with a recommended dosage schedule relative to the age of the child
  • The child is post-pubescent

In addition to the above criteria, ALL of the following conditions must apply:

  • The patient meets all the NICE TA/NHS England clinical commissioning policy criteria for the proposed medicine/indication
  • The patient does not meet any exclusion criteria for the medicine/indication in question
  • The use of the drug has been discussed at a multidisciplinary team (MDT) meeting which must include at least two consultants in the subspecialty with active and credible expertise in the relevant field of whom at least one must be a consultant paediatrician
  • The MDT should include a paediatric pharmacist and other professional groups appropriate to the disease area
  • The patient has been registered via the NHS England prior approval web-based system

All Wales Medicines Strategy Group (AWMSG) advice9

  • DUPIXENT is recommended as an option for restricted use within NHS Wales
  • DUPIXENT is licensed for the treatment of severe AD in children 6 to 11 who are candidates for systemic therapy
  • DUPIXENT is restricted for the treatment of severe AD in children 6 to 11 years old who are candidates for systemic therapy and where existing systemic therapies are not advisable
  • DUPIXENT is not recommended for use within NHS Wales outside of this subpopulation
  • This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than the PAS price

Northern Ireland formulary advice4

  • In Northern Ireland, DUPIXENT is accepted for use for the treatment of severe AD in children 6 to 11 years old who are candidates for systemic therapy and where existing systemic therapies are not advisable
  • This recommendation applies only in circumstances where the approved PAS is utilised or where the list/contract price is equivalent or lower than the PAS price
  • Where infrastructure is in place and the Service has capacity, interim commissioning of this drug is accepted on a cost-per-case basis
  • For further information see AWMSG advice for children

AD, atopic dermatitis; AWMSG, All Wales Medicines Strategy Group; BNF, British National Formulary; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; M4C, Medicines for Children; MDT, multidisciplinary team; NHS, National Health Services; NICE, National Institute for Health and Care Excellence; NICE TA, NICE Technology Appraisal; PACE, Patient and clinical engagement; PAS, Patient Access Scheme; SMC, Scottish Medicines Consortium.

References

  1. DUPIXENT Summary of Product Characteristics. September 2021.
  2. © NICE [2018] Dupilumab for treating moderate to severe atopic dermatitis. Available at: https://www.nice.org.uk/guidance/TA534/chapter/1-Recommendations. Date accessed: October 2021. 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.
  3. Scottish Medicines Consortium. Dupilumab (Dupixent). Available at: https://www.scottishmedicines.org.uk/medicinesadvice/dupilumab-dupixent-fullsubmission-smc2011/. Date accessed: October 2021.
  4. Northern Ireland Formulary Dupliumab (Dupixent). Available at: https://niformulary.hscni.net/managed-entry/managed-entry-decisions/. Date Accessed: October 2021.
  5. NHS England [2017] Commissioning medicines for children in specialised services (170001/P). Available at: https://www.england.nhs.uk/wp-content/uploads/2017/03/commissioning-medicines-children-specialised-services.pdf. Date accessed: October 2021.
  6. Sanofi Data on File. SAGB.DUP.19.09.1536(1). September 2019.
  7. All Wales Medicines Strategy Group. Dupilumab (Dupixent). Available at: https://awmsg.nhs.wales/medicines-appraisals-and-guidance/medicines-appraisals-dupilumab-dupixent/. Date accessed: October 2021.
  8. Scottish Medicines Consortium. Dupilumab (Dupixent). Available at: https://www.scottishmedicines.org.uk/medicines-advice/dupilumab-dupixent-abbreviated-smc2232/. Date accessed: October2021.
  9. All Wales Medicines Strategy Group. Dupilumab (Dupixent). Available at: https://awmsg.nhs.wales/medicines-appraisals-and-guidance/medicines-appraisals/dupilumab-dupixent5/. Date accessed: October 2021.