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New HTA Decisions in England
October 2021
Drug name
COSENTYX® (secukinumab)
Company
Novartis
Decision date
03/09/2021
Therapeutic area
Skin conditions
Therapeutic sub area
Psoriasis
Decision
Recommended with restrictions
Indication
For treating plaque psoriasis in children and young people aged 6 to 17 years.
Decision Detail
1.1 It is recommended only if: • the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and • the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and • the company provides the drug according to the commercial arrangement (simple discount patient access scheme). 1.2 Stop secukinumab treatment at 12 weeks if the psoriasis has not responded adequately. An adequate response is defined as a 75% reduction in the PASI score (PASI 75) from when treatment started. 1.3 Choose the least expensive treatment if patients (or their parents or carers) and their clinicians consider secukinumab to be one of a range of suitable treatments. Take into account availability of biosimilar products, administration costs, dosage, price per dose and commercial arrangements. 1.4 Take into account how skin colour could affect the PASI score and make any appropriate clinical adjustments. 1.5 These recommendations are not intended to affect treatment with secukinumab that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. This decision should be made jointly by the clinician, the child or young person and their parents or carers.
Summary
Clinical evidence comparing secukinumab with etanercept and placebo comes from a randomised control trial (Paediatric Study A2310) which included 162 children and young people with plaque psoriasis. The trial showed that people having secukinumab had a higher PASI response rate (PASI 75, that is, a 75% reduction in PASI score from baseline) compared with placebo and etanercept at week 12. The trial also showed that, at week 52, the higher response rates were sustained. The committee accepted these results and concluded that secukinumab was likely more effective than etanercept. To compare the effectiveness of secukinumab with ustekinumab, the company produced network meta analyses using a fixed-effect model with data from 4 clinical trials. The model provided PASI response rates and Children's Dermatology Life Quality Index scores comparing secukinumab with etanercept, ustekinumab and placebo. The committee accepted that the model was suitable for decision making. It noted that the results showed that secukinumab has a similar efficacy to ustekinumab and is likely to be more effective than etanercept and placebo. The committee also noted that the safety and outcome results were similar to those for other biologicals used for psoriasis. It concluded that secukinumab has a similar effectiveness to ustekinumab. The company's network meta-analysis did not include adalimumab as a comparator because there were no paediatric studies of adalimumab with overlapping comparators that would allow it to be connected to the network. The committee acknowledged that it had not been possible to include paediatric adalimumab data within the network. Therefore the effectiveness of secukinumab compared with adalimumab is uncertain because of a lack of evidence. However, in the absence of evidence for adalimumab, the committee concluded that it would be reasonable to assume that adalimumab and ustekinumab are equally effective, but that this was likely to be a conservative estimate. The company presented a cost-comparison analysis that modelled the total costs of secukinumab, ustekinumab and etanercept over 5 years. To determine the proportion of people who continue treatment, it took into account stopping treatment based on PASI 75 response rates. This was consistent with the stopping rules specified in previous NICE technology appraisal guidance on treatments for plaque psoriasis. The company's base-case analysis considered only the acquisition costs of secukinumab, ustekinumab and etanercept. The monitoring, safety profile, treatment administration and subsequent therapies for all 3 treatments were assumed to be similar so, these costs were excluded. The committee agreed that it was reasonable to assume similar healthcare resource use across the 3 treatments. However, the committee preferred the cost-comparison analysis over a 12-year time horizon. The committee concluded that the total costs for secukinumab were similar to or lower than those for ustekinumab, etanercept and adalimumab (the exact results cannot be reported here because the discounts are confidential). The committee therefore recommended secukinumab as an option for treating plaque psoriasis in children and young people.