mopdf.com

738FM.8 BIOLOGICS FOR THE TREATMENT OF PSORIASIS (ADULTS)Based upon:NICE CG 153 Psoriasis: The assessment and management of psoriasis (October 2012)NICE Technology Appraisals (TAs):103July 2006134January 2008146June 2008180September 2009 updated March 2017350June 2015419November 2016442April 2017475September 2017511March 2018521June 2018574April 2019575April 2019596August 2019Thames Valley Priorities Committee Policy TVPC44: Sequential use of a third or subsequentbiologic therapy for psoriasis (issued September 2019)The drugs included in this guideline are for use in secondary care only (RED listed on the Bucksformulary). They may only be initiated by a Dermatology specialist with expertise in the use ofbiologic therapies in treating psoriasis.NICE Compliance/High Cost Drug Forms A high cost drug form must be completed before initiating and continuing treatment with any ofthe biologics or immunotherapy drugs included in this guideline.The forms are completed and submitted on the Blueteq website.If the Blueteq website is not accessible, forms are also available via the BuckinghamshireFormulary www.bucksformulary.nhs.uk (they can only be downloaded if the user is linked to theBuckinghamshire Healthcare NHS Trust (BHT) server). They can be obtained by line 738FM.81 of 6Uncontrolled if printed

Use standard systemic therapies for psoriasis including ciclosporin, methotrexate and phototherapyNo –consideralternativestandardtreatment optionsIs the patient’s condition failing to respond, or is the patient intolerant of, or has acontraindication to, the standard systemic therapies?YesIf the patient has both psoriasis and psoriatic arthritis, take into account both conditions before initiating ormaking changes to treatment with biologic drugs (see also commissioning algorithm for psoriatic arthritis,TA 199 and TA 220)What are the patient’s PASI and DLQI scores?PASI 10andDLQI of 10Patient is not eligible fortreatment with biologic drugsPASI 10andDLQI of 10Listed in order of cost (drug and administration cost), with the lowest cost first- note 1 pg.3Adalimumab (TA 146, CG 153) TNF-alpha inhibitor (consider as 1st choice if jointinvolvement)Etanercept (TA 103, CG 153) TNF-alpha inhibitorApremilast (TA 419) PDE-4 inhibitorDimethyl fumarate (TA 475) immunomodulatorTildrakizumab (TA 575) IL-23 inhibitorRisankizumab (TA 596) IL-23 inhibitorBrodalumab (TA 511) IL-17 inhibitorSecukinumab (TA 350) IL-17A inhibitorGuselkumab (TA 521) IL-23 inhibitorIxekizumab (TA 443) IL-17A inhibitorUstekinumab (TA 180, CG 153) IL-12 and IL-23 inhibitorCertolizumab (TA 574) TNF-alpha inhibitorKey to terms:PASI 20andDLQI 18PASI: Psoriasis area andseverity indexDLQI: Dermatology lifequality indexCG: NICE clinical guideline(ONLY for PASI 20 and DLQI 18)Infliximab (TA 134, CG 153) TNF alphainhibitorNOTE: Infliximab may be considered 1st choicetreatment for: Patients with life threateningconditions requiring rapid disease control orobese patients with joint involvement (arthritis)who cannot be given adalimumab orustekinumabIs there an adequate response to treatment defined as either:A 75% reduction in PASI score (PASI 75) from start of treatment orA 50% reduction in PASI score (PASI 50) and five-point reduction in DLQI fromstart of treatment?Response to be first measured at: 12 weeks for brodalumab, etanercept, ixekizumab and secukinumab 14 weeks for infliximab 16 weeks for adalimumab, apremilast, certolizumab, dimethyl fumarate,guselkumab, risankizumab 28 weeks for tildrakizumab, ustekinumabMaintain sametreatment andmonitor patientYesPatient on apremilast or dimethyl fumarate or first orsecond-line biologic(When a change from a 1st line drug is required only due to adocumented local injection site reaction, this will not beconsidered to be a second biologic)Yes Patient on third-line biologic AND failedresponse to apremilast or dimethyl fumarateIs the patient continuing to show anadequate response to treatmentas defined above?Is the patient continuing to show anadequate response to treatment (asdefined above) andIs the patient continuing to tolerate thetreatment andIs the patient still without contraindicationto the treatment?NoChange to a 4 or subsequent agent isfunded if the 4th agent has a mode ofaction which has not been used beforethChange to a 4th biologic with a modeof action that has been used before isNOT normally funded. An IndividualFunding Request needs to be madevia CCG.NoConsider changing to an alternativebiologic or apremilast or dimethyl fumarate.NOTE: a 4th agent is only funded if itsmode of action has not been used beforeGuideline 738FM.8Yes – maintainsame treatment andmonitor patient2 of 6Uncontrolled if printed

Notes1. Choice of biologic drug In line with NICE guidance, if more than one agent is suitable at particular points in the treatmentalgorithm, the drug with the lowest acquisition cost (drug and administration cost) isrecommended. Where appropriate, a biosimilar product should be used in preference to theoriginator brand. To facilitate these decisions, the Bucks algorithm lists drugs in order of costwith the least expensive first. However, drug costs should not override the need for the chosen drug to be the most ‘suitable’and ‘clinically appropriate’ for the patient. The choice of treatment should be made afterdiscussion between the clinician and the patient about the advantages and disadvantages ofthe treatments available. This may include considering associated conditions2. Maximum number of biologic drugs funded The sequential use of up THREE biologics is normally funded. A third biologic is only funded if recommended by a consultant Dermatologist with expertise inbiological drugs when the second biologic is unsuitable due to inadequate response, intoleranceor contraindication. If a patient is required to switch from a biosimilar to an originator drug due to an adverse drugreaction, or if there is an injection site reaction to any biologic, this will not be classed as a switchto an alternative biologic drug.The exceptions to the rule of a ‘maximum of THREE biologic drugs’ is: Switching to a biologic drug with a mode of action that the patient has not previously tried. Inthese cases only, the maximum number of sequential biologic treatments funded will be FOUR3.PRESCRIBING INFORMATIONAdalimumab (TNF-alpha inhibitor)ALL prescribing and dispensing must be by brand name. For information about the biosimilar brands,see the formulary entry for adalimumab www.bucksformulary.nhs.uk. Use of different brands may alterthe position of adalimumab in the algorithm. Dose: Initially 80 mg by subcutaneous (s/c) injection, followed by 40 mg every other week,starting 1 week after the initial dose. Response to treatment is measured at 16 weeks. Beyond 16 weeks, patients with inadequate response to 40 mg every other week may benefitfrom an increase in dosage to 40 mg every week or 80 mg every other week. The benefits andrisks of continued 40 mg weekly or 80 mg every other week therapy should be carefullyreconsidered in a patient with an inadequate response after the increase in dosage. If adequateresponse is achieved with 40 mg every week or 80 mg every other week, the dosage maysubsequently be reduced to 40 mg every other week.Apremilast (PDE-4 inhibitor) Note: This is not a biologic. Dose: 30 mg twice daily PO, approximately 12 hours apart with no food restrictions. An initial titration schedule is shown in Table 1. No re-titration is required after initial titration.Table 1: Apremilast dose titration scheduleDay 1Day 2Day 3AM10 mgAM10 mgPM10 mgAM10 mgPM20 mgDay 4AM20 mgPM20 mgDay 5AM20 mgPM30 mgDay 6 andthereafterAMPM30 mg 30 mgBrodalumab (IL-17 inhibitor) Dose: 210 mg by s/c injection at weeks 0, 1 and 2, followed by 210 mg every 2 weeks.Certolizumab (TNF-alpha inhibitor) Dose: 400 mg (given as 2 s/c injections of 200 mg each) at weeks 0, 2 and 4, followed by 200mg every 2 weeks. (If response is insufficient a dose 400 mg every 2 weeks can be considered.)Guideline 738FM.83 of 6Uncontrolled if printed

Dimethyl fumarateNote this is not a biologic.All prescribing must include the brand name (Skilarence ). For further details see formulary entry fordimethyl fumarate - www.bucksformulary.nhs.uk. Dose: Treatment is started at a low initial dose with subsequent gradual increases. Week 1: 30 mg PO once daily (1 tablet in the evening). Week 2: 30 mg PO twice daily (1 tablet in the morning and 1 in the evening). Week 3: 30 mg PO three times daily (1 tablet in the morning, midday, and evening). Week 4: 120 mg PO once daily (1 tablet in the evening). Subsequent 5 weeks: the dose is increased by 120 mg per week (see table below). Maximum daily dose: 720 mg (3 x 2 x 120 mg tablets).Table 2: Dimethyl fumarate dose titration scheduleWeekNumber of tabletsMorningMidday Skilarence 30 mg123011EveningTotal daily dose (mg) ofdimethyl ence 120 mg456789 011122001112Stop treatment if there is inadequate response at week 16.Etanercept (TNF-alpha inhibitor)Note: ALL prescribing and dispensing must be by brand name. For information about the biosimilarbrands, see the formulary entry for etanercept in www.bucksformulary.nhs.uk. Use of different brandsmay alter the position of etanercept in the costing table. Dose: 50 mg by s/c injection once weekly. Alternatively, 50 mg twice weekly may be used forup to 12 weeks followed, if necessary, by a dose of 50 mg weekly. Treatment should be discontinued in patients who show no response after 12 weeks.Guselkumab (IL-23 inhibitor) Dose: 100 mg by s/c injection at weeks 0 and 4, followed by 100 mg s/c injection maintenancedose every 8 weeks. Response reviewed at 16 weeks.Infliximab (TNF-alpha inhibitor)Note: ALL prescribing and dispensing of infliximab must be by brand name. For information about thebiosimilar brands, see the formulary entry for etanercept in www.bucksformulary.nhs.uk. Use ofdifferent brands may alter the position of etanercept in the costing table. Dose: 5 mg/kg by intravenous (IV) infusion followed by 5 mg/kg IV infusions at weeks 2 and 6after the first infusion, then every 8 weeks thereafter. The manufacturer recommends to calculate the dose based upon actual body weight (ABW). If a patient shows no response after 14 weeks (i.e. after 4 doses), no additional treatment withinfliximab should be given.Ixekizumab (IL-17A inhibitor) Dose: 160 mg by s/c injection (two 80 mg injections) at week 0, followed by 80 mg (one s/cinjection) at weeks 2, 4, 6, 8, 10 and 12, then maintenance dosing of 80 mg s/c (one injection)every 4 weeks. Stop treatment if there is inadequate response at week 12.Guideline 738FM.84 of 6Uncontrolled if printed