Download guide explaining the Xiapex cost model tool

Xiapex® Commissioning Pathways
Prescribing information can be found at the end of this document
PP-0099 Date of Preparation: June 2015
About this slide set
• This slide set is designed to be used by clinicians and their teams to help provide information to their local
commissioners on the use and administration of Xiapex in place of surgery for Dupuytren’s contracture.
• In addition to the slide set you will have been provided with a business case template and simple Microsoft
excel cost calculator.
• The slide set can be used to communicate the different pathway options and associated costs for treating
patients living with Dupuytren’s contracture.
Slide contents:
• A brief background to Dupuytren’s contracture and Xiapex.
• Examples of commissioning pathways which follow the patient journey within secondary care
and the associated cost triggers for both Xiapex and fasciectomy.
• You may choose to use these slides as part of a local presentation, and therefore you may
choose to use your own / organisational slide design and template.
Dupuytren’s contracture and Xiapex: background
Background
• Dupuytren’s contracture is a psychosocially and physically disabling fibroproliferative connective tissue
disorder affecting the palmar fascia of the hand, in which the formation of pathologic collagen cords causes
progressive flexion deformity of the involved fingers1-3.
• Contracture of the fingers is associated with reduced hand function that can severely diminish overall
functional ability and quality of life, making it difficult to carry out simple everyday tasks such as washing and
dressing, working, driving and playing sports, thus posing a threat to independence1,4,5.
• More than two million people are thought to suffer from Dupuytren’s contracture in the UK1.
• The current standard of care for Dupuytren’s contracture is surgical intervention followed by extensive hand
therapy6. Surgical treatment is either by removing the affected tissue (fasciectomy) and sometimes also the
overlying skin (dermofasciectomy) under general anaesthetic, or by incising the affected cords (fasciotomy)
under local anaesthetic in order to restore digital extension7,8.
• Being an invasive procedure, fasciectomy carries a risk of severe postoperative complications4,7, and patients
require significant recovery time and rehabilitation therapy to regain full hand function9.
Xiapex
• Xiapex is indicated for the treatment of Dupuytren's contracture in adult patients with a palpable cord10.
• Xiapex provides an effective and minimally invasive pharmacological treatment for Dupuytren’s contracture11
which removes the intraoperative and postoperative burden of surgery. Xiapex is administered via an
injection into a palpable Dupuytren’s cord followed by a finger extension procedure after 24 hours if
necessary to facilitate cord disruption10.
• Clinical data has shown Xiapex to significantly reduce contractures and improve range of motion in joints
affected by advanced Dupuytren’s disease12. In two placebo-controlled, randomized double blind studies,
patients treated with Xiapex showed significant reductions in the contracture of the primary joint of 79.3%12
and 70.5%13. Two further open-label studies have shown clinical success (a reduction in contracture to within
0° to 5° of full extension after 30 days) was achieved in 57% of treated joints, with 69% of treated joints
achieving clinical improvement (50% or more reduction from baseline contracture) after one injection and
average contracture reductions of 73%11.
• Adverse events occurred in 97% of patients but are mostly mild and transient, localised to the injection site
and resolve without intervention within a median of 7 days11. Three year follow up data from these studies
has shown the recurrence rate (35% of clinically successful joints) to be comparable to other standard
treatments, with no new long term or serious adverse events found14.
The patient
•
Xiapex provides an alternative to fasciectomy for the treatment of moderate to severe Dupuytren’s
contracture.
•
This proposition is for the treatment of one palpable cord in adult patients with either one or two
injections. It is anticipated that the patients eligible for Xiapex will be the same patients eligible for
surgery. Patient numbers are not expected to rise within any hospital trust or CCG.
•
The following pathways illustrate the commissioning pathway through which costs for treatment will
be passed on to NHS commissioners.
Dupuytren’s contracture commissioning pathways
Commissioning pathways
Commissioning pathway contents:
• Fasciectomy pathway – (assumes an average number of follow-up attendances)
• Fasciectomy minimal pathway – (assumes a minimum number of follow-up attendances)
• Xiapex pathway – (patients are injected at follow-up outpatient attendance subsequent to their first
outpatient attendance)
• Xiapex pathway with 2nd injection– (as above, where a second injection is indicated)
• Xiapex pathway with 3rd injection– (as above, where a third injection is indicated)
Fasciectomy pathway – average follow-up
Outpatient first attendance
110 – Trauma &
orthopaedics / WF01B
£119.0015
Outpatient follow-up attendance: preop
110 – Trauma &
orthopaedics / WF01A
£70.0015
Daycase admission: surgery
T521 Palmar fasciectomy
/ HB53Z
£2,451.0015
OT attendance: post-op, splint app.
651 / Non-admitted face to
face attendance
£62.0016
Outpatient follow-up attendance:
dressing, wound & splint assessment
110 – Trauma &
orthopaedics / WF01A
£70.0015
OT follow-up attendances x7
651 / Non-admitted face to
face attendance
£434.0016
Outpatient follow-up attendance:
assessment & discharge
110 – Trauma &
orthopaedics / WF01A
£70.0015
Total cost (/patient): £3,276.00
OT = Occupational therapy. Prices correct as of 31.3.14.
Fasciectomy pathway – minimal follow-up
Outpatient first attendance
110 – Trauma &
orthopaedics / WF01B
£119.0015
Outpatient follow-up attendance: preop
110 – Trauma &
orthopaedics / WF01A
£70.0015
Daycase admission: surgery
T521 Palmar fasciectomy
/ HB53Z
£2,451.0015
OT attendance: post-op, splint app.
651 / Non-admitted face to
face attendance
£62.0016
OT follow-up attendance: dressing,
wound & splint assessment
651 / Non-admitted face to
face attendance
£62.0016
OT follow-up attendances x2
651 / Non-admitted face to
face attendance
£124.0016
Outpatient follow-up attendance:
assessment & discharge
110 – Trauma &
orthopaedics / WF01A
£70.0015
Total cost (/patient): £2,958.00
OT = Occupational therapy. Prices correct as of 31.3.14.
Xiapex pathway – 1 injection
Outpatient first attendance
110 – Trauma &
orthopaedics / WF01B
£119.0015
Outpatient follow-up attendance:
treatment
T532 Destruction of lesion
of fascia / HB56C
£230.0015
Outpatient follow-up attendance:
manipulation
110 – Trauma &
orthopaedics / WF01A
£70.0015
Outpatient follow-up attendance:
assessment and discharge
110 – Trauma &
orthopaedics / WF01A
£70.0015
Total cost (/patient): £1,139.00
OT = Occupational therapy. Prices correct as of 31.3.14.
Xiapex drug cost £650.0017
Xiapex pathway – 2 injections
Outpatient first attendance
110 – Trauma &
orthopaedics / WF01B
£119.0015
Outpatient follow-up attendance:
treatment
T532 Destruction of
lesion of fascia / HB56C
£230.0015
Outpatient follow-up attendance:
manipulation
110 – Trauma &
orthopaedics / WF01A
£70.0015
Outpatient follow-up attendance:
assessment
110 – Trauma &
orthopaedics / WF01A
£70.0015
Outpatient follow-up attendance:
treatment 2
T532 Destruction of
lesion of fascia / HB56C
£230.0015
Outpatient follow-up attendance:
manipulation
110 – Trauma &
orthopaedics / WF01A
£70.0015
Outpatient follow-up attendance:
assessment & discharge
110 – Trauma &
orthopaedics / WF01A
£70.0015
Total cost (/patient): £2,159.00
OT = Occupational therapy. Prices correct as of 31.3.14.
Xiapex drug cost £650.0017
Xiapex drug cost £650.0017
Xiapex pathway – 3 injections
Outpatient first attendance
110 – Trauma & orthopaedics /
WF01B
£119.0015
Outpatient follow-up attendance: treatment
T532 Destruction of lesion of fascia
/ HB56C
£230.0015
Outpatient follow-up attendance: manipulation
110 – Trauma & orthopaedics /
WF01A
£70.0015
Outpatient follow-up attendance: assessment
110 – Trauma & orthopaedics /
WF01A
£70.0015
Outpatient follow-up attendance: treatment 2
T532 Destruction of lesion of fascia
/ HB56C
£230.0015
Outpatient follow-up attendance: manipulation
110 – Trauma & orthopaedics /
WF01A
£70.0015
Outpatient follow-up attendance: assessment
110 – Trauma & orthopaedics /
WF01A
£70.0015
Outpatient follow-up attendance: treatment 3
T532 Destruction of lesion of fascia
/ HB56C
£230.0015
Outpatient follow-up attendance: manipulation
110 – Trauma & orthopaedics /
WF01A
£70.0015
Outpatient follow-up attendance: assessment &
discharge
110 – Trauma & orthopaedics /
WF01A
£70.0015
Total cost (/patient): £3,179.00
OT = Occupational therapy. Prices correct as of 31.3.14.
Xiapex drug cost - £650.0017
Xiapex drug cost - £650.0017
Xiapex drug cost - £650.0017
References
1.
Townley, W.A., et al., Dupuytren’s contracture unfolded. BMJ, 2006. 332: p. 397-400.
2.
Hentz, V.R., et al., Advances in the Management of Dupuytren Disease. Hand Clinics, 2012. 28(4): p. 551-563.
3.
Hindocha, S., D.A. McGrouther, and A. Bayat, Epidemiological evaluation of Dupuytren's disease incidence and prevalence rates in relation to etiology. Hand (N Y),
2009. 4(3): p. 256-69.
4.
Bayat, A. and D.A. McGrouther, Management of Dupuytren's disease – clear advice for an elusive condition. Annals of The Royal College of Surgeons of England,
2006. 88(1): p. 3-8.
5.
Desai, S.S. and V.R. Hentz, Collagenase clostridium histolyticum for Dupuytren's contracture. Expert Opin Biol Ther, 2010. 10(9): p. 1395-404.
6.
Denkler, K., Surgical Complications Associated With Fasciectomy for Dupuytren’s Disease: A 20-Year Review of the English Literature. ePlasty, 2010. 10: p. 116133.
7.
Dupuytren's contracture: Treatment 2013, NHS Choices.
8.
Thomas, A. and A. Bayat, The emerging role of Clostridium histolyticum collagenase in the treatment of Dupuytren disease. Ther Clin Risk Manag, 2010. 6: p. 55772.
9.
Bloomer, A., Dupuytren’s contracture: treatment beyond surgery. GeriMed, 2012: p. 48-53.
10. Xiapex 0.9 mg powder and solvent for solution for injection summary of product characteristics.
11. Witthaut, J., et al., Efficacy and Safety of Collagenase Clostridium Histolyticum Injection for Dupuytren Contracture: Short-Term Results From 2 Open-Label Studies.
The Journal of Hand Surgery, 2013. 38(1): p. 2-11.
12. Hurst, C.L., et al., Injectable Collagenase Clostridium Histolyticum for Dupuytren’s Contracture. New England Journal of Medicine, 2009. 361: p. 968-79.
13. Gilpin, D., et al., Injectable Collagenase Clostridium Histolyticum: A New Nonsurgical Treatment for Dupuytren's Disease. The Journal of Hand Surgery, 2010.
35(12): p. 2027-2038.e1.
14. Peimer, C.A., et al., Dupuytren Contracture Recurrence Following Treatment with Collagenase Clostridium Histolyticum (CORDLESS Study): 3-Year Data. The
Journal of Hand Surgery, 2013. 38(1): p. 12-22.
15. National Tariff Payment System: Annex 5A: National Prices. 2013, NHS England.
16. National Schedule of Reference Costs Year : 2012-13 - All NHS trusts and NHS foundation trusts. 2013, Department of Health
17. Xiapex® British National Formulary. British National Formulary.
theoretically interfere with human MMPs. No safety concerns related to the inhibition of
▼XIAPEX® Abbreviated Prescribing Information (Dupuytren’s contracture)
(See XIAPEX Summary of Product characteristics for full Prescribing Information)
endogenous MMPs have been observed, in particular no adverse events indicating the
Presentation: Powder and solvent for solution for injection for intralesional use. The vial of
development or exacerbation of autoimmune diseases or the development of a musculoskeletal
powder contains 0.9 mg collagenase clostridium histolyticum. The powder is a white lyophilised syndrome but the potential for it to occur cannot be excluded. If this syndrome were to develop,
powder and the solvent is a clear colourless solution.
it would occur progressively and is characterised by one or more of the following signs and
Indications: Treatment of Dupuytren’s contracture in adult patients with a palpable cord.
symptoms: arthralgia, myalgia, joint stiffness, stiffness of the shoulders, hand oedema, palmar
Dosage: Xiapex must be administered by a physician appropriately trained in the correct
fibrosis and thickening or nodules forming in the tendons.
administration of the product and experienced in the diagnosis and management of Dupuytren’s Long-term safety - Long-term safety of Xiapex is not fully characterised. The impact of treatment
disease. The recommended dose of Xiapex is 0.58mg per injection into a palpable Dupuytren’s with Xiapex on subsequent
cord. For an MP joint, each dose is administered in an injection volume of 0.25ml (requiring
surgery, if needed, is not known.
0.39ml solvent for reconstitution). For a PIP joint, each dose is administered in an injection
Drug Interactions: Use of Xiapex in patients who have received tetracycline antibiotics e.g.
volume of 0.20ml (requiring 0.31ml solvent for reconstitution). Approximately 24 hours after
doxycycline, within 14 days
injection, a finger extension procedure may be performed to facilitate cord disruption. If a
prior to receiving an injection of Xiapex is not recommended.
satisfactory response has not been achieved, injections and finger extension procedures may be Pregnancy & Lactation: Not recommended in pregnancy. Xiapex can be used during breast
repeated up to 3 times per cord at approximately 4-week intervals. Only one cord must be
feeding.
treated at a time.
Driving and operating machinery: Xiapex may have a major influence on the ability to drive and
Contraindications: Hypersensitivity to the active substance or to any of the excipients.
use machines due to swelling and pain in the treated hand. Other minor influences include
Warnings and Precautions: Allergic reactions - 17% of Xiapex-treated patients in phase 3 placebo- dizziness, paraesthesia, hypoesthesia, and headache, see side effects. Patients must be
controlled clinical studies had mild allergic reactions (i.e. pruritus). Physicians must be prepared instructed to avoid potentially hazardous tasks such as driving or using machines until it is safe to
to address any severe local or systemic allergic reactions including the potential for anaphylaxis do so or as advised by the physician.
following injection, including the potential for such reactions following repeated use. Whilst
Side Effects: In clinical trials, the most frequently reported adverse reactions during Xiapex
there is no evidence from the clinical data of an increased risk of serious allergic reactions upon therapy were local injection site reactions such as oedema peripheral (local to the injection site),
repeated injections, the potential for such reactions following repeated use cannot be excluded. contusion (including ecchymosis), injection site haemorrhage and injection site pain. Injection
Tendon rupture or other serious injury to the injected extremity – Injection of Xiapex into collagen site reactions were very common, occurring in the vast majority of patients, were mostly mild to
containing structures of the hand other than the Dupuytren’s cord may result in damage to those moderate in severity and generally subsided within 1-2 weeks post injection. Serious adverse
structures including possible tendon rupture or ligament damage. Care should be taken when
reactions of tendon rupture, tendonitis, other ligament injury and complex regional pain
injecting Xiapex into cords contracting the PIP joints as clinical studies indicate an increased risk syndrome related to the medicinal product were reported. Very commonly reported adverse
of tendon rupture and ligament injury associated with treatment of PIP contractures with Xiapex. reactions include lymphadenopathy, pruritus, ecchymosis, pain in extremity, oedema peripheral
This is particularly important for cords situated at the PIP joint of the fifth finger. Injections into (including injection site oedema and oedema), injection site haemorrhage, injection site pain,
cords affecting the PIP joint of the 5th finger must not be more than 2 to 3 mm in depth and not injection site swelling, tenderness,
more than 4mm distal to the palmar digital crease. Patients should be instructed to contact their contusion. Commonly reported adverse reactions include lymph node pain, paresthesia,
physician in case of symptoms of tendon rupture. Most patients experiencing tendon/ligament hypoesthesia, burning sensation, dizziness, headache, nausea, blood blister, blister, rash,
rupture or injury have gone on to have successful surgical repair. Early diagnosis and prompt
erythema, hyperhidrosis, arthralgia, joint swelling, myalgia, axillary pain, inflammation, injection
evaluation and treatment are important because tendon rupture/ligament injury may potentially site inflammation, swelling, injection site erythema, injection site pruritus, injection site warmth,
affect overall hand function. Cases of skin laceration requiring skin graft after finger extension
injection site vesicles.
procedures have been reported post-marketing. Signs or symptoms that may reflect serious
Overdose: Overdose is expected to be associated with increased local injection site reactions.
injury to the treated finger/hand after injection or manipulation should be promptly evaluated Provide routine supportive care
because surgical intervention may be required. A higher rate for skin laceration has been shown and treat symptomatically.
following two concurrent injections in the same hand in a controlled post-marketing trial. Use in Legal Category: POM.
patients with coagulation disorders – Xiapex must be used in caution in patients with coagulation Marketing Authorisation Holder: Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm,
disorders or those taking anticoagulants. Use of Xiapex in patients who have received
Sweden
anticoagulants (with the exception of up to 150mg acetylsalicylic acid daily) within 7 days prior to Package Quantities, Marketing Authorisation Numbers and Basic NHS Price: XIAPEX 0.9mg
receiving an injection of Xiapex is not recommended.
powder and solvent for solution for injection, EU/1/11/671/001, £650.00.
Immunogenicity - As with any non-human protein medicinal product, patients may develop
Further information is available on request from:SOBI Ltd. 1 Fordham House Court, Fordham
antibodies to the therapeutic protein. Since the enzymes in Xiapex have some sequence
House Estate, Newmarket Road, Fordham, Cambs. CB7 5LL. Tel: 01638 722380
homology with human matrix metalloproteinases (MMPs), antidrug antibodies could
Date of Preparation: April 2015 Company Reference: NP-0030
Adverse events should be reported. Reporting forms and information can be found at:
www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to SOBI Ltd by email: [email protected]