Download Paliperidone injection (Xeplion ® )

Supporting Evidence
Paliperidone palmitate prolonged release injection (Xeplion ®)
(50mg, 75mg, 100mg & 150mg)
Indication:
Paliperidone long action injection (*PLAI) is indicated for maintenance treatment of
schizophrenia in adult patients stabilised with paliperidone or risperidone. (1)
In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone
or risperidone, paliperidone may be used without prior stabilisation with oral treatment if
psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed. (1)
Paliperidone is an atypical antipsychotic; it is the active metabolite of risperidone and an
antagonist of serotonin 5-HT2 and dopamine D2 receptors. (1)
Patient suitability:
The recommended monthly maintenance dose is 75 mg (some patients may need 25 to 150
mg based on individual patient tolerability and/or efficacy). Overweight or obese patients may
require doses in upper range.
PLAI is suitable for those who have had recent diagnosis & few relapses.
Those patients who are stable on risperidone long acting injection or other
antipsychotic should not be switched to Paliperidone LAI.
PLAI has not been shown to be any more efficacious than risperidone long acting injection but
does have some practical advantages. There are no data on efficacy in prevention of relapse
relative to an active comparator.
Bethan Shepherd V5 Feb 2012
Key differences between Paliperidone Long Acting Injection & Risperidone Long Acting
Injection :
Paliperidone Long Acting Injection
(PLAI)
Risperidone Long Acting Injection
(RLAI)
Presentation
Pre-filled syringe: no reconstitution
needed; may also help reduce anxiety
by service user.
Vial & solvent for reconstitution ;
more nurse time
Storage
None fridge line
Requires refrigeration & appropriate
shelving
Less logistical issues especially in the
community e.g. when patient is not
home when the CPN arrives to
administer injection.
Some service users have c/o cold
injections.
Nurse should wait for injection to
climatise to room temp before
administration
Waste
Less of an issue as non fridge line; no
re-constitution needed
Waste is an issue especially once
cold chain is broken or problems with
re-constituting
Preparation
No special instructions
Must be removed from fridge
~30minutes before administration
Dose interval
Monthly (12 injections per year) so
may be more convenient for the
service user
Two weekly (26 injections per year)
No flexibility in dosing recommended
Dosing allows 7 day leeway with
missed dosages or re-scheduling:
greater flexibility
Service users seem to prefer monthly
injections (from feedback)
Licensed dose
range
4 strengths
3 strengths
Initiation of
treatment
Easier initiation
Initiation can be ‘complex’
No oral supplementation necessary;
reducing polypharmacy.
Requires oral supplementation for at
least 3 weeks
Requires first 2 doses one week apart
then monthly thereafter; reduces polypharmacy
Both PLAI & RLAI can be delivered by Polar speed direct delivery service allowing VAT
exemption of 20% (this is for outpatients only).
Bethan Shepherd V5 Feb 2012
Costing (4)
Drug / strength
Risperidone consta
25mg
Unit
cost
£79.69
Annual cost
Drug / strength
Unit cost
Annual cost
£2071.94
Paliperidone
£183.92
£2207.04
£244.90
£2938.80
£135.10
Consta
cheaper by
£314.07
£3,768.94
£44.48
Consta
cheaper by
£392.59
£4,711.08
£57.18
Paliperidone
cheaper by
50mg
Risperidone consta
37.5mg
Paliperidone
£111.32
£2894.32
Cost
difference
Consta
cheaper by
75mg
Risperidone consta
50mg
£142.76
£3,711.76
Paliperidone
100mg
Risperidone consta
75mg
£222.45
£5,738.70
Paliperidone
150mg
£1027.62
Patients prescribed unlicensed dose of risperidone consta of 75mg could switch to 150mg
paliperidone which is £1027.62 more cost effective.
Example of cost of paliperidone with initiation & maintenance dose (4)
Strength
Cost inclusive of VAT
Comments
150mg
£392.59
On day ‘one’
100mg
£314.07
On day ‘8’
75mg
£244.90 x 12 = £2,938.80
Monthly maintenance dose
Total drug cost
£3,645.46
Costs associated with initiation & maintenance treatment of schizophrenia have been
calculated per patient treated over the first year of treatment with PLAI & RLAI. Costs included
medication costs, wastage, oral antipsychotic supplementation, hospital cost & cost of
administration in the community.
Total for year for PLAI would be *£10,454.30 plus £26.27 for wastage ( 1/4 pack of consta).
Difficult to ascertain accurate figures for comparative costs of PLAI & RLAI due to sensitive
data relating to length of hospital stay; Janssen have reported that PLAI costs £238 more
expensive as inpatient but £123 less expensive in the community; weighted time PLAI is
£119 more expensive than RLAI. But assuming cost of a bed in AWP is £300, the patient
would have to be discharged just one day sooner for paliperidone to be less expensive.
(*based on drug costs, cost of hospital stay, CPN time)
Bethan Shepherd V5 Feb 2012
Additional data from Janssen has shown that service users would have to be discharged from
hospital within 27.41 days for paliperidone injection and risperidone consta to be cost neutral.
The SMC stated that providing the reduction in hospital length of stay for those patients
prescribed PLAI was greater than 0.6 days paliperidone palmitate LAI would be preferred on
cost-minimisation grounds.
Cost of relevant comparators (1)
Drug
Dose regimen
Cost per year (£)
Paliperidone palmitate
25mg – 150mg every 4 weeks
£2,391 to £5,104
Olanzapine pamoate
150mg to 300mg every 2 weeks or
300mg to 405mg every 4 weeks
£2,894 to £5,789
Risperidone LAI
25mg to 50mg every 2 weeks
£2,072 to £3,712
Side effects
Most common adverse effects reported for PLAI in phase 3 studies include insomnia, anxiety,
headache, restlessness & weight gain. Injection site reactions were typically mild in severity
and considered acceptable to patients and clinicians. Most common adverse effects In the
SPC were insomnia, headache, weight gain, injection site reactions, agitation, somnolence,
akathisia, nausea, constipation, dizziness, tremor, vomiting, RTI, diarrhoea & tachycardia.
References
1. Scottish Medicines Consortium www.scottishmedicines.org.uk Re-Submission of
paliperidone palmitate 7th November 2011
2. North East Treatment Advisory Group; Paliperidone depot injection (Xeplion) for
schizophrenia August 2011
3. Summary Product Characteristics www.medicines.org.uk
4. Janssen Cilag Pharmaceutical Representative
Bethan Shepherd V5 Feb 2012