Approved by South West London Medicines Commissioning Group: 17 July 2014
Rituximab, Eltrombopag or Romiplostim for ITP
Funding Request Form 2014-15
Rituximab, Eltrombopag and Romiplostim are used for the treatment of adults with chronic immune (idiopathic)
thrombocytopenia purpura (ITP) whose condition is refractory to standard active treatments and rescue therapies
or who have severe disease and a high risk of bleeding that needs frequent courses of rescue therapies. In South
West London, these drugs are commissioned in accordance with NICE Technology appraisals (TA 221 and TA
293) and the locally developed ITP Care Pathway. In order to minimise interpretation of NICE and variation in
access of these drugs, providers are requested to complete the following to request funding for Rituximab,
Eltrombopag or Romiplostim in line with the agreed South West London ITP Treatment Pathway (see
www.swlmcg.nhs.uk). This process has been developed as the anticipated number of requests are expected to
be small across London.
Please tick or select the corresponding CCG that the patient is registered to:
Croydon CCG
Kingston CCG
Merton CCG
Sutton CCG
Richmond CCG
Wandsworth CCG
Other CCG
Please state name:
All forms must be typed and all fields must be completed (or n/a stated where field is not applicable).
Incomplete mandatory fields and hand-written forms will result in the form being returned and may cause
delays to consideration for funding.
Anonymity – Please ensure that in order to protect patient’s identity, apart from Section A, the patient is not
referred to by name or initials within the application form.
SECTION A: CONTACT INFORMATION
1. NHS Approved Provider
Name
2. Address
3. Applicant Details
The applicant should have clinical
responsibility for this intervention
for this patient for this specific
clinical indication.
Please ensure the declaration is
signed and dated (Section H)
Name:
Designation:
Tel:
nhs.net address:
(No other email accepted)
4. Patient Details
Initials:
NHS Number:
Hospital ID number:
DoB:
Patient Address:
Registered
Consultant:
Registered GP name:
GP practice code:
Date of referral:
/
/
SECTION B: INTERVENTION REQUESTED
(NB: Intervention refers to requested treatment, investigation, etc)
5. Patient diagnosis or
Chronic (Idiopathic) Immune Thrombocytopenia (ITP) in adherence with the
condition (for which intervention
SWL treatment pathway for ITP
is requested)
6. Baseline platelets:
Date:
/
/
Platelet count:
x 109/L
7. Other relevant diagnosis or
co-morbidities
8. Details of intervention (for
which funding is requested).
Name of intervention:
(tick as appropriate)
If the intervention forms part of
a drug regimen, please
document the full regimen (e.g.
Drug X as part of regimen Y
(consisting of drug V, drug W, drug
X and drug Z).
Dose, frequency and
planned duration
of intervention:
Rituximab
Eltrombopag
Romiplostim
Rituximab;
Dose/frequency:
m2
Patient body surface:
Planned duration:
(usual dose: 375mg/m2 weekly for 4 weeks (IV
infusion))
Eltrombopag
Dose/frequency:
Planned duration:
(usual dose 25/50mg daily, titrated to desired
response, max 75mg daily (oral))
Romiplostim;
Dose/frequency:
Patient’s weight:
Planned duration:
9. Anticipated start date
Clinical Urgency
The decision to treat in the
event of immediate or lifethreatening circumstances
must be made in accordance
with NHS Approved Provider
(Trust) governance
mechanisms.
10. Is requested
intervention part of a
clinical trial?
kg
(usual dose: 1mcg/kg weekly, titrated to
achieve a platelet count of 50-100 x 109/L
(SC injection))
Your request will be acknowledged within 5 working days of receipt. A
funding decision usually takes the CSU up to 4 weeks from the date of
receipt of a full & accurately completed application with copies of
supporting clinical papers and completion of section I.
Is the case more urgent than this?
If ‘YES’ please state why
Yes
No
Tick as appropriate:
Yes /
No
If Yes, then STOP HERE. This funding route is not appropriate.
Please speak to your Trust Chief Pharmacist for drug trials.
There is no need to complete the rest of this proforma.
SECTION C: COMPARISON WITH STANDARD COMMISSIONED INTERVENTION
11. (a) What would be the
standard intervention /
management at this stage?
(b) What would be the
expected outcome from the
standard intervention?
(c) What are the patient
specific reasons that make the
standard intervention
inappropriate for this patient?
Normalisation of platelet count with minimal side effects
Page 2 of 5
SECTION D: CURRENT STATUS OF PATIENT
12. For all conditions
Please summarise the current status of
the patient in terms of quality of life,
symptoms etc including any recognised
condition-specific QoL / status scores.
What is the patient’s current clinical
severity?
Please use standard scoring systems e.g.
WHO, DAS28, 6MW, cardiac index or
those applicable to the patient’s clinical
diagnosis. Please include interpretation of
the score
SECTION E: PREVIOUS TREATMENT/INTERVENTIONS
13. Summary of previous
Start
Stop
intervention(s) this patient
Date:
Date:
has received for the
condition.
* Reasons for stopping may
include:
 Course completed
 No or poor response
 Disease progression
 Adverse effects/poorly tolerated
(please detail nature of adverse
effect/intolerance)
14. Has a previous application been submitted on behalf
of this patient?
Name of
Intervention
(for drugs include
name, dose and
frequency of use)
Tick as appropriate:
Reason for stopping* /
Response achieved or
indicate if still
continuing
Yes /
No
SECTION F: EVIDENCE FOR EFFECTIVENESS OF INTERVENTION REQUESTED
15. Governance
Has the Approved NHS
Provider approved the
requested intervention for use
through its recognised clinical
governance arrangements?
Has the Trust Drugs
and Therapeutics
Committee (DTC) or
equivalent approved
the requested
intervention for use?
Tick as appropriate:
Yes /
No
If No, then STOP HERE.
The application requires DTC approval
Evidence MUST be supplied e.g. DTC
minutes, a letter from the DTC Chairman, if
Chairman’s action has been taken
16. Outcomes
(a) What would you consider to
be a successful outcome for
this intervention in this patient?
– include details of the
parameters you intend to
measure
(b) How will you monitor this
and how frequently will you
monitor this?
(c) What stopping criteria
will be used to decide
when the intervention is no
longer effective?
(d) Detail the current
status of the patient
according to these
measures.
17. What are the anticipated
adverse effects and potential
risks of the intervention for this
patient?
18. How do the benefits outweigh
the risks?
Page 3 of 5
SECTION G: COSTS and REVIEW
The completed form must be sent to the Trust Chief Pharmacist, for completion of Part A and to the Trust service
manager for completion of part B).
PART A – ( to be completed by approved NHS provider Chief Pharmacist)
19. Total Acquisition cost (inc VAT) for duration of treatment being
applied for (or annual cost if treatment for longer than year),
£
20. State the value of any offset costs
£
21. Please benchmark these costs against London Procurement Prices
22. Application reviewed by Chief Pharmacist or nominated authorised
deputy
Name:
Signature or email confirmation:
PART B- ( to be completed by approved NHS provider service manager )
23. Application reviewed by Service Manager or nominated authorised
deputy
Name:
Signature or email confirmation:
SECTION H: APPLICANT’S DECLARATION
24. Declaration
I declare that this application is complete and accurate and that all
necessary supporting information and evidence has been provided on
this form (& attachments).
25. Patient Consent
I confirm that this funding request has been discussed in full with the
patient, including an appraisal of the benefits/risks of the intervention and
they have consented to the proposed treatment. I confirm the patient has
consented to CCG & CSU staff involved in the preparation, consideration
and funding of their case to access confidential clinical information about
them (including their NHS no.) to enable full consideration of this request
and payment of invoices. In the case of a minor or vulnerable adult I
confirm I have complied with the relevant legislation guidance including
the Children Act 2004 and Mental Capacity Act 2005.
26. Correspondence and Contact
The IFR team will copy the patient into correspondence concerning
progress and outcome of their application. If you do not want the patient
to be contacted or to receive correspondence please indicate this.
Responsible Clinician Name:
Signature or email
confirmation:
Tick as appropriate:
Yes /
No
Tick as appropriate:
Yes /
No
Patient signature (optional):
Please copy the patient into
correspondence.
Tick as appropriate:
Yes /
No
Date:
/
/
Page 4 of 5
Equality Monitoring Data
This section is for data monitoring purposes only and will be removed from the application prior to consideration by the IFR
Panel.
1
2
3
Ethnic Origin
White
British
Irish
Any other White
background
Mixed
White and Black
Caribbean
White and Black
African
White and Asian
Any other Mixed
background
Asian or
Asian British
Indian
Pakistani
Bangladeshi
Any other Asian
background
Black or
Black British
Caribbean
African
Any other Black
background
Other Ethnic
Groups
Chinese
Any other ethnic
group
Male
Female
Transgender
Not disclosed
Heterosexual
Bisexual
Gay
Lesbian
16-25
26-35
36-45
46-55
56-65
66+
Gender
Sexuality
Not disclosed
4
5
Age Group
Do you consider yourself to have a disability?
Registered
disabled
Unregistered
disabled
Not disabled
Hearing
impairment
Speech
impairment
Mobility
Impairment
Age related
impairment
Visual impairment
Learning
disability
Mental health
Other
No religion
Christian
Buddhist
Other
Hindu
Jewish
Muslim
Nature of disability
6
Religion
For South West London CCGs: Croydon, Kingston, Merton, Richmond, Sutton and Wandsworth
Forms should be submitted to slcsu.ifrswlondon@nhs.net Tel. enquiries: 020 3668 1222
Page 5 of 5
Treatment pathway for adult patients with immune (idiopathic)
thrombocytopenic purpura (ITP)
Immune thrombocytopenic purpura (ITP) is defined by a low platelet count and an increased risk of
bleeding. Fatal bleeding is rare and occurs more frequent in elderly patients and in those with severe
thrombocytopenia. Although treatment for ITP is strictly individualised, specific therapy for ITP may not
be necessary unless the platelet count is <10x109/L or there is extensive bleeding. Another important
consideration is that for some patients the morbidity from side effects of therapy may exceed any
problems caused by the thrombocytopenia. Clinical management of this condition must therefore take
into account the patient’s age, the severity of the illness, and the anticipated natural history. Treatment
for ITP is considered appropriate for symptomatic patients and for those at significant risk of bleeding.
Management of severe or life-threatening bleeding
Hospitalisation is required. General measures should be instigated to reduce the risk of bleeding,
including avoidance of drugs that may exacerbate bleeding (such as anticoagulants, anti-platelets,
NSAIDs), control of blood pressure and maintenance of urine output.
Emergency Treatment
-
Platelet transfusions (e.g. two platelet units every 4-6 hours)
with/without
-
Intravenous Immunoglobulin (IVIG) (1g/kg, repeated the following day if the platelet
count remains <50x109/L - RED INDICATION)
with/without
-
Intravenous methylprednisolone (1g per day for 3 days)
General Management
 Consider if patient is symptomatic, has a platelet count <30x109/L or requires a procedure that
may induce blood loss.
1st line treatment
-
Oral prednisolone 1 to 2mg/kg per day, given as single or divided doses
OR (if critical bleeding, unresponsive to corticosteroids, contraindication to corticosteroid)

IVIG 1g/kg per day for 2 days – RED INDICATION
For patients unresponsive to first line treatment options or with persistent or chronic ITP
consider second line pharmacological option or splenectomy.
2nd line treatment
-
Rituximab 375mg/m2 weekly for 4 weeks
-
Splenectomy - offer if severe thrombocytopenia (platelet count <10-20x109/L), a
high risk of bleeding for platelet counts <30x109/L, or patients who require
continuous glucocorticoid therapy to maintain safe platelet counts
OR
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
Splenectomy may not be appropriate due to medical co-morbidities. It is not recommended in
elderly patients or those who have hepatic or mixed hepatic/splenic sequestration of 111Inlabelled platelets.

Third line options can be considered for patients in whom first AND second line treatment
options have failed and there are ongoing complications from their thrombocytopenia
OR
for patients in whom second line treatment options are contraindicated.
3rd line treatment
Thrombopoetin receptor agonists:
-
Eltrombopag – initial dose 50mg daily (for patients of East Asian ancestry start at
a reduced dose of 25mg daily), titrate to desired response, max 75mg daily (see
local Eltrombopag prescribing policy and/or Summary of Product Characteristics
(SPC) for full details)
OR (if patient is not eligible for eltrombopag (see below) or is intolerant to eltrombopag
or has failed treatment)
-

Patients ineligible for eltrombopag treatment:
-

Romiplostim – initial dose 1mcg/kg SC once weekly, titrate to desired response
(see local Romiplostim prescribing policy and/or SPC for full details)
Patients with liver disease (Child Pugh ≥5)
Patients with dietary restrictions/GIT pathology
Patients who are unable to adhere to the dosing requirements of eltrombopag
Patients who are intolerant of eltrombopag
Patients who are known to be unresponsive to eltrombopag
Patients at high risk of non-adherence
Patients ineligible for romiplostim treatment:
- Patients with liver disease (Child Pugh ≥7)
- Patients who are unable to adhere to the dosing or administration (SC injection)
requirements of romiplostim
- Patients who are intolerant of romiplostim
- Patients who are known to be unresponsive to romiplostim
- Patients at high risk of non-adherence or non-attendance to weekly clinic appointments
- Patients who have previously developed increased bone marrow reticulin during
treatment with romiplostim
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
The following pharmacological agents offer further alternative treatment options for
consideration in unresponsive patients:
-

Mycophenolate mofetil (1000mg twice daily)
Danazol (200mg 2-4 times daily)
Dapsone (75-100mg daily)
Vinca alkaloids (vincristine total course dose 6mg, vinblastine total course dose 30mg)
Ciclosporin A (5mg/kg/day for 6 days then 2.5-3mg/kg/day)
Azathioprine (1-2mg/kg – max 150mg/day)
Cyclophosphamide (1-2mg/kg orally daily for a minimum of 16 weeks)
Responses to these agents are variable and for some of them may only be apparent after several
weeks or months. The choice of one agent over another is based on the assessment of the side
effect profile and the personal experience of the haematologist. International guidelines do not
prioritise.
References
1.
2.
3.
4.
5.
6.
SPC for Revolade. GlaxoSmithKline UK. Last updated: 04/10/2013. Available online via:
http://www.medicines.org.uk/emc/medicine/22949/SPC/Revolade/
NICE technology appraisal guidance 293. Eltrombopag for treating chronic immune (idiopathic) thrombocytopenic
purpura (review of technology appraisal 205). July 2013.
Cheng et al. January 2011. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month,
randomised, phase 3 study. The Lancet, 337;9763: 393-402.
Guidelines for the investigation and management of idiopathic thrombocytopenic purpura in adults, children and in
pregnancy. British Journal of Haematology, 2003, 120:574-596. Available online via:
http://www.bcshguidelines.com/documents/ITP_bjh_2003.pdf
Provan D et al. January 2010. International consensus report on the investigation and management of primary immune
thrombocytopenia. Blood, 115; 2: 168-186
SPC for Nplate with Reconstitution Pack. Amgen Ltd. Last updated: 15/01/2014. Available online via:
http://www.medicines.org.uk/emc/medicine/23117/SPC/Nplate+with+Reconstitution+Pack/#CONTRAINDICATIONS
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Original written by: Roberto Stasi, Consultant Haematologist, St. George’s Hospital
Adapted for use by: Leonie Woodfinden, Senior Pharmacist, Anticoagulation, St. George’s Hospital - March 2014
Reviewed by: Dr Steve Austin, Consultant Haematologist, Dr James Uprichard, Consultant Haematologist, St. George’s Hospital - April 2014
Approved by St. George’s Drug and Therapeutics Committee: 15 April 2014
Adapted and approved by South West London Medicines Commissioning Group: 17 July 2014
Review date: July 2017 (or earlier if indicated)