Patient Specific Funding Application for ROMIPLOSTIM and ELTROMBOPAG for the treatment of chronic immune (idiopathic)
thrombocytopenic purpura in Adults, NICE TA 221, issued April 2011 and NICE TA293, issued July 2013
Only fully completed forms will be accepted for consideration
The completed form must be sent by the hospital commissioning team to the High Cost Drugs Team at
If the patient does not fulfil NICE criteria
· The responsible commissioner will not normally fund any treatment where the patient does not meet the agreed criteria as outlined in this patient specific funding application form. Hertfordshire commissioning criteria are listed on page 4.
· Following a clinical trial, the responsibility for ongoing funding remains with the provider or pharmaceutical company. The commissioner will only fund treatment that meets the commissioned pathway.
· Applications can be made via the Individual Funding Requests process ONLY where the patient has exceptional clinical circumstances. Please check the commissioner websites for contact details of the IFR team.
Patient NHS No. / Trust: / GP Name:Patient Hospital No. / Consultant Making Request: / GP Practice code:
Patient initials & DoB: / Consultant Contact Details: / GP Post code:
Date of diagnosis of ITP / Platelet count at time of diagnosis
NICE recommendation ONLY covers thrombocytopenia with no identified cause. Thrombocytopenia with an identified cause, such as drug induced, is NOT routinely commissioned. Please list medication discontinued in previous month and current medication below:
Indication being applied for? / continuous maintenance treatment / treatment for planned surgical procedure
Pharmacy and Medicines Optimisation Team
East & North Herts Clinical Commissioning Group (ENHCCG)
Initiation date / Drug, dose and frequency / Continued? / Discontinuation date / Rationale for discontinuation/ comments
Yes/ No
Yes/ No
Yes/ No
Yes/ No
Splenectomised patient? / Yes/ No. If no, please state reason:
Most recent platelet count / Date measured:
Admissions for rescue treatment in last 6 months:
Date of admission / Date of discharge / Reason for admission / Platelet count on admission / Details of rescue treatment (drug, dose, frequency, course length)
Due to its more convenient route of administration, eltrombopag is routinely commissioned as the thrombopoietin receptor agonist of first choice by Hertfordshire commissioners, following agreement with local specialists.
Please indicate choice of agent / Eltrombopag / Romiplostim
Where romiplostim has been chosen above, please give rationale
For patients undergoing a surgical procedure, eltrombopag (1st choice) or romiplostim will be funded as a planned course of treatment for duration of 4 weeks.
Date of procedure: / Name of procedure:
Planned date of treatment initiation: / Planned date of discontinuation:
Eltrombopag only – Please state dose to be administered (licensed dosage range 25-75mg once daily)
Romiplostim only – please complete details in table below
Weight of patient (kg) / Romiplostim dose/kg/week (microgram/kg/wk)
(licensed dose range 1-10microgram/kg/wk)
Dose of romiplostim (microgram/wk)
Round doses, up or down, to the nearest whole vial where possible / Number of vials/week
Weekly cost / Patient able to self administer? / Yes/ No
Romiplostim funding will not be approved for continuous maintenance treatment in patients unable to self administer.
For surgical patients unable to self administer romiplostim:
How will this be managed within secondary care? State associated activity cost:
Treatment Review: Ongoing funding will only be provided for patients meeting routine commissioning criteria (see page 4)
Baseline / 6 months / 12 months / 18 months / 24 months / months
Date
Platelet count
Number of admissions for rescue treatment in previous 6 months
Drug name
Current dose
Continue?
Clinician’s Declaration
I confirm that I have discussed with the patient and that they understand and consent to their personal information being shared with commissioning and commissioning support organisations. I have also recorded this discussion in the patient’s notes.
I confirm the risks and benefits of treatment have been fully discussed with the patient and documented.
I confirm that funding approval is subject to initiation and follow up of treatment response being undertaken by a specialist haematology team.
I acknowledge and adhere to the cost effective use of romiplostim as advocated in NICE TA 221 and believe that within this Trust the above patient would be best managed using the agent as requested above.
Name of supervising consultant:
Signature: Date: / If this patient is being jointly managed by a second consultant, please state name here:
Name:
Date:
Signature (or email confirmation) by Trust Chief Pharmacist (or deputy)
Name:
Signature:
Date:
NICE Technology Appraisal 221, issued April 2011, Romiplostim for the treatment of chronic immune (idiopathic) thrombocytopenic purpura
1.1 Romiplostim is recommended for the treatment of adults with chronic immune (idiopathic) thrombocytopenia purpura:
· 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, and
· If the manufacturer makes romiplostim available with the discount agreed as part of the patient access scheme.
1.2 Only a haematologist should start and supervise treatment with romiplostim.
NICE Technology Appraisal 293, July 2013, Eltrombopag for the treatment of chronic immune (idiopathic thrombocytopenic purpura
1.1 Eltrombopag is recommended as an option for treating adults with chronic immune (idiopathic) thrombocytopenic purpura, within its marketing authorisation (that is, in adults who have had a splenectomy and whose condition is refractory to other treatments, or as a second-line treatment in adults who have not had a splenectomy because surgery is contraindicated), only if:
· their condition is refractory to standard active treatments and rescue therapies, or
· they have severe disease and a high risk of bleeding that needs frequent courses of rescue therapies and
· the manufacturer provides eltrombopag with the discount agreed in the patient access scheme.
Hertfordshire Commissioning Criteria
Initiation criteria (all must apply):
o Diagnosis of ITP >12 months duration.
o Standard active therapies (including rituximab and immunosuppressants, e.g. azathioprine, cyclosporin, mycophenolate) have failed to control bleeding requiring hospitalisation, or where patient is intolerant of these therapies.
o Patient has had a splenectomy or is unsuitable for splenectomy.
o Platetlet count <30x109, and patient is requiring more than 3 rescue treatments with IVIg in 6 months, OR
o Patient has a diagnosis of chronic ITP with a platelet count <30x109 and requires therapy to cover a planned surgical episode.
Maintenance and Stopping criteria:
o Ongoing funding will be reviewed 6 monthly and re-approved if platelet count has increased to >30x109 and admission rate for rescue treatment has fallen by 2 admissions in 6 months from baseline.
o Eltrombopag and romiplostim to cover surgical procedures in patients with chronic ITP will be commissioned for a fixed duration of 4 weeks, commencing 2 weeks before procedure.
Further criteria:
o The proforma for patient specific prior approval for romiplostim in chronic ITP must be used to apply for funding.
o Secondary care specialists will initiate and maintain prescribing responsibility.
o Eltrombopag will be commissioned as thrombopoietin receptor agonist of choice, with romiplostim reserved for patients failing to respond to eltrombopag.
o Patients will be trained to self administer romiplostim by secondary care providers.
o Long term treatment with romiplostim is not suitable for patients unable to self administer.