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 routine commissioning 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.
- 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 ONLYwhere the patient has exceptional clinical circumstances. Please check the commissioner websites for contact details of the IFR team.
Payment by the commissioner will only be made if the completed form is received no later than 15 days after INITIAL treatment commences
Patient NHS No. / Trust: / GP Name:
PatientHospital Number: / Consultant Making Request: / GP code / Practice code:
Patient initials: / Patient Dob: / // / GP Post code:
Criteria for initiation
- The patient is an adult with ADPKD?
- The patient has chronic kidney disease stage 2 or 3?
- There is evidence of rapidly progressing disease?
- Treatment will be initiated and monitored under the supervision of a physician with expertise in managing ADPKD and a full understanding of the risks of tolvaptan therapy including hepatic toxicity and monitoring requirements?
- All prescribing and monitoring will be undertaken by a secondary care specialist?
- Treatment will be discontinued if there is no response to treatment, if elevated liver enzymes and/or signs or symptoms of liver injury meet the criteria for permanent discontinuation or when renal insufficiency progresses to CKD stage 5?
- The commissioner will only be charged the actual acquisition cost of the drug to the provider with the discount agreed in the patient access scheme (PAS)?
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 for the purposes of processing this funding request and validating subsequent invoices. I have recorded/will record this discussion in the patient’s notes.
I confirm the risks and benefits of treatment have been/will be 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 renal team.
I acknowledge and adhere to the cost effective use of this treatment as advocated in the NICE TA and believe that within this Trust the above patient would be best managed using the agent as requested above.
Name of consultant (or clinician delegated by consultant):
Signature (electronic 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 nominated deputy)
Name:
Signature: Date: //
COMMISSIONING ARRANGEMENTS FOR TOLVAPTAN FOR ADPKD
NICE TA358 Recommendation:
Tolvaptan is recommended as an option for treating ADPKD in adults to slow the progression of cyst development and renal insufficiency only if:
- they have chronic kidney disease stage 2 or 3 at the start of treatment
- there is evidence of rapidly progressing disease and
- the company provides it with the discount agreed in the patient access scheme.
Other Commissioning Information
- Manufacturer has advised that the drug, will be available through the secondary care setting only and all prescribers will need to complete a risk management training program provided by the manufacturer and approved by MHRA.
- All prescribing and monitoring to be undertaken by secondary care specialists
- Tolvaptan treatment must be initiated and monitored under the supervision of physicians with expertise in managing ADPKD and a full understanding of the risks of tolvaptan therapy including hepatic toxicity and monitoring requirements.
- Treatment should be discontinued if renal insufficiency progresses to CKD stage 5.
- Tolvaptan should discontinued if elevated liver enzymes and/or signs or symptoms of liver injury meet the criteria for permanent discontinuation of tolvaptan (refer to SPC).
- A patient specific funding application form (via the web based Blueteq system) is to be completed by providers and submitted to the relevant CCG for each patient initiated on treatment. Providers who do not use the Blueteq system should complete the pro-forma available on the CCG website.
Further information from SPC
- Tolvaptan treatment must be initiated and monitored under the supervision of physicians with expertise in managing ADPKD and a full understanding of the risks of tolvaptan therapy including hepatic toxicity and monitoring requirements.
- Initial dose 60 mg/day as a split-dose regimen (45 mg upon waking and prior the morning meal and 15 mg 8 hours later). Initial dose is to be titrated upward to a split-dose regimen of 90 mg (60 mg + 30 mg) per day and then to a target split-dose regimen of 120 mg (90 mg + 30 mg) per day, if tolerated, with at least weekly intervals between titrations. Dose titration to be performed cautiously to ensure high doses are not poorly tolerated. Patients may down-titrate to lower doses based on tolerability. Patients have to be maintained on the highest tolerable tolvaptan dose.
- Treatment should be discontinued if renal insufficiency progresses to CKD stage 5
- Contraindicated in patients with elevated liver enzymes and/or signs or symptoms of liver injury prior to initiation that meet the requirements for permanent discontinuation. To mitigate risk of significant and/or irreversible liver injury, blood testing for hepatic transaminases and bilirubin is required prior to initiation, continuing monthly for 18 months and at 3-monthly intervals thereafter. Concurrent monitoring for symptoms that may indicate liver injury is recommended.
- Fluid and electrolyte status must be monitored in all patients. Administration of tolvaptan induces copious aquaresis and may cause dehydration and increases in serum sodium and is contraindicated in hypernatraemic patients. Therefore, serum creatinine, electrolytes and symptoms of electrolyte imbalances have to be assessed prior to and after starting tolvaptan to monitor for dehydration. During long-term treatment electrolytes have to be monitored at least every three months. Local specialist has advised that initial monitoring would be monthly for the first 3-6 months.
If treatments are not provided in line with the criteria laid out in this document, ENHCCG reserves the right to re-claim money from providers for the relevant drug and activity costs. ENHCCG may request an audit around patient outcomes on an annual basis.
v1 December 2015Pharmacy and Medicines Optimisation Team, NHS East & North Hertfordshire Clinical Commissioning Group (ENHCCG)
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