UCB. Certolizumab pegol (CIMZIA ) for the treatment of Rheumatoid Arthritis PATIENT ACCESS SCHEME (PAS) SUBMISSION TO NICE

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1 UCB Certolizumab pegol (CIMZIA ) for the treatment of Rheumatoid Arthritis PATIENT ACCESS SCHEME (PAS) SUBMISSION TO NICE July 23 d

2 Executive summary UCB have proposed a patient access scheme (PAS) to support the use of Certolizumab pegol (Cimzia ) in the NHS setting for use to treat rheumatoid arthritis. This is done to provide clinicians with a clear cost effective alternative to existing TNF inhibitor (TNFi) therapy. A main concern around the use of TNFi treatment is the cost to gain an adequate response in the first few months and the cost of failure for patients that have an adverse response or do not meet effective control at six months (defined as a primary failure). This reality is also driving the debate about the use of follow on TNFi therapy (described as sequential use) and is the subject of a multiple technology appraisal that UCB has been denied involvement with. In order to ensure that the treatment decision is based on clinical need rather than considerations of cost or the risk of a failed initial intervention, UCB will make Cimzia available free of charge to all NHS patients for the first three months of therapy, at which point clinical response should be clear. Only after this three month stage will the NHS be charged for continuing to use this effective therapy. 2

3 Section A Details of the Patient Access Scheme 1.1 Provide the title of the appraisal for which the patient access scheme applies This patient access scheme supports the submission of Certolizumab pegol that was made to NICE on the 22nd of June The submission considered the use of Certolizumab pegol (Cimzia ) for use to treat patients suffering from rheumatoid Arthritis in England and Wales. The expected date of issue of the FAD will be February 2010 and the first appraisal committee meeting will be on the 23 rd of September Please provide any relevant background details and the rationale for developing the patient access scheme Access to high cost medicines in rheumatoid arthritis is strictly controlled due to concerns around potential failure in the initial treatment phase, the cost of non responders as a whole and pressure on overall drug budgets. In other disease areas companies have responded to this access challenge by providing a risk share or patient access scheme. UCB has demonstrated that Certolizumab pegol is a safe and effective medicine but recognizes that in line with all other TNF inhibitors it has a primary failure rate where patients either fail to gain an adequate response or have an initial adverse reaction. In order to ensure that access to this medicine is not restricted by this concern UCB will provide a patient access scheme that eliminates any concern around failing to achieve a primary effective response and so ensuring that the NHS does not pay for any patient before the effectiveness of the treatment can be properly evaluated. 3

4 UCB will bear the cost of all patients until the end of the first 12 weeks at which stage the clinical response can be determined. 1.3 Please state whether the scheme is financially based or outcome based The scheme is financially based and has been designed to have no additional clinician involvement in normal practice in order to decide on effective patient outcomes. The scheme provides the same benefits to all patients regardless of whether they respond or not. The outcome of the scheme is to reduce the cost of drug acquisition whilst effective response is being assessed and as such the main sensitivity of the scheme is the length of time that patients are treated with Cimzia. 1.4 Please provide specific details of the patient population that the scheme applies to. Does the patient apply only to a specific subgroup? The scheme will be open to all NHS patients with moderate to severe Rheumatoid Arthritis who have been initiated onto Cimzia for the first time in line with the licensed indication. There will be no patients excluded from the offer and UCB expects a 95% uptake as feedback from customers indicates that patients currently treated with entanercept and adalimumab are managed through a homecare company provider when the patient is treated in the primary care setting. Administration of the scheme will therefore be done through the homecare provider agreed with the hospital trust when the patient is referred for treatment by their consultant. Where patients have been treated in a hospital setting and not transferred to a Homecare company provider, an 4

5 in individual discussion is needed between the hospital provider and UCB to agree a rebate that will allow the same savings to be realised. 1.5 Please provide details of when the scheme will apply to the population specified in 1.4. Is the patient access scheme dependant on certain criteria? The Cimzia patient access scheme is available to all patients at initial prescription when they are moved into the primary care setting for treatment. As Cimzia is a subcutaneous injection that can be administered by patients after appropriate training it is not intended (or expected) that patients will be managed or treated in secondary care as this would be an needless use of additional NHS resources. The scheme will apply to the population following initial diagnosis and enrolment with a homecare provider, at which point the patient will have 10 vials supplied free of charge for use during the first three months of therapy. For this reason it is expected that the vast majority of patients will be covered by the scheme. Our draft label states that Cimzia will be effective within 12 weeks of starting treatment which represents for first 10 vials administered. To align with this, the scheme will provide these 10 vials of Certolizumab pegol free of charge to each de novo patient. The NHS cost of each vial is so ten vials given free to each patient represents a reduction in cost of 3755 to the NHS in the first three months of treatment, regardless of clinical outcome. After three months, according to existing guidelines and practice, the patient can be reviewed for effective response. The evidence from our clinical trials show the achievement of an ACR20 response levels out after 12 weeks so it is considered less likely that patients who have not responded at week 12 will 5

6 then go on to show a response at week 24. At this stage non responders should be considered for alternative therapy. Due to the high value of the medicine and the need to ensure cold chain supply throughout the treatment cycle, Cimzia will be distributed directly to each individual patient through a homecare company following prescription by their referral centre after specialist consultation. Cimzia is a subcutaneously administered therapy that is intended for use by patients in a homecare setting, similar to Etanercept and Adalimumab. Patients will be trained to self inject by qualified nursing staff. It is not anticipated that Cimzia will be used in a hospital setting. The only foreseeable exception to this is where the clinician chooses to initiate the prescribing of Cimzia in hospital by administering the first treatment (two syringes, a total of 400mg) in a clinic setting and then transfer the patient to the homecare setting afterwards. In this situation the patient will still receive 10 free vials covering weeks 2 to What proportion of the population is expected to benefit from the scheme? In outline there is nothing that will prevent all NHS patients from taking advantage of the patient access scheme. Following detailed customer feedback it has been demonstrated that the majority (90%+) of hospital trusts use Healthcare at Home as a homecare provider to train patients to self inject and to distribute medicines to patients. In order to align with this established process, UCB has chosen Healthcare at Home as a preferred provider to manage the scheme and distribute Cimzia and it will be possible for all NHS patients to gain access to the 10 free vials if their patients register and are managed by Healthcare At Home. 6

7 Access to the Patient Access Scheme is not dependant on the use of Healthcare at Home as a provider and trusts are free to choose another Homecare provider if this is their local practice. UCB will then work with this Homecare provider to ensure that the same patient access scheme benefits are available to that trust. 1.7 Please explain how the NHS will be rebated through the patient access scheme After consultation with NICE and the Department of Health UCB decided to remove any element of outcome measurement or rebate and implement a simpler scheme. There will be no rebate mechanism necessary under this scheme as no patients who are registered onto the scheme will incur a cost to the NHS for the first 10 vials. This means that the NHS will not pay for Certolizumab until after week 12. Where a patient is managed solely in the secondary care setting a rebate may be required if there is not a simple mechanism to deliver the 10 free vials with a suitable control. In reality Cimzia is unlikely to be prescribed for patients who have to be managed continually in a secondary care setting or with clinician intervention. 1.8 Please provide details of how the scheme will be administered. The scheme will be administered through a Homecare delivery company that is agreed with the hospital trust. The preferred supplier will be Healthcare at Home as they currently manage the delivery of Etanercept and Adalimumab in the primary care setting and have significant experience in managing biologic therapy in the homecare environment. Each hospital that is intending to use Certolizumab pegol will be registered as a contact by Healthcare at Home. 7

8 Each prescribing clinician will then be given either an electronic or paper private prescription to prescribe Certolizumab pegol to their patients. This prescription will be sent to Healthcare At Home to fulfil. At this stage the pharmacy management of the patient and the consequent administration of the scheme will be done by Healthcare at Home. Healthcare at Home will contact the patient to discuss drug administration training through qualified nursing staff and the delivery of the medicine to the patients. Initially the patients will have six syringes delivered which will cover weeks 0 to 4 of treatment. At the end of the first month, Healthcare at home will again contact the patient to confirm they are still being treated with Certolizumab pegol and perform a basic patient follow up. If appropriate they will then deliver the next four syringes covering weeks 6 to 12. The first two deliveries (covering the initial ten syringes) will be invoiced to the PCT or hospital trusts (depending on the funding structure for that patient) at no cost. The next delivery after this will be invoiced at full NHS cost. If a hospital trust would rather use a different homecare provider then this will be possible and UCB will then work with the trust to enable this. Our initial discussions have shown that nearly 95% of Hospital trusts use Healthcare at Home which is why UCB have chosen them as preferred provider. However should any trust want to use another provider of Homecare services this will be possible and access to the Patient Access Scheme will then be through their chosen provider. There is no compulsion to chose Healthcare at Home and no link between the use of Healthcare at Home and use or availability of the patient access scheme. 8

9 1.10 What is the duration of the scheme? The scheme will last for the length of time that the NICE guidance remains in place for Certolizumab pegol and is made on the assumption that it will be available to prescribe for rheumatoid arthritis patients which have been indicated for a biologic therapy or those who have encountered a primary failure (either an initial adverse reaction or a clear failure to show any meaningful clinical response) and can therefore be switched to another TNF inhibitor therapy. It is made on the understanding that the primary reason for prescribing is not simply to take advantage of the patient access scheme itself Are there any equity or equality issues relating to the scheme? No issues have been identified by UCB in this regard If available please list any scheme agreement forms. There are a number of scheme agreement forms but only one (the funder Patient Access Scheme acceptance form) specifically relates to the scheme. There are other forms that must be completed as part of the registration of the patient, but they relate specifically to their management by Healthcare at Home and the delivery and administration of Certolizumab rather than access or management of the Patient Access Scheme. These forms are common to all patients managed by Healthcare At Home for the treatment with TNF inhibitors. A full outline of the forms is included in the appendices. The following forms will require completion and only the form in bold red type is additive due to the Patient Access Scheme: Cimzia Homecare Prescription Form 9

10 Hospital patient registration form Funder Patient Access Scheme Agreement Form 10

11 Section B Cost Effectiveness Please provide details of how the patient access scheme has been incorporated into the economic anaysis. The patient access scheme simply reduces the drug acquisition costs on the economic analysis and as such reduces the overall drug treatment costs for each patient given CZP compared to other therapies. The model has the flexibility to show the inclusion or exclusion of the patient access scheme and both scenarios have been included into the submission as scenario A (the scheme included and the cost impact outlined) and scenario B (the patient access scheme not included and CZP considered at full cost) If you are submitting the patient access scheme at the end of the appraisal process you should update the economic model to reflect the assumptions that the appraisal committee considered to be most plausible. The patient access scheme has been considered from the start and is represented in the results as scenario A Please provide details of any additional patient-related costs incurred by implementing the patient access scheme. UCB does not believe that there are any additional patient related costs incurred by the scheme. The scheme is financially based and all patient will have the first 10 vials supplied free of charge. The financial administration is done through the Homecare provider. No patient measurement is needed and no costs are incurred that would require a reclaim mechanism. 11

12 2.1.4 Please use table 2 to list any operational costs related to the patient access scheme. There are no operational costs related to the patient access scheme. The only possible requirement is for audit of invoices to ensure the payer has been charged a zero rate for the first 10 vials, however this is not independent from the need to audit high value invoices routinely and is a common pharmacy practice that would not increase simply because the initial invoices are free of charge. 2.2 Summary results All the cost effectiveness impact results are presented in detail in Section C of UCB s response to the NICE/ERG clarification questions. Scenario A2 Revised CE results (incorporating PAS) shows the revised results after the changes to the model have been completed as outlined in the questions received from NICE. 12