Specialised Services Circular

Transcription

1 Specialised Services Circular Issue date: 11 August 2015 ID Category: Status: Public & Press: SSC1535 For Action Circulation distribution list only of Palivizumab (To reduce the risk of RSV in High Risk Infants) for the 2015 Vaccination Season Circulation For action Local Team Assistant Direcrs of Specialised Regional Team IFR Leads Finance Leads Local Team Pharmacists Local Teams circulate : Acute Trust Chief Executives; Acute Trust Medical Direcrs Acute Trust Chief Pharmacists Trust Chief Pharmacists For information Regional Direcrs of Specialised Regional Medical Direcrs Regional Clinical Direcrs of Specialised Neonatal Network ODN Leads Clinical Reference Group Chairs: onward circulation relevant CRG members Background 1. RSV humanised monoclonal antibody is used protect babies who are at high risk from developing RSV infection. RSV is a clearly identified winter virus, usually occurring in the UK between Ocber and March with most infections occurring in a relatively short epidemic of about six weeks. Therefore, the antibody is offered during the winter season and helps protect against serious RSV infection in high-risk babies (Green Book Chapter 27a). Page 1 of 5

2 england/series/immunisation-against-infectious-disease-the-green-book. 2. Predisposing facrs for RSV infection include prematurity, cardiopulmonary disease, and immunodeficiency, but may also include other facrs such as bacco exposure, day care attendance, overcrowding, lack of breastfeeding and admission hospital during the RSV season. Summary 1. Policy support the commissioning of Palivizumab reduce the risk of RSV in High Risk Infants for the 2015 vaccination season remains under the remit of Public Health England and the policy guidance is contained in the Green Book (Immunisation against infectious Diseases) Chapter 27a. 2. The Green Book Chapter has been updated this year (2015) following recommendations made by the Neonatal CRG. The changes made improve the clarity regarding those infants in which the use of Palivizumab is considered costeffective and are supported by the JCVI. Overall it is expected that fewer babies will be immunised as a result of the amended policy. There will be fewer lung disease patients overall with a smaller number of additional congenital heart patients. 3. There are two main changes agreed which are: The definition for Chronic Lung Disease has been updated and is now considered be more practical and clinically relevant. The definition for CLD is now as follows preterm infants with compatible x-ray changes who continue receive supplemental oxygen or respirary support at 36 weeks post-menstrual age. The definition for congenital heart disease patients eligible receive Palivizumab has been clarified as: Preterm Infants with haemodynamically significant, acyanotic CHD OR Cyanotic or acyanotic CHD plus significant comorbidities particularly if multiple organ systems are involved. 4. Also note, revisions have been made the Presentation section of the chapter, taking in account the change in formulation from a lyophilised powder for reconstitution, a new liquid formulation Synagis solution for injection. 5. The Green Book Chapter is in the process of being updated and will be ready for the start of the 2015 RSV season. This circular gives advance notice of the eligibility criteria for the 2015 season which is provided below. Clinicians should refer the Green Book when prescribing. 6. It is recognised that there are legacy policy arrangements in place which have resulted in variations in the application of the Green Book Chapter. For the 2015 season the Green Book Green Book guidance must be followed and any hisrical legacy arrangements should cease. The babies/infants eligible receive Palivizumab for the 2015 season are as follows: High Risk - Bronchopulmonary dysplasia (BPD) (also known as chronic lung disease) Moderate or severe BPD in preterm infants, defined as preterm infants with Page 2 of 5

3 compatible x-ray changes who continue receive supplemental oxygen or respirary support at 36 weeks post-menstrual age. Children who fall in the light and dark shared area of Table 1 should be offered prophylaxis. Infants with respirary diseases who are not necessarily pre-term but who remain on oxygen at the start of the season are considered be at higher risk. These infants may include those with conditions including: a) pulmonary hypoplasia due congenital diaphragmatic hernia b) other congenital lung abnormalities (sometimes also involving heart disease or lung malformation) c) interstitial lung disease and including those receiving long term ventilation at the onset of the season. Table 1 Cost effective use of Palivizumab (shaded area) for pre-term infants with Moderate or severe BPD by chronological age (months) at the start of the RSV season (usually 1st Ocber) and gestational age at birth (weeks) Gestational age at birth (weeks+days) Chronological (months) age < <3 3 <6 6 <9 9 High Risk - Congenital Heart Disease (CHD) defined as Preterm Infants with haemodynamically significant, acyanotic CHD at the chronological ages at the start of the RSV season and gestational ages covered within the dark shaded area in Table 1. Cyanotic or acyanotic CHD plus significant co-morbidities particularly if multiple organ systems are involved. Children under the age of 24 months who have severe combined immunodeficiency syndrome (SCID), until immune reconstituted SCID is the most severe form of inherited deficiency of immunity. Affected infants are unable mount either T-cell responses or produce antibody against infectious agents. Page 3 of 5

4 7. Only patients who meet the criteria listed above will routinely be eligible for funding for Palivizumab. Where a patient does not meet the criteria in the policy and a clinician feels that a patient is exceptional an application for approval should be made through the normal regional IFR process. 8. It should also be noted that the maximum number of doses is five, administered monthly as stipulated in the Green Book Chapter and doses administered above this rate will not be funded. 9. Given the numbers of babies eligible for treatment will be marginally reduced it is not envisaged that there will be any financial implications relating the implementation of the revised policy. Actions Regional commissioning teams are requested inform their specialised children s providers of the updated JCVI guidance and advise: 1. Only patients meeting the guidance outlined above will be eligible receive Palivizumab for the 2015 season. 2. Clinicians should refer the updated Green Book Chapter before prescribing. 3. The maximum number of doses commissioned will be five and doses administered above this level will not be funded. 4. Sub regional teams should ensure Trusts are aware of the new commissioning position. This will be monired through use of the Blueteq forms. 5. Regions should ensure that costs are contained within the 2014/15 season quantum i.e. the expenditure in the previous financial year. Sub regional teams should monir costs using the drugs minimum dataset in the contract. 6. Where a clinician considers a patient is exceptional the JCVI policy an IFR application should be made in the usual way. 7. Where queries arise regarding the policy for commissioning of Palivizumab refer Trusts the Green Book Chapter 27a for further information Further Information The CRG Accountable Commissioner can be contacted for further information: Julia.grace@nhs.net Page 4 of 5

5 James D Palmer National Clinical Direcr Specialised Services Cathy Edwards Operational Delivery Direcr Specialised Page 5 of 5