Date 18/02/13 Our Ref I write in response to your request for information in relation to NHS Lothian s Formulary

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Lothian NHS Board Waverley Gate 2-4 Waterloo Place Edinburgh EH1 3EG Telephone 0131 536 9000 Fax 0131 536 9088 www.nhslothian.scot.nhs.uk Date 18/02/13 Our Ref 3560 Enquiries to Richard Mutch Extension 35687 Direct Line 0131 465 5687 Email richard.mutch@nhslothian.scot.nhs.uk Dear FREEDOM OF INFORMATION FORMULARY INFORMATION I write in response to your request for information in relation to NHS Lothian s I have been provided with information to help answer your request by Ms Jane Pearson, Pharmacist NHS Lothian. Question:- Please can you provide formulary information for the following products? Answer:- Questions Approximate date of when the product was reviewed What evidence was used to help make the decision? What were the reasons for accepting/rejecting the product? aripiprazole (Abilify ) Abilify Tablets (aripiprazole) aripiprazole (Abilify ) 5mg tablets aripiprazole 5mg, 10mg, 15mg, 30mg tablets; 10mg, 15mg orodispersible tablets; 1mg/ml oral solution (Abilify ) aripiprazole 5, 10, 15, 30mg oral tablets, 10, 15mg orodisperible tablets and 1mg/1ml oral solution(abilify ) August 2004 July 2005 June 2009 August 2010. 95/04 for specific and FAF1 Advice. 95/04 committee minutes 25th August 2004 - There are potential benefits to patients, for instance there may be less clinically significant weight. 187/05 for the specific Advice. 187/05. 498/08 for the specific Advice.. 498/08 not recommended for use in NHS Scotland, recommended for use in NHS Lothian.. 630/10 for the specific Advice. 630/10 Headquarters Waverley Gate, 2-4 Waterloo Place, Edinburgh EH1 3EG Chair Dr Charles J Winstanley Chief Executive Tim Davison Lothian NHS Board is the common name of Lothian Health Board

1st line Y/N gain in short-term use. Higher dosage than that for which FAF1 had been submitted would probably be used most regularly. Whilst there seemed to be fewer side effects associated with this drug, more may emerge if patients were more usually on the higher dosage. It was therefore suggested that an SCP should not immediately be developed for this drug, but that it should only be prescribed by specialists for a period of one year, after which guidance could be reviewed. 2nd line Y/N named patient Y/N specific types? If yes, which? Rationale positioning patient for Additional List, for Use only prescribing New strength of tablet already classified as Additional List. Additional List, for Use only. prescribing initially t recommended by SMC, only available through Individual Patient Treatment t recommended by SMC, only available through Individual Patient Treatment t recommended for use in NHS Scotland, As per SMC Advice - children 15 years and older. Added to the Additional List, for Use only for use in children 15 years & older. prescribing initially

initially developed. w the SCP has been Withdrawn and this can be prescribed by GPs where appropriate without a SCP. developed. w the SCP has been Withdrawn and this can be prescribed by GPs where appropriate without a SCP. recommended for use in NHS Lothian developed. w the SCP has been withdrawn and this can be prescribed by GPs where appropriate without a SCP. Questions Approximate date of when the product was reviewed? What evidence was used to help make the decision? What were the reasons for accepting/rejecting the product? Risperdal Consta (Risperidone) Risperidone prolonged release injection (Risperdal Consta ) March 2003. 22/02 for the specific Advice. 22/02 and Committee minutes 12th March 2003 extract below. The above drug was proposed as a treatment option for patients requiring an atypical antipsychotic and for whom depot injection was the preferred rate of administration. Members noted that the drug would be restricted to secondary care for the first year, at the end of which a shared care protocol might be considered. It was agreed that the prescribing note would Xeplion (Paliperidone) Paliperidone Palmitate 50mg, 75mg, 100mg and 150mg prolonged release suspension for injection (Xeplion ) August 2011 and then January 2012. 713/11 for the specific. August 2011 - SMC Advice. 713/11 January 2012 - SMC Advice. 713/11 and FAF1 August 2011 - As stated in SMC Advice. 713/11 t recommended at this time for use in NHS Scotland, recommended for use in NHS Lothian. January 2012 - Advice. 713/11 and committee minutes from 25th January 2012 www.ljf.scot.nhs.uk/formular ycommittee/fcminutes/pag es/default.aspx (ZypAdhera)(Olanzapin e Depot) Olanzapine 210mg, 300mg, 405mg powder and solvent for prolonged release suspension for injection (ZypAdhera) August 2010. 624/10 for the specific Advice. 624/10 this is not recommended for use in NHS Scotland, therefore is not recommended for use in NHS Lothian

1st line Y/N 2nd line Y/N contain a statement that this drug was for specialist prescribing only, not primary care. It was also agreed that costs would be monitored. It was agreed that the atypical antipsychotic risperidone long acting injection was approved for use in Lothian. January 2012 Y http://www.ljf.scot.nhs.uk/lot hianjointformularies/adult/4.0/4.2/4.2.1/(d)/pages/default.aspx named patient Y/N Specific patient types? If yes, which? Rationale for positioning Additional List. Use only. Decision overruled in Jan 12 see Entry for paliperidone. N/A As an alternative to risperidone LAI in new patients. Dosing schedule has potential advantages, as it is given monthly (up to 7 days before or after the date treatment is due) rather than fortnightly, and there is no requirement for initial oral antipsychotic supplementation. In addition, it doesn t require reconstitution and it can be stored at room temperature rather than in the fridge and may lead to reduced wastage associated with loss of a cold chain. t recommended by SMC, only available through Individual Patient Treatment t recommended by SMC, only available through Individual Patient Treatment t recommended for use in NHS Scotland, therefore is not recommended for use in NHS Lothian SMC = Scottish Medicines Consortium (full advice can be seen at www.scottishmedicines.org.uk) FAF1 = Application Form 1

Question:- Could we also request a copy of your schizophrenia treatment protocol/guidelines? Answer:- I have enclosed the copy of the NHS Lothian Prescribing Guidelines for Antipsychotic Drug Treatment of Schizophrenia and Prescribing Guidelines for Risperdal Consta Long-acting Injection with this response. I hope this information helps with your request. If you are unhappy with our response to your request, you do have the right to request us to review it. Your request should be made within 40 working days of receipt of this letter, and we will reply within 20 working days of receipt. If our decision is unchanged following a review and you remain dissatisfied with this, you then have the right to make a formal complaint to the Scottish Information Commissioner. If you require a review of our decision to be carried out, please write to the FOI Reviewer at the address at the head of this letter. The review will be undertaken by a Reviewer who was not involved in the original decision-making process. FOI responses (subject to redaction of personal information) may appear on NHS Lothian s Freedom of Information website at :- http://www.nhslothian.scot.nhs.uk/yourrights/foi/pages/default.aspx Yours sincerely Alan Boyter Director of Human Resources and Organisational Development Cc: Chief Executive