Patient and Public Reference Group for Medicines ADTC Sub-group NHS Tayside 17 th February 2015 Claire James, Senior Pharmacist Clinical Effectiveness, Ninewells Hospital
Aims To increase awareness and understanding of Scottish Medicines Consortium (SMC) processes To increase awareness and understanding of the Tayside Area Formulary and local formulary processes for new medicines
SMC remit Provide advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland on: Newly licensed medicines New formulations of existing medicines New indications for established products (licensed from Jan 2002) Excludes vaccines, branded generics, non-prescriptiononly medicines (POMs), blood products, plasma substitutes and diagnostic drugs. Only includes devicecontaining medicines if licensed as medicines by the MHRA.
SMC Composition Consortium of stakeholders from ADTCs across NHS Scotland. Multidisciplinary (34) Doctors (Consultants, GPs), pharmacists, health economists NHS executives/finance managers Pharmaceutical industry nominees (ABPI) (3) Public partners (3) PR, Scottish Government representatives
SMC Sub-committees New Drugs Committee (NDC) clinical/scientific (21) Doctors, pharmacists, nurse, health economists, academics, industry nominees (2) Including Pharmacy Assessment Team and Health Economics Team (observers and attend to present findings of critical appraisals) Patient and Public Involvement Group (PAPIG) (8) SMC members with roles in Public Involvement and Public Health, SMC Co-Vice Chairman, Public partners (3) SMC User Group Forum (SMC UGF) (18) Members of SMC and NDC and pharmaceutical industry nominees (12)
SMC Assessment process Submission of new product assessment form Scottish Medicines Consortium Clinical Assessors Assessment team Economic Assessors Assessment review Assessment & draft detailed advice document New Drugs Committee NDC detailed advice Scottish Medicines Consortium Patient interest group submission Applicant company Company comments to SMC Final SMC detailed advice document NHS Boards Area Drug & Therapeutic Committees 8 weeks 6 weeks: NDC last Tues/month; SMC 4 weeks Advice made public Applicant Company Competitor Company
SMC Assessment Outcomes Based on information provided by manufacturers ideally before the medicine is available for use: Need and clinical effectiveness (health benefits) including comparative efficacy Comparative cost-effectiveness (value for money) assessed using health economic evidence (e.g. Quality Adjusted Life Year (QALY) and cost-utility analysis) Comparative safety review but NOT safety assessment Other factors: needs of patients, views of doctors, number of people affected by condition, other treatments available for condition Production of a Detailed Advice Document (DAD). All advice and information on SMC processes is available on their website: www.scottishmedicines.org.uk
QALYs and cost per QALY Quantity and quality of life If taking a medicine were to allow someone to gain a year of life at 100% of normal quality, QALY would be 1 A year of less than perfect health has a QALY between 0 and 1 If quality of life will be 75% of a fully healthy person for 24 months of additional life that a new medicine can provide, the QALY for this new medicine would be 1.5 QALYs (2 years x 0.75 = 1.5) To help decide if a medicine provides value for money cost per QALY is used. This combines the QALY for a new medicine with the cost of a new medicine to give how many extra QALYs the new medicine gives and how much extra it costs compared with the current treatment E.g. medicine A QALY = 5, cost 20k, medicine B QALY = 8.4, cost 30k Medicine B cost per QALY = 2,941 ( 10k / 3.4 (additional QALYs)) QALYs provide the basis for discussion about individual medicines by SMC, the QALY alone does not determine the decision reached
SMC decisions SMC makes one of the following decisions about the use of a medicine within NHS Scotland: Accepted for use Accepted on the basis of a Patient Access Scheme (PAS) Accepted for restricted use e.g. restricted by patient group or restricted by prescriber Not recommended for use
What is the Tayside Area formulary (TAF)? Guides choice and awareness of a rational selection of medicines for adults included on the basis of clinical efficacy, safety, patient acceptability and cost effectiveness. Provides 1 st and 2 nd line treatment options for the majority of conditions seen in both primary and secondary care Includes more specialist medicines (ongoing development of specialist formulary lists)
Benefits of the TAF Quick guide to local choices Helps rationalise prescribing and procurement Improves cost-effective and safe prescribing Format mirrors the British National Formulary (BNF) Direct links to online BNF and manufacturers information (SPC) Links to local and national guidance Reinforces local implementation of SMC accepted medicines Approved by Tayside ADTC
Where to find TAF www.taysideformulary.scot.nhs.uk Download app for Apple (ios) or Android devices NHS Tayside website: http://www.nhstayside.scot.nhs.uk/ then click on Medicines from the Quick Links
Formulary Status Formulary 1 st choice 2 nd choice (3 rd choice etc.) Includes some medicines used out with their product licence [off-label] Restricted use Unlicensed Non-Formulary SMC not recommended
Traffic light status for medicines in Tayside Green May be initiated by primary or secondary care. Amber Can be prescribed in General Practice under the direction of a Specialist Red To be prescribed by Hospital Specialists Only Black SMC not recommended medicine
Local processing of SMC advice Groups involved (ADTC sub-groups): Medicines Advisory Group (MAG) Oncology & Haematology Medicines Management Group (OHMMG) Antimicrobial Management Group (AMG) Tayside Respiratory Managed Clinical Network (MCN) Formulary Sub-group
Local processing of SMC advice SMC advice received in confidence by Tayside Medicines Governance Unit, then: SMC Advice issued in confidence to local Lead clinicians Local lead clinicians asked to complete Local Introduction Form (LIF) MAG meets (monthly) and agrees local recommendation SMC advice In public domain Local recommendation confirmed with lead clinician SMC publish advice Local advice posted on web DTC Supplement Issued
Local recommendations for new medicines Formulary Specialist formulary list Formulary - protocol under development Non-formulary - due to one of the following reasons: Protocol under development Alternatives preferred Lack of clinician support Absence of clinician demand Non-formulary medicines can be accessed via the non-formulary process The Individual Patient Treatment Request (IPTR) process is available to clinicians to request NHS prescription for a licensed medicine (that is SMC not recommended) when a patient, for clinical reasons, is unable to be treated with other medicines which are accepted by SMC.
Any questions?