Published 30 June 2020 SP Paper 774 6th Report, 2020 (Session 5) Health and Sport Committee Comataidh Slàinte is Spòrs Supply and demand for medicines Published in Scotland by the Scottish Parliamentary Corporate Body. All documents are available on the Scottish For information on the Scottish Parliament contact Parliament website at: Public Information on: http://www.parliament.scot/abouttheparliament/ Telephone: 0131 348 5000 91279.aspx Textphone: 0800 092 7100 Email: [email protected] © Parliamentary copyright. Scottish Parliament Corporate Body The Scottish Parliament's copyright policy can be found on the website — www.parliament.scot Health and Sport Committee Supply and demand for medicines, 6th Report, 2020 (Session 5) Contents Executive Summary _____________________________________________________1 Introduction ____________________________________________________________4 Engagement___________________________________________________________4 Structure of the report ___________________________________________________5 Background ___________________________________________________________6 Research and development _______________________________________________8 Real-world experience and clinical trials _____________________________________8 Personalised medicine___________________________________________________9 Waste _____________________________________________________________10 Manufacturing technology _____________________________________________10 Preparedness for personalised medicine in the healthcare system ______________10 Research and Development - conclusions __________________________________ 11 Licensing and acceptance for use in the NHS _______________________________13 Licensing ____________________________________________________________13 Licensing for more than one indication____________________________________14 Adaptive licensing__________________________________________________16 Evidence in support of licence applications ________________________________17 Licensing - conclusions _______________________________________________18 Access to new medicines________________________________________________18 Scottish Medicines Consortium (SMC) assessments_________________________19 Speed of assessment compared with the rest of the UK ____________________21 Assessment of licensed medicines for cost effectiveness ___________________22 Changes since the Montgomery Review - review of assessment methods ______22 Changes since the Montgomery Review - Peer Approved Clinical System (PACS) Tier 2 _____________________________________________________24 Changes since the Montgomery Review - Patient and Clinician Engagement (PACE) __________________________________________________________26 Changes since the Montgomery Review - Clinical and cost effectiveness of new medicines ____________________________________________________27 Changes since the Montgomery Review - access to end-of-life, orphan and ultra-orphan medicines ______________________________________________27 Changes since the Montgomery Review - interim acceptance________________29 Value____________________________________________________________30 Scottish Medicine Consortium horizon scanning __________________________31 SMC assessment processes - conclusions ______________________________32 Health and Sport Committee Supply and demand for medicines, 6th Report, 2020 (Session 5) Patient Access Schemes ______________________________________________33 Interaction with the pharmaceutical industry _______________________________35 Access to new medicines - conclusions ___________________________________36 Scrutiny of non-medicine interventions _____________________________________36 Purchase and Procurement ______________________________________________38 A. Achieving best value in procurement_____________________________________39 B. International pricing markets ___________________________________________39 C. Wholesale Supply Chains _____________________________________________40 Shortages__________________________________________________________41 D. Pricing - Branded Medicines ___________________________________________42 Voluntary Pricing and Access Scheme (VPAS) _____________________________42 Efficacy of the Voluntary Pricing and Access Scheme (VPAS)________________43 Transparency in pricing around the UK _________________________________43 Rebate to Scotland and the New Medicines Fund _________________________45 Voluntary Pricing and Access Scheme - conclusions _______________________46 Pricing based on other considerations ____________________________________46 Value and outcome based pricing______________________________________46 Multi-indication pricing ______________________________________________52 Pricing based on other considerations - conclusions _______________________52 E. Pricing - generic medicine _____________________________________________52 Cost of generics - price increases _______________________________________53 Cost of generics - UK Government price setting powers ______________________54 F. Purchasing in Secondary Care _________________________________________55 G. Purchasing in primary care ____________________________________________57 Community Pharmacy Procurement _____________________________________57 Efficiency of Community Pharmacy Procurement _________________________58 Staff ____________________________________________________________61 Community pharmacy procurement versus central procurement ______________62 The Scottish Drugs Tariff ____________________________________________63 Financial Risk _____________________________________________________64 Over the counter medicines __________________________________________65 Purchasing and procurement - conclusions__________________________________65 Prescribing____________________________________________________________67 Freedom of the prescriber _______________________________________________68 Factors which may influence prescribing __________________________________68 Health and Sport Committee Supply and demand for medicines, 6th Report, 2020 (Session 5) A. The Quality and Outcomes Framework and the General Medical Services Contract (GMS Contract) ____________________________________________68 B. Formulary ______________________________________________________69 C. Clinical Guidelines _______________________________________________76 Freedom of the prescriber - conclusions __________________________________76 Prescribing in primary care ______________________________________________77 Reviews of prescriptions ______________________________________________79 Comprehensive reviews of prescriptions are not routinely taking place _________79 Patients' Views ____________________________________________________84 Other forms of support as part of reviews________________________________85 Digitisation of reviews of medicines ____________________________________85 Reviews of prescriptions - conclusions__________________________________85 Repeat prescribing ___________________________________________________86 Medicines Care Review Service _______________________________________86 Pharmacotherapy and repeat prescriptions ______________________________87 Delivery of repeat prescriptions _______________________________________87 Prescribing in secondary care ____________________________________________88 Delaying discharge___________________________________________________88 Collection of prescribing data in secondary care ____________________________89 Hospital Electronic Prescribing and Administration System (HEPMA) __________90 Non-pharmaceutical interventions _________________________________________99 Assessment and governance of non-medicine prescribing ___________________100 Medicines are not the only or even the most cost or clinically effective way forward 101 Communication with the public_________________________________________103 GP knowledge _____________________________________________________103 Non-pharmaceutical interventions - conclusions ___________________________103 Social prescribing ____________________________________________________104 Culture change needed ______________________________________________104 Evidence on the benefits and outcomes of social prescribing _________________105 An instinct to prescribe medicines ______________________________________106 A pill for every ill - patient expectation ___________________________________106 New General Medical Services (GMS) Contract and support from other health professionals ______________________________________________________107 Longer Appointment Times ___________________________________________109 Awareness of referral pathways and activities to prescribe ___________________ 110 Inequality _________________________________________________________ 114 Health and Sport Committee Supply and demand for medicines, 6th Report, 2020 (Session 5) Inquiry into Social Prescribing _________________________________________ 115 Social Prescribing - conclusions________________________________________ 117 Realistic Medicine ____________________________________________________ 118 Prescribing generics and biosimilars ______________________________________121 Generic medicine ___________________________________________________121 Biosimilars ________________________________________________________121 Benefits of prescribing generic medicines and biosimilars____________________122 Governance of generic and biosimilar prescribing __________________________122 Prescription charges __________________________________________________123