1. PROCUREMENT & DISTRIBUTION INTEREST GROUP Autumn Symposium 2007 http://www.pdig.org.uk/

2. Medicines Homecare Andrew Alldred Director of Pharmacy and Medicines Management Harrogate District NHS Foundation Trust Chair Yorkshire and Humber NHS Pharmaceutical Purchasing Consortia PDIG November 2007 Symposia

3. Introduction - Brief When should we use homecare for medicines When should we use homecare for medicines What are the key issues What are the key issues How can the market be developed safely How can the market be developed safely

4. What is Homecare? Homecare is the provision of medical supplies and/or clinical services to patients in the community. Homecare is the provision of medical supplies and/or clinical services to patients in the community. Clinical homecare typically involves the provision of medication, medical supplies, nursing support and clinical waste collection to patients at home. Clinical homecare typically involves the provision of medication, medical supplies, nursing support and clinical waste collection to patients at home.

5. Medicines Homecare in the UK – Size of the Market ? Difficult to assess Difficult to assess Significant growth over last 10 years Significant growth over last 10 years Healthcare at Home (2006) Healthcare at Home (2006) –£347million sales –75,000 patient visits Nationally Nationally –over 100,000 patients –~ value of £500 million for medicines Yorkshire and Humber Yorkshire and Humber –Conservative estimate £40 - £50 million

6. What does Medicines Homecare involve? Aim to support patients with chronic and acute illnesses in the community. Aim to support patients with chronic and acute illnesses in the community. –Compounding of a Medicinal Product –Supply and product monitoring –Administration –Collection of waste –Patient and Family education and support. –Data management and support

7. What are the drivers for medicines homecare? Policy Policy –Treating patients closer to home Patients Patients –Choice –Convenience –Quality of Life Pharma Industry Pharma Industry –Novel distribution route –Clinical service provision NHS Constraints NHS Constraints –Capacity –Waiting times –Bed occupancy –Admission rates –LOS Financial Financial –Infrastructure –Product costs –(PbR)

8. VAT and Medicines Homecare Medicines dispensed to individuals for their personal use, dispensed by a registered pharmacist against a prescription issued by a registered doctor (or nurse for administration) in their own home (or residential home) are zero-rated. Medicines dispensed to individuals for their personal use, dispensed by a registered pharmacist against a prescription issued by a registered doctor (or nurse for administration) in their own home (or residential home) are zero-rated. Pharmacy dispensing services provided by a registered pharmacist are exempt from VAT Pharmacy dispensing services provided by a registered pharmacist are exempt from VAT Delivery services are subject to VAT at the standard rate Delivery services are subject to VAT at the standard rate Where two or more of the above elements form part of a composite supply, the predominant element will determine the VAT liability of the whole. Where two or more of the above elements form part of a composite supply, the predominant element will determine the VAT liability of the whole.

9. NHS Policy and Structural Reform

10. Pharmacy Policy and Structural Reform

11. Medicines Homecare in the UK – The Services Low Tech Low Tech –Dispensing and Delivery Renal replacement therapy Renal replacement therapy Enteral feeds Enteral feeds Anti Retrovirals Anti Retrovirals Transplant drugs Transplant drugs EPO EPO Isotretinoin Isotretinoin Anti TNF agents Anti TNF agents Oral anti cancer agents eg imatinib Oral anti cancer agents eg imatinib

12. Medicines Homecare in the UK – The Services High Tech High Tech –Compounding and Nurse Support TPN TPN IV antibiotics in CF IV antibiotics in CF Desferral Desferral Iloprost Iloprost IV and SC Immunoglobulins IV and SC Immunoglobulins Growth Hormone Growth Hormone Infertility drugs Infertility drugs Subcutaneous methotrexate Subcutaneous methotrexate

13. Medicines Homecare in the UK – The Services Future Developments Future Developments –Delivery of chemotherapy regimens –Delivery of biological therapies –IV antibiotics for cellulitis –Management of PE and DVT –Blood Transfusions –Clinical Trials

14. Medicines Homecare in the UK – The Providers

15. What are the benefits of Medicines Homecare OrganisationPatientPharmacy Primary care Discharge patients sooner Discharge patients sooner Reduce non- essential admissions Reduce non- essential admissions Reduce readmissions Reduce readmissions Single point of contact Single point of contact Capacity gains Capacity gains Reduced waiting times Reduced waiting times Financial Financial Patient centred Patient centred Closer to home Closer to home Choice Choice Time saving Time saving Reduced travel Reduced travel Convenience Convenience Quality of life Quality of life Less risk of HCAI Less risk of HCAI Capacity gains Capacity gains Refocus skill mix and clinical priorities Refocus skill mix and clinical priorities Reduced waiting times Reduced waiting times Patient focused care Patient focused care Time Time Capacity Capacity Efficiency Efficiency Control Control Patient centred Patient centred Financial Financial Policy Policy

16. The Procurement Framework and Contracting Models Host Trust Tender Host Trust Tender –Trust selects the service –Specification developed and tendered –Trusts selects a preferred provider Pharma Company Pharma Company –Pharma tender or selection –New distribution route –No NHS involvement

17. The Genzyme Case Genzyme vs. Healthcare at Home (2003) Genzyme vs. Healthcare at Home (2003) –OFT upheld HCAH complaint that Genzyme infringed UK Competition act –Complex case around bundling of drug price with the homecare services delivery and applying a margin squeeze on competing firms –Genzyme in a monopoly situation with Cerezyme (90% of Gauchers disease market) –Would only sell Cerezyme at the bundled price and adjudged to thus be anti competitive –More likely that companies will offer a drug at an unbundled product price

18. The Governance and Quality Issues - with outsourcing comes risk –Clinical and Technical Responsibilities and liabilities of each party Responsibilities and liabilities of each party Prescription validation Prescription validation Ongoing Monitoring Ongoing Monitoring Product Quality (especially unlicensed medicines including specials) Product Quality (especially unlicensed medicines including specials) Quality of advice Quality of advice Training of staff Training of staff Quality systems Quality systems Error monitoring Error monitoring Performance standards Performance standards Transport and delivery Transport and delivery –Financial Product and service costs Tendering Compliance with SFI’s and SO’s Invoice matching Order generation Data management and reporting

19. The Governance and Quality Issues - with outsourcing comes risk Robust Contracts Robust Contracts Provider Quality status Provider Quality status –MHRA licensed –RPS registered –NHS QA audits –ISO 9000 –Professional standards

20. Best Practice in setting up Homecare Maintain control Maintain control Pharmacy led approach Pharmacy led approach Tender when appropriate Tender when appropriate Understand the risks and manage them Understand the risks and manage them Ensure appropriate resources Ensure appropriate resources Define key processes under SLA / contract Define key processes under SLA / contract –service description –Training –Patient registration –Prescription process –Delivery of medicines –Communication chains –Performance standards –Procurement –Invoicing and payments –Audit –Liability / legal issues

21. Homecare – Example Process Patient reviewed by clinician Invoice and delivery note to pharmacy Invoice matched with delivery note Rx sent to Homecare provider Prescription prepared by Homecare provider Medicine / service delivered to patient Prescription written Prescription validated Patient registered / Consented Patient Choice Patient signs delivery note Order generated Passed for Payment

22. Other issues to be resolved / managed Transparency Transparency –Unbundling of costs –Cost of services and products Data Data –Quality –Provision Quality Quality –Services –Audit –Performance standards The workforce The workforce –Training –NHS “Drain” Control Control –Keep it!

23. Summary Medicines Homecare Medicines Homecare –Significant benefits to stakeholders –Significant risks –Issues to be resolved in the market Undertaken robustly will deliver effective and efficient patient care Undertaken robustly will deliver effective and efficient patient care

24. Useful resources National Clinical Homecare Association National Clinical Homecare Association –www.nchamedical.co.uk www.nchamedical.co.uk National Homecare Medicines Committee National Homecare Medicines Committee –Homecare medicines eLibrary/documents – http://www.pasa.nhs.uk