PROCUREMENT & DISTRIBUTION INTEREST GROUP Autumn Symposium 2007

1. PROCUREMENT & DISTRIBUTION INTEREST GROUPAutumn 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 • What are the key issues • 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. • 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 • Significant growth over last 10 years • Healthcare at Home (2006) • £347million sales • 75,000 patient visits • Nationally • over 100,000 patients • ~ value of £500 million for medicines • 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. • Compounding of a Medicinal Product • Supply and product monitoring • Administration • Collection of waste • Patient and Family education and support. • Data management and support

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

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.  • Pharmacy dispensing services provided by a registered pharmacist are exempt from VAT • 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.

9. NHS Policy and Structural Reform

10. Pharmacy Policy and Structural Reform

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

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

13. Medicines Homecare in the UK – The Services • 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

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

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

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

20. Maintain control Pharmacy led approach Tender when appropriate Understand the risks and manage them Ensure appropriate resources 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 Best Practice in setting up Homecare

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

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

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

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