Patient Access Schemes from a procurement and operational perspective

1. Patient Access Schemes from a procurement and operational perspective Kirsteen Docherty Pharmacy Procurement Services Mgr UCLH Trust

2. Patient Access Schemes • The good news! • Increased opportunity for patients to receive expensive new medicines. • Increased access to medicines and enhanced sales for Pharma • Reduced cost for purchasers e.g. PCT’s & commissioners • Adherence to principles of NICE Qaly of £30K p.a. • Schemes do not interfere with NHS/PPRS price of product • Opportunity to obtain useful post marketing outcome data • Development of NHS and Industry partnerships • Outcome schemes focus towards “value for money” e.g. only pay for what works. • BUT the problem is the implementation of PAS!

3. Types of PAS • Principle: NHS List price does not change • Financially Based Schemes (FBS) – Not Risk Sharing • Discounts given via free stock for initial treatment, volume based rebates of free stock, credit/ cash or cheque. • No clinical management/results needed. • Outcome-Based Schemes (OBS) – Risk sharing • Discount based upon achievement of defined clinical result. If performance is good then no/limited discounts. Post marketing data available. • Could be time limited if success rate established.

4. Examples of PAS

5. Examples of PAS

6. Patient Access Scheme Research • Aim; • To research the operational management of PAS within Hospital Trusts • Method; • Questionnaire circulated to Hospital Trusts in the UK Jan 2010 • Researched; • Pharmacy Systems used • Responsibility for PAS within Trusts • Operational management of different PAS schemes • Information management • Trust preferences

7. Pharmacy systems used

8. Responsibility for managing the administration of PAS

9. Types of schemes available in operational terms • Free stock schemes • (a) Agreed volume at initial part of treatment • (b) Agreed volume delivered at the same time as paid stock • (c) Agreed volume at end of period or when outcome achieved. • Credit given retrospectively (e.g for non-responding patients) • Cash or cheque given retrospectively • PriceNot strictly defined as Patient Access Schemes (change in price) but some Pharma companies have given price discounts as part of an Access Scheme.

10. How Trusts manage free stock for initial treatment

11. Management of free stock for initial treatment • Advantages • If system allows set up of FOC (zero value) item then audit trail available, costs and free stock transparent and only costs incurred for paid stock will go through financial systems and on to PCT • Average price need not be affected • Disadvantages • If pharmacy system cannot manage free stock then audit trail can be difficult • Problems knowing when to dispense FOC or paid stock • If received with paid for stock then affects average price so real cost not transparent causing financial flow difficulties • Admin required to claim initial free stock • Initial training of staff in pharmacy clinical/ procurement/ dispensary required

12. How Trusts manage free stock delivered at the same time as paid stock

13. Management of free stock delivered at same time as paid stock • Advantages • If all stock booked in at same time then overall discount achieved. Means product can be managed as if it had a price discount so real costs easily captured • If system allows set up of FOC item then audit trail available and only costs incurred for paid stock will go through financial systems and on to PCT • Disadvantages • Prices need set carefully initially • Need to book in all stock at same time • Must invoice all stock at same time • Requires intervention in pharmacy procurement (and dispensary if set up FOC item)

14. How trusts manage free stock delivered retrospectively

15. Management of free stock delivered retrospectively • Advantages • None! • Disadvantages • Difficult to manage if patient specific as patient has already had treatment • Stock control systems cannot manage this effectively • Rebate may be patient specific but free stock may go to another patient. Hence difficult to manage effectively costs and rebates to correct budgets/ PCTs for individual patients. • Financial flows and total treatment costs not transparent • When to dispense FOC or paid stock • Receiving as if paid for stock will affect average price so treatment costs not transparent and all budgets/ PCTS get reduced cost • Resource intensive across departments to manage (procurement/ dispensary/clinical/finance/contracts/PCT)

16. How Trusts manage credit given retrospectively

17. Management of credit given retrospectively • Advantages • Can be coded directly to relevant budget and PCT • Can track credit through financial systems if not pharmacy systems • Need not affect average price • Disadvantages • Audit trail on pharmacy system difficult • Matching credit to specific patient difficult in existing systems hence easiest option may be to credit pharmacy budget instead of clinical or PCT • Manual management probably necessary • Financial flows and total treatment costs not transparent • If used against a later invoice then affects average price • Resource intensive across departments to manage (procurement/ dispensary/clinical/finance/contracts/PCT)

18. How Trusts manage cash or cheque given retrospectively

19. Management of cash or cheque given retrospectively • Advantages • Can be coded directly to the relevant budget and PCT • Can track through financial systems • Does not affect average prices • Disadvantages • No audit trail on pharmacy system • Matching cheque to specific patient difficult in existing systems hence easiest option may be to credit pharmacy budget instead of clinical or PCT • Manual management probably necessary • Financial flows and total treatment costs not transparent • Resource intensive across departments to manage (procurement/ dispensary/clinical/finance/contracts/PCT)

20. Preferred PAS rebate method

21. Can pharmacy stock control systems track free stock, credit, cash or cheque systems at patient level data? • If No how managed? • 50% track patients manually on spreadsheet and finance rebates PCT • 21% provide no patient level detail and pass on no rebate to PCT • 14% finance manage rebates so unsure • 15% rebate passed on through average price of medicines

22. Trusts suggested changes to pharmacy stock systems to make processing of PAS easier • “Ability to differentiate between paid for and free stock and ability to track reimbursements • “Ability to allocate specific invoices to patients. To be able to flag returns in a billing report. Ability to add credits retrospectively to system and again be able to flag that in a billing report. Ability to assign a particular patient to a particular PCT.” • “Ability to highlight PAS drugs so that when dispensed it can be recognised and a record made.” • “Option to remove average pricing to handle free stock better.” • “Should not have to change anything. Schemes should fit within the capabilities of pharmacy systems” • “To be able to zero or return the cost but not the issue data for a patient without affecting overall drug cost.” • To be able to retrospectively amend orders/ receipts and enter a credit note against an invoice already passed and consequently reduce the value of stock that has been issued to a particular patient.

23. Would Trusts choose an option for the rebate to go directly to the PCT? • Yes • “Trust could inform PCT of patients due a rebate. PCT could manage it from there” • “If PCTs managed rebates administrative effort as a whole lowered” • No • “Management and assurance process impossible to manage” • “Difficult to ensure goes to correct PCT as audit trail not robust” • “PCTs would not like this method” • “ For schemes that require clinical outcome data the PCT would not have ready access to it”

24. What would you change to improve the way PAS are managed in your Trust?

25. Example of how a credit reimbursement scheme usingUCLH pharmacy system is managed • Medicine purchased and received into dispensary stock. Drug given to patient and issued to the relevant pharmacy directorate. • Medicine is PBR excluded and hence costs should be passed on directly to PCT and not bundled as part of whole treatment. The F2 report (patient level detail) is produced by a nominee in pharmacy to pick up these issues to help Finance Contracts correctly charge the PCT. • The directorate pharmacist identifies patient due a first cycle refund and fills out the Pharma company paperwork to claim the credit. Pharmacy procurement need to be contacted to provide the order number and delivery date.

26. Example of how a credit reimbursement scheme usingUCLH pharmacy system is managed • Credit is sent from Wholesaler to Pharmacy Procurement. Procurement Manager informs directorate pharmacist of arrival. • Directorate Pharmacist identifies issue on PIMS relevant to the patient and carries out a “return transaction” from the directorate to the pharmacy. This credits the directorate budget and results in an increase in stock in the pharmacy (although stock not physically there). • Pharmacy procurement are informed and carry out a “return to supplier” transaction to make zero the additional stock holding in pharmacy which does not exist physically. • The “return to supplier” creates a negative in the stock control account. Pharmacy procurement code the credit to the stock control account to offset the negative.

27. Example of how a credit reimbursement scheme usingUCLH pharmacy system is managed • Credit sent to Finance Payments division. Must be dealt with manually because the pharmacy system cannot deal with a credit that is not related to physical stock or invoice. • The “return” carried out in point 5 appear as negative figures on the F2 report. Contracts pick up these negative figures and know to credit the PCT responsible for that patient. • The value of the PCT refund is then charged back to the directorate budget to offset the credit in point 5, resulting in a net zero effect on the directorate budget (the directorate will already have been paid by the PCT for the medicine).

28. Summary • PAS are complex operationally to manage! • PAS can be resource intensive! • Requiring; • Planning and control efforts • Management and administration across multiple departments • Set up and training • Audit control systems • Communication between multiple internal & external stakeholders • Manipulation of systems • Additional clinical monitoring (if an outcome based scheme)

29. Recommendations • Review of PAS • Limit types of schemes available • Standardise and simplify schemes • Ensure resource available for PAS management e.g. dedicated co-ordinator • Consider developing an I.T. solution for Trusts • Standardise PAS management across Trusts • Simplify internal processes & communication flows • Develop written and agreed procedures • Audit financial flow processes