1. BOPA Patient Access Scheme – Clinical Pharmacist View David Thomson, Lead Pharmacist, YCN Chair, BOPA

2. BOPA Improving access to cost- effective medicines

3. BOPA Appraisals outcomes since Jan 09 DrugTitleEoL applied? Access scheme ? Approved? Feb 10TrabectidinSoft tissue sarcomaYes Nov 09TopotecanLung cancer (small-cell)YesNoYes Oct 09TopotecanCervical cancer (recurrent)No Yes Sept 09SunitinibGISTYes Sept 09PemetrexedLung cancer (non-small cell, 1 st line) No Yes Aug 09CetuximabColorectal cancer (1 st line)NoYesLimited Jul 09RituximabLeukaemia (chronic lymphocytic, 1 st line) No Yes Jun 09CetuximabHead and neck cancer (squamous cell carcinoma No Jun 09LenalidomideMultiple myelomaYes Mar 09SuntinibRenal cell carcinomaYes

4. BOPA Appraisals outcomes since Jan 09 DrugTitleEoL applied? Access scheme ? Approved? Feb 10TrabectidinSoft tissue sarcomaYes Nov 09TopotecanLung cancer (small-cell)YesNoYes Oct 09TopotecanCervical cancer (recurrent)No Yes Sept 09SunitinibGISTYes Sept 09PemetrexedLung cancer (non-small cell, 1 st line) No Yes Aug 09CetuximabColorectal cancer (1 st line)NoYesLimited Jul 09RituximabLeukaemia (chronic lymphocytic, 1 st line) No Yes Jun 09CetuximabHead and neck cancer (squamous cell carcinoma No Jun 09LenalidomideMultiple myelomaYes Mar 09SuntinibRenal cell carcinomaYes

5. BOPA In the beginning........

6. BOPA What is the evidence?

7. BOPA CNPF Report - Research question? What has been the impact of implementing risk sharing schemes to improve access to cancer medicines in the NHS?

8. BOPA Aims and objectives To define reality – who is doing what? To obtain a general rating and estimate of administration time for 4 schemes. To assess the impact on pharmacy departments. To obtain comments and suggestions for improvement from scheme users.

9. BOPA Study design Methods Questionnaire using online tool Survey Monkey during summer 2009. Open to all BOPA membership More than one reply per trust allowed 4 schemes - Sunitinib, Bortezomib, Cetuximab, Erlotinib All schemes in operation at least 12 months between 2007 and 2009 Initial Findings 37/131 trusts responded – 28% Covered 756 patients

10. BOPA Limitations Low response rate People with issues are more likely to respond Not all respondents answered all the questions. Only views of Pharmacy Staff represented – not clinicians, finance, PCT views. From this talks perspective – views of pharmacy staff weren’t seperated into clinical, procurement etc

11. BOPA Who is impacted by schemes?

12. BOPA Reported time for scheme administration

13. BOPA Suntinib This scheme has the first cycle free and then a 5% discount on list price. The scheme required each patient to be registered with a form sent to manufacturers and free stock supplied for the first cycle. Consultants were initially very good at completing form. Enthusiasm wore off after about 6 months. It isn't in anyone's job description to chase the clinician to complete the form so it rarely gets done. Easy to apply. Free stock invoices easier to manage. Cost per drug evens out. OK provided all drug used by one speciality so see benefit of free stock Unworkable scheme. Cannot show true cost per patient as free stock supplied retrospectively. Also free stock is supplied in the form of a credit note against a previous invoice. Cannot separate out free stock from normal supplies.

14. BOPA Bortezomib Response measured by (serum M protein) after 4 cycles. If patient hasn’t responded a ‘refund’ can be claimed, but all claims must be made within 60 days. Refund can be cash, credit note, or stock replacement Requires huge investment of time to monitor patients and ensure refund timescales met. As with sunitinib issues around assigning the rebate to patients and adjusting the drug budget/ expenditure reports is a nightmare Relies on good communication. Pharmacists are in clinic and have access to patient letters. If a patient hasn't responded, the refund is claimed When the consultants want to initiate the treatment, we need to request them filling in the PBR (audit) form forward to PCT for approval. Then, we wait for confirmation from PCT to go ahead. When the patient started the treatment, e.g. Velcade, you have to keep track of the number of cycles, if they have stopped and does it entitled for VRS scheme. Then, asking for Serum M protein to be done, chasing up the consultant the claim form. It is a time wasting process. There is a lack of continuity in the clinic making it a challenge to identify nonresponding patients as a result, the pharmacy team now remind the MDT at the start of cycle 4 of the need to assess response etc. This is a step in the right direction but still potentially misses patients who do not get as far as 4 cycles treatment (for whatever reason)

15. BOPA Bortezomib – Pharmacy time

16. BOPA Bortezomib – Refund findings

17. BOPA What is a good scheme?

18. BOPA CNPF - Conclusions Pharmacy bears brunt of burden BUT –Rely on patient level data which isn’t collected as standard in the NHS –Retrospective rebates can conflict with NHS financial flows (which are different locally) Outcome based schemes take longer to administer, are preferred less BUT have less reported problems refunding payers. Schemes with upfront discount preferred BUT payers still not getting refunded (<50%) 73% of services can’t take any more schemes Dedicated post needed to administer schemes

19. BOPA Conclusions Is PASLU actually set up to solve the problem? Can anyone else? –NHS issues – can we be more consistent in terms of local requirements? –Commercial issues - Can Pharmaceutical companies work together? Are politicians willing to accept that there is a problem without headlines? These issues won’t go away and will impact on the success or failure of: –The proposed £200m drug fund –The delivery of value based pricing