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Patient Access Scheme – Clinical Pharmacist View David Thomson, Lead Pharmacist, YCN Chair, BOPA Improving access to costeffective medicines Appraisals outcomes since Jan 09 Drug Title EoL applied? Access scheme ? Approved? Feb 10 Trabectidin Soft tissue sarcoma Yes Yes Yes Nov 09 Topotecan Lung cancer (small-cell) Yes No Yes Oct 09 Topotecan Cervical cancer (recurrent) No No Yes Sept 09 Sunitinib GIST Yes Yes Yes Sept 09 Pemetrexed Lung cancer (non-small cell, 1st line) No No Yes Aug 09 Cetuximab Colorectal cancer (1st line) No Yes Limited Jul 09 Rituximab Leukaemia (chronic lymphocytic, 1st line) No No Yes Jun 09 Cetuximab Head and neck cancer (squamous cell carcinoma No No No Jun 09 Lenalidomide Multiple myeloma Yes Yes Yes Mar 09 Suntinib Renal cell carcinoma Yes Yes Yes Appraisals outcomes since Jan 09 Drug Title EoL applied? Access scheme ? Approved? Feb 10 Trabectidin Soft tissue sarcoma Yes Yes Yes Nov 09 Topotecan Lung cancer (small-cell) Yes No Yes Oct 09 Topotecan Cervical cancer (recurrent) No No Yes Sept 09 Sunitinib GIST Yes Yes Yes Sept 09 Pemetrexed Lung cancer (non-small cell, 1st line) No No Yes Aug 09 Cetuximab Colorectal cancer (1st line) No Yes Limited Jul 09 Rituximab Leukaemia (chronic lymphocytic, 1st line) No No Yes Jun 09 Cetuximab Head and neck cancer (squamous cell carcinoma No No No Jun 09 Lenalidomide Multiple myeloma Yes Yes Yes Mar 09 Suntinib Renal cell carcinoma Yes Yes Yes In the beginning........ What is the evidence? CNPF Report - Research question? What has been the impact of implementing risk sharing schemes to improve access to cancer medicines in the NHS? 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. Study design Methods Initial Findings • 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 • 37/131 trusts responded – 28% • Covered 756 patients 3 180 295 Erlotinib (pre-NICE) for NSCLC Sunitinib for Renal Cell or GIST Bortezomib for Multiple Myeloma 278 Cetuximab for advanced Colorectal 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 Who is impacted by schemes? minutes to administer Reported time for scheme administration 50 45 40 35 30 25 20 15 10 5 0 Series1 Erlotinib (pre- Sunitinib for Bortezomib for Cetuximab for NICE) for Renal Cell or Multiple advanced NSCLC GIST Myeloma Colorectal How would you rate this type of scheme Consultants were initially very good at completing form. Enthusiasm wore off 70.0% after about 6 months. It isn't in anyone's job 60.0% description to chase the clinician to complete the form so it 50.0% 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 40.0% 30.0% 20.0% 10.0% 0.0% Very Good (preferred type of scheme) Suntinib Good (manageable) scheme. Average (causesUnworkable Bad (causes lots Very BadCannot (to be true cost peravoidedpatient as free problems but show of problems) nothing unworkable) stock supplied retrospectively. insurmountable)Also free stock is supplied in the form of a credit note against a previous invoice. Cannot separate out free stock from normal supplies. 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. Relies on good communication. Pharmacists are in clinic and have access to patient letters. If a patient hasn't responded, the refund is claimed 60.0% 50.0% There is a lack of continuity 40.0% in the clinic making it a challenge to identify 30.0% nonresponding patients as a result, the pharmacy20.0% team now remind the MDT at the start of cycle 4 of the10.0% need to assess response etc. 0.0% This is a step in the right direction Very Good but still potentially misses (preferred type patients who do not get as of scheme) far as 4 cycles treatment (for whatever reason) Bortezomib Requires huge investment of time to monitor patients and ensure refund timescales met. As with sunitinib issues How would you rate this type of scheme around assigning the rebate to patients and adjusting the drug budget/ expenditure reports is a nightmare 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 Good Average (causes Bad (causes lots Very Bad (to be started e.g. Velcade, you have (manageable)patient problems but the of treatment, problems) avoidedto keep track of the number of unworkable) cycles, if they have nothing stopped and does it entitled for VRS scheme. Then, insurmountable) asking for Serum M protein to be done, chasing up the consultant the claim form. It is a time wasting process. 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 Bortezomib – Pharmacy time Bortezomib – Refund findings Which options for ‘refund’ have been chosen for velcade 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% Replacement drug stock Credit note Cash refund to Trust Cash refund to PCT What is a good scheme? 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 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