Individual Funding Requests Walsall CCG Annual Report 1 April March 2015

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1 Individual Funding Requests Walsall CCG Annual Report 1 April March 2015 Page 1 of 13

2 IFR Summary for Walsall CCG Annual Report 1 April March Overview Individual Funding Requests (IFRs) are requests to fund drugs, treatments, procedures and interventions that fall outside of the current commissioning contracts, where there is no Commissioning Policy, or when a patient does not meet the criteria within an agreed Commissioning Policy. In 2013, Walsall Clinical Commissioning Group (CCG) adopted the Collaborative Commissioning Policy - Individual Funding Requests (IFRs) March 2013 developed by Central Midlands Commissioning Support Unit, now Midlands and Lancashire Commissioning Support Unit (M&LCSU) with effect from 1 April This policy provides a national and legal framework to process IFRs for patients across 7 CCG s including Birmingham, Solihull and the Black Country and is supported by 10 generic policies. In addition to the IFR and generic policies, 2 NHS Black Country Cluster (BCC) Commissioning Policies had been implemented and approved in 2012 and were robustly applied via Walsall CCG:- Procedures of Limited Clinical Priority (PLCP) Guideline & Commissioning Policy Aesthetic Procedures Guideline & Commissioning Policy Walsall CCG also has commissioning policies for: Assisted Conception revised and implemented from 1 June 2014 Provision of NHS funded Gamete Retrieval and Cryopreservation implemented August 2014 Intralace Hair System for Abnormal Hair Loss implemented August Summary of Total Number of Requests Received for 2014/15 As previously outlined, Individual Funding Requests (IFRs) are requests to fund drugs, treatments, procedures and interventions that fall outside of the current commissioning contracts, where there is no Commissioning Policy, or when a patient does not meet the criteria within an agreed Commissioning Policy. However, the term IFR can cause some confusion, for clarity; IFR is an umbrella term which is used for: Individual Funding Requests (IFR s) NICE Requests (which are criteria based ) Criteria Based (assessed against specified Commissioning Policies) Out-of-Area Patient Transport (not currently commissioned by Walsall CCG) Prior Approvals (not currently commissioned by Walsall CCG) Every request has the potential to be a true IFR and meet the definition of clinical exceptionality. MLCSU receives a variety of requests, often because GP s and/or Provider Trusts are not sure who to approach for funding. These can include any treatment /intervention that falls outside Walsall CCG contracts, some of which may be commissioned by NHS England. The request may be for a standard NHS treatment with a HRG code, however, Walsall does not have a contract in place with that specific provider and therefore the request is forwarded to the IFR Team. MLCSU processes every request following the IFR route, thus reducing the risk of legal challenge. Page 2 of 13

3 During the period of 1 April 2014 to 31 March 2015, M&LCSU processed 125 applications on behalf of Walsall CCG: Request Received Approved Declined Pending Grand Total Criteria Based IFR TOTAL At the time this report was produced there remain 4 cases pending for Walsall CCG. The total cost of the approved requests for this period is approximately 473,333 (see Appendices 1.1, 1.2, 2, 3, 4, 5, 6 and 7). There were 3 requests received with no costs provided, however, the requests were for NHS providers and therefore the costs were indicated to be PBR Tariff. As of the 31 March 2015, there were 4 pended cases as compared to 7 for 2013/14. Additional information has been requested for these cases to enable a fully informed decision to be made. Should this information not be received, the cases will be closed in line with the policy. If the information is received, this will be reviewed to determine whether a patient meets the criteria for funding, or if exceptionality has been demonstrated. A breakdown of the treatments requested for all cases is outlined in Appendix 1.1 and a further breakdown is outlined in Appendix 1.2. A breakdown of the treatment requested for drug treatment cases is outlined in Appendix 2. There were 51 such cases and this represents 41% of the total number of cases received. Non-Drug Treatment requests accounted for 74 out of 125, this represents 59% of the total number of cases (see Appendix 3). Appendix 4 demonstrates the top 4 providers of cases that have been approved either by the IFR Screening Panel or Full IFR Panel. Appendix 5 indicates the top 4 providers for total treatment costs. Appendix 6 provides a breakdown of all approved cases that have been processed by M&LCSU, indicating the provider, the type of request, treatment requests and the cost of treatment. On 3 occasions the costs were not provided however they were highlighted as PBR Tariff. Appendix 7 provides a breakdown of costs for IFR and criteria based applications that were approved. Page 3 of 13

4 3. Comparison Data During the last financial year for the period of 1 April 2013 to 31 March 2014, M&LCSU processed 165 applications on behalf of Walsall CCG: Request Received Approved Closed Declined Grand Total Criteria Based IFR NICE TOTAL The total cost of the approved requests for this period was approximately 319,396. During the period of 1 April 2014 to 31 March 2015, M&LCSU processed 125 applications on behalf of Walsall CCG: Request Received Approved Declined Pending Grand Total Criteria Based* IFR TOTAL The total cost of the approved requests for this period is approximately 473,333. *Criteria Based requests include treatments for NICE drugs. 3.1 Comparison of Activity Data Overall, the total number of cases processed via the IFR Team has decreased from 165 to 125 (24%) for 2014/15. There has also been a reduction in the number of cases approved from 75 to 60 (20%). However, approximately 48% of the cases received in 2014/15 were approved compared to 45% in 2013/14. Criteria Based In comparison to the total number of criteria based requests (including treatments for NICE drugs) received for 2013/14 to 2014/15 there has been a slight reduction from 87 to 86. IFR In comparison to the total number of requests submitted as IFR s for 2013/14 to 2014/15, we can see that there has been a reduction from 78 to 39 (50%) received. Each request received is processed in line with the IFR Policy. Requests received arrive in many different formats, clinical letters, reports, faxes, letters, IFR proformas and on a variety of template forms from provider Trusts. Once a request is received, we review each request and follow the IFR process, many are screened/declined at an early stage. This means of those remaining, we would expect them to go through the whole IFR process, but this is often not the case. As more information becomes available relating to the case, many will not reach a full IFR Panel. In 2014/15, of the 39 requests received, they were screened and concluded, however no cases were formally recorded as IFR s as they did not meet the IFR criterion as outlined within the policy. One example of this was for a request for Gastric Pacing, the request followed the IFR process, however the patient was not deemed to be clinically exceptional and therefore the request was declined. However, the CCG reviewed the request and took the view that it was a reasonable and cost effective request and funding for treatment was approved as this would reduce future hospital admissions for the patient. Therefore, the case was approved, not as an IFR but the decision made by Walsall CCG. See Section 9 of this report: Reasons for Refusal of Treatment. Page 4 of 13

5 It was noted that in 2013/14 a number of procedures transferred to specialised services at NHS England, including Bariatric Surgery, Gender Dysphoria, Ear Surgery and Pre-Genetic Disorder (PGD) and many more. As Primary and Secondary Care providers have become familiar with the responsible commissioners of these services, fewer formal requests are received by M&LCSU. However, M&LCSU have noted more general telephone enquiries occurring prior to GP s submitting requests. In some cases, having followed the IFR process, treatment requests are not deemed to be IFR s as there is no evidence of clinical exceptionality, however, the request is clinical/cost effective. Therefore, having taken into account all information provided, Walsall CCG have agreed to fund these treatments and have recorded these with a complete audit trail via M&LCSU. An example of this includes rehabilitation following head injury and Gastric Pacing. Assisted Conception In comparison, from the total number of Assisted Conception requests received in 2014/15 compared to 2013/14, we can see that there has been a slight reduction from 15 to 10 (33%). Walsall CCG offers a prior approval scheme for Assisted Conception and those received by the M&LCSU are often requests for a second cycle in line with NICE Guidance. Following a West Midlands wide procurement exercise, the main provider of Infertility Treatment for Walsall CCG patients is now Birmingham Women s Hospital NHS Foundation Trust. Service Developments Walsall CCG has identified Zenker Diverticulum as a service development and the provider has been duly notified, this was also noted in 2013/14. Other CCG s are of the same view. Requests Breakdown The top 2 requests were for the Drug: Aflibercept and Infertility/Assisted Conception Treatment as compared to Laser Treatment and Infertility Treatment in 2013/14. Laser Treatment is not routinely commissioned (since Feb 2012) and is outlined in the Black Country Cluster Aesthetics Policy. As this policy continues to be embedded, Walsall CCG will continue to see a reduction in these types of requests. Assisted Conception as indicated above is often for a second cycle of treatment. Requests for Aflibercept are mainly submitted by Royal Wolverhampton NHS Trust, this treatment is recommended by NICE and is criteria based. However, at present this treatment is not included within the Contract and therefore individual requests for treatment are submitted for consideration of the responsible CCG. Requests for Rehabilitation for head injury were submitted to the IFR Team and following discussions with NHS England it was established that this area remains the responsibility of the CCG s. One request in 2014/15 was estimated to cost in excess of 123,000, therefore is listed as the most expensive treatment within this report and identifies a service gap for Walsall CCG patients. Open/Upright MRI Scan requests have increased since last year. The reason for the increase was due to the service being decommissioned by Heart of England NHS Foundation Trust (HEFT) and GP s/trusts being notified that the service was not available. Therefore, requests were submitted to the IFR Team (for all CCG s). In quarter 4, this has been resolved as the service has been re-commissioned by HEFT with a new MRI scanner. It was noted that there were no requests for Orthotics, Standing Frames and Orthopaedic footwear compared to 2013/14, as they were identified as contractual matters and not IFR s. Page 5 of 13

6 4. Prior Approval Scheme Walsall CCG continued to operate a Prior Approval scheme during 2014/15. These requests are assessed against pre-determined clinical criteria. Secondary care providers are required to seek CCG approval prior to treatment taking place, this includes all treatments that fall within the following criteria based commissioning policies; Aesthetics, Assisted Conception and Procedures of Limited Clinical Priority (PLCP). Prior Approval is also required for: Botulinum Toxin Type A for Urinary Incontinence and Neurogenic Overactive Bladder (2012/13) Botulinum Toxin Type A Spasticity (May 2011) Chronic Fatigue Syndrome (CFS) Myalgie Encephalomyetitis (ME) (August 2011) Application for drugs which are assessed against NICE Technical Appraisal Guidance (TAGs) are reviewed by Medicines Management and recorded by M&LCSU. These requests are included within the data. NICE TAGs are routinely included within the Host Provider Contract with Walsall Manor Hospital NHS Trust and only reviewed by Medicines Management where the Provider Trust does not have a contract / prior approval process in place e.g. Royal Wolverhampton Hospital NHS Foundation Trust (RWHT) and Dudley Group of Hospitals NHS Foundation Trust (DGH). 5. IFR Screening Panel The IFR Screening Panels are scheduled fortnightly and membership for the processing of IFR s comprises of an IFR Manager (M&LCSU), a Public Health Consultant (Local Authority) and a Senior Pharmacist or GP (CCG). Minimum quoracy for decision making is Senior Pharmacist or GP and IFR Manager. Walsall CCG opted for an additional IFR Screening Panel member to include a Commissioner of Planned Care. 6. IFR Panel The IFR Panel is scheduled monthly and panel membership consists of a member of the CCG as the Accountable Officer for the decision made by the panel. The panel includes a Consultant in Public Health (Local Authority), Head of IFR s (M&LCSU) and an IFR Manager, who presents the case. There should be at least one Medicines Management representative and one GP at each IFR Panel. The remit of the IFR Panel is to consider that IFR cases have been screened and where clinical exceptionality is highlighted, the clinical evidence and cost effectiveness is discussed to enable the CCG member to reach a decision in any particular case. 7. IFR Appeals Panel Should an appeal be received, the role of the IFR Appeal Panel is to consider appeals against decisions taken by the CCG, ensuring decisions have been taken in accordance with the policies and processes of the CCG and M&LCSU. The Appeal Panel can uphold the decision made by Walsall CCG or may refer the case back to IFR Panel for reconsideration with recommendations. The IFR Appeal Panel membership consists of a Lay Member/Chair of Walsall CCG, a Board Member GP from the CCG and the Director of Public Health (Local Authority). There were no formal appeals received for Walsall CCG during the period contained in this report, however many challenges/complaints are made to requests that have been declined. Each request is reviewed on an individual case basis and if required the case is re-considered via the Prior Approval or IFR Process. Page 6 of 13

7 8. Reasons for Approval of Treatment Approvals for treatment are supported when a patient meets the clinical criteria outlined in a specific commissioning policy or the patient is deemed to be clinically exceptional, an example of this may be a patient who requires a tonsillectomy (Procedure of Low Clinical Priority). Providing they meet the criteria, NHS funding is approved by the CCG. Alternatively, if a patient does not meet the specified criteria, or there is no criterion/commissioning policy in place to assess against, clinicians may submit an IFR application to demonstrate clinical exceptionality. Several IFRs were submitted in the period 2014/15. However, none were approved on the grounds of clinical exceptionality. 9. Reasons for Refusal of Treatment There are a variety of reasons why funding for treatment is not supported by the CCG, these include: Patient does not meet the clinical criteria Patient is not deemed to be clinically exceptional Incomplete/poor application submitted from Clinician Additional supporting information requested but not received Lack of clinical evidence to support the request Identified as a Service Development, when it is recognised that a cohort of patients may benefit from the treatment Requests for treatment are commissioned by NHS England and therefore would be re-directed An example of this is when a request is submitted for a second cycle of IVF following an unsuccessful NHS funded cycle. Unfortunately, the couple would not meet the criteria as they have already received funding for one cycle of treatment, therefore, funding for a second cycle of infertility treatment would be declined. 10. Inappropriate Referrals We process a number of inappropriate requests as GP s can, at times, find it challenging to explain to patients why they do not meet a certain criterion, or instances where it is known that NHS funding would not be supported (i.e. Laser Treatment for Hirsuitism/Assisted Conception Treatment). It is recognised that GP s wish to maintain a good relationship with their patients. However, each inappropriate request (i.e. when a patient clearly does not meet the criteria) results in additional cost in many ways including referrals, out-patient appointments, administration and clinical time and may result in a poor patient experience. Once it reaches the M&LCSU, each request will follow due process as outlined in the IFR Policy. As a direct consequence of a funding refusal, this may also lead to the CCG or M&LCSU receiving complaints, MP letters, FOI requests, challenges or appeals. M&LCSU have provided information in relation to 5 FOI requests during this financial year. Whilst we acknowledge, there may be occasions when funding initially has been refused, subsequently, a change in clinical circumstances may result in the patient meeting the criteria and funding for treatment is approved via the IFR process. Page 7 of 13

8 11. IFR Training During , 1 member of Walsall CCG and 2 Trainees from Walsall Local Authority (Public Health) attended IFR Training including legal advice on the processing of IFR applications. As outlined in the Collaborative Commissioning Policy for Individual Funding Requests, an Authorised Officer must undergo mandatory training organised by M&LCSU. This training covers both the legal and ethical framework for IFR decision making, the CCG s commissioning processes and structures, the technical aspects of interpretation of clinical evidence and research and guidance in respect of the policies relevant to their decision making. IFR Training is regularly refreshed to ensure that the Authorised Officer maintains the appropriate skills and expertise to function effectively. 12. Finance All requests are recorded by M&LCSU and applications that are Approved are relayed in quarterly reports to Walsall CCG Finance Team. 13. Patient Transport M&LCSU does not provide this service for Walsall CCG. 14. Future Reporting M&LCSU are working with Walsall CCG to develop this IFR Annual Report to include a wider range of reporting summaries and commentaries. Report produced by: Individual Funding Requests (IFR) Team Midlands and Lancashire Commissioning Support Unit Kingston House High Street West Bromwich West Midlands B70 9LD Page 8 of 13

9 Aflibercept Infertility Treatment Cryopreservation Laser Treatment MRI Scan / Open MRI / Upright MRI Rehabilitation Rituximab Referral for Assessment Adalimumab Ocriplasmin Tocilizumab Botulinum Toxin Infliximab Methotrexate Abatacept Abdominoplasty/Apronectomy Breast Augmentation Nerve Stimulation Outpatient Appointment Toric Lens Implant Azathioprine Capsule Endoscopy Certolizumab Pegol Chemotherapy Etanercept Excision Exogen Machine Gastric Pacing Golimumab Haemorrhoidectomy Insulin Pump Intralace Hair System Knee Replacement Labiaplasty Lanreotide Levamisole Liposuction Omalizumab (Xolair) Pain Management Penile prosthesis Physiotherapy Removal of Breast Implants Reversal of Sterilisation Soundbite Hearing Aid Specialist Referral Symmetrikit System Teriparatide Vedolizumab Zenker Diverticulum Number of Cases Appendix 1.1 Breakdown of treatments requested for all cases Summary Treatments Requested for all Cases Received (125 cases) Aflibercept 12 (10%) Infertility Treatment 10 (8%) Other 79 (63%) Cryopreservation 8 (7%) Laser Treatment 8 (6%) MRI Scan / Open MRI / Upright MRI 8 (6%) Appendix Breakdown of treatments requested for all cases - Detail 14 Full Breakdown of Treatments Requested for all Cases Received (125 cases) Pending Declined Approved Treatment Requested Page 9 of 13

10 Number of Cases Number of Cases Appendix 2 - Breakdown of Drug Treatment Requests 14 Breakdown of Drug Treatment Requests Received (51 out of 125 cases) Pending Declined Approved 0 Type of Drug Request Appendix 3 - Breakdown of Non Drug Treatment requests 12 Breakdown of Non Drug Treatment Requests Received (74 out of 125 cases) Pending Declined Approved Type of Non Drug Request Page 10 of 13

11 Total Treatment Costs Number of Approved Cases Appendix 4 - Top 4 Providers for Approved Cases 30 Top 4 Providers for Approved Cases The Royal Wolverhampton NHS Foundation Trust Heart of England NHS Foundation Trust Provider Midland Fertility Services Walsall Health Care NHS Trust Appendix 5 - Top 4 Providers for Total Costs (relating to approvals) 180,000 Top 4 Providers for Total Treatment Costs Relating to Approved Cases 160, , , , , ,000 80,000 81,528 60,000 52,500 40,000 20,000 0 Walsall Health Care NHS Trust The Royal Wolverhampton NHS Foundation Trust Provider Heart of England NHS Foundation Trust Staffordshire and Stoke on Trent Partnership Trust Page 11 of 13

12 Appendix 6 - Breakdown for Approved Cases relating to IFR and Criteria Based Applications (2014/15) Treatment Provider Request Type Procedure/Treatment requested Cost of treatment Number of Cases Birmingham Children's Hospital NHS Foundation Trust Criteria Based Levamisole IFR Soundbite Hearing Aid 8,000 1 Birmingham Children's Hospital NHS Foundation Trust Total 8,203 2 Birmingham Upright MRI Centre Criteria Based MRI Scan / Open MRI / Upright MRI IFR MRI Scan / Open MRI / Upright MRI Birmingham Upright MRI Centre Total 1,500 2 Dudley Group of Hospitals NHS Trust Criteria Based Golimumab 9,295 1 Dudley Group of Hospitals NHS Trust Total 9,295 1 Heart of England NHS Foundation Trust Criteria Based Abatacept 8,805 1 Adalimumab 3, , ,545 1 Infliximab 3, ,584 each 2 Penile prosthesis 2,374 1 Rituximab 4,191 each 3 Teriparatide 3,544 1 IFR Rituximab 3,450 1 Heart of England NHS Foundation Trust Total 81, John Radcliff Hospital NHS Trust IFR Nerve Stimulation Tariff 2 John Radcliff Hospital NHS Trust Total Tariff 2 Midland Fertility Services Criteria Based Cryopreservation each 2 Infertility Treatment , ,120 1 Midland Fertility Services Total 6,610 6 National Hospital for Neurology and Neurosurgery IFR Specialist Referral Tariff 1 National Hospital for Neurology and Neurosurgery Total Tariff 1 NeuroMuscular Centre Midlands IFR Physiotherapy 90 1 NeuroMuscular Centre Midlands Total 90 1 Royal Free Hospital, London Criteria Based Aflibercept 5,681 1 Royal Free Hospital, London Total 5,681 1 St Giles Hospice Criteria Based Referral for Assessment St Giles Hospice Total Staffordshire and Stoke on Trent Partnership Trust IFR Rehabilitation 52,500 1 Staffordshire and Stoke on Trent Partnership Trust Total 52,500 1 The Royal Wolverhampton NHS Foundation Trust Criteria Based Abatacept 6,095 1 Adalimumab 9,295 1 Aflibercept 6,048 each 9 12,096 each 2 Certolizumab Pegol 9,295 1 Etanercept 9,295 1 Methotrexate MRI Scan / Open MRI / Upright MRI Ocriplasmin 2,895 each 3 Tocilizumab 3,473 each 2 10,000 1 The Royal Wolverhampton NHS Foundation Trust Total 140, University Hospitals Birmingham IFR MRI Scan / Open MRI / Upright MRI 1,025 1 Rehabilitation 10,000 1 University Hospitals Birmingham Total 11,025 2 Walsall Health Care NHS Trust Criteria Based Rehabilitation 31,920 1 IFR MRI Scan / Open MRI / Upright MRI Rehabilitation 123,816 1 Walsall Health Care NHS Trust Total 156,536 3 Grand Total 473, Page 12 of 13

13 Total Treatment Costs Appendix 7 - Breakdown of Costs for Approved Cases for IFR and Criteria Based Cases 300, ,852 Costs for Approved Cases 250, , , , ,000 50,000 0 Criteria Based Type of Request IFR Page 13 of 13

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