Manx Care considerations of provision of PrEP at GUM clinic

Summary

The requester asked for an update on the review of PrEP provision policy in the Isle of Man following the conclusion of English and Welsh studies. Manx Care disclosed the original 2018 policy document stating that PrEP is not currently funded due to uncertainties regarding demand, cost, and real-world implementation, with a review pending the results of the IMPACT and PrEPared studies.

Key Facts

• Manx Care decided not to fund PrEP at the present time due to uncertainties about demand, cost, and impact.
• The policy states that funding decisions will be reviewed once results from the IMPACT and PrEPared in Wales studies are available.
• Truvada was granted European marketing authorisation for HIV prophylaxis in 2016.
• NICE concluded Truvada reduced the relative risk of acquiring HIV by between 44% and 86% in trial settings.
• The Department noted it was not possible to model potential demand or resulting costs of PrEP in the Isle of Man.

Data Disclosed

• 2018
• 2016
• 2017
• 44%
• 86%
• 13
• 68
• 10,000
• three years
• 3 January 2018
• October 2017
• July 2017
• April 2017

Original Request

Resubmitted from the Not Held response from FOI 2336477 by DHSC. RE: https://www.gov.im/media/1368207/dhsc-10-0118-pre-exposure-prophylaxisprep.pdf Further to the above information made available by DHSC in 2018; please can you disclose what review has been made to the policy of PrEP provision to at-risk groups of the Manx community, which was suggested in the policy write-up. If none has been made, please can you disclose what factors have resulted in the policy not being reviewed and further can you please advise of the department's process for instigating said review now that the English IMPACT and Welsh PrEPared studies have concluded, with and both determining provision of the drug to be all round beneficial to the health services; resulting in PrEP being made available in England and Wales following decisions made in Scotland and countries in Europe."

Data Tables (1)

Full Response Text

DEPARTMENT OF HEALTH AND SOCIAL CARE (DHSC) DHSC 10 3 January 2018 DHSC CLINICAL COMMISSIONING POLICY Pre-Exposure Prophylaxis (PrEP) for the prevention of human immunodeficiency virus (HIV) infection Anti-retroviral drugs for the prevention of HIV infection will NOT be routinely funded. This policy will be reviewed when the results of the IMPACT and PrEPared in Wales studies are available. Truvada (a combination of two anti-retroviral therapies: emtricitabine and tenofovir) was granted a European marketing authorisation for use in HIV prophylaxis (in combination with safer sex practices) in 2016. It is approved for use across all EU member states.1 The National Institute of Health and Care Excellence has appraised the evidence of effectiveness and safety of PrEP (but has not issued funding guidance for the NHS in England). NICE concluded that based on results from four randomised controlled trials, Truvada reduced the relative risk of acquiring HIV infection by between 44% and 86% compared with placebo or no prophylaxis, which is equivalent to approximate numbers needed to treat of between 13 and 68 per year. These results were obtained in the trial setting and NICE identified areas of uncertainty around uptake, adherence, drug resistance and cost effectiveness in ‘real world’ practice.2 In England, an implementation trial of PrEP on the NHS has been agreed in order to address some of the remaining uncertainties and started in October 2017. This will provide PrEP to around 10,000 people over a period of three years – the largest study as yet undertaken in the world (the Impact trial).3 In Wales, the All Wales Medicines Strategy Group declined funding for PrEP on grounds of inadequate evidence for cost effectiveness. However, from July 2017, the Welsh Government has made PrEP available on the NHS for a three year study similar to that agreed in England but which in Wales is known as the PrEPared in Wales study.4 Based on existing evidence, Scotland agreed in April 2017 to make PrEP available on the NHS for prophylactic use in people at high risk of sexually acquired HIV infection in line with specified criteria.5 1http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-Assessment_Report-Variation/human/000594/WC500226363. pdf http://www.aidsactioneurope.org/en/news/european-commission-approves-prep 2https://www.nice.org.uk/advice/esnm78/chapter/Key-points-from-the-evidence 3https://www.england.nhs.uk/2017/08/nhs-england-announces-worlds-largest-single-prep-implementation-trial-to-prevent-hiv-infec- tion/; https://clinicaltrials.gov/ct2/show/NCT03253757 4http://www.awmsg.org/awmsgonline/app/appraisalinfo/1625; http://www.friskywales.org/wales-prep-project.html 5For full details see Scottish Medicines Consortium Guidance available on line at: https://www.scottishmedicines.org.uk/files/advice/ emtricitabine_tenofovir_disoproxil_Truvada_FINAL_March_2017_for_website.pdf ; see also: https://prep.scot/ DHSC CLINICAL COMMISSIONING POLICY PrEP is not currently available on the NHS in Northern Ireland, although it is under review by the Department of Health.6 PrEP is not currently available in Ireland.7 Although the evidence around the clinical effectiveness of PrEP in a controlled trial setting is strong, advice from Public Health England has highlighted significant outstanding implementation questions that should be answered prior to using PrEP in a sustained way on a substantial scale in England. The key questions addressed by the trial are: • What proportion of those attending sexual health clinics will be at high risk and eligible for PrEP? • What proportion of those offered PrEP will accept it? What is the length of PrEP use in those who accept the offer? • What is the impact on HIV incidence in the population? • What is the impact on STI incidence in the population? The Department has appraised the available evidence and concluded that NICE and PHE have identified significant gaps in knowledge in regard to implementation of PrEP in the ‘real world’.
The Department noted that it was not possible to model the potential demand or resulting costs of PrEP in the Isle of Man. In view of the uncertainties about demand, cost and impact, the Department has decided not to fund PrEP at the present time. This decision will be reviewed when the results of IMPACT and PrEPared in Wales are available providing robust evidence of impact and enabling modelling of local demand and costs based on the trial findings. Summary of evidence Details of the marketing authorisation for Truvada can be found here:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR-Assessment_Report- Variation/human/000594/WC500226363.pdf http://www.aidsactioneurope.org/en/news/european-commission-approves-prep The NICE appraisal can be found here: https://www.nice.org.uk/advice/esnm78/chapter/Key-points-from-the-evidence Details of the Impact trial can be found here: https://www.england.nhs.uk/2017/08/nhs-england-announces-worlds-largest-single- prep-implementation-trial-to-prevent-hiv-infection/; https://clinicaltrials.gov/ct2/show/ NCT03253757 6http://www.belfasttelegraph.co.uk/news/northern-ireland/call-for-northern-ireland-to-get-hiv-prevention-drug-as-infection-rates- rise-36007895.html 7http://www.hivireland.ie/hiv/prevention/prep/; https://www.hpsc.ie/a-z/specificpopulations/menwhohavesexwithmenmsm/msminter- netsurvey2015/Ireland%20PrEP%20report%20v1.0_2017.pdf Department of Health and Social Care Crookall House, Demesne Road, Douglas, Isle of Man, IM1 3QA. DHSC10 V1 Jan 2018 Information on the PrEPared in Wales trial can be found here: http://www.awmsg.org/awmsgonline/app/appraisalinfo/1625; http://www.friskywales.org/wales-prep-project.html Details of the Scottish funding decision can be found here: https://www.scottishmedicines.org.uk/files/advice/emtricitabine_tenofovir_disoproxil Truvada_FINAL_March_2017_for_website.pdf, and https://prep.scot/ Details of the policy debate in Northern Ireland can be found here: http://www.belfasttelegraph.co.uk/news/northern-ireland/call-for-northern-ireland-to-get-hiv- prevention-drug-as-infection-rates-rise-36007895.html Details of the policy debate in Ireland can be found here: http://www.hivireland.ie/hiv/prevention/prep/; https://www.hpsc.ie/a-z/specificpopulations/ menwhohavesexwithmenmsm/msminternetsurvey2015/Ireland%20PrEP%20report%20 v1.0_2017.pdf Reason for requesting a policy recommendation: PrEP is a new clinical development for which a commissioning decision was required. The policy briefing for the Department was developed through the Health Protection Committee. Where a patient is considered to have exceptional need for and capacity to benefit from a treatment that is not routinely funded, a request for individual funding may be made to the Individual Funding Requests Panel. The patient must be made aware that the Panel may not support the request and must not be given any expectation that they will be able to have the treatment until a decision to fund has been received in writing from the Panel.
For further information contact: Tel:
+44 (0)1624 642646 Email:
clinicalcommissioning.dhsc@gov.im Website:
www.gov.im/dhscclinicalcommissioning

FOI 2429505 - PrEP at GUM Clinic
Freedom of Information Request:
“please can you disclose what review has been made to the policy of PrEP provision to at-risk groups of the Manx community, which was suggested in the policy write-up. If none has been made, please can you disclose what factors have resulted in the policy not being reviewed and further can you please advise of the department's process for instigating said review now that the English IMPACT and Welsh PrEPared studies have concluded, with and both determining provision of the drug to be all round beneficial to the health services; resulting in PrEP being made available in England and Wales following decisions made in Scotland and countries in Europe”

Our Response: Report prepared by Genito-Urinary Medicine (GUM) 19th May 2022

Date Actions/Summary Genito-Urinary Medicine raised the issue of supply of PrEP for IOM residents at a Health Protection Committee meeting. This committee, which GUM is a member of, is chaired by Public Health (PH) and reports to the Department of Health and Social Care (DHSC). The committee is responsible for highlighting It was agreed by the committee that the supply of PrEP should be escalated to the DHSC for approval and a paper was prepared by GUM/PH to present to the DHSC on 28th October 2017. This was subsequently delayed until December 2017 26 Oct 2017 HPC Meeting - GUM have agreed to support individuals who choose to purchase, at their own expense , PrEP medication by providing regular HIV testing and blood biochemistry monitoring as per British Association of Sexual GUM were fully supportive of supplying PrEP and the following correspondence was sent to Public Health (PH) from GUM : ‘Dr (Consultant) is currently a Principle Investigator on 2 sites taking part in the PrEP study. He is therefore familiar with the process and formalities. As PrEP is going to be widely available through the IMPACT trial in the UK, the at risk IOM patients will be at a disadvantage if something similar to the UK is not available in the IOM as well. In order to deliver equitable services locally this We, in the GUM Dept. would be happy to run a similar protocol as the IMPACT trial in the UK if we are supported to do so.’ 01 Dec 2017 A paper was prepared and presented by PH to the DHSC. There was information around the IMPACT trial included in the report, with recommendations that the IOM consider funding the supply of this medication. Email from Public Health to GUM with the outcome from the request to the DHSC to supply PrEP in the IOM. The policy adopted by the DHSC would be : “In view of the uncertainties about demand, cost and impact, the Department has decided not to fund PrEP at the present time. This decision will be reviewed when the results of IMPACT and PrEPared in Wales are available providing robust evidence of impact and enabling modelling of local demand and costs 27 Jul 2017 14 Nov 2017 09 Jan 2018 3rd Party Information Redacted 3rd Party Information Redacted

Manx Care Noble’s Hospital, Strang Braddan, Isle of Man IM4 4R (01624) 650 000

Our ref: 2429505 31 May 2022

Dear ###

We write further to your request which was received on 4th May 2022 which states:

"Resubmitted from the Not Held response from FOI 2336477 by DHSC. RE: https://www.gov.im/media/1368207/dhsc-10-0118-pre-exposure-prophylaxisprep.pdf Further to the above information made available by DHSC in 2018; please can you disclose what review has been made to the policy of PrEP provision to at-risk groups of the Manx community, which was suggested in the policy write-up. If none has been made, please can you disclose what factors have resulted in the policy not being reviewed and further can you please advise of the department's process for instigating said review now that the English IMPACT and Welsh PrEPared studies have concluded, with and both determining provision of the drug to be all round beneficial to the health services; resulting in PrEP being made available in England and Wales following decisions made in Scotland and countries in Europe.""

Our response Please see attached “FOI 2429505 - PrEP at GUM clinic.pdf” for our response We also attach “dhsc-10-0118-pre-exposure-prophylaxisprep.pdf” to which you refer in your request. Please quote the reference number 2429505 in any future communications.

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