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PharmacoEconomics

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Open Access 01-05-2018 | Original Research Article

New Medicines in Wales: The All Wales Medicines Strategy Group (AWMSG) Appraisal Process and Outcomes

Authors: Alice Varnava, Robert Bracchi, Karen Samuels, Dyfrig A. Hughes, Philip A. Routledge

Published in: PharmacoEconomics | Issue 5/2018

Abstract

Background

The All Wales Medicines Strategy Group (AWMSG) develops prescribing advice and is responsible for appraising new medicines for use in Wales. In this article, we examine the medicines appraisal process in Wales, its timeliness and its impact on medicines availability in Wales, and compare its processes and recommendations with the two other UK health technology appraisal bodies [the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC)].

Methods

We reviewed the medicines appraisals conducted by AWMSG between October 2010 and September 2015. The duration of the process and the recommendations made by AWMSG were compared with those of NICE and SMC. Only publicly available data were considered in this review.

Results

AWMSG conducted 171 single technology appraisals for 137 medicines during the study period (34 were for medicines previously appraised by AWMSG but these were for new indications). Of these, 152 appraisals were supported for use in NHS Wales (33 with restrictions) and 19 were not supported. Recommendations broadly concurred with SMC and NICE for the majority of appraisals. Compared with NICE recommendations, the median time advantage gained in Wales for those medicines that received a positive AWMSG recommendation and which were subsequently superseded by NICE advice was 10.6 months (range 3.5–48.3 months; n = 17).

Conclusion

This review highlights the work carried out by AWMSG over a 5-year period, and provides evidence to support the effectiveness of the appraisal process in terms of patients in Wales gaining earlier access to medicines and efficiency through reduced duplication with NICE.

Welsh Government. Health statistics Wales 2016. http://gov.wales/docs/statistics/2017/170131-health-statistics-wales-2016-summary-en.pdf. Accessed Mar 2017.

Stats Wales. Economic output—gross value added (GVA) and GVA per head (HI) 2015. 2016. https://statswales.gov.wales/Catalogue/Sustainable-Development/Sustainable-Development-Indicators/gva-by-measure-welsheconomicregion-year. Accessed Mar 2017.

Welsh Government. Prescriptions dispensed in the community 2015. 2015. http://gov.wales/docs/statistics/2016/160518-prescriptions-dispensed-community-2015-en.pdf. Accessed Mar 2017.

Roberts A, Charlesworth A. A decade of austerity in Wales? The funding pressures facing the NHS in Wales to 2025/26. 2014. https://www.nuffieldtrust.org.uk/research/a-decade-of-austerity-in-wales-the-funding-pressures-facing-the-nhs-in-wales-to-2025-26. Accessed Mar 2017.

All Wales Medicines Strategy Group. About AWMSG. http://www.awmsg.org/awmsg_about_us.html. Accessed Oct 2017.

Welsh Medicines Resource Centre. The medicines appraisal process in Wales. 2010. https://www.wemerec.org/Documents/Bulletins/DrugAppraisal2010Online.pdf. Accessed Sep 2017.

All Wales Therapeutics and Toxicology Centre. Individual Patient Funding Request (IPFR). https://www.awttc.org/pams/individual-patient-funding-request-ipfr-0. Accessed Oct 2017.

All Wales Therapeutics and Toxicology Centre. One Wales Interim Commissioning Process. https://www.awttc.org/pams/one-wales-interim-commissioning-process. Accessed Oct 2017.

All Wales Medicines Strategy Group. Launch of New Treatment Fund announcement. 2017. http://www.awmsg.org/docs/awmsg/appraisaldocs/inforandforms/Launch%20of%20New%20Treatment%20Fund%20January%202017.pdf. Accessed Apr 2017.

10.

Scottish Medicines Consortium. Abbreviated submission form and guidance notes. 2017. https://www.scottishmedicines.org.uk/Submission_Process/Submission_guidance_and_forms/Templates-Guidance-for-Submission. Accessed Apr 2017.

11.

House of Commons Health Select Committee. Written evidence from the Ethical Medicines Industry Group (NICE 23). 2012. https://www.publications.parliament.uk/pa/cm201213/cmselect/cmhealth/782/782vw21.htm. Accessed Mar 2017.

12.

National Institute for Health and Care Excellence. Topic selection. 2017. https://www.nice.org.uk/about/what-we-do/our-programmes/topic-selection#ta-selection. Accessed Oct 2017.

13.

National Institute for Health and Care Excellence. Prioritisation criteria for Technology Appraisal topics. 2017. https://www.nice.org.uk/Media/Default/About/what-we-do/our-programmes/TA-topic-selection-prioritisation-criteria.pdf. Accessed Oct 2017.

14.

All Wales Therapeutics and Toxicology Centre. Adapted version of “Appraisal process and timeline - full and limited submissions”—summary of the appraisal process in Wales by AWMSG. 2016. http://www.awmsg.org/docs/awmsg/appraisaldocs/inforandforms/AWMSG%20appraisal%20process%20flow%20diagram%20&%20timeline.pdf. Accessed Sept 2017.

15.

National Institute for Health and Care Excellence. NICE accreditation decisions. All Wales Medicines Strategy Group. 2016. https://www.nice.org.uk/About/What-we-do/Accreditation/Accreditation-decisions. Accessed Oct 2017.

16.

All Wales Medicines Strategy Group. Patients and public engagement strategy. http://www.awmsg.org/patient_strategy.html. Accessed Oct 2017.

17.

All Wales Medicines Strategy Group. Appraisal process. Submission: clinical expert opinion. http://www.awmsg.org/healthcare_submission.html. Accessed Oct 2017.

18.

All Wales Medicines Strategy Group. Independent review (IR) process. 2015. http://www.awmsg.org/docs/awmsg/appraisaldocs/inforandforms/AWMSG%20independent%20review%20process.pdf. Accessed Sept 2017.

19.

All Wales Medicines Strategy Group. Appraisal process. Horizon scanning. http://www.awmsg.org/industry_horizon_scanning.html. Accessed Oct 2017.

20.

All Wales Medicines Strategy Group. Summary guidelines for appraising medicines. http://www.awmsg.org/awmsgonline/industry_alldocs.html. Accessed Mar 2017.

21.

National Institute for Health and Care Excellence. Guide to the methods of technology appraisal 2013. Process and methods (PMG9). 2013. https://www.nice.org.uk/process/pmg9/chapter/foreword. Accessed Sep 2016.

22.

Scottish Medicines Consortium. Working with SMC—a guide for manufacturers. 2017. http://www.scottishmedicines.org/Submission_Process/Submission_guidance_and_forms/Templates-Guidance-for-Submission/Templates-Guidance-for-Submission. Accessed Apr 2017.

23.

Rawlins M. De testimonio: on the evidence for decisions about the use of therapeutic interventions. Lancet. 2008;372(9656):2152–61. https://doi.org/10.1016/S0140-6736(08)61930-3.CrossRefPubMed

24.

All Wales Medicines Strategy Group. AWMSG policy on appraising life-extending, end-of-life medicines. 2016. http://www.awmsg.org/docs/awmsg/appraisaldocs/inforandforms/AWMSG%20policy%20on%20appraising%20life-extending,%20end%20of%20life%20medicines.pdf. Accessed Oct 2017.

25.

All Wales Medicines Strategy Group. Final Appraisal Recommendation. Abiraterone (Zytiga^®). Advice no. 0612. 2012. http://www.awmsg.org/awmsgonline/app/appraisalinfo/3. Accessed Sept 2017.

26.

Scottish Medicines Consortium. Guidance for manufacturers: supplement for medicines for end of life and very rare conditions. 2017. https://www.scottishmedicines.org.uk/Submission_Process/Submission_guidance_and_forms/Templates-Guidance-for-Submission. Accessed Apr 2017.

27.

All Wales Medicines Strategy Group. Process for appraising orphan and ultra-orphan medicines and medicines developed specifically for rare diseases. 2015. http://www.awmsg.org/awmsgonline/docs/awmsg/appraisaldocs/inforandforms/AWMSG%20Orphan%20and%20Ultra%20Orphan%20process.pdf. Accessed Sept 2017.

28.

Phillips CJ, Hughes DA. HTAs and rare diseases: how to assess their cost-effectiveness. Pharm Policy Law. 2011;13(3.4):161–5. https://doi.org/10.3233/PPL-2011-0321.CrossRef

29.

Hughes DA. Rationing of drugs for rare diseases. Pharmacoeconomics. 2006;24(4):315–6. https://doi.org/10.2165/00019053-200624040-00001.CrossRefPubMed

30.

National Institute for Health and Care Excellence. NICE highly specialised technologies guidance. 2017. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-highly-specialised-technologies-guidance. Accessed May 2017.

31.

Scottish Medicines Consortium. Economic question and answer document. 2017. https://www.scottishmedicines.org.uk/Submission_Process/Submission_guidance_and_forms/Templates-Guidance-for-Submission. Accessed Apr 2017.

32.

All Wales Medicines Strategy Group. Appraisals reports. http://www.awmsg.org/app/report?execution=e1s1. Accessed Oct 2017.

33.

National Institute for Health and Care Excellence. Guidance and advice list. https://www.nice.org.uk/guidance/published?type=ta. Accessed Sept 2017.

34.

Scottish Medicines Consortium. SMC advice. https://www.scottishmedicines.org.uk/SMC_Advice/Advice_Directory/SMC_Advice_Directory. Accessed Sept 2017.

35.

All Wales Medicines Strategy Group. Tacrolimus (Advagraf^®). Reference number: 820. Appraisal information. 2011. http://www.awmsg.org/awmsgonline/app/appraisalinfo/820. Accessed Sept 2017.

36.

All Wales Medicines Strategy Group. Ferumoxytol (Rienso^®). Reference number: 145. Appraisal information. 2013. http://www.awmsg.org/awmsgonline/app/appraisalinfo/145. Accessed Sept 2017.

37.

All Wales Medicines Strategy Group. Colestilan (BindReno^®). Reference number: 1592. Appraisal information. 2014. http://www.awmsg.org/awmsgonline/app/appraisalinfo/1592. Accessed Sept 2017.

38.

All Wales Medicines Strategy Group. Final Appraisal Recommendation. Fampridine (Fampyra^®). Advice no. 2714. 2014. http://www.awmsg.org/awmsgonline/app/appraisalinfo/349. Accessed Jun 2017.

39.

All Wales Medicines Strategy Group. Pazopanib (Votrient^®). Reference number: 549. Appraisal information. 2013. http://www.awmsg.org/awmsgonline/app/appraisalinfo/549. Accessed Oct 2017.

40.

National Institute for Health and Care Excellence. NICE technology appraisal guidance: summary of decisions. 2017. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/summary-of-decisions. Accessed Jun 2017.

41.

Fischer KE, Heisser T, Stargardt T. Health benefit assessment of pharmaceuticals: an international comparison of decisions from Germany, England, Scotland and Australia. Health Policy. 2016;120(10):1115–22. https://doi.org/10.1016/j.healthpol.2016.08.001.CrossRefPubMed

42.

Ford JA, Waugh N, Sharma P, Sculpher M, Walker A. NICE guidance: a comparative study of the introduction of the single technology appraisal process and comparison with guidance from Scottish Medicines Consortium. BMJ Open. 2012;2(1):e000671. https://doi.org/10.1136/bmjopen-2011-000671.CrossRefPubMedPubMedCentral

43.

Barham L. Single technology appraisals by NICE: are they delivering faster guidance to the NHS? Pharmacoeconomics. 2008;26(12):1037–43. https://doi.org/10.2165/0019053-200826120-00006.CrossRefPubMed

44.

Casson SG, Ruiz FJ, Miners A. How long has NICE taken to produce technology appraisal guidance? A retrospective study to estimate predictors of time to guidance. BMJ Open. 2013;3:e001870. https://doi.org/10.1136/bmjopen-2012-001870.CrossRefPubMedPubMedCentral

45.

Kaltenthaler E, Papaioannou D, Boland A, Dickson R. The National Institute for health and clinical excellence single technology appraisal process: lessons from the first 4 years. Value Health. 2011;14(8):1158–65. https://doi.org/10.1016/j.jval.2011.06.007.CrossRefPubMed

46.

Bennie M, Dear J, Hems S, Black C, McIver L, Webb DJ. An investigation into the effect of advice from the Scottish Medicines Consortium on the use of medicines in Scotland’s Health Service. Br J Clin Pharmacol. 2011;71(2):283–8. https://doi.org/10.1111/j.1365-2125.2010.03826.x.CrossRefPubMedPubMedCentral

47.

McCullagh L, Barry M. The pharmacoeconomic evaluation process in Ireland. Pharmacoeconomics. 2016;34(12):1267–76. https://doi.org/10.1007/s40273-016-0437-5.CrossRefPubMed

48.

Zamora B, Maignen F, O’Neill P, Mestre-Ferrandiz J, Garau M. Comparing access to orphan medicinal products (OMPs) in the United Kingdom and other European countries. 2017. https://www.ohe.org/publications/comparing-access-orphan-medicinal-products-omps-united-kingdom-and-other-european. Accessed June 2017.

49.

Routledge PA, Williams A, Samuels K, Spears R, Hughes DA. Health technology appraisal and access to medicines; experience of the All Wales Medicines Strategy Group, 2002–2014. From the 283P Queen Elizabeth II Conference Centre London, Pharmacology; 2015: Proceedings of the British Pharmacological Society. http://www.pa2online.org/abstract/abstract.jsp?abid=32942&author=Routledge&cat=-1&period=-1. Accessed Sept 2017.

50.

Linley WG, Hughes DA. Reimbursement decisions of the All Wales Medicines Strategy Group: influence of policy and clinical and economic factors. Pharmacoeconomics. 2012;30(9):779–94. https://doi.org/10.2165/11591530-000000000-00000.CrossRefPubMed

51.

Linley WG, Hughes DA. Decision-makers’ preferences for approving new medicines in Wales: a discrete-choice experiment with assessment of external validity. Pharmacoeconomics. 2013;31(4):345–55. https://doi.org/10.1007/s40273-013-0030-0.CrossRefPubMed

52.

Welsh Government. Written statement—access to new medicines: availability of ivacaftor (Kalydeco) within NHS Wales for the treatment of cystic fibrosis. 2013. http://gov.wales/about/cabinet/cabinetstatements/previous-administration/2013/kalydeco/?lang=en. Accessed May 2017.

53.

National Institute for Health and Care Excellence. Our processes. Fast track appraisal (FTA). https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/process. Accessed Oct 2017.

54.

National Institute for Health and Care Excellence. Budget impact test. https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/budget-impact-test. Accessed Oct 2017.

55.

Hughes DA. Value-based pricing: incentive for innovation or zero net benefit? Pharmacoeconomics. 2011;29(9):731–5. https://doi.org/10.2165/11592570-000000000-00000.CrossRefPubMed

56.

Karlsberg Schaffer S, Sussex J, Hughes DA, Devlin N. Opportunity costs and local health service spending decisions: a qualitative study from Wales. BMC Health Serv Res. 2016;16:103. https://doi.org/10.1186/s12913-016-1354-1.CrossRefPubMedPubMedCentral

57.

Sculpher M, Claxton K, Pearson SD. Developing a value framework: the need to reflect the opportunity costs of funding decisions. Value Health. 2017;20(2):234–9. https://doi.org/10.1016/j.jval.2016.11.021.CrossRefPubMed

Title: New Medicines in Wales: The All Wales Medicines Strategy Group (AWMSG) Appraisal Process and Outcomes
Authors: Alice Varnava
Robert Bracchi
Karen Samuels
Dyfrig A. Hughes
Philip A. Routledge
Publication date: 01-05-2018
Publisher: Springer International Publishing
Published in: PharmacoEconomics / Issue 5/2018
Print ISSN: 1170-7690
Electronic ISSN: 1179-2027
DOI: https://doi.org/10.1007/s40273-018-0632-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

New Medicines in Wales: The All Wales Medicines Strategy Group (AWMSG) Appraisal Process and Outcomes

Abstract

Background

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

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