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Single Technology Appraisal Patiromer for Treating Hyperkalaemia

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Single Technology Appraisal Patiromer for Treating Hyperkalaemia Single Technology Appraisal Patiromer for treating hyperkalaemia [ID877] Committee Papers © National Institute for Health and Care Excellence 2019. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE SINGLE TECHNOLOGY APPRAISAL Patiromer for treating hyperkalaemia [ID877] Contents: The following documents are made available to consultees and commentators: 1. Response to consultee, commentator and public comments on the Appraisal Consultation Document (ACD) 2. Comments on the Appraisal Consultation Document from the company 3. Consultee and commentator comments on the Appraisal Consultation Document from: a. Pumping Marvellous b. British Society for Heart Failure c. Renal Association d. Royal College of Pathologists 4. Comments on the Appraisal Consultation Document from experts: a. Professor John Cleland – clinical expert, nominated Vifor 5. Additional evidence submitted by the company a. Company evidence submission 1 b. Updated company evidence submission 2 (revised after ERG critique 2: section 1.4 added) c. Nephrologist survey d. Responses to questions from the ERG 6. Evidence Review Group critique of company comments on the ACD a. ERG critique of Evidence submission 2 (response to first Appraisal consultation) b. ERG addendum: Revised patiromer PAS and other company changes c. ERG response to US claims TTD data Any information supplied to NICE which has been marked as confidential, has been redacted. All personal information has also been redacted. © National Institute for Health and Care Excellence 2019. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. Patiromer for treating hyperkalaemia Single Technology Appraisal Response to consultee, commentator and public comments on the Appraisal Consultation Document (ACD) Type of stakeholder: Consultees – Organisations that accept an invitation to participate in the appraisal including the companies, national professional organisations, national patient organisations, the Department of Health and Social Care and the Welsh Government and relevant NHS organisations in England. Consultees can make a submission and participate in the consultation on the appraisal consultation document (ACD; if produced). All non-company consultees can nominate clinical experts and/or patient experts to verbally present their personal views to the Appraisal Committee. Company consultees can also nominate clinical experts. Representatives from NHS England and clinical commissioning groups invited to participate in the appraisal may also attend the Appraisal Committee as NHS commissioning experts. All consultees have the opportunity to consider an appeal against the final recommendations, or report any factual errors, within the final appraisal document (FAD). Clinical and patient experts and NHS commissioning experts – The Chair of the Appraisal Committee and the NICE project team select clinical experts and patient experts from nominations by consultees and commentators. They attend the Appraisal Committee meeting as individuals to answer questions to help clarify issues about the submitted evidence and to provide their views and experiences of the technology and/or condition. Before they attend the meeting, all experts must either submit a written statement (using a template) or indicate they agree with the submission made by their nominating organisation. Commentators – Commentators can participate in the consultation on the ACD (if produced), but NICE does not ask them to make any submission for the appraisal. Non-company commentator organisations can nominate clinical experts and patient experts to verbally present their personal views to the Appraisal Committee. Commentator organisations representing relevant comparator technology companies can also nominate clinical experts. These organisations receive the FAD and have opportunity to report any factual errors. These organisations include comparator technology companies, Healthcare Improvement Scotland any relevant National Collaborating Centre (a group commissioned by NICE to develop clinical guidelines), other related research groups where appropriate (for example, the Medical Research Council and National Cancer Research Institute); other groups such as the NHS Confederation, the NHS Commercial Medicines Unit, the Scottish Medicines Consortium, the Medicines and Healthcare Products Regulatory Agency, the Department of Health and Social Care, Social Services and Public Safety for Northern Ireland). Public – Members of the public have the opportunity to comment on the ACD when it is posted on the Institute’s web site 5 days after it is sent to consultees and commentators. These comments are usually presented to the appraisal committee in full, but NICE reserves the right to summarise and edit comments received during consultations, or not to publish them at all, where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would be otherwise inappropriate. Please note: Comments received in the course of consultations carried out by NICE are published in the interests of openness and transparency, and to promote understanding of how recommendations are developed. The comments are published as a record of the submissions that NICE has received, and are not endorsed by NICE, its officers or advisory committees. Comment Type of Organisation Stakeholder comment NICE Response number stakeholder name Please insert each new comment in a new row Please respond to each comment 1 Consultee British Background and general comments: Patients with heart failure and reduced ejection fraction (HFREF) Thank you for your comment. Society for derive major prognostic benefit from with angiotensin converting enzyme inhibitors (ACEI), angiotensin Heart Failure receptor blockers (ARBs), sacubitril/valsartan, beta blockers and mineralocorticoid receptor antagonists (MRAs) [data summarised in ESC guidelines, 1]. For many of these drugs, the benefit is additive. For example, the combination of sacubitril/valsartan, beta blocker and MRA results in a reduction of all-cause mortality with a hazard ratio of 0.37 against placebo [2]. Renin angiotensin aldosterone inhibitors (RAASi) may lead onto hyperkalaemia, in particular in patients with co-existent chronic kidney disease (CKD). In some instances this may result in clinicians stopping or reducing doses of one or more RAASi. The British Society for Heart Failure (BSH) feel that the management of hyperkalaemia during co-existent RAASi use should be directed according to the strength of indication for the RAASi. That is when the drugs have clear prognostic benefit (i.e. HFREF or post MI left ventricular systolic dysfunction or CKD with albuminuria) every effort should be made to ensure their continuation at highest possible dose. This is very different to when they are used to treat hypertension – here many other good alternatives exist and switching the drug to a different class seems very appropriate, if problems such as moderate or severe hyperkalaemia ensue. Similarly if a patient has heart failure with preserved ejection fraction (HFPEF) RAASi have not been shown to be of prognostic benefit. The BSH, Renal Association (RA) and Think Kidneys have published guidelines on the management of changes in renal function and potassium on initiation and up titration of RAASi in patients with heart failure [3]. 1. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Eur Heart J 2016;37:2129-2200Burnett H, Earley A, Voors AA, Senni M, McMurray JJ, Deschaseaux C, Cope S. 2. Thirty years of evidence on the efficacy of drug treatments for chronic heart failure with reduced ejection fraction: a network meta-analysis. Circ Heart Fail 2017;10: pii: e003529 3. https://tinyurl.com/y7yrlk69 2 Consultee British The NICE summary documents are confusing and mix multiple conditions like heart failure, CKD and Thank you for your comment. The Society for hypertension and the acute and post-acute/chronic management of hyperkalaemia. It will be almost committee considered patiromer Heart Failure impossible to make one single recommendation for all of these things. within its marketing authorisation and the available clinical evidence. As such the BSH agree that there should not be a very broad indications such as 'hyperkalaemia in adults' for these drugs. However, we feel that availability of novel drugs to lower potassium might be of clinical 2 of 22 Comment Type of Organisation Stakeholder comment NICE Response number stakeholder name Please insert each new comment in a new row Please respond to each comment value in the management of a very select cohort patients with HFREF who develop hyperkalaemia in order to facilitate the use of life prolonging drugs (i.e. RAASi) and to prevent development of hyperkalaemia (e.g. potassium >6.0mmol/l). It is uncertain as to how many patients this might effect, but we feel the numbers will be very small. Some patients who develop hyperkalaemia will have other issues such as worsening renal function and/or hypotension, which themselves might limit continued prescribing of RAASi. In summary,
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