Clinical guideline for the introduction of Sacubitril Valsartan in primary and secondary care in Cornwall

Transcription

1 Clinical guideline for the introduction of Sacubitril Valsartan in primary and secondary care in Cornwall Page 1 of 15

2 Summary Patient clinically assessed and reviewed by a Consultant Cardiologist, Cardiology Specialty Registrar or RCHT Heart Function Specialist nurse in either the in-patient or out-patient setting. Criteria met for consideration of sacubitril valsartan (see guidance). Introduction of Sacubitril Valsartan recommended by a Consultant Cardiologist Cardiologist completes patient selection section of sacubitril valsartan checklist (appendix 3) In patient (Patient under the care of Cardiology) Cardiology completes initiation section of Sacubitril Valsartan checklist (appendix 3) Starting dose of Sacubitril Valsartan prescribed by Cardiology (one tablet 49mg/51mg twice daily unless meets criteria for lower dose see guidance) Cardiology ensures patient is known to the RCHT Heart Function Nurse (HFN) service RCHT HFN scans checklist into patient electronic record and files original in Cardiology section of medical notes Admission episode & optimisation monitored by RCHT HFN service Out-patient or patient discharged from in-patient episode (Patient under the care of GP) Out patient (Patient under the care of GP) Cardiology secretary scans checklist into patient electronic record and files original in Cardiology section of medical notes Sacubitril Valsartan checklist sent to GP with clinic letter (by Cardiology secretary) or discharge management plan (by HFN), copy both documents to Community Cardiac Specialist Nurses (CCSN) If Sacubitril Valsartan has been recommended by Cardiology in the out-patient setting: o GP completes initiation section of sacubitril valsartan checklist (appendix 3) o Starting dose of Sacubitril Valsartan prescribed by GP (one tablet 49mg/51mg twice daily unless meets criteria for lower dose see guidance) Following initiation of Sacubitril Valsartan (by either GP or Cardiology during an acute episode): o CCSN to monitor patient and optimise Sacubitril Valsartan if tolerated to maximal target dose of one 97mg/103mg tablet twice a day (see guidance) o CCSN to liaise with GP, providing clinical updates when requesting increases in prescribed dose for optimisation (current standard practice). Copies of optimisation updates to be sent by CCSN to initiating Cardiologist for filing in patients RCHT medical record and RCHT HFN for compliance monitoring Page 2 of 15

3 1. Aim/Purpose of this Guideline 1.1. The aim of this guideline is to provide structured guidance for the introduction of Sacubitril Valsartan to all qualifying patients under the care of the NHS in Cornwall. This guidance is informed by the National Institute for health and Clinical Excellence technology appraisal TA 388. Further information regarding TA388 can be found at 2. The Guidance 2.1. Patient selection Sacubitril Valsartan can only be commenced: on the recommendation of a Consultant Cardiologist, and after the patient has been clinically assessed and reviewed by a Consultant Cardiologist, Cardiology Specialty Registrar or RCHT Heart Function Specialist nurse in either the in-patient or outpatient setting Inclusion criteria Sacubitril valsartan is recommended as an option for treating symptomatic chronic heart failure with reduced ejection fraction, only in people: with New York Heart Association (NYHA) class II to IV symptoms and with a left ventricular ejection fraction of 35% or less and who are already taking a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) Exclusion criteria If any of the following patient criteria are true, the patient should not be offered Sacubitril Valsartan. Symptomatic chronic heart failure with reduced ejection fraction of greater than 35%. Symptomatic chronic heart failure with reduced ejection fraction and NYHA class I symptoms. Not taking a stable, optimised dose of ACE inhibitors or ARBs for at least 4 weeks. A history of angioedema related to previous ACE inhibitor or ARB therapy. Systolic blood pressure less than 100 mmhg. Severe hepatic impairment, biliary cirrhosis and cholestasis (Child Pugh C classification). End-stage renal failure. Hereditary or idiopathic angioedema. Taking aliskiren-containing products and either Diabetes mellitus or renal impairment (egfr less than 60 ml/min/1.73 Page 3 of 15

4 m2). Pregnant or breastfeeding. Not recommended during the first trimester of pregnancy or when breast-feeding, and contraindicated during the second and third trimesters of pregnancy. Taking direct renin inhibitors such as aliskiren. Taking ACE inhibitors or ARBs for another indication which means they cannot be stopped. Less than 18 years old Precautions and patient considerations As with any prescribing decision, please ensure consideration is given to: Co-morbidities Frailty polypharmacy If any of the following precautions are relevant to the patient then actions will need to be considered and advice given Serum potassium level greater than 5.4 mmol/l. Moderate renal impairment. Dose adjustment may be needed at initiation. Severe renal impairment. Use with caution. Lower dose for initiation. Moderate hepatic impairment (Child Pugh B classification) or with AST/ALT values more than twice the upper limit of the normal range. Dose adjustment may be needed. Renal artery stenosis. Monitor renal function. Driving vehicles or operating machines; has a minor influence on the ability to drive and use machines. NYHA class IV. Caution. Elderly patients. The dose should be in line with the renal function of the elderly patient. Co-administration of Sacubitril Valsartan: o Statins Sacubitril may reduce some drugs absorption by liver cells through effects on membrane transporters (OATP1B1 and OATP1B3). Exercise caution. Reduction in statin dose maybe required. o PDE5 inhibitors including sildenafil Co-administration is associated with a significantly greater blood pressure reduction. Exercise caution. o Potassium Concomitant use of potassium-sparing diuretics, mineralocorticoid antagonists, potassium supplements, salt substitutes containing potassium Page 4 of 15

5 or other agents (such as heparin) may increase serum potassium, and serum creatinine. Monitor serum potassium. o NSAID, including selective COX-2 inhibitors in elderly patients, volume-depleted patients (including those on diuretic therapy), or patients with compromised renal function. Monitor renal function. o Lithium Concomitant administration is not recommended. If necessary, monitor serum lithium levels. o Furosemide. Urinary excretion of sodium may be reduced. o Nitrates May reduce heart rate. o Inhibitors of OATP1B1, OATP1B3, OAT3 (rifampicin, ciclosporin), OAT1 (tenofovir, cidofovir) or MRP2 (ritonavir) May increase the systemic exposure of sacubitril or valsartan. o Metformin May reduce levels of metformin. Monitor clinically Drug Initiation In the secondary care setting Patient clinically assessed and reviewed by a Consultant Cardiologist, Cardiology Specialty Registrar or RCHT Heart Function Specialist Nurse (HFN) in the in-patient setting and criteria met for consideration of sacubitril valsartan. Introduction of Sacubitril Valsartan recommended by a Consultant Cardiologist Cardiologist completes patient selection section of sacubitril valsartan checklist Cardiologist, Cardiology Specialty Registrar or RCHT HFN completes initiation section of sacubitril valsartan checklist (appendix 3) Starting dose of sacubitril valsartan prescribed by Cardiologist, Cardiology Specialty Registrar or RCHT HFN (one tablet 49mg/51mg twice daily unless meets criteria for lower dose) Cardiologist, Cardiology Specialty Registrar or RCHT HFN ensures patient is known to the RCHT Heart Function Nursing service Admission episode and optimisation monitored by RCHT HFN On discharge, the HFN ensures partially completed Page 5 of 15

6 checklist is scanned, filed in Cardiology section of medical notes and forwards copies to GP and Community Cardiac Specialist Nurse to facilitate continued optimisation and maintenance In the primary care setting Patient clinically assessed and reviewed by a Consultant Cardiologist, Cardiology Specialty Registrar or RCHT HFN in the RCHT out-patient setting. Criteria met for consideration of sacubitril valsartan Introduction of Sacubitril Valsartan recommended by a Consultant Cardiologist Cardiologist completes patient selection section of sacubitril valsartan checklist Cardiology secretary scans checklist into patient electronic record, files original in Cardiology section of medical notes and forwards copies to GP and Community Cardiac Specialist Nurse to facilitate continued optimisation and maintenance GP completes initiation section of Sacubitril Valsartan checklist (appendix 3) Starting dose of Sacubitril Valsartan prescribed by GP (one tablet 49mg/51mg twice daily unless meets criteria for lower dose) 2.3. Optimisation and Maintenance CCSN to monitor patient and optimise sacubitril valsartan if tolerated to maximal target dose of one 97mg/103mg tablet twice a day CCSN to liaise with GP, providing clinical updates when requesting increases in prescribed dose for optimisation (current standard practice for optimisation of heart failure medication). Copies of optimisation updates to be sent by CCSN to initiating Cardiologist for filing in patients RCHT medical record & RCHT HFN for compliance monitoring Page 6 of 15

7 3. Monitoring compliance and effectiveness Element to be monitored Lead The introduction and optimisation of Sacubitril Valsartan in Cornwall The RCHT Heart Function Nursing Service Lead Tool Frequency Reporting arrangements Acting on recommendations and Lead(s) Change in practice and lessons to be shared Via the Sacubitril Valsartan checklist (Appendix 3) and optimisation updates from the community cardiac specialist nurses We will be able to provide a report at a frequency necessary to inform on-going practice, but at least annually in the absence of any other requested timeframe. This will be reported through the Cardiology specialty meeting annually. Any recommendations made will be tabled for discussion at the Cardiology Specialty meeting Required changes to practice will be identified and actioned within 1 month. A lead member of the Cardiology specialty team will be identified to take each change forward where appropriate. Lessons will be shared with all the relevant stakeholders 4. Equality and Diversity 4.2. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Diversity & Human Rights Policy' or the Equality and Diversity website Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2. Page 7 of 15

8 Appendix 1. Governance Information Document Title Clinical guideline for the introduction of Sacubitril Valsartan in primary and secondary care in Cornwall. Date Issued/Approved: 29 November 2016 Date Valid From: 29 November 2016 Date Valid To: 29 November 2019 Directorate / Department responsible (author/owner): Joanna Davies, Clinical Nurse Specialist Heart Failure Contact details: Brief summary of contents Suggested Keywords: Target Audience Executive Director responsible for Policy: Date revised: This document replaces (exact title of previous version): Approval route (names of committees)/consultation: Divisional Manager confirming approval processes Name and Post Title of additional signatories Name and Signature of Divisional/Directorate Governance Lead confirming approval by specialty and divisional management meetings Structured guidance for the introduction of Sacubitril Valsartan to all qualifying patients under the care of the NHS in Cornwall. Sacubitril Valsartan, symptomatic heart failure, heart failure with reduced ejection fraction RCHT PCH CFT KCCG Medical Director N/A New document New Document RCHT Cardiology Specialty (13/09/16) Cornwall Area Prescribing Committee Sheena Wallace Medical Services Associate Director Not Required {Original Copy Signed} Name: Alistair Slade, Cardiology Clinical Director Page 8 of 15

9 Signature of Executive Director giving approval Publication Location (refer to Policy on Policies Approvals and Ratification): Document Library Folder/Sub Folder Links to key external standards Related Documents: Training Need Identified? {Original Copy Signed} Internet & Intranet Clinical / Cardiology Intranet Only Governance Team can advise NICE Technology appraisal No, this document will provide the additional information required to facilitate delivery of evidence based therapy. Version Control Table Date Version No 15/08/16 V1.0 Initial Issue Summary of Changes Changes Made by (Name and Job Title) Joanna Davies, Clinical Nurse Specialist Heart Function All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager. Page 9 of 15

10 Appendix 2. Initial Equality Impact Assessment Form Name of Name of the strategy / policy /proposal / service function to be assessed (hereafter referred to as policy): Clinical guideline for the introduction of sacubitril valsartan in primary and secondary care in Cornwall. Directorate and service area: Is this a new or existing Policy? RCHT Cardiology Respiratory New Name of individual completing Telephone: assessment: Joanna Davies 1. Policy Aim* Who is the strategy / policy / proposal / service function aimed at? This policy is aimed at all clinical personnel involved in the delivery of NHS care to patients who qualify for introduction of Sacubitril Valsartan. It provides structured guidance for the introduction of Sacubitril Valsartan to all qualifying patients under the care of the NHS in Cornwall. 2. Policy Objectives* To provide a robust guideline, clarifying the process to be followed when considering introduction of Sacubitril Valsartan to a qualifying patient under the care of the NHS in Cornwall. 3. Policy intended Outcomes* 4. *How will you measure the outcome? 5. Who is intended to benefit from the policy? 6a) Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? Safe initiation, optimisation and maintenance of Sacubitril Valsartan to a qualifying patient under the care of the NHS in Cornwall. Outlined in section 3 above Qualifying patients under the care of the NHS in Cornwall. Yes b) If yes, have these *groups been consulted? C). Please list any groups who have been consulted about this procedure. Yes See appendix 1 7. The Impact Please complete the following table. Are there concerns that the policy could have differential impact on: Equality Strands: Yes No Rationale for Assessment / Existing Evidence Age Page 10 of 15

11 Sex (male, female, transgender / gender reassignment) Race / Ethnic communities /groups Disability - Learning disability, physical disability, sensory impairment and mental health problems Religion / other beliefs Marriage and civil partnership Pregnancy and maternity Medication Not recommended during the first trimester of pregnancy or when breast-feeding, and contraindicated during the second and third trimesters of pregnancy Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian You will need to continue to a full Equality Impact Assessment if the following have been highlighted: You have ticked Yes in any column above and No consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or Major service redesign or development 8. Please indicate if a full equality analysis is recommended. No 9. If you are not recommending a Full Impact assessment please explain why. It is not this policy which has a differential impact upon pregnancy and maternity, it is the licensing of the medication. Signature of policy developer / lead manager / director Date of completion and submission Names and signatures of members carrying out the Screening Assessment Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust s web site. Signed Date Page 11 of 15

12 Appendix 3. Sacubitril valsartan checklist Patient ID sticker Patient selection Inclusion/Exclusion criteria Inclusion criteria If all of the following patient criteria are met, the patient should be offered sacubitril valsartan. New York Heart Association (NYHA) class II to IV symptoms and A left ventricular ejection fraction of 35% or less and who are already taking a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). Exclusion criteria If any of the following patient criteria are met, the patient should not be offered sacubitril valsartan. Less than 18 years old. Symptomatic chronic heart failure with reduced ejection fraction of greater than 35%. Symptomatic chronic heart failure with reduced ejection fraction and NYHA class I symptoms. Not taking a stable, optimised dose of ACE inhibitors or ARBs for at least 4 weeks. Systolic blood pressure less than 100 mmhg. A history of hereditary or idiopathic angioedema or angioedema related to previous ACE inhibitor or ARB therapy. Severe hepatic impairment, biliary cirrhosis and cholestasis (Child Pugh C classification). End-stage renal failure. Taking direct renin inhibitors such as aliskiren. Taking ACE inhibitors or ARBs for another indication which means they cannot be stopped. Taking aliskiren-containing products and has either Diabetes mellitus or renal impairment (egfr less than 60 ml/min/1.73 m2). Pregnant or breastfeeding. Not recommended during the first trimester of pregnancy or when breast-feeding, and contraindicated during the second and third trimesters of pregnancy Page 12 of 15

13 Precautions and patient considerations If any of the following precautions are relevant to the patient, detail the action to be taken below. Patient ID sticker Precautions/patient consideration Y/N Action SBP 100 to 110 mmhg (A starting dose of 24 mg/26 mg twice daily should be considered) Moderate renal impairment. (Dose adjustment may be needed at initiation) Severe renal impairment. (Use with caution. Lower dose for initiation) Moderate hepatic impairment (Child Pugh B classification) or with AST/ALT values more than twice the upper limit of the normal range. (Dose adjustment may be needed. Renal artery stenosis. (Monitor renal function) Driving vehicles or operating machines; has a minor influence on the ability to drive and use machines. Serum potassium level greater than 5.4 mmol/l. NYHA class IV. (Caution). Elderly patients. (The dose should be in line with the renal function of the elderly patient) Co-administration of sacubitril valsartan Statins. Sacubitril may reduce some drugs absorption by liver cells through effects on membrane transporters (OATP1B1 and OATP1B3). Exercise caution. Reduction in statin dose maybe required. PDE5 inhibitors including sildenafil. Co-administration is associated with a significantly greater blood pressure reduction. Exercise caution. Potassium. Concomitant use of potassium-sparing diuretics, mineralocorticoid antagonists, potassium supplements, salt substitutes containing potassium or other agents (such as heparin) may increase serum potassium, and serum creatinine. Monitor serum potassium. NSAID, including selective COX-2 inhibitors in elderly patients, volume-depleted patients (including those on diuretic therapy), or patients with compromised renal function. Monitor renal function. Lithium. Concomitant administration is not recommended. If necessary, monitor serum lithium levels. Furosemide. Urinary excretion of sodium may be reduced. Nitrates. May reduce heart rate. Inhibitors of OATP1B1, OATP1B3, OAT3 (rifampicin, ciclosporin), OAT1 (tenofovir, cidofovir) or MRP2 (ritonavir). May increase the systemic exposure of sacubitril or valsartan. Metformin. May reduce levels of metformin. Monitor clinically. Recommending Cardiologist: Printed..... Signed..... Date.... Page 13 of 15

14 Patient ID sticker Drug initiation The patient should not commence sacubitril valsartan if until all of the following patient criteria are met. Has the patient been taking a stable dose of ACE inhibitors or ARBs up to this time? If the patient has been taking an ACE inhibitor, has there been at least a 36-hour washout period? If the patient has been taking an ARB has it been stopped? Has the patient been advised of the common and very common side effects (including hypotension, renal impairment and hyperkalaemia; see table 1, Section 4.8 EMC) and how to report side effects for the yellow card scheme The recommended starting dose of sacubitril valsartan is one tablet of 49 mg/51 mg twice daily, except in the situations described below. A starting dose of 24 mg/26 mg twice daily should be considered for patients with SBP 100 to 110 mmhg A starting dose of 24 mg/26 mg twice daily should be considered in patients with moderate renal impairment (egfr ml/min/1.73 m 2 ). There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh B classification) or with AST/ALT values more than twice the upper limit of the normal range. sacubitril valsartan should be used with caution in these patients and the recommended starting dose is 24 mg/26 mg twice daily Initiating Prescriber: Printed.... Signed.. Date.... Page 14 of 15

15 Optimisation & Maintenance The dose should be doubled at 2-4 weeks to the target dose of one tablet of 97 mg/103 mg twice daily, as tolerated by the patient unless the patient has been initiated on a lower dose due to SBP 100 to 110 mmhg egfr ml/min/1.73 m 2 Hepatic impairment (Child-Pugh B classification) Slow dose titration (doubling every 3-4 weeks) is recommended in these patients. Patient ID sticker If patients experience tolerability issues (systolic blood pressure [SBP] 95 mmhg, symptomatic hypotension, hyperkalaemia, renal dysfunction), adjustment of concomitant medicinal products, temporary down titration or discontinuation of sacubitril valsartan is recommended Date Dose and frequency Rationale for starting dose / up-titration dose Optimising HCP Copies of optimisation updates to be ed by Community Cardiac specialist nurse to rch-tr.heartfunctionservice@nhs.net (for filing in patients RCHT medical record & for compliance monitoring) Page 15 of 15