Ref. Version Supersedes Approved for Date approved Document Owner N/A MMT 17/01/2017 Lois Taylor. Switching to Alogliptin (Vipidia )

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1 Ref. Version Supersedes Approved for Date approved Document number use by Owner N/A MMT 17/01/2017 Lois Taylor Aim: Switching to Alogliptin (Vipidia ) To reduce our spend on gliptins (DDP-4 drugs) as per our QIPP plan by switching appropriate patients to our first line gliptin - alogliptin. Objectives: Switch appropriate patients to alogliptin. Identify patients who have not responded adequately to their current gliptin and should be reviewed by their clinician with a view to moving the patient s treatment on. Ensure the quantity being prescribed is appropriate and synchronised with the patients other repeat medications. Check whether the patient is regularly ordering their gliptin; if a possible compliance issue is highlighted raise this with the clinician. Inclusion criteria: Patients taking a gliptin i.e. sitagliptin (Januvia Janumet ), saxagliptin (Onglyza Komboglyze ), vildagliptin (Galvus, Eucreas ) or linagliptin (Tragenta Jentadueto ) for the management of Type 2 diabetes. Exclusion criteria: Patients aged under 18 years. Patients who are pregnant. Patients who are currently breast feeding. Patients with Type 1 diabetes. Patients with hypersensitivity or intolerance to alogliptin or any of its excipients. Patients with severe hepatic impairment (Child-Pugh score >9) Patients with congestive heart failure of a New York Heart Association (NYHA) functional class III-IV. Previous treatment failure with alogliptin. Patients undergoing renal dialysis. Patients taking linagliptin with egfr under 60 Patients taking gliptin as monotherapy See link to the full summary of product characteristics for alogliptin. Page 1 of 6

2 Responsibilities The CCG medicines management technician or pharmacist is responsible for obtaining agreement from the practice GP prescribing lead that this work can start. The GP is responsible for ensuring all relevant practice staff are aware that this work is being looked at and to advise colleagues that they should all be using alogliptin as a first line gliptin wherever appropriate. The practice is responsible for ensuring any additional monitoring which they deem to be appropriate following the switch is undertaken. The practice is responsible for ensuring patients who are impacted by this switch are informed in an appropriate manner such as a letter. The CCG medicines management technician/pharmacist can support the practice by providing a template letter (appendix 2). The CCG medicines management technician/pharmacist is responsible for submitting their audit sheets and highlighting any patients with potential issues to the GP for sign off. The CCG medicines management technician/pharmacist is responsible for advising community pharmacies of the work that will be going on so that they can adjust their stock levels of medicines if needed. Protocol 1. Obtain agreement from the GP prescribing lead that they are happy for this work to start. Share this protocol with them to check they are happy with the inclusion/exclusion criteria etc. 2. Run a search to identify all patients currently on a gliptin that isn t alogliptin. Use the alogliptin search that is available in central reporting on SystmOne under Clinical Reporting, South East Essex PCT folder, Prescribing and Meds Man folder for GPs, PIS folder. 3. Export the results of this search to a CSV file and save in the agreed folder on the practice shared drive. 4. Complete the audit results table (appendix 1). 5. Highlight all patients with an HbA1c of 58mmol/mol to the GP for review. Ensure patient is compliant with diabetic treatment, and document if patient not requesting at appropriate intervals, any diabetic medication on repeat template. If GPs need support with these reviews Dr Alex Shaw (Southend) or Dr Sami Ozturk (CP&R) are available to support practices with this. (to be booked via MMT) 6. Go through all patients identified on the search and check them against the exclusion criteria. Highlight any patients who meet any of the exclusion criteria to the GP, these patients are not suitable to be switched to alogliptin under this protocol, but a prescriber may decide it is appropriate to switch. 7. Recommend remaining patients to be switched to alogliptin taking care when a patients egfr is 60ml/min. Refer to the BNF or tables below when determining which dose of alogliptin to switch the patient to. If patient taking a combined product switch to combined alogliptin product with same dose of metformin. Combined products are not suitable for patients with egfr <50. Patients should not be prescribed lower dose products unless they have renal function <50ml/min. Patients taking Saxagliptin 2.5mg once, Sitagliptin 50mg or 25mg once should be referred to GP for review as the doses are sub therapeutic. Page 2 of 6

3 8. Submit audit results table to the prescribing lead in the agreed way and request their approval of the switches within 2 weeks. If no response within 2 weeks please follow up and see if there is any further support we can offer practice to facilitate timely approval of the switches. Ensure approval of prescriber before making any changes. If no response with 1 month, escalate to your line manager. 9. Once signed GP approval has been given, implement the agreed action i.e. switch patient to alogliptin and stop the previous gliptin. Document the reason for starting alogliptin in administrative notes i.e. CCG switch from sitagliptin to 1 st line gliptin alogliptin. Also record reason for stopping previous gliptin 10. Save the audit results sheet in the practice in an agreed place. Table for Switching where egfr is >50ml/min Switch from (providing Saxagliptin 5mg once Linagliptin 5mg once Sitagliptin 100mg once Vildagliptin 50mg twice a day To saving per month Potential annual saving Table for switching where egfr is 30ml/min to 50ml/min Switch from (where Saxagliptin 2.5mg once Sitagliptin 50mg once Vildagliptin 50mg once a day To Alogliptin 12.5mg once Alogliptin 12.5mg once Alogliptin 12.5mg once saving per month Potential annual saving Table for switching where egfr is <30ml/min Switch from To saving per month Potential annual saving Saxagliptin 2.5mg once Alogliptin 6.25mg once Sitagliptin 25mg once Alogliptin 6.25mg once Vildagliptin 50mg once a day Alogliptin 6.25mg once References: PrescQIPP bulletin 78, November 2014 BNF 72, September 2016 March 2017 Page 3 of 6

4 Page 4 of 6 NICE Type 2 diabetes in adults: management NG28, December 2015 (last updated July 2016) Summary of product characteristics for products Home - electronic Medicines Compendium (emc) NICE new medicines summary on alogliptin, May 2013

5 Appendix 1. Audit results table for alogliptin switch Date NHS number D.O.B egfr ml/min Date of last egfr Last HbA 1C mmol/mol Date of last HbA 1C Any exclusions applicable to the patient - list Current gliptin, strength and dose Other medicines being used for Type 2 diabetes? Recommendation to GP Switch/stop/flag issue with GP? GP authorisation Complete Tech/pharm acist initial and date Ex. 20/11/20 16 Ex. 20/11/ /12/ /08/2016 Saxagliptin 5mg once /07/ /04/2016 Sitagliptin 100mg once metformin metformin Alogliptin 25mg once Stop gliptin as HbA1c has not reduced by a minimum of 5.5mmol/l Page 5 of 6

6 Appendix 2. Template letter for alogliptin switch Practice letter head Address Tel Fax Private and Confidential ~ [Title]~[Forename]~[Surname] ~[Patient address] ~[County] ~[Postcode] Dear ~[Title]~[Surname] Important information about your repeat prescription In line with good clinical practice we regularly review the medicines we prescribe to ensure that we are using the most cost effective medicines. Your doctor has reviewed your current medication and made the following change; On your next supply of medication your prescription will be changed from: [Insert current gliptin and dose] to [insert new gliptin and dose] [Insert name of new medicine] is from the same group of medicines as [insert name of old medicine] and works in the same way. Please use up all supplies of [insert name of old gliptin] before starting your new medication. We do not expect you to experience any problems with your new medicine however if you have any queries or problems please speak to your community pharmacist or your GP practice. As with all medicines please read the patient information leaflet for your new medicine. Yours Sincerely [Insert nominated GP] Page 6 of 6