Medicines Management Programme Update

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1 The Medicines Management Programme (MMP) Medicines Management Programme Update Michael Barry Clinical Lead HSE-Medicines Management Programme (MMP) What are our values? Ensuring that the patient is at the very centre of our thinking Every recommendation that we make should attempt to ensure the best possible healthcare outcomes for everyone. Advocacy for all not the few Drug expenditure under the Community Drugs Schemes /10/2010 Over 45 cost containment measures introduced since 2006 Drug expenditure under the Community Drugs Schemes Drug expenditure in Ireland 65 million items 75 million items HTDS Cost GMS Volume 502 million in 2014 (27% of total expenditure) Over 45 cost containment measures introduced since 2006

2 Most frequently prescribed medicines Acetylsalicylic Acid Atorvastatin Levothyroxine sodium Paracetamol Bisoprolol Calcium combinations Salbutamol (Inhaled) Esomeprazole Amlodipine Rosuvastatin Most expensive medicines - HTD Clinical nutritional products Pregabalin Salmeterol + other drugs for OAD Formoterol + other drugs for OAD Tiotropium Lignocaine 5% patch (Versatis) Atorvastatin Escitalopram Esomeprazole Olanzapine Areas of interest to the HSE-MMP Reimbursement application process for prescribers e.g. PNH, ahus, Multiple Sclerosis Reference Pricing Generic prescribing (safety & cost effective ) Preferred Drugs Inhaled medications NOACs Diabetic test strips Prescribing tips Prescribing incentive scheme Pharmacy fees Reimbursement application - Eculizumab (Soliris ) Paroxysmal Nocternal Haemoglobinuria(PNH) Atypical Haemolytic Uraemic Syndrome (ahus) 430,000/patient/year Clinical review of applications for centralised reimbursement and outcome follow-up Reimbursement application for MS therapy Natalizumab (Tysabri) Patient aged years High disease activity RRMS despite previous treatment with beta-interferon or glatiramer acetate Baseline assessments i.e. JC Virus Antibody, prior immunosuppressive therapy, VZV Serology, MRI scanning 3 months prior to therapy Reference pricing The HSE sets a price for the original branded product and its generics (phase 1 reference pricing) If the patient wishes to obtain the original branded product they will have to pay the difference between the reference price and the price of the originator product Over 60 products have been reference priced to date Atorvastatin ( Lipitor ) was the first drug to be reference priced on 1 st November 2013 Esomeprazole ( Nexium ) followed on the 1 st January 2014.

3 PPI Market 2013 = 89.5 million/annum Esomeprazole 1/1/2014 Lansoprazole 1/3/2014 Omeprazole 1/3/2014 Pantoprazole 1/4/2014 Rabeprazole 1/5/2014 Statin Market 2013 = m/annum Atorvastatin 1/11/2013 Rosuvastatin 1/2/2014 Pravastatin 1/3/2014 Simvastatin 1/5/2014 PPI Market Oct 2015 = 44 million/annum Statin Market 2015 = 45.7 m/annum Total PPI expenditure (GMS & DP) - January 2013 = 7,460,493 October 2015 = 3,672,752 = 3,787,741/month Total statin expenditure (GMS & DP) - July 2013 = 8,869,054 August 2015 = 3,811,930 = 5,057,124/month As prescribers we can influence drug expenditure even after reference pricing Generic Prescribing is safer prescribing What s in a name? Medication error! Aoccdrnig to rscheearch at an Elingsh uinervtisy it deosn't mttaer in waht oredr the ltteers in a wrod are the olny iprmoatnt tihng is that the frist and lsat ltteer is at the rghit pclae. The rset can be a toatl mses and you can sitll raed it wouthit a porbelm. Tihs is bcuseae we do not raed ervey lteter by itslef but the wrod as a wlohe Example: Trental 400 mg three times daily x 3/12 & Tegretol 400 mg three times daily x 3/12 Med Safety Today, Issue 10, Feb 05, NI Med Governance Team

4 Example: Medication error! Pentoxifylline 400 mg three times daily x 3/12 Generic Prescribing is cost-effective prescribing Example: the drug nobody prescribes yet everyone is taking & Carbamazepine 400 mg three times daily x 3/12 Would this medication error have happened if the medication was prescribed generically? Generic prescribing -Pregabalin (Lyrica) Prescribing generically can reduce expenditure ( including out of pocket spending for those who pay for their medicines) considerably Lyrica 50 mg x 84 = Pregabalin 50 mg x 84 = Lyrica 100 mg x 84 = Pregabalin 100 mg x 84 = For patients who pay for their medicines e.g. you commence a patient on 150 mg/day for neuropathic pain Lyrica 50 mg three times daily x 28 days = Pregabalin 50 mg three times daily x 28 days = Statins - SIMVASTATIN PPI - LANSOPRAZOLE ACE inhibitor - RAMIPRIL ARB - CANDESARTAN SSRI - CITALOPRAM SNRI - VENLAFAXINE OAC - WARFARIN (NOAC: APIXABAN) Antimuscarinics - TOLTERODINE SR Statins - SIMVASTATIN PPI - LANSOPRAZOLE ACE inhibitor - RAMIPRIL ARB - CANDESARTAN SSRI - CITALOPRAM SNRI - VENLAFAXINE LABA + ICS Budesonide + Formoterol (Bufomix) Antimuscarinics - TOLTERODINE 20% of all GMS items in terms of volume and expenditure

5 Calculated Ingredient cost per statin prescription after reference pricing Anything but United - ABU If we prescribed any other statin in preference to rosuvastatin savings of over 4 million/year could be made If we prescribed any other statin in preference to rosuvastatin savings of over 4.0 million/year could be made ABR = 4,000,000 per annum National Prescribing rates of Preferred Drugs Inhaled medicines for Asthma and COPD Highest prescribing rates for preferred drugs RAMIPRIL as % of all ACE inhibitors = 66% [SHB] CANDESARTAN as % of all ARBs = 13% [SEHB] LANSOPRAZOLE as % of all PPIs = 31% [NEHB] SIMVASTATIN as % of all Statins = 10% [NWHB] CITALOPRAM as % of all SSRIs = 23% [ERHA] VENLAFAXINE as a % of SNRIs = 72% [ERHA] There are over 50 licensed inhalers for asthma and over 25 licensed inhalers for COPD Expenditure on inhalers for asthma and COPD is approx. 98 million per annum ( 86 million GMS & 12 million DPS ). It is estimated that COPD accounts for 84% of this expenditure ( 82 million/annum ) ICS and LABA inhalers for Asthma & COPD 50 million on ICS and LABA combination inhalers ( 44 million GMS) e.g. Symbicort and Seretide 2.4 million/month Seretide (GMS only) 1.3 million/month Symbicort (GMS only) New products in this group including hybrid ( generic ) inhalers offer opportunity to reduce expenditure The Symbicort equivalent Bufomix ( budesonide 320 µg + formoterol 9 µg ) is 35% cheaper than Symbicort [ 42% cheaper than Seretide ] Therefore the most cost-effective inhaled corticosteroid + long acting beta 2 agonist combination product is Bufomix

6 Non Vitamin K Oral Anti-Coagulants (NOAC s) Apixaban (Eliquis ) Rivaroxaban (Xarelto ) 27,094 Edoxaban (Lixiana ) Dabigatran (Pradaxa ) 13,671 4,971 NOAC expenditure/month = 2,199,138 NOACs do the patients that we treat differ from those who participated in the clinical trials? There are significant age differences between patients studied in the pivotal clinical trials and those being treated with NOAC in clinical practice e.g. % of patients at or above 80 years of age: Drug Clinical Trial PCRS database Rivaroxaban 18.5% 37.5% Dabigatran 17% 37% Apixaban 13.3% 45.5% Implications: Dose adjustment for dabigatran as such patients should be treated with 110 mg twice daily. Apixaban dose also influenced by patient age. In addition to the age related reduction in CrCl which is of relevance for dabigatran, rivaroxaban & apixaban The MMP recommends that NOACs are avoided where the CrCl < 30 ml/min Reimbursement Approval form for NOACs enhancing safety

7 Diabetic Test Strips for BGM Blood Glucose Test Strips Total expenditure in 2014: 46.8million 26 individual test strips reimbursed International evidence suggests limited clinical benefit for type 2 patients not on insulin NCPD published new guidelines in 2015 MMP recommendations to go live April 2016 Reimbursement recommendations for test strips for Type 2 Diabetes Patient group Testing recommendation Limit on yearly dispensing Patients receiving insulin 4 times daily and when required Patients receiving noninsulin anti-diabetic drugs Patients receiving sulphonylurea or meglitinide drugs: May test 1-2 times daily or if feeling hypoglycaemic. Patients on oral drugs other than sulphonylurea or meglitinides (i.e. metformin and/or a thiazolidinedione, DPP-4 inhibitor or GLP-1 analogue): May test 3 times per week if needed No limit recommended Test according to specialist recommendations 1200 test strips per year Two boxes (100 test strips) per month will be reimbursed 600 test strips per year One box (50 test strips) per month will be reimbursed Diet alone Not required 100 test strips per year One pack per 6 months to allow for periodic testing where recommended Sodium Valproate Safety Tips and Tools Preferred Drugs Prescribing and Cost Guidance Non-Vitamin K oral anticoagulants (NOACs) Oral Methotrexate Preferred antibiotics in Primary Care Medicines Management Programme Available on:

8 2016 and beyond Affordability the real issue!! Measurement of health outcomes in the clinical setting Use of fampridine for multiple sclerosis Use of eculizumab for PNH and ahus DAA in the treatment of Hepatitis C Failure of any technology to deliver satisfactory health outcomes should prompt a discussion around price reduction/disinvestment Oral nutritional supplements in the community setting Use of drugs such as pregabalin, versatis patch Supporting the use of biosimilars e.g. Adalimumab & Etanercept Hospital prescribing High Tech medicines e-authorisation processes (PAH, MS) Disinvestment???? Affordability the real issue!! million/yr million million/yr

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