Medicines Management Programme

Regional Prescribers’ Forum Cork University Maternity Hospital

November 7th 2013

Dr Helen FlintDr Helen Flint

National Lead Medicines Management National Lead Medicines Management

Office of the Nursing & Midwifery Services DirectorOffice of the Nursing & Midwifery Services Director

Clinical Strategy and Programmes DirectorateClinical Strategy and Programmes Directorate

Health Services Executive, Dublin, IrelandHealth Services Executive, Dublin, Ireland

““The prescribing of medicines is The prescribing of medicines is the commonest healthcare intervention in the commonest healthcare intervention in developed countries”developed countries”

National Medicines Information Centre, 2004

Approximately 10,000 medicinal products authorised for use in Approximately 10,000 medicinal products authorised for use in IrelandIreland

this includes products authorised nationally and through EU this includes products authorised nationally and through EU assessment procedures, with no national licenses issued for some of assessment procedures, with no national licenses issued for some of the latter, which is how the IMB countthe latter, which is how the IMB count

the figures relate to product authourisations (licenses), rather than to the figures relate to product authourisations (licenses), rather than to substances, so includes a significant number of generics as well as substances, so includes a significant number of generics as well as ‘product families’, i.e. different strengths and formulations of the same ‘product families’, i.e. different strengths and formulations of the same brand/substance etc., as each is the subject of an individual brand/substance etc., as each is the subject of an individual authorisation (license)authorisation (license)

includes parallel product authourisations (PPAs), where licenses are includes parallel product authourisations (PPAs), where licenses are granted for products which are already the subject of an authorisation, granted for products which are already the subject of an authorisation, but there is parallel importation of version for sale, usually because of but there is parallel importation of version for sale, usually because of priceprice

Number of prescriptions?

No published Irish studies relating to the number of prescriptions written No published Irish studies relating to the number of prescriptions written here on a daily basishere on a daily basis

Difficult to capture that information as details of purely private prescriptions (i.e. where the patient does not make a claim under the DPS) would be recorded only on individual GP records

Annual report from the PCRS details the number of prescription items that pharmacists were reimbursed for on the GMS, DPS and LTI scheme

This could be used as a guide to the number of prescriptions written under these community schemes

How many prescriptions?

United Kingdom United Kingdom every day 2 million written by General Practitioners2 million written by General Practitioners 0.5 million in hospitals0.5 million in hospitals 927 million items dispensed overall927 million items dispensed overall

One Irish hospital (600 beds)One Irish hospital (600 beds) 4-18 drugs per patient (mean= 14)4-18 drugs per patient (mean= 14) 8400 drugs administered daily

Polypharmacy

Common in IrelandCommon in Ireland One-in-five people <50 years take five or more medicinesOne-in-five people <50 years take five or more medicines One-in-two people <75 years take five or more medicines (Dublin One-in-two people <75 years take five or more medicines (Dublin

TILDA, 2011)TILDA, 2011) Patients taking two medicines have a 13% risk of adverse drug-Patients taking two medicines have a 13% risk of adverse drug-

drug interactions (an avoidable cause of adverse drug reactions)drug interactions (an avoidable cause of adverse drug reactions) Four medicines = 38% riskFour medicines = 38% risk Seven or more = 82% riskSeven or more = 82% risk Associated with increased risk of adverse drug reactionsAssociated with increased risk of adverse drug reactions Prescribing cascade Prescribing cascade FallsFalls Non-complianceNon-compliance

““The annual cost to the State of The annual cost to the State of supplying medicines exceeds €2.24 billion – a greater supplying medicines exceeds €2.24 billion – a greater than six-fold increase has occurred over a decade. than six-fold increase has occurred over a decade. This level of growth in expenditure is unsustainable”This level of growth in expenditure is unsustainable”

Tilson and Barry, 2010Tilson and Barry, 2010

Where does taxpayer invest?

Lipid modifying agents - €160MLipid modifying agents - €160M Acid Related Disorders - €127MAcid Related Disorders - €127M Renin-Angiotensin system - €75mRenin-Angiotensin system - €75m Drugs for Obstructive Airways Disease - €110MDrugs for Obstructive Airways Disease - €110M Clinical Nutritional Products - €52MClinical Nutritional Products - €52M Psycholeptics and Psychoanaleptics - €149MPsycholeptics and Psychoanaleptics - €149M

The above groups accounted for 36% (23m) of all prescriptions and The above groups accounted for 36% (23m) of all prescriptions and 53% of all drug costs under the GMS / DPS / LTI schemes in 200853% of all drug costs under the GMS / DPS / LTI schemes in 2008

Pharmacoeconomic Evaluation in Ireland

The National Centre for Pharmacoeconomics (NCPE) The National Centre for Pharmacoeconomics (NCPE) in Ireland in Ireland evaluates cost-effectiveness of new medicines prior to evaluates cost-effectiveness of new medicines prior to reimbursement reimbursement and conducts pharmacoeconomic (P/E) and conducts pharmacoeconomic (P/E) evaluations to inform public policy (e.g. infant pneumococcal evaluations to inform public policy (e.g. infant pneumococcal vaccination) and prescribing in primary care (e.g. statins for vaccination) and prescribing in primary care (e.g. statins for primary and secondary prevention of coronary heart disease) primary and secondary prevention of coronary heart disease)

Pharmacoeconomics

Pharmacoeconomics Pharmacoeconomics refers to the scientific discipline that refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy compares the value of one pharmaceutical drug or drug therapy to anotherto another

Sub-discipline of health economicsSub-discipline of health economics

A pharmacoeconomic study evaluates the cost (expressed in monetary terms) and effects (expressed in terms of monetary value, efficacy or enhanced quality of life) of a pharmaceutical product

Pharmacoeconomic assessment of all new medicines

National Centre for Pharmacoeconomics/HSE consider the cost–National Centre for Pharmacoeconomics/HSE consider the cost–effectiveness of all new medicines following receipt of an application effectiveness of all new medicines following receipt of an application for reimbursementfor reimbursement

In practice, all medicines are subjected to a preliminary rapid review In practice, all medicines are subjected to a preliminary rapid review (2–4 weeks)(2–4 weeks)

review of the number of eligible patients in the populationreview of the number of eligible patients in the population the rate of uptake and whether the technology replaces or is added to current the rate of uptake and whether the technology replaces or is added to current

practicepractice the potential budget impact of the new technologythe potential budget impact of the new technology the price compared with the appropriate comparatorsthe price compared with the appropriate comparators clinical effectiveness, as well as cost–effectiveness data from other clinical effectiveness, as well as cost–effectiveness data from other

jurisdictions (if available)jurisdictions (if available) Products are then either recommended for reimbursement or referred Products are then either recommended for reimbursement or referred

for a formal pharmacoeconomic assessmentfor a formal pharmacoeconomic assessment

The average time from the issue of the product licence to The average time from the issue of the product licence to reimbursement was 7 months (average duration of the P/E reimbursement was 7 months (average duration of the P/E process was 2.7 months)process was 2.7 months)

Of interest, the review noted that the NCPE recommendations Of interest, the review noted that the NCPE recommendations concurred with those of the UK evaluation agencies (the concurred with those of the UK evaluation agencies (the National Institute for Health & Clinical Excellence, the Scottish National Institute for Health & Clinical Excellence, the Scottish Medicines Consortium and the All Wales Medicines Strategy Medicines Consortium and the All Wales Medicines Strategy Group), with the exception of two anti-cancer agents sunitinib Group), with the exception of two anti-cancer agents sunitinib and lapatinib, which were reimbursed in Irelandand lapatinib, which were reimbursed in Ireland

The NCPE publishes all of its pharmacoeconomic evaluations The NCPE publishes all of its pharmacoeconomic evaluations on its website: check out www.ncpe.ie]on its website: check out www.ncpe.ie]

PCRS Annual Report 2011

1,768,344 people held Medical Cards1,768,344 people held Medical Cards

18,737,510 General Medical Services prescriptions were dispensed 18,737,510 General Medical Services prescriptions were dispensed (57,986,608 GMS items) (57,986,608 GMS items)

3,269,901 Drug Payment Scheme prescriptions reimbursed 3,269,901 Drug Payment Scheme prescriptions reimbursed (10,105,249 DPS items)(10,105,249 DPS items)

€€1.8bn of the €2.5bn paid out by PCRS was on pharmaceutical 1.8bn of the €2.5bn paid out by PCRS was on pharmaceutical services services

Disinvestment: new drugs for old

““……the funding of new, expensive the funding of new, expensive medicines relies increasingly on releasing funds by medicines relies increasingly on releasing funds by displacing other treatments” displacing other treatments”

Hughes and Ferner, 2010Hughes and Ferner, 2010

Generic prescribing

A generic medicine contains the same qualitative and A generic medicine contains the same qualitative and quantitative composition of active substances as the proprietary quantitative composition of active substances as the proprietary version of that drugversion of that drug

Reduces the potential for confusion and errorReduces the potential for confusion and error Cost-effective and safe for the patientCost-effective and safe for the patient Exceptions: modified-release preparations/ some combination Exceptions: modified-release preparations/ some combination

products/drugs with a narrow therapeutic indexproducts/drugs with a narrow therapeutic index ““Bio-similar medicines” similar to reference product: additional Bio-similar medicines” similar to reference product: additional

studies on case-by-case basisstudies on case-by-case basis

indicator of good prescribing practiceindicator of good prescribing practice

Generic Usage in Primary Care

Ireland 2008:

11% - 18% of prescription items dispensed generically

England 2008:

83% of prescription items prescribed generically

Canada 2009:

56% – 61% of all prescriptions were generic

Objective: Objective: Introduces a system of generic substitution and reference pricing Introduces a system of generic substitution and reference pricing

Benefits: Benefits: Enhance price competitionEnhance price competition Increase usage of generics (~18% in Ireland)Increase usage of generics (~18% in Ireland) Improve value for moneyImprove value for money Ensure continued access to innovative medicinesEnsure continued access to innovative medicines Consistent with best international practice (patient safety and commercial Consistent with best international practice (patient safety and commercial

arrangements)arrangements)

International Perspective:International Perspective: 24 of 27 EU Member States have generic substitution24 of 27 EU Member States have generic substitution

/ reference pricing/ reference pricing 83% rate of generic prescribing in UK83% rate of generic prescribing in UK

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Roles under the legislation

Department of Health (DoH):

- Preparation of legislation

- Policy decisions

Health Service Executive (HSE):

- Reimbursement and pricing of medicines

Irish Medicines Board (IMB):

- List of Interchangeable Medicines on IMB website

Health (Pricing and Supply of Medical Goods) Bill 2012

Reference pricing involves the setting of a common Reference pricing involves the setting of a common reimbursement price, or reference price, for a group of reimbursement price, or reference price, for a group of interchangeable medicinesinterchangeable medicines

Eligible patients will not face any additional costs for products Eligible patients will not face any additional costs for products priced at or below the reference pricepriced at or below the reference price

If a patient would like to receive a particular brand that costs If a patient would like to receive a particular brand that costs more than the reference price then the patient will have to pay more than the reference price then the patient will have to pay the additional cost of that productthe additional cost of that product

In cases where substitution is prohibited for clinical reasons, In cases where substitution is prohibited for clinical reasons, patients will not face any additional costs if the prescribed patients will not face any additional costs if the prescribed product costs more than the reference priceproduct costs more than the reference price

Health (Pricing and Supply of Medical Goods) Bill 2012

The Bill provides for the introduction of a system of generic substitution The Bill provides for the introduction of a system of generic substitution and reference pricingand reference pricing

Currently, when a specific brand of medicine is prescribed for a patient, Currently, when a specific brand of medicine is prescribed for a patient, a pharmacist can only supply that particular brand, even when less a pharmacist can only supply that particular brand, even when less expensive generic versions of the same medicine are availableexpensive generic versions of the same medicine are available

The Bill permits pharmacists to substitute medicines which have been The Bill permits pharmacists to substitute medicines which have been designated as interchangeable by the Irish Medicines Boarddesignated as interchangeable by the Irish Medicines Board

A generic medicine is a medicine that is similar to an original, brand A generic medicine is a medicine that is similar to an original, brand named medicine. It has the same active substances as the original named medicine. It has the same active substances as the original medicine and is made to the same standard to make sure it is safe and medicine and is made to the same standard to make sure it is safe and effectiveeffective

A generic medicine must meet exactly the same standards of quality A generic medicine must meet exactly the same standards of quality and safety and have the same effect as the original medicineand safety and have the same effect as the original medicine

Substitution will only be allowed where it is safe to do soSubstitution will only be allowed where it is safe to do so

Role of IMB

Establish, consult, publish and maintain a List of Establish, consult, publish and maintain a List of Interchangeable Medicines on IMB websiteInterchangeable Medicines on IMB website

Medicines on the List may be substituted for each other in order Medicines on the List may be substituted for each other in order to enable savings to be made for patients or the HSE, or both, to enable savings to be made for patients or the HSE, or both, where lower priced medicines are supplied where lower priced medicines are supplied

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Criteria for interchangeability

INCLUDED:INCLUDED: Same qualitative and quantitative compositionSame qualitative and quantitative composition Same pharmaceutical form Same pharmaceutical form Same route of administrationSame route of administration

EXCLUDEDEXCLUDED Differences in bioavailability whih may lead to clinically Differences in bioavailability whih may lead to clinically

significant differences in efficacysignificant differences in efficacy Device with significantly different instructions for use Device with significantly different instructions for use

e.g. inhalerse.g. inhalers Biological medicines cannot be safely substituted Biological medicines cannot be safely substituted