IPU Guide to Generic Substitution & Reference Pricing

IPU Guide to Generic Substitution & Reference Pricing
Questions & Answers
Below are some Q&As which outline the details of the Health (Pricing and Supply of Medical Goods)
Act 2013 and how they will affect you and your patients. You can find details of the generic
substitution lists published, the ongoing consultations and the reference price implementation
dates in the Generic Substitution & Reference Pricing Table by clicking here.
Generic Substitution
1.
What is generic substitution?
Generic substitution, under this legislation, permits pharmacists to substitute a brand
medicine for a generic version which has been designated as interchangeable by the HPRA.
2.
Will the HPRA be providing a standard name for each list of interchangeable medicines?
Yes – an interchangeable code (IC Code) will link all of the products in a list.
3.
What types of medicines will be in a particular list?
A list will be linked to an INN (International Non-proprietary Name), e.g. atorvastatin tablets.
A medicine can only appear in one list.
4.
What happens if all of the medicines within a list do not have the same licensed indications?
If the HPRA puts such medicines into a list then they are to be considered interchangeable and
no liability will fall on the pharmacist.
5.
Will salts, esters, ethers, isomers, etc. be considered interchangeable?
Yes, unless equivalence is not demonstrated or if a dose change is required.
6.
Will excipients be considered as interchangeable, e.g. sugar free versus sugar-containing?
This will be decided on a case-by-case basis when the HPRA reviews that list.
7.
Will dose forms be considered interchangeable?
It is likely that, in general, non-coated/film-coated tablets would be considered
interchangeable, as would effervescent/soluble/dispersible tablets. It is not likely that
modified release and slow release, etc. would be considered interchangeable. Depending on
the active substance in question and the approved generic medicines, immediate release
capsules and tablets may be considered interchangeable; this will be decided on a case-bycase basis.
8.
Will biologicals be considered interchangeable with biosimilars?
No, biologicals are excluded from this legislation.
9.
Will every medicine be considered interchangeable?
No, a medicine will not be considered interchangeable if it cannot be safely substituted, e.g.
narrow therapeutic index. For a small number of medicines, it is not advisable for patients to
switch between different brands, e.g. considerable variance in bioavailability between brands.
10. When will the HPRA publish the lists?
The HPRA has to date published 31 lists. They will continue to publish the generic substitution
lists for individual groups of medicines on an ongoing basis. The plan is to publish one list at a
time, subject to successful completion of the consultation phase, with the aim of publishing 23 lists per month. Each list will take 42 days to formally publish post initial publication (28 days
consultation and 14 days review). You can find details of the generic substitution lists
published and the ongoing consultations in the Generic Substitution & Reference Pricing Table
by clicking here.
11. How has the HPRA determined which lists to publish first?
The HPRA has been asked by DoH to prioritise the classes of medicines that currently result in
the greatest costs. The initial twenty medicines identified included statins, proton pump
inhibitors, ACE inhibitors and angiotensin II receptor blockers (ARBs): atorvastatin,
simvastatin, pravastatin, rosuvastatin, omeprazole, lansoprazole, pantoprazole,
esomeprazole, rabeprazole, perindopril, ramipril, candesartan, losartan, valsartan, clopidogrel,
lercanidipine, olanzapine, quetiapine, risperidone, anastrozole.
The HPRA also published an interchangeable list for co-amoxiclav in January 2014. This is
outside the 20 prioritised medicines; the HPRA prioritised the development of a list for coamoxiclav in view of the fact that Augmentin was in short supply. This decision was taken for
purpose of facilitating product availability during this time.
12. Does this mean I have to wait for the HPRA to publish a list before I can substitute?
Yes. For example, you may get a prescription for Lipitor and Amoxil and the HPRA has only
produced the list for “atorvastatin” but not for “amoxicillin”. In this case, you can only
substitute the Lipitor but not the Amoxil, under this legislation. However, you may wish to
discuss such scenarios with your local GP and agree that it is ok for you to substitute other
medicines, where appropriate, in such cases. You would also need to inform the patient of
this substitution and make sure that you claim for exactly what you supplied.
You must make sure that, in such cases, you do not substitute medicines which are
unsuitable for substitution. For example, Epilepsy Ireland recommends that patients on
established anti-epilepsy drugs (AEDs) should not have their medicines substituted for a
different brand. Epilepsy Ireland is not against the use of generic AEDs when prescribed for
new patients, on the condition that there will be an adequate supply of that generic available
in the longer term. However, they are opposed to any switching of AEDs, both from brand-togeneric and from generic-to-generic. Pharmacists should record the relevant brand or generic
AED on the patient’s medication record (PMR) to ensure that no substitution takes place.
13. Will there be pricing information on the HPRA lists?
No, this is outside the remit of the HPRA. The HPRA will forward their lists to the HSE who will
add in the prices. Please note that reference pricing does not commence until at least 8 weeks
after the publication of an HPRA interchangeable list.
14. Will there be any change to the reimbursement price of generic medicines once included
on an interchangeable list?
This will depend on whether the medicines had previously been reduced to or below 40% of
the pre-patent expiry price agreed under the APMI Agreement 2012. In the case of
atorvastatin, all generic atorvastatin products on the HPRA list of interchangeable medicines
had their prices reduced to not more than 40% of the pre-patent expiry price of the branded
product, Lipitor, on 1 September 2013. Likewise, all generic esomeprazole 40mg products on
the HPRA list of interchangeable medicines had their prices reduced to not more than 40% of
the pre-patent expiry prices of the respective branded products on 1 December 2013.
However, in the case of rosuvastatin, omeprazole, pravastatin, lansoprazole, quetiapine and
ramipril products, these medicines did not experience a price reduction as they were already
slightly below the 40% pre-patent expiry price agreed under the APMI Agreement. For
subsequent lists, where considered applicable, those medicines will likely be reduced in price
on the first day of the month following publication of the interchangeable list.
15. In general, what are the criteria for inclusion in a list of interchangeable medicines?
Medicines will be included in the list if they have the same qualitative and quantitative
composition, same pharmaceutical form (in most cases) and the same route of
administration.
16. In general, what are the criteria for exclusion from interchangeability?
Medicines will be excluded from being interchangeable: if differences in bioavailability lead to
clinically significant differences in efficacy; if the medicine contains more than two active
ingredients; if the medicine is contained in a device with significantly different instructions for
use, e.g. inhalers (although some simple inhalers may be considered for substitution); if the
medicine is a biological/biosimilar; if the medicine cannot be safely substituted, e.g. narrow
therapeutic index, modified release; if the medicine is unlicensed; and if the medicine is
patented.
17. How will the HPRA notify prescribers and pharmacists of the lists?
The HPRA will establish and publish the lists on its website. A new version of the list will be
created each time an addition or deletion is made. The HPRA would like pharmacists to
register with the HPRA for notification by text or email regarding changes/updates to the lists.
18. Since most EU Member States have some form of generic substitution/reference pricing in
place, why doesn’t the HPRA use those lists instead of creating their own?
The HPRA is using lists from other Member States as a starting point, especially those from
Denmark, Sweden and the Netherlands.
19. How will the HPRA address food stuffs and medical devices?
The focus will just be on medicines for now. The HPRA will only review products that have a
Product Authorisation (PA) Number; many food stuffs do not.
Reference Pricing
20. What is reference pricing?
Reference pricing involves the setting of a common reimbursement price, or reference price,
for a group of interchangeable medicines. It means that one reference price is set for each
group or list of interchangeable medicines, and this is the price that the HSE will reimburse to
pharmacies for all medicines in the group, regardless of the individual medicine’s price.
21. When will the first reference price be published?
The consultation and notification periods provided for in the legislation mean that the first
reference price can be implemented no earlier than 8 weeks after the publication of the
interchangeable list and the HSE must give 28 days’ notice to pharmacists. The reference price
for atorvastatin was introduced on 1 November 2013. The reference prices for esomeprazole
and rosuvastatin were expected to be introduced on 1 December 2013. However, the HSE
only gave notice of the reference price of esomeprazole 20mg on 28 November; consequently
this was implemented on 1 January 2014. You can find dates for the reference price
implementation dates in the Generic Substitution & Reference Pricing Table by clicking here.
22. Will pack sizes be considered interchangeable for reference pricing purposes, e.g. 2 x 28 = 1
x 56?
The HPRA will include all pack sizes in a list of interchangeable medicines. When it comes to
reference pricing, HSE will apply a reference price on a per-unit basis, i.e. per tablet or per
capsule.
23. How will pharmacists know what the reference and reimbursement prices are?
HSE will produce a list for both prescribers and pharmacists, indicating the reference price
(where applicable) and the reimbursement price. This information will be carried on the IPU
Product File. HSE shall give 28 days’ notice to community pharmacy contractors prior to
implementing the reference price.
24. How often will the reference price be changed?
HSE has said that they do not intend to change reference prices frequently. The Act says that
the reference price should be reviewed at least once a year but not more than once every 3
months. HSE has said that they would give a minimum of 4 weeks’ notice before changing a
reference price, as per the legislation. HSE confirmed that it was their intention to implement
any price changes on the 1st of the month (unless DoH says otherwise). Reference prices will
be determined by reviewing prices in all other EU Member States, taking into account any
previous agreements in place, e.g. IPHA Agreement, and also considering security of supply
concerns.
Pharmacists and Prescribers
25. What must the pharmacist do to implement this legislation?
If no clinical exemption is indicated, the pharmacist must offer the patient the least expensive
medicine that they have in stock within a list of interchangeable medicines as determined by
the HPRA (in some cases, this may indeed be the branded product). If a clinical exemption is
indicated, the pharmacist must dispense that brand.
The pharmacist should also explain about generic substitution to the patient, highlighting that
generics have the same active ingredients, same effects and same safety profile as previously
supplied medicines but may not look the same.
When reference pricing is introduced for a specific group, the pharmacist should provide
information to patients regarding the price of: the prescribed product; the product offered for
substitution; and the group reference price.
Once reference pricing is introduced, in addition to recording exactly what was dispensed, the
pharmacist must also record and transmit data on the product prescribed, i.e. whether the
medicine was prescribed as proprietary, branded generic or INN. If a clinical exemption was
indicated, the pharmacist must indicate the clinical exemption on the dispensary system.
The following specific scenarios are outlined in the Act (with reference to the relevant section
of the Act in brackets):
The pharmacy has the branded medicinal product and one generic substitute of lower cost
(S7)
On receipt of a prescription for a branded interchangeable medicinal product, the pharmacist
offers the patient the generic substitute. If the patient agrees, dispense.
The pharmacy has the branded medicinal product and two or more generic substitutes of
lower cost (S8)
On receipt of a prescription for a branded interchangeable medicinal product, the pharmacist
offers the patient the generic substitute with the lowest cost. If the patient agrees, dispense.
If substitution is not agreed, proceed to offer the substitute at the next lowest cost and so on
until substitution has been agreed, then dispense.
The pharmacy does not have the branded medicinal product in stock but does have one
substitute medicinal product which the pharmacist reasonably believes is of equal or lower
cost than the branded product (S9)
On receipt of a prescription for a branded interchangeable medicinal product, the pharmacist,
after informing the patient that they do not have stock of the branded product, offers the
patient the substitute. If the patient agrees, dispense.
The pharmacy does not have the branded medicinal product in stock but does have two or
more substitute medicinal products which the pharmacist reasonably believes are of equal
or lower cost than the branded product (S10)
On receipt of a prescription for a branded interchangeable medicinal product, the pharmacist,
after informing the patient that they do not have stock of the branded product, offers the
patient the generic substitute with the lowest cost. If the patient agrees, dispense. If
substitution is not agreed, proceed to offer the substitute at the next lowest cost and so on
until substitution has been agreed, then dispense
Patients who decline substitution (S26)
If the patient does not agree to the substitution and the product has a reference price, the
patient is liable to pay the difference between the reference price and the medicine
dispensed and any other related cost arising under the relevant scheme (GMS levy/DPS copayment). This also applies even if the pharmacy did not have stock of the cheaper medicines.
Payment of the supplement is mandatory, not discretionary.
The prescription for an interchangeable medicinal product is written using a common name
e.g. generic, INN (S11)
If the prescription is issued using the common/generic/INN name, the pharmacist must
dispense the cheapest medicinal product which is in stock at that time.
The prescription is for a medicinal product which is not listed as interchangeable but is
prescribed generically (S16)
If the prescription is issued using the common/generic/INN name, the pharmacist must
dispense the cheapest medicinal product which is in stock at that time. However, if the
patient requests a different generic/brand than the cheapest, that can be dispensed at no
extra cost to the patient.
26.
Does the patient have to pay the supplement?
Members are reminded that the requirement for the patient to pay the difference between
the reference price and the medicine dispensed is enshrined in Section 26 of the Health
(Pricing and Supply of Medical Goods) Act 2013 and is therefore mandatory and not
discretionary. The payment of this supplement is in addition to the prescription levy for GMS
patients (which is also mandatory) and the DPS co-payment for DPS patients.
27. Can the pharmacist be held liable for substitution?
If a pharmacist substitutes a branded interchangeable medicinal product for another in the
group listed by the HPRA, no action or other proceedings can be taken against the pharmacist
or the prescriber on the grounds of substitution (S12).
28. What are the criteria for clinical exemption?
If the prescriber feels that, for clinical reasons, the medicinal product should not be
substituted, they must write, by hand, “Do not substitute” on the prescription (S13). The
pharmacist must dispense that brand and complete the clinical exemption field on the
dispensary system.
29. Who in the pharmacy is responsible for ensuring this legislation is implemented?
This Act prescribes that the pharmacy contractor must ensure that all employee pharmacists
comply with this legislation; failure to do so shall be deemed failure to comply with the
conditions of the Community Drugs Schemes (S14).
30. Can a pharmacist still exercise their professional judgment?
Nothing in this legislation affects a pharmacist’s discretion not to dispense a medicinal
product if, in his or her professional opinion, it is prejudicial to the health of the patient or the
health and safety of members of the public (S15).
31. Who supervises compliance of pharmacists with this Act?
Amendments have been made to the Pharmacy Act (S32) to facilitate the PSI in imposing
duties on pharmacy owners, superintendent pharmacists and supervising pharmacists to
supervise compliance with this legislation by their pharmacists. Failure to comply is dealt with
under Part 6 (Fitness to Practise) of the Pharmacy Act. Similar provisions have been made for
doctors, dentists and nurses and their respective regulators.
32. What must prescribers do to implement this legislation?
Prescribers have been asked to write all prescriptions using the INN where appropriate and
also to explain to patients about generic substitution. Where a prescriber wishes, for clinical
reasons, to be exempt from substitution, they must write “Do Not Substitute” in their own
handwriting on the prescription. The prescriber must keep a record of his/her reason for this
clinical exemption. It is not the intention of DoH to make generic prescribing mandatory but it
can be made so if considered necessary. The Troika recommended in their last review of the
programme that doctors should be required to write prescriptions using the active ingredient.
33. What happens if the prescriber does not indicate “Do Not Substitute” in his/her own
handwriting?
DoH said that they have informed prescribers that this is a requirement of the legislation. If
prescribers do not do this, then the Minister can make further regulations.
34. What happens if a doctor requisitions a branded product in a stock order?
Only interchangeable products that are at the reference price can be supplied on stock orders.
Where the doctor does not wish the patient to use a generic and the proprietary cannot be
procured at the reference price, a prescription should be written, indicating the clinical
exemption, and provided to the patient to present in a pharmacy.
Dispensary Systems
35. What prices need to be included on the dispensary system?
The reference price (where there is one), the reimbursement price (for use when there is no
reference price or for when there is a reference price but the prescriber indicates a clinical
exemption) and the trade price (for pharmacy use). The IPU liaised with system vendors to
ensure that the necessary IT changes were made prior to the introduction of the first
reference price (for atorvastatin) on 1st November 2013.
36. What information is the pharmacy expected to transmit to HSE?
The IPU and HSE have agreed that, in addition to recording exactly what has been dispensed,
pharmacies will record the medicines prescribed by the GP which have been designated
interchangeable and for which a reference price has been allocated. The Pharmacy
Contractors’ Committee (PCC) has liaised with the HSE to reduce the burden of additional
administration being placed on pharmacists. While there is still work to be done by
pharmacists in counselling patients on the new legislation, there is significantly less
administration than was originally proposed by the HSE.
The following will take place for reference priced products only:

Record how the medicine was prescribed by the prescriber
Once you have dispensed a prescription for a reference-priced product, you will be
asked by your IT system to tick one of four boxes set out below. This will show the HSE
how the medicine was prescribed. The four options, from which you will tick one, are:
-INN (International Non-proprietary Name) Prescribed;
-Proprietary Prescribed;
-Branded Generic Prescribed; or
-‘Do not Substitute’ written by the prescriber

Transmit the name of prescriber to the HSE
The HSE had originally requested that pharmacists collect and transmit the Medical
Council number. However, it has now been agreed that for reimbursable claims where
the prescriber does not hold a GMS Contract, the prescriber name on the prescription
record will be transmitted to the HSE. This is an IT solution which will not require extra
administrative work for pharmacists.

DPS prescriptions with ‘Do Not Substitute’ (Clinical Exemption)
The HSE originally wanted pharmacists to send the HSE copies of all prescriptions
which state ‘Do Not Substitute’. However, they have now agreed that, for the small
number of prescriptions which will fall into this category, you should keep a copy in
your pharmacy, rather than sending them in.
37. What fields will be required on the dispensary system?
The changes listed above have been made to dispensary systems to facilitate this legislation.
38. How often will I get an update to my IPU Product File?
The IPU will facilitate a live download of the IPU Interchangeable File every time the HPRA
produces a new interchangeable list, even if this occurs several times a month. Your IT vendor
should be able to facilitate such multiple downloads. Pharmacies that update using CDs will
only receive an update once a month.
Patients
39. How will this legislation affect patients?
Once reference pricing is introduced, eligible patients using State drug schemes like the
Medical Card or Drugs Payment Scheme will not face any additional costs for products priced
at or below the reference price. If a patient would like to receive a particular brand that costs
more than the reference price then the patient will have to pay the additional cost of that
product. In cases where substitution is prohibited for clinical reasons, patients will not face
any additional costs if the prescribed product costs more than the reference price.

If there is no clinical exemption and the patient accepts the cheapest interchangeable
medicine offered, that medicine is dispensed.

If there is no clinical exemption and the patient is not happy to accept the cheapest
interchangeable medicine offered and a reference price is in place, where the patient is a
GMS patient, they pay the difference between the cost of the brand and the reference
price, in addition to the prescription levy. Where the patient is a DPS patient, they pay the
difference between the cost of the brand and the reference price, in addition to the €144
monthly co-payment (or part thereof).

If the patient is a private patient, they should be offered the cheapest generic in stock but
they will pay in full for whatever they wish to have.

If the prescriber has indicated a clinical exemption, the patient does not have to pay the
difference between the brand and the reference price if GMS or DPS.

The patient can claim the tax back for any supplements paid on their MED 1 form.
Communications
40. What has the IPU done to assist members with the implementation of the legislation?
We did everything within our remit to ensure that you were as adequately prepared as
possible to deal with the proposed changes. The following were among the issues we
addressed:




We held regional roadshows in September 2013 to brief members on the legislation and
its implementation;
We produced this IPU Pharmacist’s Guide to Reference Pricing and Generic Substitution,
which includes everything you need to know about how the legislation will be
implemented. The online guide is updated regularly. This guide will assist in staff training;
A comprehensive communications programme, including a radio campaign, was rolled-out
in association with the IPU, HSE, DoH, HPRA, IMO, ICGP, PSI and patient groups. Leaflets
and posters were posted to all pharmacies;
The HPRA and DoH websites both contain detailed information for healthcare
professionals and for patients. The HSE has developed a website www.hse.ie/generics
with general information on generic medicines, substitution, and an introduction to
reference pricing. The HSE website also has two information videos, featuring a GP and a
Pharmacist, to introduce the new legislation to patients and explain how they will be
affected and how to get more information if they need it. These are available on the
website, but also can be circulated to surgeries and pharmacies for use on patient display
screens, where they exist.