Medicines for Ireland claim that Irish patients are missing out unfairly

Medicines for Ireland, the representative association for generic and biosimilar suppliers in Ireland, has cautioned that a promised new National Biosimilar Policy may lead to no meaningful change.

The association has expressed concern that the State’s existing medicine pricing agreement with IPHA is “protectionist”, claiming that its terms, including an enforced price entry point, restrict competition in the medicine market, in particular for biosimilar over biologic medicines.

The Department of Health completed a public consultation on biosimilars in September and Medicines for Ireland has called on the Department to resist pressure from vested interests to maintain the “status quo”.

The association has highlighted the current “poor uptake” of biosimilars, claiming that this has resulted in a negative impact on affordability and access to medicines for Irish patients.

The association stated: “Biosimilar medicines, which are subject to the same regulatory checks and standards as biologics, have had negligible uptake in the Irish market. In some cases, as low as 0.2 per cent market share”.
Medicines for Ireland has criticised the Department of Health’s failure to create the conditions for competition in the market and the absence of government policy to shape the market.

Commenting on the submission, Jeffrey Walsh, Joint Chairperson of Medicines for Ireland and Commercial Manager, Pinewood Healthcare, said: “Biosimilar medicines have been around for over 10 years now, yet we’re not seeing any meaningful penetration of the market here. Patients are missing out unfairly in Ireland.

“That has to be a cause for alarm. While we welcomed the Department’s public consultation and commitment to formulate a national policy, we are increasingly concerned that nothing will materialise from this process. All the while, significant savings which could ensure increased and faster access to medicines for Irish patients, are passing us by”.

He continued: “Exacerbating the dearth of a government policy to drive a viable market in the Irish market, is the State’s own pricing agreement with the Irish Pharmaceutical Healthcare Association, whose members represent the biologics industry here. This provides for a 30 per cent drop in price on biologic medicines when an equivalent biosimilar medicine enters the market.

“While this discount appears attractive at first, in reality, it is creating a false and, inevitably, closed market. It ensures that the dominant position of biologics is maintained as biosimilars either do not launch here at all or fail to secure any real increased patient uptake, which may inevitably lead to their withdrawal from the market”.

According to Sandra Gannon, Joint Chairperson of Medicines for Ireland and General Manager of Teva Pharmaceutical’s Ireland:

“This blocker clause is sending out the message to biosimilar companies that Ireland is closed for business. The long-term implications of this ill-thought out approach will have negative knock-on effects, particularly for patient access.
She stated: “The 30% discount was sewn into the national medicine pricing agreement in an attempt to block genuine competition. Incumbent biologic manufacturers dominant in the Irish market are actively blocking change, while ironically, also calling on the Minister to provide access to new medicines!

“This attempt to block now extends to a proposal in IPHA’s biosimilar consultation submission document to offer the State an automatic discount, without even a biosimilar competitor in the Irish market, going even further that their existing agreement with the Department of Health”.

In its consultation submission to the Department, Medicines for Ireland has recommended that measures to increase biosimilar uptake, including compulsory biosimilar prescribing quotas or gain share schemes whereby hospitals which switch to biosimilars can share in savings realised.

“We need to move beyond a position of protecting higher cost medicines such as biologics when more affordable but equally safe alternatives are available, to a position whereby we are actively supporting measures which attracts biosimilars to the Irish market, increases their usage by patients and creates budget to pay for new medicines”, concluded Ms. Gannon.

Source: imn.ie/medicines-ireland-claims-irish-patients-missing-unfairly/


Absence of a unified policy on allergies and anaphylaxis will continue to put patients’ lives at risk

At an event at the European Parliament this week, Medicines for Ireland, the representative association for generic and biosimilar suppliers in Ireland, will highlight to legislators, policy makers and healthcare stakeholders a unified policy on allergies and anaphylaxis could result in less admissions to hospital and decrease the threat to life for sufferers as a direct consequence of anaphylaxis.

Hosted by Mairead McGuinness MEP, Vice-President of the European Parliament, the event will bring together leading experts to review the existing policy environment in respect of allergies and anaphylaxis, and debate a number of core reforms that will better improve the lives of allergy sufferers, including enhanced access to adrenaline auto-injectors (AAIs) in an emergency.

Food allergy is a growing public health concern, affecting more than 17 million people in Europe. It is a leading cause of anaphylaxis in children aged 0 – 14, with research indicating a sharp increase in hospital admissions for anaphylaxis in children – 7-fold – over the last 10 years.

Patient advocacy groups argue that the prescription of emergency medication must be encouraged to protect allergy sufferers who are at risk of a severe allergic reaction or anaphylaxis.
However, in most European countries a prescription is required to carry an AAI and is only usually prescribed once someone has suffered a severe allergic reaction.
Medicines for Ireland, as part of its ‘Responding to public health challenges of anaphylaxis through public policy’’ event, will debate why an EU-wide strategy is needed to improve the health and quality of life of allergy and anaphylaxis sufferers, including better access to AAIs.

“We know that in an emergency, rapid access to medicine is a matter of life and death,” said Owen McKeon of Medicines for Ireland. “That there is not a unified policy on the prevention and management of allergies and anaphylaxis, despite food allergy affecting more than 17 million people and growing, should be of genuine concern to healthcare professionals and national health systems across Europe.

“We are calling on all advocates – legislators, policy makers, healthcare professionals and patients – to implement the necessary reforms and regulation that improves the health and quality of life of food allergy sufferers. We have seen first-hand that the wider availability of adrenaline auto-injectors (AAIs) in the community is achievable. However, without adequate policy, prevention and treatment is varied and access to adrenaline in an emergency is limited.”

Countries like Ireland are leading the way when it comes to better access and wider availability.
This follows the death of Dublin teenager in 2013, when the former Minister for Health Leo Varadkar – now Irish Prime Minister – introduced legislation that broadened the capacity for public access to adrenaline in emergency situations by allowing trained members of the public to administer AAIs where required.

“We believe that all Member States should follow Ireland’s lead in protecting allergy sufferers who are at risk of a severe allergic reaction or anaphylaxis,” said Mr McKeon. “This starts with implementing a number of core reforms, which we will consider, discuss and debate with international experts at our event this week.”
Among those speaking at the event include Professor Dr Antonella Muraro, Past-President of the European Academy of Allergy and Clinical Immunology (EAACI).

Also speaking is Professor Dr Margitta Worm, Head of Allergy and Immunology at Charité Hospital in Berlin, and Irish consultant allergist, Dr Ranbir Kaulsay of the Bon Secours Consultants Clinic and Beacon ENT & Allergy Clinic.

Medicines for Ireland’s broad objective is to support pathways for policymakers and clinicians to work together to develop proposals to advance the core objective of increasing access to emergency medicines to those who need it most, when they need it most.


Saving Lives – responding to the public health challenges of allergies and anaphylaxis

Mairead McGuinness MEP, Vice President of the European Parliament and member of the Committee on the Environment, Public Health and Food Safety, will host a breakfast briefing on the public health challenges of anaphylaxis at the European Parliament on 22 November.

Ms McGuinness hosts the event on behalf of Medicines for Ireland, the representative body for the Irish generic and biosimilar medicines industry.

The event, a high-level, multi-stakeholder breakfast briefing, will discuss the public health challenges around anaphylaxis and access to Adrenaline Auto-Injectors (AAIs) in Europe, with a particular focus on examples of good policy practice as demonstrated by Member States – including Ireland.

Our speakers include Ms Antonella Muraro, Past-President of EAACI and current chair of the EAACI Anaphylaxis Task Force; Professor Dr Margitta Worm, Head of Allergy and Immunology at Charité Hospital in Berlin; and Dr Ranbir Kaulsay, Consultant Allergist at Bon Secours Hospital, Dublin, Ireland.
Food allergy is a growing public health concern affecting more than 17 million people in Europe alone. Moreover, food allergy is a leading cause of anaphylaxis in children 14 years and younger. Research indicates that there is a 7-fold increase in hospital admissions for severe allergic reactions in children in the last 10 years. While anaphylaxis is considered uncommon, figures may be underestimated due to under-reporting of incidence. What is clear, however, is that the mortal threat to life as a direct consequence of anaphylaxis is significant.

In an emergency scenario, ease of accessibility and a rapid response can be a matter of life and death. Countries such as Ireland, among others, have taken a positive step in this direction by expanding access to AAIs – in the case of Ireland, through legislation. We believe that all EU Members States must now work together in ensuring greater access to adrenaline in emergency situations.

This event will consider, debate and examine how to increase awareness of and access to AAIs in practice, and the roles that must be played by all advocates – legislators, policymakers, healthcare professionals and others – to improve the health and quality of life of food allergy sufferers.
We will call on those in attendance to bring the message of a unified policy on the prevention and management of allergies and anaphylaxis, as well as enhanced access to AAIs back to their national governments.

To find out more or register your attendance, please contact Nuala at info@medicinesforireland.ie.


'It'll be better for patients': Generic drugs firms want a new price deal with the HSE

A GROUP OF some of the biggest generic drug makers in Ireland are pushing for the HSE to change the way it decides how much to pay for medicines.

Right now, branded and generic drugs manufacturers negotiate separate deals with the HSE. A newly-launched campaign group, Medicines for Ireland, said that the HSE should negotiate one deal with the industry as a whole.

It said that this would result in more competition between drug makers, and would make medicine cheaper for the state and for patients.

Medicines for Ireland published its policy manifesto today, in which it called for several reforms of the current system of medicine supply.

The group is made up of several of the largest generic drugs manufacturers operating in Ireland, including the likes of Mylan, Teva Pharma and Clonmel Healthcare.

Generic medicines are copies of branded medicines developed by drug companies. When the patent for a branded medicine expires, other companies can then make generic copies.

Separate

Medicines for Ireland’s new manifesto has six core proposals, one of which was to set up a new Medicine Pricing Agreement, “between the Department of Health and pharmaceutical industry”.

“(This would end) the existing situation where only part of the industry participates in these negotiations,” it said.

At the moment, the HSE does its drug price negotiations for branded medicines with the Irish Pharmaceutical Healthcare Association (IPHA), which represents multinational companies operating in Ireland that make branded, on-patent drugs.

Generics companies have had separate agreements with the HSE.

However, Medicine in Ireland in Ireland said that the HSE should agree one pricing decision with the industry as a whole.

The group said that many of its members make both patented and generic medication, and argued it doesn’t make sense to negotiate two separate agreements.

Cost

Medicine in Ireland said that this would make pricing agreements simpler and more competitive, resulting in savings for the HSE and the consumer.

“(One deal) would be better for consumers and patients,” a spokeswoman for the group said.

A spokesman for the IPHA disagreed, saying that generic and branded drugs manufacturers were very different and should each have their own agreements with the HSE.

“Branded products are very different. We’re the companies that invest in the development of medicines. It costs billions to do, and most end up in failure,” the IPHA spokesmand told Fora.

“Our companies invest billions to bring products to market, and when they get approved they charge a certain amount, but they have to. Generic (manufacturers) don’t have to bear the burdens of research and development.”

Last year, the HSE reached a new deal with the IPHA, which it was said would deliver savings of hundreds of millions of euros.

The agreement was criticised by generics companies, which said that it “blocked” cheaper medicines from entering the market.

https://fora.ie/generic-drug-cost-ireland-3482208-Jul2017/


Medicines for Ireland manifesto calls for ‘radical overhaul’ of medicines policy

A National Medicines Strategy for Ireland providing a long-term roadmap for how Ireland procures, supplies and affords medicines for Irish patients, is one of the key proposals contained in Medicines for Ireland’s policy manifesto published today.

Medicines for Ireland is a recently launched grouping of medicine suppliers, including some of the largest suppliers of medicines to the HSE.

The group says it has come together to push for “radical reform” of the current system of medicine supply, against a backdrop of growing difficulties experienced by Irish patients in affording and accessing life-savings medicines.

Medicines for Ireland’s manifesto has six core proposals, which it says are critical to ensuring a properly functioning market and to safeguarding patients.

These are a National Medicine Strategy which sets out a long-term plan for medicine usage and supply in Ireland; establishment of new National Medicines Office to implement this strategy and oversee the €2 billion annual medicine spend; a new Medicine Pricing Agreement, which sets medicine prices, between the Department of Health and pharmaceutical industry - ending the existing situation where only part of the industry participates in these negotiations; a Biosimilar Strategy, driven by the HSE, to kick-start switching to more affordable but equally effective biosimilar medicines. This has the potential to unlock hundreds of millions in savings in the years ahead; driving competition in the medicines market through dynamic pricing schemes, particularly for high-volume medicines; and measures to tackle the growing problem of medicine shortages (currently over 140 medicines out of stock, according to the group).

Speaking on the launch of the manifesto, Ms Sandra Gannon, Joint Chairperson of Medicines for Ireland and General Manager of Teva Pharmaceuticals Ireland said: “Reform is vital to safeguard patients. We spend over €2 billion each year on medicines yet we have no long-term vision for how we spend this money or on what. We need to think more strategically and treat the procurement and supply of medicines like other long-term issues, particularly with agreed multi-annual budgeting.

“Additionally, the Irish medicine market is not operating as it should. Many aspects of the Irish market are closed off from genuine competition or are subject to structural barriers which are impeding the market from functioning effectively.

“Uptake of biosimilars is just one example where Ireland is missing the opportunity to provide essential medicines to patients at a more affordable price.

“Biosimilars currently make up less than 1 per cent of the total market (0.6 per cent) for this type of medicines with more expensive biologics the remaining 99 per cent. As biosimilars can be up to 30 per cent cheaper, this makes no sense. This situation is exacerbated by both a national medicine pricing agreement which acts against the wider uptake of biosimilars and a lack of awareness amongst prescribers of the financial savings which could be realised.”

http://www.medicalindependent.ie/99514/medicines_for_ireland_manifesto_calls_for_radical_overhaul_of_medicines_policy


STATE OVERSPEND EXPOSED: HSE wastes hundreds of millions of euro on brand name drugs despite cheaper alternatives being available, it’s claimed

The Department of Health forks out billions of euro each year on biologic drugs

The State has wasted hundreds of millions of euro on brand name drugs despite cheaper alternatives being available, it is claimed.

The Department of Health forks out billions of euro each year on biologic drugs that are prescribed in hospitals for serious conditions such as debilitating arthritis.

But this cost could be slashed by more than 30 per cent if hospitals switched to prescribing near identical biosimilar meds.

In the same way as generic prescriptions are cheaper than name brand drugs in pharmacies, once a biologic’s patent ends then other companies are allowed to create similar drugs and release them onto the market for a better price.

For example, last year the Government spent more than €60million on 56,000 packs of biologic Enbrel, which treats serious conditions such as rheumatoid arthritis and ankylosing spondylitis.

Benepali is the biosimilar drug that has the same effect and is 30 per cent cheaper, yet the HSE handed out only 54 packs of the drug.

Such complex generics are used as best value practice by hospitals across Europe with 23 biosimilars on the market.

However just 11 of them are available in Ireland and less than one per cent of those are prescribed by our doctors.

The State’s bill for hi-tech meds has jumped from €170m in 2005 to more than €590m in 2016 — up ten per cent last year alone.

This year, Health Minister Simon Harris declared he will publish a consultation paper on the use of biosimilar drugs in order to try to make some savings in the next health budget.

Medicines for Ireland, a group of eight drug companies who are the largest suppliers of meds to the HSE, claim they’ve been shut out of talks with the Government.

The group sent a series of proposals to Mr Harris this week, pleading with him to start a bio-similar strategy for hospitals to switch to cost effective alternatives that could save hundreds of millions.

Medicines for Ireland also called on the Government to allow them be part of the negotiations in the National Medicine Pricing Agreement in order to drive down prices with market competition.

The group also hit out at the Department of Health for failing to develop a long-term plan on medicine supply in Ireland that has led to a growing problem with shortages and supply.

https://www.thesun.ie/news/1242457/hse-wastes-hundreds-of-millions-of-euro-on-brand-name-drugs-despite-cheaper-alternatives-being-available-its-claimed/


State needs new strategy to afford rising cost of medicines and new therapies

By Dominic Coyle, The Irish Times

Ireland needs a national strategy to cope with its rapidly rising medicines bill, especially if it hopes to afford a range of expensive new therapies coming to market in the next few years.
That’s the views of industry group Medicines for Ireland, which has called for a radical overhaul of medicines policy here.

The comment from the industry group, which represents manufacturers of generic and biosimilar drugs, come as a growing number of cutting-edge drugs are marooned at the desk of Minister for Health Simon Harris. Two weeks ago, Mr Harris said there were three drugs awaiting a decision from him on whether to push for additional funding at Cabinet. In figures released this week, he confirmed there were now nine drugs in that position.

Sources in the pharmaceutical sector say a further 14 novel drugs were coming through the approvals system but there appeared to be no scope in the medicines budget to pay for them. Another 40 medicines are likely to face similar problems next year.
The Minister has already persuaded his Government colleagues to find extra money to pay for cystic fibrosis drug Orkambi and leukaemia drug Ibruntinib.

Sinn Féin health spokeswoman Louise O’Reilly says the growing queue of drugs in financial limbo is a cause of concern, especially for patients waiting for treatment.
Launching its “manifesto”, Medicines for Ireland said reform is vital to safeguard patients. The current regime was leading to a growing number of drugs that were out of stock each year, it added.
“We spend over €2 billion each year on medicines, yet we have no long-term vision for how we spend this money or on what,” says Sandra Gannon, country head of generics group Teva and joint chairperson of the lobby group.

Opportunities ignored

Medicines for Ireland says that even with the current pressure on the health budget, the Government is ignoring opportunities to save money that could be used on newer drugs.

The State’s spending on high-tech biologic medicines has more than doubled to €662 million in the past 10 years, and Ireland currently ranks eighth in health spending per head of population among 35 OECD states.

However, the group alleges there is a lack of proper competition, citing the case of arthritis drug Enbrel – one of the biggest budget items on the HSE’s medicines bill.
One “biosimilar” drug, Benepali, entered the market in Ireland last September after Enbrel lost patent protection but, in May, it sold just 36 packs compared to 14,157 for Enbrel.

It wants the HSE to adopt a new biosimilar strategy which, it says, would unlock hundreds of millions of euro in savings in the years ahead, as well as a new accord on pricing with all industry players, not just the more established proprietary drug companies.


Leading Irish medicine suppliers join together to drive reform agenda

It was announced today that a new national healthcare organisation, Medicines for Ireland, has launched and is calling for a fundamental reform of medicine policy in Ireland.

The group has warned that without critical reforms and a long-term strategy for medicine procurement Irish patients will face increasing difficulty in accessing and affording life-saving medicines.

Medicines for Ireland is a grouping of key medicine suppliers including some of the largest suppliers of medicines to the HSE. The new organisation is a coming together of the memberships of Healthcare Enterprise Alliance and the Irish Generic Manufacturers Association. Its members include Accord Healthcare, Consilient Healthcare, Clonmel Healthcare, Fannin Healthcare, Mylan, Pinewood Healthcare, Rowa Pharmaceuticals and Teva Pharmaceuticals.

Recent research has shown that usage of generic medicines has grown from 11% to 53% over the last four years, with the State achieving hundreds of million in savings as a result. The new organisation is committed to continuing this reform momentum.

Medicine for Ireland’s focus will include the development of a longer-term vision for medicine procurement. The organisation hopes to introduce measures to urgently tackle the growing problem of medicine shortages (with currently over 140 medicines unavailable).

Furthermore, it hopes to create proactive initiatives to create greater competition in the medicines market, particularly hospital medicines where spend has grown from €315 million in 2009 to over €600 million in 2016.

The roll-out of a National Biosimilars Policy which expands the usage of biosimilar medicines, to counterbalance the unsustainable cost of biologic medicines is also planned. Medicines for Ireland is currently finalising a comprehensive policy document which will examine the critical issues facing medicine supply in Ireland and will publish its proposals in the coming weeks.

Joint Chairperson of Medicines for Ireland, Sandra Gannon said, "Medicines for Ireland’s launch is a significant development. It marks the coming together of the leading players in the supply of medicines in Ireland. We are driven by and share the common objective of improving the supply, accessibility and affordability of medicines for Irish patients. To do so, we need significant reform."

She added, "Medicines now play a key part in helping Irish people live better and for much longer than ever before. With the growing importance of medicines, the issue of ensuring that Irish patients can access the treatments they need and the State can continue to pay for these medicines is crucial."

Source: www.businessworld.ie


Medicines for Ireland urges procurement reform as supply ‘increasingly at risk’

A new national healthcare organisation, Medicines for Ireland, has launched today and is calling for a fundamental reform of medicine policy in Ireland. The group has warned that without critical reforms and a long-term strategy for medicine procurement, Irish patients will face increasing difficulty in accessing and affording life-saving medicines.

Medicines for Ireland is a grouping of medicine suppliers including some of the largest suppliers of medicines to the HSE. The new organisation is a coming together of the memberships of Healthcare Enterprise Alliance and the Irish Generic Manufacturers Association. Its members include Accord Healthcare, Consilient Healthcare, Clonmel Healthcare, Fannin Healthcare, Mylan, Pinewood Healthcare, Rowa Pharmaceuticals and Teva Pharmaceuticals.

According to Medicines for Ireland, its membership was to the fore in driving and implementing generic substitution in 2013. This policy change resulted in Ireland’s traditional low levels of generic medicine usage being dramatically reversed. Usage of generic medicines has grown from 11 per cent to 53 per cent over the last four years, with the State achieving hundreds of million in savings as a result, outlined the organisation.

Over the period ahead, Medicine for Ireland’s focus will include: Developing a longer-term vision for medicine procurement; Introducing measures to urgently tackle the growing problem of medicine shortages (with currently over 140 medicines unavailable); Proactive initiatives to create greater competition in the medicines market, particularly hospital medicines where spend has grown from €315 million in 2009 to over €600 million in 2016; and roll-out of a National Biosimilars Policy which expands the usage of biosimilar medicines, “to counterbalance the unsustainable cost of biologic medicines”.

Medicines for Ireland said it is currently finalising a “comprehensive policy document” which will examine the critical issues facing medicine supply in Ireland and will publish its proposals in the coming weeks.
Ms Sandra Gannon, Joint Chairperson of Medicines for Ireland and General Manager of Teva Pharmaceuticals Ireland, commented: “Medicines for Ireland’s launch is a significant development. It marks the coming together of the leading players in the supply of medicines in Ireland. We are driven by and share the common objective of improving the supply, accessibility and affordability of medicines for Irish patients. To do so, we need significant reform.

“Medicines now play a key part in helping Irish people live better and for much longer than ever before. With the growing importance of medicines, the issue of ensuring that Irish patients can access the treatments they need and the State can continue to pay for these medicines is crucial. Recent experience has shown such access is no longer guaranteed. Medicine shortages are becoming a worsening problem and increasingly our ability to pay for them is also at risk.”

“Several factors are threatening the supply of medicines to Irish patients. These include the spiralling cost of the High-Tech Medicines Scheme which has grown by almost €300 million in just seven years (€315 million in 2009 to over €600 million in 2016); increasing medicine shortages with over 140 medicines currently out of stock and the failure to embrace more affordable medicines such as biosimilars,” she added.

Mr Jeffrey Walsh, Joint Chairperson of Medicines for Ireland and Commercial Manager, Pinewood Healthcare, said: ‘We believe that without fundamental reforms at Government, hospital and community levels in how we procure and supply medicines then the existing problems will accelerate. We need reforms across a range of areas including in our national pricing agreements, hospital pharmacy, the extent to which full competition in the market is fostered and in our resistance to adopt newer, more affordable medicines such as biosimilars.”

Noting Ireland’s “underdeveloped approach” to biosimilars and the failure to date of the promised public consultation on biosimilars to materialise, Mr Owen McKeon, Board Member, Medicines for Ireland and Country Manager of Mylan Ireland, said: “Time is running out for Irish policy makers to combat rising costs of biological medicines. Irish people have far less access to certain medicines that many of our European neighbours. It’s time for all stakeholders to come together to examine Medicines for Ireland’s proposals.”

Source: www.medicalindependent.ie