New system follows rise in cost of drugs
Irish Medical Times
July 10, 2013
Gary Culliton reports on the passing of the new Health Bill and the remaining concerns of neurologists regarding the switching of anti-epileptic drugs.
The commencement of the Health (Pricing and Supply of Medical Goods) Act 2013 will allow for the introduction of a system of generic medicine substitution and reference pricing, the Government has pledged.
The Irish Medicines Board (IMB) will now commence a review of an initial 20 active substances, which equates to approximately 1,500 individual medicines. From the end of the year onwards, hundreds of thousands of prescriptions will be subject to generic substitution, “which will offer choice and reduced prices to patients”, the Government believes.
The new system has been introduced following a rise in the costs of drugs to the State, which increased by 221 per cent in the ten years to 2010. Between 2000 and 2010, the cost of drugs under the General Medical Scheme (GMS) increased from €338.8 million to €1.23 billion, and the cost of drugs under the Drugs Payment Scheme increased from €140.6 million to €173.4 million. The Long Term Illness Scheme cost €41.7 million in 2000 and €126.9 million in 2010. High Tech drugs scheme spending was €51.9 million in 2000, but rose to €361.2 million in 2010.
Statutory procedures
The Bill will deal with statutory procedures governing the supply, reimbursement and pricing of medicines and other items to patients under the GMS and community drug schemes. The aim is to ensure better value for the taxpayer and help to reduce budgetary overruns in the Department of Health.
The introduction of the Health (Pricing and Supply of Medical Goods) Act 2013 will allow for greater access to generic medicines, which will play a significant part in driving down budgetary overruns and significantly reduce the costs of medicines to patients, the Government believes.
The Department of Health has said it is committed to establishing high-level annual targets by the end of September for the share of generic drug penetration of the medicines market over the medium term. These targets will be informed by the findings of a recent ESRI report, which reviews the usage of generics in Ireland and comparable EU jurisdictions.
Legislation from a number of jurisdictions, including Canada, was reviewed as part of the work of the Joint Department of Health/HSE working group on reference pricing and generic substitutions.
In addition, the IMB has reviewed the policy on interchangeability of anti-epileptic drugs in a number of countries, including, Denmark, Sweden, the UK and the Netherlands.
Under the Health (Pricing and Supply of Medical Goods) Bill, the IMB has statutory responsibility for establishing and publishing a list of interchangeable medicinal products. Responding to Dáil questioning, Minister of State Alex White told Labour Deputy Dominic Hannigan that, in deciding whether to add a group of medicinal products to that list, the Board must be satisfied on a number of grounds regarding each medicinal product that falls within the group.
Medicines must have the same qualitative and quantitative composition in each of its active substances as each of the other medicinal products that fall within the drug group.
In addition, medicines must be in the same pharmaceutical form as — or in a pharmaceutical form that is appropriate for substitution for — each of the other products in the group. The medicine must have the same route of administration as each of the other medicinal products that fall within the group.
One group that has been very vocal on the changes have been neurologists, who plan to write ‘Do not substitute’ on prescriptions for epilepsy drugs. “You are within your rights to say that as a doctor,” said Dr Kevin Murphy, Consultant Neurologist, Sligo General Hospital.
“That is an avenue which can be pursued. If I have an existing epilepsy patient, I would not want to see generic substitution. If a patient’s epilepsy is well controlled, you do not want to run the risk. If a person — who has been seizure-free for years — has a seizure, there are consequences for their driving and self-confidence.”
Many of the epilepsy drugs are known by their brand names. ”You depend on consistency of production and the constitution of the drug. If a patient’s epilepsy is well controlled on a drug and a decision is taken to substitute that medicine with another brand (or a generic), the patient may not be getting the same level of the drug,” said Dr Murphy, who added that there was evidence of this in the literature.
At one point, generic substitution was a major issue in the US — particularly in relation to epilepsy. This phenomenon was widespread a few years ago, said Dr Murphy. “We don’t have a problem if you are starting treatment with an epilepsy drug. The prescriber could start with a generic, provided he or she sticks with that.”
The IMB is now due to come up with a list of interchangeable drugs, and Epilepsy Ireland has said it will seek to influence matters at this level.
Anti-epileptic drugs
Minister White has said he is satisfied that the provisions of the new legislation address concerns raised in relation to the substitution of anti-epileptic drugs. “Generic medicines must meet exactly the same standards of quality and safety and have the same effect as the originator medicine,” said Minister White. “All of the generic medicines on the Irish market are required to be properly licensed and meet the requirements of the Irish Medicines Board.”
To further enhance the patient safety aspect of generic substitution, Section 13 of the Bill allows a prescriber to indicate on a prescription that a branded interchangeable medicinal product should, for clinical reasons, not be substituted, the Minister stressed.
Gary Culliton reports on the passing of the new Health Bill and the remaining concerns of neurologists regarding the switching of anti-epileptic drugs.
The commencement of the Health (Pricing and Supply of Medical Goods) Act 2013 will allow for the introduction of a system of generic medicine substitution and reference pricing, the Government has pledged.
The Irish Medicines Board (IMB) will now commence a review of an initial 20 active substances, which equates to approximately 1,500 individual medicines. From the end of the year onwards, hundreds of thousands of prescriptions will be subject to generic substitution, “which will offer choice and reduced prices to patients”, the Government believes.
The new system has been introduced following a rise in the costs of drugs to the State, which increased by 221 per cent in the ten years to 2010. Between 2000 and 2010, the cost of drugs under the General Medical Scheme (GMS) increased from €338.8 million to €1.23 billion, and the cost of drugs under the Drugs Payment Scheme increased from €140.6 million to €173.4 million. The Long Term Illness Scheme cost €41.7 million in 2000 and €126.9 million in 2010. High Tech drugs scheme spending was €51.9 million in 2000, but rose to €361.2 million in 2010.
Statutory procedures
The Bill will deal with statutory procedures governing the supply, reimbursement and pricing of medicines and other items to patients under the GMS and community drug schemes. The aim is to ensure better value for the taxpayer and help to reduce budgetary overruns in the Department of Health.
The introduction of the Health (Pricing and Supply of Medical Goods) Act 2013 will allow for greater access to generic medicines, which will play a significant part in driving down budgetary overruns and significantly reduce the costs of medicines to patients, the Government believes.
The Department of Health has said it is committed to establishing high-level annual targets by the end of September for the share of generic drug penetration of the medicines market over the medium term. These targets will be informed by the findings of a recent ESRI report, which reviews the usage of generics in Ireland and comparable EU jurisdictions.
Legislation from a number of jurisdictions, including Canada, was reviewed as part of the work of the Joint Department of Health/HSE working group on reference pricing and generic substitutions.
In addition, the IMB has reviewed the policy on interchangeability of anti-epileptic drugs in a number of countries, including, Denmark, Sweden, the UK and the Netherlands.
Under the Health (Pricing and Supply of Medical Goods) Bill, the IMB has statutory responsibility for establishing and publishing a list of interchangeable medicinal products. Responding to Dáil questioning, Minister of State Alex White told Labour Deputy Dominic Hannigan that, in deciding whether to add a group of medicinal products to that list, the Board must be satisfied on a number of grounds regarding each medicinal product that falls within the group.
Medicines must have the same qualitative and quantitative composition in each of its active substances as each of the other medicinal products that fall within the drug group.
In addition, medicines must be in the same pharmaceutical form as — or in a pharmaceutical form that is appropriate for substitution for — each of the other products in the group. The medicine must have the same route of administration as each of the other medicinal products that fall within the group.
One group that has been very vocal on the changes have been neurologists, who plan to write ‘Do not substitute’ on prescriptions for epilepsy drugs. “You are within your rights to say that as a doctor,” said Dr Kevin Murphy, Consultant Neurologist, Sligo General Hospital.
“That is an avenue which can be pursued. If I have an existing epilepsy patient, I would not want to see generic substitution. If a patient’s epilepsy is well controlled, you do not want to run the risk. If a person — who has been seizure-free for years — has a seizure, there are consequences for their driving and self-confidence.”
Many of the epilepsy drugs are known by their brand names. ”You depend on consistency of production and the constitution of the drug. If a patient’s epilepsy is well controlled on a drug and a decision is taken to substitute that medicine with another brand (or a generic), the patient may not be getting the same level of the drug,” said Dr Murphy, who added that there was evidence of this in the literature.
At one point, generic substitution was a major issue in the US — particularly in relation to epilepsy. This phenomenon was widespread a few years ago, said Dr Murphy. “We don’t have a problem if you are starting treatment with an epilepsy drug. The prescriber could start with a generic, provided he or she sticks with that.”
The IMB is now due to come up with a list of interchangeable drugs, and Epilepsy Ireland has said it will seek to influence matters at this level.
Anti-epileptic drugs
Minister White has said he is satisfied that the provisions of the new legislation address concerns raised in relation to the substitution of anti-epileptic drugs. “Generic medicines must meet exactly the same standards of quality and safety and have the same effect as the originator medicine,” said Minister White. “All of the generic medicines on the Irish market are required to be properly licensed and meet the requirements of the Irish Medicines Board.”
To further enhance the patient safety aspect of generic substitution, Section 13 of the Bill allows a prescriber to indicate on a prescription that a branded interchangeable medicinal product should, for clinical reasons, not be substituted, the Minister stressed.