I thank the Chairman and members for the opportunity to present on behalf of the Irish Osteoporosis Society. I would like to give a quick introduction before proceeding. I am accompanied today by Ms Aoife Ní Eochaidh, a board member of the society, who is a chartered physiotherapist and specialist in women's health issues, and another IOS board member, Ms Maureen Murphy, who has osteoporosis and has suffered some of the consequences of generic substitutions. I am a consultant rheumatologist, and I know few people in the room. I have worked in the field of osteoporosis for a long time and I have been involved in clinical research, trials and observational studies for diagnosis, management and treatment of osteoporosis. I have written research papers, review articles and book chapters. I currently see many patients with osteoporosis with my colleagues in Galway, where we run an outpatient osteoporosis service, fracture liaison programmes, an in-patient consultation service, bone densitometry services and research. We also run a certification course in bone densitometry every year, which is recognised by international societies.
The Irish Osteoporosis Society wishes to have osteoporosis medications included with anti-epileptic drugs in being exempt from substitution with generics. The rationale for generic substitution is that a designated interchangeable medicine will have the same quality and clinical efficacy as the branded equivalent.
For the information of members I will explain briefly what osteoporosis is and how we treat it. Osteoporosis is a disease of men and women which results in fragile bones that are easy to break with very little trauma - for example, upon coughing, sneezing or bending down to tie shoes. The problem with osteoporosis is fractures, which means broken bones. The lifetime risk of fractures for a 50 year old white female today is one in two for the rest of her life and one in five for a man. Fractures are associated with increased morbidity - that is, associated medical problems such as pain, suffering and depression - and mortality, which is the risk of dying, and increased risk of future fracture. Fractures are preventable, and the goal of treatment is solely fracture prevention. More post-menopausal women suffer fractures each year than the total number of women who develop breast cancer, suffer a stroke or a heart attack, or die from cardiovascular disease. This has been shown in multiple studies of hundreds of thousands of women.
Osteoporosis is a major problem in Ireland. We estimate that about 300,000 people have osteoporosis currently; there are approximately 20,000 osteoporosis fractures annually in Ireland. Treating such fractures is expensive. We spend more than €225 million annually treating them. This number is projected to double by 2020 and triple by 2030. Of note, we spend approximately €25 million on preventive measures such as medications. Hip fractures are the single greatest fracture problem in osteoporosis. Of the 106 bones in the average skeleton, the hip bone suffers the most serious consequences of breakage. There are about 3,000 such breakages in Ireland annually and more than 300 per year in the hospitals where I work. The average hospital stay for a person with a broken hip is about 18 days, at a cost of about €13,000. Fewer than a third of these patients go directly home from hospital, and fewer than 50% regain fully functional independent living. Around 35% of men will die in the year following a fracture, and 20% of women.
The doctor is the best placed person to prescribe medications for any disease, depending on an individualised clinical assessment of fracture risk, the effectiveness - which encompasses not just efficacy but compliance and ease of administration - and safety of a drug, including side effects, any additional disorders or concerns the patient may have, and cost. Cost represents not just the direct cost of the medicine but also indirect costs incurred through the pros and cons of the treatment option offered.
Osteoporosis treatment encompasses a multi-faceted approach rather than just drug treatments. Approved osteoporosis therapies have been shown to reduce the risk of fracture and to improve quality of life and to reduce the risk of dying, or mortality. Unfortunately, many patients with osteoporosis are not diagnosed or treated for their osteoporosis before or after their fracture and hence the number of fractures we encounter. Approved therapies are not all the same. There are differences in quality and there clearly are demonstrable differences in dissolution times, bioavailability and in active ingredients, resulting in different efficacies and side-effect profiles. This is not true of any drug in particular but of both branded and generic drugs. Only 1% to 2% of oral bisphosphonates are actually absorbed, if taken correctly, and they are not straightforward to take. Clinical efficacy of approved therapies have different indications because they have different efficacies. Some drugs are approved for prevention, some for treatment, some are approved for men, others for women and others for both, while some are approved for corticosteroid-induced osteoporosis.
Similar to other conditions, non-compliance is a big problem in osteoporosis and this appears to increase when generic medications are substituted. There are well-established scientific methods for designing and analysing studies to compare medical therapies, which can be complex and costly. The important clinical outcome in osteoporosis studies is demonstration of fracture prevention. There are no published studies showing equivalent efficacy for generic osteoporosis medications. Generics often are approved based on the results of small studies, even single-dose bioavailability studies in healthy subjects. This is not adequate to establish clinical safety and efficacy in osteoporosis patients who may have complex medical problems. While not many studies are available, those that do exist suggest that generic osteoporosis medications may be less efficacious, may cause more side effects and thus may be more expensive in the long run.
As I stated, osteoporosis is an expensive disease for the patient and the State. The best way to make cost savings in respect of osteoporosis is to promote bone health and to implement effective fracture prevention strategies, including use of proven therapies. Any perceived cost savings through the use of cheaper medications may be offset or actually made worse in the long run because of ancillary medication use and complications of substitution.