POSITION PAPER November 2011 IMPROVING ACCESS TO MODERN CATARACT SURGERY IN EUROPE THROUGH EXPANDING PATIENT CHOICE. Page 1 of 8

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1 POSITION PAPER November 2011 IMPROVING ACCESS TO MODERN CATARACT SURGERY IN EUROPE THROUGH EXPANDING PATIENT CHOICE Page 1 of 8

2 Contents SUMMARY... 3 DEFINITIONS... 5 MONOFOCAL INTRAOCULAR LENSES AS STANDARD CATARACT TREATMENT... 5 ADVANCED TECHNOLOGY INTRAOCULAR LENSES... 6 RESTRICTIONS OF PATIENT CHOICE IN EUROPE... 6 POSITION OF THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE (EESC)... 7 POSITION OF THE EUCOMED OPHTALMOLOGY WORKING GROUP... 7 ABOUT EUCOMED... 8 Page 2 of 8

3 SUMMARY Patients in Europe undergoing cataract surgery should be made aware of all the treatment options available and should be able to choose which type of lens they want to have implanted into their eyes. This is in line with the EU Cross-border Directive, which states that healthcare providers should provide relevant information to help individual patients make an informed choice, including the range of treatment options 1. Patients should no longer lose the public health insurance for the reimbursement of the cataract surgery when they wish to have an advanced technology intraocular lens implanted. There are two types of intraocular lenses available to replace the patient s natural lens when he or she has developed a cataract: 1. Monofocal intraocular lenses, which only provide good vision at long distances 2. Advanced technology intraocular lenses, which in addition to correcting distance vision can also simultaneously correct presbyopia and/or astigmatism. Advanced technology intraocular lenses fall into two categories: a. Presbyopia-correcting intraocular lenses, which provide patients with good near, middistance and distance vision; b. Toric intraocular lenses, which provide patients the added benefit of correcting astigmatism in order to have even better distance vision than available with a monofocal intraocular lens. Generally in Europe, patients are reimbursed by the public health insurance system for their cataract surgery if they are implanted with a monofocal intraocular lens after the removal of the cataract. The residual presbyopia or astigmatism has to be corrected following the surgery, and this is traditionally corrected with spectacles, which patients must pay for themselves. However, when the patient requests an advanced technology intraocular lens to be used after the removal of the cataract (a reimbursable illness), so that they can correct everything at once and avoid the secondary purchase of spectacles, the patient loses their right to basic cataract disease reimbursement, and has to pay for the entire medical procedure out of their own pocket. This is known as the All or Nothing principle. Eucomed s Ophthalmology Sector Group does not favor the All or Nothing principle and holds the opinion that patients should be allowed to choose advanced technology intraocular lenses and pay the incremental costs for implanting them (the difference in cost between a monofocal intraocular lens and an advanced technology intraocular lens and procedure), without losing their underlying right to reimbursement for the basic cataract surgical procedure. The additional payment of the patient, also known as co-payment, benefits the patient and will not increase government healthcare expenditure. Page 3 of 8

4 Patient informed choice and co-payment Patients wishing to know about the different lenses available should be informed of the different (treatment) options. One of these options is the choice for advanced technology lenses through copayment. Co-payment is a payment made by an individual who has health insurance to offset some of the cost of care. Eucomed and the Ophthalmology Sector Group do not favor co-payment schemes in general but make an exception for cataract surgery due to the very specific circumstances of this treatment. After cataract surgery all patients will need to correct their near- and mid- distance vision, which can be done through purchasing spectacles (reading glasses and in some cases additional glasses for mid-distance vision) or through the use of an advanced technology intraocular lens (lens with built-in reading glasses). Patients with astigmatism also need to purchase spectacles in order to correct their distance vision after cataract surgery, or they could choose to implant a Toric intraocular lens (lens with build-in astigmatism correction) at the time of their cataract surgery. As patients in most cases purchase their glasses on their own account, it should also be possible for them to pay the additional costs related to implanting advanced technology lenses (the difference in cost between monofocal and advanced technology lenses and procedure) without losing their right to the underlying reimbursement for the basic procedure. Avoiding the need to purchase spectacles after cataract surgery in order to see properly at all distances is an enormous benefit for patients. All cataract patients should have the opportunity to choose and pay for this option without losing their right to the reimbursement of the basic cataract procedure. Page 4 of 8

5 DEFINITIONS CATARACT A cataract is a clouding (opacity) of the natural lens in the eye that results in blurred vision. Left untreated this will lead to blindness. Most cataracts are related to aging, and within Europe, the treatment of cataracts is the most frequently performed surgical procedure. Cataract surgeries are predominantly performed on a day care basis (day surgery accounts for 90% or more of all cataract surgeries in many European countries). PRESBYOPIA Presbyopia is a condition in which a patient is unable to change the focusing distance of their eyes (for example, to read clearly at the normal position). This develops in most people between 45 and 55 years because their natural lens becomes increasingly hard with age. For the majority of people, this results in the need to wear glasses for the first time. ASTIGMATISM Astigmatism is a condition in which a patient has a variation or disturbance in the shape of their cornea. If the degree of astigmatism is great enough to cause eyestrain, headache, or distortion of vision, then prescription lenses are required for clear and comfortable vision. Approximately 64% of all patients that have cataract surgery each year have astigmatism, and will benefit from some type of correction through spectacles or the choice of a Toric intraocular lens 2. MONOFOCAL INTRAOCULAR LENSES AS STANDARD CATARACT TREATMENT The standard cataract treatment involves the removal of a patient s cloudy natural lens from inside their eye, and the implantation of a monofocal (single fixed focus) intraocular lens to replace the natural lens. This procedure will provide the patient with good quality distance vision, but leave them requiring spectacles for close and intermediate work. In addition, patients with astigmatism will most likely require spectacles for proper distance vision Original research has demonstrated that the treatment of cataracts is one of the most cost effective procedures in healthcare, as it has been demonstrated to directly improve a patient s quality of life and also reduce the number of falls amongst the elderly, when compared to those left untreated and awaiting treatment 3. Page 5 of 8

6 ADVANCED TECHNOLOGY INTRAOCULAR LENSES Technology now exists which allows patients undergoing cataract surgery the choice of having their presbyopia, astigmatism or both, corrected at the same time as having their cataracts treated - all within the same procedure. This can be achieved by implanting an advanced intraocular lens which corrects for more than just distance vision. Advanced technology lenses such as multifocal, accommodating and Toric intraocular lenses are capable of providing improved vision for near and intermediate distances, in addition to distance vision, to help alleviate presbyopia and/or astigmatism, thus improving the quality of their post-surgery vision and greatly reducing the patients dependency on glasses for reading and other near-distance tasks. Advanced technology intraocular lenses are rapidly gaining popularity and acceptance with ophthalmologists, clinicians and standards-setting agencies 4 around the world, based on the benefits they can provide to patients. RESTRICTIONS OF PATIENT CHOICE IN EUROPE Generally in Europe, patients are reimbursed by the public health insurance system for their cataract surgery if they are implanted with a monofocal intraocular lens after the removal of the cataract. The residual presbyopia or astigmatism has to be corrected following the surgery, and this is traditionally corrected with spectacles, which patients must pay for themselves. However, when the patient requests an advanced technology intraocular lens to be used after the removal of the cataract (a reimbursable illness), so that they can correct everything at once and avoid the secondary purchase of spectacles, the patient loses their right to basic cataract disease reimbursement, and has to pay for the entire medical procedure out of their own pocket. This is also known as the All or Nothing principle and leads to the following dilemmas for European patients: If a patient accepts that the implant after surgery will give only good distance vision and it is thus necessary to buy glasses for near and mid-distance vision, ALL costs of the cataract surgery, including the standard intraocular lens, are reimbursed. If a patient wants good near, mid-distance and distant vision after cataract surgery or correction of their astigmatism, and thus chooses an advanced technology intraocular lens, NONE of the medical procedure is reimbursed. It is not even possible for patients to pay the difference between the standard lens and the advanced technology lens (and procedure.) It is important to separate the removal of a cataract from the implantation of a specific intraocular lens. In most countries the cataract reimbursement decisions and policies were formulated when only monofocal intraocular lenses were available and accepted as the industry standard for correcting patients vision after cataract surgery. The removal of a cataract should still fall under the same set of decisions that led to the current reimbursement guidelines. However, the introduction of advanced technology intraocular lenses provides a further refractive correction opportunity that has proven and profound patient benefits. Patients should have the option to choose this refractive benefit without losing reimbursement for the removal of a cataract. Page 6 of 8

7 POSITION OF THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE (EESC) One of the opinions of the European Economic and Social Committee on the report Dealing with the impact of an ageing population on healthcare and welfare systems 5 is that systems for additional payments and complementary insurance should be made more flexible. The text stresses the importance of age-related cataract and the burden it represents by including it in the list of age-related conditions - which also include cancers and Alzheimer disease. Considering the impact of age-related conditions on ageing societies and the need to provide elderly patients with the most appropriate care and treatment, the European Economic and Social Committee suggests making systems for additional payments and complementary insurance more flexible. The report has been drafted upon a request from several departments (Directorates-General) of the European Commission. POSITION OF THE EUCOMED OPHTALMOLOGY WORKING GROUP Eucomed s Ophthalmology Sector Group does not favor the All or Nothing principle and holds the opinion that patients should be fully informed and allowed to choose advanced technology lenses and be allowed to pay the incremental costs associated with implanting these lenses (i.e., the difference in cost between monofocal and advanced technology lenses and procedure). The additional payment of the patient, sometimes known as a co-payment, benefits the patient and will not increase government healthcare expenditure. This is in line with the EU Cross-border Directive, which states that healthcare providers should provide relevant information to help individual patients make an informed choice, including the range of treatment options 1 References 1. EU Cross-border Healthcare Directive, Official Journal of the European Union, April 2011, Recital 20, Article 4.2.b. 2. Ferrer-Blasco T, Montés-Micó R, Peixoto-de-Matos SC, González-Méijome JM, Cerviño A. Prevalence of corneal astigmatism before cataract surgery. J Cataract Refract Surg Jan;35(1):70-5. N = 4540 eyes 3. S Brannan, C Dewar, J Sen, D Clarke, T Marshall, P I Murray. A prospective study of the rate of falls before and after cataract surgery. Br J Ophthalmol 2003;87: National Institute of Health and Clinical Excellence Multifocal IOL review June SOC/367 - CESE 972/2010 The impact of population ageing on health and welfare systems, 15 July 2010 Page 7 of 8

8 ABOUT EUCOMED Eucomed represents the medical technology industry in Europe. Our mission is to make modern, innovative and reliable medical technology available to more people. Eucomed members include both national and pan-european trade and product associations as well as medical technology manufacturers. We represent designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. The industry we represent employs more than 500,000 highly skilled workers, turns over 95 billion per year, invests some 7.5 billion in R&D and encompasses of approximately 500,000 different medical technologies from sticking plasters and wheel chairs through to pacemakers and replacement joints. Eucomed promotes a balanced policy environment that enables the medical technology industry to meet the growing healthcare needs and expectations of society. For more information visit Page 8 of 8