sou · H0B375 · 2012-10-31 00:00:00 — Öppenvårdsapoteken behöver dock inte ha ett särskilt tillstånd för att handla med narkotiska läkemedel. Ikraftträdande (kapitel 19) Ett genomförande av utredningens förslag kräver författnings- ändringar. Författningsförslagen föreslås träda i kraft . Förutom tid för sedvanlig remissbehandling och proposi- tionsarbete kommer det krävas förberedelsetid hos berörda aktörer t.ex. för att revidera och ta fram nya föreskrifter samt utveckla IT- system. Förslaget om ny prissättningsmodell för originalläkemedel utan generisk konkurrens innebär relativt omfattande förändringar för den berörda myndigheten , men även för flera andra aktörer, t.ex. landstingen. Det är centralt att förberedelserna ges tillräcklig tid och att aktörerna samverkar i tillräcklig grad . En del av förberedelserna kan omfatta avtalsreglering av ett antal punkter mellan staten och landstingen/Kommuner och Landsting. Utredningen föreslår att får ett uppdrag om att ta fram ett gemensamt söksystem. Utredningen har lämnat förslag på reglering som krävs för att söksystemet ska kunna fungera. har redovisat sitt uppdrag kan det finnas behov av att revidera utredningens förslag. Utredningen bedömer att samtliga förslag är förenliga med EU- rätten. Förslaget om att införa tillstånd för narkotikahantering måste anmälas till . The mandate of the Inquiry is to carry out an on overview of cer- tain issues that concern pricing, supply and market conditions within the pharmaceutical and pharmacy area. This report covers issues concerning pricing, supply and dis- pensing obligations as well as certain other questions of importance for retail pharmacy (öppenvårdsapotek) operations. The Inquiry shall review the pricing of original pharmaceuticals without competition from generic products and propose a long- term sustainable pricing model. A starting point for a future pricing model, according to the Inquirys directive, is that it must create preconditions for good cost control and for pharmaceutical prices to be below, or on a level with, comparable countries. Fur- thermore, the model must ensure the satisfactory availability of effective pharmaceuticals and offer good preconditions for the research based pharmaceutical industry. The Inquiry may also submit proposals concerning pricing and the substitution by ge- neric pharmaceuticals, on condition that at least the same price squeeze as at present is achieved and the savings that arise accrue to the public purse. The Inquiry shall survey and analyse the problems (where they exist) regarding the supply and dispensing obligation in respect of regulatory pharmaceuticals and products and, where appropriate, propose the requisite changes so that patients shall obtain such pharmaceuticals and products within a reasonable period. In addition, the Inquiry shall review certain other questions that relate to the Prescription Register and cer- tain other statutes of significance for retail pharmacies. Those aspects of the mandate which it is intended the Inquiry will consider in future reports are shown in Chapter 1. Background descriptions (Chapters 2–9) pharmaceutical costs amount to around billion annually. This covers the use of pharmaceuticals in hospitals, out- patient prescription as well as non-prescription medicinal products. The pharmaceutical costs cover payment to the pharmaceutical manufacturer for research and development of new pharmaceuti- cals, production and distribution of pharmaceuticals as well as payment for the pharmacy system, with the object of obtaining a high level of accessibility and good pharmaceutical advice. The patient pays the entire cost for non-prescription (over-the counter) pharmaceuticals and in that case the pricing is free. The patient makes a co-payment for prescribed drugs that are included in the reimbursement system and for these pharmaceuticals the prices are regulated. The prices for in-patient medication (sluten- vårdsläkemedel) are negotiated in public procurement processes and there the patient pays the patient fee that applies for the in- patient treatment concerned. The task of the Inquiry is to review the pricing model for reimbursed original prescription pharma- ceuticals. This is the single largest component of the total cost for pharmaceuticals, about billion. The patients own co- payment towards this cost amounts to about 20 per cent, the re- maining part being paid by the relevant county council (landsting) and this is financed through a special central government grant. Whether or not the total cost for pharmaceuticals, at present, is at an optimum level is not a question for this Inquiry. The stipula- tion in and Act (1982:763) that the entire population shall have access to good care on equal terms and conditions forms the basis on which the Swedish health care system shall be run. It is the responsibility of the re- gional health authorities to ensure that such takes place. Pharma- ceuticals are a self-evident part of the care provided and access to effective treatment is a prerequisite for a modern health care system. The rapid developments in the life sciences have gradually increased the benefits of pharmaceuticals for both patients and the health care system as a whole. Societys scope for financing phar- maceuticals is not, however, unlimited which underlines the im- portance of setting clear priorities and achieving the greatest possi- ble cost effectiveness. The size of the cost of pharmaceuticals is determined partly by the demographics, the general health of the population, assessments and the availability of pharmaceuticals and partly by which prices are paid and how they are procured. The mandate of the Inquiry is to develop pricing so that it leads to prices which are as attractive as possible for the public purse, at the same time as the goals of good availability of pharmaceuticals and good care on equal conditions are supported. To achieve this, it is necessary for the Inquirys analysis and proposals to start from the principle that pricing cannot be isolated as an individual issue but must function as an integral part of a whole. Total costs for pharmaceuticals rose sharply for a number of years, particularly during the 1990s. The rate of increase, however, has declined and in recent years has only been marginal. An expla- nation is that new, expensive drugs are only used to a limited ex- tent. Another important explanation is that the expiry of patents for several block-buster products opened the door to generic com- petition and substitution by generic copies at lower cost. Generics account for about half the volume but comprise only 17 per cent of the total cost. The forecast of () concerning the medication cost trend for the reimbursement system is a cost reduction in year 2012 (-2.5 per cent) and a modest rise in 2013 (1.0). This is explained mainly by changes in the incremental benefits in the high-cost threshold (högkostnadsskyddet) and the expiry of patents. For the years 2014 to 2016, the rate of increase is expected to be between 1.5 and 4 per cent per year. The development of pharmaceuticals implies ever improved treatment possibilities for an increasing number of individuals at ever higher ages. One of the great challenges in the medication field is how the public purse shall be able to afford the financing of new costly pharmaceuticals. Examples include biological drugs which is the group of pharmaceuticals that has the largest volume growth at present. These drugs, with large, complex and instable molecules, are often and with good effect at the same time as the treatment required costly. The pharmaceutical industry in makes annual invest- ments of the order of billion in the research and develop- ment of pharmaceuticals. This industry in 2011 had around 13 000 employees, exports of billion and imports of billion kronor. To develop a new drug through research is a long and costly process. It is reported to take from ten to twelve years and the average cost is in the region of billion. In order for a drug to be covered by the reimbursement scheme the company concerned applies to the Dental and (). In the application the company states the price of the product and health economic documentation is en- closed. The application is granted if TLV finds that the health eco- nomic analysis shows that the requested price is justified on the basis of the value the pharmaceutical delivers in terms of improved health, i.e. it is cost-effective. The reimbursement decision is thus based on value, which is often described in terms of ap- plying the Value Based Pricing of pharmaceuticals. In actual fact, there is free pricing under a value-based ceiling price. There are few countries that apply the value based pricing of pharmaceuticals. Moreover, is more or less alone in wid- ening the analysis from a health care perspective to include the effects which reduced sickness rates imply for e.g. the social insur- ance system and industrial production. This means that has a relatively high willingness to pay. Most EU countries apply inter- national reference pricing in some form, instead. International comparisons of pharmaceutical prices show that has prices that are on a level with comparable European countries where new pharmaceuticals are concerned. On the other hand, the prices for older pharmaceuticals are shown to be higher in than in comparable countries. One explanation for this may be that in those countries that apply international reference pricing the actual prices are changed annually, which delivers a gradual adjustment to lower prices. The Swedish price model is relatively undynamic. Dynamism occurs only after the patent ex- piry date, when the product is subject to generic competition within the generic substitution framework. During the patent pro- tection period, normally about ten years, prices in principle are only changed as a consequence of TLV initiating a review of its reimbursement decision. The bargaining power is weak however since TLV can only push for credible price reductions on products which, owing to competition from equivalent products, are no longer cost-effective. This results in very weak price dynamism up until patent expiry which means that the prices in are higher in comparison with other countries. Considerations and proposals for new pricing model for original pharmaceuticals without generic competition (Chapter 10) The mandate of the Inquiry is to develop pricing of original pharmaceuticals without generic competition. As described above, the mandate has the aim of ensuring attractive prices during the entire life cycle of the medicinal product. However, the pricing cannot be seen in isolation but needs to be function within its larger context. In order for the pricing model (in the following also designated the price model) to be sustainable over the longer term the Inquiry considers that it must be able to guarantee advanta- geous prices for the public purse, support innovation across the entire value chain and promote a proper use of pharmaceuticals. The Inquirys proposals therefore include, besides proposals for changes in how the pricing works, also parts that cover increased possibilities for collaboration between the health care system and the pharmaceutical industry, enhanced follow-up and evaluation of new pharmaceuticals as well as better support for decisions, e.g. in the form of more systematic cost-effectiveness assessment of in- patient drugs. The current value-based reimbursement decision as applied in permit a relatively high willingness to pay for innovative drugs. Through basing the reimbursement decision on the assess- ment of cost effectiveness it is ensured that also very expensive pharmaceuticals can be used in health care, on condition that the price is proportionate to the value in terms of improved health outcomes. In this way, the value based model supports research and development of new cost-effective medicinal products. The price model, nevertheless, must also support the adoption and use of new innovative products also after they have been found to be cost-effective. To enable this to take place efficiently it is necessary that assessments of the cost effectiveness and the pricing are integrated into a wider context. Within the framework of the national pharmaceutical strategy, a project is now under way with the object of creating a national introduction process for pharma- ceuticals in . The price model and assessments of cost ef- fectiveness based on early follow-ups should be viewed as natural elements in such a process and constitute important bases for deci- sion which can contribute to the good use of pharmaceuticals. It is the judgement of this Inquiry that both the price model adopted and access to background material on the pharmaceuticals cost effectiveness influence the decisions of county councils re- garding utilisation of a particular drug. New pharmaceuticals may be innovative or not, cost effective or not, as the case may be. De- cisions concerning how early and extensive the utilisation of new pharmaceuticals shall be, need to be based on data concerning their cost effectiveness to a greater extent than at present. Such back- ground data is required for both in-patient and out-patient drugs. The Inquiry proposals facilitate the release of resources for such analyses. A challenge for the price model is to deliver as advantageous prices as possible. A very costly pharmaceutical may be cost- effective for a limited treatment group. Too high prices imply that patient groups cannot be provided with access to existing treat- ments. For this reason, it is of the greatest importance to seek to achieve as advantageous prices as possible for the public purse. The Inquiry has adjudged that the existing price model needs to be de- veloped to meet the challenge posed by ever more very expensive treatments, e.g. biological pharmaceuticals. The Inquirys proposals are to retain todays value based pricing for new pharmaceuticals, but to develop the application mainly in respect of the link price-volume to introduce international reference pricing (IRP) after 5 years, with further amplification after 10 years for the county councils and the pharmaceutical industry to enter collaboration agreements for follow up, evaluation and dis- counts for those pharmaceuticals that in other countries are handled as in-patient pharmaceuticals and where the treatment cost per patient or the product cost per pack is high and where there are several therapeutic alternatives or for new, innovative pharmaceuticals that are identified within the framework of the national introduction process which is being drawn up within the context of the national pharmaceutical strategy. A precon- dition is that such agreements are drawn up for sufficiently large regions, on the basis of a broad community perspective, as well as in close collaboration with the Dental and () in respect of prioritisation and cost The agreements must not imply negative effects for the pharmacies changeover to parallel-imported products. to introduce a threshold limit for entitlement to reimbursement in order to simplify and facilitate for companies as well as to re- lease investigative resources on behalf of all kinds of pharma- ceuticals and technology products to enable retail pharmacies to negotiate the purchase price of so- called non-substitutable generic products in the same way as with other non-substitutable pharmaceuticals and thereby ex- pand the parallel import share to utilise the savings that arise through reduced prices to stimu- late innovation and well-developed collaboration between the health care sector and the pharmaceutical industry, an improved follow-up and evaluation, improved use of pharmaceuticals etc. Through introducing a ceiling price updated annually based on IRP, when a pharmaceutical is subsidised during five years, in con- junction with other proposals from the Inquiry approximately billion annually is released. Whether this implies consequences for the total cost of pharmaceuticals remains a question for the regional health authorities and how decisions on the use of phar- maceuticals are taken. The Inquiry is of the opinion, nevertheless, that more advantageous prices, possibilities for expanded co- operation between the health care sector and the pharmaceutical industry as well as greater use of background data on the cost ef- fectiveness as a whole strengthens the conditions for optimising the pharmaceutical spend and attaining the objectives concerning good health care on equal terms across the population in . Furthermore, the proposal on consolidating part of the savings achieved to stimulate innovation within the pharmaceutical area should be significant here. Lower prices affect the pharmacies in the form of lower pay- ment through gross and the decrease in parallel imports. The gross (trade ) is estimated to show a decline of about million. The parallel import, as a consequence of lower prices, is expected to decline and to to a level applica- ble at the time of the re-regulation of the Swedish pharmacy mar- ket. However, the pharmacies are given compensation for the decline through the Inquirys proposal to give the pharmacies the right to negotiate purchase prices on so-called non-substitutable generic pharmaceuticals and the increase in parallel imports that is expected to arise through this proposal. Proposals for lower prices affect pharmaceutical companies mainly in respect of earnings on older products which have been subsidised for more than ten years. The price effect on the compa- nies is limited through part of the former parallel import being reduced. A developed price model give the health authorities better pre- conditions for meeting the challenges that the launch of new, ever more numerous and very expensive pharmaceuticals entails. The model combines the benefits of value based pricing by conceding high willingness to pay for new, innovative pharmaceuticals with reference pricings simple and transparent method in this context for achieving increased price dynamism. Regional collaboration agreements with pharmaceutical companies offer further scope for combining risk sharing arrangements with collaboration on follow- up and evaluation. The regional collaboration agreements can, if correctly applied, fulfill a central function in the innovation system and in the system for rapid assessment and deciding making re- garding the use of new pharmaceuticals. However, this puts high demands on the application of this by the county councils. A pre- requisite is that such agreements are drawn up for sufficiently large regions on the basis of a broad social perspective as well as in close interaction with the Dental and () concerning prioritisation and cost-effectiveness analyses. The more detailed forms of such collaboration should be agreed between the central government and county councils/Authorities and Regions. Certain collaboration agreements are subject to judicial review and supervisory matters at TLV. The Inquiry is unable to anticipate these processes. The legal position may therefore be considered to be somewhat unclear and it may be necessary, when the judicial reviews are concluded, to review the regulatory framework. Collaboration agreements between the health care system and pharmaceutical companies are also expected to become an im- portant instrument for both the supply of pharmaceuticals and cost control, e.g. the systematic introduction of new pharmaceuticals in respect of joint creation and diffusion of knowledge in health care, the follow-up of results and the sharing of data with pharmaceutical companies concerning medicinal results in clinical practice. All in all, this increases the , at an earlier stage than at present, of identifying and optimising the use of new, inno- vative products. evaluations also provide improved founda- tions for deciding upon the cost effectiveness of pharmaceuticals in day-to-day clinical use. Besides new drugs, it is proposed that the regional collaboration agreements could also cover high cost products that are handled as out-patient care in but which in comparable countries are procured within in-patient care. For such products there do not exist relevant public prices in comparable countries. International reference pricing does not therefore offer a relevant price for these products. Discount agreements as part of a wider collaboration agreement may solve this particular pricing problem. A discount agreement means that county councils in receive compen- sation from the pharmaceutical company concerned. Such a dis- count is frequently calculated on the basis of the Pharmacy Pur- chase Price (AIP). Since the Pharmacy Purchase Price is not af- fected by the collaboration agreement it is slightly misleading to speak of discounts. Nevertheless, it is a term that is commonly used, e.g. in the case of the public procurement of in-patient drugs by the county councils. Other terms used are repayment and re- fund. High willingness to pay through value-based reimbursement de- cisions for new products means that is adjudged to be, also in future, an attractive market for an early launch of new products. In discussions on the effects of the price model on the availability of new products there is often a focus on possible, negative effects of using international reference pricing. Of the total bil- lion released through the Inquirys proposals, million derives from pharmaceuticals covered by the benefits scheme of up to ten years. For these pharmaceuticals, where most are covered by patent protection, the income effect of the price change is thus limited. On average, this implies small price reductions but for certain individual products it may mean quite significantly lower costs. This, in itself, should have a positive effect on the use of pharmaceuticals. significant, however, is the effect of the price reduction on products that have been subsidised for more than ten years. These cost reductions release resources that enable increased use of new, innovative and cost-effective products. For patients, the released resources mean that more of them can be afforded treatment. A clear and systematic national introduction process for pharmaceuticals strengthens the twin objectives of having new pharmaceuticals being used as widely as possible as soon as possible and, at the same time, avoiding the emergence of regional divergences. An important factor from the patient view- point is equal access to good care across the country. It is therefore of central importance when regional collaboration agreements with pharmaceutical companies are concluded, that county councils (with responsibility for health care) co-operate well both between one another and with the relevant national au- thorities e.g. TLV. The ambition must be that all patients can be offered equivalent care regardless of the county council to which they belong. A natural forum for identifying those pharmaceuticals where collaboration agreements can provide added value for pa- tients, the health care system and companies is the future national introduction process for pharmaceuticals. An additional patient factor is the access to pharmaceuticals. Retail pharmacies in constitute an extended arm of the health care system through distribution of pharmaceuticals and pharmaceutical advice to patients. It is therefore a prerequisite that the regional collaboration agreements are so prepared that the pharmacies still have the possibility of creating added value for the patient concerning the products covered by the agreements.