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Delisting products from national reimbursement lists: A dilemma to payors and a potential threat to Industry and patients

27 February 2014 Maria McGee

Having attended the LSE Risk Sharing and Managed Entry Agreements (MEA) Summit in London on 14 February, I was struck by the wide-spread audience of Industry stakeholders, patient representatives, payors and HTA members, affiliates of International bodies and healthcare academics that were represented at the Summit. While the discussion primarily centred on MEAs, with its strengths and weaknesses, the conversation also touched upon a related dilemma; namely the practice of delisting pharmaceutical products from national reimbursement lists. This controversial issue caught my attention as I discovered, through the exchange of experience and knowledge at the Summit, that it is seemingly gaining momentum- if not simply re-gaining attention- among payors in Europe.

The core justification behind the practice of delisting pharmaceutical products is that of cost-savings. As it currently stands, the practice nonetheless remains a last resort for many payors, grappling with the moral concerns raised by removing funding to an already reimbursed product from a given market and patient group. The practice presents a financial concern to the Industry and a risk to patients whom are faced with losing funding to an ongoing treatment.

On the other hand, delisting products from a reimbursement list is likely to present opportunities elsewhere in the system, as it frees up resources for other products which in turn can enter into a country's funding scheme. This benefit extends all the way from the manufacturer to the individual patient in a given population group and therapeutic area, for which the product is indicated. This trade-off is from an individual patient point of view, and for the single manufacturer, a highly sensitive one while the practice of delisting can be more easily justified at a societal level. So in other words- the risks associated with this kind of resource allocation needs to be viewed in relation to its cost-effectiveness potential.

In light of these complex factors, and also in an attempt to avoid potential media uproar, payors have historically been reluctant to frequently utilise this strategy. However, continued economic constraints and the recent discussion at the Summit suggest it is becoming a more central part of reimbursement authorities' cost-effectiveness agenda across Europe.

The current picture of delisting practices in some selected European markets indicate that delisting of reimbursement products is already taking place in some countries - Spain and Italy for instance represent countries currently engaged in this practice. Meanwhile, in Portugal, the latest amendment to the Order of Pharmacists states that delisting is imposed on generic products when the manufacturer is unable to demonstrate that its product maintains "some of the original therapeutic quality or is different to the new generic products". In Hungary, a draft legal amendment saw the price limit, beyond which a product must be delisted, raised from 30% to 50% higher than the reference price, for biologic and biosimilar products. Interestingly, the government in France recently announced it is committed to reaching its healthcare savings target without introducing delisting of reimbursed products, as highlighted in a report by IHS (Clients can find more details in the February 11 Same-Day Analysis alerts). In addition, and tying back to the main focus of the LSE Summit (MEAs) the Polish Ministry of Health (MoH) representative claimed there is an opportunity for marketing authorisation holders to engage in risk-sharing agreements with the Polish MoH, in instances where a product is under the risk of being delisted from the reimbursement list in the country.

Looking more specifically at one of the most recent delisting decisions issued by the Swedish TLV, this case suggests that the Swedish Agency looks at price and therapeutic value prior to making a decision on its continued funding. The originator product Vagifem (estradiol; Novo Nordisk, Denmark) vaginal tablets, 10mcg, indicated in the treatment of menopausal changes, was removed for the high-cost-protection scheme in October last year as the manufacturer was unable to prove its added therapeutic value over comparator products included under the reimbursement scheme. In addition, the TLV commented on its high price, which was set nearly four times as high as the price of its comparator. The criteria for issuing delisting decisions often mirrors the principles used in assessing new products for inclusion onto the reimbursement scheme, varying from country to country. Similar to Sweden, clinical effectiveness and cost-effectiveness are taken into consideration by the CVZ in the Netherlands when considering delisting a product, in addition to factors such as necessity and feasibility of care.

This brief country overview is evidently not an exhaustive picture of the delisting landscape across Europe, but provides some insight into current practice and dilemma. Out of the countries represented at the LSE Summit, payors from Sweden, Italy and the Netherlands were most active in the debate and representatives from these countries spoke avidly about the issue; calling for a continued discussion. It was agreed among various speakers present at the Summit that the practice of delisting reimbursed drugs is "rising in importance", presents an "increase in efficiency" while at the same time is "comparatively difficult" to implement. In summary, the dilemma of delisting already reimbursed products is indeed a contested one and while it is important to note that there is a distinction between discussion and implementation, the issue is nonetheless associated with certain medium-term risks.

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