Is innovative Immunotherapy Affordable to Payors?
D. Brehmer*1, C Schreder2
1Private ENT Clinic Goettingen, Witten/Herdecke University Faculty of Health / School of Medicine, Friedrichstr. ¾, 37073 Goettingen, Germany
2Stallergenes GmbH, Carl-Friedrich-Gauß-Straße 50, 47475 Kamp-Lintfort, Germany
Allergic Rhinits (AR) is a widespread problem across the world . Disease prevalence and incidence show an increasing trend. While AR is trivialized in itself, the follow-on diseases, such as allergic asthma (AA) can result in significant cost to payors.
AR can be treated in several ways. First step treatments consist of symptomatic approaches such as antihistamins, locally and systematically, or corticosteroids. These substances are known to have a positive effect on the prevalent disease, but have no long-term or preventative effect.
Allergen immunotherapy (AIT) is a treatment concept that grounds on a causal approach, as patients are exposed to the disease-causing allergen in increasing dosages. The objective is to “educate” the immune system to not react as strongly towards the allergen as in the past. Treatments like these are given over a course of 3 years, either with in an intermittent or perennial application scheme. The route of administration is either subcutaneous (SCIT) or sublingual (SLIT).
Whilst SCIT was always deemed to provide efficacy (which was not proven for the entire class), SLIT has shown increasing development potential of the past years. The launch of two grass tablets e.g. marked a new generation of AIT products with strong evidence behind it. Lately the entered the US market. But also sublingual drop products came with new compelling data recently .
An extremely important factor in AIT is the individual adherence of the patient. The course of 3 years is necessary to generate a sustainable effect. Therefore strong focus is put on this aspect. Both treatments, SCIT and SLIT, are known to have a moderate compliance [4, 5].
AIT presents significant cost over time. An average 3 years treatment is between 1,500 to 4,500 Euros in Germany. In order to come to a positive risk-benefit ratio, payors have to put an eye on the proper usage of this product range. This includes the selection of the best evidence-based (EbM) compounds and an optimal adherence.
Lately there have been discussions, if SLIT is affordable to payers simply from a budget impact perspective. The basic question was: does SLIT blow payers´ budgets? Can sickness funds simply afford innovation, such as AIT-tablets e.g.? These questions cannot be answered in one sentence. First it has to be clear that only a cost-effectiveness estimation yields at the true value of a product, as it encounters the two dimensions efficacy and cost. One SLIT product is not as the other looking at the EbM-level they present. But these days third parties sometimes just put an eye on the cost. Therefore budget impact constraints due to new entrants or follow-on developments have to be estimated.
A number of research projects have been presented in the late past around the budget impact of modern SLIT products. Ronborg and colleagues came to the conclusion that the investigated SLIT tablet is cost-saving in comparison to a SCIT compound. But within this study travel cost for patients e.g. were included as well, therefore the results need to be differentiated a little. A more straight forward budget impact analysis was presented within two health-economic congress contributions [7, 8]. Here the examined SLIT drop product and the grass tablet as an innovation were found to have both a positive impact on payers´ budgets. More cost analyses can be found in the literature, but they all come up with the same findings that SLIT in itself is not a pure cost-driver for payers.
There is no substantiation of the old prejudice that especially modern and EbM SLIT products blow third parties´ budgets. It is exactly the opposite as this state-of-the-art compounds present value for money, which is not always the case for elder brands.But the outcome of AIT can only be as good as the diagnosis was. And that means that a specific nasal provocation test must be performed prior to initiating AIT to confirm diagnosis of allergic Rhinitis and evaluate clinical relevance of the allergic sensitization. Unfortunately this is not always carried out; this could mean that patients receive expensive AIT only due to an allergic sensitization without clinical relevance is present.
Therefore payors should ensure an unhindered access of EbM-products to physicians and patients. Austerity measures banning the more increased use of this product class lead to a loss of quality in the provision of health care to allergic sufferers. And in the end this blows the sickness funds budgets. Not the products itself.
Scientific evolution in AIT is affordable – if payors put the right focus. The allergic march across nations can be slowed down systematically, if physicians are enabled to provide care with more user-friendly, effective and cost-sparing treatment alternatives. Patients need to be granted access to these innovations. The allergologic societies in the countries have to take responsibility to convey this message to their political counterparts.