Flyer Roadmap

5 Strategic framework of the road map Before a specific roadmap to market access for a drug, medical device or innovative diagnos- tic product is drawn up, the basic framework conditions should be defined. Once this strate- gic framework has been established, the operational details are designed and specified. Pricing decision With regard to setting the "right" ex - factory price, there is no simple formula. The pricing decision is always complex and should involve a number of considerati- ons: How high is the product benefit? How high does it compare to the usual standard of care? Is there a risk of re - and or parallel imports due to inconsistent international pricing? Is it a short - term or long - term therapy? Do patients have to participate in the financing? What is the willingness - to - pay for the product? Irrespective of the manufacturer's fixed selling price, it is important to know, if possible before market entry, whether you want to offer and use the product in several care segments with different reimbursement mechanisms (outpatient and inpatient, nursing or homecare). These strategic criteria influence the struc- ture of the road map. Decision on the care sectors Of central importance for the final road map to market access is the choice of the relevant care sector in which the product is to be used and reimbursed. The main directional decisi- on is between the outpatient and inpatient sectors. The outpatient sector is subject to the authorization requirement, while the inpatient sector is subject to the prohibition require- ment. In addition, different reimbursement procedures and mechanisms apply in each case. Beyond these two central care sectors, there are other areas with their own specific regulati- ons, such as the nursing sector, homecare, hospice care and other specialized areas of care. Decision on the payer segments There are far fewer choices here, as more than 90% of the population is insured with GKV funds. Nevertheless, it may be advisable to initially target only the self - payer submarket and/ or the PKV market and only then seek broad reimbursement from the GKV funds. The temporal sequence is the key point here, for example initial only self - payers and PKV in- surants as well as GKV insurants with corresponding PKV supplementary insurance. Sometimes other payers, such as the nursing care insurance or also the professional associ- ation can be of importance.