Hurdles and Aids - product evaluation, benefit assessment and market access
Competence in the Market Access of Medicinal Products and Medical Devices
when accessing the market
for Market Access
Conditions for accessing a market in Germany are very complex, in some respects even complicated. Has this been taken into consideration so
If so, sufficiently?
Framework and Special Demands
We identify and sort out for you the relevant conditions and thus form the basis for decisions by means of
· a succinct portrayal of the relevant paths to registration, DRG-coding and coverage of costs through health insurance based on current law and the Resolutions of the Common Federal Committee
(Beschlüsse Gemeinsamer Bundesausschuss, G-BA).
Assessment of Products
Is there really a promising product with a sound line of argument that is beneficial to the patient's health, guaranteeing an 'early benefit evaluation'?
What's the status quo?
The Relevant Product Profile
and its Clinical Added Value
We analyse and specify for you the preconditions for a product with evidence-based additional benefits and enable you to make decisions by means of
· the depiction of the regulatory requirements for the prospective planning of the clinical development program, give retrospective expertise advice on epidemiological data and the medical demands based on current clinical guidelines.
Assessment of Market Access
Where are you if you look at the total access-to-the-market process?
Are there any sustainable, easytounderstand, meaningful measures, means and media for Sales & Marketing (launch)?
The Way to the Clinical User and Patient
We develop and prioritise for you the Marketing & Sales schedule for a successful Marketing & Sales launch by means of
· the characterisation of diagnosis-based patient potentials in the
clinical and outpatient area, as well as
· the structures of the decision-makers on the target market and
· the determinnation of your options for the product positioning as
well as sales and communications planning.
Assessment of Market Processes
Is there a planning process for implementing the launch?
Were business targets set with regard to roll-out, market entry, sales or other operational measures?
Operational Success and Outlook
We assist you to raise the chances for a successful market launch by means of
· decision support for the allocation of resources based on exemplary scenarios of market penetration, product sales, reimbursement, and the effects on the operative business.
· a sales model tailored to the needs of the market, i.e. a key account and/or sales rep-based approach
Assessment of Organisational Progress
To implement a fully successful launch, it is of decisive importance to consolidate all forces involved.
What is the required preparation like for identification, mental motivation, and targeted communication?
A Holistic Pragmatic Approach
We assist your launch project organisation in implementing the common targets by means of
· bringing together market-access relevant internal competences at an early stage, identifying the targets in a transparent manner and reaching smooth agreement on tasks and outcome.
CC agency partner for strategic communication design
International Licensing Groups
European Pharma Licensing
Pharmaceutical Licensing Group Limited UK (PLG)
Pharmaceutical Licensing Group Benelux (PLGB)
Nordic Pharma Licensing Group (NPLG)
Pharma Licensing Group Spain (PLGS)
Pharma Licensing Club France (FPLG)
Swiss Healthcare Licensing Group (Swiss HLG)
Pharmaceutical Licensing Group Italy (PLG-Italy)
Japanese Pharma Licensing Association (JPLA)
PLG CEE Pharmaceutical Licensing Group Central and Eastern Europe
Canadian Healthcare Licensing Association (CHLA)
DiBe Consulting Member of
Pharma-Lizenz-Club Deutschland (PLCD)
Deutsche Fachgesellschaft für Market Access
BIO Deutschland -
Branchenverband der Biotechnologie-Industrie
Forum MedTech Pharma
Health Care Bayern e.V.
Market Access Medical Devices Pharma Marktzugang von Arzneimitteln weltweit