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Hurdles and Aids    -    product evaluation, benefit assessment and market access

Competence in the Market Access of Medicinal Products and Medical Devices

Hurdles

when accessing the market

Assistance

for Market Access

Upfront Assessment

 

Conditions for accessing a market in Germany are very complex, in some respects even complicated. Has this been taken into consideration so

far?

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.

 

https://www.novartis.de/

Market Access Medical Devices Pharma Marktzugang von Arzneimitteln weltweit