Market Access

 

Your challenge

You know that a successful launch or line extension of your prescription medicine requires the expertise and capacity of many corporate divisions: Management, strategic planning, health policy, regulatory affairs, health economics, medical, marketing, sales and project management.

Our value proposition
  • Strategic and operational support in all phases before, during and after an AMNOG process: from planning of clinical trials to G-BA consultations, the preparation of dossiers and statements in accordance with section 35a SGB V to the active participation in oral hearings and price negotiations.
  • Application of the special consulting product saproma® non idem to determine and communicate the competitive added value of your prescription medicine.

 

Study planning

  • Strategic consulting for the optimization of pivotal studies with regard to current Health Technology Assessment (HTA) requirements.

Compassionate Use Programmes (CUP)

  • Strategic advice on and preparation of CUP (re)notifications according to the German Ordinance on Medicinal Products for Compassionate Use (AMHV)

AMNOG Process (section 35a SGB V)

  • Strategic consulting on the benefit assessment of medicinal products in accordance with the Act on the Reform of the Market for Medicinal Products (AMNOG) for Orphan Drugs & Non-Orphan Drugs, ATMPs & Non-ATMPs
  • Conception, establishment and management of HTA Advisory Boards
  • Strategic consulting on the development of value stories of prescription medicines
  • Consultations by the Federal Joint Committee (G-BA): Definition of questions to ask advice for. Preparation of all request forms and active participation in consultations, preparation and follow-up of minutes.

  • AMNOG Dossiers (Early Benefit Assessment): Strategic advice on the outline, evaluation and prioritization of scenarios, preparation of individual or all dossier modules, critical review
  • Application of the special consulting product saproma® non idem (net-benefit-oriented, normed, indication-specific, descriptive evaluation method) to determine patient preferences, prioritization of study endpoints and quantification of the additional medical benefit
  • Commenting procedure and oral hearings within the scope of AMNOG processes Preparation of the written statement and representation of the client´s perspective in oral hearings

Pricing & Reimbursement

  • Strategic advice on and preparation of pricing and reimbursement dossiers for prescription medicines from a German and international perspective
  • Application of the special consulting product saproma non idem (net-benefit-oriented, normed, indication-specific, descriptive evaluation method) for the additional benefit-based calculation of price corridors
  • Negotiation of the refund amount with the National Association of Statutory Health Insurance Funds (GKV-SV) according to section 130 SGB V: Strategic consulting, operational preparation and follow-up of all negotiation rounds, active representation of the client´s perspective in negotiations

  • Design of a generic risk-sharing model for the care of chronically ill patients
  • Elaboration of and advice on comments on the amendment of existing reference price groups including systematic literature search and literature evaluation
  • Advice on and preparation of applications for recognition of New Testing and Treatment Methods (NUB) according to section 6, paragraph 2 Hospital Remuneration Act (Krankenhausentgeltgesetz (KHEntgG) (Krankenhausentgeltgesetz (KHEntgG)

Real World Evidence

  • Consulting on the implementation of routine practice data collection and evaluation according to the Law for More Safety in the Supply of Medicines (GSAV)
  • Conception, organization and implementation of interactive face-to-face events for comparative benefit assessments.
  • Application of the special consulting product saproma® PRO (Patient-Reported Outcomes) for the development of concepts and instruments for an interactive patient (self-)management
  • Development and implementation of an IT-assisted Total Quality Management concept to improve the care of multiple sclerosis patients (TQMS)

  • Development of the PROMISE software (Practice-Oriented Multiple Sclerosis Information System for the Compliance with Quality Standards in the Care of Multiple Sclerosis Patients): Documentation and information system for healthcare professionals, internet and CD-ROM-supported patient self-assessment for quality management-oriented data mining
  • Development of software and hardware for a computer-aided self-assessment of wheelchair patients with hand tremor

Marketing and Sales

 

Your challenge

In your company, you have strategic responsibility for marketing and sales of prescription medicines in competitive markets. New legal framework conditions increase the number and diversity of decision-making processes relevant to you. Moreover, the type and number of your customers also change. You recognize the necessity to adapt your goals and strategies to the new market conditions.

Our value proposition
  • Qualified conception and implementation of marketing and sales measures in all phases of the product life cycle.
  • Application of the special consulting product saproma® VAN (Value Net) for the indication-related positioning of your product or your company in healthcare

 

Pricing & Reimbursement

  • Consulting on the marketing strategy for new launches
  • Launches of prescription medicines: Establishment and management of interdisciplinary, national and international product teams
  • Conception of materials for product training of in-house staff and sales force

  • Conception and testing of detail aids for sales force
  • Development of innovative product complementary services
  • Preparation or assessment of national and international (pre-)launch plans including revenue and sales planning

Healthcare Management

  • Application of the special consulting product saproma® CIP (Customer-lnitiated Projects) for the conception and management of healthcare-oriented, customer-initiated projects
  • Evaluation of the importance of patient self-assessment for outpatient and inpatient care of multiple sclerosis patients
  • Conception and implementation of a three-level, regional network for the routine care of multiple sclerosis patients
  • Network-based quality assurance in the care of multiple sclerosis patients in a municipal hospital

  • Development of a modular nurse concept to establish a competence network for the routine care of multiple sclerosis patients
  • Agreement between AOK Baden-Wuerttemberg and the Regional Association of SHI-accredited Physicians of North-Wuerttemberg (KVBW) on the promotion of structured treatment and care of patients suffering from multiple sclerosis
  • Foundation of the Association for Quality Development in Neurology and Psychiatry (QUANUP)

Customer Relationship Management

  • Stakeholder Mapping: Systematic stakeholder analyses including presentation of the impact cascade
  • Application of the special consulting product saproma® CAN (Customer-Aligned Networks) to establish and use sustainable structures for customer retention and communication

  • Implementation of satisfaction surveys of external and internal customers to optimize the service portfolio
  • Conception and implementation of sales guidelines

Medico-Scientific Events

  • Advisory boards, expert panels and satellite symposia: conception, identification of suitable experts, expert coaching, moderation of face-to-face meetings
  • Development and implementation of FSA code-compliant concepts for continuing medical education in accordance with the recommendations of the German Medical Association

  • Workshops with interactive application of the Analytic Hierarchy Process (AHP) for the comparative assessment of medicines.

General Management

 

Your challenge

You are convinced that motivation and identification of your employees with your company are essential success factors. You understand that corporate goals and strategies based on the expertise and market intelligence of your employees promote motivation and identification. You are therefore looking for effective and efficient ways of finding goals and strategies in an appreciative manner.

Our value proposition
  • Interactive, transparent development and prioritization of broadly communicable corporate goals and strategies by designing and supporting effective decision-making processes
  • Application of the special consulting product saproma® Strate for effective and efficient goal and strategy development.

 

Strategy consulting

  • Application of the special consulting product saproma® Strate for participatory goal and strategy development
  • Conception and monitoring of effective decision-making processes
  • Interactive development and prioritization of broadly communicable corporate goals and strategies

  • Application of the special consulting product saproma® VAN for the indication-related positioning of the product/company in healthcare
  • Optimization of the product portfolio to promote differentiation
  • Preparation and conceptual support of business reviews

Organizational development

  • Establishing and leading cross-functional national and international product teams

  • Establishing, managing and (re)positioning the Market Access division within a pharmaceutical company

Interim Management

 

Your challenge

You have human resources responsibility in a pharmaceutical company. Parental leave, leaving the company, reorganization or another reason has resulted in a short-term vacancy in general management, marketing or market access. Or you only need an additional personnel resource for a specific project or a limited phase in the life cycle of a product, which will relieve you of work in a very short time.

Our value proposition
  • Interim management with minimum instruction periods by experts with strong communication skills and many years of experience in a wide range of functions and therapeutic indications.
  • External management of projects in general management, marketing and market access.

 

Market Access Interim Management

  • Market Access for oncological prescription medicines
  • Market Access for pneumological prescription medicines

Marketing Interim Management

  • Marketing for neurological prescription medicines
  • Marketing for cardiological prescription medicines
  • Marketing for antibiotics
  • Marketing for a pneumological prescription medicine

  • Marketing for an analgesic
  • Marketing for an immunosuppressant
  • Marketing for endocrinological prescription medicines