Case Studies

Case 1: Written statement and oral hearing revise the initial benefit assessment of the IQWiG

Topic: Preparation and support of the hearing procedure
Client: Biopharmaceutical company based in the United States
Active Ingredient: Immunmodulator

Challenge

  • Our client was in the middle of the benefit assessment process according to § 35 a SGB V (AMNOG-Procedure) when we were assigned to this this project. Previously, the dossier to a newly launched product was negatively evaluated by IQWIG, meaning it had no additional benefit.
  • The next important milestone was the hearing procedure with an oral hearing at the G-BA.
  • The lack of experience put considerable psychological pressure on the oral hearing team.
  • Due to its extensive oral hearing experience such as its psychological-didactical skills SKC was appointed to train the pharmaceuticals company hearing team.

Solutions and overall approach

  • The oral hearing is a key milestone in the AMNOG process: at this point the basis for argumentation for the G-BA-decision can be improved significantly.
  • In this case our hearing and negotiation training took place as four coordinated workshops.
  • The focus lay on the analysis of previously completed oral hearings for oncologics as well as the strategy development for the written statement procedure.
  • Preparation measures included:
    • the exegesis of the IQWiG-evaluation,
    • the analysis of precedent cases/the analysis of set precedents,
    • the strategy – and argumentation development,
    • the realistic oral hearing simulation,
    • the integration of key opinion leaders.
  • Core of the workshop are several rounds of realistic oral hearing simulations in form and content. The experience gained from the simulation is used as a learning platform for future procedures.

Outcome

  • It was possible to relativize the IQWiG-evaluation during the hearing. The G-BA decision and the main reasons extensively considered the value messages, which were developed and communicatively prepared with the client. A significant additional benefit was granted for the entire population.
  • The points of criticism of the individuals entitled to attend the hearing were anticipated and prepared for in advance, so that their positions were convincingly refuted on the basis of objective arguments.
  • The oral hearing team had internalized a consistent tactic and was perfectly compatible. The roles within the team were clearly defined according to the respective strengths and the oral hearing proceeded very smoothly.
  • The feedback from within the company and from the head of the G-BA was very positive.

CASE 2: Strategic support and negotiation management throughout the entire launch of an innovative product in the German market (AMNOG)

Topic: Strategic market access
Client: An internationally operating pharmaceutical company based in the UK
Active ingredient: Psychotherapeutic

Challenge

  • The German organization, which was AMNOG-inexperienced and understaffed for the procedure, had great difficulties to explain the importance of the AMNOG-process for the launch and price-setting process to the English parent company. The preparations proceeded in a fragmented and asynchronous manner.
  • Although the internationally scheduled launch date was already approaching, the value dossier preparation had only just begun.
  • SKC was assigned to support the process with a stringent project management and strategic sparring in order to compensate the lack of market access resources.

Solutions and Overall Approach

  • The market access project management of the most important pipeline product was comprehensively drafted and backed up by an internal and external communication schedule.
  • The overall strategy in the AMNOG-procedure was developed together with the various specialist departments (regulatory, medical, commercial, legal) and coordinated within the organization.
  • The strategic support of the value dossier development including all associated AMNOG-processes took place correspondingly: preparation of the G-BA consultation materials, analysis of the G-BA advice meeting, preparation of the written statement, preparation of the oral hearing, scenario calculations for price fixing, preparation of the price negotiation with negotiation training, team building and stress test.
  • Mandated by the management, SKC conducted the negotiation with the SHI umbrella organization as the team leader.
  • Simultaneously, SKC supported the AMNOG-procedure by preparing the market penetration: alignment of marketing, sales and PR activities with the AMNOG-process, development of a comprehensive stakeholder management concept, training and supervision of the market access manager, support in establishing relations with the SHI.

Outcome

  • It was possible to launch the product, to have it evaluated by the IQWiG and G-BA and to negotiate a marginal and anticipated markdown with the SHI umbrella organization all within the scheduled timeframe.
  • The German organization was specially honored for its outstanding management results by the corporate headquarter with the CEO’s Excellence Award.

CASE 3: Commercial assessment of a potential licensed product for the 5 major EU markets

Topic: Product- und portfolio evaluation, commercial due diligience
Klient: Medium-sized pharmaceutical company based in Germany
Wirkstoff: Psychotropic

Challenge

  • Our client had received an offer for a marketing license for a Phase III product for the 5 major EU markets. The product fitted perfectly into the portfolio; however the indication was characterized with a high proportion of generics with the equivalent price pressure.
  • Two approval scenarios existed for the product, a wide range of indications with minimal differentiation or a subpopulation with high medical needs.
  • As experts in market access, SKC was assigned to assess the reimbursement level and the anticpated market penetrations independently for both scenarios in the EU5.

 

Solutions and overall approach

  • Specific factors of influence affecting the market penetration of new drugs were summarized for each country and evaluated in terms of their significance and impact for both indications.
  • These factors were then applied as forces on the standard functions for the market penetration of new drugs.
  • On this foundation the curve was adjusted in its maximum height and its angel of inclination.
  • The revenues for the years 1 to 5 were calculated based on the years of treatment and the pricing.
  • The review was presented to the client as a comprehensive PowerPoint documentation, structured according to the countries and label scenarios with an executive summary, the Excel models and the sources used. Open questions were clarified in a results workshop with the management and subsequently amended in the documentation.

Outcome

  • The client was able to precisely determine his negotiation position on the basis of the results, with regard to the maximum price and the evaluation of the two approval scenarios.
  • As a result, the client was able to negotiate the value of the option in an informative, factual and comprehensive manner regardless of the licensors’ very optimistic market models.

Clients

  • Alexion Pharmaceuticals
  • Astellas Pharma
  • Bayer Vital
  • Berlin Chemie
  • Bristol Myers Squibb
  • Celgene
  • Destin Arzneimittel
  • Gilead
  • HMNC
  • Laboratoires C.T.R.S.
  • Lilly
  • Lundbeck
  • MerckSerono
  • Mundipharma
  • Novartis
  • Piramal
  • Pfizer
  • Roche Pharma
  • Santen
  • Shionogi & Co.
  • Shire Deutschland
  • United Therapeutics
  • UCB Germany
  • Verband forschender Arzneimittelhersteller

Your Contact Person

Prof. Matthias P. Schönermark, M.D., Ph.D.
schoenermark[at]skc-beratung.de