Our services comprise

pharmaceutical products and medical devices

Pricing &
reimbursement

Payer strategy
analysis

Early access / named patient sales
for orphan drugs

AMNOG-Dossier writing
for reimbursement in Germany

PRICING & REIMBURSEMENT

We take the payers’ perspective, developing a value based pricing concept by defining a viable price range, which should be a balance between the markets’ and the company’s perspective. Usually, Pioneer Market Access recommends testing and verifying the results of such analysis within a larger sample. The analysis would comprise physicians’ and payers’ opinions at least in the key countries in Europe and could be enriched by data including the USA, too. The result will be a purchase decision analysis, showing potential market access barriers and opportunities for your product. For sure, we would not leave you alone with the results, but develop ideas and suggestions.

IN SPECIFIC WE...

  • Explore the market and product potential on a country by country basis as needed
  • Analyse the barriers to market access and make suggestions, how to overcome them
  • Verify your value based European target price
  • We also prepare a market survey for your key countries of interest and
  • Your strategic market access plan on a country by country basis.

WORK WITH US

We'll do everything we can to make our next best project!

MARKET ANALYSIS

We describe a market in question targeted to your needs. The analysis should comprise:

  • a market analysis on your and your competitors‘ market position
  • your strength and weaknesses
  • information on a pricing strategy vis-à-vis competition or indirect competitors
You also can expect suggestions for marketing activities - and most important: inform you on the market access barriers on a country by country basis and how to overcome them.

MARKET ACCESS PLAN

Afterwards we can prepare a strategic market access plan. This plan will include an EU 5 price band definition. It would as well comprise an analysis on your competitors‘ market position, pricing strategy, strength and weaknesses plus their marketing activities and - most important - inform you on the market access barriers on a country by country basis. Our services comprise hospital and retail products and medical devices.

PRICING

We take the payers’ perspective and develop a value based pricing concept. Pioneer Market Access then defines a viable price range, which balances the markets’ and the company’s perspective.

Usually, Pioneer Market Access recommends testing and verifying the results of such analysis using professional market research. The analysis should comprise physicians and payers at least in the key countries in Europe and might include the USA, too. The result will be a purchase decision analysis, showing potential market access barriers.

REIMBURSEMENT

In Germany Pioneer Market Access could also prepare a reimbursement dossier for Germany.

ORPHAN DRUGS

Named patient sales or early access programs

First of all: Early access/named patient sales are LEGAL. We understand early access programs only as paid by health insurances in the respective countries for treatments on a patient by patient basis. Early market access prior to marketing approval is usually only allowed for rare disorders and in some cases for non-rare, but life threatening conditions or organ saving products. “Named Patient Sales” is usually used for describing a process to pave the way for early treatment for individuals, who are heavily affected and/or chronically patients. The following list shows the preconditions to carry out a Named Patient Sales Program:

  • Prevention of a rare or a serious disease
  • No satisfactory alternative method available
  • Efficacy and safety are presumed (sometimes starting already after publishing ph2 data)
  • A significant benefit can be expected for the patients and
  • Named Patient Sales should NEVER be a replacement for a clinical trial!

Only, if your product fulfils these requirements, the treatment may be paid by the statutory health insurances prior EMA approval!

In Summary we will

01

Help patients’, which are in an urgent need of your product

.
02

Provide you with early revenues as the products will be reimbursed

.
03

Ongoing sales during reimbursement negotiations

.
04

A proof that your product is marketable

.
05

And: It makes investors and potential partners happy!

.

LIST OF CONSULTING PROJECTS

Pioneer Market Access provides its services for pharmaceutical products in hospital and retail markets.

CURRENT LIST OF CLIENTS

See our trusted clients

08/16 – mid Sep. 16 development of a response to IQWiG for the G-BA hearing, 07/15 – 06/16 AMNOG-dossier development until final submission for the indication womens’ health, specifically writing module 4. Strategy development for market access, competitor and price analysis, key opinion-leader identification and ad board organisation for a new antibiotic 02/15 – 05/15, ongoing project, therefore no disclosure of the client

Report on early market access in France and Italy, price and budget impact analysis for Germany, France, Italy and UK, strategic market entry plan 06/14 - 11/14, AOP Orphan.

Market Access and business development planning for Germany & Austria; AMNOG-dossier proof reading of all sections, responsible for price analysis and price recommendation, prevalence section, expenses and savings for the German healthcare system, access to treatment section; stakeholder mapping, sales according § 73 (3) AMG, (2 pts. put on early access treatment), gastroenterology indication, 10/13 – 04/14, NPS Pharmaceuticals, USA

European Market Access Consultant, 1st EU-registered gene therapy in ultra-rare lipid disorder, starting AMNOG-dossier preparation, strategic planning, price analysis including market research in 2012/2013, before in 2010/11 named patient sales project France, Amsterdam Molecular Therapeutics, now uniQure BV, Amsterdam, 2011 – 2013

Price analysis and recommendation including price negotiation, company wants to stay anonymous, 2012, orphan drug

08/16 – mid Sep. 16 development of a response to IQWiG for the G-BA hearing, 07/15 – 06/16 AMNOG-dossier development until final submission for the indication womens’ health, specifically writing module 4. Strategy development for market access, competitor and price analysis, key opinion-leader identification and ad board organisation for a new antibiotic 02/15 – 05/15, ongoing project, therefore no disclosure of the client

08/16 – mid Sep. 16 development of a response to IQWiG for the G-BA hearing, 07/15 – 06/16 AMNOG-dossier development until final submission for the indication womens’ health, specifically writing module 4. Strategy development for market access, competitor and price analysis, key opinion-leader identification and ad board organisation for a new antibiotic 02/15 – 05/15, ongoing project, therefore no disclosure of the client

Business analysis for gene therapy in peripheral arterial disease for France, including market research and Ad Board organisation, Anges, Japan, 2010

Exploring market chances according to local legal situation in Norway, indication headache, generic competition and price analysis, Desitin, Germany, 2010

Marketing & sales plan for UK & Germany in GI-disorders, Movetis, Belgium, 2009

European business planning followed by market research in 5 EU- countries for HIV indication (lipid disorder), orphan drug application writing and submission, Theratechnologies, Canada, 2009

Market access for a speciality-pharma start-up company, indications brain cancer, pain, Archimedes Pharma, Germany, late 2008/mid 2009, afterwards business analysis for market expansion to Austria and Switzerland until end 2009

Dossier writing and successfully putting a medical device containing Polyethylenglycol containing laxative onto the drug list after change of the law in Germany, WUVO GmbH, Germany, 2008

Business planning for new country head, MPS VI, Biomarin, Germany, 2008

Request for proposal

We are looking forward to hearing from you.

DR. UTE VITS, MBA

(Henley Management College)
Managing Partner

Contact Info

Pioneer Market Access®
Brückenweg 9
D – 82237 Steinebach | Germany

info@pioneer-market-access.eu
www.pioneer-market-access.eu

OBEN