Download
1 / 22
220 likes | 343 Vues
Module 4 The Healthcare Marketplace 2013. “ The Role of the Pharmaceutical Physician in Commercialisation of products” Dr Richard Browning Consultant in Pharmaceutical Medicine Hatchetts Ltd. Hatchetts. April 2013… Pharma Times.
E N D
Module 4 The Healthcare Marketplace 2013 “The Role of the Pharmaceutical Physician in Commercialisation of products” Dr Richard Browning Consultant in Pharmaceutical Medicine Hatchetts Ltd. Hatchetts
April 2013… Pharma Times • “…. there is a massive transformation within the industry, with the need to re-organise sales and marketing activities and take more creative approaches to customer collaboration” • “ ….76% of pharma executives listed the growing healthcare system price and budget pressures as the top challenge for the next two years, with 70% citing the increasing need to demonstrate cost effectiveness and prove outcome, whilst 69% expected more restrictive market access.”
What is the role? • Let’s settle for “Medical Affairs” • Let’s look at the role • Let’s look at the responsibilities • Let’s look at the qualities required • Let’s look at the practical activities
1980 to 2000… model of commercialisation Product approval Pharmaceutical Physician Marketing product manager ( + team including Market Research and Agency) Programme..Ads. etc Sales Representatives ( in their 1000’s) Detail Aids..leave behinds Prescribing doctors
Drivers of change to the model • The clinician has lost his monopoly as the prescribing decision maker • To what influences? • 1.) Technology Assessment
1) Technology Assessment ….National • Centralised…. Evaluation of therapeutic, financial or other advantage. e.g. NIHCE • Evaluate data from the perspective of value and proper use • Will access registration data • Opportunity to provide more data • Will disseminate assessment of appropriate product usage
1) Technology Assessment ….Regional • Will receive National Guidance e.g. Regional Prescribing Advisory Groups. • Will take into account local perspective • Opportunity to provide more data..to generate , package and present • Will disseminate draft for local input • Final guidance will include local CCG input
1) Technology Assessment …Local..CCG • The Prescribing Committee( or equivalent) of the Clinical Commissioning Group will receive the local Guidance • The CCG will agree managed care guidelines and integrated care pathways with secondary…. and intermediate care • New medicines may or may not be included in those pathways
1) Technology Assessment ….Local..clinicians • The Prescribing Committee • May value additional information • May work with industry in assessing and/or improving local care • May be an opportunity for industry • Prescribers will receive information from the CCG Prescribing Committee. • …but prescription will still depend on other influencers……( but remember…will be the ultimate responsibility of the person who signs the script!)
Drivers of change to the model • The clinician has lost his monopoly as the prescribing decision maker • To what influences? • 1.) Technology Assessment • 2.) Patients
2) Patients as influencers • Physicians no longer “tell” patients what to do..it is the practice now to “agree a Plan” • Information will drive Patients to seek consultation • Informed patients participate in their treatment decision.
2) Patients as influencers • Disease State Advocacy Groups ( formerly voluntary patient groups) • These groups do not ask for older cheaper technologies • The more informed a group is, the more informed will be its decisions • This is an opportunity for Medical Affairs
Medical Affairs…the most quickly evolving function in the drug development industry today • Medical Affairs has been constantly re-inventing itself • The generation, packaging and provision of information is the paramount requirement • The nature of the information has evolved in terms of the value proposition • The channels through which this occurs have been constantly expanding • The customers have changed from just the prescriber.. to include a wide variety of external influencers.
Previous model of commercialisation Product approval Pharmaceutical Physician Marketing product manager ( + team.. including Market Research and Agency) Sales Representatives ( in their 1000’s) Prescribing doctors
Evolved model of medical input to commercialisation National Health Technology Assessment Local Integrated Care Pathways Regional Technology Assessment Strategic Publications Programmes Internal Colleagues Pharmaceutical Physician Speaker programmes Thought Leader Development Patients +Disease state Advocacy Groups Disease awareness and education programmes Presentation 1- to- 1 + Mass audience
Post Approval Clinical Studies( commercialisation studies) • Should be addressing in late phase development • An evolving requirement as time progresses • Comparative effectiveness • New competitors/populations/indications • Safety studies • Expanded access programmes Including: Planning, protocols, investigators, outsourcing etc..and financial responsibility.
Qualities for a Medical Affairs doctor in the Commercial team • This is not a soft option !! • You must ..at a minimum.. be a first class doctor • You must become the expert on your product and any therapeutic area • Able to network with first class people in academia and business • Able to balance business imperatives with medical and ethical views • Able to present……. • You can “Live or die on your feet”.
Expectations of medical Affairs from the team • Cultivate a network of experts..Thought Leader Development • Develop and implement a Strategic Publications Programme • Plan and execute or outsource a Post Approval Studies Programme • Look for opportunities to work with and join bodies which will provide opportunity for influence • Work with the team in the development of a wide variety of programmes and materials ..be knowledgeable on the relevant processes and applicable Codes of Practice
All scientific data packages All communications with healthcare professionals in any form All relevant presentations Journal Advertisements Publications and reprints Relevant Internal documents…POAs etc Sales Aids Exhibition stands Samples Dosage cards Internet sites/electronic materials/data systems CD ROMs/memory sticks/related gadgets CDs DVDs Sponsored journals Commissioned books Symposium and meetings materials Invitations/letters Programmes Proceedings Education materials Etc.etc.etc. Communication Materials requiring medical input and approval include:
Communication Materials …golden rules …Read diligently and check for balance, relevance, truthfulness and reflection of current medical opinion. …Sign.. only if OK or with minor changes.. in ink.. on the materials themselves …If major issues, don’t sign!….discuss. …Try to see it how others might see it…
Medical contribution to thecommercialisation of products.remember this…….. • This is all about enabling others to make an informed decision • Always remember that what you develop lives after you ..and that it is not enough -to avoid doing the wrong thing…. -you must enable the company to do the right thing.
