Novo Case
ABPI Code of Practice
Scope: This code of practice only applies to promotion material (this ranges from rep material, direct advertising, supply of samples)
Novo Company
Diabetes Industry & Science
Market extension (increase market share within the industry) is allowed as a reason for increasing/using promotional material
Out of scope: promotional material for professionals that aims to promote the sale of OTC (whereas if it aims for the prescription of OTC then that's ok). Labelling is also out of scope as this is not considered promotoinal material
PAGB is used as a guidance for OTC where objective is to increase sales or recommendations
How would you increase market share?
Market Authorisation: promotional material must only be used once the product that is being promoted has market authorisaton
this might pose as a problem when at international meetings - as you might be going to a meeting with the purpose of discussing changes/ promotions but certain countries there or the country you are in, you do not have market authorisation
there are a few conditions: the meeting must be significantly international, relevant and proportional to the purpose of the meeting, clearly communicated that certain markets lack authorisation, providing sample promotion material for those countries which is not relevant to that country, and any material must be certified (as specified by the Code)
Certification: done by a medical practionioner or pharmacist
There is a requirement to provide advanced notification to the payers/policy makers (e.g. NHS) if the product being promoted will affect their ependitures.
this information should be provided before the promotional material is developed and during the process of market authorisation, should also be included in the horizon database (NHS, latest news on emerging technology)
Should provide non-promotional information as a way to inform the payers. This would be a description of key changes in terms of new active substance, or new substance prepared in a new way or significant addition to existing range or novel application
this should only be provided to policy makers and it should state the costs or savings
PAGB is the national trade association that represents manufacturers of branded OTC mediciens and food suppls. In additin to advertising, it provides regulatory and public affairs support. There are two codes: one for the public and one for the professional.
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Key aim: increase market share of both insulin (40%) and GLP-1 (60%)
Key Aim: break the pandamic cycle & develop a reporting system to measure the progress
Corporate social responsibility = following the UN sustainability development goals . It is apart of LEAD which are a select few companies that will set an example in the area of sustainability. There is one key issue in focus - 2030 Global development agenda
Areas of focus: diabetes, obesity, haemophilia, growh hdisorders
Two key areas of interest: good health and well-being; responsible consumption and production - these are the goals that NN is confident they can make an impact with
Changing Diabetes: platform that aims to break the Rules of Halves for diabetes - have developed several key programmes - in children, pregnancy.
Changing diabetes in children - teaching children how to successfully manage their condition and live healthy lives
Basics: What is diabetes?
Type 1: the complete loss of insulin producing cells (beta cells of the pancreas). It can occur suddenly, usually in younger, skinne rpeople. these people must inject insulin daily and balance their food intake and activity to help with the insulin profile
Type II: insulin no longer works properly - causing glucose to accumulate (hyperglycaemia)
Reducing the burden of disease: early diagnosis and treatment, lifestyle changes, awareness and understandng
Poor glycaemic control (i.e. blood glucose control) does lead to some serious complications. A key area is non adherence.
Most common reason - fear of hypoglycaemia (confusion, trembling, sweating etc). Some might consider this more dangerous than hyperglycaemia, thus releaving the underlying route cause. In an aftermath of hypoglycaemia, 25% of pateints report reducing their insulin dose and the same amount go to their doctor
another is the rigidity - 33% admit to insulin omission or non-adherence
Management
Taking the medication, exercise, diet, emotional well being
Type 1: have to have insulin from the first moment of being diagnosed as their body no longer produces insulin, whereas for type II there is a progressive decline, so they can start wtih non-insulin based treatment (e.g. to help boost insulin secretion)
Three main types of insulin product: fast-acting, to have injections after each meal. Premix (biphasiic) - two injections, and long-acting