Marketing in Pharmaceutical Industry Flashcards
What is the role of governance in a pharmaceutical company?
- Determines objectives of organisation
- Defines ethics, culture, and governance framework
- Ensures compliance with regulatory, statutory and legal obligations
What are the main functions of management in a pharmaceutical company?
- Delivers the objectives of organisation
- Works within the ethical and cultural framework
- Provides assurance to the governing body
List the core functions typically found in pharmaceutical companies.
- Research and Development
- Manufacturing
- Drug Supply/Distribution
- Commercialisation
What are the typical divisions within pharmaceutical companies?
- Core Functions
- Support Functions (e.g., Finance, Human resources, External affairs & communications, Investor relations)
What is the purpose of commercial input in drug development?
- Target Selection and Target Product Profile (TPP)
- Commercial valuations
- Competitor intelligence
- Sales projections
Fill in the blank: The maximum R&D investment occurs during the _______ phase.
pre-launch
What is the role of NICE in relation to new medicines?
Conducts Health Technology Appraisals (HTAs) to recommend or not recommend medicines for use within NHS England
Define Quality Adjusted Life Year.
A measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life.
What are the components of a SWOT analysis?
- Strengths
- Weaknesses
- Opportunities
- Threats
List the strategic imperatives in marketing.
- Small number (3-6) of ‘most important’ priorities
- Derived from the situational analysis
- ‘What we want to achieve’
What are typical marketing tactics during the launch phase?
- Secure national level funding
- Insight gathering
- Develop key messages
- Identify opportunities to incorporate new treatment into guidelines
What is the role of the Medical Department in pharmaceutical companies?
- Identify new information about hazards associated with a medicine
- Collect and collate details of adverse events
- Assess the impact of new safety data on the drug
What is the purpose of evidence generation in pharmaceutical marketing?
To generate robust ‘real world evidence’ to address clinically-important data gaps. But it may not truly reflect the real world.
Fill in the blank: The Market Access Department advocates for funding by health authorities such as _______.
the NHS
What is the NICE threshold for cost per QALY gained?
£30,000 per QALY gained
What factors are considered in the measurement of effectiveness for NICE assessments?
Quality Adjusted Life Year (QALY) and specific monitoring requirements
List the types of study used in evidence generation.
- Interventional studies
- Observational studies
- Prospective and retrospective data collection
What is the significance of the utility score in QALY calculations?
It reflects a patient’s quality of life on a scale from 0 to 1.
What is the role of the Market Access Department in local access?
- Overcome local barriers restricting use of NICE approved drugs
- Negotiate local commercial contracts
What does pharmacovigilance involve?
- Identify new hazards associated with a medicine
- Collect adverse events
- Assess safety data
What quality of life measures does NICE prefer?
Generic quality of life measures (EQ5D, SF-36)
What does NICE not consider when evaluating costs?
Positive impact on wider societal costs
What is a challenge for expensive one-off therapies?
Full cost paid upfront with benefits accruing over many years
What does the NHS expect regarding pricing for treatments?
A single price for a treatment, regardless of indication
What are the key responsibilities of the MHRA?
Ensuring safety, quality, and efficacy of medicines, medical devices, and blood components
What mechanism does the MHRA use to achieve its responsibilities?
Approval of clinical trials and granting of Marketing Authorisation
What legal framework was introduced by the Medicines Act, 1968?
A licensing and governance system for medicines
What does the ABPI Code of Practice set standards for?
Company behaviour in pharmaceutical sales and interactions with healthcare professionals
What must promotion of prescription-only medicines to healthcare providers be?
Evidence-based, balanced, not misleading, and consistent with approved SPC
Is direct-to-consumer promotion allowed for prescription-only medicines in the UK?
No
What is allowed in disease awareness promotion?
Promotion is allowed for over-the-counter (OTC) products
What are the principles outlined in the ABPI Code of Practice?
- Benefitting patients
- Acting with integrity
- Promoting transparency
- Treating everyone with respect
