Drug Commercialisation & Launch in the UK Flashcards
What is drug commercialisation?
The process of bringing a new pharmaceutical product to market and ensuring patient access.
What are the four key phases of drug commercialisation?
- Regulatory Approval,
- Pre-Launch,
- Promotional Launch,
- Post-Launch.
What is the purpose of regulatory approval?
Regulatory agencies (FDA, EMA, MHRA) ensure the drug is safe, effective, and of high quality before market entry.
What are the key activities in the pre-launch phase?
- Ensuring market access & reimbursement.
- Developing brand & marketing strategy.
- Engaging stakeholders (HCPs, regulators, payers, patient advocacy groups).
What happens during the promotional launch?
- The drug becomes available in hospitals, pharmacies, and clinics.
- Sales teams & Key Account Managers (KAMs) are trained.
- Healthcare professionals (HCPs) and patients are educated on the drug.
What is the focus of the post-launch phase?
- Monitoring market performance & adoption.
- Conducting post-marketing surveillance & pharmacovigilance.
- Managing lifecycle strategies (new indications, reformulations).
What is Kadcyla® (trastuzumab emtansine)?
A targeted therapy (antibody-drug conjugate) for HER2+ metastatic breast cancer (mBC).
How does Kadcyla work?
It combines trastuzumab (Herceptin®) with the cytotoxic agent DM1, selectively delivering chemotherapy to HER2+ cancer cells while minimising systemic toxicity.
What is the unmet medical need in HER2+ mBC?
50% of patients experience recurrence despite first-line therapy, requiring better treatment options with improved tolerability.
How does Kadcyla improve treatment outcomes?
- Increases progression-free survival.
- Reduces systemic chemotherapy-related side effects.
- Provides a targeted approach for HER2+ patients.
Who is the target patient population for Kadcyla?
Adults with HER2+ metastatic breast cancer who have previously received HER2-targeted therapy.
Where are HER2+ mBC patients treated?
Secondary care settings (hospitals & oncology centres), managed by oncologists, nurses, and MDTs (Multidisciplinary Teams).
Who prescribes Kadcyla?
Oncology specialists in secondary care hospitals.
Who funds Kadcyla in the UK?
- NHS reimbursement (90-100% of cases).
- Private sector funding (10-13% of cases).
How does Kadcyla address clinical needs?
- Provides better disease control.
- Offers improved tolerability compared to chemotherapy.
Who are the key stakeholders in the pre-launch phase?
- Market Access Team
- Marketing & Brand Strategy Team
- Medical Affairs
- Business Insights
- Policy & Patient Advocacy Groups
- Sales & Commercial Team
Why is NHS reimbursement critical for Kadcyla?
Ensures broad patient access and funding for HER2+ patients.
How was Kadcyla approved in the UK?
It was approved through the Cancer Drugs Fund (CDF) to allow early access while additional cost-effectiveness data were collected.
What are the different regulatory agencies in the UK?
- NHS England (NICE) – England
- Scottish Medicines Consortium (SMC) – Scotland
- All Wales Medicines Strategy Group (AWMSG) – Wales
- Department of Health (NI) – Northern Ireland
What is Kadcyla’s brand vision?
“Kadcyla will become the new standard of care for eligible HER2+ mBC patients.”
What are key marketing strategies for Kadcyla?
- Disease awareness campaigns.
- Medical education programs.
- Promotional materials (scientific publications, brochures, sales rep engagement).
Who is the target audience for marketing?
- Oncology specialists.
- Multidisciplinary Teams (MDTs).
- Healthcare providers.
What is the role of sales representatives (Key Account Managers - KAMs)?
- Engage oncologists and healthcare professionals.
- Provide data on Kadcyla’s efficacy and safety.
- Support adoption by educating prescribers.
What are the key steps in the HER2+ metastatic breast cancer patient journey?
- GP Referral → Lump detected.
- Diagnosis & HER2+ testing.
- First-Line Treatment (1L HER2+ therapy).
- Second-Line Treatment (2L Kadcyla).
Who are the key stakeholders in this journey?
- Primary Care (GPs, Breast Physicians).
- Secondary Care (Oncologists, MDTs, Pathologists, Geneticists).
- Tertiary Care (Cancer specialists, chemotherapy nurses).
What are the key discussion points between sales reps and clinicians?
- Patient population & treatment goals.
- Current treatments used by clinicians & limitations.
- Kadcyla’s efficacy & safety data.
How do sales reps persuade clinicians to use Kadcyla?
By presenting data on Kadcyla’s superior progression-free survival and reduced side effects.
What is post-marketing surveillance?
The collection of Real-World Evidence (RWE) to assess drug performance, adverse events, and market uptake.
What are potential areas for Kadcyla’s market expansion?
- Expanding indications (e.g., early-stage breast cancer).
- Developing new formulations (e.g., subcutaneous injections)
