Named Patient Programmes
Through our Named Patient Programmes, Masters is able to provide patients and healthcare professionals across the world access to potentially life-saving medicines.We provide these programmes in partnership with pharmaceutical and biotech manufacturers to allow them to provide access to their products during clinical trials, and during the launch phase, while complying with the regulatory requirements in all countries where they are carried out.
In addition, a Named Patient Programme provides significant benefits to the manufacturer:
Market Data
The manufacturer can gain an early indication of potential demand within a market, helping them in the planning of the launch strategy.
Patient Information
Through the programme, patients’ demographics, diagnosis and previous treatment can be collected and fed back to the manufacturer, giving more detailed market information prior to launch
Relationship Development
Establishing the programme pre launch enables relationships to be developed at an early stage with key opinion leaders, and doctors who would be likely prescribers post-launch.
Operational Planning
By having the drug supplied on a Named Patient Supply basis, the manufacturer can gain information on that market early in the process so that it can address any operational issues in advance, increasing the chances of a successful launch.
Master’s Named Patient Programmes can be used at a number of stages through the product life cycle:
During Clinical Trials
For patients who don’t fit the study protocol, a Masters Named Patient Programme allows patients access to the study drug outside of the Clinical Trial setting.In addition the programme ensures that patients receive the drug in a well managed and controlled manner, ensuring that all associated risks are minimised.
The Named Patient Programme also enables companies to receive additional useful data on the performance of their drug, and its use alongside the Clinical Trial.
Post Clinical Trial
Once a clinical trial has ended patients who have responded well to treatment will want to continue to receive the drug.
By setting up a Masters Named Patient Programme pharmaceutical and biotech companies are able to ensure both that patients can continue to receive access to the treatment, while minimising the associated risks of providing access to the drugs after the trial has ended.In addition the Masters Programme can enable the pharmaceutical and biotech companies to be provided with continued information on the patients.
Pre Launch
Patients and healthcare professionals are increasingly aware of developmental drugs and are requesting early access to them prior to launch.Establishing a pre launch Masters Named Patient Programme enables Pharmaceutical and Biotech companies to:
- Meet patient requests on a managed, reliable, and ethical basis, until the product is launched.
- Receive useful data on the performance of the drug and it’s use outside of a clinical trial.
- Gain valuable market feedback from key opinion leaders, and doctors which can be used in the design of the launch programme in that market.
- Minimise the risks associated with pre launch access outside of a clinical trial.
Staggered Launch
During a phased launch programme of a new drug, requests for access to that drug by patients and healthcare professionals will increase from markets where the product is still to be launched.
By setting up a Named Patient Programme in partnership with Masters, as part of the launch programme, Pharmaceutical and Biotech companies will be able to meet this demand.Formal Launch Not Planned
A Named Patient Programme can provide an alternative route to certain markets where a formal launch is not planned for example because it is not commercially viable to obtain product registration.Product Discontinuation
When a product is being discontinued either globally or in a particular market, by partnering with Masters and implementing a Named Patient Programme, a pharmaceutical company can:- Minimise the impact of the discontinuation, by ensuring continuity of supply and meeting patient needs in a reliable and ethical way.
- Maintain the loyalty of healthcare professionals in a market, by minimising problems for them caused by the product withdrawal.
- Extend the revenue generating potential of a product, and avoid doctors moving patients to other competitor products.
- Provide a platform for the phased withdrawal in other markets as well.