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Take-off after pre-launch

Named patient programmes are shown to significantly boost the market share of a drug

Rocket taking off New results from a recent study of named patient programmes (NPPs) conducted by Eularis – and published in the September 2008 edition of  the Journal of Medical Marketing – found that implementing pre-launch NPPs had a significant effect on the cash market share of a drug within the first year of launch.

The aim of this retrospective study was to evaluate whether an NPP had a significant positive effect on revenues derived from participating drugs during the first year of launch, and to quantify any positive effects.

Eularis examined pharmaceutical product data for a sample of drugs in the same drug market – some of which had been used in an NPP and others which had not.

The study results showed that the odds of spending $1 on a drug in a particular drug market were 1.362 times higher if a NPP had been conducted prior to launch than if one had not been conducted. Results achieved by NPP participation also varied depending on the expected market share of the drug, therefore the larger the drug's market share, the larger the effect of these programmes.

The purpose of NPPs
NPPs allow pharmaceutical and biotech companies to make medicines available, in pre-launch phase, to patients who have an unmet medical need and who have no suitable alternative currently available in their country. Patients abroad with genuine, unmet medical needs can acquire potentially life-saving medicines before they are licensed and available in their home country.

Pre-launch NPPs allow access to drugs already licensed in other countries – but not in the doctor's or patient's own country – or access to drugs in late-stage development. 

Reimbursement, in many countries, is paid by the country's national health system or by the patients themselves, although sometimes companies do provide medication free of charge to patients. These NPPs open doors for pharma companies to achieve significant financial and non-financial benefits for their drugs during the first year of launch.

There are, however, a number of mechanisms which exist by which patients can acquire pre-launch medicines. In the US, access to pre-launched medicines outside of clinical trials is facilitated by Treatment Investigational New Drug Applications (IND) and single patient INDs.

Within Europe, pharma companies can charge for drugs supplied through NPPs, unlike in the US, where charging of drugs has vast limitations.

Optimising opportunities
In the current marketing, medical and economic climate, pharma is  seeking different ways to optimise the launch of new, specialist medicines. A growing number of European and US companies are recognising the potential of using pre-launch NPPs as part of their global market access strategy to generate significant financial and non-financial benefits and, importantly, to respond to growing demand from doctors and patients themselves.

Revenue may not be the driver for today's pharma companies in order to provide necessary and appropriate access to new medicines for doctors and patients, but it is essential to be able to evaluate the financial impact of implementing such a strategy. Ideally, companies should assess the combined, rather than individual, opportunities that an NPP will offer. This provides a better picture of the overall cost and benefits. However, these new data indicate that it is worth assessing the long-term financial returns to be made from an NPP. The costs associated with implementing such a programme using internal resources must be taken into account.

Outsourcing to a specialist organisation can be advantageous, as they are often better equipped to manage worldwide complexities. Regardless of the approach, these programmes are essential for meeting global demand for pre-launch medicines.

This study provides further evidence of the substantial overall benefits that pre-launch NPPs can generate, such as early product visibility and relationship development with doctors. Pre-launch NPPs are also an ethical and controlled way to respond to global demand and to provide access to new and innovative medicines to patients who really need them.

A significant launch
To launch a new antibiotic in 2005, the most significant breakthrough in this treatment area in 15 years, the pharma company had planned a staggered global launch spanning two years. During clinical development and initial product launches, the company had conducted an NPP, which was managed internally through its R&D and medical affairs departments.

However, the first market launch generated global interest from healthcare professionals and patients seeking to make use of the NPP. This interest placed a significant demand on the company's internal resources, and it decided to outsource the management of this expanding programme to an NPP specialist.

Specific challenges
As well as easing the burden on its internal resources, the company also needed an NPP specialist capable of handling the following specific challenges:
• Conducting patient screening according to strict criteria before allowing patients drug access; this included identifying infection type and previous patient treatments
• Reviewing results of the screening with the requesting doctor to ensure accuracy, and supply treatment only to appropriate patients
• Providing fast patient screening and delivery of the drug, since it was used in emergency situations and required a 24-hour turnaround time.

Outstanding delivery
The company decided to outsource the work to a partner with worldwide experience and the resources to manage their specific NPP needs. From then on, the NPP specialist implemented and managed the entire programme. This included handling all regulatory requirements, screening of patients against treatment criteria and providing initial responses to pharmacists' queries.

The company provided regular monthly reports about product use, which included details of requests for the drug, indication, country of origin and doctor information.

Marketing benefits
Conducted over 23 months, this successful NPP included 23 doctors participating in 25 different countries. According to the pharma company's senior executives, one of the major benefits of outsourcing this work was the time saved by the internal medical and marketing departments.

Based on the reports produced, which detailed product demand and uptake during the programme, the company was able to forecast and plan its future launch patterns. In addition, by involving various doctors in the programme, the company developed a network of key opinion leaders and brand advocates that helped to strengthen the drug's message at each of its market launches.

Benefits to patients
Patients are the main beneficiaries of NPPs but pharma companies can also realise multiple benefits, especially if these programmes are incorporated into a product's global marketing plan. To optimise these opportunities, a company should ideally start an NPP as early as possible in a product's Phase 2 clinical trial programme. This allows companies to begin establishing access mechanisms for the product up until launch.

The Author
Dr Andree K Bates, is president of Eularis
To comment on this article, email pme@pmlive.com

14th February 2009

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