Pharmaceutical Executive Europe - October 2008 - (Page 21)

a formal launch is not planned ● a sales infrastructure does not exist ● it is not commercially viable to seek a marketing authorisation. ● Communicating availability Companies providing access to named patient drugs must exercise caution when communicating such programmes. Sponsoring companies can provide information regarding pre-launch access following an unsolicited request to physicians at medical conferences for example, but cannot solicit interest from target physicians, advocacy groups or patients, nor can the company use their sales force to promote such programmes. Where a strategic partnership with a named patient specialist provider is formed, the specialist will be able to advise on the permitted mechanisms to communicate the programme to prescribers. Where a strategic partnership with a named patient specialist provider is formed, there are a variety of mechanisms that can be utilised to communicate to prescribers, which your specialist partner will be able to advise on. benefit to patients with unmet medical needs, these programmes can offer important benefits to the sponsoring company in the areas of assessment and planning, relationship building and operations. Assessment and planning. By their very nature, these programmes provide two important insights: if a company is receiving pre-launch demand for a drug, knowing where that demand is coming from can help define the unmet need. Also, knowing about patients’ demographics, diagnosis and previous treatment at the time their physicians make the decision to request the medication helps the company understand where the drug fits into the current treatment pathway. medication may ultimately be the go-to physicians locally or regionally for others who are trying to gain that experience. Operations. When launching a new drug, a company must align its deployment and operations objectives around its overall strategy, while tailoring tactics to the local situation. In the context of a named patient programme, the sponsoring company can work out any problems in the supply chain, fine-tune its educational support for physicians, pharmacists and patients, and co-ordinate internal functions ahead of time — increasing the chances that the launch will run smoothly. others prefer to partner with a named patient programme specialist who is often better equipped to manage worldwide logistical and regulatory complexities. Regardless of the approach, these programmes are essential for meeting global demand for pre-launch medicines. References 1. ‘Hero helps fight for cancer drugs,’ BBC website, 13 May, 2008 (http://news.bbc.co.uk/2/hi/programmes/breakfast/7398632.stm) 2. Official Journal L142, 25/05/1989 p 11–13. Council Directive 89/341/EEC, May 1989. 3. Official Journal, 2001, L311 p 67–128. Directive 2001/83/EC of the European Parliament of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. 4. Official Journal, 2004, L136 30/4/2004 p 1–33. Conclusion Pre-launch access to drugs can provide months and perhaps years of treatment for patients with unmet medical needs when all other therapeutic options have failed or no other options are available. The benefits of named patient programmes are best realised when a company incorporates planning for such programmes early in a drug’s clinical development stages and includes all relevant stakeholders in the process. Although some companies prefer to manage their programmes in-house, Relationship building. Named patient programmes foster relationship development with local key opinion leaders and other physicians who would be likely prescribers post-launch. Participating physicians may be a key resource for regulators and other local healthcare providers who are considering the benefits the drug can provide to patients in that country. Post-launch, physicians who have experience with the About the author Natalie Douglas is managing director of IDIS, a global leader in strategic solutions for pre-launch medicines. Benefits to the sponsoring company In addition to providing significant 22 Pharma in Turkey Interviews with the country’s leading executives 37 Last words Who said what in pharma’s last four weeks 3 News The monthly round-up of European stories 6 Calendar Upcoming events in Europe and around the world http://news.bbc.co.uk/2/hi/programmes/breakfast/7398632.stm http://news.bbc.co.uk/2/hi/programmes/breakfast/7398632.stm

Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe - October 2008

Pharmaceutical Executive Europe - October 2008 Contents News and Analysis Calendar BioFutures Strategy Fundamentals Executive Recruitment: Small Company, Big Career Executive Recruitment: Instant Pharma Named Patient Programmes Executive Review: Turkey

Pharmaceutical Executive Europe - October 2008

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