Pharmaceutical Executive Europe - October 2008 - (Page 20)

Canada’s well-defined Special Access Programme (SAP) provides access to nonmarketed drugs to practitioners treating patients with serious or life-threatening illnesses when conventional therapies have either failed, are unsuitable, or are unavailable. In this procedure the practitioner is responsible for initiating a request on behalf of a patient and ensuring that the decision to prescribe the drug is supported either by credible evidence available in the medical literature or provided by the manufacturer. This process is time intensive as each case requires a review, followed by an authorisation by Health Sante to enable an unregistered drug to be administered to a patient with an otherwise unmet medical need. In 1987, the FDA formally put in place regulations to facilitate patient access to pre-launch drugs. FDA-recognised expanded access programmes (EAPs) include treatment investigational new drugs (treatment INDs), treatment protocols, and single-patient INDs. Treatment INDs and treatment protocols allow a cohort of patients, who would not otherwise qualify for clinical trials, to gain access to a pre-launch drug, generally when the drug is in Phase III trials. A single-patient IND is a request from a physician to the FDA that an individual patient be allowed access to a pre-launch drug on an emergency or compassionate basis— when all other options have failed. Preparing for pre-launch access As part of a global market access strategy, pre-launch programmes are typically put in place at any stage post-Phase II and can run in parallel with Phase III trials until commercial launch. Timing for a pre-launch access programme should be carefully thought through; ensuring care is taken not to interfere with established clinical trials. If the programme is started too late, there may not be sufficient use of the programme. In cases where demand for the drug is extremely high, however, starting the programme within just a few months of expected authorisation is warranted. Sufficient planning time must be allowed to bring key stakeholders into the process; these stakeholders include medical affairs, clinical development, regulatory, supply chain, pharmacovigilance, and the global commercial group and affiliates. In addition, adequate time must be allocated to develop information for physicians and pharmacists regarding dosing, administration and restrictions, and establish treatment criteria to ensure proper selection of patients Some companies have in-house resources to manage named patient programmes. Many companies, however, choose to partner with a specialist to handle the development, implementations and project management required to execute a successful programme. Throughout the product life cycle named patient programmes can be utilised to provide patient access at a number of stages throughout a product’s life cycle (Figure 1): ● during Phase III, to patients with an unmet medical need who do not meet the clinical trials inclusion criteria ● bridging the gap between the end of Phase III and receipt of marketing authorisation ● in conjunction with a global launch whilst approval and reimbursement is being sought across countries worldwide. named patient programmes also provide an alternative route to patient access as part of a global commercialisation strategy where: Figure 1 When can a Named Patient Medicine be utilised? Staggered global launch Temporary supply problems Alongside Pahse III trials Pre-launch named-patient programmes Post-trial access Discontinuation management Pre-launch Post-launch 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

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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