{"id":2531,"date":"2017-12-14T10:00:32","date_gmt":"2017-12-14T09:00:32","guid":{"rendered":"http:\/\/ceptonstrategies.com\/en\/?p=2531"},"modified":"2019-08-07T16:00:34","modified_gmt":"2019-08-07T15:00:34","slug":"2531","status":"publish","type":"post","link":"https:\/\/ceptonstrategies.com\/en\/2531\/","title":{"rendered":"Why Managed Access Programs should be a key component of your strategy for Europe"},"content":{"rendered":"

Managed Access Programs (MAPs) provide patients with anticipated access to drugs before their full-fledged commercialization. As often seen in Europe, the situation is complex: on one hand, MAPs can refer to several different schemes within a country, on the other hand MAPs are regulated at country level, with almost as many situations as there are countries. Yet, MAPs are an integral part of a successful market entry strategy for Europe. How can you maximize your chances to implement a successful MAP that will help the patients in need and speed up your adoption by the medical community?<\/em><\/p>\n

What are MAPs and why are they necessary?<\/strong><\/p>\n

While market authorization can now be granted at a European Level, \u201cPricing and Reimbursement\u201d are still the prerogative of each Member State: in some countries, a drug can fall into the paradoxical state where it is approved and yet cannot be prescribed, for lack of reimbursement. To mitigate this problem, Managed Access Programs have emerged in most European countries.<\/p>\n

MAPs are programs designed to accelerate patient access to new, efficacious drugs, in an ethical, compliant, and controlled way until they become fully marketed (approved, with price and reimbursement schemes in place). MAPs bridge the gaps that exist between clinical trials and commercially available drugs: they are usually set up once phase III results are known, and the marketing authorization has been filed, i.e. even before the marketing authorization is granted.<\/p>\n

For the sake of clarity, MAPs in this article will be considered to be mostly Compassionate Use Programs, but be aware that the term \u201cMAP\u201d sometimes has a broader definition and could be used interchangeably with – or include – programs such as Early Access Programs, conditional approval, PriMe (Pri<\/em>ority Me<\/em>dicine scheme) \u2026<\/p>\n

Even within a given country, MAPs could either concern individual patients or groups of patients. The first case is referred to as NPP for Named Patient Program, the second as Cohort Programs.<\/p>\n

Who will benefit from a MAP?<\/strong><\/p>\n

The patients<\/em><\/strong><\/p>\n

Getting access to effective medicine when no other option is available: the benefit to the patient is obvious.<\/p>\n

One way for patients to receive treatment early is to be included into clinical trials (e.g. Open label extension after the randomized phase of the pivotal trial), but not all patients are eligible to participate in the trials, which are protocol-driven and have stringent inclusion and exclusion criteria. Thus, MAPs are often the only option for patients who cannot wait for the drug to be commercialized and cannot enter clinical trials.<\/p>\n

Furthermore, MAPs are validated by local authorities and the drug can only be distributed through well defined channels, reducing the risk for counterfeit drugs.<\/p>\n

The physicians<\/em><\/strong><\/p>\n

For physicians, MAPs are extremely useful as well, because on top of the direct benefit it provides to their patients, it also allows them to better understand the drug and have their first hands on experience with a new drug.<\/p>\n

It can also please the early adopters within the physician population, who, once convinced of the benefits the drugs bring to patients, can become the best brand advocates, whether to recommend to their colleagues or to intervene as experts during pricing and reimbursement negotiations.<\/p>\n

The payers<\/em><\/strong><\/p>\n

Most compassionate use programs require the drug to be provided free of charge by the market authorization holder (MAH). Some named patient programs and the Autorisation Temporaire d\u2019Utilisation in France (ATU, \u2018Temporary Authorization for Use\u2019<\/em>) are the exception to the rule: the healthcare system would pay for the drug in this case.<\/p>\n

The MAH still takes care of the pharmacovigilance (PV): this provides safety data from a larger population sample in a more \u201creal-life\u201d setting, which helps better assess the safety, tolerability, and Quality of Life aspect of the reimbursement and pricing negotiations.<\/p>\n

The market authorization holder<\/em><\/strong><\/p>\n

Despite having to provide the drug for free in most cases and assuming the costs of PV, some associated benefits have been noticed as MAPs became more common:<\/p>\n