Nice Managed Access Agreement
The more confident we are of the number of patients, the more confident the payers will be about our budget impact forecasts; an AMA may define the number of patients who can access treatment over the life of AMA, but appropriate patients need to be identified, i.e. it is necessary to identify the patients most likely to match or benefit most from the technology. The following groups/individuals have managed to expect the agreement: Although there are now formal nice guidelines on MAas on their website, the guidelines are limited and it is therefore essential to use precedents. A MAA can be used to restrict access to patients and reduce the number of patients eligible for treatment, or the scope may be narrower than your marketing authorization. A MAA is a hybrid document. To begin the development of an MAA, you must assume that it is a clinical document, but you must have a commercial agreement for the evaluation points collected. It is also very unlikely that all patients will meet the marketing authorisation criteria, so which subpopulations are ready to act? The National Institute for Health and Care Excellence (NICE) has recommended that the first drug be made available through the cancer prevention fund`s new access to management system. Interim guidelines published in September indicated that osimertinib should be made available to patients with a particularly aggressive form of lung cancer for the next two years, while other efficacy and cost-effectiveness data were collected and analyzed.1 Emma Harvey is an independent medical advisor specializing in rare diseases and biotechnology. She participated in two aperitifs of special technology DE NICE (HST) and represented Alexion as clinical director of Strensiq™ (asfotase alfa) and kanuma™ (sebelipase alfa).
She represented Alexion on the first appeal against a determination of the final evaluation of NICE (FED) for an HST, for sebelipase alfa. For both products, she led the creation of Managed Access Agreements and worked closely with specialist physicians, patient groups and NHS England. Since her independence, Emma has advised other companies on their NICE HST clinical records and whether a Hand Access Agreement (MAA) can help answer unanswered questions. NHS England has announced a new example of its negotiations with companies and stressed its willingness to use access to management agreements to ensure the cost-effectiveness of a product. So what is the role of the Managed Access Agreement (MAA)? Subscribe and access all BMJ articles and more. For an AMA to meet its objective, it is very important that patients participate in follow-up appointments and that all necessary data is collected (see data collection section), as this is used to show whether or not there will be access to treatment in the future after the end of the MAA.