So what is the role of the Managed Access Agreement (MAA)? initial 10-day temporary access to APM Health Europe However, other experts warned that the proposals could exacerbate serious problems of access to treatment already affected by people with rare diseases. According to one industry, it was highly unlikely that the cost per QALY of rare disease treatments would be less than or equal to $10,000, making them inoperative with the proposed expedited assessment route. In addition, there is evidence to suggest that none of the products that went through NICE`s HST program would result in a cost per QALY of $100,000 or less. The correct application of this mechanism, put in place three years ago, should mean that no further budgetary control measures are necessary to limit the state`s risk. But, he said, the PPRS cap is still not being used to improve access – while it would improve the health of the population at no cost to the government. If you are a money, pharmacy or consulting professional, our premium data keeps you up to date on regulatory, cheap, market access and cost-benefit issues that affect all stakeholders. The following groups/individuals drew themselves in the agreement: One analyst was however not as sure. “The UK`s HTA processes are world-class; They set the scale and, as they are examined after Brexit, if they do not go bankrupt, why should we want to fix them? “,” he asked. And with the previous access process, an early yes shows confidence in the data. Early access means discounts that break the overall price policy – some companies will accept it because an early NICE agreement is so important,” he stressed. Now that the MAA has been agreed, the extended access program for people with type 1 ADM is closed and it is no longer possible to access treatment with the drug through this route.
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. Although there are now official 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.