|
3.2 Pre-launch
|
3.2.1 Horizon Scanning Activities15-18
|
Activity-making to identify new emerging health technologies with potential use to predict possible impacts on the health system |
Yes |
Yes |
|
3.3 Peri-launch
|
3.3.1 Profit limitation1919 England. Department of Health & Social Care. The 2019 Voluntary Scheme for Branded Medicines Pricing and Access. [access in 2019 Dec 10]. Available in: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/761834/voluntary-scheme-for-branded-medicines-pricing-and-access-chapters-and-glossary.pdf.
https://assets.publishing.service.gov.uk...
|
Rate-of-return regulation for companies and an overall limit spending on branded medicines over the lifetime of the agreement |
No current activities |
Yes |
| 3.3.2 External price referencing20-22
|
Practice of using the price(s) of a medicine in several countries in order to derive a benchmark to set or negotiate the price of a medicine in a given country |
Yes |
No current activities |
| 3.3.3 Health technology assessment 14,23-28
|
A tool employed to assess the use of new medicines to consider the safety, efficacy, effectiveness, organizational variables, economic implications, the social consequences, and the legal and ethical aspects |
Yes |
Yes |
| 3.3.4 Pharmacoeconomic analyses including health economic threshold 23,29-31
|
Most frequent analysis is cost-utility or cost-effectiveness defining a tool and the limit between costs and benefits by incremental cost-effectiveness ratios per quality-adjusted life year |
Under development |
Yes |
| 3.3.5 Value-based in pricing 32-36
|
Process whereby pricing of medicine is regulated per its therapeutic value aggregate, depending heavily on the context of the country and economic and cultural needs. Value based on price has been proposed as a logical and fair policy to promote access and reward useful innovation |
No current activities |
Yes |
| 3.3.6 Multiple Criteria Decision Analysis 37,38
|
Extension of decision theory that supports decision-makers with multiple (possibly conflicting) objectives by decomposing the decision objectives into key criteria |
No current activities |
Under development |
| 3.3.7 Managed entry agreements 39-43
|
Contract of funding and/or sharing risk between government and manufacturers to manage entry in the health system with possible decrease of the high budget impact and uncertainty of effectiveness. MEAs have a common denominator, increasing access to new medicines in a context of uncertainty and higher price. These Managed entry agreements exist in two formats: outcome-based and financial agreement |
Under development |
Yes |
|
3.4 Post-launch
|
3.4.1 Guidelines and formularies rules 20,44-46
|
Support which should be recommended within clinical practice guidelines with strong methodological competencies necessary, considering both clinical expertise and skills in the systematic assessment of the available evidence |
Yes |
Yes |
| 3.4.2 National policies or plan for Rare Diseases 47-54
|
Policy or regulatory initiatives, programs, or other established mechanisms that influence and facilitate patient access to orphans |
Yes |
Yes |
| 3.4.3 National policies or plan for oncological diseases 55-61
|
Policy or plan that may be influence regulatory framework for access to treatment, including medicines for oncological diseases |
Yes |
Yes |
| 3.4.4 Compulsory licensing and productive development policy62-66
|
Transfer of intellectual property formalized during specific years to develop the medicine in public industries |
Yes |
No current activities |
3.4.5 Accelerated or fast-track access 6767 England. Accelerated Access Review: Final Report - Review of innovative medicines and medical Technologies. 2016. [access in 2020 Jul 24]. Available in: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/565072/AAR_final.pdf.
https://www.gov.uk/government/uploads/sy...
|
An intersectoral (industry, public sector, academia, patients) articulation to identify key priorities and develop a sustainable framework for the adoption of innovation, simplifying the development and approval process, pricing, assessment, and commercial regulation |
No current activities |
Yes |
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Source: Elaborated by the authors.