Health Economics and Outcomes Research (HEOR) is the most common label given to the function within healthcare and especially medical device
companies with the responsibility for generating evidence of value of new interventions for reimbursement agencies and local health care payers. Moreover customers, hosipitals, key stakeholder
and opinion leaders in the specific industry can benefit from HEOR. While "health economics" refers to skills in economic evaluation, "outcomes research" refers to expertise in observational
studies or in the development and use of new health outcomes measurements. HEOR results can influence the design of clinical trials as to best meet the needs of healthcare payers, as well as on
other studies and analyses (meta-analyses, modelling, observational studies) that may be required. HEOR activities mostly go hand in hand with market access, KOL relationship, market and
reimbursement specialists and agencies or but also local healthcare payers.
The proposed market access changes in Germany can be interpreted in a mixed way. The greater potential to obtain an added benefit rating without “severe outcomes” will surely improve the assessment, the G-BA has traditionally been conservative to value evidence based endpoints. Such a shift in policy can increase the probability of a favorable outcome of the benefit assessment and also price negotiations could provide a greater incentive for manufacturers to invest in less prevalent diseases and/or therapy areas.
Removal of the mix price calculations could be beneficial as well. This would ease the current price pressure, especially in light of the way in which the German assessment tends to split the data into multiple sub-groups where it is often challenging to demonstrate an added benefit.
Conversely, some of the proposed changes may represent new obstacles for industry. Currently, the lack of reimbursement restrictions beyond the licensed indication provides physicians a great deal of discretion when prescribing a drug for a particular patient subgroup, regardless of the added benefit rating. Such prescriptions represent a significant percentage of the sales volume, and therefore revenue, for the product. Limiting or removing this physician discretion by imposing access restrictions on the reimbursable population beyond the licensed indication has the potential to significantly impact patient access and product revenues, especially if the G-BA decides to impose restrictions on all groups with no added benefit. While a higher price may be achievable for reimbursement restricted to patient sub-groups with stronger data, the price/ volume trade-off in some cases will not be revenue optimizing compared to unrestricted reimbursement for the licensed population at a lower price.
Although pharmaceutical companies will remain free to set initial prices, the time period in which they can do so will be shortened, and negotiated prices may be retroactively applied if sales exceed €250 million. Furthermore, the re-evaluation of pre-AMNOG drugs seeking new indications will likely limit the ability of companies to expand the labels of older products while maintaining the previously established price, creating additional risk for to revenue over the course lifecycle management. These proposed AMNOG changes in combination with the decision to extend the AM-VSG price moratorium until the end of 2022 are set to negatively impact revenue potential in the German market.
(c) MedTech Academy 2017
Prospitalia: 553 Critical Care Clinics including 136.190 Beds / Hospital Beds, 63 Clinic pharmacies, 771.000 listed products, more than 400 contracted suppliers. Turnover 2,2 Trillion Euro as a total of all 1200 Prospitalia members, which equals a turnover of 1,83 Billionen Euro per Prospitalia member.
SANA: 363 Akutkliniken, 60 Rehakliniken, 142 Senioreneinrichtungen, 616 Rahmenverträge. Umsatz 2,0 Mrd. Euro der insgesamt 560 Einrichtungen, das entspricht einem Umsatz pro Einrichtung von ca 3,63 Millionen Euro.
UNICO: 17.500 Betten, 4,4 Millionen Patienten, 12 Unikliniken. Hoher Investitionsanteil am Umsatz im Vergleich zu anderen EKGs. Umsatz 1,4 Mrd. Euro der insgesamt 12 Einrichtungen, das entspricht einem Umsatz pro Einrichtung von ca 116,7 Millionen Euro.
clinicpartner: 173 Akutkliniken, 222 Pflege- und sonstige Einrichtungen. Sonstige Einrichtungen der Mitglieder: 22 Mitgliedsapotheken, 56 Laborstandorte in Mitgliedseinrichtungen. Umsatz 1,3 Mrd. Euro der insgesamt 395 Einrichtungen, das entspricht einem Umsatz pro Einrichtung von ca 3,3 Millionen Euro.
AGKAMED: 170 Akutkliniken, über 40 Klinikapotheken, mehr als 100 Altenheime und 60 weitere Einrichtungen. Umsatz 1,1 Mrd. Euro der insgesamt 330 Einrichtungen, das entspricht einem Umsatz pro Einrichtung von ca 3,3 Millionen Euro.
GDEKK: Schwerpunkte öffentliche Kliniken. Umsatz 1,1 Mrd. Euro der insgesamt 75 Einrichtungen, das entspricht einem Umsatz pro Einrichtung von ca 14,7 Millionen Euro.
PEG: Umsatz 0,9 Mrd. Euro der insgesamt 2900 Einrichtungen, das entspricht einem Umsatz pro Einrichtung von ca 0,3 Millionen Euro. Zusätzlich umfassendes Beratung- und Fort- & Weiterbildungsangebot.
The ANVISA (Agência Nacional de Vigilância Sanitária) is responsible for the regulation of medical devices in Brazil. Brazil’s general regulations and schemes of medical device classification are comparable to those in the European MDD 93/42/EEC.
Medical devices which are subject to IEC 60601, will likely need to obtain an INMETRO certification (National Institute of Metrology, Standardization and Industrial Quality) through an authorized local certifier in Brazil.
(c) MedTech Academy 2017