The German DiGA-Process- Update 2022

European Business Council Japan, 07.11.2022
Dr. Philipp Kircher

Former member of the hih

Warm greetings from myformer colleagues at hih andlast year's speakers at EBC!

Prof. Ariel Dora Stern

Jan Brönneke, LL.M.

Publications on DiGA

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Büro München
Thalkirchner Straße 56
80337 München
TEL: +49 (0)89 51 61 890 - 0
FAX: +49 (0)89 51 61 890 - 19
muenchen@gnd-law.de

Büro Berlin
Mommsenstraße 4510629 Berlin
TEL: +49 (0)30 52 67 369 - 0
FAX: +49 (0)30 52 67 369 - 9berlin@gnd-law.deShort Recap on DiGA

The DiGA Fast Track
2020

DVG
Draft bill
15.05.2019

DVG
Entry into
force
19.12.2019

2021

DiGAV
Coming intoforce
21.04.2020

Framework
contract
according to§ 134 Abs. 4
ans 5 SGB V
16.12.2021

First DiGA
listed06.10.2020

DiGA-Guidance
document
published
04.05.2020

2022

DVPMG
Entry intoforce
09.06.2021

First DiGA
delisted“Mika”
25.03.2022

Frist ruling on
prices byarbitration bodyon DiGA „somnio“
11.01.2022

Third DiGA
delisted“Rehappy”
26.09.2022

Second DiGA
delisted“M-sense Migräne”
04.04.2022

Fourth DiGA
delisted“ESYSTA”
04.10.2022

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Definition: Digital Health Application (DiGA)
Medical Device

Main function

Class I or IIa according toMDR and transitional periods(Class I and IIa MDD)

is essentially based on
digital technologies

PurposeSupport insured persons or
support the care provided byhealth care professionalDiGA§ 33a SGB V

Functionalities
Detection, (monitoring),treatment, alleviation,(compensation) of diseases,injuries or disabilities

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DiGA Directory by BfArM• List of all DiGA
• Indication / Contraindication• Evidence• Provisional / permanent listing• Information for service providers• Information for patients• Prices• Filter options• Open API / Interoperable Data
https://diga.bfarm.de/de8

The Fast Track according to DVG (1/2)
BfArM

Application of manufacturer

BfArM

Consulting(remunerated)

On registration in DiGA-registry
according to §139e SGB V

Examines and decides within 3months (net)General requirements
safety | quality | functionality |privacy | data security

Positive care effects
medical benefit | structural &procedural improvementsx?

✓✓

Listing in DiGA-registry

Preliminary listing &12 months trial period

The Fast Track according to DVG (2/2)
DiGAStandard Care

BfArM

Preliminary listing& trial period of
12 months

12-months trial in first
healthcare market

Decides on finallisting• Plausible
justification• Evaluation
concept byindependentscientificinstitution• Producer bears
costs

Manufacturer sets price
Preliminary reimbursementof physicians if applicable✓

Positive careeffects

Price negotiations withGKV-SV

Arbitration if negotiations
stuck after 1 year
Adaption of physician‘sreimbursement scheme ifapplicable

Prescription by physicians and psychotherapists
Permission by health insurance fund (with corresponding indication)

Experiences with theFast Trackhttps://www.bfarm.de/EN/Medical-devices/Tasks/DiGA-and-DiPA/Digital-Health-Applications/_node.html

Number of applications at BfArM

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https://www.bfarm.de/EN/Medical-devices/Tasks/DiGA-and-DiPA/Digital-Health-Applications/_node.html

Results of assessment by BfArM

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34 of 38 DiGA (28.10.2022)
Delisted

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DiGA market after two years
How is the new market developing?
From October 2020 to date, a total of 38 DiGAs have been listed under the fast track process.

Actual prices of the 38 DiGAs in chronological order of their listing in the DiGA Directory.

DiGA market after two years
How is the new market developing?
• The majority of DiGAs (>75%) make use of the trial rule (provisional listing).
• The period of one year is regularly not sufficient for proof of benefit.

(Initially) provisionally listed(initially) permanently listed

DiGA market after two years
How is the new market developing?
Success of the trial period can by no means be taken for granted ➔ 4 out of 8 DiGAs were not able toshow a positive care effect within the trial period.

(Initially) provisionally listed

Proof of a positive care effect successful
Proof of a positive care effect has not been provided

Delisting of „Mika“ and „M-Sense Migräne“"Evaluation decision of the BfArM
At the request of the manufacturer, the DiGA was deleted from the list pursuant to § 139eparagraph 6 sentence 9 of the Fifth Book of the Social Code (SGB V) in conjunction with § 19 of
the Digital Health Applications Ordinance (DiGAV)."18

Delisting of „Rehappy“"Evaluation decision of the BfArM
The DiGA was deleted from the list pursuant to § 139e paragraph 4 sentence 8 of the Fifth Book of theSocial Code (SGB V) after examination of the evidence of positive supply effects. No positive care effectcould be demonstrated for digital health applications."

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Delisting of „ESYSTA“"Evaluation decision of the BfArM
The DiGA was deleted from the list on 04.10.2022 in accordance with § 139e paragraph 4 sentence 8 ofthe Fifth Book of the Social Code (SGB V). For the digital health application in question, no positive careeffect could be demonstrated during the trial period."
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More fundamental issues
with the BfArMCan Human Components be a Part of a DiGA?
• How can a DiGA be distinguished from a personal
service provision?
• How can a DiGA be distinguished from telemedicine
and video consultations?
• BfArM has strict requirements to prevent the billing
rules for medical treatment from being infiltrated via
DiGA• Expert opinion on human components by GND• Originally for a specific DiGA manufacturer-> association wanted update to be generally usable.
• Distributed to all member companies• Discussed in BMG• Discussed in BfArM• Publication requested and planned
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Evidence Assessment – Subgroup Analyses in Retrospect• The BfArM increasingly asks for subsequent subgroup analyses, although the subgroups were
not prespecified for this purpose.
• Frequently, the results of the subgroup analysis are then not statistically significant. TheBfArM subsequently restricts the patient population accordingly.
• Subgroups formed by BfArM seem independent of the DiGAs medical claim and do notalways seem plausible:• Differentiation according to ICD-10 four-digit and more (without regard to collection function).
• Differentiation according to symptom status/duration not mapped in ICD-10 (e.g. acute, subacute,recurrent, chronic)• Differentiation according to previous experience with therapies, therapy aptitude, concomitant medication,
concomitant manual or personal therapy• Differentiation according to the use of support services of a DiGA
• Differentiation according to e-mail information of the users about the existence of a support conversation,
which itself is permissible in the opinion of the BfArM.
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What‘s new?

Latest Update of the DiGA-Guide• New section on Interoperability• New Section on the criteria for “plausible justification”
of a possible positive care effect• New supplementary notes on systematic data
evaluation

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Caution! English version of the DiGA-Guide is not up to date!

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Plausible justification of a possible positive care effect (trial period)
Section 139e (4) Sentence 3 SGB V:„(…) the manufacturer must include with the application a plausible justification of the contribution of the digital
health application to improving care (…).“
Section 14 DiGAV:„(…) the manufacturer must submit at least the results of a systematic data evaluation on the use of the digital healthapplication as plausible justification that a positive health care effect can be demonstrated in the course of a trial.“
Reasoning in the draft bill for the DiGAV:„The systematic evaluation of data obtained in the course of using the digital health application, which iscalled for here, serves to provide initial hints for this statement.”
DiGA Guide„Sufficient plausibility and robustness of the results according to the current state of science is expected.”(page 99)
„The systematic evaluation of data required here serves to provide initial plausible evidence for the improvement incare. The submitted data evaluation must plausibly show that it is highly probable that a positive effect can bedemonstrated within the framework of the trial study.” (page 153)
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Plausible justification of a possible positive care effect (trial period)

Quote from BfArMs decision (declining provisional listing):“In the present case, the change from baseline to three months is statistically borderline significant (p = 0.04),
but the patient relevance of the result appears questionable.““(...) so that no clear, sufficiently robust improvement is presented."

Even if a manufacturer presents data to show plausible justification in the application for a trial
period, and the data is already statistically significant, this does not guarantee a provisional listing.
BfArM demands a „clear, sufficiently robust improvement“ to be presented.

28Until now

Self-disclosure on over 120 aspect• Data protection (40 questions)• Data security (48 questions)• Interoperability (6 questions)• Robustness (4 questions)• Consumer protection (8 questions)• Ease of use and accessibility (3 questions)• Support for service providers (3 questions)• Quality of medical content (10 questions)• Patient Safety (6 questions)

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In the Future

New data protection test criteria as a basis for certificates• Agreement with BfDI and BSI?
• Pseudonymization as a new principle• No revealing of identity by e-mail or telephone!
• Verifiability of consent for minors?
• Review of billing?
• Post-Market-Surveillance?
• In-app purchases?
• Continuation of treatment?
• Data exchange with ePA and Co.?

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Pricing

Pricing – what is the ‘right’ price for a digital product?
Intended use (MDR)
ClaimFirst Year

After First Year

DiGA-Manufacturer sets pricefreely(Exception: ceiling amount)

Negotiated / RegulatedRemuneration

Quality of Evidence?
Proven effects?

§ 139 para. 4 SGB V –Framework agreement
Federal associations of GKV andDiGA-producers

Prices of self-payers?
Prices within EU?
Seite 32

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DiGA market after two years
How is the new market developing?
•Average (freely set) manufacturer price since start of supply is around 491 €.

•Permanent remuneration amounts show a significant reduction of the price level.

•Average relative price change after price negotiation/arbitration is -47%.

Initial prices

Remuneration priceIs the DiGA Fast Track reallythe best opportunity to enter theGerman health care market?

Thank you for your attention.
Munich Office
Thalkirchner Strasse 56
80337 Munich
PHONE: +49 (0)89 51 61 890 - 0
FAX: +49 (0)89 51 61 890 - 19
muenchen@gnd-law.de

Title | Name | Place/Date (edit by "Insert > Header and Footer")Office Berlin
Mommsenstrasse 45
10629 Berlin, Germany
PHONE: +49 (0)30 52 67 369 - 0
FAX: +49 (0)30 52 67 369 - 9berlin@gnd-law.de35

Questions?

Title | Name | Place/Date (edit by "Insert > Header and Footer")

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