INSPIREINcreaSe PharmaceutIcal REporting

Pilot project to capture cancer medication data from hospitalsA public/non-profit/private partnership

October 2019

Contact

• Cancer registry of Norway• Project manager: Lena Holmström lena.holmstrom@kreftregisteret.no

• Media: Elisabeth Jakobsen elisabeth.jakobsen@kreftregisteret.no

• LMI (Pharmaceutical industry)• Contact: Monica Larsen monica.larsen@lmi.no

• Media: Espen Snipstad espen.snipstad@lmi.no

• INVEN2 (TTO: agreements and fincances)• Contact: Siri Kolle siri.kolle@inven2.com

• Media: Elisabeth Kirkeng Andersen e.k.andersen@inven2.com

INSPIRE: A collaboration project

• Collaboration agreement between• Cancer registry / Oslo university hospital• LMI (Pharmaceutical industry)

• Project specific agreements and funding• Nine pharmaceutical companies: AbbVie, BMS, Merck, MSD, Novartis, Pfizer, Roche,

Sanofi Genzyme og Takeda• Norwegian Cancer society

• Other collaborators• Regional health authorities – all four regions have members on the project board• Norwegian patient registry• Norwegian medicines agency• National procurement office for hospital supplies (Sykehusinnkjøp)• Health directorate

Cancer registry – short background

Cancer registry of Norway

• Population based health registry (est. 1952)• Regulation: Helseregisterloven / Kreftregisterforskriften

• Mandatory reporting

• No patient consent necessary

• Obligation to deliver data to others (application needed)

• Research• Causes of cancer, occupational exposure et.c.

• Screening• Breast cancer (mammography) and cervical cancer (PAP smear)

Clinical registries at the Cancer registry

• Childhood cancer

• Breast cancer

• Gyn. cancer (ovarian)

• Melanoma

• Lung cancer

• Lymphoma

• Prostate cancer

• Colorectal cancer

• (Oesophagus and ventricular cancer)

• We can follow each patient over time, from diagnostic work up, through treatments, «cure» or relapse(s), and death

• Purpose of clinical registries• To document adherence to clinical guidelines

• Publish results annually

• All clinical registries have their own advisory board • Active physicians: surgery, oncology, pathology,

radiology• Researchers• Registry advisor

PATHOLOGY

RADIATION THERAPY

DRUG THERAPY

DEATH

DIAGNOSTICSAND

SURGERY

NORWEGIAN PATIENT

REGISTRYDATA SOURCES

CANCER REGISTRY OF NORWAY

Data sources -Cancer registry ofNorway

The INSPIRE project

Cancer treatment and data availability, today

Surgery

• Complete data at CRN*

Radiation therapy

• Complete data at CRN*

Medication

• Incomplete or lacking

*CRN = Cancer

Registry ofNorway

Why do we need cancer medication data?

Kirurgi

Stråle-behandling

Medication

• Overview/statistics

• Who gets treated, with what drug(s), for whatcondition?

• Prognosis? Survival?

• Quality assesments

• Adherence to national guidelines?

• Regional or other differences?

• Research

• Who benefits from new cancer drugs and whodoesn’t?

INSPIRE: Project description

• Cancer medication treatment in hospitals (chemo, hormonal, immuno…)

• Data capture all cancers

• Analysis lung and breast cancer first

• Report results lung and breast cancer first

• Cancer registry of Norway manages the project

• Financed in collaboration with the pharmaceutical industry and the Cancer Society

• GOAL• Knowledge on cancer drug treatment

PILOT PROJECT

INSPIRE: Timeline 2019 - 2020

Phase 20191st Q

20192nd Q

20193rd Q

20194th Q

2020 1st Q

2020 2nd Q

2020 3rd Q

2020 4th Q

Planning

Delivery

Final delivery

Operation

INSPIRE: Data captureHealth netHospital Cancer registry

Data extraction

Encryption

File transfer service

Patient-specification /

list

Cancer registry

ICT systems for

medication

Data handling (automated

process)

CurationAnalysisResults

File up load

Curation (remove non-

cancer patients)

sFTP serverMedication file

Patient registry

Who may have recieved cancer medication?

Patient spec

Down load patient-

specification

Patient spec

File

INSPIRE: Cancer medication variables

Variables Comment

Patient Name, SSN

Regimen, name oftreatment/courseDate Date for each drug

ATC Drug identification code

Generic drug name Ex. Cisplatinum

Dosage and unit

Dose reduction/increase % 0 - 100%

Administration iv, sc, et.c.

• Each drug, every time, for all patients

• The Cancer registry canaccumulate• Length of treatment

• Course number

• Line of treatment (1st, 2nd)

• Changes in treatment

INSPIRE: Limitations

• Analysis on lung cancer and breast cancer treatment• Data curation is limited to one cancer diagnosis at a time

However

• Data capture will cover all cancer medications for all cancers

• Only hospitals that use cancer medication software• South east region, Western region and Middle region

• North region: No system in use

• No clinical assessments/evaluations • Side effects, reasons for changing treatment et.c.

INSPIRE: Why do data capture using database extraction?

• Time: Can be implemented quickly

• Simple: No, or few, changes in ICT systems

• Data already exists: The data is already in place in clinical practice

• Sought after: Will reduce manual reporting from physicians

• National infrastructure and a new registry for pharmaceuticals, are underway but will take time to implement

INSPIRE gives us

Surgery- Complete data

at CRN

Radiation therapy

- Complete data at CRN

Medication

- Complete data at CRN**

1) Knowledge on cancer drug treatment

2) Knowledge on the complete courses of treatment for all cancer patients

** Complete data for

participatinghospitals

INSPIRE: AmbitionsAmbitions Dependencies

All types of cancer • Cancers with clinical registries• Childhood, breast, gyn, melanoma, lymphoma, lung, prostate, colorectal

• Next step will be discussed fall 2019• Requires funding

National coverage • ICT systems for cancer medication treatment in place in all hospitals

Automatic reporting • National projects: Large and complex projects, lots of stake holders• Requires changes in hospital ICT systems

More biomarkers • Reported to the registry in the pathology reports, not a part of INSPIRE• Standardisation required (methods, reporting results; pos/neg, actual value,

above/below X….)• Structured reporting required (not manual registration)• Clinically relevant or everything? (Gene sequencing? Tumour sequencing?)

Private clinics • The reporting is mandatory, but we need a functional infrastructure (planned)

https://www.kreftregisteret.no/Forskning/Prosjekter/inspire2/