Patient Survey & Comments Regarding Off-Label Drug Promotion
Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research...
-
Upload
sabina-collins -
Category
Documents
-
view
212 -
download
0
Transcript of Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research...
![Page 1: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/1.jpg)
Clarifying the Regulatory Framework of Off-Label UsageInstitute for International ResearchWashington, DCJuly 17, 2002
Reimbursement for Off-Label Uses
![Page 2: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/2.jpg)
Overview
Shifting gears from enforcement
What enables off-label reimbursement?
Reimbursement planning checklist
Additional information
![Page 3: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/3.jpg)
Shifting Gears from Enforcement to Reimbursement
Payer decisions are independent of FDA enforcement for same product
Unlike labeling and advertising, no legal limitations on off-label reimbursement But there are some helpful mandates
![Page 4: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/4.jpg)
What Enables Off-Label Reimbursement?
Use not matched to label Cost neutral Pressure from 6 Ps Published evidence Legal mandates Technology assessment
![Page 5: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/5.jpg)
Use Not Matched To Label
If there is no PA and the use is not “far off” enough to trigger software recognition E.g. SSRIs; oral antibiotics; some
cancer agents
![Page 6: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/6.jpg)
Cost Neutral
Off-label reimbursement is almost always an economic issue Even when couched in clinical terms
If off-label use is drug cost neutral, reimbursement typically happens
![Page 7: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/7.jpg)
Pressure From 6 Ps
Prescribers are the most influential Pharmacists influence formulary drugs Patient advocates affect decisions Plaintiffs trigger reconsideration Politicians occasionally impact payers Press coverage can help
![Page 8: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/8.jpg)
Published Evidence
Compendia First source for most payers AHFS DI USP DI
Peer-reviewed journals Influential with larger, national payers
![Page 9: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/9.jpg)
Legal Mandates
Medicare – cancer
Medicaid – all rebate drugs
State laws – primarily cancer, AIDS
![Page 10: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/10.jpg)
Medicare “Anticancer chemotherapeutic
regimen”
“Medically accepted indication” means that the off-label use Is included or approved for inclusion in
compendia, or Carrier determines based on “supportive
clinical evidence” in peer- reviewed pubs
![Page 11: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/11.jpg)
Medicaid
Rebate law requires coverage of off-label use if included or approved for inclusion in compendia
Not limited to cancer
No consideration of peer-reviewed pubs
![Page 12: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/12.jpg)
State Laws
39 states (1999)
Typically cancer or HIV/AIDS
N/A to ERISA regulated plans
![Page 13: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/13.jpg)
Off-Label Tech Assessments
All or nothing: Done once for product, rather than case-by-case
Tend to be clinically driven with cost undercurrent
E.g. - Medicare, BCBSA TEC
![Page 14: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/14.jpg)
Medicare Coverage Process
National coverage (or non-coverage) decision – binding on contractors
OR
Contractor (Carriers, FIs, DMERCS) decisions at local level
![Page 15: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/15.jpg)
National Process is Slow But Transparent
1. Request for coverage policy2. MCAC recommendation (sometimes)3. CAG staff decision4. Publication www.cms.hhs.gov/coverage
5. Reconsideration (?!) -- See Ocular Photodynamic Therapy With Verteporfin 4/12/00 – 3/28/02 on website
![Page 16: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/16.jpg)
Contractor Process Can Be Mysterious LMRPs are published www.lmrp.net
See e.g. Noridian Neupogen/Leukine Policy effective 6/01/02
But informal, equally conclusive decisions are not published Notice via claim denials
Contradictory outcomes for no apparent reason are common
![Page 17: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/17.jpg)
BCBSA TEC
Triggered by request from member plan
Advisory, not binding
Non-BCBS insurers subscribe
www.bcbs.com/healthprofessionals/tec.html
![Page 18: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/18.jpg)
Devices
Closer scrutiny than drugs
Mfgr should expect that: Routine claims processing will identify
unlabeled uses All will be rejected unless supported
by solid published data
![Page 19: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/19.jpg)
Reimbursement Planning Checklist Favored category (Ca; HIV/AIDS) Payer mix How far off (Dx; dose; route of
admin.) Treatment setting Prior authorized; case managed Formulary Cost – product, Rx budget, overall
![Page 21: Clarifying the Regulatory Framework of Off-Label Usage Institute for International Research Washington, DC July 17, 2002 Reimbursement for Off-Label Uses.](https://reader035.fdocuments.us/reader035/viewer/2022070401/56649f1e5503460f94c36725/html5/thumbnails/21.jpg)
1875 Eye St., N.W. - Suite 900
Washington, DC 20006 USA
202.785.3800
www.tag-associates.com