P87 CCG biologics pathways: re-introduction of the postcode lottery by stealth
Authors: Mistry Jatin , Hill Diane , Kaul Arvind 
Published: April 2020

Abstract

Background
NICE guidance approves pathways for inflammatory arthritis biologic therapies. Locally, CCG's commission pathways based on their interpretation of NICE guidance. For patients to have equal access to biologics, CCG pathways in different areas must be uniform. We examined whether CCG biologics pathways complied with this standard.

Methods
Using Freedom of Information requests, direct requests and internet searches, we found 21 approved biologics pathways in England for rheumatoid arthritis, 12 for psoriatic arthritis and 11 for ankylosing spondylitis. This covered 22.8 million people in England for RA (2017 population estimates). CCG Pathways were compared to NICE guidance with respect to restrictions and number of therapies allowed before an Individual Funding Request (IFR) was needed.

Results
We studied NICE guidance and determined an 'ideal' pathway for patients requiring &gt; 1 biologic. All CCG pathways followed NICE guidance for 1st line biologics but there was significant variation for biologic failures. 18/21 CCG RA pathways indicated the maximum number of drugs that the CCG would commission without the clinician needing IFR. 7/18 allowed 1-3 biologics serially, 10/18 allowed 4-6 and 1/18 was unrestricted. Rituximab is NICE approved in RA in inadequate responders/intolerance to DMARDs/anti-TNF-α. 17/21 RA pathways allowed rituximab 1stline for haematological or treated solid malignancies, 4/21 did not. 6/21 CCG’s allowed rituximab 5 years after solid organ malignancy, 5/21 after 10 years, 10/21 did not specify or allow this usage. NICE guidelines for RA approve 11 biologics. 14/21 RA pathways allowed all 11 biologics, 7/21 pathways excluded sarilumab, tofacitinib or baricitinib or all three. NICE guidelines for PsA recommend the least expensive drug used first of the injected biologics or JAK inhibitors. IFR was required after 3 drugs in 9/12 pathways with 1/12 allowing 4 lines of therapy. For AS, 5/11 allowed 2 lines of therapy, the remainder 3 or 4 lines. Again, many pathways pre-specified which biologics could be used and excluded other NICE approved drugs at specific stages.

Conclusion
NICE specify the least expensive drug should be used for injected biologics with variation for administration mode/dosage. CCG’ s commission variably restrictive pathways potentially against NICE guidance, both with number and type of therapies before IFR submission is required. Some pathways allowed little scope to use therapies from earlier pathway points without breaching CCG limits. The IFR process for NICE approved therapies can exhibit wide variation in our experience with different outcomes for similar cases, and is time consuming with CCG decision making being opaque, despite NICE approval being legally enforceable. CCG biologic pathways introduce wide regional variation and potential unfairness in their interpretation of NICE guidance. This may disadvantage the worst affected patients who fail several therapies and prevent access to life changing therapy depending on geographical location.

Disclosures
J. Mistry None. D. Hill None. A. Kaul None.