Resolution

1. The following procedures shall be followed by public institutions of higher education in the resolution of transfer credit disputes involving lower-division courses: a. If an institution of higher education does not accept course credit earned by a student at another institution of higher education, the receiving institution shall give written notice to the student and to the sending institution that transfer of the course credit is denied. b. The two institutions and the student shall attempt to resolve the transfer of the course credit in accordance with Board rules and/ or guidelines. c. If the transfer dispute is not resolved to the satisfaction of the student or the sending institution within 45 days after the date the student received written notice of denial, the institution whose credit is denied for transfer shall notify the Commissioner of the denial.

An additional benefit is not proven b1.) Adult patients with moderate to severe active rheumatoid arthritis for whom initial therapy with biotechnology DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) is indicated; filgotinib as monotherapy Appropriate comparator therapy: bDMARDs or tsDMARDs (abatacept or adalimumab or baricitinib or certolizumab pegol or etanercept or golimumab or infliximab or sarilumab or tocilizumab or tofacitinib or upadacitinib) in combination with MTX; if necessary as monotherapy taking into account the respective authorisation status in case of MTX intolerance or unsuitability Extent and probability of the additional benefit of filgotinib as monotherapy compared to the appropriate comparator therapy: An additional benefit is not proven b2) Adult patients with moderate to severe active rheumatoid arthritis for whom initial therapy with biotechnology DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) is indicated; filgotinib in combination with MTX

Appropriate comparator therapy:
bDMARDs or tsDMARDs (abatacept or adalimumab or baricitinib or certolizumab pegol or etanercept or golimumab or infliximab or sarilumab or tocilizumab or tofacitinib or upadacitinib) in combination with MTX

Extent and probability of the additional benefit of filgotinib + MTX compared to adalimumab + MTX:
Hint for a minor additional benefit c1) Adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to, or have been intolerant to previous treatment with one or more bDMARDs and/or tsDMARDs; filgotinib monotherapy Appropriate comparator therapy: Change of bDMARD or tsDMARD therapy (abatacept or adalimumab or baricitinib or certolizumab pegol or etanercept or golimumab or infliximab or sarilumab or tocilizumab or tofacitinib or upadacitinib, in combination with MTX; if applicable. as monotherapy, taking into account the respective marketing authorisation status in the case of MTX intolerance or unsuitability; or in patients with severe rheumatoid arthritis, rituximab, taking into account the marketing authorisation status) depending on the previous therapy.

Extent and probability of the additional benefit of filgotinib as monotherapy compared to the appropriate comparator therapy:
An additional benefit is not proven c2) Adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to, or have been intolerant to previous treatment with one or more bDMARDs and/or tsDMARDs; filgotinib in combination with MTX

Appropriate comparator therapy:
Change of bDMARD or tsDMARD therapy (abatacept or adalimumab or baricitinib or certolizumab pegol or etanercept or golimumab or infliximab or sarilumab or tocilizumab or tofacitinib or upadacitinib, in combination with MTX; or in patients with severe rheumatoid arthritis, rituximab, taking into account the respective marketing authorisation status) depending on previous therapy. Extent and probability of the additional benefit of filgotinib + MTX compared to the appropriate comparator therapy: An additional benefit is not proven Study results according to endpoints: 2 a1) Adult patients with moderate to severe active rheumatoid arthritis who do not have poor prognostic factors 1 and who have had an inadequate response to, or were intolerant to previous treatment with a disease-modifying anti-rheumatic drugs (classical DMARDs, including methotrexate (MTX)); filgotinib monotherapy No data submitted.

Requirements for a quality-assured application
The requirements in the product information are to be taken into account. The European Medicines Agency (EMA) provides the contents of the product information (summary of product characteristics, SmPC) for Jyseleca (active ingredient: filgotinib) at the following publicly accessible link (last access: 06 January 2021): https://www.ema.europa.eu/documents/product-information/jyseleca-epar-product-information_de.pdf In accordance with the requirements of the European Medicines Agency (EMA) regarding additional risk minimisation measures, the pharmaceutical company must provide training material and a patient identification card. The training material for medical professionals includes instructions on how to manage the potential side effects associated with filgotinib, particularly severe and opportunistic infections including TB and herpes zoster and the risk for impaired spermatogenesis. The potential effect of filgotinib on sperm production and male fertility in humans is currently unknown. The reversibility of these potential effects is not known. The potential risk of decreased fertility or infertility should be discussed with male patients prior to initiation of treatment.
Therapy should be started by a doctor experienced in the diagnosis and treatment of rheumatoid arthritis.
The use of the drug must also be carefully weighed against established therapies against the background of a comparatively new mode of action and the associated still existing uncertainties in the risk profile.

Annual treatment costs:
Adult patients with moderate to severe active rheumatoid arthritis who do not have poor prognostic factors 1 and who have had an inadequate response to, or were intolerant to, previous treatment with a disease-modifying anti-rheumatic drugs (classical DMARDs, including methotrexate (MTX)); filgotinib monotherapy