DISCREPANCY BETWEEN NATIONAL DRUG
FUNDING RECOMMENDATIONS AND LOCAL
UPTAKE IN THE SWEDISH INPATIENT SECTOR
McGee M, Izmirlieva M, Marinoni G, Ando G
OBJECTIVES
Since 2012, the Swedish Dental and Pharmaceutical
Benefits Agency (TLV) has carried out cost-effectiveness
assessments on behalf of the national New Drug
Therapies (NLT) group for new, high-cost, inpatient
pharmaceutical products without therapeutic
alternatives. The TLV issues mandatory recommendations
in the outpatient setting, and the new assessments
in the inpatient setting are being conducted under a
pilot project called Klinikläkemedelsprojektet. Upon
cost-effectiveness assessment by the TLV, the NTL
group issues non-legally binding national drug funding
recommendations for Sweden’s 21 County Councils,
which are themselves responsible for local inpatient
drug provision and their associated costs. The present
research identifies and analyzes the level of alignment
between the 2013 NLT group’s national funding
recommendations and the actual procurement practices
of the Stockholm Country Council´s (SLL) following
implementation of the Klinikläkemedelsprojektet.
Table 1.1: Discrepancies between NLT-group funding recommendations
versus SLL uptake
Recommended by the NLT group – not procured by the SLL
Brand
name
Manufacturer
Indication
cabazitaxel
Jevtana
Sanofi
For the
treatment
of hormonerefractory,
metastatic
prostate
cancer
patients
previously
treated with
docetaxel
SEK1.18 million
– SEK1.44
million
Fluenz
MedImmune
Prophylaxis of
influenza 2 to
18-year-old
children
SEK215,000
aflibercept
Zaltrap
Sanofi
For
combination
therapy with
irinotecan /
5-fluorouracil
/ folinic acid
chemotherapy
in metastatic
colorectal
cancer
patients
resistant to
or who have
progressed
after
oxaliplatin
treatment
Costminimisation
analysis
Active
autoantibodypositive
systemic lupus
erythematosus
(SLE)
SEK980,000
belimumab
Benlysta
GlaxoSmithKline
The SLL procured 3 out of the 11 NLT-group recommended
products (see Figure 1).
Figure 1: Summary of NLT group’s national funding opinions and SLL’s local
procurement activity
Roche
HER2-positive
metastatic
or locally
recurrent
unresectable
breast cancer
in patients
not previously
treated with
anti-HER2
therapy or
chemotherapy
SEK 2.565
million
collagenase
Clostridium
histolyticum
Xiapex
Swedish Orphan
Biovitrum
Dupuytren's
contracture
with a palpable
cord
Ca. SEK26,000
per treated
point
belatacept
Nulojix
Bristol-Myers
Squibb
Prophylaxis
of transplant
rejection in
combination
with
corticosteroids
and a
mycophenolic
acid
Cost of
treatment ca.
SEK140,000/
year
vemurafenib
Zelboraf
Roche
BRAF V600
mutationpositive
unresectable
or metastatic
melanoma
3
11
8
14
1*
3
The company
will offer
belimumab
below list price,
bringing the
estimated cost
per QALY at
SEK750,000
Perjeta
SLL
NLT
Cost per
treatment cycle
is SEK12,405
for aflibercept,
which is
SEK919 lower
than for
comparator
treatment
bevacizumab
pertuzumab
Results: 1 Combined decisions issued for new anticoagulants were not
included in this study
2
data retrieved from SLL’s Kloka listan 2014 and the full September 2014
procurement/price list (including 2013 amendments)
RESULTS
SEK860,000 to
SEK1 million for
some patients
reassortant
influenza
virus (live
attenuated)
METHODS
The NLT group issued 15 national funding
recommendations for inpatient drugs in 2013, of which 14
are included in this research1. The 14 recommendations,
which include 5 cancer drugs, 3 ophthalmology
treatments, and 6 products indicated for a variety of
diseases such as influenza and lupus, were compared
with the SLL’s 2014 procurement lists2. The selection
criteria for the year and region of interest were based
upon factors expected to enhance the reliability
and generalizability of the analysis. Indeed, 2013 is
the most recent full year of data in terms of funding
recommendations from the NLT group, while the SLL is
the largest council in the country. SLL’s decisions are also
highly influential beyond its specific council.
Cost per
QALY* /
Other healtheconomic
evaluations
INN
2
*QALY calculations based on list prices
NTL Recommended
NLT Not Recommended
SLL Procured
SLL Not Procured
*Lucentis’ retinal vein occlusion (RVO) indication gained national
recommendation while its diabetic macular edema (DME) indication was
rejected by the NLT group; the SLL did not disclose for which indication
Lucentis is procured.
The eight products not currently procured by the SLL
despite positive funding recommendations by the NLT
group were found to be cost effective by the latter even
though some exceeded the informal cost-effectiveness
threshold of ca. SEK800,000 per QALY3, with the notable
exception of pertuzumab (see table 1). In this case,
the NLT group noted that while pertuzumab’s list price
was initially “very high,” a deal was reached with the
manufacturer.
Qualitative interviews carried out by IHS in May 2014 found that payers in
Sweden apply an informal cost-effectiveness threshold of ca. SEK800,000
per QALY.
3
CONCLUSIONS
Since the NLT’s recommendations are not binding
and are in a pilot phase, it is not surprising there is a
significant discrepancy between the national funding
recommendations and local procurement decisions. It is
likely cost-effectiveness ratios come into consideration
alongside other factors, such as local healthcare needs.
While the Klinikläkemedelsprojektet is designed to
support local decision making, final uptake decisions
remain with the country councils. Consequently, NLTgroup funding recommendations or pricing deals at the
national level do not guarantee local market access, and
patient access to new innovative inpatient medicines
remain heterogeneous across Sweden. Further research
is needed to identify whether the present findings can be
extended to the other 20 Swedish county councils and
whether county council procurement patterns become
more aligned with the national recommendations in
the future, especially as the Swedish government is
considering turning the Klinikläkemedelsprojektet into a
permanent initiative.4
The Swedish Agency for Health and Care Services Analysis (Vårdanalys)—
Värdefullt men inte fullvärdigt
4
IHS LIFE SCIENCES
www.ihs.com/LifeSciences
Gustav.Ando@ihs.com
6799-0914JK
6799-0914JK