Transcript Assessed only by SMC - Tolley Health Economics

Keith Tolley, Director, Tolley Health Economics Ltd
IDF Europe Symposium 30th September 2012
Tolley Health Economics Ltd
Strategic Consulting in Health Economics and Market Access
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Reimbursement policies for new drugs
 Consideration of the evidence on therapeutic
benefit vs similar drugs used in practice to
determine:
 Level of reimbursement.
 Price drug reimbursed at.
 May also contain consideration of cost-
effectiveness of new drugs:
 Added health benefits
 Resource savings
 (Incremental) cost of new drug
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Diabetes treatment pathway and costs
(as was until 5 years ago)
Schematic treatment pathway
OAD
monotherapy
Diet and
exercise
(in most countries
metformin)
OAD
combination
therapy 1
OAD
combination
therapy 2
(e.g. metformin
+
OAD)
(e.g. metformin
+
2 OADs)
Treatment cost per day in Euro (€):
Spain
Germany
USA
Insulin
therapy
€4.94
€3.85
€4.10
€3.47
€2.27 €2.25
€0.11 €0.29
Diet + exercise
€0.55
metformin
€0.28
€0.56 €0.72
metformin + SU
met + SU + TZD*
Source: SKP research. * Competact + generic SUs (Germany and USA) , Actos + gener. metformin + generic SUs (Spain)
** Including average price for two blood glucose test strips and 40 IU of Lantus
Insulin**
Emerging benefits in diabetes
Comparison of annual drug
costs in UK for licensed diabetes drugs
Drug
Class
Dose regimen
Cost
per
day (€)
Liraglutide
GLP-1
0.6mg to 1.8mg once daily by subcutaneous
injection
1.64 to 4.93
Exenatide prolonged
release
GLP-1
2mg once weekly by subcutaneous injection
3.29
Exenatide
GLP-1
5 micrograms to 10 micrograms twice daily
by subcutaneous injection
2.86
Linagliptin
DPP-4
5mg orally once daily
1.49
Dapagliflozin*
SGLT-2
10mg orally once daily
?
Sitagliptin
DPP-4
100mg orally once daily
1.49
Vildagliptin
DPP-4
50mg orally twice daily
1.42
Saxagliptin
DPP-4
5mg orally once daily
1.41
Pioglitazone
TZD
15mg to 45mg orally once daily
*not yet licensed in UK
0.74 to 1.10
UK reimbursement
 All new drugs for type 2 diabetes have been listed
for reimbursement by Department of Health
 However, new drugs and technologies, including
for diabetes, are assessed for clinical and costeffectiveness by:
 NICE (covering England and Wales)
 Scottish Medicines Consortium (covering Scotland)
 Guidance and recommendations issued are
intended to be followed by local health payers
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NICE clinical guidance number 87 in
Type 2 diabetes, May 2009
Treatment
line
Recommended treatment
Alternative treatment option if
primary drug not tolerated
1st line
• Metformin
• Sulphonylurea (SU)
2nd line
• Sulphonylurea (SU)
• TZD (add to met or SU) – if risk of
hypoglycaemia, preference for
Pioglitazone
• DPP-4 (add to met or SU) - if risk
of hypoglycaemia
3rd line
• NPH insulin or other insulin
• Pioglitazone add to met+SU
• DPP-4 (sitagliptin) add to
met+SU
• Exanetide (add to met+SU) if high
BMI >35, weight gain an issue with
insulin, and continue if 1%
reduction in HbA1c over 6 months
and 3% weight loss
4th line
• NPH insulin or other insulin
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Single appraisals of newer type 2
diabetes drugs (NICE and SMC)
Assessed by NICE and SMC
 Liraglutide (2010):
 Recommended by NICE in patients with high BMI, or where
weight loss would be beneficial
 Where weight loss is sustained as well as HbA1c reduction
 Only recommended in dual/triple therapy in restricted
circumstances: when met/SU and TZD/DPP-4 not tolerated,
and only the lower dose of 1.2mg daily.
 SMC restricted liraglutide to use as a third line agent as
economic case had not been made vs SU as dual therapy.
 Exenatide prolonged release (2012):
 Similar recommendations to liraglutide 1.2mg.
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Single appraisals of newer type 2
diabetes drugs (NICE and SMC)
Assessed only by SMC:
 Exenatide in combination with insulin (2012):
Recommended:

Assessment based on a comparison with insulin glargine
alone
 Linagliptin (2012): Recommended in combination
with metformin in patients for whom an SU is
inappropriate.

Comparator was sitagliptin, showing similar efficacy, lower
costs.
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Single appraisals of newer type 2
diabetes drugs (NICE and SMC)
Assessed only by SMC:
 Sitagliptin monotherapy (2010): Recommended when
metformin and SU contraindicated or not tolerated:

Comparator was TZD
 Saxagliptin (2010)– Recommended as add-on to
metformin when SU inappropriate:


Comparator was sitagliptin, showing similar efficacy, lower costs.
Recent non-recommendation in combination with insulin (2012)
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France
 As a chronic potentially life threatening condition
Type 2 diabetes drugs (typically) receive 100%
reimbursement.
 To determine price for reimbursement, new drugs are
given an ASMR rating (therapeutic benefit) vs current
therapies.
 Transparency Committee of the Haute Autorité de
Santé determine ASMR rating:
 Rating is I-V
 To attain a higher price classification require ASMR I-III
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ASMR (Amelioration du service
medical rendu) rating in France
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Transparency Committee
recommendations
 Liraglutide (2009)
 Compared with exenatide, it was considered there was a
small efficacy benefit and an advantage of once daily
administration
 Improvement in actual benefit - rating of IV: ‘minor
improvement in dual or triple therapy with met/SU.
 Insufficient for price premium over exenatide
 Saxagliptin (2009):
 Compared to sitaglitin, the TC considered no
improvement in actual benefit in dual therapy with met
or SU, hence received a V rating.
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Germany
 2011 Act for the Restructuring of the Pharmaceutical
Market in Statutory Health Insurance (AMNOG)
process of assessing therapeutic benefit of new drugs
 To support price negotiations or reference pricing
 Reimbursement pricing decisions made by G-BA, with
IQWiG performing appraisals of therapeutic benefit
according to rating scale:
 1=major benefit, 2= significant added benefit, 3=
slight benefit, 4=unquantifiable benefit, 5=no
added benefit, 6=less benefit than comparator
 An assessment of linagliptin performed by IQWiG in
2011 and published in 2012
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Comparisons assessed by IQWiG
Appropriate
comparator
therapy of the G-BA
Appropriate
comparator therapy of
the pharmaceutical
company
Monotherapy
Linagliptin
a sulfonylurea
Sitagliptin
Dual combination therapy
Linagliptin + metformin
a sulfonylurea+
metformin
Sitaglitin + metformin
Triple combination therapy
Linagliptin + a sulfonylurea +
metformin
Human insulin +
metformin
Sitagliptin + a
sulfonylurea + metformin
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IQWiG conclusion
 Considered their comparators to be the correct ones
 “Overall, there is no proof of added benefit from
linagliptin. Thus, there are also no patient groups for
which therapeutically relevant added benefit can be
deduced”.
 Rating of 5
 Linagliptin added to reference pricing not price
negotiation (needs a rating of 4 or above for this)
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Conclusions
 Type 2 diabetes drugs tend to be reimbursed, following an
assessment of therapeutic benefit, and (in some countries) costeffectiveness.
 Newer drugs reimbursement coverage tends to be restricted
 Submissions to reimbursement agencies have to present patient
relevant benefits:
e.g. Reduction in complications, reduction in weight in patients at higher
risk
 Increasing focus on price in countries previously considered free
pricing:
 Germany AMNOG law
 UK – Value Based Pricing on the way!
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