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Sibutramine Hydrochloride

Not recommended EndocrinologyNot applicable line

Management of type 2 diabetics with obesity and abnormalities in high density lipoproteins (HDL) and triglycerides.

5
Submissions
3 resub
2006–08
On the record
$15k–75k
ICER range
5 sourced ICERs · 2006–2008
ICER stated
Cost basis

Decisions on record

3 decisions
  • Meeting Mar 2008 Not recommended Sibutramine is indicated for the management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. Sibutramine is recommended for obese patients with an initial body mass index greater than or equal to 30kg per square metre, o
  • Meeting Jul 2007 Not recommended The management of obesity, including weight loss and maintenance of weight loss; should be used in conjunction with a reduced calorie diet. no PSD
  • Meeting Nov 2006 Not recommended For the management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. Sibutramine is recommended for obese patients with an initial body mass index (BMI) greater than or equal to 30 kg per square metre or greater than or e no PSD

Access path

5 submissions · public record
  1. Mar 2006
    Not recommended

    uncertain long-term weight loss and model duration, high potential for use outside restriction, underestimated net…

  2. Mar 2006
    Not recommended

    doubts about extent of clinical benefit claimed, concerns about total cost to PBS ($30-60 million Year 3 estimated…

  3. Nov 2006
    Not recommended

    doubts about the extent and duration of clinical benefit, uncertain cost-effectiveness, high ICER when compared to…

  4. Nov 2006
    Not recommended

    doubts about the extent and duration of clinical benefit, uncertain cost-effectiveness, concerns about higher blood…

  5. ↻ resubmitted
    Mar 2008
    Recommended

    ICER rose $45,000 → $75,000 (+67%)

  6. PBS listing
RecommendedDeferredNot recommended

Cost-effectiveness

5 sourced ICERs · 2006–2008

ICER range dependent on UKPDS mortality factor assumption: $15,000–$45,000 when UKPDS mortality rate is halved (base case); $45,000–$75,000 when UKPDS mortality factor assumed zero.

The Committee noted that the structure of the economic model remained the same and a sensitivity analysis was conducted around the UKPDS mortality factor. The ICER per extra QALY gained was between $45,000 and $75,000 when the UKPDS mortality factor is assumed zero as compared to the base case ICER per extra QALY gained of between $15,000 and $45,000 when the UKPDS mortality rate is halved. PBAC · 2008
ICER uncertain ×2ICER / price too highEconomic model disputed ×2Surrogate endpoint

Decision context

PopulationType 2 diabetic adults between 18 and 65 years of age with obesity (BMI ≥30 kg/m²), who are normotensive or have adequately controlled hypertension (<145/90 mmHg), have not adequately responded to weight-reducing regimen alone, and have either triglycerides >150 mg/dL or HDL <50 mg/dL (females) or <40 mg/dL (males).

Why it was knocked back

  • no direct data on cardiovascular outcomes, weight loss may be counterbalanced by effects on blood pressure and pulse rate in terms of cardiovascular risk, lack of data on sustainability of weight loss over time, economic modelling hampered by limitations in predicting long term weight changes, fourfold increase in risk of tachycardia with sibutramine

Submission history

5 entries
DecidedOutcomeComparatorICEREvidence
Mar 2008 Recommended lifestyle modification (reduced calorie diet and/or exercise) $15k–75k Meta-analysis · Weight loss
Nov 2006 Not recommended standard medical management consisting of lifestyle modification (specifically, a reduced calorie diet and/or exercise) $45k–75k RCT, Meta-analysis · QoL, Weight loss
Nov 2006 Not recommended standard medical management consisting of lifestyle modification (reduced calorie diet and/or exercise) $15k–45k Meta-analysis
Mar 2006 Not recommended placebo for standard medical management (lifestyle modification; reduced calorie diet and/or exercise); also noted that $15k–45k RCT · weight loss
Mar 2006 Not recommended placebo for standard medical management (lifestyle modification including reduced calorie diet and/or exercise); surgica $15k–45k Meta-analysis

Similar precedents

By decision profile
Prucalopride63%Ezetimibe With Simvastatin63%Semaglutide63%Liraglutide61%Exenatide60%Ezetimibe60%Sunitinib Malate60%Rosiglitazone Maleate60%

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to type 2 diabetics with specific lipid abnormalities and age/BP criteria absent from TGA label.