Savient's pharmacoeconomic data
Pharmacoeconomic modeling data, presented by US Pharmaceutical company Savient, predict net cost savings and lives saved per 1000 patients treated with the anabolic agent oxandrolone, with an approved indication for weight gain after weight loss, compared with megestrol acetate or placebo.
Pharmacoeconomic modeling data, presented by US Pharmaceutical company Savient, predict net cost savings and lives saved per 1000 patients treated with the anabolic agent oxandrolone, with an approved indication for weight gain after weight loss, compared with megestrol acetate or placebo.
The study was entitled: 'A Cost-effectiveness Model of the Economic Impact of Oxandrolone versus Megestrol Acetate or Placebo in Cancer Patients with Involuntary Weight Loss.'
Results of the cost-effectiveness model, comparing four months of treatment for each of the agents - drug plus hospitalisation plus long term care admission from hospital - demonstrated a cost savings of $3,076 for oxandrolone compared with the appetite stimulant megestrol acetate and $4,771 compared with placebo. Cost savings of megestrol compared with placebo was $1,695.
Cost savings accrued primarily from lower hospi-talisation costs. These were predicted at $8,727, $12,668 and $14,937 for oxandrolone, megestrol and placebo, respectively. Costs for long-term care admission from hospital followed a similar pattern but contributed less to the total cost analysis at $2,715 compared with $3,908 and $4,631, respectively.
The pharmacoeconomic modeling compared outcomes data from published clinical trials data1-5 of oxandrolone and megestrol acetate and published meta-analysis of megestrol placebo6. Body Mass Index (BMI) was the basis for comparison between studies. BMI, when it reaches critically low levels, has been demonstrated to be associated with increased risk for complication(s) and early death. The positive upward shift in BMI distribution from baseline to that calculated for four months of treatment was greatest in those treated with oxandrolone, least (or negative) in placebo treatment, and intermediate with megestrol.
In the pharmacoeconomic model, the differential rates of BMI improvement with treatment were used to infer or predict both cost savings and the numbers of lives saved per 1000 treated patients. Based on this model comparing treatment options, lives saved were estimated at 3.18 lives for oxandrolone versus megestrol, 4.72 lives for oxandrolone versus placebo, and 1.54 lives for megestrol versus placebo.
Changes in BMI were used to infer economic costs associated with hospitalisation, transfer to long term care facility and mortality for hospitalised patients with cancer, based on data from the government statistics.7, 8
'Pharmacoeconomic modeling is increasingly important in the decision-making process in healthcare,' said Dr. Hatoum. 'This type of modeling allows clinicians, insurers and other payers to consider effectiveness in the context of fiscal implications for the healthcare system that goes beyond the simple cost of drugs. Prevention of costly adverse outcomes such as hospitalisation or long term care placement needs to be considered in societal healthcare decisions,' she said.
Economic burden of cancer
The total yearly economic burden of cancer in the US exceeds $150bn9, with evidence that involuntary weight loss and malnutrition add significantly to risks of treatment complication and decreased survival.10
The financial costs of cancer treatment are a burden to people diagnosed with cancer, their families, and society as a whole. Based on 1990 data, the total economic burden of cancer in 1996 was an estimated $143.5bn. Cancer treatment accounted for about $41bn in 1995, the most recent year for which there is information. This was just under 5% of total US spending for medical treatment. In the 10 years from 1985 to 1995, the overall costs of treating cancer more than doubled.9
Involuntary weight loss, defined as unintentional and undesirable weight loss, is estimated to occur in 40-80% of patients with cancer, resulting in increased risk for hospitalisation, longer hospital stays, increased complications, requirement for treatment modifications due to toxicity, as well as decreased quality of life, and decreased survival. Involuntary weight loss is often inadequately addressed by the oncology community in the context of treating the underlying cancer.
'The use of pharmacoeconomic modeling and resulting data expand our understanding of the importance of stopping weight loss in patients with cancer as well as being able to predict the economic consequences of weight repletion after weight loss', commented Dr Hatoum. 'These data, combined with efficacy and safety data for any pharmacologic agent, are imperative aspects of decision making in attempts to control the growing economic burden of cancer care,' she said.
In contrast to appetite stimulants, which are associated with weight gain primarily as gain in fat, oxandrolone is associated with weight gain primarily with gain of lean tissue weight. While use of appetite stimulants such as megestrol acetate (Megace) has been associated with improved sense of well being in clinical trials, findings associated with weight gain in clinical studies with oxandrolone (Oxandrin) have included improved scores for global quality of life and performance status or functionality.
About Oxandrolone
Oxandrolone (Oxandrin 10mg or 2.5mg tablets) is a synthetic testosterone derivative, which has been associated with increased muscle protein synthesis and improved nitrogen balance. It is indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma and in some patients who without a known pathophysiologic cause, fail to gain or maintain normal weight. Oxandrolone is also indicated as an adjunctive therapy to offset protein catabolism associated with prolonged use of corticosteroids.