tamoxifen

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6 PHARMACOECONOMICS -Amanda Cameron- When choosing which disease management programmes to fund, health maintenance organisations must consider both the needs of its membership and the realities of economic survival - what is good for patients is not necessarily good. for the bottom-line. In the case of breast cancer, a programme encouraging the use of the hormonal drug tamoxifen would provide clear benefits for women since the agent has been shown to reduce the risk of breast cancer by 49%. But what about the cost of such a programme? Researchers at the 4th Annual Disease Management Congress [Boston, Massachusetts, US; October 1999] presented data examining the cost of breast cancer in two managed-care populations and the impact of a breast cancer risk management programme. About 180000 new cases of breast cancer are diagnosed annually in the US and this number rises by 1-2% each year. The disease devastates the lives of women and burdens health maintenance organisations with high healthcare expenditures. Breast cancer burden for MCO At one fairly large mixed-member managed-care organisation (MCO), a retrospective claims database analysis showed that the average per-patient direct medical cost over a 5-year period was about $US20 000 higher for patients with breast cancer than without breast cancer ($US26 965 vs $US6237, respectively). * The difference was mainly due to higher costs for radiation, surgery and other medical services (including the cost of treating the adverse effects of tamoxifen). The analysis was conducted by Dr Kenneth McDonough, medical director of the Disease Management Group at AstraZeneca, US, using claims data for patients who were enrolled in the MCO for up to 5 years during the period 1993-1998. Focusing on 7090 patients whose cancer could be staged based on the claims data, Dr McDonough found that the average per-patient direct medical cost increased with breast cancer progression, from $US22 632 in stage I disease to $US37 044 in stage II disease, $US41 817 in stage III disease, and $US57 730 in stage IV disease. These values represented actual paid costs (not charges) over a 3-year period. Potential ROI Given that a diagnosis of breast cancer drives up the cost of healthcare, an MCO considering the implementation of a risk management programme would be interested in determining the potential return on investment (ROI) of such a programme. Dr McDonough performed a simple ROI analysis for the implementation of a breast cancer risk manage- ment programme encouraging the use of tamoxifen. Applying a breast cancer risk algorithm to the claims data for the 1.15 million women enrolled at the MCO, he found that 37250 (3.2%) were candidates for risk assessment based on healthcare claims data and 20050 (1.7%) were candidates for tamoxifen therapy.** Of the candidates for tamoxifen therapy, 8215 were aged 35 years and at high risk for developing breast cancer, 11 785 had estrogen receptor-positive breast cancer and another 50 had ductal carcinoma in situ. Assuming that 5650 (28%) ofthe 20 050 tamoxifen candidates received tamoxifen in the first year,t it was estimated that the annual average cost of therapy would be $US1.93 million and the annual Inpharma-27 Nov 1999 No. 1215 average medical savings due to treatment would be $US2.12 million. The net savings generated by tamoxifen therapy would therefore amount to SUS 190 ooo/year or a total of $US950 000 over 5 years. Dr McDonough concluded that 'this programme could be provided with pretty much of an exchange for the medicine cost versus the breast cancer savings', with the limitation that only $US950 000 would be available for administration of the programme over 5 years. So, if the programme cost $US950 000 over 5 years then it would not be cost saving, but would be cost neutral or have an additional cost. In this case, it would be up to the plan to decide the relative importance of a breast cancer programme over programmes for other diseases. BlueCross-BlueShield does 'the right thing' Tamoxifen ['Nolvadex'] - marketed by AstraZeneca- is widely used for the treatment of early and advanced breast cancer and was approved last year in the US for use in women at high risk for developing breast cancer. BlueCross-BlueShield of Minnesota (BCBS-MN) was so impressed with the reported clinical benefits of tamoxifen that it decided to implement a breast cancer management programme encouraging its use before performing a cost analysis, according to Dr Alan Heaton, senior director of Pharmacoeconomics & Outcomes Research for Prime Therapeutics, St. Paul, Minnesota, US. BCBS-MN took the following per- spective, said Dr Heaton: 'This is the right thing to do, now what's it going to cost?' BCBS-MN has a membership of approximately 1.5 million individuals. A retrospective claims database analysis identified 668 new cases of breast cancer for the year 1996. Direct medical costs for these patients (mean age 57 years) over the first 2-3 years after diagnosis totalled SUS 17.54 million, of which SUS 1.91 million (11 %) was attributable to the cost of pharmaceuticals. The cost of healthcare for breast cancer patients from the perspective of the MCO was equivalent to a per-patient cost of around $US26 255 over the 2- to 3-year period. Dr Heaton noted that * The cost was adjustedfor comorbidity differences between control and breast CXUlCer paJients. ** The algorithm was based on US Natinnal Cancer Institute risk assessment criteria. t The assumption that only 28% oftamoxifen therapy candidates would actually start treatment wiJhin the first year of the programme was based on the logistics of conJacting > 20 (XX) women, educating their physicians 10 discuss with them the benefits and risks of therapy. making a decision 10 start tamoxifen, medicaJion complionce concerns and the membership turnover rate wiJhin the hedJh plan. 1173-832419911215-00061$01.00° Adl. International LlmItecl1999. All right. reaerved

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Page 1: Tamoxifen

6 PHARMACOECONOMICS

-Amanda Cameron-

When choosing which disease management programmes to fund, health maintenance organisations must consider both the needs of its membership and the realities of economic survival - what is good for patients is not necessarily good. for the bottom-line. In the case of breast cancer, a programme encouraging the use of the hormonal drug tamoxifen would provide clear benefits for women since the agent has been shown to reduce the risk of breast cancer by 49%. But what about the cost of such a programme? Researchers at the 4th Annual Disease Management Congress [Boston, Massachusetts, US; October 1999] presented data examining the cost of breast cancer in two managed-care populations and the impact of a breast cancer risk management programme.

About 180000 new cases of breast cancer are diagnosed annually in the US and this number rises by 1-2% each year. The disease devastates the lives of women and burdens health maintenance organisations with high healthcare expenditures.

Breast cancer burden for MCO At one fairly large mixed-member managed-care

organisation (MCO), a retrospective claims database analysis showed that the average per-patient direct medical cost over a 5-year period was about $US20 000 higher for patients with breast cancer than without breast cancer ($US26 965 vs $US6237, respectively). * The difference was mainly due to higher costs for radiation, surgery and other medical services (including the cost of treating the adverse effects of tamoxifen).

The analysis was conducted by Dr Kenneth McDonough, medical director of the Disease Management Group at AstraZeneca, US, using claims data for patients who were enrolled in the MCO for up to 5 years during the period 1993-1998.

Focusing on 7090 patients whose cancer could be staged based on the claims data, Dr McDonough found that the average per-patient direct medical cost increased with breast cancer progression, from $US22 632 in stage I disease to $US37 044 in stage II disease, $US41 817 in stage III disease, and $US57 730 in stage IV disease. These values represented actual paid costs (not charges) over a 3-year period.

Potential ROI Given that a diagnosis of breast cancer drives up

the cost of healthcare, an MCO considering the implementation of a risk management programme would be interested in determining the potential return on investment (ROI) of such a programme.

Dr McDonough performed a simple ROI analysis for the implementation of a breast cancer risk manage­ment programme encouraging the use of tamoxifen. Applying a breast cancer risk algorithm to the claims data for the 1.15 million women enrolled at the MCO, he found that 37250 (3.2%) were candidates for risk assessment based on healthcare claims data and 20050 (1.7%) were candidates for tamoxifen therapy.** Of the candidates for tamoxifen therapy, 8215 were aged ~ 35 years and at high risk for developing breast cancer, 11 785 had estrogen receptor-positive breast cancer and another 50 had ductal carcinoma in situ.

Assuming that 5650 (28%) ofthe 20 050 tamoxifen candidates received tamoxifen in the first year,t it was estimated that the annual average cost of therapy would be $US1.93 million and the annual

Inpharma-27 Nov 1999 No. 1215

average medical savings due to treatment would be $US2.12 million. The net savings generated by tamoxifen therapy would therefore amount to SUS 190 ooo/year or a total of $US950 000 over 5 years.

Dr McDonough concluded that 'this programme could be provided with pretty much of an exchange for the medicine cost versus the breast cancer savings', with the limitation that only $US950 000 would be available for administration of the programme over 5 years. So, if the programme cost ~ $US950 000 over 5 years then it would not be cost saving, but would be cost neutral or have an additional cost. In this case, it would be up to the plan to decide the relative importance of a breast cancer programme over programmes for other diseases.

BlueCross-BlueShield does 'the right thing' Tamoxifen ['Nolvadex'] - marketed by AstraZeneca­

is widely used for the treatment of early and advanced breast cancer and was approved last year in the US for use in women at high risk for developing breast cancer.

BlueCross-BlueShield of Minnesota (BCBS-MN) was so impressed with the reported clinical benefits of tamoxifen that it decided to implement a breast cancer management programme encouraging its use before performing a cost analysis, according to Dr Alan Heaton, senior director of Pharmacoeconomics & Outcomes Research for Prime Therapeutics, St. Paul, Minnesota, US. BCBS-MN took the following per­spective, said Dr Heaton: 'This is the right thing to do, now what's it going to cost?'

BCBS-MN has a membership of approximately 1.5 million individuals. A retrospective claims database analysis identified 668 new cases of breast cancer for the year 1996. Direct medical costs for these patients (mean age 57 years) over the first 2-3 years after diagnosis totalled SUS 17.54 million, of which SUS 1.91 million (11 %) was attributable to the cost of pharmaceuticals. The cost of healthcare for breast cancer patients from the perspective of the MCO was equivalent to a per-patient cost of around $US26 255 over the 2- to 3-year period. Dr Heaton noted that

* The cost was adjustedfor comorbidity differences between control and breast CXUlCer paJients. ** The algorithm was based on US Natinnal Cancer Institute risk assessment criteria. t The assumption that only 28% oftamoxifen therapy candidates would actually start treatment wiJhin the first year of the programme was based on the logistics of conJacting > 20 (XX) women, educating their physicians 10 discuss with them the benefits and risks of therapy. making a decision 10 start tamoxifen, medicaJion complionce concerns and the membership turnover rate wiJhin the hedJh plan.

1173-832419911215-00061$01.00° Adl. International LlmItecl1999. All right. reaerved

Page 2: Tamoxifen

PHARMACOECONOMICS 7

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these costs could also be interpreted from an employer perspective, since they represent the money that actually changed hands between the health plan and the employer.

- Interestingly, healthcare costs for breast cancer patients were highest among women aged 30-40 and 75-85 years; breast cancer accounted for most of the costs in younger women whereas there was a signi­ficant contribution from comorbidity in the older group.

On a per-member per-month (PMPM) basis, breast cancer patients cost BCBS-MN $US841 each, compared with $US336 for patients with type 2 diabetes mellitus and $US166 for those with hypertension. The disease­specific contributions to these PMPM costs were $US462, $US226 and $US56, respectively.

The challenge of demand management The approval of tamoxifen for use in women at

high-risk for breast cancer presented BCBS-MN with the challenge of demand management. A programme was needed that could manage the demand from low­risk patients while ensuring that high-risk patients had the opportunity to discuss the possibility of appro­priate therapy. Dr Heaton described the MCO's response as looking very much like National Committee for Quality Assurance criteria in terms of patient identi­fication, programme implementation and outcomes measurement.

BCBS-MN identified patients suitable for the breast management programme through both claims analysis and patient self-report using newsletters, a web site, self-assessment mail-outs, and mammography centre­based education. The MCO then set about implementing its programme by sending out a provider newsletter, organising provider dinners, distributing a risk­assessment tool and hand-delivering specific patient­provider information.

Physicians were given a presentation outlining the risk factors for breast cancer, the risks and benefits of tamoxifen therapy and the results of the baseline claims analysis. They were shown how to use the risk-assessment tool, and were asked to calculate the 5-year and lifetime risk for patients aged ~ 35 years.

For non-high-risk patients (those with a 5-year risk score of < 1.67%), physicians were advised to continue with basic preventive measures: monthly breast self­examinations, periodic office examinations, regular mammograms, and annual reassessment of breast cancer risk. For high-risk patients (those with a 5-year risk of ~ 1.67%), they were advised to continue these preventive measures as well as discuss with patients the risks and benefits of tamoxifen, allowing patients to make an informed decision about their healthcare. Lastly, physicians were given a list of patients identi­fied as being at high risk, and were encouraged to evaluate these patients.

1173-8324199n215-0007/$Ol.aao Adlslnternetlonal Limited 1999. All rlghts ..... rved

Greater use of tamoxifen Dr Heaton described how BCBS-MN's breast

cancer programme has contributed to the improved use of tamoxifen in this managed-care population.

Of 932 958 women enrolled at BCBS-MN at base­line, 265 026 were aged ~ 35 years, 10744 had a family history of breast cancer and 10 596 had a personal history of the disease. Of 21 296 women identified as being at high risk for developing breast cancer, only 94 (0.004%) were receiving tamoxifen before programme implementation. By the end of 1998, about 2400 members were receiving tamoxifen, mostly for the secondary prevention of breast cancer. Since then, numbers have nearly doubled, with around 4200 members receiving tamoxifen. Dr Heaton commented that this increase is a result of greater use oftamoxifen for risk reduction as well as for secondary prevention of breast cancer.

An analysis of the economic, clinical and humanistic outcomes of the programme is underway, noted Dr Heaton. The cost of administering the programme has been estimated at $US84 OOO/year.

Will the managed-care market respond? Dr McDonough made the point that tamoxifen

therapy appears to have its maximum benefit at 5 years of treatment based on the most recent evidence. A breast cancer risk management programme would present a cost to an MCO for the first 5 years, but would begin to generate savings after reaching its breakeven point at 5 years.

'Many managed-care plans think that a breakeven point of 5 years is too long', said Dr McDonough. However, in more mature managed-care markets, such as Minnesota, MCOs appear to have a greater community focus and less of a focus on short-term economic gains.

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Inpharma- 27 Nov 1999 No. 1215