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Table 1 Factors likely to influence future utilization and expenditure considered in the forecasting model.

From: Forecasting drug utilization and expenditure in a metropolitan health region

Factor

Estimated impact on expenditure

Comment

Decreasing expenditure

Patent expiries and the subsequent introduction of generics

50-90% decrease

In Sweden, since generic substitution was introduced in 2002, reimbursed prices for generics have been decreasing down to 10 to 20% of the price of the original brand within a year after patent expiry [10, 11]. Since it may take a year for the prices to decrease by 90%, we estimated expenditure for a drug on an annual basis to be reduced by 50% the first year after patent expiry. We have not applied the same estimates for biosimilars since these are not considered interchangeable and questions still remain about their clinical efficacy, safety, and immunogenicity [12].

Changes in prices and reimbursement status

0-20% decrease

All existing drugs are currently being reviewed by the Swedish Dental and Pharmaceutical Benefits Agency (TLV) (value-based pricing for existing drugs) [10]. Individual assessment was performed for each planned reimbursement review since the impact of them has been variable.

Increasing expenditure

Likely new drugs to be launched and new indications for existing drugs

0-x% increase

The potential impact on the healthcare budget was assessed based on estimates of likely/anticipated price for each new product, target patient populations and time for diffusion. Target populations were estimated based on the prevalence and/or incidence of the diseases and conditions or procedures for which each new medicine was likely to be prescribed. Data on the prevalence and incidence were collected from various published and unpublished sources including the Swedish National hospital discharge register, the National prescribed drug register, databases from the County Council, and published scientific studies [13].

Variable impact

New guidelines from national authorities or the regional DTC [11].

+/-5% annual change

Some guidelines were considered to increases in utilization, e.g. National Guidelines for diabetes suggesting stricter targets for HbA1c. Other guidelines were suggested to decrease utilization, e.g. regional guidelines for stricter management of infectious diseases. Overall, guidelines were predicted to have a limited impact during the first two years since prior studies have shown that guidelines are slowly adopted in the healthcare system [14].

Introduction of incentives and budgets for drug prescribing along with greater scrutiny of prescribing

+/-0

The regional budgetary model that had been applied for a number of years included voluntary financial incentives for primary care practices linked to the level of adherence to the DTC recommendations and local assessment of prescribing performance in a "prescribing quality report" [15]. A decision had been taken to allocate strict drug budgets for primary care in 2011. However, at the time when the forecasting was performed, it was not clear how it should be constructed. Budgets have also been introduced for ambulatory care prescribing from hospitals. These budgets are, however, only partly allocated and to certain drugs. Consequently, we have not predicted the change in budgeting system to have any impact on the overall trends for 2010-2011.

Major structural changes in healthcare provision, organization and reimbursement

0-3% annual increase

A number of structural changes were expected to take place during 2010-2011. A reform increasing patient access to primary healthcare was expected to increase the prescribing of antibiotics, analgesics and antiasthmatics by 3% while changes in access to community pharmacies (state monopoly for pharmacies replaced by new law opening up for private pharmacies) were not expected to influence net expenditure during 2010-2011.