Thomas.
Agreed, the two terms are not identical. However, as best that I can tell, "fully substitutable" is a designation that is more financially consequential than medically or scientifically consequential. See below:
Background
Most countries promote the use of generic drugs, and several countries have introduced generic substitution in order to increase the use of generics [1-6]. Generic substitution has contributed to increased use of generic brands and to cutting the escalating costs in several countries [2,3,6]. Some studies have shown that physicians were reluctant to generic substitution policies [7-9]. There have been concerns that physicians might perceive it as a threat to their autonomy, and would thus oppose such policies. An Australian study reported that physicians more frequently switched therapy for patients using non-substitutable drugs than for patients using substitutable drugs, i.e. pharmaceutical products containing the same active ingredient with the same strength [5]. The study showed that therapy was changed in a small proportion of the patients. The authors of the study noted that possible explanations for the low frequency of switched therapy include a clear price signal for the investigated products contributed to cost-consciousness among prescribers and patients; and that prescribers were aware of the fact that problems following changed therapy [5].
In order to increase price competition for medically equivalent products where the patent had expired, Sweden introduced mandatory generic substitution on 1 October 2002 [10,11]. Prescriptions issued on or after 1 October 2002 were covered by the reform. Prescriptions are valid for one year in Sweden and thus the reform was fully implemented a year after the introduction. According to the Swedish Pharmaceutical Benefits Scheme, PBS, patients' expenses/co-payments for reimbursed medicines are accumulated during twelve-month periods, starting on the day of the first purchase. The patient co-payment corresponds to the price of the drugs within the scheme until the accumulated costs have reached a certain level and thereafter a decreasing proportion of the price until the high-cost threshold has been reached. After the high-cost threshold there is no co-payment for reimbursed pharmaceuticals during the rest of the period. The Swedish Medical Products Agency produces a list of products that are substitutable, based on the judgement that they are medically equivalent. To be considered as medically equivalent the products must contain the same active pharmacological substance, of the same strength and in a comparable package size. According to the law on generic substitution, pharmacy personnel are obliged to offer the patient the cheapest available substitutable drug according to the MPA's list, unless substitution is restricted [10]. Prescribers can restrict substitution for medical reasons by marking 'substitution not allowed' on the prescription. Substitution can also be restricted for other reasons: e.g. divided doses, such as divided tablets, potential reactions to non-active ingredients or differences in taste. The pharmacist makes this decision. If substitution is restricted by the physician or the pharmacist, the total cost of the prescribed drug is added to the patient's accumulated cost of drugs purchased within the PBS. The patient can oppose substitution and retain a more expensive product, given that he or she pays the price difference between the prescribed and cheapest (reimbursed) product out of pocket. In this case, the cost of the cheapest product is added to the patient's accumulated cost of reimbursed drugs if the patient has not yet reached the high-cost threshold. The price difference is paid out of pocket, irrespective of the patient's co-payment status.
The aim of the reform was to reduce costs for off-patent pharmaceuticals, through increased price competition, as well as substituting with cheaper equivalents. The introduction of generic substitution was followed by notable reductions in price for several top-selling products, which were highlighted in the media and elsewhere. These price cuts helped to curb the increase of overall pharmaceutical expenditure in Sweden after the introduction of generic substitution [12]. Parallel with the introduction of generic substitution, decentralisation of the responsibility for costs of pharmaceuticals within the PBS, from the government to the county councils, was in progress [13,14]. The decentralisation was initiated in 1998, continued in 2002 and fully implemented in January 2005. The responsibility of providing care to citizens lies with the county councils. County councils have had budget responsibility for inpatient drugs for many years. The aim of the shift of the budget responsibility was to integrate outpatient drug costs in the healthcare budget and make prescribers more cost-conscious. Today, this budget responsibility is handled at a central level in some county councils, whereas in some it has been decentralised to the care-unit level. The process has started a debate regarding cost issues of pharmaceuticals among physicians.
The introduction of generic substitution implied considerable changes in the prescribing process for prescribers and patients. The prescribers had to inform the patient that the pharmacy might substitute the prescribed drug with a cheaper equivalent and ensure that reports on performed substitutions sent by the pharmacies were documented in the patient records. The patients faced a new situation when asked to make decisions about substitution themselves; previously the prescribers had dealt with this. Investigating how the sales patterns of prescribed drugs have developed following the reform indicates whether the pattern of prescribing has changed since the reform was introduced. Earlier studies on effects of pharmaceutical reimbursement policies have shown differences between overall effects and effects in subgroups of the population. A previous study reported that although increased cost-sharing was not associated with negative effects on health status, decreased use of essential pharmaceuticals or hospital admissions on an overall level a negative impact on these outcomes was observed for particularly vulnerable groups such as the elderly and the poor [15-17]. Investigating how the sales patterns have developed in different age and gender groups could indicate whether the reform affected these groups differently.
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