USING PHARMACOECONOMIC ANALYSIS TO MAKE DRUG INSURANCE-COVERAGE DECISIONS

Our objective was to institute a cost-effectiveness-based reimbursemen t eligibility and coverage scheme for drugs in the Canadian province o f British Columbia. All applications from drug manufacturers requestin g Pharmacare (British Columbia government-funded drug insurance plan) coverage were evaluated by the Pharmacoeconomic Initiative (PI) of Bri tish Columbia. PI recommendations are according to a majority decision reached by a multidisciplinary volunteer expert committee and are bas ed. on a critical evaluation of pharmacoeconomic studies submitted by manufacturers seeking reimbursement eligibility. Coverage for drugs is universal and completely free for the financially indigent. Others ar e charged a small copayment and/or a deductible. PI assessments are ev idence-based. Published guidelines from the Canadian Coordinating Offi ce of Health Technology Assessment (CCOHTA) and/or Ontario Ministry of Health guidelines for the economic evaluation of pharmaceuticals are recommended for preparing submissions to the PI. Between January 1996 and December 1996, the PI made recommendations on 21 submissions; 4 of these were cost-effectiveness or cost-utility analyses; 3 were cost-m inimisation analyses; 6 were cost comparisons or cost-consequence anal yses; and 8 were provincial formulary budget impact studies. Of the 21 PI recommendations, 18 were accepted by Pharmacare and decisions are pending for 2 others, thus providing a concordance rate of 95% (18/19; kappa = 0.89). A total of 7 of the 21 products were recommended for f ormulary inclusion by the PI; 4 were as per drug company requests (i.e . full-benefit status) and 3 were recommended under restricted use. On ly 5 of 21 submissions, of which 4 had favourable reviews, complied wi th either the CCOHTA or the Ontario Ministry of Health guidelines. Mos t studies were conducted, not from a societal perspective, but from th e perspective of the provincial healthcare system. Most of the analyse s were short term and therefore discounting was not applied. Sensitivi ty analysis was not performed in more than half (52%) of the submissio ns, and 48% of applications used inappropriate comparators. Ontario is the only other Canadian province with a similar process, with cost-ef fectiveness criteria for reimbursement eligibility. However, analysis in that province during the same approximate time period demonstrated a low concordance between Ontario Drug Benefit and PI decisions (kappa = 0.07). Currently, the mandated or suggested use of technology asses sments of pharmaceuticals with cast effectiveness as the primary end-p oint is a reality in several countries worldwide. Our results, based o n actual experience from implementing such a programme, suggest that w hile industry is slow to adapt to the new reporting requirements it ma y also be sceptical about the importance of cost effectiveness and gui deline compliance in decision-making.