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BRISTOL-MYERS SQUIBB’s CAPOTEN REINSTATED ON MEDI-CAL FORMULARY

Executive Summary

BRISTOL-MYERS SQUIBB's CAPOTEN REINSTATED ON MEDI-CAL FORMULARY, effective Dec. 1, after five months & under prior authorization for California's 4.5 mil. Medicaid members, Bristol- Myers Squibb announced Nov. 4. The state agency decided to readmit Capoten (captopril) to its formulary after the angiotensin- converting enzyme inhibitor, already approved for treatment of hypertension and congestive heart failure, became the first drug in its class indicated for left ventricular dysfunction following a heart attack. Capoten was placed on prior authorization July 1 along with four other ACE inhibitors following Medi-Cal's review of the therapeutic category, the third category in which Medi-Cal sought to restrict the number of covered single-source outpatient drugs ("The Pink Sheet" April 12, p. 5). Based on a combination of price and therapeutic considerations, Medi-Cal retained on its formulary three ACE inhibitors - Hoechst Roussel's Altace, Ciba-Geigy's Lotensin and Merck's Vasotec -- for estimated one-year savings of $4.3 mil. on $36.8 mil. in spending. Medi-Cal and BMS resumed their negotiations about Capoten after FDA granted the drug supplemental approval Sept. 23 for improving survival and reducing the incidence of overt heart failure in clinically stable, post-myocardial infarction patients with left ventricular dysfunction ("The Pink Sheet" Oct. 4, T&G- 4). The reinstatement of Capoten on the formulary was required to be cost neutral, Medi-Cal said, and the agency had to be assured that it would achieve the same level of savings that it originally sought from the therapeutic category. Medi-Cal also has reinstated Warner-Lambert's Accupril (quinapril) on the formulary, effective Nov. 1, as a result of litigation brought by the company against the California department. The department determined that its contract required it to take the product back on its formulary, leaving only three ACE inhibitor products -- BMS' Monopril (fosinopril) and two comarketed lisinopril products, Merck's Prinivil and Zeneca's Zestril -- on prior authorization. Accupril became the third ACE inhibitor indicated for congestive heart failure Oct. 29 when FDA approved the product for expanded use as adjunctive therapy for the treatment of CHF. In addition to Capoten, Iisinopril and Vasotec (enalapril) are already approved for CHF. Medi-Cal recently has completed therapeutic category reviews of beta blockers, calcium channel blockers and antilipidemics. The results of the reviews are expected to be announced imminently. The state is seeking at least $18 mil. in savings from its therapeutic category reviews. Formulary changes from reviews of ulcer drugs and nonsteroidal anti-inflammatory drugs were implemented July 1.
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